COMMISSION STAFF WORKING DOCUMENT IMPACT ASSESSMENT REPORT Accompanying the documents Proposal for a Regulation of the European Parliament and of the Council on the supplementary protection certificate for medicinal products (recast) and Proposal for a Regulation of the European Parliament and of the Council on the supplementary protection certificate for plant protection products (recast) and Proposal for a Regulation of the European Parliament and of the Council on the unitary supplementary protection certificate for medicinal products, and amending Regulation (EU) 2017/1001, Regulation (EC) No 1901/2006 as well as Regulation (EU) No 608/2013 and Proposal for a Regulation of the European Parliament and of the Council on the unitary supplementary protection certificate for plant protection products
Date: 2023-04-27
Institutions: Directorate-General for Internal Market, Industry, Entrepreneurship and SMEs, European Commission
Subjects: European patent, market approval, medicinal product, pharmaceutical legislation, plant health legislation, plant health product

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   EUROPEAN COMMISSION  Brussels, 27.4.2023  SWD(2023) 118 final  COMMISSION STAFF WORKING DOCUMENT  IMPACT ASSESSMENT REPORT  Accompanying the documents   Proposal for a Regulation of the European Parliament and of the Council on the supplementary protection certificate for medicinal products (recast)  and   Proposal for a Regulation of the European Parliament and of the Council on the supplementary protection certificate for plant protection products (recast)  and  Proposal for a Regulation of the European Parliament and of the Council on the unitary supplementary protection certificate for medicinal products, and amending Regulation (EU) 2017/1001, Regulation (EC) No 1901/2006 as well as Regulation (EU) No 608/2013  and  Proposal for a Regulation of the European Parliament and of the Council on the unitary supplementary protection certificate for plant protection products                      {COM(2023) 221 final} - {SEC(2023) 172 final} - {SWD(2023) 117 final} - {SWD(2023) 119 final}  
 
 
1. 

2. 

INTRODUCTION: POLITICAL AND LEGAL CONTEXT ................................................. 5 

PROBLEM DEFINITION ....................................................................................................... 7 

2.1.  Market context – pharmaceutical and agrochemical industries .................................... 7 
2.2.  SPC rules, market size and applications for SPC protection ........................................ 8 
2.3.  What are the problems? .............................................................................................. 12 
2.3.1.  Legal uncertainty and cumbersome monitoring of SPC protection ...................... 13 

2.3.2.  High cost and burden of seeking and maintaining SPC protection ....................... 14 

2.3.3.  Key elements affecting the problems and consequences that are out of the scope of 
this impact assessment ...................................................................................................... 16 

2.4.  What are the problem drivers? .................................................................................... 16 
2.4.1.  Divergent national practices on SPC ..................................................................... 16 

2.4.2.  Lack of transparency of SPC-related information ................................................. 20 

2.5.  Consequences ............................................................................................................. 21 
2.5.1.  EU less attractive for medicines and PPP development ........................................ 22 

2.5.2.  Hampered joint cross-country public procurement ............................................... 24 

2.6.  How likely is the problem to persist? ......................................................................... 25 

3.  WHY SHOULD THE EU ACT?........................................................................................... 26 

3.1.  Legal basis .................................................................................................................. 26 
3.2.  Subsidiarity: Necessity of EU action .......................................................................... 27 
3.3.  Subsidiarity: Added value of EU action ..................................................................... 27 

4.  OBJECTIVES: WHAT SHOULD BE ACHIEVED? ........................................................... 27 

4.1.  General objectives ...................................................................................................... 28 
4.2.  Specific objectives ...................................................................................................... 28 

5.  WHAT ARE THE AVAILABLE POLICY OPTIONS? ....................................................... 28 

5.1.  What is the baseline from which options are assessed? .............................................. 28 
5.2.  Description of the policy options ................................................................................ 28 
5.2.1.  PO1: Guidelines for the application of the current SPC regimes .......................... 28 

5.2.2.  PO2: Mutual recognition of national decisions ..................................................... 29 

5.2.3.  PO3:  Centralised  filing  and  examination  of  SPC  applications  resulting  in  a  non-
binding opinion ................................................................................................................. 30 

5.2.4.  PO4: Centralised filing and examination of SPC applications resulting in a binding 
opinion .............................................................................................................................. 32 

5.2.5.  PO5: A ‘unitary SPC’ complementing the unitary patent ..................................... 32 

5.3.  Overview of policy options ........................................................................................ 33 
5.4.  Options discarded at an early stage ............................................................................. 34 

6.  WHAT ARE THE IMPACTS OF THE POLICY OPTIONS? ............................................. 35 

6.1.  PO1: Guidelines on application of the current SPC regimes ...................................... 35 
6.2.  PO2: Mutual recognition of national decisions .......................................................... 37 
6.3.  PO3: Centralised filing and examination of SPC applications resulting in a non-

binding opinion ........................................................................................................... 39 

6.4.  PO4:  Centralised  filing  and  examination  of  SPC  applications  resulting  in 

a binding opinion ........................................................................................................ 45 

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6.5.  PO5: A ‘Unitary SPC’ complementing the unitary patent .......................................... 47 
6.6.  Common impacts ........................................................................................................ 50 
6.6.1.  Biosimilar and generic market entry ..................................................................... 50 

6.6.2.  Social impacts ....................................................................................................... 55 

6.6.3.  Digital impacts ...................................................................................................... 56 

6.6.4.  Environmental impacts .......................................................................................... 57 

7.  HOW DO THE OPTIONS COMPARE? .............................................................................. 57 

7.1.  Comparison of impacts ............................................................................................... 57 
7.2.  Best option and possible combinations of options to improve it further .................... 62 
7.3.  Coherence with other EU policies and the charter of fundamental rights .................. 63 
7.4.  Compliance with the proportionality principle ........................................................... 65 

8. 

PREFERRED OPTION ......................................................................................................... 65 

8.1.  REFIT (simplification and improved efficiency) ....................................................... 68 
8.2.  Application of the ‘one in, one out’ approach ............................................................ 68 

9.  HOW WILL ACTUAL IMPACTS BE MONITORED AND EVALUATED? .................... 68 

ANNEX 1: PROCEDURAL INFORMATION ............................................................................. 70 

1.  LEAD DG, DECIDE PLANNING/CWP REFERENCES .................................................... 70 

2.  ORGANISATION AND TIMING ........................................................................................ 70 

3.  CONSULTATION OF THE RSB ......................................................................................... 70 

4.  EVIDENCE, SOURCES AND QUALITY ........................................................................... 71 

ANNEX 2: STAKEHOLDER CONSULTATIONS ...................................................................... 72 

ANNEX 3: WHO IS AFFECTED AND HOW? ............................................................................ 82 

ANNEX 4: ANALYTICAL METHODS ....................................................................................... 84 

ANNEX 

5:  SUPPLEMENTARY  EVIDENCE  SUPPORTING  THE 

IMPACT 

ASSESSMENT...................................................................................................................... 88 

ANNEX 6: SME TEST ................................................................................................................ 137 

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Term/Acronym 

Basic patent 

Glossary 

Meaning/Definition 

(legal definition of Art. 1(c) of the SPC regulations) a patent which protects a 
product as such, a process to obtain a product or an application of a product, and 
which is designated by its holder for the purpose of the procedure for grant of a 
certificate 

Biosimilar (product) 

a biological medicine highly similar to another already approved biological 
medicine (i.e. the reference medicine) 

BoA 

CJEU 

EA 

EBE 

EEA 

EFPIA 

EFSA 

EMA 

Board of Appeal of the newly proposed examination authority  

Court of Justice of the European Union. 

The examination authority - the newly proposed authority that would be in charge of 
the examination of SPC applications  

European Biopharmaceutical Enterprises 

European Economic Area 

European Federation of Pharmaceutical Industries and Associations 

European Food Safety Authority 

European Medicines Agency 

Enhanced cooperation 
area 

The group of EU Member States that are part in the enhanced cooperation regarding 
unitary patent protection and that have ratified the UPC Agreement 

EPO 

EUIPO 

FDA 

European Patent Office 

European Union Intellectual Property Office 

U.S. Food and Drug Administration 

Follow-on manufacturer  Firm producing generics and/or biosimilar products 

Follow-on product 

Generic and/or biosimilar products 

FTE 

Full time equivalent – a unit of measure obtained by comparing an employee's 
average number of hours worked to the average number of hours of a full-time 
worker  

Generic (product) 

a medicine or plant protection product that is developed to be the same as the 
original product  that has already been authorised 

HERA 

European Health Emergency Preparedness and Response Authority 

IFAH-Europe 

International Federation for Animal Health 

INN 

IP 

MA 

MPI 

NACE  

International Non-proprietary Names 

Intellectual property 

Marketing authorisation 

Max Planck Institute for Innovation and Competition 

Statistical classification of economic activities in the European Community; NACE 
is the acronym for Nomenclature statistique des activités économiques dans la 
Communauté européenne 

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NPO 

National patent office(s) 

Originator or innovator  Company that was first to develop and produce a specific medicine 

PPP 

PTR 

RDP 

R&D 

SME 

SPC 

SPC evaluation 

Plant protection product 

Patent term restoration 

Regulatory data protection 

Research and development 

Small or medium-sized enterprise(s), as defined in Commission Recommendation 
2003/361 and its subsequent amendments 

Supplementary protection certificate  

European Commission, Commission Staff Working Document, Evaluation of the 
Regulation (EC) No 469/2009 of the European Parliament and of the Council 
concerning the supplementary protection certificate for medicinal products, and 
Regulation (EC) No 1610/96 of the European Parliament and of the Council 
concerning the creation of a supplementary protection certificate for plant protection 
products 

SPC manufacturing 
waiver 

Regulation (EU) 2019/933 amending Regulation (EC) No 469/2009 concerning the 
supplementary protection certificate for medicinal products - allows to start early 
export to non-EU countries or prepare pre-launch stockpiling in the EU 

SPC Regulations 

Regulations (EC) 469/2009 and 1610/96 

TRIPS 

UP-MS 

Agreement of the World Trade Organization (WTO) on Trade-Related Aspects of 
Intellectual Property Rights 

Member States of the unitary patent area – countries participating in the unitary 
patent system, i.e. having ratified the UPC Agreement (17 Member States, 
tentatively, at the time where the unitary patent system will be launched).  

UPC 

Unified Patent Court 

UPC Agreement or 
UPCA 

WHO 

WIPO 

Agreement on a Unified Patent Court  

World Health Organization 

World Intellectual Property Organization 

Country codes used in the text: 

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AL- Albania  
AT - Austria  
AU - Australia 
BE - Belgium 
BG - Bulgaria  
DE - Germany  
DK - Denmark 
CH - Switzerland  
CN – China 
CY - Cyprus  
CZ - Czechia 
EE – Estonia 
FI - Finland 
FR- France  
EL - Greece  
HR - Croatia  
HU - Hungary  
IE - Ireland  
IT - Italy 
JP – Japan 
KR - South Korea 
LV - Latvia  
LT - Lithuania  
LU - Luxembourg  
MC - Monaco  
MK - North Macedonia  
MT - Malta 
NL – Netherlands, the  
NO –Norway 
PL - Poland  
PT - Portugal  
RO - Romania  
RS - Serbia 
SK - Slovakia  
SI – Slovenia 
ES - Spain 
SE - Sweden  
SM – San Marino 
TR – Turkey 
UK - United Kingdom, the  
US – United States of 
America, the  

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1. 

INTRODUCTION: POLITICAL AND LEGAL CONTEXT 

Supplementary protection certificates (SPCs) are sui generis intellectual property (IP) rights that 
extend by up to five years1 the 20-year term of patents related to medicinal or plant protection 
products (PPP). They aim to offset the loss of effective patent protection due to the compulsory and 
lengthy testing required in the EU for the regulatory marketing authorisation of these products. The 
relevant EU legislation is Regulations (EC) 469/2009 and 1610/96, on SPCs for medicinal and plant 
protection products respectively. Between 25 and 81 SPC applications were filed annually per 
Member State and more than 26 000 national SPCs have been granted since 19932. The average 
duration of the SPC protection is estimated at 3.5 years3. 

The Commission’s Intellectual Property Action Plan4 of November 2020, building on the SPC 
evaluation5, highlighted the need to tackle the remaining fragmentation of the EU’s IP system, which 
leads to complex and costly procedures. The plan noted that, for medicinal products and PPPs, 
protection through SPCs is only available at national level. At the same time, there is a single 
procedure for granting European patents, as well as a single set of rules for obtaining marketing 
authorisations. In the same vein, the Pharmaceutical Strategy for Europe6 emphasised the 
importance of investments in R&D to provide for innovative medicines while stressing that the 
differences across Member States in the implementation of IP regimes, especially for SPCs, lead to 
duplications and inefficiencies, affecting the competitiveness of the pharmaceutical industry. Both 
the Council7 and the European Parliament8 have called on the Commission to fix these deficiencies. 

Of particular importance for this Impact Assessment is the unitary patent system, expected to enter 
into force in June 2023. It will allow for a single patent covering all participating Member States in a 
unitary manner9. However, but for the policy initiative in question, there would not be a 
corresponding unitary SPC to accompany (extend) it in a unitary manner.  

1 An additional 6-month period of protection is available, subject to specific conditions, for medicinal 
products for use in the paediatric population, as defined by Regulation (EC) 1901/2006. 
2 Data for 1993–2014 from Mejer, M. (2017) 25 years of SPC Protection for Medicinal Products in Europe: 
Insights and challenges, European Commission, DG GROW, p. 6. Data for 2015–2021 as in Figure 17 in 
Annex 5A. 
3 Copenhagen Economics, Study on the economic impact of supplementary protection certificates, 
pharmaceutical incentives and rewards in Europe, Publications Office of the European Union, Luxembourg, 
2018. 
4 European Commission, Commission communication – Making the most of the EU’s innovative potential: 
An intellectual property action plan to support the EU’s recovery and resilience, COM(2020)760 final , 
2020 (https://eur-lex.europa.eu/legal-content/EN/ALL/?uri=CELEX:52020DC0760). 
5 European Commission, Evaluation of EU Regulations 469/2009 and 1610/96 on supplementary protection 
certificates for medicinal and plant protection products, SWD(2020) 292 final 
(https://ec.europa.eu/docsroom/documents/43847). 
6 European Commission, Commission communication – Pharmaceutical Strategy for Europe, 
COM(2020)761 final, 2020 (https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:52020DC0761). 
7 Council of the European Union, Intellectual property policy and the revision of the industrial designs 
system in the Union, Council conclusions (10 November 2020), 12339/20 
(https://www.consilium.europa.eu/media/46671/st-12750-2020-init.pdf). 
8 European Parliament Committee on Legal Affairs, Report on an intellectual property action plan to 
support the EU’s recovery and resilience, 2021/2007(INI) 
(https://www.europarl.europa.eu/doceo/document/A-9-2021-0284_EN.html). 
9 The unitary patent (UP) is a legal title that will provide uniform protection across all participating 
countries on a one-stop-shop basis. At the time of writing this impact assessment, 17 Member States ere 
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The COVID-19 pandemic has underlined the importance of having a strong and balanced IP system to 
provide the necessary incentives to develop new treatments and vaccines to be accessible to 
patients. It has also further highlighted the need of transparent and easily accessible information on 
the status of IP rights, including SPCs, to facilitate potential collaborations, licensing and freedom-to-
operate analyses10. Patents and SPCs are key to support the EU in its efforts to build a European 
Health Union and other related initiatives such as the new European Health Emergency Preparedness 
and Response Authority (HERA)11, EU FAB12 and the Pharmaceutical Strategy for Europe. 

All these combined are behind the Commission’s efforts to simplify the EU SPC system, as well as 
improve its transparency and efficiency, including the possible creation of a unitary supplementary 
protection certificate to complement the unitary patent. This initiative was announced in the 
Commission Work Programme for 2022 (initiative number 16 under Annex II REFIT initiatives)13. 

This initiative runs in parallel with other ongoing Commission efforts in the field of health, with by far 
broader scope, and which aim at fostering innovation and availability of medicines. These may 
include introducing conditionality to the period of regulatory data/market protection for medicines14 
or revision of the current legislation on medicines for rare diseases and for paediatric use15. 

2.  PROBLEM DEFINITION 

2.1.  Market context – pharmaceutical and agrochemical industries 

The pharmaceutical industry (part of the EU Health ecosystem16) is of key importance for the EU’s 
economy. Pharmaceuticals and other medical non-durable goods accounted for around one sixth of 
total current health expenditure in EU-27 in 202117. This estimate excludes expenditure on 

expected to participate in the UP system. For updates and more information, see: 
https://ec.europa.eu/growth/industry/strategy/intellectual-property/patent-protection-eu/unitary-patent_en. 
10 Discussions in this regard have been taken to the World Intellectual Property Organisation (WIPO), 
where national/regional patent offices were invited to share information on their collaborations with 
publicly accessible databases of patent status information concerning medicines and vaccines, such as 
MedsPaL. See: WIPO, Standing Committee on the Law of Patents, 32nd session, SCP/32/7, 2020. 
11 European Commission, Commission Communication – HERA Incubator: Anticipating together the threat 
of COVID-19 variants, COM/2021/78, 2021. 
12 European Commission, ‘Questions and answers : HERA incubator – Anticipating together the threat of 
COVID-19 variants’, 2021 (https://ec.europa.eu/commission/presscorner/detail/en/qanda_21_642). 
13 European Commission, Annexes to Commission communication – Commission work programme 2022, 
COM(2021) 645 final, 2021, p. 9 (https://eur-lex.europa.eu/resource.html?uri=cellar%3A9fb5131e-30e9-
11ec-bd8e-01aa75ed71a1.0001.02/DOC_2&format=PDF#page=9). 
14 Data protection is a period of protection during which pre-clinical and clinical data and data from clinical 
trials handed in to the authorities by one company cannot be referenced by another company in their 
regulatory filings. For more explanations, see: Annex 5A. 
15 European Commission, Revision of the EU general pharmaceuticals legislation, Inception impact 
assessment, 2021 (https://ec.europa.eu/info/law/better-regulation/have-your-say/initiatives/12963-Revision-
of-the-EU-general-pharmaceuticals-legislation_en); and European Commission, Revision of the EU 
legislation on medicines for children and rare diseases, Inception impact assessment, 2020 
(https://ec.europa.eu/info/law/better-regulation/have-your-say/initiatives/12767-Medicines-for-children-
rare-diseases-updated-rules_en). 
16 European Commission, Commission communication – A new industrial strategy for Europe, 
COM(2020)102, 2020. 
17 OECD (2022), ‘Pharmaceutical spending’, indicator, doi: 10.1787/998febf6-en (accessed on 18.8.22). 
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pharmaceuticals consumed in hospitals and other health care settings, which typically accounts for 
20% on top of retail spending18. 

There are around 4 000 enterprises manufacturing basic pharmaceutical products and 
pharmaceutical preparations19 in EU-27 that generate turnover of EUR 334 billion yearly and employ 
626 thousand staff20. Firms active in the sector range from multinational firms to SMEs concentrating 
on certain niche markets. Producers can be divided into i) the developers of new pharmaceutical 
products (the originators); and ii) the follow-on manufacturers that develop biosimilar21 or generic 
medicines22 (once the IP and regulatory data protection have expired for the original medicines). 
Nonetheless, there are many cases where large pharmaceutical groups are active in both market 
segments. The generic and biosimilar industries association reports that its members employ 190 000 
direct employees in over 400 manufacturing and R&D sites in Europe, and invest up to 17% of its 
turnover in R&D23.  

The broadly understood European health industries spent roughly EUR 36.6 billion on innovation in 
2020 and recorded R&D intensity24 of around 12.1%, which was more than in any other industry25. In 
this regard, the role of SMEs in pharmaceutical innovation is significant, for example in such critical 
areas as the global preclinical antibacterial pipeline26. 

The innovative agrochemical industry is part of the EU agri-food ecosystem. As in the pharmaceutical 
sector, two strategic groups of producers may be distinguished: firms manufacturing new products 
based on their own R&D and producers of generic (‘follow-on’) pesticides. There are over 544 
enterprises active in this sector27 in the EU that altogether employed 27 600 persons and generated 
turnover of EUR 12.7 billion28. The annual industry expenditure on crop protection R&D worldwide 
more than doubled from USD 3.06 billion to USD 6.71 billion between 1995 and 201229. A study 

18 OECD (2021), Health at a Glance 2021: OECD indicators, OECD Publishing, Paris, 
https://doi.org/10.1787/ae3016b9-en, p. 236. 
19 Defined as division 21 of NACE Rev.2. – a very broad definition which in addition to medicinal active 
substances, includes also for example tests or diagnostic preparations, impregnated bandages, etc.  
20 Eurostat, Annual detailed enterprise statistics for industry (NACE Rev. 2, B-E), sbs_na_ind_r2 (last 
update: 18.5.22, extracted on: 5.06.22). 
21 A biosimilar is a biological medicine highly similar to another already approved biological medicine (i.e. 
the reference medicine). Source: European Medicines Agency, ‘Biosimilar medicines: Overview’, 2021 
(https://www.ema.europa.eu/en/human-regulatory/overview/biosimilar-medicines-overview). 
22 A generic medicine is a medicine that is developed to be the same as a medicine that has already been 
authorised. Source: European Medicines Agency, ‘Generic medicine’, 2021 
(https://www.ema.europa.eu/en/glossary/generic-medicine). 
23 Medicines for Europe, Communications Toolkit: Generic medicines group, 2016 
(https://medicinesforeurope.com/docs/20160518%20-%20Comms-Kit-Generic-Medicines.pdf). It should be 
noted that these numbers are not directly related to SPC as such. 
24 For an enterprise, R & D intensity is the ratio of a firm's R & D investment to its revenue (the percentage 
of revenue that is reinvested in R & D). Source: Eurostat, ‘Glossary: R & D intensity’, 2022 
(https://ec.europa.eu/eurostat/statistics-explained/index.php?title=Glossary:R_%26_D_intensity). 
25 European Commission, The 2021 EU Industrial R & D Investment Scoreboard, JRC/DG RTD, p. 12. 
26 See: Annex 6. 
27 Defined as NACE Rev.2: 20.2 Manufacture of pesticides and other agrochemical products. 
28 Eurostat, Annual detailed enterprise statistics for industry (NACE Rev. 2, B-E), sbs_na_ind_r2 (last 
update: 18.5.22, extracted on: 5.6.22). 
29Phillips McDougal, R&D trends for chemical crop protection products and the position of the European Market, ECPA, 2013. 

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conducted in 2018 stated that around 7%-10% of the sector’s revenue was devoted to research and 
development annually over the last 50 years30. 

The pharmaceutical and agrochemical sectors are global and highly competitive (see: Section 2.5.1). 
Finally, it is important to note that the pharmaceutical and agrochemical markets are among the 
most regulated, as placing products on the market requires complex and lengthy authorisations to 
ensure safe usage (see: Annex 5A). 

2.2.  SPC rules, market size and applications for SPC protection 

An SPC takes effect at the end of the term of a basic patent (20 years), and is granted for a term 
equal to the period which elapsed between the date on which the application for the basic patent 
was filed and the date of the first authorisation to place the product on the market in the EU (which 
often takes more than 10 years of development), reduced by five years. The term of an SPC cannot 
exceed 5 years. An additional 6-month extension of the SPC can be requested if a paediatric 
investigation plan has been concluded for the protected medicinal product31.  

SPC protection is available only for new patented active ingredients (“products”), while medicines 
based on new formulations (e.g. involving additional ingredients) or new uses of known products are 
usually not entitled to SPC protection. IPRs, including SPCs, run in parallel with the regulatory data 
protection32 provided by the EU pharmaceutical legislation for medicinal products33.  

Some products may not be eligible for SPC protection at all (if the marketing authorisation was 
granted quickly34), some may enjoy SPC protection having the full duration (5-year, or 5 ½ years with 
paediatric extension). The average duration of an SPC for medicinal products in the EU amounts to 
3.5 years35. 

The benefits of an SPC for its holder36 are significant. Since an SPC ‘confer[s] the same rights as 
conferred by the basic patent’37, the monopoly resulting from the basic (reference) patent is 
extended and enables its holder to prevent competitors from exploiting the invention 
(manufacturing the product, offering it for sale, storing it, etc.) in those Member States in which an 
SPC has been granted38. 

30Phillips McDougal, Evolution of the Crop Protection Industry since 1960, Phillips McDougall 
AgriService, 2018, p. 3. 
31 See: Article 13 of Regulation (EC) 469/2009 and Article 36 of Regulation (EC) No 1901/2006. 
32 Includes: data exclusivity (8 years), market protection (10 years) and market exclusivity for orphan 
medicinal products (additional 2 years). See: Annex 5A for more details. 
33 In certain cases the regulatory protection period extends beyond the term of a possible SPC, which 
implies that the latter would not be the decisive factor regarding generics entry. 
34 No later than 5 years after the filing of the patent application (cf. Article 13(1) of Regulation 469/2009). 
35 Copenhagen Economics, Study on the economic impact of supplementary protection certificates, 
pharmaceutical incentives and rewards in Europe, Publications Office of the European Union, Luxembourg, 
2018. 
36 The SPC holder usually also holds the reference patent, although other situations are possible – for 
instance where the patentee licenses the patent and the licensee invests in the clinical trials and obtains the 
marketing authorisation and the SPC. 
37 Cf. Article 5 of Regulation 469/2009 – subject to the SPC manufacturing waiver introduced by 
Regulation 933/2019 – and of Regulation 1610/96. 
38 Some further limitations may still apply to the patent rights, such as the Bolar exemption, which is also 
relevant to the SPC protection (i.e. it allows to conduct the testing required to obtain regulatory approval for 

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Market size and applications for SPC protection 

In the period 2014-2021 there were between 25 and 81 SPC applications filed annually with 
respective national patent offices of the individual EU Member States. The highest number of 
applications was filed in Germany (81 on average per year), followed by Italy and Spain (76) and 
France (75). SPCs were less frequently applied for in smaller jurisdictions, such as Croatia (32) and 
Malta (25). The total number of SPC applications filed in all Member States increased from about 500 
applications in 1993 (in then EU-12) to a total of 1 459 SPC applications filed in the EU-27 in 202139. 

Figure 1: Number of SPC applications filed – yearly average by country in 2014-2021 

Source: “Current trends in activity at the NPOs and at the EPO”, Administrative Council of the EPO (documents: CA/36/19, 
CA/31/18, CA/13/17, CA/9/16) and “Exchange of information on current trends in activity at the NPOs and at the EPO”, 
May 2022. Note: data missing for the following countries – 2014: BE, SE, 2015: SE.  

During 2014-2021 the European Commission40 issued 88 central marketing authorisations on average 
per year41. An SPC can be requested within six months after receiving such authorisation42. With up 
to 81 SPCs registered annually in Member States, and given that marketing authorisations of new 
active ingredients via national route are negligible43, we can assume that nearly all new medicines 
benefit from SPC protection in at least one country (estimated at 86% by an earlier study44).  

In terms of global composition, EU firms accounted for around one third of SPCs applied for in the 
largest (German) patent office in 2010-202145 whereas up to 19% of all SPC holders were SMEs46 – 

the generic/biosimilar during the patent/SPC protection period of the reference medicine). In addition, 
Regulation (EU) 2019/933 introduced two distinct limitations to the SPC protection in the form of a 
manufacturing waiver (allowing, during the SPC protection, generic and biosimilar companies’ production 
in the EU for export-only purposes to non-EU countries that do not provide for equivalent SPC protection) 
and a 6-month stockpiling waiver (allowing, during the last 6 months of SPC protection, generic and 
biosimilar companies’ production in the EU for storing purposes and entry in the EU market as of the date 
of expiry of the SPC). 
39 European Patent Office, Exchange of information on current trends in activity at the NPOs and at the 
EPO, 2022 (https://www.epo.org/about-us/governance/documentation/ac-documents.html). 
40 Companies apply for marketing authorisations at EMA, which concludes on the safety, quality and 
efficacy of the medicines. Marketing authorisations are granted by the European Commission. 
41The number includes marketing authorisations for human, veterinarian and plant protection products. The 
marketing authorisations issued to follow-on producers are excluded (see: Annex 5A).  
42 Article 7(1) of the SPC regulations. 
43 Max Planck Institute for Innovation and Competition, Study on the Options for a Unified SPC System in 
Europe, 2022, pp.71–72. 
44 Kyle, M., Economic Analysis of Supplementary Protection Certificates in Europe, MINES ParisTech 
(CERNA), PSL Research University and CEPR, 2017, pp. 18–⁠
45 Based on SPC data from German NPO covering years 2010–2021; the remaining shares of applications 
were: US – 39 %, CH – 12 %, JP – 8 %, UK – 5 % and 4 % from other countries (see: Annex 5A). 
46 After matching the German NPO data on SPC with the Orbis database, 8 % of SPC holders were 
classified by Orbis as small or medium-sized companies and did not belong to any corporate group. Another 

⁠19. 

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817676757272676665636159585858575755505050474545423225DEESITFRELNLPTBEATIEDKHUFIPLSEROLUCZSIBGSKCYEELTLVHRMT 
 
 
 
                                                                                                                                                                                     
such data can be a good proxy for the EU market as whole, given that SPCs are predominantly sought 
in the EU largest economy. The estimates based on German data are also aligned with the SMEs 
share among the holders of EU-centralised marketing authorisation, as in 2010-2012 they accounted 
for around 13% of all firms47. Nonetheless, SPCs are predominantly held by companies belonging to 
large corporate groups, with 16 of them holding half of all SPCs granted48. Universities or research 
institutes held roughly 7% of all SPC issued in DE in the period under scrutiny49.  

Additionally, SPCs are granted in an increasing number of Member States for a given product. Since 
their first entry into force in the 1990s up to 2014, SPCs were applied for in 20 countries on 
average50. In value terms, SPC protection increases the turnover generated from a given medicine, by 
around 13% over the period of 12.5 years from market launch of a medicine, which translates into 
around EUR 37 billion51 total gain across the Single Market. Finally, nearly eight times more SPCs are 
applied for and granted for medicinal products than for PPPs52. 

Different types of protections available 

SPCs and patents are not the only forms of protection available for pharmaceutical products or PPPs. 
Besides intellectual property rights, the regulations establishing the conditions under which 
medicines (or plant protection products) can be marketed offer data protection (exclusivity) based 
on the initial marketing authorisations. In case of medicinal products, a 10-year market protection is 
also foreseen. Once certain conditions are fulfilled53, such rights will result from the marketing 
authorisations (MA) and are referred to as regulatory data protection (RDP). Although marketing 
authorisations and SPCs have some features in common, they are distinct and separate, and have 
different policy objectives.  

First, they differ in their effect. Patents and SPCs allow their holders to prevent third parties from 
performing activities infringing these rights. On the contrary, market protection is the period of time 
within which a generic or biosimilar cannot be placed on the market, even if a marketing 
authorisation has already been granted. Data exclusivity concerns a period of time within which 
another application (e.g. from a generics maker) cannot rely on data (such as results of clinical trials) 
already submitted in support of the originator’s own marketing authorisation. Second, they pursue 
different objectives. SPCs protect patented medicines (or plant protection products) so as to 
incentivise innovation, i.e. the development of new products, by compensating for the years of 

11 % of SPC holders were not matched – as the Orbis database has better coverage with regards to large 
companies, it is more probable that the unmatched companies are SMEs (see: Annex 4).  
47 Lincker, H., Ziogas, C., Carr, M., Porta, N. and Eichler, H.-G., ‘Where do new medicines originate from 
in the EU?’, Nature Reviews Drug Discovery, Macmillan Publishers Limited, 2014, pp. 92–93. 
48 See:  Annex 5A for more details on the most frequent global ultimate owners of companies holding SPCs. 
49 Based on the same dataset as above (i.e. extracted from the German NPO). 
50 Mejer, M., 25 years of SPC protection for medicinal products in Europe: Insights and challenges, 
European Commission, DG GROW, 2017, p. 7. 
51 Based on a sample of 232 active pharmaceutical ingredients. Source: European Commission, Evaluation 
of EU Regulations 469/2009 and 1610/96 on supplementary protection certificates for medicinal and plant 
protection products, SWD(2020) 292 final, p. 38 (https://ec.europa.eu/docsroom/documents/43847). 
52 Based on replies from BE, DK, FR, DE, NL, PT and RO to questions Q20 and Q21 of the Allensbach 
survey conducted under the 2018 Study on the legal aspects of SPCs in Europe by the Max Planck Institute 
for Innovation and Competition. 
53 Concerning for example significant pre-clinical tests or clinical trials related to authorisation of a new 
active substance or new therapeutic indication for a well-established substance, provided that significant 
pre-clinical or clinical studies were carried out in relation to the new indication. 

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effective patent protection lost due to the regulatory authorisation procedures. On the other hand, 
RDPs intend to offer protection to the investment-intensive data generated for the regulatory 
authorities in order to demonstrate quality, safety and efficacy of a pharmaceutical product, ignoring 
such aspects as novelty or inventive steps, which characterise patents.  

The interactions between the two are presented in Figure 2, below – the figure assumes a basic 
scenario in which there was no paediatric extension of the SPC. It may be noted that the starting 
points of both protections are different: patent protection starts from the filing of the patent 
application, SPC protection starts from the expiry of the patent, while RDPs are triggered by the 
marketing authorisation. 

Figure 2: The effective protection period for medicinal products  

Source:  Copenhagen  Economics,  Study  on  the  economic  impact  of  supplementary  protection  certificates,  pharmaceutical 
incentives  and  rewards  in  Europe,  European  Commission,  Directorate  General  for  Internal  Market,  Industry, 
Entrepreneurship and SMEs, 2018, p.42. 

As shown in the previous figure, the effective protection for medicinal products depends on the 
development time and the duration of clinical trials, calculated from the patent filing date (the 
horizontal axis). If this “delay” from patent filing to marketing authorisation is shorter than five years, 
then the last protection to expire would be the patent, as no SPC will be granted54. If that delay is 
longer than 5 years, then the SPC steps in to allow for additional IP protection (i.e. 15 years in total – 
the vertical axis), until the delay reaches 10 years. Subsequently, if the delay took between 10 and 15 
years, the SPC protection would gradually decrease until the total protection time reaches 10 years 
(i.e. 5 years “left” from the patent and 5 years from the SPC). Finally, in cases where the delay lasted 
longer than 15 years, the RDP (8 years of data protection and 2 additional years of market 
protection) would be that last protection to expire. More details about the regulatory context of the 
current SPC rules, patent systems and marketing authorisations in the EU are provided in Annex 5B. 

54 See: to this extent Article 13 of Regulation (EC) 469/2009. 

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2.3.  What are the problems? 

This impact assessment draws from the evaluation55 of current SPC rules, which indicated a number 
of problems impacting the efficiency and effectiveness of the rules currently in force. The fact that 
SPCs are administered and managed at national level creates significant red tape and entails extra 
costs for businesses, which is especially challenging for SMEs. It also emerged that national 
procedures have resulted in different approaches and outcomes (nearly a quarter of SPC procedures 
concluded with contradictory outcomes56), undermining legal certainty and thus the proper 
functioning of the Single Market.  

In addition, national granting procedures, including transparency obligations, generate costs and 
administrative challenges for national administrations (especially for those with limited 
administrative capacity). Some national administrations do not make full use of digital solutions, and 
there is no EU-wide SPC database. This hampers innovation and the availability of new medicines and 
PPPs, as well as access to affordable generic products, due to the uncertainty faced by generics 
manufacturers. 

The findings from the SPC evaluation have been completed by more recent research carried out for 
this impact assessment. The key problems that have been identified in this context are: 1. Legal 
uncertainty about SPC status; 2. Cumbersome monitoring of SPCs; and 3. High cost and burden of 
seeking and maintaining SPC protection in the EU. Problem 3 mainly concerns the originators, 
Problem 2 is typical for the follow-on manufacturers (and to some extent other originators as well), 
while Problem 1 is common to both groups. 

These problems are caused by divergent national practices for application and grant of SPC as well as 
insufficient and patchy information on the SPC status in each EU country. They should be seen in a 
general context of pharmaceutical and PPP sector acting globally and with increasingly cross-border 
value chains. Additionally, the currently fragmented SPC system will stand at odds with the upcoming 
launch of the unitary patent. While pharmaceutical and PPP companies will have a one-stop-shop to 
obtain a unitary patent to cover all the countries participating in the unitary patent system, they will 
still need to apply separately in each Member State to extend their patent protection by an SPC. 
Quoting one Member State from the Commission expert Group on Industrial Property Policy: “In the 
case of supplementary protection certificates based on unitary patents, it is obvious that a uniform 
system for the grant of unitary protection certificates is required.” 

55 DG GROW, Evaluation of EU Regulations 469/2009 and 1610/96 on supplementary protection 
certificates for medicinal and plant protection products, SWD(2020) 292 final 
(https://ec.europa.eu/docsroom/documents/43847). 
56 Based on sample research around 26 % of SPC were granted in one Member State, but rejected or 
withdrawn in another. Source: Mejer, M., 25 years of SPC protection for medicinal products in Europe: 
Insights and challenges, European Commission, DG GROW, 2017, p. 13. 

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Figure 3: Problem tree – current settings of the SPC system in the EU 

Note:  problems  are  numbered,  as  this  is  how  they  are  sometimes  referred  to  in  the  following  sections  of  the  impact 
assessment. 

2.3.1.  Legal uncertainty and cumbersome monitoring of SPC protection 

Although common eligibility criteria are defined in the SPC Regulations (notably Articles 2 and 3)57, 
around one in four SPC applications covering the same product  resulted in divergent decisions in 
Member States58 (in respect of 740 products approved between 2004 and 2014 and referring to the 
same basic patent). Some Member States grant SPCs for a certain product while equivalent 
applications are refused in others, or granted with a different scope. This was corroborated by the 
public consultation results: fragmentation causes legal uncertainty because decisions on granting 
protection can conflict across Member States concerning the national SPCs of the same product. 

Divergent national SPC decisions stand in contrast to the simplicity and unitary nature of the 
upcoming unitary patents59. SPC users might be forced to rely on the current system of nationally 
granted SPCs to extend their unitary patents, not benefitting from certainty about maintaining the 
same scope of protection in the Member States where the unitary patent took effect. Moreover, 11 
(out of 71) originators responding to the Commission public consultation cast doubts on the 

57 Article 3: ‘(a) the product is protected by a basic patent in force; (b) a valid authorisation to place the 
product on the market as a medicinal product has been granted in accordance with Directive 2001/83/EC or 
Directive 2001/82/EC, as appropriate; (c) the product has not already been the subject of a certificate; (d) 
the authorisation referred to in point (b) is the first authorisation to place the product on the market as a 
medicinal product.’ 
58 Mejer, M., 25 years of SPC protection for medicinal products in Europe: Insights and challenges, 
European Commission, DG GROW, 2017, p. 13. 
59 Once the Unified Patent Court becomes operational, it will be able to handle litigation relating to SPCs as 
well, provided that these SPCs are based on a European patent (unitary or not) as basic patent. However, 
this would only apply to those Member States that have ratified the UPC Agreement. 

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possibility of granting national SPCs for a product covered by a unitary patent, positing that only 
additional legislation would allow for this.  

Follow-on producers often face difficulties to ascertain the status of SPC protection in due time. This 
may hamper the launch of their competing product (i.e. generic or biosimilar), or their participation 
in tenders for the purchase of medicines. (In this regard, it is worth recalling that SPCs tend to 
protect medicines with significant sales). Follow-on producers face high cost and significant burden in 
up to date monitoring SPC protection throughout the Single Market. This can be onerous, if some of 
the follow-on manufacturers may need to monitor up to 27 SPCs (on average 20) per each product 
and the information may be dispersed across various IT systems, formats and linguistic regimes. In 
practice, such lack of transparency makes it much more cumbersome to enter the generic/biosimilar 
market, especially for SMEs.  

Respondents to the 2017 Commission public consultation indicated that the information published 
by public authorities was not always comprehensive or up-to-date, and nearly all who had an opinion 
(i.e. 96% of follow-on producers - predominantly SMEs, around 80% of health professionals or 
patients and 70% of patent offices or lawyers) stated that access to private databases monitoring SPC 
status is very costly60. 

According to Medicines for Europe61, transparency of SPC granting procedures is of utmost 
importance as it guarantees possible third party observations or oppositions. The generic association 
also claims that lack of transparency and of harmonisation results in legal uncertainty62. 

Finally, difficult access to SPC information may also cause problems for EU based manufacturers of 
generic and biosimilar medicines when applying for the SPC manufacturing waiver63, as they need to 
establish the exact status of the exclusivity in a given jurisdiction. Thus, in order to start early export 
to non-EU countries or prepare pre-launch stockpiling in the EU, they need to monitor SPC protection 
in multiple Member States, which is especially relevant in presence of cross border value chains (e.g. 
logistics and outsourcing of production). 

2.3.2.  High cost and burden of seeking and maintaining SPC protection 

SPC users face excessive costs of seeking and maintaining SPC protection in the EU, as multiple 
parallel procedures64 before national patent offices (NPOs) are required to obtain SPC protection in 
the Single Market or part of it. While in any single Member State SPC protection was sought only for 
up to 81 products annually (2014-2021), SPC applications in the EU totalled around 1 550 annually. 
The need to seek multiple national SPCs for the same product (on average in 20 Member States) 

60 See: Annex 2. 
61 Medicines for Europe is an association representing European generic and biosimilar industry. According 
to its website the association members supply over 67% of all medicines in Europe. Source: 
https://www.medicinesforeurope.com/medicines-for-europe/  
62 Reply of the association of generics manufacturers, Medicines for Europe, to the public consultation 
question: ‘How well do the original objectives of the SPC regulations still correspond to the needs within 
the EU?’ 
63 SPC manufacturing waiver – Regulation (EU) 2019/933 amending Regulation (EC) No 469/2009 
concerning the supplementary protection certificate for medicinal products. 
64 SPC applications are currently filed at the national patent office of each EU Member State where 
protection is sought. Each national office carries out examination and takes the decision to grant protection 
for its territory based on the requirements of the SPC regulations.  

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results in unnecessary administrative burden (e.g. preparation of several SPC dossiers, including 
multiple translations of the application, exchanges with the national offices, payment of 
administrative fees to each NPO and engagement of in-house or external legal advisors, additional 
communications in case of re-examinations) and high maintenance fees for the prolongation of SPC 
rights, separately in each jurisdiction. This may result in heavy red tape, especially burdensome for 
innovative SMEs.  

Based on current65 average coverage (20 Member States) and duration (3.5 years), SPC protection of 
a given product would cost around EUR 98 50066 on average. In order to cover all 27 Member States 
for 5 years one should pay nearly EUR 192 000 in total (not including any fees charged by patent 
attorneys). 

If the granting of SPCs remained limited to the national routes, it would remain as burdensome as 
today for companies to obtain and maintain SPCs based on unitary patents. An SPC applied for and 
maintained for 3.5 years in the 17 unitary patent countries67 would cost around EUR 79 00068 (EUR 
117 000 for the entire period of 5 years). 

In comparison to the overall cost of medicine/PPP development the direct monetary cost of 
obtaining SPC is relatively minor (the median capitalized R&D investment to bring a new drug to 
market is estimated at USD 985.3 million and the mean investment at USD 1 335.9 million69). Three 
quarters of innovators said the SPC cost is always relatively low in comparison to sales, while only 4% 
(including the only SME that replied) considered it high70. It should be noted however that the 
administrative cost of applying to up to 27 NPOs with accompanying costs on hiring legal advice in 
each country and translating the documents represent lost/unproductive resources.  

As indicated earlier, one in five SPC applicants is an SME, for which these costs could be significant as 
SMEs have more limited financial resources, fewer in-house specialists, and limited geographical 
presence. They are also more likely to be a single invention companies that cannot easily 
compensate development cost of one medicine with a successful sales of another. Yet they face the 
same long authorisation process which reduces the effective time of patent protection as large firms. 
SMEs are key players in research on often neglected topics, like antibacterial substances (SMEs 
responsible for 81% of preclinical projects) or orphan medicines71 (42% of medicines developed by 

65 Based on information about application and maintenance fees available on the NPOs’ websites in the 
second quarter of 2022. The SPC evaluation estimated the cost (in terms of administrative fees) of 5 years 
of SPC protection covering all EU-27 countries at EUR 177 869 in 2016. 
66 Average between the lowest cost for an SPC lasting 3 years (EUR 68 274) and the highest cost for an 
SPC lasting 4 years (EUR 128 711), as provided in Annex 5B. 
67 At the time of writing this impact assessment, 17 Member States were expected to join the unitary patent 
system. 
68 Average cost between SPCs lasting 3 years (EUR 66 998) and 4 years (EUR 90 984) in UP Member 
States. 
69 Wouters, O.-J., McKee, M., Luyten, J., ‘Estimated research and development investment needed to bring 
a new medicine to market, 2009–2018’, JAMA, Vol. 323, No 9, 2020, pp. 844–853; or DiMasi, J. A., 
Grabowski, H. G., & Hansen, R. W., ‘Innovation in the pharmaceutical industry: New estimates of R&D 
costs’, Journal of health economics, Vol. 47, 2016, pp. 20–33. 
70 See: Annex 2. 
71 A medicine for the diagnosis, prevention or treatment of a life-threatening or chronically debilitating 
condition that is rare (affecting not more than five in 10 000 people in the European Union) or where the 
medicine is unlikely to generate sufficient profit to justify research and development costs. 

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SME according to EMA72). In this regard, only one patent office in the EU offered reduced 
administrative fees for SPCs to universities or SMEs73. This is further corroborated by the public 
consultation results. While only 13% of originators considered SPC registration procedures as 
complex, this view was held by around 40% of follow-on manufacturers (generally firms with thinner 
resources)74. 

2.3.3.  Key elements affecting the problems and consequences that are out of the scope of this 

impact assessment 

The following issues are significantly contributing to the identified consequences, but are outside the 
scope of this initiative which focuses on concerns connected to SPC. Medicinal products and PPP are 
subject to strict requirements to ensure the safety of their users. Before being placed on the market 
in the EU, medicinal products have to be assessed and the conclusion concerning their benefits 
versus their risks has to be favourable in terms of safety, quality and efficacy75. The EMA medicines 
marketing authorisation process76 involves, among others, clinical trials, inspections of medicines’ 
manufacturers and compliance with good clinical, manufacturing, distribution and pharmacovigilance 
practices. All these are essential to ensure safe usage, yet very demanding on producers (not only in 
terms of cost). Moreover, there are differences in pricing schemes for medicines across the EU 
countries, as well as worldwide, that affect the pharmaceutical market. The price controls and 
different reimbursement schemes for national or private health services affect sales of 
manufacturers and their decisions to invest77, as well as the prices and availability of medicines to 
patients. In the EU, Member States are responsible for setting and controlling the prices and 
reimbursement of medicines. Negotiations on pricing and reimbursement of novel medicines, or 
generics, are conducted irrespective of the status of any patent and SPC.  

In addition, SPCs are currently enforceable before national courts.78 For litigation enforcing an 
exclusive right in the EU, parties might face a cost of between EUR 40 000 and EUR 200 000 per 
jurisdiction79. 

72 Lincker, H., et al. (2014). 
73 Reply to the Commission’s survey on the transparency of the SPC system. 
74 Open public consultation (OPC): ‘How would you rate the degree of complexity of registration 
procedures for SPCs in the EU?’ A majority of both originators (72 %) and follow-on manufacturers (61 %) 
considered the registration complexity as reasonable. Based on around 50 replies in each group (see: 
Annex 2). 
75 European Commission, ‘Legal framework governing medical products for human use in the EU’, 2022 
(https://ec.europa.eu/health/medicinal-products/legal-framework-governing-medicinal-products-human-use-
eu_en) 
76 European Medicines Agency, ‘Marketing authorisation’, 2021 (https://www.ema.europa.eu/en/human-
regulatory/marketing-authorisation). 
77 ‘Today’s pricing policies promote a convergence of list prices at levels that are less affordable for lower-
income OECD countries […]. This practice encourages firms to launch drugs in countries where it can set a 
price freely at market entry or negotiate high prices. It also distorts the signals that the market sends about 
the value of new medicines.’ Source: OECD, Pharmaceutical Pricing Policies in a Global Market, 2008 
(https://www.oecd.org/els/health-systems/pharmaceutical-pricing-policy.htm). 
78 The Unified Patent Court will allow for centralised litigation of European patents within the EU for 
countries ratifying the UPC Agreement. 
79 Based on estimates for DE, FR and NL. Source: Cremers, K., Ernicke, M., Gaessler, F. et al., ‘Patent 
litigation in Europe’, European Journal of Law and Economics, Vol. 44, 2017, pp. 1–44. 

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2.4.  What are the problem drivers? 

The problem drivers form two key thematic blocks, namely “Divergent national practices on SPC” and 
“Lack of transparency”. Both are discussed below.  

2.4.1.  Divergent national practices on SPC  

Multiple procedures before NPOs are required to obtain SPC protection in the Single Market or part 
of it. EU NPOs’ divergent national practises concern:  

(1) The substantive examination of the SPC applications.  

Under Article 10(5) of Regulations 469/2009 and 1610/96, Member States may allow the NPOs to 
grant SPCs without verifying that the substantive conditions laid down in paragraphs (c) and (d) of 
Article 3 are met, i.e. that (c) the product has not already been the subject of a certificate, and (d) the 
marketing authorisation is the first authorisation to place the product on the market as a medicinal 
or plant-protection product. According to Max Planck Institute for Innovation and Competition80 – 
MPI (2018), NPOs of 15 Member States do not use the exemptions from verifying substantive criteria 
(CZ, DE, DK, FR, HR, HU, IE, IT, LT, LV, NL, PL, PT, SE, SK) while others do81. Moreover regarding 
requirement (d) three NPOs (DE, LV and IE) reported difficulties in applying it, especially when the 
first marketing authorisation had been issued by another Member State, while one (DK) conducts 
informal internet search only. In addition it adds further confusion as there were cases where 
examining Member States referred questions to the CJEU wishing to refuse an SPC, but they noted 
that the very same SPC had been granted elsewhere in the EU. The substantive conditions causing 
most problems have been the scope of the patent, but also difficulties to abide by the CJEU’s case 
law on determining which the first marketing authorisation in the EU is. 

(2) The opportunities of affected 3rd parties to get involved in the grant procedure. 

The SPC Regulations rule out opposition proceedings82. Nevertheless, one Member State (DK) 
introduced a possibility for any person to request administrative re-examination of SPCs.83 
Furthermore, most NPOs (at least 18 - AT, CZ, DE, DK, ES, FI, HR, HU, IE, IT, LU, LV, NL, PL, PT, RO, SE, 

80 Two studies by Max Planck Institute for Innovation and Competition are referred to in this impact 
assessment, namely: “Study on the Legal Aspects of Supplementary Protection Certificates in the EU”, 
2018) and “Study on the options for a united supplementary protection certificates (SPCs) system in 
Europe”, 2022. See: Annex 1.4. 
81 Some NPOs (especially with lower number of cases) may not have the administrative capacities when 
conducting substantive examination, and hence make use of this legal exemption. 
82 Opposition procedures enable third parties to challenge the granting of an IP right during the grant 
procedure (ex ante opposition procedure) or during a period of time subsequent to the granting of the IP 
right (ex post opposition procedure). The 2018 Max Planck Institute study contained an analysis of 
SPCs/patent term extension in several non-EU countries. Based on the study, neither of the systems 
provided for in the two big pharmaceutical markets of US and JP seem to have a true pre-grant opposition 
procedure. This is contrary to, for example, Australia or Israel, which (as set out in the study) do have 
opposition procedures. 
83 Pedersen, J. M. and Justesen, J. in Ridderbusch & von Uexküll (eds.), European SPCs Unravelled: A 
practitioner’s guide to supplementary protection certificates in Europe, 2021: ‘Further, it is important to 
note that, in Denmark, any person may file a request for administrative re-examination of SPCs with the 
DKPTO (BEK, Sections 78–81), based on the grounds in Article 15 of the SPC Regulation. As any person 
includes third parties, this means that a type of opposition procedure is essentially available in Denmark, 
regardless of Article 19(2) of the SPC Regulation, although the administrative re-examination is not 
formally considered an opposition procedure by the DKPTO.’ 

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SK,) allow the submission of third-party observations, although this is not formally allowed by at least 
two NPOs (EL, LT)84. 

(3) The duration of the grant procedure. 

Time from the filing of the SPC application to the final grant decision can take, for instance, from 17 
months in FR to 31 months in DE85. 

There are differences in the way NPOs process the SPCs applications. The percentage of applications 
pending over all SPC applications ranged from less than 10% in 8 Member States (CY, ES, IT, LU, MT, 
PT, SE, SI) to up to 50% in 7 NPOs (BE, BG, DE, FI, HU, PL, RO). This was due to differences in patent-
office procedures, such as waiting for decisions by national courts or proceedings of differing 
lengths86. 

Some stakeholders consulted as part of the MPI (2018) study confirmed that there were significant 
differences in the duration of examination87 (which can sometimes take more than a year), and 
expressed their wish for uniform timing and deadlines. Others have criticised the rules in some 
Member States that impose deadlines within the granting procedures. Both originators and generics 
companies highlighted the importance of a quick decision on a product’s eligibility for an SPC.  

(4) The outcome of the procedure.  

Rejections: globally, 80% of SPC applications were granted88. The ratio of rejections per Member 
State was quite divergent though, reflecting different approaches by NPOs. Five countries (CY, EE, FI, 
IT, LU) rejected fewer than 5% of applications while 6 NPOs (DK, ES, MT, NL, PL, SE) rejected more 
than 15%89.  

Geographical coverage: The outcome of the procedure, typically grant or refusal, can vary across 
NPOs, i.e. the same product can be granted SPC protection in some Member States and not in others. 
Based on sample research around 26% of SPC were granted in one Member State but rejected or 
withdrawn in another90. 

What is protected: Some patent offices describe the scope of the granted SPC in different terms, so 
the same product can have different scope of protection across the EU.  

84 See: Annex 5B. 
85 Median time calculated from all SPC applications in Germany and France filed between 1995 and 2005, 
which receive a grant decision. Source: MPI (2018), p. 103. 
86 Cabinet Alice de Pastors, ‘Latest news on medicinal product SPCs in Europe: Medicinal product SPCs 
filed from 1991 to 2013’, SPC News 28, 2014. 
87 Question 62 of the Allensbach survey to stakeholders. 
88 Data for 2004–2014. Source: Mejer, M., 25 years of SPC protection for medicinal products in Europe: 
Insights and challenges, European Commission, DG GROW, 2017, p. 13. 
89 Cabinet Alice de Pastors, ‘Latest news on medicinal product SPCs in Europe: Medicinal product SPCs 
filed from 1991 to 2013’, SPC News 28, 2014. 
90 Sample of 706 applications from 2004 to 2014. Source: Mejer, M., 25 years of SPC protection for 
medicinal products in Europe: Insights and challenges, European Commission, DG GROW, 2017, p. 13. 
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The case law regarding SPCs has evolved gradually over the years91. For instance, after the Neurim92 
judgement (issued in 2012 and reversed in 2020 by Santen93) it was possible to get multiple SPCs for 
the same product based on different marketing authorisations. Some NPOs interpreted it as 
applicable only to a situation when one SPC is sought for a product of veterinary use and another of 
human use. Others considered that it applies only to products for the same species (e.g. only 
veterinary or only human). The reversal in Santen clarified these divergences. Moreover, several 
cases have been referred regarding the protection of combination products94 and what would 
constitute a prior certificate. In Actavis I95 and II96, the CJEU held that once an SPC had been obtained 
for a mono product (a product which contains one active ingredient), no certificate based on a 
combination product could be obtained. Yet, it is still unclear as the two recent references to the 
CJEU97 concern (among others) the protection of combination products.  

Additionally, the CJEU judgement on Actavis I introduced a new requirement that the product must 
embody the “core inventive advance of the patent” (inventive-advance test) but it was unclear when 
this test should apply. The “core inventive advance” in the context of Article 3a was rejected by the 
court in Royalty Pharma Collection Trust98. Nevertheless, doubts remain, as a recent court referral 
(Teva, Case C-119-22) inquires, among others, about the core inventive advance in the context of 
Article 3c. In general, the two recent references further highlight that there is uncertainty on the side 
of the courts regarding the relationship between Article 3a and 3c99. All that shows that CJEU 
jurisprudence on SPC is still being developed, as new issues arise, thereby progressively clarifying the 
interpretation of the substance of the SPC Regulations and thus improving legal certainty. 

Duration of protection: Expiry date for as much as 80% of products based on the same basic patent is 
not homogenous across Member States. This is driven by differences in national examination and 
interpretations of marketing authorization date100. 

The stakeholders feedback concerning the outcome of the procedure has shown that around 80% of 
innovators and follow-on manufacturers (including 6 SMEs out of the 13 SMEs responding from the 

91 It must be noted that most of the referrals concerned Articles 1 – 3 of the SPC Regulations. This suggests 
that uncertainty in the application of the SPC Regulations concerns rules obtaining SPCs, instead of the 
extent of protection or rights conferred by the SPC. MPI (2022), p.81. 
92 Judgment of the Court of Justice of 19 July 2012, Neurim Pharmaceuticals (1991) Ltd v Comptroller-
General of Patents, C-130/11, ECLI:EU:C:2012:489.  
93 Judgment of the Court of Justice of 9 July 2020, Santen SAS v Directeur général de l’Institut national de 
la propriété industrielle, C-673/18, ECLI:EU:C:2020:531). 
94 See: Article 1(b) of Regulation 469/2009: ‘product’ means the active ingredient or combination of active 
ingredients of a medicinal product. 
95 Judgment of the Court of Justice of 12 December 2013, Actavis Group PTC EHF and Actavis UK Ltd v 
Sanofi, C‑443/12, ECLI:EU:C:2013:833. 
96 Judgment of the Court of Justice of 12 March 2015, Actavis Group PTC EHF and Actavis UK Ltd v 
Boehringer Ingelheim Pharma GmbH & Co. KG, C-577/13, ECLI: EU:C:2015:165. 
97 Request for a preliminary ruling from the Markkinaoikeus (Finland) lodged on 17 February 2022, Teva 
B.V. and Teva Finland Oy v Merck Sharp & Dohme Corp., C-119/22; 
Reference for a preliminary ruling from the Supreme Court (Ireland) made on 2 March 2022, Merck Sharp 
& Dohme Corp v Clonmel Healthcare Limited, Case C-149/22. 
98 Judgment of the Court of Justice of 30 April 2020, Royalty Pharma Collection Trust v Deutsches Patent- 
und Markenamt, C-650/17, ECLI:EU:C:2020:327, paragraphs 30–32. 
99 In particular, the MPI (2022) study highlights that not all the issue around Article 3a have been solved by 
recent cases. 
100 Mejer, M., 25 years of SPC protection for medicinal products in Europe: Insights and challenges, 
European Commission, DG GROW, 2017, p. 12. 

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generics sector), as well as nearly all patent offices, judges and lawyers (96%) responding to the 
Commission consultation, confirmed that authorities in different EU countries had taken different 
decisions (e.g. some authorities might grant a SPC while others refuse it for the same product) on SPC 
applications impacting at least one of their products. Only around 20% of producers reported that 
this had not happened to them 101. 

In the Allensbach survey102, 62% of the respondents (48% of originator respondents and 83% of the 
generic producer respondents) agreed or strongly agreed that the examining practice and procedures 
of the NPOs differed significantly in the predictability, transparency and quality of the rights granted 
(26% of the respondents disagreed). The MPI (2022) study highlights the complexity of the system as 
the main reason for the divergent granting practices at a national level, including lack of uniformity 
both in the length and outcome of the examination103. This in turn results in cross-country 
differences in the way SPC applications are handled104.  

To conclude, as signalled earlier in the problem tree, the increasing complexity of the SPC 
examination process make it more difficult for NPOs to deal with it in a coherent manner. In turn, EU 
NPOs’ divergent national practises are the source of legal uncertainty (problem 1) and generate high 
cost of applying and maintaining SPC protection in the EU (problem 3). As they are in line with the 
SPC regulations these problems cannot be solved by Commission launching infringement actions 
against these Member States. 

2.4.2.  Lack of transparency of SPC-related information  

When it comes to transparency of SPC proceedings as such, Member States’ national patent offices 
follow uncoordinated and different practices (e.g. content of the application, public accessibility, 
updates of SPC data bases – to the extent these exist and the status of the granted/refused SPCs). A 
study conducted in 2018 by Technopolis105 concluded that “Whilst most [of SPC-related] information 
is in the public domain, registers are not well linked or easy to navigate without expert knowledge” 
and recommended to “Improve clarity and ease of use of EU and national data registers on 
protections and exclusivities for pharmaceutical products”. 

Additionally a survey of NPOs in 2020 found that publication of information can take from a couple of 
days to several months or even more than a year. Only 14 NPOs publish information in English in 

101 Question 11 to innovators (out of 49 answers) and 4 to follow-on manufacturers (out of 43 answers). 
102 Max Planck Institute for Innovation and Competition, Study on the Legal Aspects of Supplementary 
Protection Certificates in the EU, Annex III: Allensbach survey, 2018 
(https://ec.europa.eu/docsroom/documents/29524). 
103 MPI (2022), p. 75.  
104 „One stakeholder has divided the NPOs into three groups: a group […] which follows strict deadlines 
and examines the application in depth; a group which usually waits for official actions from other offices; 
and a third group of NPOs which very easily grants the certificates with a low intensity examination of the 
substantive requirements.” Source: MPI (2022), p. 75. The differences in procedural approaches are also 
confirmed by data on the procedural outcomes, see Table 5.5 of the MPI (2022) study.  
105 Technopolis, “Effects of supplementary protection mechanisms for pharmaceutical products”, 2018 
(https://www.technopolis-group.com/report/effects-of-supplementary-protection-mechanisms-for-
pharmaceutical-products/). 

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addition to official language of the country, which could especially cumbersome for SMEs. About half 
of NPOs do not provide online access to SPC application documents106.  

In practice, the above translates into limited transparency about the state of play, and outcome of 
the SPC procedures across the EU. If available at all, the information is provided via national websites 
in multiple formats - from structured databases that are available for download, to selected 
documents in pdf format, which is cumbersome for processing. Difficulties in accessing such service 
can affect around 300 follow-on manufacturers107 and procurers active in the health sector, 
generating an annual approximate cost of roughly 13 million EUR108 if outsourced to private 
providers. Due to the complexity of accessing information on the exclusivity status of pharmaceutical 
products, several private companies offer specific data-intelligence products. Figure 4 summarises 
the availability of various pieces of information related to an SPC application that were available 
across EU-27 via searchable databases (i.e. with a possibility to upload search output into structured 
format, such as Excel or CSV file). Libraries of non-searchable PDF documents were not taken into 
account109. 

Figure 4: Number of Member States where selected SPC information was available in a structured format via their NPOs 
websites  

Source: In-house analysis based on information collected from the NPO websites in April 2022.110 

As shown above, information which is of primary importance for the generic producers, namely the 
SPC duration or validity, was easily available only in two countries. Alternatively, follow-on producers 
could calculate the SPC duration on their own by comparing patent and marketing authorisation 
dates111 (with the risk of errors in case of some interruption in the administrative procedure or 
litigation) or else, view a pdf copy of the SPC decision (if available). Still, both approaches are error 
prone especially if conducted in non-native language which would be predominantly the case. 

106 See: Annex 2. 
107 See: Section 6.6.1. 
108 Based on a cost of around EUR 40 000 for a yearly subscription (own market research) and one central 
purchasing body in charge of procuring medicines per Member State. 
109 Article 11 of the SPC regulations requires publication (without specifying the format) of the following 
information: (a) the name and address of the holder of the certificate; (b) the number of the basic patent; (c) 
the title of the invention; (d) the number and date of the authorisation to place the product on the market 
(…) and the product identified in that authorisation; (e) where relevant, the number and date of the first 
authorisation to place the product on the market in the Community; (f) the duration of the certificate. 
110 This table is different from Table 2.1, Annex V of the 2018 Max Planck Institute study as it also takes 
into account the ability to search for data easily. Some information may be available in an unsearchable 
format (PDF as images) in the native language. 
111 Which were also hardly ever available in a structured format (i.e. basic patent number available in basic 
patent number or a reference to marketing authorisation ware hardly ever available in three countries, or a 
reference to marketing authorisation in one Member State only). 

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11233716171718Paediatric extensionMarketing authorisation numberSPC duration or validity periodPatent numberSPC type (medicnes or PPP)Country of the applicantApplication statusTitle (SPC subject matter)Name of the applicantYear of the SPC filling 
 
 
 
                                                           
Further details on country-specific practices related to limited transparency of SPC granting 
procedures can be found in Annex 5B. 

To summarize, in the current settings, the SPC information is incoherent, dispersed across 27 
jurisdictions and not easily accessible. This is in sharp contrast to high transparency and accessibility 
standards concerning primary patent data. Lack of transparency drives problem 1 on legal 
uncertainty, as well as constitutes the main direct reason for which monitoring of the SPC system in 
the EU is burdensome and costly (problem 2). 

2.5.  Consequences 

All market players are impacted by significant legal uncertainty of the SPC system (problem 1). SPC 
users face considerable administrative and management costs associated with the current 
fragmented SPC system (problem 3). At the same time, lack of harmonisation of SPC-related 
information can be an entry barrier for the follow-on manufacturers (problem 2). These triggers 
several consequences that are described in the following sections.  

2.5.1.  EU less attractive for medicines and PPP development  

Temporary exclusivity in use offered by patent protection has been used across most jurisdictions 
and – at least in the case of pharmaceuticals – has time and again been confirmed to incentivise 
investment in R&D and facilitate knowledge sharing112. A precise causal relationship between R&D 
activities in a particular jurisdiction and the SPC coverage in this area, however, is difficult to capture 
given the plethora of confounders. Nevertheless, it could be broadly discussed at three levels: 
location of investment in the EU’s Single Market, market share of EU-based firms and overall global 
levels of innovation and R&D spent.  

The recent COVID-19 crisis showed how vital the localization of production is for securing supplies in 
times of sudden collapse of global value chains. When it comes to geographical locus of 
pharmaceutical investment, IQVIA (2021) shows that countries with a strong IP protection113 (any 
kind, not only SPC) have eight times higher levels of clinical research activities on average114. On the 
other hand, patent holders can seek SPC protection in a country different from where the R&D or 
manufacturing of the novel product took place, which makes unambiguous identification of SPC 
effects problematic. Still, since the SPC Regulations do not differentiate between EU-based 
companies and their foreign competitors115 they contribute to investment location decisions of all 
capital intensive firms alike116. Finally, and somewhat intuitively, the views of the stockholders 
additionally expose the different perspectives between the originators and the follow-on 
manufacturers. Around 90% of innovators responding to the public consultation considered that 

112 The relevant economic literature is far too vast to reference here. For a comprehensive recent meta 
summary see: Spulber, D., The Case for Patents, Northwestern University, 2021. 
113 Measured by the U.S. Chamber 2021 International IP Index, the IP index of the Global Innovation Policy 
Centre. See: Annex 5B. 
114 IQVIA Institute for Human Data Sciences, The Impact of Pharmaceutical IP Provisions in EU Free 
Trade Agreements, institute report, 2021. 
115 Which is in clear contrast to local manufacturing requirements contained in the SPC waiver, for example. 
116 Most developed countries (e.g. US, JP and others) have comparable patent extension regimes 
incentivising the development of new products. For more details see: Max Planck Institute for Innovation 
and Competition, Study on the Legal Aspects of Supplementary Protection Certificates in the EU, 2018 
(https://ec.europa.eu/docsroom/documents/29524), pp. 603–617. 

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possibility of obtaining EU SPC plays a role when deciding on investments in R&D, manufacturing or 
marketing in the EU. 80% said that there were instances where SPC eligibility was a decisive factor for 
product development. Half considered that SPC impacted prioritisation of innovation in their firm 
(e.g. on oncology). On the contrary, nearly all follow-on manufacturers responding to the 
consultation favoured countries with no SPC when deciding on manufacturing localisation, or 
considered that while it depends on the circumstances, no SPC was a key factor117.  

We now turn to the competitive position of EU based pharmaceutical firms. Their home-base is much 
more fragmented than it is the case for their major global competitors originating from jurisdictions 
with harmonised protection systems. Currently, most big markets offer an SPC equivalent (called 
patent term restoration or patent term extension) of up to five years. This includes the US, JP, KR and 
recently also CN, which has introduced a new regime of patent term extension for pharmaceuticals. 
Following a single procedure in the above jurisdictions a company can not only gain protection 
covering the whole territory (e.g. 330 million citizens in the US or 125 million in Japan), but also pay 
much lower fees (for instance application and renewal fees amount to around EUR 3 000 in the US 
and EUR 4 200 in JP)118. In comparison, in the EU firms need to apply separately in each of 27 
Member States, and pay considerably higher fees (for instance only in DE - 83 million citizens - the 
application and renewal fees of EUR 16 950)119. This – at least at the margin – cripples their scale up 
in the home base of the Single Market.  

Thirdly, and in the overall global sense, the importance of SPC protection to recuperate investment is 
expected to grow due to the following macro trends concerning all market players: 

-  very high R&D intensity characterising the pharmaceutical and PPP sectors, 
-  decreasing productivity in pharmaceutical and PPP research and development,  
- 

increasing regulatory pressure in both sectors. 

This phenomenon can be found in many sectors, including the pharmaceutical and PPP sectors, and 
implies that ideas/treatments that are ‘easy’ to find are developed and exploited first. Then, as the 
stock of knowledge increases, new ideas/treatments become harder to find or inventions and output 
can only be sustained or increased by large increases in research effort that offset declining 
productivity 120. 

As mentioned in the introduction, in 2020 European health industries invested more than EUR 36.6 
billion in R&D. In pharmaceuticals, the clinical productivity index measured by IQVIA (composite 

117 See: Table 36 in Annex 2. 
118 For a 5-year long SPC. 
The US Patent Office: extension of term of patent USD 1 180 (≈EUR 1 100) and maintenance fee after 
3.5 years of USD 2 000 (≈EUR 1 900), exchange rate EUR 1 = USD 1.05 (ECB on 29.6.2022). Source: 
United States Patent and Trademark Office, ‘USPTO fee schedule’, 2022 (https://www.uspto.gov/learning-
and-resources/fees-and-payment/uspto-fee-schedule). 
The Japanese Patent Office: application for registration of an extension of the term of patent right 
JPY 74 000 (≈EUR 500) plus annually JPY 59 400 + JPY 4 600 per claim (≈EUR 450). For calculations 10 
claims were assumed, exchange rate EUR 1 = JPY 144 (ECB on 29.6.2022). Source: Japan Patent Office, 
‘Schedule of fees’, 2022 (https://www.jpo.go.jp/e/system/process/tesuryo/hyou.html). 
119 German Patent and Trade Mark Office, ‘Patent fees’, 2022 
(https://www.dpma.de/english/services/fees/patents/index.html). 
120 OECD, Pharmaceutical Innovation and Access to Medicines, OECD Health Policy Studies, OECD 
Publishing, Paris, 2018. 

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Clinical Development Productivity Index) dropped in 2021 by 30% in comparison to a decade ago121. 
This is driven chiefly by an increase in complexity and in duration of medicines development 
(including clinical trials and failure rates). A common hypothesis to explain this trend is that more 
stringent requirements to gain marketing authorisation have increased the costs of clinical trials.  

Similar patterns can be observed in the plant protection sector, where the major companies invested 
around 7-10% of their annual sales in R&D over the last 50 years122. According to a study by 
Deloitte123 the agrochemicals industry has experienced declining revenues and margins that were 
primarily due to: longer product-development cycles, escalating costs124 and increasing stringency of 
regulatory requirements: this hampers the further development of innovative technologies and the 
use of some types of crop-protection agents. This global trend of decreasing numbers of new active 
ingredients can also be observed at EU level. 

Given the above described mechanism, it could be argued that the European SPC regime composed 
of 27 national systems125 may not bring all benefits that could have materialised, if the rules were 
harmonised and more coherent across the EU. The precise impact however, is not quantifiable, but 
more based on the perception of the EU market as an attractive place for research, development and 
production. While by no means the key factor, a fragmented SPC system in the EU may contribute to 
lowering the incentives for the pharmaceutical and PPPs investments in the EU (especially for SMEs 
and innovative start-ups), as well as it may affect the global market share of EU-based firms.  

2.5.2.  Hampered joint cross-country public procurement 

Joint cross-country procurement for pharmaceutical products in the EU is currently regulated by 
Directive 2014/24/EU, as well as by Decision 1082/2013/EU on serious cross-border threats to 
health. In Recital 33, the public procurement Directive states in particular that “contracting 
authorities should be able to choose to provide jointly their public services by way of cooperation 
without being obliged to use any particular legal form. Such cooperation might cover all types of 
activities related to the performance of services and responsibilities assigned to or assumed by the 
participating authorities […]”. Furthermore, “the important role joint procurement may play, not least 
in connection with innovative projects” is also recognised (Recital 71). As far as Decision 
1082/2013/EU is concerned, it aims at improving cooperation of the EU and Member States in case 
of serious cross-border threats to health, including the possibility of conducting the joint 
procurement initiatives. 

121 Although Phase II trials saw a decline of less than 10 %. Source: IQVIA institute for Human Data 
Science, Global Trends in R&D: Overview through 2021, 2022, p. 32. 
122 Phillips McDougall, Evolution of the Crop Protection Industry since 1960, 2018. 
123 Deloitte, The Future of Agrochemicals: Capturing value through innovation, resourcefulness, and digital 
alchemy, 2019. 
124 The average development period for a new PPP has increased from 8.3 years in 1995 to 11.3 years in 
2010–2015; the overall R & D costs for a new PPP increased from USD 152 million in 1995 to 
USD 286 million in 2010–2014. Source: Evolution of the Crop Protection Industry since 1960, Phillips 
McDougal 2018; for further details see: Annex 5B. 
125 Contrary to the European patent system which is in the process of being ‘defragmented’, at least for 
certain Member States, thanks to the upcoming launch of the unitary patent system. 

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Furthermore, in the reaction to the COVID-19 the Commission issued guidance on using the public 
procurement framework in the emergency situation related to the pandemics126, where it mentions 
clearly the importance of launching joint procurement actions for various medical supplies (“public 
buyers […] are encouraged to procure jointly and to take advantage of the Commission’s joint 
procurement initiatives”).  

While discussing the actual EU public procurement framework, it should be also noted that 
pharmaceuticals could be an ideal commodity for the aggregation of demand. Once the items(s) to 
be procured are described by internationally recognised nomenclature (e.g. International Non-
proprietary Names (INN)127 and/or ATC128), they constitute relatively homogeneous goods (i.e. 
interchangeable and therapeutically equivalent). Yet, despite characteristics that should facilitate 
procurement processes (i.e. evaluation, comparability of bids, etc.), cross-country joint procurement 
doesn't happen at a large scale in the EU129.  

Currently public procurement of pharmaceutical products is predominantly local, but contracts are 
often awarded to subsidiaries of foreign firm (around 60% of deals registered at the EU level)130. 
Unfortunately, calls for tender for pharmaceuticals involving two or more countries do not occur very 
often, although especially in case of small countries, it could leverage their buyer power by pooling 
volumes and/or address various concerns in terms of security of supply. 

Several cross-country initiatives have been recently established in Europe to jointly procure 
pharmaceuticals as described in Table 1 below.  

Table 1: Overview of three European country collaborations on procuring medicines and vaccines, 2010–2021 

Name of initiative 
Nordic Pharmaceutical Forum131 (established: 2015) 
Baltic Procurement Initiative (agreement: 2012) 
Beneluxa Initiative132 (established: 2015) 

Countries 
DK, SE, IS, NO 
EE, LV, LT 
AT, BE, IE, LU, NL  Joint negotiations on medicines 
Source: Based on Vogler, S. et al., European collaborations on medicine and vaccine procurement, Bulletin World Health 
Organisation 2021, Policy & practice, p.717. 

Activity 
Joint procurement of medicines 
Joint procurement of vaccines 

Currently such initiatives seem to focus on older medicines with expired patents to avoid potential 
legal barriers that otherwise could prevent such procurement from taking effect. It can be inferred 
that similar concerns also relate to newly elapsed patents where differences in SPC coverage and 
expiry dates could hamper the scaling-up of joint public procurement of medicines at the EU level. 

126 European Commission, Commission communication – Guidance from the European Commission on 
using the public procurement framework in the emergency situation related to the COVID–19 crisis, 2020/C 
108 I/01, C/2020/2078. 
127 An International Non-proprietary Name (INN) is a WHO nomenclature of pharmaceutical substances or 
active pharmaceutical ingredients. Each INN is a unique name that is globally recognised and is public 
property. A non-proprietary name is also known as a generic name. 
128 Anatomical Therapeutic Chemical (ATC) is a classification system, where the active substances (drugs) 
are divided into different groups according to the organ or system on which they act and their therapeutic, 
pharmacological and chemical properties. 
129 This is also for historic reasons and due to country-specific structures of health systems, including 
different regulatory pricing and reimbursement regimes (e.g. mandatory discounts, etc.), which pose 
challenges when it comes to cross-country joint procurement. 
130 Contracts below EUR 200 million covered by the EU public procurement directives (See: Annex 5B). 
131 AMGROS, ‘About AMGROS: International cooperation’ (https://amgros.dk/en/about-
amgros/cooperation-partners/international-cooperation/). 
132 https://beneluxa.org/ 

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This in turn may make demand pooling more problematic, especially in a situation of crisis. In 
particular, contracting authorities intending to procure medicinal products and EU joint procurers of 
medicines (like the future HERA and EU Fab which aim at preparing the EU for future health 
emergencies by securing production capacity around the EU) could face increasing challenges to 
accept bids from generic and biosimilar sectors as the status of SPC protection in some Member 
States might not be clear. Three quarters of healthcare respondents to the public consultations 
considered that joint procurement by a group of countries would be easier with one SPC covering the 
whole EU133.  

To conclude, the patchy and incoherent SPC systems, due to its asymmetric implementation across 
various EU countries and insufficient transparency about the SPC status, can be perceived as a risk 
factor and a legal obstacle hampering joint cross-country procurement.  

2.6.  How likely is the problem to persist? 

Should no action be taken, the impacts of the current problems – in particular legal uncertainty and 
costs of obtaining SPC protection in the EU for the innovative pharmaceutical (and PPP) industry – 
will only intensify, driven by the steady increase in the number of new medicines authorised every 
year and in the average number of Member States in which SPC protection is sought for a given 
product. In the context of the ongoing review of the EU’s pharmaceutical legislation, it is currently 
envisaged to make certain regulatory incentives and rewards conditional upon the actual launch of 
the product concerned on the market134. As a consequence, shortening of the basic data protection 
period from 8 to 6 years is contemplated (unless the certain conditions related to market presence 
are met), which might impact the demand for SPC (i.e. the share of SPC as the last measure to 
expire135 would increase by roughly 5% from 49.6% currently to 54.9% of molecules136, see: Annex 5B 
for more detail). While recognising that there could be interaction between the two instruments, 
such impact is expected to be low in the context of the envisaged reform as it would potentially add 
from 0 up to 5 new SPCs each year depending on firms’ response to the new rules137. The above 
factors will also exacerbate the transparency issues that have been identified (mostly affecting 
generics makers) as more and more Member States need to be monitored.  

The above occurs in a global context with increasing product development time and R&D costs 
combined with stringent regulatory requirements. Medicine market is expected, nevertheless, to 

133 See: Annex 2, Table 27. 
134European Commission, Revision of the EU general pharmaceuticals legislation, Inception impact 
assessment, 2021 (https://ec.europa.eu/info/law/better-regulation/have-your-say/initiatives/12963-Revision-
of-the-EU-general-pharmaceuticals-legislation_en). 
135 See: section 2.2. 
136 Understood as a unique pharmaceutical active ingredient or their combination, as defined by 
International Non-proprietary Names (INN). 
137 Based on the preferred option of the draft impact assessment on ‘Revision of the EU general 
pharmaceuticals legislation’ which lowers the basic data protection period from 8 to 6 years but allows for 
an additional 2 years if all EU markets are covered. The draft estimates that potentially around 5 % of 
products can be affected by the change. With around 88 marketing authorisations issued each year, this 
could translate into 4 to 5 additional SPC applications in case firms do not choose to cover all EU markets. 
At the time of writing this impact assessment, this initiative was at a draft stage, thus these estimates are 
preliminary and dependent on initiative’s adoption and its final form. 

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grow at 3–6% compound annual growth rate (CAGR) through 2026, reaching about USD 1.8 trillion in 
2026, including spending on COVID-19 vaccines138.  

In addition, should no action be taken, the unitary patent system (expected early 2023) would not be 
mirrored by a unitary SPC – that would have optimally ensured the availability of unitary protection 
over the whole duration of the entire (patent and SPC) protection period of a given product. The 
pharmaceutical and PPPs sectors might thus not internalise the full advantages of the unitary patent 
system. 

Furthermore, the EU SPC regime would keep having inferior attractiveness at the worldwide level 
due to its fragmentation and high costs comparing with other jurisdictions. In this regard, the 
European Biopharmaceutical Enterprises (EBE), which represents the interests of biopharmaceutical 
companies in Europe (60% of its members are SMEs) in reply to the Commission public consultation, 
underlined that any legal uncertainty around SPCs had the potential to deter investment, postpone 
development decisions and undermine Europe’s reputation as a safe haven for research and 
development. The EBE said that any uncertainty would particularly impact EU-based pharmaceutical 
SMEs and start-ups, which have fewer resources to undergo lengthy development pathways for their 
products (they rely on the prospect of getting patent protection and a subsequent SPC in their 
financing strategies). This, in turn, could ultimately be detrimental to the EU’s strategic autonomy. 

3.  WHY SHOULD THE EU ACT? 

3.1.  Legal basis 

Article 114(1) TFEU governs measures for the approximation of the provisions by law, regulation or 
administrative action in Member States. It would therefore be the appropriate legal basis for a 
potential harmonisation or centralisation of the SPC procedures in order to address the current 
divergent outcomes of national procedures and different transparency mechanisms across EU 
Member States.  

Article 118(1) TFEU allows for measures for the creation of European intellectual property rights to 
provide uniform protection of intellectual property rights throughout the Union and for the setting 
up of centralised Union-wide authorisation, coordination and supervision arrangements. The unitary 
patent, governed by Regulation 1257/2012, is already based on Article 118 TFEU. A unitary SPC, if 
proposed, would have unitary character and confer the same rights as the basic patent subject to the 
same limitations and the same obligations. Hence, Article 118(1) is the appropriate legal basis for a 
Regulation governing the unitary SPC. A language regime for the unitary SPC could be based on 
Article 118(2)139. 

3.2.  Subsidiarity: Necessity of EU action  

As explained, despite the fact that SPCs are already harmonised by EU law140, there are still cases 
where some Member States have granted SPCs while identical applications have been refused in 

138 IQVIA, The Global Use of Medicines 2022: Outlook to 2026, 2022, p. 2. 
139 Note for this section that the choice of the examination authority may require Article 352 of the Treaty 
on the Functioning of the European Union as a legal basis should the EPO be chosen. 
140 Regulations (EC) 469/2009, 1610/96. 

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others, or granted with a different scope. SPC applicants thus face diverging decisions across the EU 
concerning the same application at hand, while incurring costs for applying and maintaining SPCs in 
several Member States. The above is equally burdensome for follow-on companies that need to 
monitor SPC status across many jurisdictions. National publication practices also vary across Member 
States. Consequently, further EU intervention is needed to address these issues and can, unlike 
national intervention by Member States, ensure a coherent framework, as well as ease the current 
burden of applications and renewal fees to be paid in several Member States.  

EU action is necessary to provide a unitary SPC for the unitary patent. An EU IP right (such as a 
unitary SPC) can only be created by the EU141. National protection systems alone cannot achieve this 
objective, as a bundle of national SPC in the enhanced cooperation area of the unitary patent would 
not give full continuation of the unitary effect of the unitary patent in that area. Consequently, EU 
action is also needed to create a new unitary right to accompany the unitary patent.  

3.3.  Subsidiarity: Added value of EU action 

EU-level action would enhance the integrity of the internal market by providing for a 
unitary/centralised, balanced and transparent SPC system in the EU and mitigate the negative 
consequences resulting from diverging procedures that applicants face. Hence, action at EU level is 
also justified to ensure the smooth functioning of the internal market for innovative products subject 
to marketing authorisations, and to permit the benefits of an efficient industrial property framework 
to be reaped in the relevant product markets.  

4.  OBJECTIVES: WHAT SHOULD BE ACHIEVED? 

With reference to the problems presented above, the following section presents the objectives that 
should be achieved in order to address them (Figure 5). 

Figure 5: Objectives of the initiative 

4.1.  General objectives 

The general objective of the proposed policy actions is to improve the availability of novel medicinal 
products for EU patients, and of plant protection products for agriculture, and to incentivise firms to 
develop those products in the EU. 

141 Even the unitary patent, although based on the European patent system, was created by two EU 
Regulations. 

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4.2.  Specific objectives 

In connection with the general objectives and with the problems identified earlier, three specific 
objectives have been defined: 

(1) Increase predictability and legal certainty of SPC protection in the EU. This  specific 

objective can be obtained by: 

o  Facilitating substantive examination procedures;  
o  Facilitating involvement of affected third parties;  
o  Facilitating granting procedures. 

(2) Facilitate the monitoring of SPCs in the Single Market, preferably by offering a single 
point of access to information about the status of SPCs in the EU (e.g. filed, granted, 
refused, invalidated, renounced or withdrawn), as well as access to structured data on 
the subject. 

(3) Reduce  cost  and burden of seeking  and maintaining SPC protection by  investigating 
possible  administrative  cost  reductions;  improve  access  to  procedures  to  all 
stakeholders, especially SMEs. 

5.  WHAT ARE THE AVAILABLE POLICY OPTIONS? 

5.1.  What is the baseline from which options are assessed? 

The baseline scenario  (Option  0)  is  ‘no policy  change’. The SPC system  would continue to 
operate on the basis of the existing EU and national rules. 

5.2.  Description of the policy options 

5.2.1.  PO1: Guidelines for the application of the current SPC regimes  

The Commission would, in cooperation with national offices, propose common 
guidelines/recommendations for the application of SPC rules. The guidelines would describe how to 
assess the eligibility of a product for SPC protection, including substantive conditions of Article 3 of 
the SPC Regulations. This could help narrowing gaps regarding divergent interpretations currently 
observed among patent offices. Guidelines would be a “living document” to be updated according to 
the evolution of the CJEU’s jurisprudence (e.g. on how to interpret Article 3). For example, guidelines 
could clarify what constitutes a prior certificate (in particular as regards any combination product), 
and the relationship and split between the subsections of Article 3. The guidelines would further seek 
to identify and build on NPOs best practices, so that the practice of the examiners remains consistent 
and predictable142. 

Regarding SPC data, the guidelines would propose common rules for the publication and accessibility 
of SPC information in national registers. The rules would concern in particular: 

- 

the  scope  of  information  that  should  be  publicly  accessible,  such  as:  the  SPC  filing 
reference  number,  SPC  application  status  (e.g.  in  force,  cancelled,  revoked,  expired, 
annulled),  name  of  the  SPC  holder(s)  including  change  of  ownership  if  applicable, 
description  of  product  concerned  by  SPC,  EP  reference  number,  marketing 

142 Major NPOs develop and maintain guidelines which reflect their examination practices, any settled 
interpretation of certain legal provisions or any doctrines developed over years of practice, etc. 

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authorisation  reference  number,  SPC  date  of  expiry  (if  not  revoked  or  annulled), 
implementation  of  the  SPC  manufacturing  waiver  for  medicinal  products,  as  well  as 
the availability of SPC information in a multilingual format (e.g. native language and 
English);  

- 

- 

the  scope  of  information  that  should  be  accessible  to  stakeholders  concerned  by  the 
case143,  such  as:  access  to  formally  admissible  SPCs  dossiers,  third  parties  opinions, 
SPC opinions or grant decisions, etc.;  

the ways in which common technical rules on data exchange, storage, publication and 
data exploration could be agreed between NPOs144 (e.g. via a dedicated working group 
of NPO IT experts).  

Additionally, the guidelines should promote cooperation and data sharing between NPOs and the 
EPO (regarding existing European patens) and with the EMA (on marketing authorisations). These 
guidelines would not be legally binding, and might co-exist with nationally developed guidelines. 

5.2.2.  PO2: Mutual recognition of national decisions  

Under this option, the Commission would propose a legislative initiative that would enable SPC 
applicants to file an SPC application in a designated NPO, the so-called “reference office”, of its 
choice. Only NPOs of Member States that fulfil a number of conditions could act as reference offices. 
These conditions would include having sufficient resources to conduct substantive examination of all 
the conditions for granting an SPC (in accordance with Article 3 of the SPC Regulations)57. An up-to-
date list of offices would be published. A system allowing third parties to submit their written 
observations concerning an ongoing SPC procedure would be set up at all the reference offices. All 
communication with the reference office would be in the language(s) accepted by that office. 
Following the grant of an SPC by the chosen reference office, the SPC applicant could seek SPC 
protection in other Member States. In other words, the decision of the reference office would be 
implemented by the other national patent offices. For this option to be operative, the basic patents 
of the designated and reference Member States should be based on the same European patent to 
have a common set of claims145 (in order to result in the same scope of patent protection). In the 
same vein, for medicinal products, the marketing authorisation should be based on a centralised 
marketing authorisation for the related SPCs. 

To avoid the risk of “double SPC protection” or “double attempt of SPC protection”, the possibility of 
seeking SPC protection through purely national routes in the Member States should not be available 
once this mutual recognition procedure is triggered for a product. 

The option should preferably be combined with PO1 as all NPOs that can act as reference offices 
would be expected to work on the basis of common guidelines relying on the best practices and on a 

143 For example, commercially sensitive information may involve more restricted access rules. 
144 A decentralised data management system (a data mesh) could be proposed to integrate data from the 
disconnected IT systems of NPOs. 
145 Rule 138 of the EPC, based on Article 139(2), provides for the possibility that at least one Member State 
had a different set of claims if a national patent application was filed on the same priority date of the 
European patent (‘a national patent application and a national patent in a Contracting State shall have with 
regard to a European patent designating that Contracting State the same prior right effect as if the European 
patent were a national patent’). 

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common interpretation of EU legislation and case law. Each NPO would be expected to cooperate in 
setting up an SPC data exchange system with features as described in PO1. 

5.2.3.  PO3: Centralised filing and examination of SPC applications resulting in a non-

binding opinion 

The Commission would set up a single entry point for filing SPC applications in the EU for holders of 
European patents and EU-centralised marketing authorisations146. Applicants would use a common 
form, attach the patent dossier and marketing authorisations and select in which Member States 
they seek SPC protection. Such application would be examined147 by a dedicated “central 
examination authority” (potentially with involvement of experts from NPOs). All conditions for 
obtaining a certificate would be examined148. The application would be published and open to 
written observations as to validity/eligibility by third parties (most importantly, originators, follow-on 
manufacturers or public health authorities). Written observations149 would be considered by the 
examiners in the process of issuing the opinion. However, examiners would not have to give reasons 
concerning how the observations were taken into account150. The outcome of the examination would 
be a non-binding opinion on whether the SPC should be granted or not. The examination authority 
could be a “virtual office” composed of SPC examiners from NPOs or an existing authority such as: 
the European Union Intellectual Property Office (EUIPO), the European Patent Office (EPO) (both of 
which are specialised in granting IP rights), or an EU regulatory agency dealing with marketing 
authorisations, such as the European Medicines Agency (EMA) or the European Food Safety 
Authority (EFSA)151. All interactions with the authority should be possible in electronic form in all EU 
languages, and the same would apply to the availability of decisions taken by the examination 
authority (e.g. e-submission using a standard application form and e-access to SPC documents by 
applicants).  

Applicants would be charged a central fee. It would cover filing and examination only. It should also 
fully cover any additional costs of the central authority. An annual SPC maintenance fee could be 
collected by Member States in which the SPC is granted (no application fee at the national level). The 
submission of written observations could also be subjected to a fee. 

The application, opinion and observations would be sent for further processing to each Member 
State designated by the applicant. Each NPO would decide whether to grant a national SPC in its 

146 In case of PPP there is no central marketing authorisation, but a mutual recognition system following a 
single assessment. 
147 Notably assessment of compliance with Articles 2 to 3 of the SPC regulations. 
148 As per Article 3 of the SPC regulations (see: footnote 57), exemptions of Article 10(5) would not apply 
to the central authority (see: Section 2.4.1). 
149 As the centralised procedure results in a non-binding opinion that does not have to be followed by the 
designated NPOs, opposition proceedings cannot be established. 
150 As opposed to the formal opposition proceedings in the patent system which, contrary to third-party 
observations, are inter partes proceedings. 
151 EUIPO is already responsible, inter alia, for the single filing, examination and grant of the EU trade 
mark and the registered Community design, two unitary intellectual property rights valid across the 27 
Member States of the EU. EPO grants the European patents with unitary effect that serve as ‘basic patents’ 
for SPC applications under which a unitary SPC is requested. EMA is responsible for the assessment of 
centralised EU marketing authorisations of medicines, and EFSA - for the risk assessment of plant 
protection products. These organisations were the most frequently mentioned by the industry in public 
consultations and Allensbach survey. 

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territory or not. Appeals against such national decisions would be governed by national law. While 
the opinion of the EU examination authority would be non-binding, the freedom of NPOs to deviate 
from the opinion could be restricted to cases where factual circumstances in the country concerned 
have changed, for instance whereas the validity of the patent underlying the SPC has been 
challenged by means of a request for revocation or the marketing authorization for a product has 
been withdrawn. 

The examination authority would need to develop and maintain guidelines for its own examination 
practice, following open and inclusive consultation with NPOs. The national SPC route could be 
closed for applicants able to use the centralised procedure152.  

The examination authority would provide a single access point for e-submission of SPCs using 
standard forms, as well as an IT system (a data warehouse) for a comprehensive recording and on-
line accessibility of up-to-date data related to SPCs filed through the centralised procedure. The key 
building blocks of such IT system153 should include a central database, ETL tools154, metadata, and 
data access tools. The business requirements of this IT tool should be in line with common rules for 
the publication and accessibility of SPC information foreseen in PO1. For completeness, it would be 
also recommended that key information on SPCs granted by NPOs via the national route is shared 
with the examination authority and is made accessible through its central web portal. 

Figure 6: Steps of Policy Option 3 

5.2.4.  PO4: Centralised filing and examination of SPC applications resulting in a binding 

opinion  

This option is identical to PO3, except for the key distinguishing feature that the examination 
authority would issue a binding opinion on the validity of a centralised SPC application. The NPO of 
each Member State designated in the application would have to implement it and formally grant, or 
refuse, the SPC in its territory. Therefore, in practice, the result of the centralised procedure under 
this option would be equivalent to either the granting of a bundle of national SPCs, or the rejection 
of the application, for all designated Member States.  

152 It may be foreseen that under certain conditions the centralised procedure has to be used in order to 
reduce the risk for national discrepancies (e.g. as soon as certain criteria are met, such as holding a 
European patent and  a centralised marketing authorisation). 
153 A detailed analysis of current IT systems processing SPC data in each NPOs would precede the 
harmonisation of data input and further data integration into a central SPC database. It would focus in 
particular on the systems used, volume of data, system change management (e.g. upgrades, external 
provider), online accessibility, etc. 
154 ETL is a process that extracts, transforms, and loads data from multiple sources to a data warehouse or 
other unified data repository. Source: IBM, ‘ETL (extract, transform, load)’, 2020 
(https://www.ibm.com/cloud/learn/etl). 

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Given the binding nature of the above, an applicant should be able to appeal a (negative) opinion 
before it is transmitted to national offices.  

Figure 7: Steps of Policy Option 4 

A central IT system for SPC data would be set-up, as described in PO3. 

5.2.5.  PO5: A ‘unitary SPC’ complementing the unitary patent 

Under this option, the Commission would present a legislative proposal for the creation of a “unitary 
SPC” title, granted by an EU-level authority (the central examination authority, as in PO3 and PO4). It 
would take effect at the end of the lawful term of a basic patent that would be a European patent 
with unitary effect (i.e. the unitary patent). Therefore, it would have unitary effect only for the 
territories of the Member States covered by that basic unitary patent155.  

Figure 8: Steps of Policy Option 5 

The unitary SPC protection would be optional for the users of the unitary patent system (it could 
become the only choice after a transitional period). Once it is chosen, the national route in Member 
States participating in the unitary patent system would be closed to avoid duplication of protection.  

The key features described in policy options PO3 and PO4 (centralised procedure) would broadly 
apply to this option. In particular, applications for unitary SPCs would be submitted to the 
examination authority, which would conduct the formal and substantive examination of the 
applications, take written observations into due consideration and grant or refuse the unitary SPC 
protection. The unitary SPC protection would come into effect in the territories of the Member 
States participating in the unitary patent system (party to the UPCA – assuming that they are covered 
by the basic unitary patent concerned) without any validation by the NPOs. 

The linguistic regime in this option could be as in PO3 and PO4, however instead of covering all EU 
official languages, it could be limited to the official languages of the unitary patent area. All 

155 The enhanced cooperation for unitary patent protection remains open to all EU Member States which 
may join any time. Please note that European patents to which unitary effect has been attributed at different 
dates might have different geographical coverages, depending on the state of play of UPCA ratifications at 
these dates. 

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administrative fees (application and annual renewal) would be paid to the central examination 
authority.  

It should be possible to lodge an appeal against the decision on granting or refusing protection to the 
examination authority (the Board of Appeal)156. Judicial appeals related to the decision of the 
examination authority, if it is an EU agency/body, would be addressed to the CJEU. A central IT 
system for unitary SPC data would be set-up, as described in PO3. 

Conversion of unitary SPCs into national SPCs 

There  are  rare situations  in  which a European patent with  unitary  effect  may see its unitary 
effect  being  denied  or  revoked  by  the  UPC  at  the  time  when  the  validation  deadlines  have 
already expired – making it impossible to validate the European patent nationally any longer 
(except in few Member States where no validation formalities are required). To address such a 
risk, the vast majority of the UPCA Contracting States have introduced national “safety-net” 
legislation  providing  for  a  possibility  to  convert  a  unitary  patent  into  a  national  patent. 
Although such situations should be quite exceptional,  they  remain possible, and therefore it 
would  be  advisable  to  provide  for  a  procedure  allowing  unitary  SPCs  to  be  converted  in 
national SPCs, under specific conditions.  

5.3.  Overview of policy options 

The  table  below  provides  a  short  summary  of  key  differentiating  features  of  all  options 
considered. 

Table 2: Main features of the analysed policy options 

PO1: Guidelines 

PO2: Mutual  
recognition 

PO3: Centralised 
procedure with a non-
binding opinion 

PO4: Centralised 
procedure with a binding 
opinion 

PO5: Unitary SPC 

NPOs examination 
procedures 
harmonisation 

New IP right 

Filing authority 

n/a 

n/a 

Examination authority 

n/a 

Guidelines 

EA guidelines + possible national follow up 

No 

No 

No 

Yes 

One ‘reference NPO’ per 
application 

One centralised EA + 
NPOs can re-examine 

One centralised EA 

One centralised EA 

Third party 
observations 

n/a 

Yes 

Yes, at the centralised EA 

Granting authority 

n/a 

NPOs, but cannot depart 
from the reference NPO’s 
opinion 

NPOs 

NPOs, but cannot depart 
from the EA´s opinion 

Centralised EA 

For which patents 

n/a 

European patents (EP) 

EP with unitary effect 
(unitary patents) 

For medicinal product: 
which marketing 

n/a 

Centralised (marketing authorisation issued by the European Commission following EMA opinion) 

156 Unlike PO4, this would be a full procedure and thus entail a review against negative grant decisions by 
the BoA and, ultimately, the CJEU. As in Article 165 of the EU trade mark regulation, the composition of 
the Boards of Appeal could be comprised of three members, with the possibility of a Grand Board for 
specific cases. 

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PO1: Guidelines 

PO2: Mutual  
recognition 

PO3: Centralised 
procedure with a non-
binding opinion 

PO4: Centralised 
procedure with a binding 
opinion 

PO5: Unitary SPC 

authorisations (MAs)? 

Centralised litigation 

For those MS having ratified the UPCA (17 UP-MS as of 2022) 

Member States (MS) 
covered 

All 27 MS 

Binding nature  
Legal basis 

Voluntary 

Art. 114 TFEU  
+ voluntary guidelines 

Relation with the 
launch of the unitary 
patent system 

Irrespective of the unitary patent system launch 

*EA – examination authority, EP- European Patent, NPOs – national patent offices 

5.4.  Options discarded at an early stage 

MS having ratified the 
UPCA (17 UP-MS as of 
2022) 

Art. 118 TFEU 

Once the unitary patent 
system starts 

The option where the centralised examination authority would grant national SPC directly was 
discarded as it does not appear to be feasible based on the EU treaties (neither Article 114 TFEU on 
harmonisation of national laws, nor Article 118 TFEU on unitary IP rights). 

Extending the 20-year term of protection of the basic patent by up to five years (the US model) as an 
alternative to the current SPC system – while this would have the same practical result – was also 
discarded. First of all, this would represent an extremely drastic change and would require very deep 
modifications in both legislation and Member States’ (national offices’) operations. This change 
would likely open up several years of fluctuating granting practices and case law, and is not expected 
to result in particular savings as each Member State concerned would still have to examine and grant 
extension requests. In addition, there are no evident advantages in replacing the current SPC system 
with a patent term extension regime. On the contrary, a sui generis right offers more flexibility to the 
EU legislator, as was shown by the introduction of the SPC manufacturing waiver in 2019 (Regulation 
2019/933).  

An option to amend SPC Regulations by: i) elimination of the possibility to grant SPC without verifying 
all the criteria157; and ii) codifying CJEU jurisprudence - was also rejected. From Commission’s 
contacts with Member States it emerges that this exemption is vital for NPOs with limited resources, 
and even large NPOs reported problems in applying all the criteria. More importantly, even without 
the exemption significant divergences between NPO decisions would remain due to differences in 
national SPC administrative procedures. At the moment, the transposition of CJEU jurisprudence into 
the EU law would be premature. While the Santen case clarified some aspects of prior case law, the 
latest two referrals to the CJEU have demonstrated that there are still uncertainties in particular on 
Article 3a and 3c (see: section 2.4.1). 

Finally the option to eliminate SPCs altogether is not considered further following the findings of the 
evaluation that SPC system supports research of new active ingredients, is fit for purpose and brings 

157 Article 10(5) discussed in Section 2.4.1 allows granting SPC without verifying if the product has not 
already been the subject of a certificate, and if the marketing authorisation is the first authorisation to place 
the product on the market. 

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added value. As well as the fact that all major jurisdictions (e.g. the US, JP, CN) around the world 
offer comparable additional patent protection. Lastly, eliminating SPCs would be incompatible with 
the international commitments of the EU taken in a number of bilateral and regional trade and 
cooperation agreements with third countries, as they include commitment to some form of extended 
protection. 

6.  WHAT ARE THE IMPACTS OF THE POLICY OPTIONS? 

Further to the analysis below on the impact of the identified options, the tables in section 7 provide a 
detailed summary of the impact of all options described above. All quantifications quoted below are 
based on calculations in Annex 5D to 5G. Additional material on the impacts on SMEs is also provided 
in Annex 6 (the SME Test). 

The most important analysis concerning objective 1 (legal certainty) and largely 2 (monitoring) is not 
quantifiable. Where possible, quantifications where made (mainly on objective 3 – cost reduction) 
using the following assumptions for EU wide impacts: around 100 SPC applications per year, out of 
which 80 SPC granted (based on the analysis in section 2 taking into account future increases and 
historical averages for the rejection rate); 300 follow-on companies158 and at least one medicines 
procurement office per Member state interested in monitoring SPC status. It is also assumed that 
applicants use of legal advice in each Member State where they apply for SPC, as well as that SPC 
protection is sought in all EU Member States and maintenance fees are paid for the maximum five-
year-long protection (for alternative scenarios see: Annexes 5D and 5E).  

PO 0: No action (status quo or base-line scenario) 

The problems identified in Section 2 would persist with the described consequences, even if the 
Commission continues to promote better implementation of the SPC Regulations. A status quo would 
worsen those problems considering the increasing average number of Member States in which SPC 
protection is sought for a given product and the entry into force of the unitary patent system.  

Table 3: PO0 (baseline) costs and savings to applicants for receiving EU27 wide SPC protection (EUR).  

Application fee 
Maintenance fees for 5 years 
Translation costs 
Agent/attorney’s fees 
Total 
Source: own estimations, numbers rounded see: Annex 5E 

EUR per application 

8 800 
183 000 
4 000 
54 000 
249 800 

6.1.  PO1: Guidelines on application of the current SPC regimes 

Several Member States already have national guidelines, which could be a source of inspiration/best 
practices for the common guidelines developed jointly the Commission and Member States. Four out 
of five patent offices responding to the public consultation, several judges and IP lawyers stated that 
national guidelines exist in their Member State and are frequently updated following CJEU rulings159. 

158 “Within three years following the LoE [loss of exclusivity] the ratio of generic companies to originators 
is about 6:1” (source: European Commission, Directorate General Competition, Pharmaceutical Sector 
Inquiry, 2009, p. 74). With up to 50 molecules where competition emerges, the estimated number of follow-
on producers affected is 300. Also see: section 6.6.1. 
159 See: Annex 2. 

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Moreover, since the CJEU line of judgements on SPC is still evolving, guidelines seem a good 
instrument which could be frequently and easily updated.  

The main drawback of this option is that the effectiveness of any guidelines is undermined by the fact 
that they are not mandatory. Therefore, if this option is chosen, it is essential to secure wide 
acceptance by Member States. This may entail a long negotiation process to settle for the commonly 
accepted version. Nonetheless, the adoption of guidelines alone gives no certainty that the situation 
would improve. Several countries would like to continue developing their national guidelines to cater 
for country specific legal situation/processes. The freedom to depart from guidelines, combined with 
the possibility to interpret them differently, shows limitations of this option.  

As far as the exchange of SPC-related information is concerned, developing common guidelines on 
the scope of publication and the characteristics of dedicated IT tools, can prove very useful to NPOs. 
The degree of data integration160 will depend on the willingness and technical capabilities of NPOs, 
but having better access to standardised and searchable SPC data could undoubtedly facilitate 
knowledge sharing. It shall be nonetheless noted that upgrading the existing SPC databases to 
common standards would imply certain costs (especially if historical files needed to be converted to 
new formats as well). If NPOs decided to create an EU-wide central SPC database, it could actually 
limit the IT cost per country. 

Consequently, guidelines are expected to limit divergence, but cannot eliminate it altogether. Their 
scope and the extent of uptake would be the deciding factor. The IT costs may limit the interest of 
NPOs with lower number of applications or low SPC fees. Cost to applicants would not change. 

Stakeholder feedback 

This option was the preferred action to improve consistency of interpretation of SPC previsions 
throughout the EU to around 75% of follow-on manufacturers, healthcare sector and patent offices 
and lawyers during the public consultations. On the contrary only 7% of originators selected it.  

On 21 October 2019, the Group of Industrial Property Policy (GIPP) experts from EU Member States 
discussed the possibility of creating common guidelines regarding the granting of SPCs. Guidance in 
the form of good practices prepared by a working group of national SPC experts, possibly under co-
ordination by the Commission, was the option preferred by the majority of Member States taking the 
floor. For many participants, this option would have an advantage of offering more flexibility 
compared to SPC guidelines issued by the Commission, which would have to stay within the strict 
limits of the case law of CJEU. Some Member States pointed out that the usefulness of any such 
guidance could be limited in light of the still evolving CJEU case law and the fact that Court has the 
final say in interpreting the provisions of the SPC Regulation. A few Member States were reluctant 
regarding soft-law approaches as it may be premature in light of the upcoming entry into force of the 
unitary patent and of the evolving case law, and result in a duplication of efforts on EU and national 

160 NPOs can for example agree to use standard specifications to structure their SPC data and enable 
interoperability. The scope of such data exchange can stretch from just a few key variables (e.g. the SPC 
identifier, date of submission or decision, identification of the applicant, subject matter, SPC status) to 
capturing all information that constitutes an SPC file. Similarly, NPOs could agree on periodic data feeds 
(hence accepting some time lags) or target real-time data processing to strengthen the informative prowess 
of a common IT system. 

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level. During the GIPP meeting in November 2022, eight Member States expressed preliminary 
support for this option out of 17 that took the floor. 

6.2.  PO2: Mutual recognition of national decisions 

Linguistic regime 

As far as PO2 (mutual recognition) is concerned, only one language would be necessary to prosecute 
the application at the reference office, potentially eliminating upfront translation costs. However, 
savings of this option could be lower, if the resulting bundle of national SPCs and the dossier on 
examination conducted in the reference office required translation into all official languages of the 
designated Member States – adding around EUR 870 per each additional language161. The translation 
cost could be covered either by an increase in fees charged by the reference office, or by diminishing 
the income from maintenance fees received by NPOs. It is also possible that not all NPOs would 
require such translations. Nevertheless, EU law cannot impose the use of any (other than local) 
language on national authorities as this is in Member States’ competence only.  

Impact on NPOs  

Those NPOs that decide to act as reference office would conduct the formal and substantive 
examination of SPC applications (would have had to be done anyway with the current system of 
nationally granted SPCs, albeit the numbers of applications may differ). Since it is expected that 
several NPOs would obtain the status of a reference office, their SPC-related workload would 
decrease compared to the current situation, because the average workload would be shared by 
several offices. On the other hand, reference offices risk not having a homogenous workload year 
after year, which might create challenges regarding the employment of their SPC department. Based 
on an earlier analysis 15 NPOs could qualify as not applying any exemptions. Using the geographical 
distribution of applicants to the German office, one could expect that around 58% of applications 
would be in English, up to 23% in German, up to 20% in French, up to 13% in Italian, 7% in Dutch, and 
3% in Swedish162. With around 100 SPC applications expected annually, it would be likely that only 
three reference offices emerge: that is IE for English applications, DE for German and FR for 
French163. Regardless of which offices become the reference ones, with an average application fee of 
EUR 360 charged by qualifying NPOs, the remaining NPOs would lose around EUR 0.84 million 
annually in application fees (on average around EUR 32 300 per NPO)164. Additional variable 
translation fees of EUR 870 per language of designated Member State would probably be charged to 
cover translations (around EUR 20 000 for the whole EU). Non-reference offices would get their SPC-
related tasks considerably facilitated as they would receive SPC applications that had been already 
examined (and cleared of any formal errors, if detected). As analysed in PO1, NPOs would have to 
invest in the readjustment of their IT systems to common publication rules and/or invest in creating a 

161 Note there are 24 official EU languages, but translation would be needed for 23 (24 less the language of 
the application). 
162 For countries with several official languages (e.g. BE has three: French, Dutch and German) it was 
assumed that all applications can be in any of these languages, hence the sum is above 100 % and that all 
non-European applicants will apply in English. For details see: Annex 5C. 
163 AT (German-speaking) and BE (French-speaking) offices are using SPC examination exemptions thus 
are not considered. 
164 See: Annex 5F, Table 69. 

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central publication hub for the EU. The one-off cost of the latter is expected at EUR 19 000 per NPO 
with annual maintenance cost of around EUR 2 200165.  

Impact on applicants and follow-on manufacturers 

Regarding problem 3 (cost and burden of applying and maintaining SPC protection), option PO2 can 
be expected to reduce the cost (both administrative fees and attorney fees, as well as translation 
related to filing and prosecution) of applying for SPC protection. This option would introduce a single 
filing of an SPC application at an NPO that would undergo one substantive examination followed by 
an automatic recognition by the EU Member State designated in the SPC application (no additional 
re-examination by the other NPOs is expected). The application forms and internal processes would 
continue to differ between NPOs. Maintenance costs would not be reduced, as the outcome of this 
option is a bundle of national SPCs and therefore Member States would be expected to continue to 
request annual maintenance fees as currently.  

SPC applicants would be able to choose one reference office to examine their file. This should lead to 
an increase of predictability and legal certainty regarding SPC protection in the EU. Divergent 
examination outcomes for the same product would be eliminated. In addition, the quality of 
examinations should improve, as only NPOs verifying all conditions stipulated by the SPC Regulations 
could qualify as a reference office (therefore meeting expectations of follow-on producers - 86% of 
whom thought NPOs should check all conditions)166. However, improvements in predictability would 
be limited by the fact that some reference offices could be more lenient than others, and each 
reference office could adopt/change its own standards of assessment. Consequently it is vital that 
common guidelines developed in PO1 are followed. The date on which SPC is granted in each 
Member State could still slightly differ due to length of internal processing in each NPO. This option 
cannot provide unitary SPC protection for unitary patents understood as a single IP title for the EU, 
but a bunch of national patents.  

This option would, to some extent, boost transparency because as in PO1 each NPO would be 
expected to publish the same kind of information in comparable formats. Alternatively, a network of 
reference offices could establish a common publicly available database on common SPC applications, 
updated with national SPCs information. Nevertheless, follow-on producers and health sector 
procurement offices would need to consult each NPO database to gain a complete picture of the 
market, unless a more integrated data exchange system is agreed between the NPOs. This should 
produce individual savings of around EUR 40 000 (approximate cost of acquiring commercial dataset 
with comparable data) and EU wide annual savings of EUR 12 and 1 million respectively. Follow-on 
producers and health sector would also gain opportunity to influence the SPC granting process, as 
each reference office should allow for submission of third party observations.  

One of the main advantages of PO2 is that its implementation is not linked to that of the unitary 
patent system, and not restricted to those Member States (currently 17) that are not part of the 
enhanced cooperation area. It can be operative for all EU Member States, as soon as the related 
legislation is adopted. 

165 Based on the estimated cost of developing a central database of EUR 0.5 million that could be shared 
equally between all NPOs. See: Annex 5F. 
166 See: Annex 2. 

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Nonetheless, this option could create forum shopping across the internal market (e.g. SPC applicants 
might file applications in NPOs perceived as more lenient when assessing the requirements for 
granting SPC applications). It would improve harmonisation between national decision-making 
regarding SPC applications only as far as guidelines can allow (discussed under PO1). 

This option is expected to reduce the cost of applying for five-year-long SPC protection covering the 
whole EU by approximately 18% (due to a single application fee, a single attorney fee, as well as 
potentially limited translation costs). This would result in savings of around EUR 44 200 per applicant 
167. Savings on attorney fees would at the same time represent a loss of income for this group 
estimated at EUR 52 000 per SPC application. 

Table 4: PO2 costs and savings to applicants for receiving EU27 wide, five year long SPC protection  

EUR per application 

Savings vis-à-vis baseline 

Filing fees 
Maintenance fees for 5 years 
Translation costs 
Agent/attorney’s fees 
Total 
Source: In-house estimations, numbers rounded to 100s, see: Annex 5E 

20 400 
183 000 
 200 
2 000 
205 500 

Stakeholder feedback 

-11 600 
 0 
3 800 
52 000 
44 200 

On 21 October 2019, the Group of Industrial Property Policy experts from EU Member States 
discussed the possibility of creating a mutual recognition mechanism for the grant of SPCs across EU 
Member States. The majority of Member States expressed the view that a system based on a mutual 
recognition of SPC was not desirable. 

In the Allensbach survey168, in response to question Q70 asking which one of the listed authorities 
should grant unitary SPCs, only 6% of respondents supported such organisational setting (i.e. 3 
originators and 16 generics companies chose “national patent offices based on a mutual recognition 
system” as the best option). By contrast, around 85% of originators supported this option in the 
Commission public consultations169. 

6.3.  PO3:  Centralised  filing  and  examination  of  SPC  applications  resulting  in  a  non-

binding opinion 

Linguistic regime 

For reasons of accessibility (especially to SMEs) and transparency, PO3 to PO5 foresee that the SPC 
application filed with the examination authority, third party observations and the outcome of SPC 
examinations should be available in all 24 EU languages. Other language combinations are analysed 
in Annex 5C. 

Consequently, translation costs would be generated in the examination authority which needs to 
process applications and third party observations in its working language(s) (e.g. for EPO: German, 
English, French; EUIPO: German, English, French, Italian and Spanish; EMA: English). Additionally, in 

167 Or 23 % cheaper in case of an average SPC (covering 20 Member States for 3.5 years). 
168 See: Annex 2, Figure 13. 
169 See: Annex 2, Table 28. 

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case of PO3-4 the examination authority would need to translate the decision into languages of the 
designated NPOs.  

Translation costs relating to the application itself are expected to be low. A standard application form 
would be available in all languages. Much of it is about information not requiring any translation, 
such as the references of the basic patent and of the relevant marketing authorisation (already 
translated)170, and in most cases the identification of the product. Additionally, as discussed under 
PO2, between 78% and 90% of applications have historically been filed in English, German and 
French, so in the working languages of the authorities considered. Translation of third party 
observations and of the SPC dossier for each designated NPO is expected to be the main cost-driver 
responsible for up to 9% and 65% of translation costs respectively.  

English, French and German as the preferred languages for applying for an SPC were the first choice 
for originators (78%) and patent attorneys/lawyers (63%) and the second for follow-on producers 
(25%). The follow-on producers added Italian and Spanish to the three above as their preferred 
choice (34%). All EU languages were selected by 19% of follow-on producers, 8% of patent offices 
and 3% of originators. The language preferences are similar when it comes to publication of the 
granted SPCs. Finally, the healthcare sector (e.g. hospitals, health ministries, pharmacists) would 
welcome SPC publication in English, French and German (46%) followed by all EU languages (38%)171. 

Annual translation costs for the central authority in respect of approximately 100 SPC applications 
are expected to be around EUR 3 million172. The bulk of such cost is due to translations to national 
languages of NPOs when transmitting the opinion of the central authority. Machine translations (if of 
sufficient quality) could limit the translation costs.  

The choice of an examination authority 

Under options 3 to 5, a dedicated authority should be designated to conduct SPC examinations. All 
authorities considered (EUIPO, EPO, EMA and EFSA) are potentially suitable for that task.  

When vesting an institution with SPC responsibilities a few criteria should be considered. First, there 
is the accountability to the EU public, in particular the European Parliament. Second, there is the 
need for alignment with the EU’s overarching political values and current policy priorities. Third, 
experience with substantive SPC assessment, and more broadly post-grant patent law, is relevant. 
Last but not least, the possibility of judicial review by EU Courts is of an appreciable importance.  

The EPO has been granting European patents for nearly four decades; hence it has accumulated 
valuable practical expertise in similar matters or functions (including its Boards of Appeal). It will also 
be granting unitary patents. However, the EPO is not an EU body, thus any decision to enhance or 
modify its mandate (e.g. amending fees) would go beyond the competences of the EU and require 
the consent of all members of the European Patent Organisation (39 countries including 12 non-EU 
countries). It is impossible to foresee whether or not the European Patent Organisation members 
would agree to take up a new duty related to SPC examination, especially if it didn't affect all the 
contracting parties. Finally, the decisions of the EPO are not subject to the review of the CJEU, nor to 

170 The centralised marketing authorisation issued by the EMA is already officially available in all official 
languages of the EU. 
171 See: Annex 2, Table 30. 
172 It would equal roughly EUR 3 million in PO4 and EUR 1 million in PO5. See: Annex 5D, Table 58. 
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the scrutiny of the European Parliament. Full and clear accountability of the granting body was 
requested by the main European association of generic and biosimilar industries.  

These concerns do not affect EU agencies. When looking at experience in administering IP rights, the 
EUIPO would be best equipped to take up the role of centralised SPC examination authority, while 
the current duties of the EMA/EFSA are probably the least related to such new tasks. Furthermore, 
entrusting the EMA/EFSA with SPC evaluation and granting would also imply a split in the registration 
of SPCs for medicinal products (EMA) and PPPs (EFSA), creating room for disparity of practices.  

If the role of the examination authority is taken up by any of the above organisations, a specific 
department for the implementation of the task related to the centralised SPC procedure should be 
set up. Alternatively, the substantive examination could be conducted by a pool of national SPC 
examiners (a “virtual office”) acting alone or under the administrative support/coordination of a 
central body. This would allow to benefit from the experience of national SPC examiners, gathered 
through national procedures. A self-standing virtual office would most likely require one coordination 
office, thus cost-wise it would be similar to choosing an agency. It would also appear to be legally 
impossible for a virtual office itself to grant unitary SPCs as in PO5173.  

A system of compensation to national offices (loss or SPC revenue, remuneration to examiners) 
should also be set up (e.g. EUIPO already has a system of sharing its surplus with Member States)174. 
Key characteristics and consequences stemming from a decision in favour of any of the above 
institutions is presented in Table 46 in Annex 5C.  

Around 85% of originators in the public consultation preferred that NPOs acted as such authority 
(either as virtual office, or through mutual recognition (PO2)). The EPO was chosen by 48% of follow-
on manufacturers and 6% of originators. The EUIPO was selected by only 1-2% of those 
respondents175. Similarly, 54% of respondents to the Allensbach survey were in favour of establishing 
a virtual patent office composed of examiners from national patent offices176. The second most 
supported choice was the EPO (25%), followed by the EUIPO (8%) and the EMA (7%). The virtual 
office solution shows that stakeholders recognise that SPC expertise is located in NPOs. High support 
for the EPO can be due to the fact that SPC stakeholders are most familiar with this organisation as it 

173 In practice this would mean that one of the NPOs is issuing a unitary SPC to cover the whole EU in case 
of PO5, which in itself does not seem to be legally possible given that the unitary SPC would have effect in 
all Member States participating in the unitary patent system. 
174 Pursuant to Article 172 of Regulation (EU) 2017/1001 of 14 June 2017 on the European Union trade 
mark, the EUIPO shall offset certain costs incurred by national IPOs. More generally, Article 152 provides 
for financial support which may be given from the EUIPO to national IPOs for projects in the framework of 
promoting convergence of practices and tools. Similar provisions or amendments to allow for fee sharing 
could be envisaged here. The EPO already has a system in place for sharing a fraction of the renewal fees 
with Member States: European Patent Convention (Article 39(1)) states that ‘Each Contracting State shall 
pay to the Organisation in respect of each renewal fee received for a European patent in that State an 
amount equal to a proportion of that fee […]’ and Regulation (EU) No 1257/2012 of 17 December 2012 
implementing enhanced cooperation in the area of the creation of unitary patent protection states in 
Article 13 that ‘The EPO shall retain 50 per cent of the renewal fees referred to in Article 11 paid for 
European patents with unitary effect. The remaining amount shall be distributed to the participating 
Member States in accordance with the share of distribution of the renewal fees set pursuant to Article 9(2)’. 
175 See: Annex 2. A high number of follow-on producers (38 %) chose the creation of a new EU agency. 
This option, however, is not considered, as it would involve disproportionate costs (new management, 
infrastructure, personnel) for approximately 100 SPC applications a year. 
176 MPI (2018) – Annex III Allensbach survey, Question 70 (see: Figure 30 in Annex 5C). 

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deals with patents, while EU agencies are not associated with patents by stakeholders, which could 
explain the low support they enjoy. 

Though such preferences are divergent, the choice in favour of the EUIPO is compatible with 
Medicines for Europe’s (largest association of follow on producers in the EU) view that the granting 
authority for the unitary SPC should be accountable to the EU Institutions (e.g. CJEU and European 
Parliament) given the impact of SPC protection on access and affordability of medicines. 

Table 5: Merits of potential candidates for the central authority 

Selection 
criteria-> 

Accountability to 
the EU public 

Alignment with the EU 
policies 

EPO 

(0/+) Some, 
indirectly, as EU 
MS have 70% of 
the votes 

EUIPO 

(++) Full, EU 
agency 

(0/+) Policy reflects 
views of all 39 member 
states; changes require 
the majority of them to 
agree  
(++) Implements EU 
policy/legislation  

EMA and 
EFSA  

(++) Full, EU 
agencies 

(++) Implement EU 
policy/legislation 

Technical expertise 
with SPC 
examination 
(0) None, only 
expertise in European 
patents, collaboration 
with NPOs 

(0) None, but 
experience with other 
IP rights, collaboration 
with NPOs 
(0) None, expertise in 
marketing 
authorisations 

(+) Accountable 
to the MSs 
concerned 

Virtual 
office of 
NPO 
experts 
* Stakeholders support based on MPI (2018) – Annex III Allensbach survey 
Source: Own analysis 

(++) Implement national 
IP policy, as well as 
existing EU 
policy/legislation   

(++) Skilled SPC 
experts already 
available 

Other considerations* 

(++) Around 25% support from 
stakeholders regarding new SPC-
related tasks  

(+) Around 8% support from 
stakeholders 

(+/0) Around 7% support from 
stakeholders;  
SPC responsibility split between 
EMA (medical SPCs) and EFSA 
(PPP SPCs) 
(++/-) Highest stakeholder support 
at 54%; no coordination centre; not 
suitable for granting a unitary SPC 
(PO5) 

The table above compares merits of different choices for the central authority. Against such a multi-
dimensional backdrop none of these organisations is perfect for the job. It would seem however, that 
the best result in terms of the three criteria identified at the beginning of this section could be 
achieved by combining the expertise of NPOs with the EU accountability of the EUIPO (which already 
implements various aspects of the EU IP policy). Such solution would allow to implement both 
centralised (PO3 and 4) and unitary (PO5) SPC activities. The new authority would be tasked with 
setting up a network of examiners from NPOs, creating guidelines and standard application forms, 
developing working methods and an IT system, as well as dealing with the daily routine of 
administering the SPC procedure (implying expenses related to salaries of examiners and 
translations).  

Cost-wise, the establishment of a centralised SPC processing function in an existing authority is 
expected to create one-off costs of around EUR 1.4 million (including EUR 0.5 million for creating a 
central database) and recurrent annual costs (without translations) of around EUR 0.75 million (PO3). 

In PO3 the examination authority would only charge a single application fee. In order to cover all 
costs (depreciation of one-off cost and recurrent cost) the minimum fee should amount to around 

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EUR 19 500, accompanied by translation fees of EUR 870 per language, i.e. per designated Member 
State (thus around EUR 20 000 for the entire EU)177.  

Impact on NPOs  

As the application fee of the examination authority would be high (at least 3.8 times higher than the 
sum of national application fees), NPOs might continue seeing demand for national SPCs, limited only 
by other costs that applicants would need to bear such as national attorney fees, or by the hassle of 
dealing with several offices and national procedures, in various languages and by using national 
agents where required (unquantifiable). 

In case all applications arrived via the central authority, the workload of NPOs relating to SPCs would 
be substantially diminished. The patent offices would also lose income from application fees, 
amounting to up to EUR 32 600 per NPO (around EUR 0.88 million for the EU)178. NPOs would still be 
entitled to charge maintenance fees. At the same time, a centralised examination scheme able to 
cover all Member States will result in savings of resources at NPOs, compared to today’s situation 
where multiple examination procedures are (redundantly) conducted in parallel in several Member 
States. 

A number of examiners from NPOs would be carrying out substantive analysis of SPC applications for 
the examination authority. This task is expected to be equivalent to the involvement of two persons 
working full time to cover all SPCs per year (2 FTEs/year). It can of course be spread among a higher 
number of persons working on SPCs only occasionally. Their remuneration could be covered by 
maintenance fees charged subsequently by each designated NPO, or they could be paid by the 
central authority directly. The risk of the former solution is a perverse incentive to give a positive 
opinion, as otherwise no income would follow for that application. A further problem, could arise if 
examiners came from countries where protection is not sought, as it would further increase the costs 
of application process borne by the central authority, while the NPOs of countries that have not 
contributed to the evaluation would collect substantial amounts for maintenance fees. To avoid such 
dubious incentives, the examination authority should pay examiners directly. The NPOs additional 
income from such transfers is estimated at EUR 0.62 million EU-wide. The net result of this option on 
all EU NPOs is thus estimated at – EUR 0.26 million (or – EUR 9 500 per NPO)179. 

As regards non-binding opinions issued by the central authority, it is expected that NPOs would 
implement them without reopening the file, at least in the case of positive opinions – mainly because 
it would guarantee the maintenance of fee income for up to five years. For the same reason, 
however, NPOs might be tempted to reinvestigate negative opinions. Re-examination might also be 
triggered by appeal by an unsatisfied applicant. In any case, historically only around 20% of decisions 
were negative180, so the re-opening should not concern more than around 20 applications a year. 
NPOs may also reinvestigate positive SPC decisions, if for various reasons they consider that the 
central authority is too lenient in granting SPCs. The likelihood of NPOs issuing divergent opinions 

177 Based on EUIPO estimates. See: Annex 5D. 
178 See: Annex 5F. 
179 Impact per NPO assumes that examiners remuneration is equally distributed between all NPOs. See: 
Annex 5F for details. 
180 Data for 2004–2014. Source: Mejer, M., 25 years of SPC protection for medicinal products in Europe: 
Insights and challenges, European Commission, DG GROW, 2017, p. 13. 

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could be limited if the central authority guidelines became a reference point also for NPOs, thus 
contributing to harmonisation of practices. Moreover, if the right to deviate from the central 
examination authority’s opinion was restricted only to changes in factual circumstances (e.g. patent 
revocation, marketing authorisation withdrawal), the room for divergence would be almost 
completely eliminated.  

Finally, it is also difficult to propose maintenance fees that would be much lower (so that the 
centralised procedure is even more cost-attractive when compared to the national route), because 
the central examination authority must bear all the cost of SPC examination (including translations), 
while not being able to recuperate it later via maintenance fees - the latter would be still collected by 
the NPOs. At this stage, it is not expected that NPOs would either lower the maintenance fees or 
remove them completely. 

Impact on applicants and follow-on manufacturers 

PO3 should significantly reduce the problem of divergence, as this option implies a single filing of the 
SPC application that would undergo one substantive examination by the same authority (unless the 
NPOs’ discretion to reinvestigate files goes beyond changes in factual circumstances, as explained 
above). As no possibility to centrally challenge the non-binding opinion is envisaged, dissatisfied 
applicants would need to launch appeals in all designated Member States. In any case, such 
divergence is not expected to concern more that 20% of cases.  

Applicants will be required to present a centralised marketing authorisation181 when applying for an 
SPC based on the new rules. This is in line with the current situation where most of the national 
applications for medicinal SPCs are based on centralised marketing authorisations182. Although using 
national marketing authorisations would not be impossible, it could cause additional difficulties due 
to possible differences between the national decisions (such as divergent identification of products 
concerned183, different permitted uses or different issuing dates184). Mitigating these differences 
within the national marketing authorisations would entail a considerably higher examination 
workload for the authority. It should be noted, however, that a majority of originators and follow-on 
manufacturers called for allowing national marketing authorisations in the process185.  

The centralised procedure reduces applicants’ need for national legal assistance (estimated at EUR 
2 000 per country), translations of applications and costs of dealing with separate authorities. At the 
same time, national appeals would entail the need to rely on legal advice in each designated country. 
The EU wide loss of income for IP attorneys is estimated at EUR 0.4 million. Nevertheless, the sum of 

181 The marketing authorisations for PPPs are based on a mutual recognition system. This however should 
not pose a significant problem, as there are much fewer SPC applications for PPPs than for medicinal 
products (see: Section 2.2). Differences here could be mitigated more easily by the national authority. 
182 See: Annex 5B, Table 41. 
183 Max Planck Institute for Innovation and Competition, Study on the Legal Aspects of Supplementary 
Protection Certificates in the EU, 2018, p. 586: ‘According to what is reported in the literature, in some 
national marketing authorisations “the active substance is only described in terms of the active moiety, and 
not in the terms of the actual substance used, which may be a salt”. In others, by contrast, the active 
substance is identified by referring to the active part of the compound, which can be shared by a several 
variants (salt, esters).’ 
184 This is significant, as an SPC application can be filed only within 6 months after the grant of the MA. 
See: Article 7 of Regulation 469/2009. 
185 See: Annex 2, Table 31. 

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central application and national maintenance fees in PO3 for SPCs protected in the whole EU is 
expected to be higher than the sum of national fees by 16% due to added cost of the examination 
authority. Taking all the above factors into consideration, PO3 would be cheaper than the national 
route for applicants seeking five-year-long SPC protection in 17 or more Member States. In case of 
the SPC sought in EU27 for the full term of five years, PO3 is expected to be on average 6% cheaper 
than the baseline186. 

Despite all that, results of the public consultation suggest that for most stakeholders SPC costs are 
less important than legal certainty/predictability and their ability to monitor the status of SPCs. It is 
challenging to quantify the former factors, though.  

By creating one central, multilingual SPC database187 covering all SPCs (granted by the central 
procedure and preferably also by the national route) PO3 would significantly decrease the burden of 
monitoring SPC protection for SPC users e.g. hospital procurement, and competing generics and 
biosimilars. These savings are estimated at around EUR 40 000 per company with the EU wide saving 
of around EUR 1 and 12 million respectively. Nevertheless, the completeness, accuracy and 
timeliness of data would depend on cooperation among NPOs. They would provide information on 
whether they followed the non-binding opinion, as well as on any changes in status (e.g. withdrawal 
of the application or revocation of the patent). Any failures or delays in updating the database could 
mislead or confuse market participants and consequently undermine the credibility and usefulness of 
this dataset. Additionally, follow-on producers would be able to influence the SPC granting process 
and provide written observations in any EU language before the decision on granting an SPC is made.  

PO3 would not provide unitary SPC protection based on unitary patents, but a bundle of national 
SPCs. As in PO2, the implementation of PO3 is not linked to the unitary patent system, and can cover 
all Member States irrespective of whether they are part of the enhanced cooperation area of the 
unitary protection.  

Table 6: PO3 costs and savings to applicants for receiving EU27 wide, five year long SPC protection  

EUR per application 

Savings vis-à-vis baseline 

Filing fees 
Maintenance fees for 5 years 
Translation costs 
Agent/attorney’s fees 
Total 
Source: In-house estimations, numbers rounded to 100s, see: Annex 5E 

39 500 
183 000 
 0 
12 800 
235 300 

Stakeholder feedback 

-30 700 
 0 
4 000 
41 200 
14 500 

The idea to develop PO3 was a result of analysis of earlier consultations where stakeholders opted 
for a unitary SPC and granting by NPOs188, hence PO3 combines “unification” at the SPC application 
examination level with national SPC granting.  

This was also suggested by e.g. the European Federation of Pharmaceutical Industries and 
Associations (EFPIA) expressed that “As the timeline for the entry into force of the unitary 

186 Or 3 % cheaper in case of an average SPC (i.e. covering 20 Member States for 3.5 years). 
187 As the complexity of the search process increases with the number of languages, the proposed standard 
form for e-submission of SPC should be predominantly based on structured input (e.g. pre-defined data 
fields sourced from dedicated dictionaries). 
188 See: Annex 2, Table 26 and Table 28. 

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patent/Unified Patent Court system remains unknown, EFPIA commends the Commission’s reflection 
to provide an intermediate solution. A single application portal and a unified grant mechanism can be 
helpful steps towards a unitary SPC”. 

During the Commission expert Group on Industrial Property Policy (GIPP) meeting in November 2022, 
five Member States expressed preliminary support for this option out of 17 that took the floor.  

6.4.  PO4: Centralised filing and examination of SPC applications resulting in a binding 

opinion 

Linguistic regime 

The rules for the use of languages would be as in PO3 (see: section 6.3). 

Impact on the examination authority 

Impact under this option would be as in PO3 (see: section 6.3), albeit the creation of a review 
mechanism (that allows for the authority’s binding decision to be challenged under a simplified 
procedure) would increase annual costs to EUR 1.5 million. Since the examination authority could 
only charge an application fee, to cover all the cost it should amount to around EUR 20 800 plus 
variable translation fee of EUR 870 per language of designated Member State (around EUR 20 000 for 
the whole EU)189. 

Impact on the NPOs  

The key difference between PO3 and PO4 is that the NPOs would be expected to follow the binding 
opinion with no room for discretion. While most Member States/NPOs should recognise the merits 
of a binding opinion in terms of EU-scale coherence, some of them might possibly deplore that the 
central examination authority is more strict, or less strict, than their average national practice. 
However, such concerns would be mitigated by involving NPO examiners in the centralised 
examination process. 

The remaining impacts on the NPOs would remain as described in PO3 (in particular, the 
maintenance fees would be paid to NPOs). Given the relatively high application costs of the 
centralised procedure190 compared to a single national SPC application (and other factors such as the 
requirement that the centralised procedure would only be available where the basic patent is a 
European patent and, for medicinal products, where the product was centrally authorised), the 
demand for national SPCs is expected to diminish but not disappear entirely. As in PO2 and PO3 the 
maximum income loss of NPO is estimated at EUR 20 000 per office and EUR 0.5 million EU-wide 
annually. 

Impact on applicants and follow-on manufacturers 

A single examination procedure and a single decision on granting protection as foreseen in PO4 
would eliminate nearly all currently observed sources of divergence described in the problem 
statement. The central procedure would substantially increase legal certainty and predictability. 
Although the central fees are higher in comparison to the national route, this option produces overall 
cost savings of around 10% for applicants on attorney fees and translation for a EU-wide protection 

189 See: Annex 5D for details. 
190 See: Table 7 below. 

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for five years191. It would also be easier to contest the negative opinion on granting an SPC by filing a 
request for review. The central review system would help companies economise on attorney fees. 
This option would bring benefits to all EU countries regardless of their participation in the enhanced 
cooperation. However, it would not provide unitary SPC protection for the unitary patents, but a 
bundle of national SPCs. 

Table 7: PO4 costs and savings to applicants for receiving EU27 wide, five year long SPC protection  

EUR per application 

Savings vis-à-vis baseline 

Filing fees 
Maintenance fees for 5 years 
Translation costs 
Agent/attorney’s fees 
Total 
Source: In-house estimations, numbers rounded to 100s, see: Annex 5E 

40 800 
183 000 
 0 
2 000 
225 800 

-32 000 
 0 
4 000 
52 000 
24 000 

A central database envisaged under PO4 would provide an accurate and timely picture of the SPC 
status covered by the central procedure, as data feeds could occur once the binding decision is 
taken. Follow-on producers and health sector procurement offices would benefit from up-to-date 
information on SPCs with estimated savings as in PO3 of EUR 40 000 per firm or EUR 12 and 1 million 
EU-wide respectively. As in PO3 follow-on produces would also be able to submit written 
observations before an SPC is granted.  

Loss of income of IP attorneys is equal to the gain of applicants and amounts to EUR 52 000 per case 
and EUR 5.2 million EU-wide. 

European SPC title 

An alternative model could be based on the EPO system for European patents. The examination 
authority would issue one central “European SPC title” which would be subsequently registered in 
each designated Member State. Such a title would have exactly the same economic consequences as 
described above. It might, however, require a different legal basis – Article 352 TFEU192 - which 
requires unanimity of the Council and the consent of the European Parliament. This means that the 
Parliament would have the power to accept or reject a legislative proposal by an absolute majority 
vote, but could not amend it. Therefore, the Parliament would have less influence on the contents of 
the legislative proposal than in the ordinary legislative procedure.  

Stakeholder feedback  

The idea to develop PO4 was a result of analysis of earlier consultations, where stakeholders opted 
for a unitary SPC and granting by NPOs193, hence PO4 combines “unification” at the SPC application 
examination level with national SPC granting.  

This was also suggested by e.g. the European Federation of Pharmaceutical Industries and 
Associations (EFPIA) expressed that “As the timeline for the entry into force of the unitary 

191 Or 8 % cheaper in case of an average SPC (covering 20 Member States for 3.5 years). Overall this 
options is cheaper than the baseline for applicants seeking protection in more than 13 Member States. 
192 Consolidated version of the Treaty on the Functioning of the European Union, Part seven: General and 
final provisions, Article 352 (ex Article 308 TEC), OJ C 326/47 (https://eur-
lex.europa.eu/LexUriServ/LexUriServ.do?uri=CELEX:12008E352:EN:HTML). 
193 See: Annex 2, Table 26 and Table 28. 

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patent/Unified Patent Court system remains unknown, EFPIA commends the Commission’s reflection 
to provide an intermediate solution. A single application portal and a unified grant mechanism can be 
helpful steps towards a unitary SPC”. 

During the Commission expert Group on Industrial Property Policy (GIPP) meeting in November 2022, 
eight Member States expressed preliminary support for this option out of 17 that took the floor.  

6.5.  PO5: A ‘Unitary SPC’ complementing the unitary patent 

Linguistic regime 

The rules for the use of languages would be as in PO3 and PO4. However, as the unitary SPC would 
be granted directly by the central authority, 2/3 of translation costs relating to the transmission of 
the SPC dossier to the designated NPOs would be eliminated. This would result in a translation 
budget of around EUR 1 million, or EUR 10 000 per SPC application. For reasons of transparency and 
accessibility it could be advantageous that firms from UP Member States are allowed to 
communicate with the central authority in their own language. 

Impact on the examination authority 

As in PO3 (see: section 6.3), but the examination authority would (in addition to assessing 
applications) grant unitary SPCs, and collect maintenance fees. Since the costs can be spread now 
over the lifetime of each SPC, the application fee could be lowered to be more competitive vis-à-vis 
NPO fees and the outstanding cost could be recuperated via maintenance fees. Nevertheless, an 
application fee that would be too low could create a bias towards granting SPCs to recover all costs 
as they are generated mostly during the registration phase. It would also mean that successful 
applicants would subsidise unsuccessful ones by paying higher maintenance fees. As discussed in 
Annex 5D, the easiest solution is to charge all fees at the application stage with no central 
maintenance fees. This would mean fee of approximately EUR 28 900.  

Impact on NPOs  

As long as the unitary SPC fees are cost-based, they would be up to four times lower than total fees 
charged by the 17 UP Member States for a five-year-long SPC194. Taking all costs into account it 
appears that the national SPC route would likely be chosen only if protection is sought in less than 
four Member States195 – or where the conditions for obtaining a unitary SPC (e.g. the existence of a 
basic European patent with unitary effect and, for medicinal products, of a centralised authorisation) 
are not met. As on average an SPC covers 20 countries, it is safe to assume that for the UP countries 
most/all applications would be for a unitary SPC (at least in the medium/long term, as explained 
below). If NPO experts were to be involved in the central examination network, they would receive 
remuneration directly from the examination authority to the tune of EUR 0.75 million EU wide. The 
total loss of income for the 17 UP NPOs is estimated at EUR 8.7 million (EUR 512 900 per NPO), which 
is equivalent to 2.6% of their income from patents196.  

However, it is to be expected that NPOs will be affected in a very progressive manner only by the 
introduction of a unitary SPC, due to: 

194 Almost three times lower for a typical SPC lasting 3.5 years. 
195 Less than five Member States in case of an average SPC lasting 3.5 years. 
196 See: Annex 5F. 

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 

 

the  progressive  penetration  of  the  unitary  patent  in  the  first  years  following  its 
introduction  –  both  because  of  users’  initial  cautiousness  (as  it  happened  when  the 
European  patent  was  launched)  and  of  legal  factors  (e.g.  where  the  conditions  for 
attributing unitary effect to a certain European patent are not met), and 
the fact that the criteria for granting a unitary SPC may not be fulfilled in each and every 
case.  

Impact on applicants and follow-on manufacturers 

The unitary SPC would make it possible to extend a unitary patent in a unitary manner. For 
applications requesting unitary protection in the UP Member States there would be a single 
procedure and therefore no scope for divergent national outcomes197. Legal certainty and 
predictability could be assured. Costs associated with the SPC (application fee, maintenance fees, a 
single attorney fee, no translations) would be five times lower than seeking five-year-long SPC 
protection in each UP Member State separately198. The central database would provide a full, 
accurate and up-to-date picture of the status of unitary SPCs, while as regards nationally granted 
SPCs it would continue to rely on input from NPOs.  

Nevertheless, this option does not cover all EU countries and would not provide any solution 
concerning the 10 Member States that will initially be outside the UP system. Thus, applicants 
wishing to obtain protection in the whole EU199 would need to file 10 additional SPC applications. In 
this case, the cost of EU-wide protection for five years would amount to half of the cost of the 
baseline. For the applicants filing with NPOs outside the UP MSs, the problems of the baseline would 
continue (divergent national assessments or dates of granting SPCs). Follow-on producers and health 
sector procurement centres would need to monitor ten additional national databases. This means 
that their savings would be proportionally lower than in PO3-4 and amount to around EUR 25 000 
per firm, or EUR 7.6 and 0.7 million per year respectively. That said, the UPC Agreement is open to all 
Member States, and more may be expected to join in the medium and longer term. 

Even taking the above factors into consideration this option would produce savings of almost 50% for 
SPC applicants in comparison with the baseline for an EU-wide, five-year-long SPC200. This translates 
into saving of EUR 122 400 on average per applicant on a five-year-long SPC protection and may be a 
key factor in case of smaller firms. Legal attorneys would lose the equivalent of what applicants save 
– around EUR 32 000 per SPC, or EUR 0.32 million for the whole EU.  

Table 8: PO5 costs and savings to applicants for receiving EU27 wide, five year long SPC protection  

Filing fees 

EUR per application 

Savings vis-à-vis baseline 

31 900 

-23 100 

197 In case of PO5, the requirement to hold a central marketing authorisation is even more important than in 
PO3 and PO4. In addition to concerns and differences between national MAs mentioned in Section 6.3, 
since a unitary SPC is valid in the territory of all UP Member States, this requires uniformity in the 
underlying MAs. Should one national MA be revoked, the unitary SPC would thus cover a Member State 
without a basis (if the unitary SPC should be considered not to have effect in the Member State concerned it 
would thus contradict its unitary nature). 
198 Almost 4 times lower in case of SPC lasting 3.5 years. 
199 Member States currently outside the UPC Agreement: CY, CZ, EL, ES, HR, HU, IE, PL, RO and SK. 
200 Or 62 % in case of an average SPC covering 20 Member States for 3.5 years, whereby the group of 20 
Member States is assumed to consist of 17 UP Member States and 3 non-UP Member States. This option is 
cheaper than the baseline for SPCs covering more than 3 Member States in case of 5-year-long protection), 
or more than 4 Member States in case of 3.5-year-long-protection. 

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Maintenance fees for 5 years 
Translation costs 
Agent/attorney’s fees 
Total 
Source: In-house estimations, numbers rounded to 100s, see: Annex 5E. 

71 900 
1 600 
22 000 
127 400 

Stakeholder feedback  

111 100 
2 400 
32 000 
122 400 

The joint position paper of 2015 of the European industry associations of innovators201 in the field of 
pharmaceutical and agrochemicals (ECPA, EFPIA and IFAH-Europe), i.e. the users of the SPC system, 
supports the concept of unitary SPCs being granted on the basis of unitary patents. In an EFPIA 
statement on the Commission SPC evaluation report of 2020, EFPIA expressed that “We particularly 
await the entry into force of the Unitary Patent & Unified Patent Court and further support the 
creation of a unitary SPC: one SPC for the EU rather than one SPC by country […] the unitary SPC can 
simplify the application procedure, reduce duplication and facilitate a consistent application of the 
SPC Regulation across the EU.”202 There was a wide support to creation of a unitary SPC across all 
respondents to the public consultations (see: table below). As well as among Member States 
participating in November 2022 GIPP meeting (11 out of 17 who expressed preliminary views). 

Table 9: Do you favour the creation of a unitary SPC title for the unitary patent? 

Yes 
No 

No. of answers 

Customers, 
health 

Patent offices, 
lawyers 

Follow-on 
manufacturers 

Agree answers only  Originators* 

Ministries and 
other public 
authorities 
100% 
0% 
5 
*response did not receive this question instead we report here those who chose “Create a unitary SPC for the unitary 
patent” as answer to Q37 “What would be your preferred option to improve consistent interpretation throughout the EU of 
the ‘substantive’ provisions of the SPC regulation (e.g. the scope of protection, eligibility of SPC protection)?”.  
Note: ”Don’t know“ and No answer not taken into account. Questions had slightly different formulations to each group but 
with the same meaning. 
Source: Public Consultations on Evaluation of SPC 

79% 
21% 
11 

98% 
2% 
55 

81% 
19% 
27 

74% 
n/a 
68 

Respondents from all groups (originators, follow-on producers, health sector representatives, patent 
offices and lawyers) were expecting (almost unanimously) the following benefits of a unitary SPC: 
higher legal certainty, the same protection across the EU, the reduction of registration, maintenance 
and SPC monitoring costs, easier licensing and access to joint procurement by group of Member 
States, as well as a boost to investments (see: table below). 

Table 10. The benefits of a unitary SPC – stakeholders’ views 

Agree answers only* 

Originators 

Follow-on 
manufacturers 

Customers, 
health 

Patent offices, 
lawyers 

Legal certainty 
Reduce cost/red tape of SPC-related 
litigation 
Same protection in all EU 
Reduce red tape relating to registration 
Specialised court 

94% 
98% 

98% 
98% 
98% 

100% 
100% 

x 
x 
94% 

85% 
83% 

x 
x 
71% 

91% 
71% 

92% 
86% 
86% 

Ministries and 
other public 
authorities 
100% 
100% 

100% 
80% 
100% 

201 European Federation of Pharmaceutical Industries and Associations, Proposal for a Unitary SPC, ECPA, 
EFPIA and IFAH-Europe Joint Position Paper, 2015 (https://www.efpia.eu/media/15414/ecpa-efpia-and-
ifah-europe-joint-position-paper-proposal-for-a-unitary-spc-july-2015.pdf). 
202 European Federation of Pharmaceutical Industries and Associations, ‘EFPIA reaction to SPC evaluation 
publication’, 2020 (https://www.efpia.eu/news-events/the-efpia-view/statements-press-releases/efpia-
reaction-to-spc-evaluation-publication/). 

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Reduce cost and red tape relating to 
monitoring SPC-protected products 
(freedom to operate) 
Reduce maintenance costs 
Make licensing easier 
Boost value of investments 
Make joint procurement by a group of 
EU countries easier 

x 

98% 
93% 
95% 
x 

98% 

x 
98% 
x 
x 

83% 

x 
x 
x 
75% 

x 

88% 
79% 
x 
x 

No. of answers 

51-64 
* the residual to 100% is the number of those disagreeing; x - response not available to that group of respondents 
Note: No answer and “Neither agree nor disagree” not taken into account (also in no. of answers provided).  
Source: Public Consultations on Evaluation of SPC 

43-56 

7-13 

14-25 

x 

100% 
100% 
100% 
x 

3-5 

6.6.  Common impacts  

The following section analyses impacts common to PO2-PO5. The impacts presented below are 
chosen because of their political and/or economic significance.  

6.6.1.  Biosimilar and generic market entry  

Although the proposed reform does not affect the core provisions of the SPC rules (such as 
conditions for granting, its scope or duration), but focuses mainly on the administrative simplification 
of the procedures, the relationship between the loss of exclusivity of SPC-protected products and the 
market entry of follow-on equivalents will undoubtedly form part of the discussion surrounding the 
proposed review. In particular, in case of the pharmaceutical sector, it could be claimed that a more 
efficient and coherent SPC system could, indirectly but adversely, affect access to less expensive 
generic or biosimilar medicines203. It could also be claimed that one could expect similar patterns in 
the agrochemical sector. 

Generics and biosimilar medicines play a key role in today’s pharmaceutical markets and health care 
systems. Since the introduction and codification of the SPC regime in 1993, the European and global 
markets for pharmaceuticals have undergone very significant changes. Above all, global demand for 
medicines has been increasing, with a significant switch towards generics and biosimilars204 that 
keeps public health expenditure in check. 

In this context, IQVIA data covering years 2010-2021 were used to verify whether market entry 
patterns differ significantly across the EU and how quickly the follow-on medicines actually start to 
compete with the original products. The results are presented in Figure 9 and indicate how much 
time (in months) it took for a first follow-on product to enter the market after the loss of exclusivity 
due to the SPC expiry205. The four-year period was chosen, as the average SPC duration is 3.5 years. 
The figure presents biosimilar and generic molecules separately, because the complexity of 
introducing these two types of products on the market differs significantly (i.e. it is much more 

203 It would as such extend a monopoly for pharmaceutical products concerned to Member States previously 
de facto not covered by any SPC. 
204 ‘All OECD countries view generic and biosimilar markets as an opportunity to increase efficiency in 
pharmaceutical spending, but many do not fully exploit their potential’. Source: OECD, “Generics and 
biosimilars”, 2022 (https://www.oecd-ilibrary.org/sites/fd887b83-
en/index.html?itemId=/content/component/fd887b83-en). See: Figure 31 in Annex 5C for further 
background data. 
205 The SPC dummy variable was estimated based on the relationship between the patent expiry date, the 
regulatory protection expiry date and a potential SPC expiry date – further details on the methodology are 
provided in Annex 4. 

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challenging in case of large biosimilar molecules). These different characteristics are also confirmed 
by the number of products captured in both parts of the graph – up to 10 products in case of 
biosimilar and 40 in generic molecules. Nonetheless, Figure 9 shows that in case of both types of 
products the speed of entry is much faster in lager and/or wealthier countries, which may be 
explained by the fact that market entry decisions are related to other factors than only the market 
exclusivity. In other words, in certain EU markets - especially the EU-10 enlargement countries - the 
entry of follow-on equivalents seem to be delayed when compared with the rest of the EU (it is not 
to say that the entry does not occur, but if it happens, this may take place within period longer than 
4 years)206. This said, it should be also added that, contrary to analysis presented in section 6.6.2, the 
present analysis does not adjust for the turnover of considered products207. Markets for high 
turnover products are known to be more contestable and hence entry delays can be expected to be 
shorter for products with higher usage (and higher related health benefits) across the population.  

Figure 9: Time-to entry of follow-on medicines over 1 to 48 months after the loss of exclusivity (LoE), by country - number of 
medicines that were previously covered by SPC  

206The same holds true if the analysis is carried out using all observations, irrespective of the reason behind 
the loss of exclusivity, except for a higher number of molecules captured (i.e. 4 years after the loss of 
exclusivity up to 200 molecules had at least one generic product available on the market, whereas in case of 
biosimilar molecules the number was around 30). See: Figure 31 in Annex 5C. 
207 Nonetheless, the market entry patterns across countries in both sections section are similar. 

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Source: In-house analysis based on IQVIA data covering molecules with the loss of exclusivity from 01/2010 onwards. 

It can be therefore concluded that a more centralised SPC system would not significantly slow down 
entry of follow-on products in smaller/lower income Member States, as these markets face delayed 
entries anyway, due to other factors than SPC208. Literature on the subject, as well as reports 
prepared by the industry corroborate the above asymmetry and point towards the price and 
reimbursement rules209, legal uncertainty connected to the country, quality and readiness of 
healthcare systems, differences in the value assessment process, overall levels of pharmaceutical 
spending, size of the market, etc.210 All these elements are outside the scope of the proposed 
initiative. 

The fact that follow-on market entry usually takes several years and is especially challenging in case 
of biosimilar products is also confirmed when looking at the sheer number of molecules (see Figure 
10 below). Only 15% of biological medicines had their first biosimilar product available on the market 
within less than 4 years. In case of smaller molecules (generics), the number grew from 28% of 
molecules in year one to roughly 1/3 of molecules having a follow-on equivalent in four years. 

208 The above is based on historic patterns, whereas in the future market access strategies of follow-on 
producers might well develop in a way that ensures more coherence across all parts of the EU. In such a 
case, the savings generated by generic entry would be higher than what the historic trends currently suggest 
(in that sense, the generic entry benefit calculations in this impact assessment could be seen a lower bound). 
On the other hand, policy efforts to assure the availability of pharmaceuticals in (so far) Member States that 
aren’t supplied might trigger new national SPC applications in those very Member States, thus affecting the 
future counterfactual as well. 
209 There are significant price differences between pharmaceuticals across the EU, but as mentioned earlier, 
the pricing of medicines remains a national competence. 
210 Medicines for Europe, Removing access barriers in Central and Eastern Europe: How can we ensure 
equitable access to medicines for all European patients?, 2022; European Federation of Pharmaceutical 
Industries and Associations, The root cause of unavailability and delay to innovative medicines, analysis 
developed with the support of Charles Rivers Associates (CRA), 2020. 

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Figure 10: Share of molecules with a follow-on products in 1 to 4 years after the loss of exclusivity (LoE) [%]  

Source: In-house analysis based on IQVIA data covering molecules with the loss of exclusivity from 01/2010 onwards. 

The above doesn't preclude a situation that for some molecules the follow-on competition is quite 
fierce – the available data show that fewer, but more profitable substances are chosen by the generic 
companies for which several competitors come up with follow-on equivalents. 

When analysing the generic and biosimilar market entry it should be also noted that even if an SPC is 
granted for a certain medicinal product it may happen that another protection measure (e.g. the 10-
year market exclusivity, as defined by EU pharmaceutical legislation) expires after the SPC211. In such 
case the SPC has no decisive influence on the moment from which follow-on products may be placed 
on the market. Although the current proposal does not refer to any changes in the scope or duration 
of SPC regime, a change in the regulatory protection rules which is contemplated within other 
current Commission initiatives might impact the role of SPC as the last protection to expire. In this 
context, the impact of a hypothetical shortening of the regulatory protection by two years was 
estimated, showing that the share of SPC as the last exclusivity to expire would increase by roughly 
5% - from 49.6%212 currently to 54.9% of molecules (see: Annex 5C for more details). Needless to say, 
this relatively modest increase is not due to any SPC reform contemplated in this impact assessment, 
but rather the consequence of the SPC system’s existence as such (i.e. it might materialise also in the 
status quo, should market exclusivity rules be reformed).  

As mentioned above, claims that a more streamlined SPC system would affect the entry of follow-on 
products could also be made with regards to the agrochemical sector213. However, such negative 
impact on PPPs seems to be even less probable than in the case of medicines. First, the market is 

211 See: Table 54 in Annex 5C. It should however be noted that the number of cases where SPC is the last 
protection to expire is higher in terms of turnover, than when measured by molecules. In those cases, the 
scope of the SPC can have a decisive influence on the entry of generics and biosimilars on the market, and 
even on patient access to a given medicine. 
212 Commission services in the impact assessment accompanying the proposal for a revision of Regulation 
(EC) No 726/2004 estimate that SPC is the last protection measure to expire in 48 % of molecules– based 
on a basket of 217 products selected using IQVIA Ark Patent intelligence data, where the loss of protection 
was between 2016–2024 in four countries: FR, DE, IT and ES. 
213 It is estimated that in 2020-2027 nearly 40 active ingredients will come off-patent (12 herbicides, 17 
fungicides, 8 insecticides and 2 nematicides). Source “New Generics in Crop Protection 2022”, IHS Markit 
2022. 

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highly consolidated214 (e.g. in 2018, the top four firms controlled around 70% of the global pesticide 
market215 or top six firms controlled 81% of the EU market216), whereas a large share of non-patent-
protected products are also sold by the originators217, leading to potentially lower price reductions218 
and hence lesser market impacts. Second, due to factors linked to the specific characteristics of the 
agrochemical sector and its future developments219, including efforts to promote diversified cropping 
systems in the EU220, a more coherent and streamlined SPC system could actually foster and 
incentivise R&D in safer and more sustainable alternatives to agrochemicals.  

Finally, it should be noted that PO2-PO5 propose various instruments intended to support new 
entrants, such as the right to submit third party observations during the SPC procedure, as well as 
significantly increased transparency in the publication of SPC-related information. The central SPC 
database should benefit around 300 follow-on producers221 annually, each saving up to EUR 25 000 
(PO5) to EUR 40 000 (PO2-4) (approximate cost of a commercial dataset), producing EU wide savings 
of EUR 7.6 million (PO5) to EUR 12 million (PO2-4). These instruments are expected to be bring 
positive impacts on entry of competing – more affordable – generic and biosimilar products. 

6.6.2.  Social impacts  

Healthcare budgets 

Regarding likely social impacts, this initiative aims to improve incentives for pharmaceutical and 
agrochemical innovation in the EU and as a result generates demand for advanced skills Europe (e.g. 
researchers, doctors, engineers).  

Broad social impacts in the context of healthcare can be also understood as “ensuring access to 
affordable medicines and that health systems remain financially sustainable” (i.e. one of the 
objectives of the EU pharmaceutical strategy). Against this background, an argument can be made 
that a unitary SPC (PO5) could actually worsen the supply possibilities for health systems of smaller 
Member States, which prior to the unitary SPC entry were typically not covered by SPC protection 
(and as part of the unitary patent system will now automatically be). An example might be useful 

214 Elsheikh E. and Ayazi H. “The era of corporate consolidation and the end of competition: Bayer-
Monsanto, Dow-DuPont, and ChemChina Syngenta.” Haas Institute for a Fair and Inclusive Society at the 
University of California, Berkeley, CA. October 2018, aasinstitute.berkeley.edu/shahidi 
215 Heinrich-Böll-Stiftung,”The PESTICIDE ATLAS 2022”, page 12. 
216 European Commission, Evaluation of Regulation (EC) No 1107/2009 on the placing of plant protection 
products on the market and of Regulation (EC) No 396/2005 on maximum residue levels of pesticides, 
SWD(2020) 87 final, Brussels, 20.5.2020, page 11. 
217 Idem.   
218 For example, based on a selection of plant protection products a study finds that the follow–on products 
were placed on the market with an average price 15% lower comparing to branded pesticides (5%-35% 
range). Source: Stajszczak A, Majewski E., “Importance Of The Generic Segment Of The Plant Protection 
Products – The Case Of The Polish Market”, APSTRACT Vol. 11. Number 1-2. 2017, pages 25-34.  
219 EPRS | European Parliamentary Research Service “The future of crop protection in Europe”, Brussels, 
February 2021. 
220 The ongoing debate on the future of food system in Europe involves a discussion on the negative impacts 
of PPPs on human health and biodiversity. In this context, the EU Farm-to-Fork strategy calls to reduce the 
overall use and risk of chemical pesticides by 50% and the use of more hazardous pesticides by 50% by 
2030. See: European Commission, “A Farm to Fork Strategy for a fair, healthy and environmentally-
friendly food system” COM(2020) 381 final, Brussels, 20.5.2020. 
221 ‘Within three years following the LoE [loss of exclusivity] the ratio of generic companies to originators 
is about 6:1’ (source: Pharmaceutical sector Inquiry (2009), p. 74). With up to 50 molecules where 
competition emerges, the estimated number of follow-on producers affected is 300. 

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here. Latvia will be part of the unitary patent system. As a result of PO5 a unitary SPC will be binding 
in Latvia (through a ‘blanket effect’ common to all Member States participating in the unitary patent) 
whereas in the counterfactual/baseline, there might not be an SPC binding in Latvia (possibly due to 
delayed generic entry into smaller Member States, described earlier and thus limited incentive to 
apply for an SPC).  

In order to investigate the size of such an effect in practice the same IQVIA dataset for years 2010-
2021 was used to estimate the budgetary impacts of a hypothetical unitary SPC, if it resulted in a 
longer period of exclusivity in some countries otherwise not covered by an SPC222. The estimated 
hypothetical expenditure was defined as the supplementary payment for original medicines in the 
period concerned in the absence of generic products. Figure 11 below presents the results of such 
analysis using 2010-2021 sales data for UP Member States223, as only those countries would be 
concerned by the proposed unitary SPC.  

Figure  11:  Estimated  (theoretical)  budgetary  impacts  of  a  hypothetical  unitary  SPC,  as  %  of  overall  spending  on 
pharmaceuticals by country 

Source: In-house analysis based on IQVIA data covering molecules with the loss of exclusivity from 01/2010 onwards. 

As shown on the graph, the estimated additional expenditure to healthcare systems could reach up 
to 0.48% in LV, while being negligible for many other countries (e.g. LU, BE, and IT). Figure 11 also 
confirms what has been argued earlier, that SPC protection has been sought less frequently in 
smaller Member States, potential benefits would not play out equally across countries.  

Overall, for all countries covered by this analysis (i.e. UP Member States except for Malta) the total 
lost benefits of a unitary SPC would amount to EUR 37 million budgetary impact per year.224 If the 
above costs (lost benefits) for public healthcare budgets was re-invested by innovative companies in 
R&D, the option would produce a neutral cost-benefit outcome. 

222 For further details concerning the methodology applied, please see: Annex 4. 
223 Except for MT, which is not available in the available IQVIA dataset. 
224 The average difference in 2010–2021 was compared with the total pharmaceutical expenditure in the last 
available year, as reported by Eurostat. See: country-by country estimates in Table 55 of Annex 5C. 

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Healthcare stakeholders  

Health stakeholders along with others would be able to influence SPC granting process by submitting 
third party observations during the SPC procedure. Additionally, central database for SPCs envisaged 
under PO3-5 and possibly also PO2 would benefit national medicines procurement offices and can 
facilitate cross-border joint purchases. At least 27 central purchasing bodies (there could be more 
than one per Member State though) could benefit from savings of up to EUR 25 000 (PO5) to 40 000 
(PO2-4) per year (commercial database access cost), resulting in EU-wide savings of EUR 0.7 million 
(PO5) to EUR 1 million (PO2-4).  

IP attorneys 

The changes proposed in PO2 to PO5 by creating one central application procedure are likely to 
reduce demand for legal advice/representation before NPOs in each Member State where SPC is 
sought. Under assumption of an average cost of legal help of EUR 2 000 per country and SPC, the loss 
of income for this group in case of SPCs protected in the whole EU and 100 SPC applications per year 
can amount up to EUR 0.3 million (PO5), EUR 0.4 million (PO3) to EUR 0.5 million (PO2 and PO4)225.  

6.6.3.  Digital impacts 

With regards to the potential digital impacts, this initiative fulfils the objectives of the European 
Strategy for data, insofar as the establishment of the centralised SPC procedure and a single 
database is concerned. In particular, the digital accessibility to all steps of the SPC procedure would 
be ensured (e.g. e-submission via one-stop-shop, e-access to SPC documents). The new database 
would also contribute to a single market for data226 by facilitating the availability of data, as well as 
data quality and its interoperability across Member States. The envisaged SPC database would 
improve the cross-border access, exchange (in particular by better sharing of data between national 
public authorities i.e. NPOs) and analysis of data on the market exclusivity status of pharmaceuticals 
and PPPs, which consequently should support the earlier market entry of the follow-on equivalents.  

6.6.4.  Environmental impacts 

None of the proposed options influences the current EU legal provisions concerning the 
environmental protection directly. However, sustainability is one of the four key pillars of 
Pharmaceutical Strategy for Europe227. Similarly, as far as PPP are concerned, there is a number of 
initiatives concerning the sustainable use of pesticides228. Against such backdrop, modernising the 
SPC regime and thus – at the margin – increasing resources available to pharmaceutical and plant 
protection firms is to be expected to generate also an environmentally positive impact. Consequently 

225 In case of an average SPC covering 20 Member States, the losses are EUR 0.3 million (PO3 and PO5), 
EUR 0.4 million (PO2 and PO4). 
226 The proposed initiative is aligned with the following actions of the European strategy for data: i) the 
establishment of a cross-sectoral governance framework for data access and use; ii) investments in data and 
strengthening Europe’s capabilities and infrastructures for hosting, processing and using data, 
interoperability. 
227 European Commission, Commission communication – Pharmaceutical Strategy for Europe, COM(2020) 
761 final, 2020 (https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:52020DC0761). 
228 European Commission, ‘Sustainable use of pesticides’, 2022 
(https://food.ec.europa.eu/plants/pesticides/sustainable-use-pesticides_en). 

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the considered options “do no significant harm” in terms of achieving the EU’s environmental 
objectives229.  

7.  HOW DO THE OPTIONS COMPARE? 

7.1.  Comparison of impacts 

Table 11 provides information comparing the policy options in the light of the effectiveness and 
efficiency criteria as well as impact on most affected stakeholders (see: also Annex 6 for the SME 
test). Table 12 overleaf provides information comparing the policy options in the light of the criteria 
of effectiveness (how each option achieves the specific objectives) and efficiency (cost-benefits 
analysis).  

229 European Commission, Better regulation toolbox – tool 36 Environmental impacts, 2021 
(https://ec.europa.eu/info/law/law-making-process/planning-and-proposing-law/better-regulation-why-and-
how/better-regulation-guidelines-and-toolbox/better-regulation-toolbox-0_en). 

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Table 11: Comparison of policy options against the effectiveness and efficiency criteria 

Options 

Increase predictability and legal certainty of SPC protection in the EU by 
facilitating: 

Facilitate SPC monitoring  

Reduce cost of applying and 
maintaining SPC protection 

Examination 
procedures 

3rd parties involvement 

Granting procedures 

Baseline 
PO 1: Guidelines 

(0) 

(0) 

(0) 

(0/+) Guidelines can provide examining best practices, but would not be mandatory and 
could be interpreted differently across NPOs 

(0) 
(0) 

Cost efficiency230 
(EUR million) 
only quantifiable 
costs and benefits for 
all stakeholders (see 
next table for details) 
(0) 
Net effect 0-13 
Benefits 0-13.1 
Cost 0-0.1 

PO 2: Mutual 
recognition 

(++) One examination 
instead of many. 

(++) Written 
observations possible 

Risk of forum shopping  

(++) One examination 
instead of many, but 
NPO can still re-examine  

(+ +) Written 
observations possible. 

(++) One grant decision valid 
in all MS, but need of some 
administrative steps in each 
NPO (including payment of 
national maintenance fees) 
(++/+) One opinion, but re-
examination possible (the 
practice of the EA can 
influence national practices). 

(+++) One examination 
instead of many. 

(+ +) Written 
observations possible.  

(++) One opinion with 
validity binding upon all MS. 

PO 3: Centralised 
procedure with a 
non-binding 
opinion 

PO 4: Centralised 
procedure with a 
binding opinion 

PO 5: Unitary 
SPC 

(+++UP-MS, 0 others) 
One examination instead 
of many. 
(limited to UP-MS). 

(+++UP-MS, 0 others) 
Written observations 
possible and access to 
review within the EA.  

(+++UP-MS, 0 others)  
One grant procedure and 
decision instead of many (17 
UP-MS). 

(+++ UP-MS, 0 others) EA would host a 
central unitary SPC register and publicly 
accessible database on unitary SPC. 

(0) 
(+) Guidelines can provide data 
publication best practices, but would not 
be mandatory 
(+) Some level of data integration could 
be achieved, but there will not be a 
single authority hosting a centralised 
database because several offices can act 
as reference office.  
(++) EA would host a central SPC 
register and publicly accessible database 
on centrally-examined SPCs, but some 
risks as data also depend on NPOs input.  

(+++) EA would host a central SPC 
register and publicly accessible database 
on centrally-examined SPCs. 

(++) One procedure, 18% lower costs 
(attorney, translations)) for protection in 
the whole EU. Maintenance fees might 
be due in 27 EU MS. 

Net effect 11.3 
Benefits  20.6 
Cost  9.3 

(++/+) One procedure, 6% lower costs 
(attorney, translations)) for protection in 
the whole EU. 
Maintenance fees might be due in 27 
MS. 
(++) One procedure, 10% lower costs 
(attorney, translations) to obtain SPC 
protection across the EU. 
Maintenance fees might be due in 27 
MS. 
(+++ UP-MS, 0 others) One procedure, 
49% lower costs (attorney, translations)) 
for protection in the whole EU. 
Significantly reduced maintenance fee 
paid centrally. 

Net effect 10.1 
Benefits 18.2 
Cost 8.1 

Net effect 10.1 
Benefits 19.4 
Cost 9.3 

Net effect 6.3 
Benefits 58.3 
Cost 52 

Note: For details of calculations see Annex 5G. Quantifications present maximum potential impacts. Not all impacts are quantifiable. Numbers rounded. 

230 Only quantifiable costs (including income losses) and savings/benefits presented (not covering options impact on objective 1, and only to a certain extent objective 2). 
Annual effects refer to an EU-wide, 5-year long SPC protection from the fifth year onwards. In the preceding years benefits would be lower, as the system would not yet 
be fully operational (the number of active SPCs is assumed to increase gradually until year 5). 

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Generic/biosimilar 
manufacturers, including SMEs 
300 

Healthcare sector, patients and 
users of PPPs 
At least 27 (one healthcare 
authority per MS) 

PO1-4: 27 
PO5: 17 (UP-MS) 

Patent offices (NPOs)  

IP agents/attorneys 

(0) 

(0) 

(0) 

Table 12: Comparison of the impacts of policy options on stakeholders (including quantifiable annul costs and benefits). 

Originators, including SMEs 

No. 
affected 

100 applicants and up to 400 SPC owners 
paying maintenance fee 

Baseline 
PO 1: 
Guidelines 

(0) 
(0/+)Improvement of the predictability of the 
national procedures if guidance followed. 
Divergence in NPO practices would continue. 
No reduction of cost or administrative burden. 

Costs (€)  0 

Benefits (€)  0 

Net (€)  0 

PO 2:  
Mutual 
recognition 

(++) One application to one reference office 
with substantially lower overall costs. . 
Maintenance fees still due at the national 
level. Despite common PO1 guidelines, 
possible divergent practices of reference 
offices.  

(0/+) Improvement of the predictability of the national procedures and 
improvement monitoring of SPC protection across the EU if guidance 
followed. 

0 

0 

EUR 0 - 40 000 (database access); 
EUR 1 million EU-wide 
EUR 0 - 40 000;  
EUR 1 million EU-wide  

EUR 0 - 40 000 per firm (database 
access); EUR 12 million EU-wide  
EUR 0 - 40 000 per firm;  
EUR 12 million EU-wide 
(+) Easier search for active SPC due to harmonized IT system (either 27 
harmonized national systems, or one central);  
Possibility to influence granting process through written observations. 
(=/-) Risk of forum shopping towards more lenient reference offices 
that could result in additional grants of SPCs.  

Costs (€)  EUR 11 600 on application fee per firm 
EUR 1.2 million EU-wide 

0 

0 

Up to 2700 cases (1 per MS per SPC) 
except  for PO3: up to 2 060 and  
PO5: 1 600 
(0) 
(+)Improvement of the predictability 
of the national procedures if guidance 
followed. 
No impact on the number of 
application handled 

0 

0 

0 

(-) Loss of income generated by 
managing national SPC applications 
as less application would be handled 
by the non-reference offices and to 
some extent by reference offices as 
well (if there is more than one 
reference office).  
Loss of EUR 2 000 per application 
per MS; EUR 5.2 million EU-wide 

(+) Potential for introducing best 
examining and publication practices. 
Exchange of information to facilitate 
examination. (–) impacts depend on the 
extent of voluntary uptake. 
(+) information exchange 
Updates to IT: 0 up to EUR 4 100  per 
NPO per year 
EUR 0.1 million EU-wide. 
0 

0 

(+) As in PO1 + Reduced workload and 
application income of all NPOs 
Reference NPOs can face irregular 
workload. Less workload for the non-
reference NPOs.  

Updates to IT systems (up to EUR 
4 100 per NPO per year; EUR 0.1 
million EU-wide); Application fee loss 
26 NPOs: up to EUR 32 300 (EUR 0.84 
million EU wide) 

Benefits (€)  EUR 55 800 savings per application per firm 

EUR 5.6 million EU-wide 

Net (€)  + EUR 44 200 per application per firm 
+ EUR 4.4 million EU wide 
(+/++) One application to central authority. 
PO1 guidelines mandatory for the central 
authority NPOs can request examination 
potentially for up to 20% of cases – room for 
divergent outcomes on the same file. Savings 
on attorney fees. Maintenance fees still due at 
the national level. 

PO 3: 
Centralised 
decision 
with a non-
binding 
opinion 

Up to EUR 40 000 (database 
Up to EUR 40 000 (database 
access); EUR 1 million EU-wide 
access) EUR 12 million EU-wide 
+ EUR 40 000;  
+ EUR 40 000 per firm;  
+ EUR 12 million EU-wide 
+ EUR 1 million EU-wide  
(+/++) Easier search for active SPC due to once central database 
managed by the examination authority (e.g. when launching competing 
products or for joint cross border procurement). Database completeness 
depends on NPOs cooperation and timely updates (e.g. for SPC granted 
via national route); Up to 20% of products may continue to receive 
divergent SPC decisions in MS.  
Possibility to influence SPC granting process through written 
observations. 

Costs (€)  EUR 30 700 on application fee per firm 

0 

0 

- EUR 36 400 per NPO; 
- EUR 0.95 million EU wide 
(=+) As in PO1 + Lower workload for 
the NPOs, if no re-examination, 
dependent on usage of central 
procedure.  
Lower income from application fees, 
however the income generated by SPC 
application fees is negligible (0.1%) 
compared to the total patent fee 
revenue. 
Marginal cost for data feeding the 

- EUR 2 000 per application per MS 
- EUR 1.2 million EU-wide 
(-) Benefits to specialised IP 
agents/attorneys that will handle 
centralised SPC applications. Other 
agents may lose income earlier 
generated by managing national SPC 
applications. National appeals (in up 
to 20% of SPC cases) may to some 
extent limit income losses.  

Loss of EUR 2 000 per application 

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Originators, including SMEs 

Generic/biosimilar 
manufacturers, including SMEs 

Healthcare sector, patients and 
users of PPPs 

Patent offices (NPOs)  

IP agents/attorneys 

EUR 4.5 million EU-wide 

Benefits (€)  EUR 45 200 savings per application per firm 

EUR 5.6 million EU-wide 

EUR 40 000 (database access) 
EUR 12 million EU-wide 

Net (€)  + EUR 14 500 per application per firm 
+ EUR 1.5 million EU-wide 
(++) As in PO3 but no re-examination by 
NPOs. No divergent outcomes on the same 
file. Savings on attorney fees. Maintenance 
fees still due at the national level.  

PO 4: 
Centralised 
decision 
with a 
binding 
opinion 

Up to EUR 40 000 (database 
access) 
EUR 1 million EU-wide 
+ EUR 40 000;  
+ EUR 1 million EU-wide  

+ EUR 40 000 per firm;  
+ EUR 12 million EU-wide 
(++) as in PO3, but better quality information as no room for 
conflicting NPO decision on centrally applied SPCs. Possibility to 
influence SPC granting process through written observations. 

Costs (€)  EUR 32 000 on application fee 

0 

0 

Benefits (€)  EUR 56 000 overall savings per application 

PO 5: 
Unitary 
SPC 

Net (€)  + EUR 24 000 per application per firm 
+ EUR 2.4 million EU-wide. 
(+++/0) One application and one granting 
body. All fees paid just to the central 
authority.  
Benefits limited to 17 UP-MS. No change for 
applications to the remaining MS. 

EUR 40 000 (database access) 
EUR 12 million EU-wide 

Up to EUR 40 000 (database 
access) 
EUR 1 million EU-wide 
+ EUR 40 000;  
+ EUR 40 000 per firm;  
+ EUR 12 million EU-wide 
+ EUR 1 million EU-wide.  
(++/0) For UP-MS database with complete information. Need for 
monitoring national SPCs in all MS. (-) Some negative impact on 
healthcare systems in those MS where SPC would not apply, if not for 
the unitary coverage. 

Costs (€)  EUR 23 100 

0 

Benefits (€)  EUR 34 400 savings on application fee : 

EUR 22 200 – annual savings on maintenance 
fee per SPC owner 

EUR 25 000 (database access for 
17 UP-MS) 
EUR 7.6 million  

Net (€)  + EUR 26 000 per firm (application) 

+ EUR 25 000 per firm;  

EN 

higher pharmaceutical costs of up 
to EUR 2.2 million per UP 
country (due to wider SPC 
coverage); EUR 37 million in 
total.  
Up to EUR 25 000 (database 
access for 17 UP-MS)  
EUR 0.7  million  
(+) more R&D on novel 
medicines - EUR 37 million in 
total. 
+ EUR 25 000;  

63 

per MS; EUR 4.1 million EU-wide 

0 

- EUR 2 000 per application per MS 
- EUR 4.1 million EU-wide 
(-) Benefits specialised IP 
agents/attorneys that would handle 
centralised SPC applications, while 
other agents may lose income earlier 
generated by managing national SPC 
applications.  
Loss of EUR 2 000 per application 
per MS; EUR 5.2 million EU-wide 

0 

- EUR 2 000 per application per MS 
- EUR 5.2 million EU-wide. 
(-) Benefits specialised IP 
agents/attorneys that would handle 
unitary SPC applications, while other 
agents in UP-MS may lose income 
earlier generated by managing 
national SPC applications. No impact 
on non UP-MS.  

Loss of EUR 2 000 per application 
per MS; EUR 3.2 million in total  

central database;  
Application fee loss 27 NPOs: up to 
EUR 32 600 (EUR 0.88 million EU 
wide).  
Examiners remuneration: EUR 23 100 
(if shared equally between all NPOs); 
EUR 0.6 million EU-wide. 
- EUR 9 500 per NPO; 
- EUR 0.26 million EU-wide 
(+) As in PO1 + Lower workload for 
the NPOs (just registration of central 
SPCs) dependent on usage of central 
procedure. Lower income for the NPOs 
equal up to 0.1% of income from patent 
fee.  
Marginal cost for data feeding the 
central database. 
Application fee lost (27 NPOs): up to 
EUR 32 600 (EUR 0.88 million EU 
wide) 
Examiners remuneration: EUR 27 700 
(if shared equally between all NPOs); 
EUR 0.75 million EU wide 
- EUR 4 900 per NPO; 
- EUR 0.13 million EU-wide. 
(=/--) Lower work load for the NPOs of 
UP-MS dependent on usage of central 
procedure. No SPC application and 
maintenance fees, equal to up 0.4% of 
patent fee income. Less income for the 
NPOs of UP-MS, however the income 
generated by SPCs is relatively small 
compared to the total budget. 
Up to EUR 34 100 - application fee lost 
(17 NPOs) – EUR 0.58 million  
Up to EUR 522 800 - maintenance fee 
loss (17 NPOs); EUR 8.9 million in 
total.  
Examiners remuneration: EUR 44 000 
(if shared equally between all 17 
NPOs); EUR 0.75 million in total.  

- EUR 512 900 per NPO; 

- EUR 2 000 per application per MS 

EN 

 
 
 
 
 
 
 
Originators, including SMEs 

+ EUR 22 200 per SPC owner (maintenance) 
+ EUR 10 million in total. 

Generic/biosimilar 
manufacturers, including SMEs 
+ EUR 7.6 million in total.  

Healthcare sector, patients and 
users of PPPs 

Patent offices (NPOs)  

IP agents/attorneys 

+ EUR 0.68 million in total.  

- EUR 8.7 million in total.   

- EUR 3.2 million in total.   

Note: For details of calculations see Annex 5G. Quantifications present maximum potential impacts. Not all impacts are quantifiable. Numbers rounded. 

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All the options are expected to improve on the status quo, but to a varying extent.  

PO1 is the least effective as it is uncertain whether guidelines would be followed by all Member 
States, and how they would be interpreted. Thus the same application would continue to be assessed 
separately by different NPOs, which might - as currently - result in different SPC granting decisions. It 
is equally uncertain if best practices on the publication of SPC information would be followed by all 
NPOs. Consequently, the benefits of PO1 are low and uncertain. SCP applicants will most likely not 
benefit in terms of legal certainty or the costs of procedure. In NPOs where an SPC database is setup, 
follow-on manufacturers or national health public procurement authorities may get a slightly better 
picture of the SPC situation, yet they would still need to collect such information across multiple 
websites containing information on other jurisdictions. 

PO2 should improve the situation substantially, as SPC applications would be examined by only one 
office. This means no risk of divergent decisions on the same file. However, if there were more than 
one reference office, the applicants may tend to choose a more lenient one over others (the risk of 
forum shopping). SPC would continue to be granted by several NPOs and the duration of such 
procedure may be different in each of them. Applicants would be charged one application fee, but 
would continue to pay national maintenance fees to each office where an SPC is sought. Their savings 
would come mainly from the reduced need for legal assistance in the filing process and savings on 
translation cost which would be no longer necessary (estimated savings of 18% in comparison to the 
baseline). Follow-on manufacturers and health sector would be able to influence the SPC process by 
providing written observations to the reference office. They are also expected to benefit from the 
improved access to SPC data (saving of up to EUR 40 000 per company), although it is uncertain 
whether such information is to be available in one central or several local databases. NPOs other 
than the reference office are expected to lose revenue from the application fees of up to EUR 32 300 
per year, but would also take advantage from significantly reduced workload while still receiving 
maintenance income. The demand for legal advice is also expected to be reduced especially in 
Member States without the reference office. To summarise, although PO2 provides substantial 
benefits, it cannot however guarantee the same level of examination quality in situations, where 
there is more than one reference office. 

PO3 eliminates the problem of forum shopping and inconsistencies in the examination process of 
PO2, as there would be only one central authority following the same methodology. It would 
however allow NPOs to re-examine the SPC application (estimated to occur in up to 20% of cases), 
which could still result in divergent decisions on the same file. This option is also slightly more 
expensive than PO2, as the centralised examination authority would be established and its expenses 
would need to be covered by the application fees (including the costs of translations of documents to 
be transmitted to NPOs, as the latter would continue to grant SPCs). Thus the cost of PO3 are only 
6% lower in comparison to the baseline. The follow-on producers and the healthcare representatives 
should benefit from the possibility of providing written observations, as well as an access to one 
central SPC database. The loss of revenue for NPOs would be lower than in PO2 (EUR 9 500 to EUR 
36 400 per NPO). The patent attorneys would also see their revenues diminished, but to a lesser 
extent than in PO2 as they might still handle national appeals in cases of negative decisions. Overall, 
PO3 thus appears slightly more efficient in terms of reaching the objectives, but still carries the risk 
of national challenge to the centralised opinion.  

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PO4 eliminates the NPO’s discretion, as the central opinions would be binding. There would also be 
no risk of forum shopping as in PO2. The only difference could be the potential difference in the 
registration date, as the granting would still take place at the NPOs (these however are expected to 
be minor differences). This option scores highest in terms of providing legal certainty and 
predictability, which should also benefit follow-on producers and health sector procurers seeking an 
up-to-date information on the SPC status. Nevertheless this option is producing only limited savings 
of around 10% in comparison to baseline, as the application fees should cover the cost of the central 
authority and applicants would have to pay maintenance fees to each selected national office. The 
bulk of savings would come from the reduced need for legal advice and elimination of applicant own 
translation costs. The follow on producers and health sector procurement officers would have access 
to the most complete and up to date database on SPC and would be able to submit written 
observations during the application examination process. Patent attorneys are likely to lose income 
to the amount similar to PO2. Also, the national patent office are likely to lose revenues from 
application fees, but would see significant reduction of the workload and would continue receiving 
maintenance fees. This option is producing the best results in terms of objective 1 and 2 albeit with 
only moderate cost reductions. 

PO5 scores best across all the objectives but only for holders of a European patent with unitary 
effect. Applicants seeking protection in the (currently) 17 Member States participating in the unitary 
patent system would only need to interact with the central authority in order to have their 
applications assessed and SPC granted. Consequently all the fees would be paid only to one 
authority, and due to elimination of most of the translation costs this option is producing significant 
cost reductions. However, applicants seeking to cover the whole EU would need to additionally apply 
individually to each NPO outside the UP system. Consequently the cost of covering the whole EU is 
expected to be halved in comparison to the baseline. But the savings of this option would increase as 
more countries join the UP system and as unitary patents become more widely used. Similarly to 
PO4, the follow-on producers and health procurement officers would be able to influence SPC 
examination and would have access to the most accurate SPC database (nonetheless, containing 
information limited to unitary SPCs only). Patent attorneys are likely to lose income in the UP-MS. 
The NPOs in the UP-MS are likely to lose both application and maintenance fees. This option may 
result in a wider territorial SPC coverage, as unitary SPC would automatically cover all UP-MS. This 
may mean that SPC would be protected in countries where it was not the case before – resulting in 
delayed entry of generic/biosimilar competitors and increased spending on medicines (by up to EUR 
2.2 million on average per Member State per year). These additional resources as well as savings on 
administrative fees should however contribute to higher R&D spending on novel medicines.  

7.2.  Best option and possible combinations of options to improve it further 

As discussed above PO5 is the best option to fulfil the policy objectives and produce the highest 
benefits. However, PO5 provides for a single examination (and granting) procedure only for the 
(currently 17) Member States participating in the unitary patent system. As the UP system still covers 
only a subset of Member States, in order to eliminate the key problem of divergences between 
national SPC systems, it is necessary to combine the unitary SPC with another option to cover the 
remaining (currently 10) Member States that are not part of the UP enhanced cooperation - at least 
in the interim, until the UP system covers the whole EU. In other words, given the current coverage 

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of the unitary patent system, a dual system that differentiates between the participating and non-
participating Member States must be proposed. Although a combination of two options means that 
two different administrative settings would need to be implemented, it seems to be the only method 
to ensure implementation across the whole EU. Moreover, there may be cases where the basic 
patent may not be a unitary patent, thus requiring the applicant to file applications in up to 27 
Member States. A combination of options would therefore also cater to these scenarios, allowing 
applicants to benefit from a centralised examination, despite not meeting the granting criteria for a 
unitary SPC. When deciding on which option could best complement PO5, all possible combinations 
are analysed below, notably PO1, PO2, PO3 and PO4.  

Combining PO1 with PO5 would not bring much change for SPC applicants in the 10 non-UP MS. Even 
if the guidelines were followed and NPO practices were aligned, there would still be 10 different 
authorities deciding on the SPC application, resulting in potentially contradictory decisions. Thus 
predictability and legal certainty of the SPC procedures would not improve much.  

The situation would ameliorate if PO5 was combined with PO2 (mutual recognition). However, 
companies would still need to file two applications: one to the central authority to cover the 17 UP-
MS and another one to the NPO acting as a reference office for the remaining Member States. As 
two different authorities would evaluate and grant SPCs, the risk of divergent decisions would 
remain. Also any third party willing to submit written observations (either electronically or in 
traditional way) would need to run the procedure twice.  

PO3 or PO4 envisage that the central authority (the same as in PO5) would receive applications, 
conduct their examination and issue either a non-binding (PO3) or binding (PO4) opinion regarding 
whether a national SPC should be granted or not in the various Member States designated in the 
application. PO3, however, allows NPOs to depart from the central examination outcome (e.g. an 
NPO could grant an SPC even if the central authority concluded it should not be granted, or vice-
versa). This would create a risk of perpetuating the problem of divergence. Only PO4 eliminates the 
risk of NPOs diverging from the central examination, as it envisages a binding opinion which the 
NPOs of the designated Member States would need to follow. 

Consequently a combination that provides the highest level of legal certainty and predictability, while 
covering all Member States, is the combination of PO5 with PO4.  

7.3.  Coherence with other EU policies and the charter of fundamental rights 

The  EU  policy  areas  which  have  the  closest  links  with  the  proposed  initiative  are  those 
concerning  the  protection  of  public  health,  especially  with  regards  to  pharmaceuticals,  and 
food safety – the latter with regards to PPP.  

As  far  as  the  medicinal  products  are  concerned,  the  proposed  initiative  is  aligned  with  the 
following objectives of the Pharmaceutical Strategy for Europe:  

  Equal  and  affordable  access  to  medicines:  As  discussed  in  section  2.3,  follow-on 
producers face difficulties to ascertain the status of SPC protection in due time. This 
may hamper the launch of their product (i.e. generic or biosimilar), their participation 
in tenders for the purchase of medicines, or their reliance on the SPC manufacturing 
waiver.  The  proposed  centralised  SPC  procedure  would  increase  predictability  and 

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legal certainty for generic/biosimilar companies by improving overall transparency of 
the SPC protection status across the EU. This is expected to facilitate market entry of 
generic  and/or  biosimilar  products,  which  by  inflicting  downward  pressure  on 
medicine  prices,  should  positively  impact  the  access  to  affordable  medicines  for  EU 
patients.  

  Enhancing  crisis  preparedness  and  response  mechanisms,  strengthening  the 
resilience  of  pharma  supply  chains:  The  pharmaceutical  supply  chains  are 
increasingly  complex  and  exposed  to  vulnerabilities,  including  the  EU’s  dependency 
on third countries for materials or ingredients used in  pharmaceutical manufacturing. 
In this context, the proposed review of SPC rules is expected to strengthen the EU’s 
industrial  base,  and  our  manufacturing  capacity  for  medicines.  The  proposed  SPC 
reform would provide additional transparency in the process, as well as a single access 
point  to  up-to-date  information  on  SPC  status.  This  should  help  the  EU  (generic) 
industry  to  map  dependencies,  and  facilitate  cross-border  procurement  of  medicines 
(e.g. better pricing and procurement practices are recognised as enablers to security of 
supply). Given the competition for raw materials and (relatively) fewer dependencies 
on patented drugs, assuring the right balance of investment incentives through robust 
SPCs enhances resilience.  

  Administrative  burden  reduction:  As  explained  earlier  in  this  impact  assessment, 
the  fact  that  SPCs  are  administered  at  national  level  creates  significant  red  tape  and 
entails  extra  costs  for  businesses,  which  is  especially  challenging  for  SMEs  (nearly 
19% of all SPC holders). As the result of the proposed changes, the cost and burden of 
obtaining  and  maintaining  SPC  protection  in  the  EU  will  be  significantly  reduced. 
Additionally,  the  cost  of  monitoring  the  SPC  status  should  also  decrease  (currently 
follow-on manufacturers need to assess it separately for each Member State), as such 
information  would be publicly  available through  a single access  point provided by a 
new central website. The central database could also provide information on the RDP 
status of SPC medicines.  

  Supporting  competitiveness, 

innovation  and  sustainability  of 

the  EU’s 
pharmaceutical  industry:  As  mentioned  above,  the  improved  coherence  and  legal 
certainty  as  regards  SPCs  will  facilitate  and  thus  promote  the  operation  of 
pharmaceutical  firms  in  the EU. A more coherent  SPC protection provided for these 
products  is  expected  to  generate  savings  and  encourage  investment  in  research  and 
development for innovative medicines and treatments. 

Finally, it is important to highlight that the proposed pharmaceutical legislation revision does 
not affect the incentives pertaining to intellectual property rights (patents and SPCs), however 
as mentioned earlier, both policies are interlinked231.  

As  far  as  PPPs  are  concerned,  the  proposed  initiative  is  aligned  with  the  integrated  Food 
Safety policy of the EU with regards to plant health and approval of active substances used in 
PPPs.  

231 In particular, as a marketing authorisation is a pre-condition for granting an SPC thus, if a marketing 
authorization is withdrawn, the SPC lapses. The so-called “sunset clause” present in pharma legislation 
ensures that a marketing authorisation becomes invalid where, within three years of its granting, it is not 
followed by the actual placing on the market of the authorised product. Where such invalidity leads to 
withdrawal, the SPC can therefore also lapse. 

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Finally, the proposed options do not extend the scope of the existing SPC protection which is 
already  defined by the EU regulations.  The options proposed do  not  conflict  with  other EU 
international  treaties  or  EU  pharmaceutical  and  phytosanitary  legislations.  The  SPC-related 
procedures  would  be  available  to  applicants  from  the  EU  and  third  countries  alike.  To 
summarise, all the considered options are compatible with the goals of the EU health and food 
safety policies. Finally, the initiative is also coherent with the Charter of Fundamental Rights 
(e.g. Article 35 on access to health232). 

7.4.  Compliance with the proportionality principle 

None of the options go beyond what is necessary to achieve the identified problems/objectives. 
Their respective scope is limited to those aspects that Member States cannot achieve satisfactory on 
their own and where the Union action can produce better results (for example, in terms of consistent 
decisions on SPC applications in order to remove current legal uncertainty, as well as transparency) 
or is necessary (as in case of creating a new EU IP right - a unitary SPC to complement the unitary 
patent). Options considered provide a mix of Member States and EU level actions with gradual 
increase of the EU level intervention. Possible legal instruments for implementing policy options are 
in case of PO1 a set of recommendations; and in case of PO2-5 an amendment (or recasting) of the 
existing SPC regulations.  

8.  PREFERRED OPTION 

The preferred option of this impact assessment is policy option PO5 (the establishment of a unitary 
SPC, i.e. a new IP right) combined with policy option PO4 (a centralised procedure with a binding 
opinion). It combines the advantages of a one-stop-shop SPC procedure with the possibility to obtain 
unitary SPC protection in countries where the corresponding unitary patent takes effects (i.e. 
Member States participating in the enhanced cooperation area of the unitary patent that have 
ratified the Unified Patent Court Agreement at the date of the grant). The preferred option would 
encompass: 

-  a  centralised  procedure  for  the  filing  and  examination  of  SPC  applications  that  rely  on 

- 
- 

European patents, with the possibility to request a unitary SPC (if applicable); 
the possibility to submit third parties’ observations during the examination; 
stakeholders’ right to use any EU language when contacting the examination authority in 
relation to the centralised SPC procedure;  

-  a single access-point providing information on the SPC status, also available in all official 

languages of the EU. 

As discussed in section 6.3 the EUIPO managing a virtual office of SPC experts from NPOs would be 
the preferred choice for the central examination authority. This solution combines both the expertise 
in the assessment of SPCs with accountability to the EU public and assurance that EU IP policy goals 
are implemented. 

232 ‘Everyone has the right of access to preventive health care and the right to benefit from medical 
treatment under the conditions established by national laws and practices. A high level of human health 
protection shall be ensured in the definition and implementation of all Union policies and activities.’ 

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The considered combination of options (PO4 and PO5) would not replace the existing nationally-filed 
SPCs, however it may be foreseen that under certain conditions the centralised procedure has to be 
used in order to reduce the risk for national discrepancies.  

The implementation of the preferred option would require adopting a new regulation establishing 
unitary SPC protection in the Member States where the unitary patent has effect, and amending 
Regulation (EC) No 469/2009 on medicinal product and Regulation (EC) 1610/96 on PPPs to introduce 
the centralised procedure with a binding opinion that can operate in all 27 Member States. The 
mandate of EUIPO would have to be extended to cover new responsibilities. Additional legislation to 
establish the linguistic regime of the unitary SPC might also be required. 

This option offers the most balanced and proportionate approach, which also takes into account the 
views and concerns of stakeholders. The preferred option would fully address the three identified 
problems (i.e. legal uncertainty, cumbersome monitoring of SPCs and high costs and burden of 
seeking and maintaining SPC protection). It would: 

- 

Increase predictability and legal certainty in the Single Market regarding SPC protection 
by eliminating the possibility of divergent national decisions on granting SPC protection 
across the EU. Such outcome would be achieved through unitary SPC protection for the 
participating EU Member States in the enhanced cooperation area and through a binding 
opinion of the examination authority about the validity of the SPC in the non-participating 
Member States; 

-  Significantly decrease the cost of monitoring SPC protection across the EU and therefore 
improve  transparency,  because  such  information  would  be  publicly  available  through  a 
single access point provided by means of a website with search functions. 

-  Significantly  decrease  the  cost  and  burden  of  SPC  protection  in  the  EU,  as  it  would 
simplify  the  SPC  procedure  and  reduce  the  current  cost  of  up  to  27  application  and 
renewal fees. For instance a five-year long, EU-wide SPC would cost 55% less than the 
baseline233, producing savings of around EUR 137 000 per product. The bulk of savings 
would  result  from  the  unitary  SPC,  as  the  firms  would  avoid  paying  high  renewal  fees 
annually  in  each  of  the  Member  States  of  the  unitary  patent  protection  (initially  17).  In 
addition,  the  filing  and  prosecution  of  one  single  SPC  application  could  potentially  be 
carried out by one patent agent/attorney office, thus also leading to savings as compared to 
the necessity to involve potentially up to 27 patent agents/attorneys.  

Table 13: PO4+5 costs and savings to applicants for receiving EU27 wide, five year long SPC protection  

EUR per application 

Savings vis-à-vis baseline 

Filing fees 
Maintenance fees for 5 years 
Translation costs 
Agent/attorney’s fees 
Total 
Source: In-house estimations, numbers rounded to 100s, see: Annex 5E 

38 800 
71 900 
 0 
2 000 
112 700 

-30 000 
111 100 
4 000 
52 000 
137 100 

This preferred combination of two options (PO4 and PO5) would overcome the limitations in scope 
that characterise PO5 (i.e. creating a unitary SPC). First, the unitary SPC would be limited to EU 
Member States of the unitary patent area (initially 17 Member States). Second, a unitary SPC could 

233 Or 65 % in case of an average SPC covering 20 Member States for 3.5 years, whereby the group of 20 
Member States is assumed to consist of 17 UP Member States and 3 non-UP Member States. See Annex 5E 

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only be granted on the basis of a unitary patent, whereas many SPC users might still continue using 
European patents without unitary effect to protect some of their products (or, in certain cases, the 
conditions for attributing unitary effect to the basic patent may not be met). The preferred 
combination of PO4 and PO5 would provide for a centralised procedure able to result in the granting 
of national SPCs in some or all Member States, and/or in a unitary SPC (covering those Member 
States in which the basic unitary patent has effect). Applying for a unitary SPC would never be 
mandatory. 

Regarding the options set out in the Call for Evidence, there was overall support for an EU initiative 
which would comprise a combination of the unitary SPC and a centralised granting procedure 
(sometimes referred to by the respondents as a “dual” system). Some stakeholders took the view 
that a centralised granting mechanism alone may not be sufficient to tackle the problems identified. 
Respondents further highlighted the need for a transparent system. In particular, some stakeholders 
emphasised that there was a need for a balanced system and that the initiative should not shift the 
current relation between generics and originators. The combination of a centralised grant 
mechanism for national SPCs based on European patents and a unitary SPC system for unitary 
patents, was supported by representatives from all key groups of market players, namely 
manufacturing new products based on own R&D and producers of generics in both sectors (i.e. 
pharmaceuticals234 and PPPs235) . 

Table 14: How the preferred option achieves the policy objectives? 

Objective  

Preferred option: PO5 (unitary SPC) + PO4 (centralised procedure with a binding opinion) 

Examination 
procedures 

Reducing cost of applying and 
maintaining SPC protection 
Increase 
predictability 
and legal 
certainty of SPC 
protection in 
the EU by 
facilitating: 

Granting 
procedures 

3rd parties 
involvement 

(++) One procedure, 55% lower costs (fees, attorney, translations) for a five-year long, protection in the 
whole EU (national maintenance fees might be still due for non UP-MS).  

(+++) One examination procedure eliminated divergent outcomes on the same file  

(+++) Right to submit third parties opinions  

(+++) One granting procedure for UP- MS and a binding decision for the remaining MS.  

Facilitate SPC monitoring  
Cost efficiency (EUR million) 

(+++) One single register and publicly accessible data of SPCs hosted by the EA   
Net effect 10.5 from 5th year operations; Benefits  65.4; Cost 54.9 

Table 15: Impacts of the preferred option (PO4 + PO5) on stakeholders (qualitative analysis) 

Stakeholder 
Originators, including SMEs 
(100 applications, 400 
owners paying maintenance 
fees) 

Impacts 
(+++/++) For 17 UP-MS: one application and one granting body. All fees paid to the central authority only. The 
same registration date. No divergent outcomes. 
For the remaining 10 MS: one application + NPOs grant SPC based on central authority opinion. Registration 
date might still differ depending on NPO process. Maintenance fees still due at the national level. 

Costs  EUR 30 000 per application, EUR 3 million EU-wide 

234 For example, Medicines for Europe (association of generic and biosimilar producers of pharmaceuticals) 
stated that a unitary SPC should be created for coherence with the unitary patent system and with the 
objective to tackle fragmentation and legal uncertainty (https://www.medicinesforeurope.com/wp-
content/uploads/2021/02/Medicines-for-Europe-Position-Paper-on-Unitary-SPC-Unified-Mechanism-for-
SPC-granting-March-2021.pdf)  
235 For example, one of the largest associations of PPP producers in the EU, which expressed support for the 
combination of the centralised examination and unitary SPC - meeting with the Commission Services on 4 
October 2022. 

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Benefits  EUR 56 000 per application, EUR 22 200 per maintenance fee; EUR 14.5 million EU-wide 
Net  EUR 26 000 per application, EUR 22 200 per maintenance fee; EUR 11.5 million EU-wide 

Follow-on manufacturers, 
SMEs (300 firms) 
Healthcare sector, patients 
and users of PPPs 
At least 27 (one healthcare 
authority per MS) 

(++) Database with almost complete information on centrally assessed/granted SPCs. NPOs participation 
necessary for nationally granted SPCs.  
Possibility to influence SPC granting process through written observations.  

Costs 

Benefits  

Follow-on manufacturers: 0 for generics; 
Healthcare: (+) up to EUR 2.2 million per UP country (due to wider SPC coverage). EU total of EUR 37 million 
Up to EUR 40 000 (database access) per firm/authority (+) EUR 37 million more R&D on novel medicines (EU 
total) 

Net  EUR 12 million (follow-on firms) and EUR 1 million (healthcare authorities) EU-wide 

Patent offices (NPOs) 
27 MS  

 (=/-) Loss of examining work load in the NPOs of the 27 EU MS. Loss of revenue for UP-MS equal to 0.4% and 
for others 0.3% of patent fee income. 
(-) Loss of application fee: up to EUR 32 600 per NPO; Loss of maintenance fee: up to EUR 522 800 per UP 
NPO; EUR 9.8 million 

Costs 

Benefits  Examiners remuneration: EUR 32 300 (if shared equally between all NPOs); EUR 0.87 million EU-wide 

Net 

IP agents/attorneys 
Up to 2700 (1/per MS per 
SPC) 

Costs 
Benefits 
Net 

- EUR 8.9 million EU-wide 
(-) Benefits specialised IP agents/attorneys that would handle centralised and unitary SPC applications, while 
other agents in UP-MS may lose income earlier generated by managing national SPC applications.  

Loss of EUR 2 000 per application per country 

- EUR 5.2 million EU-wide 

Note: Tables present maximum potential impacts from 5th year of new system operation; numbers rounded. 
Assumptions: 100 SPC applications per year, 80 SPC granted; 5-year-long SPC protection. 
Source: In-house analysis. 

8.1.  REFIT (simplification and improved efficiency) 

The following table summarises cost savings of the preferred option, in relation to the single grant 
mechanism (which would be introduced as amend existing legislation on SPC). 

Table 16: REFIT – cost savings 

Description 

Amount 

Comments 

REFIT Cost Savings – Preferred Option(s) 

Reduction of SPC 
application costs 

EUR 11.5 million  Due to replacement of 27 national procedures by one central 

with lower fees and need for just one legal representative. 
Materialising in full from 5th year onwards.236 

Reduction of monitoring cost 
for follow-on producers and 
health sector. 

EUR 13 million  Corresponds to cost of purchasing private SPC database 

access. Consisting of approximate savings of EUR 40 000 
for around 300 follow-on manufacturers and at least 27 
national health procurement offices. 

8.2.  Application of the ‘one in, one out’ approach 

This initiative would allow SPC applicants to use a single filing and examination procedure instead of 
up to 27 national procedures. It would in particular lower the translation costs incurred by applicants 

236 This is a net figure consisting of higher application costs for around 100 SPC applicants or EUR 3 
million and lower cost of legal advice (EUR 5.2 million) and translations (EUR 0.4 million) for 100 SPC 
applicants as well as lower cost of SPC maintenance of EUR 8.9 million for around 80 companies which 
should receive SPC given historical application rejection rate of 20%. Detailed calculations available in 
Annexes 5E and 5G. 

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before filing an SPC and limit the need for legal advice while dealing with each NPO. This is expected 
to produce annual EU-wide savings of EUR 5.6 million. This figure includes annual savings of EUR 52 
000 on legal advice and EUR 4 000 on translation for approximately 100 SPC applicants per year.  

9.  HOW WILL ACTUAL IMPACTS BE MONITORED AND EVALUATED? 

The legislation to be proposed would include a provision requiring an evaluation every five years, the 
first one five years after the grant of the first SPC under the new procedure. This should be done 
taking due account of the combined effect of other features of the EU legislation, especially in the 
pharmaceutical sector. The objective of the monitoring would be to determine whether or not the 
new initiative impacted long-term trends in the availability of novel medicinal products and plant 
protection products (albeit, it should be recognised that a direct causal link may be difficult to 
establish). To that aim, the available data on medicines237 and PPPs238 should be monitored, for 
example in 5-year intervals (in line with the evaluation schedule), as well as using other monitoring 
tools (e.g. dedicated surveys among SPC holders to test perceptions). The historical data on new 
product entries before this legislation enters into force should serve as a baseline. Additionally, the 
following indicators will be established and monitored with regards to each objective: 

Table 17: Monitoring indicators 

Research question 

Indicators 

How do the new system 
compares with the 
baseline in terms 
information available on 
SPC protection? 

Objective 1. Increase predictability and legal certainty  of SPC protection 

-  Duration of the protection, as defined in the SPC decision;  
-  Share of negative decisions (i.e. number of negative decisions divided by the total 

number or applications received); 

-  Number  of  countries  covered  by  an  SPC  for  a  given  product  (a  non-divergent 

decision); 

-  Number of unitary-SPC; 
-  Number of SPC-related referrals to the CJEU. 

How do the new system 
compares with the 
baseline in terms of 
accessibility and 
completeness of SPC 
information? 

How do the new system 
compares with the 
baseline in terms of 
number of procedures 
per year and its 
duration? 

Objective 2. Monitoring SPC protection 
-  Number of variables available (e.g. state of the procedure, date of entry into force, 
date of expiry, status of the paediatric extension, SPC holder’s identification, usage 
of the SPC manufacturing waiver); 

-  Quality  of  information  available  (e.g.  share  of  observations  with  non-missing 

information provided in key variables239); 

-  Timeliness  of  the  information  available,  determined  by  general  characteristics  of 
the IT system to be established and its frequency of updates (i.e. what is the time 
lag  between  an  administrative  action  and  accessibility  of  such  information  in  the 
database?).  

Objective 3. Reduce cost and burden of seeking and maintaining SPC protection  
-  Number  of  SPCs  applications  submitted,  including  a  subset:  number  of 

applications requesting the unitary SPC;  

-  Number of SPCs granted following the centralised procedure, including a subset: 

number of the unitary SPCs granted; 

-  Country distribution of the SPC holders (to allow comparisons by country);  
-  Duration  of  the  SPC  procedure  in  moths  (i.e.  date  of  filing  less  the  date  of  the 

decision).  

Sources of 
information 

- Centralised EA’s 
SPC database;  
- CURIA website, 
- PATSTAT database; 
- Data from this impact 
assessment 
(comparison with the 
baseline).  

Centralised EA’s SPC 
database. 

- Centralised EA’s 
SPC database;  
- EA annual reports; 
- Data from this impact 
assessment 
(comparison with the 

237 EMA, EPAR summaries of opinions for human and veterinary medicines 
(https://www.ema.europa.eu/en/medicines/download-medicine-data ). 
238 EU Pesticides Database (https://food.ec.europa.eu/plants/pesticides/eu-pesticides-database_en). 
239 Some of the information may be mandatory (e.g. the identification of the applicant), hence in such cases 
the accessibility would be 100 %. 

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Research question 

Indicators 

Sources of 
information 

How do the new system 
compares with the 
baseline in terms of the 
cost per SPC procedure? 
Is the cost of SPC 
procedure significant for 
SMEs? 

-  Cost  of  the  SPC  protection  (i.e.  fees  paid  per  SPC  following  the  centralised 

baseline). 

procedure and/or unitary-SPCs). 

-  Number of SMEs among SPC holders240; 
-  Cost  of  the  SPC  protection  for  the  SMEs  (i.e.  fees  paid  per  SPC  following  the 

centralised procedure and/or unitary-SPCs). 

240 Based solely on the identification information provided in the application, or by combining this 
information with other databases where the firm’s size classes can be determined (e.g. Orbis, see Annex 4). 

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ANNEX 1: PROCEDURAL INFORMATION 

1.  LEAD DG, DECIDE PLANNING/CWP REFERENCES 

DG for Internal Market, Industry, Entrepreneurship and SMEs (DG GROW). 

2.  ORGANISATION AND TIMING 

The deadline for adoption of a proposal by the Commission is April 2023.  

Inter-service meetings took place on 26.01.2021, 06.05.2022, 19.07.2022 and 24.08.2022. 

The following Commission services participated: DG COMP, EUIPO, SANTE, SJ, SG, TRADE, RTD and 
GROW.  

3.  CONSULTATION OF THE RSB 

A meeting with the RSB took place on 28.09.2022. On 30.09.2022 the RSB delivered a negative 
opinion. On 23.11.2022 a revised version of the impact assessment was submitted to the RSB. The 
table below shows RSB initial comments and how they were addressed in the revised text. 

Table 18: RSB comments to the initial version of the impact assessment 

RSB comments 

(1) The report is neither sufficiently clear about the 
main problem that needs to be tackled nor how 
important it is. 

(2) The report does not sufficiently explain the 
coherence between this initiative and the parallel 
revision of the general pharmaceuticals legislation. 

(3) The net impacts of each option and combination of 
options are not sufficiently analysed. The comparison 
of options does not unequivocally allow the 
identification of the preferred option, including in 
terms of proportionality. The choice of the preferred 
examination authority is not sufficiently argued. 

(4) The presentation of the views of different 
stakeholder categories is not sufficiently accurate or 
balanced throughout the report. 

EN 

DG GROW replies 

The report now presents in section 2.3 “legal uncertainty” as the 
main problem. The SME angle of the “high cost” problem was 
supported by extracting elements from the “SME test” annex into 
the main text. 
Additionally the fact that upcoming unitary patent would not be 
met with a unitary SPC at the EU level is highlighted throughout 
the impact assessment.  
The report now explains in section 2.2 the differences between the 
SPC system and alternative (not related to patent protection) 
instruments available to pharmaceutical firms, such as market 
protection or data protection offered by the pharmaceutical 
legislation. 
In addition to already presented assessment of the impacts of the 
pharmaceutical reform on the current SPC system (which is 
independent of the proposed reform) in section 2.6 and the impact 
on biosimilar/generic entry in section 6.6.1., the coherence of the 
preferred option with pharmaceutical reform is now further 
elaborated in section 7.3. 
The report now in addition to tables in section 7.1 provides 
explanation of the tables with net impacts of each option (a 
combination of mainly unquantifiable impacts and quantifiable 
ones where available). 
Section 7.2 was added to explain which combination of options is 
better in view of meeting the first objective of legal certainty. 
It is now clearly stated that all options are proportional and do not 
go beyond what is needed to achieve the objectives. 
The argumentation for choosing the examination authority in 
section 8 has been expanded and refers clearly to the selection 
criteria and analysis in section 6.3. 
The views of different stakeholders are now more prominently 
presented drawing on the analysis in Annex 2. Additional 
subsection was added to Annex 2, which explains how available 
consultation results were matched with the policy options and what 
were the methodological limitations of the public consultation used 

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in this impact assessment. 

On 16.12.2022 delivered a positive opinion on the revised text. The table below shows further 
changes implemented in the impact assessment in order to align it with RSB comments expressed in 
the second opinion. 

Table 19: RSB comments to the revised version of the impact assessment 

RSB comments 
(1)  The  report  is  not  sufficiently  clear  about  the 
the  divergences  of  national 

drivers  behind 
practices for SPCs. 

(2)  The  report  does  not  sufficiently  justify  the 

choice of the preferred option. 

DG GROW replies 

Further insights on the underestimated complexity of the SPC 
examination procedure was added to section 2.4.1, as well as 
stakeholder’s feedback on NPOs approaches to implementing the 
SPC procedures.  
Section 8 was reedited, so that the choice of the preferred option 
was substantiated in a more comprehensive manner.  

4.  EVIDENCE, SOURCES AND QUALITY 

The analysis presented in this impact assessment is based on the following key sources: 

-  Max Planck Institute for Innovation and Competition, Study on the Options for a Unified 

SPC System in Europe, 2022 (https://op.europa.eu/en/publication-detail/-
/publication/94cb20ea-2ff0-11ed-975d-01aa75ed71a1/language-en). 

-  European Commission, Evaluation of EU Regulations 469/2009 and 1610/96 on 
supplementary protection certificates for medicinal and plant protection products, 
SWD(2020)292, 2020 (https://ec.europa.eu/docsroom/documents/43847). 

-  Max  Planck  Institute  for  Innovation  and  Competition,  Study  on  the  Legal  Aspects  of 
2018 

Certificates 

Europe, 

in 

Supplementary 
(https://ec.europa.eu/docsroom/documents/29524). 

Protection 

-  Technopolis,  ‘Effects  of  supplementary  protection  mechanisms  for  pharmaceutical 
(https://www.ivir.nl/publicaties/download/effects-of-supplementary-

products’, 
protection-mechanisms-for-pharmaceutical-products.pdf). 

2018 

-  Copenhagen  Economics,  Study  on  the  economic  impact  of  supplementary  protection 
certificates, pharmaceutical incentives and rewards in Europe, Publications Office of the 
European Union, Luxembourg, 2018 (https://ec.europa.eu/docsroom/documents/29521). 

-  European Commission, Summary of the replies to the public consultation on 

Supplementary Protection Certificates and patent research exemption for sectors whose 
products are subject to regulated market authorisations, SWD(2018)242, 2018 
(https://eur-lex.europa.eu/legal-content/EN/TXT/PDF/?uri=CELEX:52018SC0242). 

-  Mejer, M., 25 years of SPC protection for medicinal products in Europe: Insights and 

challenges, European Commission, DG GROW, 2017. 

Additionally, the following data sources were used in order to perform in-house analysis: 

-  MIDAS  database  provided  by  IQVIA,  as  a  flat  file  covering  EU–27  except  for  MT  and 

CY, for the years 2010–2021; 

-  National data related to the cost of SPC (application and maintenance), as collected from 

respective NPO websites in March 2022. 

-  German Patent  and Trade Mark Office, Data uploaded from the German  national  patent 
Schutzzertifikat 

concerning 

SPCs 

- 

office, 
(https://register.dpma.de/DPMAregister/pat/basis). 

DPMA 

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The remaining sources are provided in the footnotes, whenever they are referred to in the text. 

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ANNEX 2: STAKEHOLDER CONSULTATIONS  

This annex documents all the consultation activities conducted in the context of the revision of SPC 
regulation.  

From 8 March to 5 April 2022 interested parties could provide feedback to Commission’s Call for 
Evidence241. In 2020 there was a dedicate survey to Member States on SPC transparency. Questions 
relevant to this initiative were also asked in earlier consultations: on evaluation of the EU SPC system 
(took place between 12 October 2017 and 4 January 2018)242 and as part of a legal study (between 22 
May and 23 June 2017)243. Additionally several bilateral meetings with stakeholders took place 
between 2018 and 2022, including meetings with Member States as part of the Commission expert 
Group on Industrial Property Policy244, representatives of associations of pharmaceutical companies 
(originators, generic and biosimilar producers) and plant protection products manufacturers. 

Feedback on call for evidence 

By the end of consultation period 59 replies arrived (51 from the EU Member States). Almost half of 
responses came from business and business organizations. One in six was from EU citizens and 
similar number of NGOs. Five percent came from authorities and two percent from trade unions. 

Figure 12. Distribution of respondents to call for evidence by type of respondent and country of origin. 

Source: Commission services’ own analysis 

While the answers or the respondents were grouped into businesses, NGOs, citizens245, etc., the 
analysis also looks at the subgroups of originator companies and generic companies and their 

241 For complete summary of replies see: https://ec.europa.eu/info/law/better-regulation/have-your-
say/initiatives/13353-Medicinal-plant-protection-products-single-procedure-for-the-granting-of-SPCs_en  
242 https://eur-lex.europa.eu/legal-content/EN/TXT/?qid=1593699690365&uri=CELEX:52018SC0242 
243 MPI (2018) - Allensbach survey. 
244 https://ec.europa.eu/transparency/expert-groups-register/screen/expert-
groups/consult?lang=en&do=groupDetail.groupDetail&groupID=3434  
245 Note that the feedback received from individuals, while pertaining to a considerable percentage here, 
almost exclusively did not relate to the initiative. 

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Business Association22%Company/Business organisation27%EU Citizen17%NGO (Non-governmental organisation)17%Public authority5%Trade Union2%Other10%3511111333466615UKSwitzerlandHungaryLatviaNetherlandsPolandPortugalDenmarkFranceSpainItalyAustriaBelgiumSwedenGermany 
 
 
                                                           
respective associations into account to reflect the group of stakeholders’ views best. The following 
feedback could be broadly observed: 

The originator companies and their associations supported the introduction of a unitary SPC and the 
creation of a centralised procedure. Guidelines could help as supporting measures, but not as a 
standalone solution to the problems highlighted in the Call for Evidence. In particular, using the 
expertise of NPOs through a virtual examination body, was favoured by a majority of stakeholders.  

The generic companies and their associations highlighted that a Unitary SPC may tackle the current 
fragmentation with several advocating that a single procedure should only be considered if there 
were pre-grant opposition proceedings (a procedural element that should ideally be introduced for 
both procedures). They further took the view that the timely access to generic medicine as well as 
the impact on generics should be taken into account, in particular regarding the potential extension 
of the geographical scope through the Unitary SPC. Moreover, it was underline that multiple 
litigation in several Member States was also a problem faced by stakeholders at the moment.  

More broadly, the main takeaways from the feedback are discussed below. Regarding the options set 
out in the call for evidence, there was overall support for an EU initiative which would comprise a 
combination of the unitary SPC and a centralised granting procedure. National procedures should still 
exist alongside them. Some stakeholders took the view, that a single granting mechanism alone may 
not be sufficient to tackle the problems identified. Respondents further highlighted the need for a 
transparent system. In particular, some stakeholders emphasised that there was a need for a 
balanced system and that the initiative should not shift the current balance between generics and 
originators.  

Those respondents that addressed guidelines, mostly favoured them as measures to support the new 
system, but not as a standalone option. In particular, these guidelines may for example either codify 
or clarify CJEU case law, or be based on best practices from NPOs, and thus provide guidance for 
national procedures. 

Responses were split on point c2) of the Call for Evidence regarding targeted amendments of the SPC 
Regulations on the basis of the best practices of national patent offices and CJEU case law aimed at 
further harmonising the current SPC system. Some responses were in favour of this option, while 
others cautioned that any further amendments might lead to even more cases and would therefore 
cause further uncertainties. As regards the granting authority, the majority of feedback received 
favoured a virtual granting authority. Some organisations favoured the EPO, while others highlighted 
the need for a central EU granting authority which would also be accountable to the CJEU. Expert 
knowledge, whether this be within the authority itself or its appellate body, was also pointed out as 
an important criterion by some stakeholders.  

Last, while only very few respondents represented the PPP industry, the feedback received also 
favoured the single procedure in combination with the unitary SPC to address the current 
fragmentation. 

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Survey to Member States on SPC transparency 

The European Commission conducted a targeted survey among national patent offices in early 2020 
to obtain details on their transparency practices. Based on this survey, different practices across 
NPOs have been identified. Most national patent offices (NPOs) provide for an online searchable 
database, although the search criteria are very variable (in two Member States, only the SPC number 
can be used as a search criterion). Publishing SPC-related information takes varying amounts of time, 
ranging from a few days to several months, and even more than a year in specific situations. Only a 
slight majority of NPOs (14) publish SPC-related information in English in addition to their official 
languages. Only about half of the NPOs make the documents of the file of a given SPC application 
accessible online (e.g. in PDF format). However, the other ones usually provide for file inspection 
and/or are able to provide copies. Only a slight majority of NPOs (15) provide the European Patent 
Office with detailed information on SPCs (which the EPO then publishes). When asked which source 
they would consider to be the most suitable for providing centralised access to SPC information, 
seven NPOs mentioned the EPO databases (possibly with improvements), four did not express any 
preference, and 14 mentioned a new centralised website. 

Public consultation (responses relevant to this initiative) 

A total of 231 replies were provided to the on-line consultation: 43 replies from the general public, 
71 from originators industry/associations, 63 from generics and biosimilars industry/associations, 15 
from health authorities/doctors/patients groups (mostly from national organisations dealing with 
health insurance/reimbursement/health technology assessment, from a doctors’ organisation, and 2 
from patients’ associations), 34 from patent offices/practitioners, and 5 from industry/trade 
authorities. The tables below present statistics on those respondents who took a position that is 
“don’t know” answers and “no answers” are not taken into consideration246. 

Problems with current SPC rules: Respondents broadly support the way in which SPC issues are 
regulated at EU level, which is found to be globally effective. However, most respondents claim that 
there are different practices for registration and SPC enforcement across Member States (a few 
originators and generics manufacturers disagree).  

Table 20. Have authorities in different EU countries ever taken different decisions on SPC applications for one (or more) of 
your products? Examples: some EU countries granted SPC national applications for one of your products but refused others; 
you were granted different durations of SPC protection for one of your products in different EU countries; national grant 
authorities 
differently). 
Q11 (to Originators) and Q4 (to Follow on manufacturers) Q2 (to to Patent offices, judges, lawyers) 

interpreted 

rulings 

Justice 

Court 

EU 

of 

Originator/innovator 
Follow on manufacturer 
Patent offices, judges, lawyers 
Note: ”Don’t know“ and No answer not taken into account (also in no. of answers provided). 
Source: Public Consultations on Evaluation of SPC 

82% 
79% 
96% 

Yes 

No 

18% 
21% 
4% 

No. of 
answers 
49 
43 
28 

246 The number of “don’t know” and “no reply” answers is the difference between number of all responses 
in a given category of respondent and the number of answers (of those taking a position) presented in each 
table either in the last column or the last row. 

EN 

80 

EN 

 
 
 
 
                                                           
Generics manufacturers mostly support SPC registration with substantive examination, but consider 
that transparency is not optimal (information published by public authorities is not always 
comprehensive or up-to-date, and private databases monitoring SPC status are expensive).  

Table 21: Based on your experience, do you think that all EU countries’ national patent offices should conduct substantive 
examination  (i.e.  actual  verification  of  the  conditions  stipulated  in  the  SPC  Regulation)  of  SPC  applications?  Q28  (to 
Follow-on manufacturers) 

Yes 
No – some of them might not have the necessary administrative capacity/resources 
No – it’s unnecessarily cumbersome, even for the offices with enough resources 

Note: ”Don’t know“ and No answer not taken into account (also in no. of answers provided).  
Source: Public Consultations on Evaluation of SPC 

% 
86% 
5% 
9% 
No. of answers  56 

Table 22: About your use of databases to monitor the status of your competitors’ SPC protection across EU Member States. 
Q6 (to Follow on manufacturers), Q5 (to Customers, health), Q4 (to Patent offices, judges, lawyers)  

Agree answers only* 

Follow on 
manufacturers 

Customers, 
health 

specialised databases are very costly 
to our knowledge, there are no databases available to conduct such 
monitoring 

96% 
4% 

No. of answers 

55 

* the residual to 100% is the number of those disagreeing. 
Note: ”Don’t know“ and No answer not taken into account (also in no. of answers provided).  
Source: Public Consultations on Evaluation of SPC 

83% 
75% 

14 

Patent 
offices, 
lawyers 
69% 
30% 

16-23 

The level of registration fees or litigation costs is predominantly acceptable for SPC holders, as such 
costs can be compensated by additional sales resulting from the SPC protection. 

Table  23:  How  would  you  rate  the  degree  of  complexity  of  registration  procedures  for  SPCs  in  the  EU?  
Q13 (to Originators) and Q9(to Follow on manufacturers)  

Originator/innovator 
Follow on manufacturer 
Note: ”Don’t know“ and No answer not taken into account (also in no. of answers provided). 
Source: Public Consultations on Evaluation of SPC 

72% 
61% 

High 
13% 
39% 

Reasonable  Low 

No. of answers 

15% 
0% 

54 
51 

Table  24: 
Q15 (to Originators): 

Is 

the  cost  of  registering  and  maintaining  an  SPC 

in  all  28  EU  countries  proportionate?.  

YES, the cost is always relatively low compared with product sales 
The cost of SPC protection barely exceeds the value of sales in some small markets. But we always register 
the SPC in all EU countries where the corresponding patents are in force. 
The cost of SPC protection barely exceeds the value of sales in some small markets. So we do not register 
the SPC in all EU countries where the corresponding patents are in force. 
NO, the administrative burden to register and maintain it in all EU countries is high 
Other: please specify 

% 
77% 
2% 

0% 

4% 
17% 

No. of answers  53 

Note: ”Don’t know“ and No answer not taken into account (also in no. of answers provided). 
Source: Public Consultations on Evaluation of SPC 

Respondent noted however that other jurisdictions such as the US or Japan provide more attractive 
SPC-type protection than the EU system. 

EN 

81 

EN 

 
 
 
 
 
Table 25: In your experience, do other jurisdictions (e.g., the US or Japan) provide for SPC-type protection to certain types 
of 
EU? 
not 
Q26 (to Originators) and Q13 (to Follow on manufacturers) 

innovations 

develop 

eligible 

SPC 

that 

you 

are 

the 

for 

an 

in 

Originator/innovator 
Follow on manufacturer 
Note:”Don’t know“ and No answer not taken into account (also in no. of answers provided). 
Source: Public Consultations on Evaluation of SPC 

95% 
79% 

Yes 

No 

5% 
21% 

No. of 
answers 
44 
34 

Unitary SPC: A very large majority of the respondents across all categories favour the creation of a 
unitary SPC, which would extend unitary patents once such exclusive rights expire. 

Table  26:  Do  you  favour  the  creation  of  a  unitary  SPC  title  for  the  unitary  patent?  Q37  (to  Originators),  
Q29 (to Follow on manufacturers), Q15 (to Customers, health), Q27 (to Patent offices, judges, lawyers). Q9 (to Other public 
authorities) 

Originators* 

Follow-on 
manufacturers 

Customers, 
health 

Yes 
No 
No. of answers: 

74% 
x 
68 

98% 
2% 
55 

79% 
21% 
11 

Patent 
offices, 
lawyers 

81% 
19% 
27 

Ministries 
and other 
public 
authorities 
100% 
0% 
5 

* respondents did not receive this question instead we report here those who chose “Create a unitary SPC for the unitary patent” as 
answer to Q37 “What would be your preferred option to improve consistent interpretation throughout the EU of the ‘substantive’ 
provisions of the SPC regulation (e.g. the scope of protection, eligibility of SPC protection)?”.  
Note: ”Don’t know“ and No answer not taken into account (also in no. of answers provided). Questions had slightly different formulations 
to each group but with the same meaning. 
Source: Public Consultations on Evaluation of SPC 

Regarding the benefits of a unitary SPC, a great majority of originators consider that it could boost 
the value of investments, reduce the red tape related to registration and litigation, provide a uniform 
protection across the EU, improve legal certainty, reduce maintenance costs, offer a specialised 
court, and finally - it would make licensing easier. A large majority of follow-on manufacturers, 
including SMEs, shared these views. 

One Member State considered that it would also simplify and enhance the efficiency of the SPC 
application process. 

Table 27. What would be the benefits of a unitary SPC?:Q43 (to Originators), Q35 (to Follow on manufacturers), Q17 (to 
Customers, health), Q34 (to Patent offices, judges, lawyers). Q12 (to Other public authorities) 

Agree answers only* 

Originators 

Follow-on 
manufacturers 

Customers, 
health 

Patent 
offices, 
lawyers 

Legal certainty 
Reduce cost/red tape of SPC-related 
litigation 
Same protection in all EU 
Reduce red tape relating to registration 
Specialised court 
Reduce cost and red tape relating to 
monitoring SPC-protected products 
(freedom to operate) 
Reduce maintenance costs 
Make licensing easier 
Boost value of investments 

EN 

94% 
98% 

98% 
98% 
98% 
x 

98% 
93% 
95% 

100% 
100% 

x 
x 
94% 
98% 

x 
98% 
x 

82 

EN 

85% 
83% 

x 
x 
71% 
83% 

x 
x 
x 

91% 
71% 

92% 
86% 
86% 
x 

88% 
79% 
x 

Ministries 
and other 
public 
authorities 
100% 
100% 

100% 
80% 
100% 
x 

100% 
100% 
100% 

 
 
 
 
Make joint procurement by a group of 
EU countries easier 

x 

x 

75% 

x 

No. of answers 

14-25 
* the residual to 100% is the number of those disagreeing;x - response not available to that group of respondents 
Note: No answer and “Neither agree nor disagree” not taken into account (also in no. of answers provided).  
Source: Public Consultations on Evaluation of SPC 

43-56 

51-64 

7-13 

x 

3-5 

Opinions diverge regarding the practicalities for implementing such a new title247. While some 
respondents favour the grant of that title by a virtual office composed of national experts working on 
behalf of an EU agency, others prefer either to entrust the EPO with this task, or to set up a new EU 
agency to do so. 

Amongst SMEs manufacturing generics and biosimilars, half of them favoured the grant of unitary 
SPCs by a new EU agency, while the other half favour the EPO for this purpose. 

Table  28:  Which  granting  authority  would  you  favour  to  grant  and  register  a  unitary  SPC?  Q38  (to  Originators),  
Q30 (to Follow-on manufacturers), Q10 (to Other public authorities) 

Agree answers only* 

Originators 

Follow-on 
manufacturers 

EU Intellectual Property Office 
European Patent Office 
A new EU agency 
European Medicines Agency 
EU countries' patent offices (e.g. virtual office 
approach or mutual recognition with reference 
offices, under EU rules) 
None of the above, please indicate your alternative 
preference 

1% 
6% 
1% 
1% 
86% 

4% 

2% 
48% 
38% 
0% 
7% 

5% 

Ministries and 
other public 
authorities 
0% 
20% 
0% 
40% 
20% 

20% 

No. of answers 
* the residual to 100% is the number of those disagreeing.  
Note: ”Don’t know“ and No answer not taken into account (also in no. of answers provided). Not all groups of respondents have received 
this question. 
Source: Public Consultations on Evaluation of SPC 

69 

50 

5 

Similar results emerged from the MPI (2018) study: 

247 A position document of 2021 of Medicines for Europe proposes to take into consideration the following 
aspects for the set-up of a centralised procedure: i) that the European Parliament oversees the granting body; 
ii) if an SPC is revoked in one EU Member State, the granting authority should revoke the SPC protection 
automatically in all other EU Member States; iii) the procedure for invalidating SPCs (i.e. oppositions) 
should be also unified; iv) only products with European marketing authorisations should be eligible; v) 
ensure the highest level of transparency (e.g. publication of data) in the SPC granting procedures; vi) 
provide for third party observations. https://www.medicinesforeurope.com/wp-
content/uploads/2021/02/Medicines-for-Europe-Position-Paper-on-Unitary-SPC-Unified-Mechanism-for-
SPC-granting-March-2021.pdf  

EN 

83 

EN 

 
 
                                                           
Figure 13. Authority to grant SPC title - study survey, MPI (2018) 

Source: MPI (2018), Annex III 

Concerning the languages to be used for a unitary SPC, a clear majority favoured the EPO language 
regime (English, French, German), which is the regime that is applicable to the unitary patent. 
However, SMEs manufacturing generics and biosimilars preferred the five-language regime of the 
EUIPO (English, French, German, Italian and Spanish). 

Table 29:  Which  language  combination  would  you prefer  for  registering  unitary  SPC applications?  Q39  (to  Originators), 
Q31 (to Follow on manufacturers), Q29 (to Patent offices, judges, lawyers). Q9 (to Other public authorities) 

Agree answers only* 

Originators  Follow-on 

manufacturers 

English, French, German, Italian and Spanish (as for 
the EU Intellectual Property Office) 
English, French, and German (as for the European 
Patent Office) 
All EU official languages (as for the centralised 
marketing authorisations) 
English only 
None of these (please state your alternative preference) 
No. of answers 

6% 

78% 

3% 

9% 
3% 
64 

34% 

25% 

19% 

22% 
0% 
59 

Patent 
offices, 
lawyers 

8% 

63% 

8% 

17% 
4% 
24 

Ministries 
and other 
public 
authorities 
0% 

40% 

40% 

20% 
0% 
5 

* the residual to 100% is the number of those disagreeing.  
Note: No answer not taken into account (also in no. of answers provided). Source: Public Consultations on Evaluation of SPC 

EN 

84 

EN 

 
 
 
Table  30:    Which  language  combination  would  you  prefer  for  publishing  unitary  SPCs?  Q39  (to  Originators),  Q31  (to 
Follow  on  manufacturers),  Q16  (to  Customers,  health),  Q29  (to  Patent  offices,  judges,  lawyers).  Q9  (to  Other  public 
authorities) 

Agree answers only* 

Originators 

Follow-on 
manufacturers 

Customers, 
health 

Patent 
offices, 
lawyers 

6% 

34% 

x** 

8% 

Ministries 
and other 
public 
authorities 
0% 

English, French, German, Italian and 
Spanish (as for the EU Intellectual 
Property Office) 
English, French, and German (as for 
the European Patent Office) 
All EU official languages (as for the 
centralised marketing authorisations) 
English only 
None of these (please state your 
alternative preference) 

No. of answers 

77% 

5% 

9% 
3% 

64 

22% 

21% 

22% 
0% 

58 

46% 

38% 

15% 
x** 

13 

58% 

17% 

13% 
4% 

24 

40% 

40% 

20% 
0% 

5 

* the residual to 100% is the number of those disagreeing. ** response not available to that group of respondents 
Note: No answer not taken into account (also in no. of answers provided). Source: Public Consultations on Evaluation of SPC 

The majority of respondents considered that national marketing authorisations should be also 
allowed (in addition to the EU marketing authorisations) as a basis for getting a unitary SPC, even 
though the latter would then not be enforceable in those Member States where no marketing 
authorisation would have been granted (through mutual recognition or decentralisation procedure). 

Table 31: Should the unitary SPC be available only for products authorised by way of a centralised marketing authorisation 
(e.g. 
Originators),  
Q32 (to Follow-on manufacturers), Q30 (to Patent offices, judges, lawyers). 

Medicines 

European 

Agency)? 

assessed 

Q40 

the 

(to 

by 

Agree answers only* 

Yes 
No 

Originators 

Follow-on 
manufacturers 

No. of answers 

5% 
95% 
59 

38% 
62% 
37 

Patent 
offices, 
lawyers 
58% 
42% 
24 

Note: ”Don’t know“ and No answer not taken into account (also in no. of answers provided).  
Source: Public Consultations on Evaluation of SPC 

In the absence of a unitary SPC, a majority of the respondents were of the opinion that NPOs could 
grant – pursuant to the current legislation – national SPCs for products covered by future unitary 
patents. 

How SPC rules should be updated: EFPIA suggests that guidance at EU level would improve the 
situation. This should not extend to amending the SPC acquis, as EFPIA considers that such an 
amendment process could lead to years of uncertainty; generics manufacturers seem to be split on 
whether to clarify aspects of the SPC Regulation implementation via legislative amendments. 

IP practitioners (including patent offices), generics manufacturers and health practitioners support 
‘guidance’ approach, especially since court proceedings in some Member States may take too long. 
Additionally many IP practitioners already have experience with national guidance. 

EN 

85 

EN 

 
 
Table 32: How to improve consistent interpretation throughout the EU of the ‘substantive’ provisions of the SPC regulation 
(e.g. 
Originators),  
Q27 (to Follow on manufacturers), Q14 (to Customers, health), Q25 (to Patent offices, judges, lawyers). 

protection)? 

protection, 

eligibility 

scope 

SPC 

Q37 

the 

(to 

of 

of 

Originators 

Follow-on 
manufacturers 

Customers, 
health 

Create a unitary SPC for the unitary patent 
Guidelines developed jointly by the European 
Commission and EU countries 
Amend the SPC Regulations to provide extra clarity 
Don't change the current SPC system - rely on 
referrals to the Court of Justice of the EU 

74% 
7% 

1% 
18% 

55% 
75% 

46% 
x* 

No. of answers 

68 

54-57 

55% 
73% 

45% 
x* 

11 

Patent 
offices, 
lawyers 
59% 
74% 

55% 
x* 

22-23 

* Stakeholder was not presented with this answer 
Note: Single choice question to Originators, multiple choice question for the rest. ”Don’t know“ and No answer not taken into account (also 
in no. of answers provided). Questions had slightly different formulations to each group but with the same meaning. Source: Public 
Consultations on Evaluation of SPC 

Table 33: National implementing guidelines and their updates. Q6 (to Patent offices, judges, lawyers). 

Q6. Has your country (e.g. your national patent office) adopted implementing 
guidelines for examining and registering SPCs?    
If ‘yes’ to Question 6, do you usually update the guidelines following a judgment from 
the Court of Justice of the EU? 
Note: ”Don’t know“ and No answer not taken into account (also in no. of answers provided).  
Source: Public Consultations on Evaluation of SPC 

Yes 

No 

81% 

19% 

No. of 
answers 
27 

80% 

20% 

20 

Impact  on  innovation.  SPCs  are  considered  to  have  a  proportionate  impact  on  investment 
along  all  steps  of  the  value  chain:  R&D,  clinical  trials,  manufacturing,  distribution  and 
commercialisation.  Some  innovators  consider  SPC  availability  as  the  main  factor  for 
investment  decisions  in  manufacturing.  However,  the  importance  that  the  majority  of 
innovators ascribe to SPCs is moderate, as they consider that SPCs are one factor in a package 
of  elements:  aside  from  the  availability  of  SPCs,  decisions  on  investments  in  research 
(excluding clinical trials and field trials) are driven by a combination of factors such as access 
to high skilled labour and recruitment of patients. With regard to the most important factors 
when  investing  in  clinical  trials,  innovators  consider  health  infrastructure  and  proximity  of 
research universities. 

Table 34: For innovative products or potential innovative products, does the possibility of getting EU SPC protection play a 
role when your company/organisation is deciding on the following investments? Q6 (to Originators) 

Yes* 

No 

Clinical trials (medicinal products), or field trials (for plant protection products) 
Manufacturing 
Marketing in EU Countries 
R&D (excluding clinical/field trials) 
Distribution 
* Composed of answers: YES, always, YES, to some extent, YES, but only if the investment will take place in the EU 
Note: ”Don’t know“ and No answer not taken into account (also in no. of answers provided). 
Source: Public Consultations on Evaluation of SPC 

97% 
94% 
91% 
88% 
80% 

3% 
6% 
9% 
12% 
20% 

No. of 
answers 
34 
33 
33 
34 
30 

EN 

86 

EN 

 
 
 
 
 
Table 35: Impact of SPC on originators decision on innovation (Q7 and 8 to Originators) 

Q7. Has a prospective product's eligibility for SPC protection ever been a decisive 
factor in its development (i.e., without an SPC you would have discarded it despite 
having already invested in part of its development)? 
If you answered ‘yes’ to Question 7, was the prospective product being developed (or 
did most of its development take place) in the EU? 
Q8. Have the SPC regulations influenced the prioritisation of certain types of 
innovation in your organisation? (e.g. oncology or highly sought-after treatments) 
Note: ”Don’t know“ and No answer not taken into account (also in no. of answers provided). 
Source: Public Consultations on Evaluation of SPC 

Yes 

No 

80% 

20% 

No. of 
answers 
41 

94% 

6% 

50% 

50% 

18 

38 

On the other hand follow-on manufacturers favour countries without SPC when deciding where to 
produce generic/biosimilar medicines. 

Table 36: Do you favour countries with no SPC protection when looking for a location to base or outsource your biosimilars 
manufacturing? Q19 (to Follow on manufacturers): 

Yes 
Depends on the circumstances but it is a key factor. 
No 

Note: ”Don’t know“ and No answer not taken into account (also in no. of answers provided). 
Source: Public Consultations on Evaluation of SPC 

% 
71% 
27% 
2% 
No. of answers  45 

The Commission expert Group on Industrial Property Policy (GIPP) 

The meeting of the Commission expert Group on Industrial Property Policy (GIPP) on 18 November 
2022 was dedicated solely to the SPC reform. Several Member States shared their preliminary 
positions regarding the policy options presented in this impact assessment in the meeting and/or in 
written contributions in advance (see table below).  

Table 37: Preliminary support of the Commission expert Group on Industrial Property Policy (GIPP) to policy options 
expressed during 18 November 2022 meeting: 

PO1 

PO2 

PO3 

PO4 

PO5 

No. of answers 
Total number of Member States expressing preliminary position: 16 
Source: GIPP meeting 18 November 2022. 

5 

8 

0 

8 

11 

Among 17 Member States who took a preliminary position, a clear majority (11) supported PO5 – 
unitary SPC to complement unitary patent. Regarding the current national SPC framework Member 
States taking the floor agreed that current SPC fragmentation is a problem. To solve this 
fragmentation, some called for solely guidelines (PO1) others for a centralised procedure and/or the 
unitary SPC. Among those recognising the need for a centralised procedure, more Member States 
opted for PO4 where the examination opinion is binding on national authorities (8 Member States) 
than PO3 where it is not binding (5 Member States).  

As regards functioning of the central procedure all Member States who replied (9) considered that 
opposition procedure should not be added to SPC examination process – some noting that such an 
opposition is not even available during patent granting process. Five Member States agreed that 

EN 

87 

EN 

 
 
 
 
 
 
third party observations should be allowed (no Member State was against). As regards adding a 
possibility to review a central SPC decision (and consequently reduce the risk of post-grant national 
litigation) three Member States were in favour and one was against. 

In addition to the questions sent in advance, some Member States taking the floor also referred to 
the need for more transparency in the system.  

Last, the role of NPOs was emphasised by several Member States. In particular, more information on 
the exact design of a system in practice would be required. Some Member States referred to the 
need to uphold the high quality of substantive examinations.  

How stakeholders’ views were matched with different policy options 

This section explains how we used the available consultations to gauge stakeholders’ opinion on the 
different policy options presented in this impact assessment. 

Stakeholders views on PO1 (guidelines) are based on responses presented in Table 32 (second row). 
Views on PO2 (mutual recognition) are approximated by responses presented in Table 28 (fifth row) 
and Figure 13 (last row). There were no questions that could directly show stakeholders views on 
PO3 and PO4 (centralised application examination, with national SPC granting following non-binding 
or binding opinion respectively). We indirectly infer these from i) general support for a unitary SPC 
(Table 26), as both these options provide “unification” at the SPC application examination level; and 
ii) support for granting of a unitary SPC by NPOs (Table 28, fifth row). All consultations point to 
generally wide support for creating a unitary SPC to supplement the unitary patent (PO5) – see for 
instance Table 26 above or Table 27 for the expected benefits of a unitary SPC. 

The binding vs. non-binding nature of the central opinion was discussed during several meetings 
where Member State participated, the views however were not systematically collected, so we 
decided to assess these two option mostly on efficiency of achieving the objectives (especially 
predictability and legal certainty) without presenting the views of stakeholders. 

Table 28 shows stakeholders views on the most appropriate authority to grant SPC. While Table 29 
and Table 30 present language preferences for SPC application and publication respectively. 

Finally, amendment of the Regulations to clarify SPC rules was favoured by several stakeholders 
(Table 32, third row) - it was however an early discarded option due to reasons explained in section 
5.4.  

EN 

88 

EN 

 
 
 
 
ANNEX 3: WHO IS AFFECTED AND HOW? 

Practical implications of the initiative 

The proposed initiatives (a centralised SPC granting procedure and/or unitary SPC) are of a 
procedural nature, in the sense that they would not provide new rights, or alter the scope of the 
rights already conferred by the existing national SPCs. These initiatives are intended to simplify the 
granting of SPCs, through a centralised application and examination procedure. This would reduce 
the cost and administrative burden for the applicants, increase legal certainty and facilitate access to 
information on SPCs status (which is beneficial for all stakeholders, including for instance generic and 
biosimilar manufacturers). The proposed changes also secure more stakeholders involvement 
through the new rules on third parties observations. 

Summary of costs and benefits 

I. Overview of Benefits (total for all provisions) – Preferred Option 

Description 

Amount 

Comments 

Direct benefits 

Lower SPC maintenance 
fees for SPC holders 

EUR 111 100  

Savings per SPC holder for EU-wide, five year long protection. 
Affecting up to 400 firms per year (SPC owners). 

Saving on legal advice for 
SPC applicants 

EUR 52 000 

Saving on translation cost 
for SPC applicants 

EUR 4 000 

Savings per applicant. Due to dealing with one authority instead of 27 
with different procedures and requirements. Affecting up to 100 firms 
per year. 

Savings per applicant. As application can be in one of the official EU 
languages, instead of languages of each Member State. Affecting up to 
100 firms per year. 

Saving on SPC search cost 
for generic/biosimilar 
manufacturers and health 
sector 

EUR 40 000 

Saving per firm/healthcare authority. Concern identification of active 
SPC on a given territory. Based on cost of acquiring commercial 
database. Affecting up to 300 generic/biosimilar firms and at least 27 
central pharmaceutical procurement bodies. 

Potentially higher 
investments in novel 
medicines 

Indirect benefits 

EUR 37 million  

Estimated total annual additional income of originators due to extended 
territorial coverage of unitary SPC protection. 

Administrative cost savings related to the ‘one in, one out’ approach* 

Saving on legal advice for 
SPC applicants 

Saving on translation cost 
for SPC applicants 

EUR 52 000 

As above 

EUR 4 000 

As above 

II. Overview of costs – Preferred option 

Action (a)   

Direct adjustment 
costs 

EN 

Citizens/Consumers 

Businesses 

Administrations 

One-off 

Recurrent 

One-off 

Recurrent 

One-off 

Recurrent 

EUR 1.4 
million for 
the central 
authority 

89 

EN 

 
 
  
 
 
 
 
 
 
EUR 1.8 
million 
annually for 
central 
authority 

Direct 
administrative 
costs 

Direct regulatory 
fees and charges 

Direct 
enforcement costs 

Indirect costs 

Application fee 
potentially 
higher by EUR 
30 000 per 
applicants in 
comparison to 
baseline 

EUR 37 
million 
estimated total 
additional 
spending on 
medicines due 
to extended 
territorial 
coverage of 
unitary SPC 
protection. 

Costs related to the ‘one in, one out’ approach 

Direct adjustment 
costs  

Total   

Indirect 
adjustment costs 

Administrative 
costs (for 
offsetting) 

Relevant sustainable development goals 

III. Overview of relevant Sustainable Development Goals – Preferred Option(s) 
Relevant SDG 

Expected progress towards the Goal 

Comments 

SDG no. 3 – good health and 
wellbeing  

By facilitating access to SPC for innovators this 
initiative might marginally incentivise more R&D 
expenditures for novel medicines, especially the 
complex ones, requiring longer development and 
testing, and thus longer time to recuperate 
investment costs.  

EN 

90 

EN 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
ANNEX 4: ANALYTICAL METHODS 

Section 1.2 

Key economic indicators for the two sectors of interest provided in Section 1.2. of this impact 
assessment are based on Structural Business Statistics of Eurostat (Annual detailed enterprise 
statistics for industry, NACE Rev. 2, B-E)248. The sectors are defined according to NACE Rev.2 
classification249 namely group 20.2 with its only sub-class 20.20 and the entire division 21 with all its 
subcomponents:  

o  20.2 Manufacture of pesticides and other agrochemical products250, 

  20.20 Manufacture of pesticides and other agrochemical products  

  21 Manufacture of basic pharmaceutical products and pharmaceutical preparations251, 

o  21.1 Manufacture of basic pharmaceutical products, 

  21.10 Manufacture of basic pharmaceutical products252 

o  21.2 Manufacture of pharmaceutical preparations, 

  21.20 Manufacture of pharmaceutical preparations253. 

The remaining analytical methods applied in each of the above-mentioned studies and consultations 
are explained in the respective documents. 

248 Eurostat [sbs_na_ind_r2] last update: 18.05.22; extracted on: 05.06.22. 
249 NACE Rev.2 - Statistical classification of economic activities in the European Community, Eurostat, 
https://ec.europa.eu/eurostat/documents/3859598/5902521/KS-RA-07-015-EN.PDF  
250 This class includes: - manufacture of insecticides, rodenticides, fungicides, herbicides, acaricides, 
molluscicides, biocides, - manufacture of anti-sprouting products, plant growth regulators, - manufacture of 
disinfectants (for agricultural and other use), - manufacture of other agrochemical products n.e.c.; this class 
excludes: - manufacture of fertilisers and nitrogen compounds, see: 20.15. source NACE Rev. 2 – Statistical 
classification of economic activities in the European Community, Structure and explanatory notes European 
Commission, Eurostat, Office for Official Publications of the European Communities, Luxembourg, 2008. 
251 This division includes the manufacture of basic pharmaceutical products and pharmaceutical 
preparations; this also includes the manufacture of medicinal chemical and botanical products. 
252 This class includes: - manufacture of medicinal active substances to be used for their pharmacological 
properties in the manufacture of medicaments: antibiotics, basic vitamins, salicylic and O-acetylsalicylic 
acids etc., - processing of blood; this class also includes: - manufacture of chemically pure sugars, - 
processing of glands and manufacture of extracts of glands etc. source NACE Rev. 2 – Statistical 
classification of economic activities in the European Community, Structure and explanatory notes European 
Commission, Eurostat, Office for Official Publications of the European Communities, Luxembourg, 2008. 
253 This class includes: - manufacture of medicaments: antisera and other blood fractions, vaccines, diverse 
medicaments, including homeopathic preparations, - manufacture of chemical contraceptive products for 
external use and hormonal contraceptive medicaments, - manufacture of medical diagnostic preparations, 
including pregnancy tests, - manufacture of radioactive in-vivo diagnostic substances, - manufacture of 
biotech pharmaceuticals; this class also includes: - manufacture of medical impregnated wadding, gauze, 
bandages, dressings etc., - preparation of botanical products (grinding, grading, milling) for pharmaceutical 
use; this class excludes: - manufacture of herb infusions (mint, vervain, chamomile etc.), see: 10.83, - 
manufacture of dental fillings and dental cement, see: 32.50, - manufacture of bone reconstruction cements, 
see: 32.50, - manufacture of surgical drapes, see: 32.50, - wholesale of pharmaceuticals, see: 46.46, - retail 
sale of pharmaceuticals, see: 47.73, - research and development for pharmaceuticals and biotech 
pharmaceuticals, see: 72.1, - packaging of pharmaceuticals, see: 82.92; source NACE Rev. 2 – Statistical 
classification of economic activities in the European Community, Structure and explanatory notes European 
Commission, Eurostat, Office for Official Publications of the European Communities, Luxembourg, 2008. 

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Section 2.1. 

The estimates on the SMEs shares among the SPC holders were based on data  
uploaded from the German national patent office – DPMA ( 
https://register.dpma.de/DPMAregister/pat/basis) concerning SPCs (Schutzzertifikat). The SPC 
holders names (Anmelder/Inhaber) were matched with Orbis database254 in order to obtain their size 
classes and information on the global ultimate owner name and type. The above was implemented 
using the batch matching tool available in Orbis and complemented by manual inspection of the 
output that resulted in some further corrections.  

Finally, 86% of German SPC holders (present or past) were successfully matched with Orbis. At this 
point, only data covering years 2010-2021 were kept for further analysis (by the year of submission 
provided in the Anmeldetag variable). Firms’ company size classes as provided by Orbis (i.e. very 
large companies, large companies, medium-sized companies and small companies) were compared 
with their corporate ownership information and all SMEs belonging to a corporate group were 
removed from their initial size class. As a result, 8% of SPC holders were identified as SMEs. Within 
the retained dataset, another 11% of observations had no size class allocated, ether because such 
information was missing in Orbis or because it was not matched. It can be assumed that Orbis 
coverage is are biased towards large companies therefore if a company is not found/matched, it is 
more probable that it is a smaller organisation. Such assumption backed the 8% to 19% estimate for 
SMEs presented in section 2.1. 

The universities were identified by text search of SPC holder’s names using the following or similar 
terms: university, universität, academy, research institute, college, education, research council, 
research foundation, forschungszentrum, etc. The search resulted in 4.4% of observations being 
captured. Then, the SPC holders with a global ultimate owners classified by Orbis as "Foundation, 
research Institute" were added to the count (another 2.8%) resulting in the final estimate of 7%, as 
mentioned in section 2.1. 

Sections 6.6.1 and 6.6.2 

The dataset underpinning the findings presented in sections 6.6.1 and 6.6.2 was the MIDAS database 
of IQVIA255, containing various descriptive variables characterising the pharmaceutical market256. The 
dataset used in this impact assessment covered sales from 2010 to 2021 and its geographical 
coverage was 25 Member States, notably EU-27 except for CY and MT. In case of several countries, 
only retail market data was available – these included DK, ET, EL, LV, LU and SI. For all remaining 
countries, data for the retail and hospital markets were combined and used (238 215 observations).  

254 Orbis by Bureau Van Dijk (a Moody's Analytics company) is a database containing information on 
private companies and entities across the globe, including their financial information and corporate linkages 
(https://orbis.bvdinfo.com/). 
255 https://www.customerportal.iqvia.com/sites/portal  
256 In particular: country to which the data pertained, corporation (i.e. company owning the medicine), 
molecules list, product name, product launch date, generic/non-generic product classification, identification 
of biologic molecules, volume measures such as ex-manufacturer sales (i.e. wholesaler purchase price and 
the manufacturers' selling price in EUR) and standard units sold (i.e. the number of standard ‘dose’ units 
sold). 

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The IQVIA dataset contains a variable e_dt_prtexp, which refers to the estimated protection expiry 
date of a given product. Unfortunately, this variable may refer to various reason behind the loss of 
protection, namely not only the SPC expiry date, but also the estimated patent expiry date, data 
exclusivity expiry date, orphan drug exclusivity expiry date, SPC extension expiry date granted for a 
paediatric formulation or even on-going litigation. In order to establish whether or not the loss of 
exclusivity was due to the expiry of SPC, a publicly available dataset containing information on the 
central marketing authorisations was uploaded from the EMA website257. After basic text cleaning of 
both dataset (i.e. the intprd variable referring to the international product name in IQVIA and the 
medicine name from the EMA), the names of medicines were matched. As a result, the IQVIA 
working dataset has been expanded by the marketing authorisation date. Based on this, the standard 
regulatory protection date could be established by adding 10 years to the EMA decision date258. Only 
observation having at least one of the following dates were retained for further analysis: the patent 
expiry date, the estimated protection expiry date of the original product (per country) or the 
estimated regulatory protection date (EMA-based). At this stage, the potential SPC expiry date was 
calculated, as follows:  

  Step 1: Patent filling date was calculated by subtracting 20 years from the patent expiry 

date available in IQVIA (pat_exp_dt). 

  Step  2:  Time  elapsing  between  the  patent  filling  date  and  marketing  authorisation  was 

calculated. 

  Steps  3  and  4:  The  above  period  was  shortened  by  5  years  and  adjusted  to  5  years 

maximum. 

  Step  5:  A  potential SPC  expiry  date  was  established  by  adding  the  above  period  to  the 

patent expiry date. 

In order to generate an SPC dummy variable259 the expiry dates of the three instruments were 
compared (i.e. the patent expiry date, the EMA plus 10 years date and the potential SPC expiry date). 
If the potential SPC expiry date was the last one to lapse and it was shorter than the loss of 
exclusivity as provided by IQVIA, then the observation was identified as positive260. In case of 
observations where the IQVIA loss of exclusivity date was missing, but the potential SPC expiry date, 
the EMA plus 10 date or the patent expiry dates were available, the dataset was completed by using 
one of these dates, depending on which one elapsed the last. Observations without the loss of 
exclusivity date were removed from the dataset, as well as those where the above date lapsed 
before 1 January 2010261. As a result 61 080 observations were retained for further analysis. 

257 https://www.ema.europa.eu/en/medicines/download-medicine-data 
258 The 6 months of a paediatric extension, as well as the orphan drugs regulatory protection were ignored, 
as it was impossible to identify them within the available datasets. Instead, a general 10 year extension was 
used for all matched products. 
259 A Boolean variable that can only take the value 0 or 1 to indicate the absence or presence of a specified 
condition (i.e. determining whether or not a medicine was covered by an SPC). 
260 If the potential SPC expiry date lapsed after the IQVIA loss of exclusivity date, it was assumed that an 
SPC could have been the last protection to expire, but it was either not requested or awarded for the 
particular observation in question. 
261 Although SPC entered into force in 1993, taking such an early cut-off date would confound the results of 
market entry analysis for Member States joining the EU more recently. Instead, year 2010 was chosen, as it 
was aligned with the available sales data (2010-2021). 

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The biosimilar and generic molecules entry was first calculated only for products, which entered the 
market following an SPC expiry (determined by the earlier created SPC dummy variable) and then 
separately for all follow-on products entering the market (i.e. irrespective of the instrument behind 
the loss of exclusivity, notably the patent expiry or regulatory protection expiry). The market entry 
was defined as the first launch of a follow-on product on a local market after the loss of exclusivity 
(or SPC expiry in particular262). The number of competitors that could have appeared on the market 
after the first entry was not taken into account.  

The budgetary impact of the unitary SPC has been estimated using the same IQVIA database, but 
using only data for the enhanced cooperation countries263. The following steps were undertaken:  

  Step 1: An average SPC expiry date per substance was calculated across all UP Member 

States, where this substance was awarded an SPC. 

  Step 2: The sales at manufacturing prices, as well as the volume of sales in standard units 
for  years  2010-2021  were  summed  up  by  country,  molecule  and  by  four  product 
classes264.  

  Step 3:  Sales in  each  year were divided by  sales  volume expressed in  standard units to 
obtain unit prices for each group (i.e. for a particular molecule in a given country, when it 
was sold as an original product and/or as a follow-on product). 

  Step 4:  For  each molecule in  a  given  country  and  year (e.g.  Adalimumab in  Austria, in 
2018)  a  ratio  between  the  price  of  the  original  product  and  its  follow-on  version  was 
calculated, if the latter was actually put on the market. In rare cases where the calculated 
ratios  per  product  were  lower  than  1  (i.e.  biosimilar  or  generic  product  would  be  more 
expensive than the original) or higher than 10 (i.e. the follow-on product would enter the 
market at a price of 10% of the original product) the results were judged implausible and 
replaced by nulls.  

  Step  5:  For  each  country  and  year,  a  median  ratio  of  price  differences  between  the 
original  products  and  their  follow-on  equivalents  was  calculated265,  separately  for 
biological and small molecules (i.e. two ratios per country for each year in 2010-2021).  
  Step 6: The yearly sales of follow-on products (generic and biosimilar) after the loss of 
exclusivity were identified for each molecule in a given country. Then, they were retained 
only if the sales occurred under no SPC coverage and before the year of an average SPC 
expiry  date per substance calculated across all UP Member States where  this substance 
was  awarded  an  SPC  (see:  Step  1  above).  The  period  between  the  individual  loss  of 
exclusivity in a given country with no SPC and the year where SPCs for a given molecule 
would on average lapse in all SPC-covered countries is referred to as the “gap years”.  
  Step  7:  The  sales  in  gap  years  were  retained  and  multiplied  by  the  ratios  of  price 
differences  for  each  country  (see:  Step  5  above),  molecule  and  year.  As  a  result,  a 
hypothetical value of sales of original products was obtained (i.e. the “would-be” cost of 

262 The results in such case, as presented on Figure 9 in section 6.6.1, partially depends on the number of 
SPCs previously in force in a given country.  
263 Except for Malta, as the available IQVIA data do not cover this country. 
264 Defined as follows: biologic original, biosimilar (large molecules follow-on products), small molecules 
original, generic (small molecules follow-on products). 
265 The present analysis does not consider whether, in particular markets, generics may enter in the absence 
of their respective originator for a given product (albeit such instances are still rather exceptional). In this 
regard, potential negative health effects on the population (from the delayed availability of therapeutic 
options) are not assessed. 

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medicines  purchased  in  the  gap  years,  if  original  products  were  bought  these  countries 
instead of follow-on equivalents).  

  Step  8:  A  difference  between  the  amounts  spent  on  follow-on  medicines  and  the 
estimated cost of original products was calculated to obtain a hypothetical extra cost that 
would have been borne by the healthcare systems if the generic entry did not occur in the 
gap years.  

  Step 9: The extra cost was compared with the overall yearly spending on pharmaceuticals 
by country, as provided by Eurostat in the COFOG database266 and presented in Table 55. 

266 Eurostat COFOG - general government spending on medical products, appliances and equipment, 
extracted on 04.08.22. 

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ANNEX 5: SUPPLEMENTARY EVIDENCE SUPPORTING THE IMPACT ASSESSMENT  

A.  Evidence supporting section 1 (introduction)  

Regulatory context of the current SPC rules - patent systems in the EU 

SPCs are granted only for products protected by a ‘basic patent’ in force in the respective 
Member States. In the EU, patents are governed, and can be implemented, according to the 
following three different levels (the table below displays the applicable levels in each EU 
Member State):  

(1) 
The national legislation of the 27 Member States for national patents, which are filed, 
examined and granted in each Member State where protection is sought, and are enforceable 
before their national courts. Contrary to other IP rights, there is no EU directive on patent law 
and, therefore, the national patent legislation of EU Member States is not harmonised by EU 
law.  

The European Patent Convention (EPC), which establishes a one-stop-shop for the filing, 

(2) 
examining and granting of European patents by the European Patent Office (EPO). Once 
granted, a European patent requires validation in most of the Member States where protection 
is sought. It confers to its owner the same rights as national patents, enforceable before national 
courts 

The unitary patent package , which will introduce a European patent with unitary effect 

(3) 
(the unitary patent) – that is single patent not requiring national validation – and a single 
jurisdiction, the Unified Patent Court (UPC), for the Member States having ratified the UPC 
Agreement. Regarding the UPC, once operational, all European patents (unitary or not) as well 
as any SPCs based on them may be enforced before the UPC (optionally during a transitional 
period of 7 years) for these Member States.  

Figure 14: Example of patent application following points (2) and (3) above  

A key advantage of the unitary patent system is that centralised litigation before the UPC will 
apply not only to unitary patents but also to non-unitary European patents and to SPCs based 
on (unitary or non-unitary) European patents (see: Art. 3.b Unified Patent Court Agreement 
together with Art. 2.g). The figure below explains the procedural simplifications for patent 
applicants brought about by the unitary patent in the participating Member States. 

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Figure  15.  Unitary  Patent  system,  participating  Member  States  and  applicable  procedures 
state of play expected as of mid-2022. 

for  registration.  

Source: Commission services’ own analysis 

The table below summarises EU Member States’ profiles regarding patent and SPC protection, as 
well as EU official languages (updated in March 2022). 

 Table 38: Patent protection across the EU 

Member State 

“Purely” 
national patent 
system, based 
on national 
patent law 

Yes 
Yes 

Yes 
Yes 
Yes 
Yes 
Yes 
Yes 

Austria 
Belgium 

Bulgaria 
Croatia 
Cyprus 
Czech Republic 
Denmark 
Estonia 

EN 

Part of the 
European 
patent system 
(i.e. a granted 
European 
patent can be 
validated as a 
national patent) 
Yes 
Yes 

Yes 
Yes 
Yes 
Yes 
Yes 
Yes 

Part of the 
enhanced 
cooperation for 
unitary patent 
protection 

UPC 
Agreement 
ratified 

Could unitary 
SPCs of PO 5 
take effect? 

EU official 
languages 

Yes 
Yes 

Yes 
No 
Yes 
Yes 
Yes 
Yes 

Yes 
Yes 

Yes 
No 
No 
No 
Yes 
Yes 

Yes 
Yes 

Yes 
No 
No 
No 
Yes 
Yes 

German 
Dutch 
French 
German 
Bulgarian 
Croatian 
Greek 
Czech 
Danish 
Estonian 

97 

EN 

Unitary patentOne application at European Patent Office (EPO)One single set of fees (for filing fee, examination fee, grant…)No national validation and translation costMaintenanceATBEPTITDEFRFIEEDKBGNLMTLULTLVSISEESIEPLCZSKHUHRROCYCHUKUSJPApplication and grantTRISELOne annualRenewal Fee Annual renewal fees in each country concernedPotential LitigationUnified Patent Court-Centralized litigation of unitary and non-unitary European patents (+ related SPCs) -Significant simplification and increased legal certainty National courtsUSJPGeographical coverage…*Note: Blue box indicates EU Member State* Altogether additional 11non-EUcountries are members of the European Patent Organization (AL, CH, IS, LI, MC, MK, NO, RS, SM, TR, UK); ** in US, the renewal fees are paid after 3½, 7½ and 11½ years); +Validation and feesin each MS concerned + translation costsESIEPLCZSKHUHRROCYCHUKTRISEL…*ESIEPLCZSKHUHRROCYCHUKTRISEL…*ESIEPLCZSKHUHRROCYCHUKTRISEL…*Japan Patent OfficeUS Patent & Trademark Office**European Patent Organization members 
 
 
 
 
Finland 

France 
Germany 
Greece 
Hungary 
Ireland 

Italy 
Latvia 
Lithuania 
Luxembourg 

Malta 

Netherlands 
Poland 
Portugal 
Romania 
Slovakia 
Slovenia 
Spain 
Sweden 

Yes 

Yes 
Yes 
Yes 
Yes 
Yes 

Yes 
Yes 
Yes 
Yes 

Yes 

Yes 
Yes 
Yes 
Yes 
Yes 
Yes 
Yes 
Yes 

Yes 

Yes 
Yes 
Yes 
Yes 
Yes 

Yes 
Yes 
Yes 
Yes 

Yes 

Yes 
Yes 
Yes 
Yes 
Yes 
Yes 
Yes 
Yes 

Yes 

Yes 
Yes 
Yes 
Yes 
Yes 

Yes 
Yes 
Yes 
Yes 

Yes 

Yes 
Yes 
Yes 
Yes 
Yes 
Yes 
No 
Yes 

Yes 

Yes 
Yes267 
No 
No 
No 

Yes 
Yes 
Yes 
Yes 

Yes 

Yes 
No 
Yes 
No 
No 
Yes 
No 
Yes 

Yes 

Yes 
Yes 
No 
No 
No 

Yes 
Yes 
Yes 
Yes 

Yes 

Yes 
No 
Yes 
No 
No 
Yes 
No 
Yes 

Finnish 
Swedish 
French 
German 
Greek 
Hungarian 
English 
Irish 
Italian 
Latvian 
Lithuanian 
French 
German 
Maltese 
English 
Dutch 
Polish 
Portuguese 
Romanian 
Slovak 
Slovene 
Spanish 
Swedish 

Regulatory context of the current SPC rules - marketing authorisations (MA) in the EU, other 
relevant legislation 

An SPC shall be granted if, among other conditions, in the Member State in which the SPC application 
is submitted and at the date of that application, the product is protected by a basic patent in force 
and a valid marketing authorisation to place the product on the market as a medicinal product (or 
PPP) has been granted in accordance with the relevant EU legislation268. 

Under Union law, medicinal products for human or veterinary269 use, as well as PPPs, need a 
marketing authorisation before they can be placed on the EU market.  

Marketing authorisations for medicinal products 

In the EU, a medicinal product for human use may be authorised either by the European Commission 
through the centralised procedure or by national competent authorities through a mutual 
recognition, decentralised or national procedure. 

Table 39: Overview of marketing authorisation types available for medicinal products 

Authorising body 
European Commission 

Procedure 
Centralised 

National authorities 

Mutual recognition, 
decentralised, national 

Body assessing 
European Medicines 
Agency (EMA) 
National authorities 

Geographic scope 
EU-27 

MS concerned  

267 Germany still has to deposit its instrument of ratification with the Council (as of July 2022). 
268 https://ec.europa.eu/health/human-use/legal-framework_en  
269 The centralised procedure is mandatory for all veterinary medicinal products listed in the Annex to 
European Regulation (EC) No 726/2004. In addition, optionally, an application for an authorisation for 
veterinary medicinal products can be made if the requirements of Article 3 (2) of Regulation (EC) 726/2004 
are met (e.g. if they contain a new active substance). 

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According to calculations of the Max Plank Institute study of 2022270, based on the example of 
Germany, the number of new active ingredients authorised for the first time by the national 
authorities is negligible. Therefore, almost all recently SPC applications for medicinal products rely on 
an EU-wide marketing authorisation.  

The SPC aims to incentivise investments for new active ingredients of medicines and PPPs that 
require lengthy development times. With the exception of the 6-month paediatric extension of the 
SPC271, the SPC does not target specifically medicines for specific parts of the population or specific 
conditions (e.g. orphan diseases or antibiotics). The EU legislation has specific incentives for orphan 
and paediatric medicines that are out of the scope of this impact assessment.  

Additional incentives relevant to pharma and PPP are: 

-  EU regulatory protections that apply to medicinal product and PPPs (e.g. Regulatory 
Data  Protection  (RDP)  for  medicinal  products  and  PPPs  and  market  protection  for 
medicinal products) as of the date of their authorisation, and that basically guarantee 
the innovator pharmaceutical, or agrochemical, company a minimum of protection of 
its new medicinal product, or PPP, of 10 years even where the original patent and SPC 
protection would sum up to fewer than ten years. 

-  A 10-year market exclusivity for orphan medicinal products (medicines for conditions 

that affect a small number of the EU population). 

The graphics below summarises the concepts discussed above, as well as visualises their impacts on 
the effective protection period. 

270 Max Planck Institute for Innovation and Competition, Study on the Options for a Unified SPC System in 
Europe, 2022, p. 70. 
271 Paediatric investigations of medicinal products are rewarded with 6 months of extension of the SPC if an 
SPC exists. Paediatric means that it can be used for treating children aged 0 to 18. If the paediatric 
investigation concerns an orphan medicinal product, the market exclusivity may be extended from 10 to 12 
years. 

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Figure 16: The pharmaceutical incentives in the EU – summary 

Source:  Copenhagen  Economics,  Study  on  the  economic  impact  of  supplementary  protection  certificates,  pharmaceutical 
incentives  and  rewards  in  Europe,  European  Commission,  Directorate  General  for  Internal  Market,  Industry, 
Entrepreneurship and SMEs, 2018, p.41 

Marketing authorisations for plant protection products (PPPs) 

Regulation (EC) No 1107/2009 is the legislation concerning the placing of plant protection products 
on the market in the EU. PPPs (e.g. pesticides) are products consisting of, or containing active 
substances, safeners or synergists, and intended for uses such as protecting plants against harmful 
organisms, preserving plant products, etc. PPPs contain at least one approved active substance 
(these may include micro-organisms, pheromones and botanical extracts).  

Regarding the procedure of granting of marketing authorisation for PPPs272, a zonal system of 
authorisation operates in the EU to enable a harmonised and efficient system to operate (i.e. 
generally there is no unitary EU-wide marketing authorisation for PPPs273). The EU is divided into 
three zones: North, Central and South. EU Member States assess applications on behalf of other 
Member States in their zone, and sometimes on behalf of all zones (for some uses the EU is 
considered a single zone), and subsequently mutual recognition takes place in the remaining zones. 
The actors in the procedure can be the applicants, EU Member States, the European Commission and 
the European Food Safety Authority (EFSA). 

272 https://ec.europa.eu/food/plants/pesticides/authorisation-plant-protection-products/ppp-auth_en  
273 Each plant protection product is subject to national authorisation. The so called mutual recognition 
procedure under Article 40 of Regulation (EC) No 1107/2009 aims to facilitate the recognition of a national 
authorisation issued in one Member State in other Member States, from the same zone or not.  

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Number of marketing authorisations for medicinal and plant protection products 

The table below presents the total number of marketing authorisations for human and veterinary 
medicinal products issued to originators (that is without generic and biosimilar marketing 
authorisation), as well as plant protection products. The total represents an upper bound for SPCs 
applications which can be obtained half a year after receiving marketing authorisation.274 Hence SPC 
application should take place in the year of marketing authorisation (for marketing authorisation 
issued in the first half of the year) or in the year of marketing authorisation or the following year (for 
marketing authorisation issued in the second half of the year). 

Table 40: Number of marketing authorisation issued per year for products that potentially can apply for SPC protection 

Year 
2004 

2005 
2006 
2007 
2008 
2009 
2010 

2011 
2012 
2013 
2014 
2015 
2016 

2017 
2018 
2019 
2020 
2021 

Human* 
27 

Veterinary* 
4 

18 
28 
45 
35 
53 
26 

36 
35 
53 
56 
59 
44 

54 
62 
42 
63 
62 

10 
4 
4 
10 
7 
6 

15 
6 
11 
18 
15 
5 

17 
9 
17 
14 
13 

PPP 
7 

3 
7 
23 
7 
131 
21 

31 
14 
23 
28 
18 
23 

21 
14 
22 
9 
15 

Total  
38 

31 
39 
72 
52 
191 
53 

82 
55 
87 
102 
92 
72 

92 
85 
81 
86 
90 

Avg. (2004-2021) 
Avg. (2010-2021) 
Avg. (2014-2021) 

10 
12 
14 
* does not include marketing authorisation issued for generics or biosimilar 
Source: In-house analysis based on European Medicines Agency database275 and EU Pesticides database.276 

44 
48 
55 

22 
19 
19 

78 
81 
88 

274 Article 7(1) of the SPC Regulations: “The application for a certificate shall be lodged within six months 
of the date on which the authorisation referred to in Article 3(b) to place the product on the market as a 
medicinal/plant protection product product was granted.” 
275 https://www.ema.europa.eu/en/medicines/download-medicine-data  
276 https://ec.europa.eu/food/plant/pesticides/eu-pesticides-database/active-substances/?event=search.as  

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B.  Evidence supporting section 2 (problem statement) 

Market context - SPC statistics  

As far as the reliance on SPC protection is concerned, it is significant and still growing in the Single 
Market. The total number of SPC applications filed in all Member States increased from about 500 
applications in 1993 (in then EU-12) to a total of 1 459 SPC applications filed in the EU-27 in 2021277. 
To put the SPC data into a broader context of IP protection sought by the industry, the EPO reports 
that in 2021 the pharmaceutical sector filed 9 026 European patent applications, ranked as the 7th in 
terms of the number of applications submitted (interestingly, the medical technology sector was the 
2nd)278.  

As shown in Figure 17 below, the yearly number of SPC application filed in EU-27 between 2014 and 
2021 ranged from roughly 1 250 to 1 827, with a peak in 2015 and slight fluctuations in the trend 
afterwards. Additional (survey-based) data on the number of SPC applications is presented in Table 
31 overleaf. 

Figure 17: Number of SPC request filed in 2014-2021 

Source: “Current trends in activity at the NPOs and at the EPO”, Administrative Council of the EPO (documents: CA/36/19, 
CA/31/18, CA/13/17, CA/9/16) and “Exchange of information on current trends in activity at the NPOs and at the EPO”, 
May 2022. Note:  data missing for the following countries and replaced by country averages – 2014: BE, SE, 2015: SE. 279 

277 Exchange of information on current trends in activity at the NPOs and at the EPO, European Patent 
Office, May 2022. 
278 European Patent Office, Patent Index 2021, Statistics at a glance, p.4. 
279 Another reason for the higher amount of applications in the first half of the graph may be observed due 
to in the Neurim judgment of 19 July 2012 (C/130/11). Here, the Court took a far reaching approach in its 
interpretation of Article 3(d) of Regulation 469/2009 as to which SPCs could be protected. Following this, 
national patent offices also took different approaches on how to apply Neurim (some NPOs took a strict, 
literal approach, while most NPOs took a wider approach. See: page 229f. of MPI (2018)). Moreover, it is 
recognised in the sector that SPC users started to apply for a high amount of SPCs around this time in order 
to test the boundaries of the system. In 2020, the CJEU rejected Neurim in its Santen decision (C-673/18). 

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Table 41: SPC applications in selected NPOs in 2018-2019 

Country 

Q20: Applications filed in 
2018 

Q20: Applications filed in 
2019 

Q22: Relying on national 
patents 281  

Q23: Single active 
ingredient 282 

Q23: Combinations of 
active ingredients 283  

61 
65 (60 MP; 5 PPP) 
36 
52 
58 (58 MP) 
59 
77 (68 MP; 9 PPP) 
83 (67 MP; 16 PPP) 
59 
56 
62 
65 
42 
47 
68 (61 MP; 7 PPP) 
59 

50 
46 (43 MP; 3 PPP) 
23 
50 
41 (40 MP; 1 PPP) 
42 
58 (48 MP; 10 PPP) 
65 (56 MP; 9 PPP) 
48 
46 
46 
46 
34 
83 
47 (41 MP; 5 PPP) 
58 
47 (41 MP; 6 PPP) 
43 (38 MP; 5 PPP) 
41 (38 MP, 3 PPP) 
61 
47 

Austria 
Belgium 
Croatia 
Czechia 
Denmark 
Finland 
France 
Germany 
Greece 
Hungary 
Ireland 
Italy 
Lithuania 
Luxembourg 
The Netherlands 
Poland 
Portugal 
Romania 
Slovak Republic 
Spain 
Sweden 
Note: MP-medical product, PPP – plant protection product, MA – marketing authorisation 
Source: Study on the options for a unified SPC system in Europe, Max Planck Institute for Innovation and Competition, 2022, p. 71-72; Questionnaire for the NPOs. .

89 
94 
46 
78 
83 
n.a. 
106 (100 MP; 6 PPP) 
102 
85 
84 
91 
98 
n.a. 
n. a. 
75 
84 
86 
69 (64 MP; 5 PPP) 
70 
107 
n.a. 

22 
17 
13 
24 
16 
n.a. 
29 (16 MP; 13 PPP) 
21 
22 
18 
17 
13 
n.a. 
n. a. 
24 
33 
22 
30 (23 MP; 7 PPP) 
15 (11 MP; 4 PPP) 
27 
n.a. 

63 (56 MP; 7 PPP) 
44 (41 MP, 3 PPP) 
73 
60 

0 
0 
0 
2 
0 
0 
0  
0 
0 
7 
0 
0 
0 
0 
0 
15 
0 
0 
1 
0 
0 

Q21: Medicinal products 
relying on national MAs 
280  
2 
3 
3 
16 
2 
6 
23 (4/116 MP; 19/19 PPP) 
4 
5 
5 
5 
2 
1 
0 
4 
6 
4 
3 
3 
3 
5 

280 How many of the SPC applications filed in 2018 and 2019 for medicinal products relied on a national MA? 
281 How many SPC applications filed in 2018 and 2019 relied on national patents? 
282 How many applications filed in 2018 and 2019 with your office were for single active ingredients and how many of them were for combinations of active ingredients?  
283 Idem 

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As far as the use-patterns in SPCs are concerned, an increase in the number of new molecules 
protected can be observed, as well as in the expansion in geographic coverage. According to Kyle 
(2017), in the early 1990s, 75% of new drug introductions had an SPC in at least one country, and on 
average in 6-7 countries. In more recent years, the share is 86% with at least one and 18-19 countries 
on average284. Likewise, Mejer (2017) concluded that SPCs are granted in an increasing number of 
Member States for a given product (see: Figure 18, below). Since its entry into force until 2014, SPCs 
were applied for in 20 countries on average285. 

Figure 18: Average number of countries where SPC protection is applied for the same product 

Source:  Mejer,  M.,  25  years  of  SPC  protection  for  medicinal  products  in  Europe:  Insights  and  challenges,  European 
Commission, Directorate General for Internal Market, Industry, Entrepreneurship and SMEs, 2017, Figure 2, page 8. 

As mentioned in section 2.2, the SPC are predominantly held by companies belonging to large 
corporate groups – around half of the SPCs belong to 16 multinationals.  

Table 42: List of 20 most frequent global ultimate owners of companies holding an SPC in Germany (submission year 2010-
2021) 

Global ultimate owner’s name 
BAYER AG 
NOVARTIS AG 
GSK PLC 
MERCK & CO., INC. 
ASTRAZENECA PLC 
SANOFI 
C.H. BOEHRINGER SOHN AG & CO. KG 
PFIZER INC 
SYNGENTA GROUP* 
ABBVIE INC. 
AMGEN INCORPORATED 
GILEAD SCIENCES INC 
ROCHE GROUP* 
TAKEDA PHARMACEUTICAL COMPANY LIMITED 
NOVO NORDISK FONDEN 
BASF SE 
JOHNSON & JOHNSON 
ELI LILLY AND COMPANY 

Freq.  Percent 
44 
40 
29 
29 
25 
23 
22 
21 
20 
18 
15 
15 
14 
14 
13 
11 
11 
9 

6.33 
5.76 
4.17 
4.17 
3.60 
3.31 
3.17 
3.02 
2.88 
2.59 
2.16 
2.16 
2.01 
2.01 
1.87 
1.58 
1.58 
1.29 

1 
2 
3 
4 
5 
6 
7 
8 
9 
10 
11 
12 
13 
14 
15 
16 
17 
18 

Cum. 
6.33 
12.09 
16.26 
20.43 
24.03 
27.34 
30.50 
33.53 
36.40 
38.99 
41.15 
43.31 
45.32 
47.34 
49.21 
50.79 
52.37 
53.67 

284 Kyle, M. (2017), p. 18-19. 
285 Mejer, M. (2017), p. 7. 

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19 
20 

54.96 
56.26 
Source: In-house analysis based on DPMA register matched with IQVIA data SPC. Note: Syngenta group is owned by the 
government of China; Roche group is owned by a physical person. 

GENMAB A/S 
ZOETIS INC. 

1.29 
1.29 

9 
9 

Market context - changes in the global market  

Although extremely important for the European economy, the EU pharmaceutical sector is no longer 
in a dominant position globally. Looking at the history of the pharmaceutical industry, it can be seen 
that it has undergone profound changes since the introduction and codification of the SPC regime in 
the EU in 1992 and 2009 respectively. These changes can be seen as not only driven by the growing 
global demand for medicines, but also a significant switch towards generics and biosimilars to 
alleviate public health expenditure (and indirectly push originators to develop more innovative 
medicines). Additionally, significant transition in the global market structure have been observed as 
well. The fast-growing economies of Asia, Central and South America – the so-called “pharmerging” 
regions – combined with ageing populations in the traditional industrialised regions, have driven 
massive global demand for medicines over the last decades. In 2017, most sales (in value terms) on 
the world pharmaceutical market were made in North America (48.1%), followed by Europe (22.2%) 
and Africa, Asia & Australia (excluding JP, 17.0%). The amount of sales in JP was at 7.7%, with the 
least amount of sales in Latin America at 5.1%.286 

Pharmaceutical R&D worldwide used to be mainly situated in the US, the EU and JP287, but the 
situation changes dynamically with a remarkable increase in R&D spending in CN (see: Figure 19 
below). 

Figure 19: Business enterprise research and development expenditure in pharmaceuticals in 2008-2017 [USD PPP, million 
constant prices]  

286 Breakdown of the world pharmaceutical market -2017 sales, EFPIA based on IQVIA (MIDAS) data 
Note : Europe includes Turkey and Russia, source : https://www.efpia.eu/publications/data-center/the-
pharma-industry-in-figures-economy/world-pharmaceutical-market  
287 Gambardella, A., Orsenigo, L., & Pammolli, F. (2000), Global competitiveness in pharmaceuticals: a 
European perspective, available at https://mpra.ub.uni-muenchen.de/15965/1/MPRA_paper_15965.pdf 

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Source:  In-house analysis  based on Business  enterprise  R&D  expenditure  by  industry,  Joint  OECD-Eurostat  international 
data  collection  on  resources  devoted  to  RD,  Data  extracted  on  06  Jun  2022  from  OECD.Stat.  Note:  data  missing  for  the 
following EU countries: CY, BG, HR, LU, MT; PPP - purchasing power parity. 

To complete the above, JRC (2021) provides more recent figures on the magnitude of differences 
between the key market players. In 2020 the US spent EUR 93.4 billion on health innovation 
compared to nearly EUR 36.6 billion by the EU288.  

The dynamics of R&D investments mirror the patterns that can be observed between the EU and the 
key market players in the number of medicines that are in clinical trials for a potential future 
regulatory approval (see: Figure 20, below). 

Figure 20: Number of drugs and country share of pipeline Phase I to regulatory submission, based on company headquarters 
location, 2006-2021 

Source: Global Trends in R&D: Overview through 2021. IQVIA institute for Human Data Science, February 2022. 

The US dominance in the number of prospective drugs is also clearly correlated with the availability 
of new medicines on the market (see: Figure 21, below), with a significant gap between the leader 
and the following main geographical areas.  

288 The 2021 EU Industrial R&D Investment Scoreboard, European Commission, JRC/DG RTD, page 12. 

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Figure 21: Main global markets in the sales of new medicines 

Source: www.efpia.eu, The Pharmaceutical Industry in Figures, Key Data 2021 

The US also leads in the number of SPC filings in Europe. For instance the US applicants accounted for 
around 39% of all SPC applications in the German NPO289 over the period 2010-2022, while the EU-27 
firms accounted for 33% of applications. 

Figure  22:  SPC  applications  to  German  NPO,  by  country  of  origin,  between  2010-2022  (A)  and  distribution  of  EU27 
applications by Member State (B). 

Source: In-house analysis based on DE NPO data - DPMA register (https://register.dpma.de/DPMAregister/pat/basis) 

289 DE was chosen as the largest economy and the market with the highest number of SPC applications in 
the EU (see: Figure 1). 

EN 

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EN 

US, 39%EU27, 33%CH, 12%JP, 8%UK, 5%other, 4%A0%1%1%1%1%4%5%6%7%7%8%11%13%34%HUFIATLUPTESITIENLSEDKFRBEDEB 
 
 
 
                                                           
As for the plant protection industry, between 2003 and 2011 Europe was the leading regional 
agrochemical market worldwide, but in 2012 it was overtaken by Asia290. The number of new active 
ingredients introduced and in development, between the 1980s and the 2005 to 2014 period has 
fallen by 40.7% in PPP. However, the proportion of these active ingredients focussed on the 
European market has fallen from 33.3% to only 16.4%291. 

Problem drivers - high cost and burden of applying and maintaining SPC protection 

According to the most recent data submitting an SPC in 27 countries and paying fees for the duration 
of 5 years (without the paediatric extension) would cost nearly EUR 192 000 in total.292 Currently, an 
SPC applied in 20 Member States for a period of 3.5 years would cost around EUR 98 500293 on 
average. The same SPC submitted and maintained for 3.5 years in the unitary patent countries294 
would cost around EUR 79 000295 (compared to the cost of EUR 117 000 for the entire period of 5 
years). The figure below shows the ranges of total application and renewal fees for a 5-year long SPC 
across various numbers of Member States in 2022 (i.e. the vertical spikes show the minimum and 
maximum cost among all combinations of a given number of Member States), as well as the cost 
level for UP Member States (the red line, as mentioned above: EUR 117 000). Detailed data about the 
cost ranges by each year and each combination of countries are provided in Table 43.  

290 R&D trends for chemical crop protection products and the position of the European Market, ECPA, 
Phillips McDougall, September 2013, p.11. 
291 Idem, p.15. 
292 Based on information about application and maintenance fees available on the NPOs’ websites in second 
quarter of 2022. SPC evaluation estimated the cost (in terms of administrative fees) of five years of SPC 
protection covering all EU-27 countries at EUR 177 869 in 2016. 
293 Average between the lowest cost for an SPC lasting three years (EUR 68 274) and the highest cost for an 
SPC lasting four years (EUR 128 711). 
294 At the time of writing this impact assessment, 17 Member States were expected to initially participate in 
the unitary patent system. 
295 Rounded average between an SPC lasting three years (EUR 66 998) and four years (EUR 90 984) in UP-
MS countries. 

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Figure 23: Cost ranges for the application and maintenance fees depending on the number of countries where the SPC was 
sought – the 5th year (cumulative) 

Source: In-house analysis based on information collected from the NPO websites in March 2022. 

It should be underlined that on the one hand this figure presents costs of SPC maintenance for 5 
years, whereas the SPC average duration is 3.5 years. On the other hand, due to data availability 
issues, it doesn't cover the cost of paediatric extensions, which would increase the total even more. 
Still, it can be assumed that it is a good proxy of the magnitude of the administrative cost involved. It 
is also important to note that the above cost calculations do not include in-house and external 
patent-lawyer fees, which typically largely exceed the administrative fees (hence, constituting a 
lower bound of the cost range).  

Table 43: Cumulative cost ranges by years and number of countries where SPC application was submitted and maintained 
[EUR] 

Number 
of 
countries 
1 

2 

3 

4 

5 

6 

7 

8 

9 

10 

11 

12 

13 

EN 

Year 1 

Year 2 

Year 3 

Year 4 

Year 5 

min 

max 

Min 

Max 

min 

Max 

min 

max 

min 

max 

361 

892 

1461 

1923 

3338 

3901 

5377 

7369 

8664 

2974 

5079 

6579 

9214 

10714 

11897 

13332 

15476 

16326 

10139 

17801 

11587 

18985 

13037 

20420 

13772 

22564 

617 

1659 

2687 

3496 

5922 

6953 

9411 

13355 

15637 

18095 

20695 

23936 

25301 

6003 

9152 

12716 

17643 

20243 

22234 

24983 

28927 

31481 

34081 

36072 

38821 

42765 

885 

2436 

3935 

5091 

8528 

9451 

13627 

20327 

27226 

1165 

3223 

5205 

6708 

13315 

19455 

29187 

38057 

1456 

4020 

6496 

8346 

17597 

26060 

39196 

50037 

31026 

11156 

43157 

13805 

56537 

10027 

33878 

13123 

47037 

16240 

61912 

13632 

37941 

18038 

52301 

22628 

68412 

19576 

43885 

26182 

60445 

33172 

78508 

22886 

48587 

30411 

67726 

38211 

88908 

26492 

52387 

35326 

72826 

44599 

95408 

30292 

55239 

40426 

76592 

51099 

100143 

36237 

59303 

48812 

81970 

61940 

107201 

38508 

65247 

52912 

90114 

67222 

118042 

109 

EN 

 
 
 
 
14 

15 

16 

17 

18 

19 

20 

21 

22 

23 

24 

25 

26 

27 

14861 

23653 

17005 

24388 

18440 

25838 

19624 

27285 

21098 

28761 

21948 

30055 

24092 

32048 

25527 

33524 

26711 

34087 

28211 

35502 

30846 

35964 

32346 

36533 

34451 

37064 

37425 

37425 

27076 

31020 

33769 

35760 

38360 

40913 

44857 

47606 

49597 

52197 

57125 

60689 

63837 

69840 

44540 

45905 

49146 

51746 

54203 

56486 

60430 

62887 

63918 

66344 

67153 

68181 

69223 

69840 

40968 

67707 

56635 

93838 

73722 

124542 

46912 

69978 

64779 

97938 

84563 

129824 

50976 

75923 

70157 

106323 

91621 

140665 

53827 

79723 

73923 

111423 

96357 

147165 

57627 

83328 

79023 

116338 

102857 

153553 

62330 

86639 

86304 

120567 

113256 

158592 

68274 

92583 

94448 

128711 

123352 

169136 

72337 

96188 

99713 

133626 

129852 

175524 

75189 

97687 

103593 

135593 

135227 

177959 

78989 

101124 

108693 

140041 

141727 

183418 

85888 

102280 

117563 

141544 

152568 

185268 

92588 

103779 

127295 

143526 

165704 

187744 

96764 

105330 

133434 

145584 

174167 

190308 

106215 

106215 

146749 

146749 

191764 

191764 

Problem drivers - divergent national practices on SPC  

The practical differences in the way NPOs process the SPCs applications are presented on the the two 
figures below296. The percentage of applications pending over all SPC applications ranged from less 
than 10% in 8 Member States to up to half of them in 7 NPOs (Figure 24).  

Figure 24: Percentages of SPC applications pending by Member States 

Source: Figure based on data from Alice de Pastors “Latest news on medicinal product SPCs in Europe - Medicinal Product 
SPCs  filed  from  1991  to  2013”, SPC  News  28  –  September  2014.  Note:  HR  is  not  taken  into  account  as  insufficient  time 
elapsed between Croatia’s entry to the EU and the data collection. 

The ratio of rejections was also quite divergent, with 5 countries rejecting less than 1 in 20 
applications while 6 NPOs rejected more than 15% (see: Figure 25). 

296 ‘Latest news on medicinal product SPCs in Europe - Medicinal Product SPCs filed from 1991 to 2013’, 
SPC News 28, Cabinet Alice de Pastors, 2014.  

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Figure 25: Percentages of SPC applications rejected by Member States 

Source: Figure based on data from Alice de Pastors “Latest news on medicinal product SPCs in Europe - Medicinal Product 
SPCs  filed  from  1991  to  2013”, SPC  News  28  –  September  2014.  Note:  HR  is  not  taken  into  account  as  insufficient  time 
elapsed between Croatia’s entry to the EU and the data collection. The last category is an open one. 

The above presented discrepancies in the SPC applications pending stem mainly from differences in 
patent-office procedures, such as waiting for decisions by national courts or lengthy proceedings, 
whereas SPC applications refused relate mainly to different approaches by NPOs. The following 
section presents additional evidence on practices related to substantive examination of the SPC 
applications and involvement of third parties that may add further insight on the source and 
magnitude of the observed discrepancies. 

Problem drivers - EU Member States’ practices related to substantive examination of the SPC 
applications and involvement of third parties 

According to the first MPI (2018) study on the SPC system, the examination of SPC applications in the 
various national patent offices (NPOs) differs significantly. The study found that: 

-  A majority of the NPOs (CH, CZ, DE, DK, FR, HR, HU, IE, IT, LT, LV, NL, PL, PT, RS, 
SE, SK, UK) have declared that they provide for an examination of all four requirements 
stipulated in Art. 3 SPC Regulations. 

-  The NPOs of AT and LU examine only Art. 3(a) and 3(b) Reg. 469/2009.  
-  The FI, EL, RO, and ES NPOs do not examine compliance with the requirements under 

Art. 3(d) Reg. 469/2009.  

-  Several NPOs have confirmed that the capabilities to examine Art. 3(d) Reg. 469/2009 are 
limited.  For  example,  the  LV  NPO  has  pointed  out  that  it  is  difficult  to  examine 
compliance with Art. 3(d) SPC Regulations concerning the first marketing authorisation; 
therefore, in case of doubt the LV NPO requires the applicant to clarify this by confirming 
that  the  information  provided  is  correct.  Ireland  stated  that  it  does  not  perform  an  ex-
officio search for all marketing authorisations and makes the examination of Art. 3(d) by 
searching  for  marketing  authorisations  in  the  online  register  of  the  Health  Products 
Regulatory Authority.  
Such difficulties are relevant according to the German NPO with respect to the application 
of Art. 13 SPC Regulations, when the first relevant marketing authorisation in the EU is a 
national marketing authorisation granted in another EU Member States. 

The  UK  IPO  informed  that  examination  of  Art.  3(d)  is  conducted  on  the  basis  of  an 
“informal  (basic  internet)  search”  using  information  provided  by  the  applicant,  a  third 
party,  or  information  that  can  be  obtained  by  consulting  other  SPC  applications 

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concerning the same product. However, the IPO does not conduct a formal search in order 
to  establish  compliance  of  SPC  applications  with  the  requirements  of  Art.  3(d).  Similar 
practice is also followed by the DK NPO. 

Regarding the participation of third parties in the grant procedure: 

- 

-  A majority of the NPOs of the countries examined (AT, CZ, DE, DK, ES, FI, HR, HU, IE, 
IT,  LU,  LV,  NL,  PL,  PT,  RO,  RS,  SE,  SK,  UK)  allow  the  submission  of  third-party 
observations. 
In some states there is an express legal basis for third party submissions (DE, DK, FI, HU, 
IE, NL, PL, PT, RS, SE, SK, UK). 
In others, it is just standard practice to accept third party observations (AT, HR, ES, IE, 
RO, LU, LV).  
In  EL  LT  and  CH  it  is  not  possible  for  a  third  party  to  file  observations  regarding  SPC 
applications.  

- 

- 

-  With the exception of DK, none of the countries examined informs the third party about 
the  reasons  why  his  or  her  observations  were  not  taken  into  account  and  the  SPC  was 
granted.  
In  no  country  does  the  third  party  become  a  party  to  the  procedure,  which  remains  ex 
parte.  
In  DE,  DK,  FI,  HR,  IE,  NL,  PL,  PT,  SE,  SK  and  UK  it  is  possible  to  file  observations 
anonymously and/or through a front man. 

- 

- 

-  With the exception of DK, no country allows for opposition to SPCs. 

Problem drivers - EU Member States’ practices related to access to information on SPC 
and procedural transparency 

According to the Allensbach survey conducted in the framework of the MPI (2018) study, most 
respondents agree that, when it comes to examining SPC applications, ‘the practice and procedures 
of the national offices in the EU Member States differ significantly in terms of predictability, 
transparency and quality of the rights granted’. 

The study report mentions in particular (in § 20.2.5.6) that: 

-  Some NPOs publish almost the entire file (e.g. DE, FI, FR, NL, SE, ES). 
-  Other countries make only such information public as referred to in certain provisions of 

the SPC Regulations.  

-  Still others publish the information required by the SPC Regulations as well as additional 

information, e.g. on the applicants’ agent(s) and the status of the application. 

-  A clear majority of NPOs (AT, CH, DE, DK, ES, FI, FR, EL, HR, HU, IE, LT, LU, LV, 
NL, PT, RS, SE, SK, UK) allow for public access to almost all information concerning the 
procedure of  granting an SPC with  exceptions regarding business  secrets, personal  data, 
records of consultations and parts of files relating solely to internal office procedure, trade 
or  business  secrets,  documents  protected  by  copyright  law,  documents  containing 
sensitive  information  about  individuals  or  documents  the  applicant  has  asked  to  be  kept 
confidential. 

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The Commission conducted a survey among NPOs in early 2020 to obtain details on their 
transparency practices that may be summarised as follows: 

-  Most  NPOs  provide  an  online  searchable  database,  although  the  search  criteria  are  very 
variable  (in  two  Member  States,  the  only  search  criterion  that  can  be  used  is  the  SPC 
number). 

-  Publishing  SPC-related  information  takes  varying  amounts  of  time,  ranging  from  a  few 

days to several months, and even more than a year in specific situations. 

-  Only a slight majority of NPOs (14 out of 27) publish SPC-related information in English 

in addition to their official languages. 

-  Only  about  half  of  NPOs  make  the  documents  in  a  file  for  a  given  SPC  application 
accessible  online  (e.g.  in  PDF  format).  However,  the  other  NPOs  usually  allow  file 
inspection and/or are able to provide copies. 

-  Only  a  slight  majority  of  NPOs  (15)  provide  the  European  Patent  Office  (EPO)  with 
detailed information on SPCs (which the EPO then publishes, although it is often mixed 
with other legal information). 

-  When  asked  which  source  they  would  consider  to  be  the  most  suitable  for  providing 
centralised  access  to  SPC  information,  7  NPOs  mentioned  the  EPO  databases  (possibly 
with  improvements),  4  did  not  express  any  preference,  and  14  mentioned  a  new 
centralised website. 

-  These transparency issues are in line with those already identified in the WIPO’s surveys 

of 2019297 and of 2002298.  

Consequences – EU less attractive globally 

Currently most big markets offer SPC equivalent (called patent term extension) of up to 5 years (see 
Table 44). 

Table 44: SPC Situation around the world 

Country 
Australia 
Canada 
Israel 
Japan 
South Korea 
Singapore 
USA 
Taiwan 
China* 
India* 
Source: Study on the Legal Aspects of Supplementary Protection Certificates in the EU, MPI (2018); *own research 

Type and period of maximum protection 
Patent extension by up to 5 years 
Certificates of supplementary protection for up to 2 years 
Patent extension by up to 5 years 
Patent extension by up to 5 years 
Patent extension by up to 5 years 
Patent extension by up to 5 years 
Patent extension by up to 5 years 
Patent extension by up to 5 years 
Patent extension comparable to the EU SPC regime 
No such extension mechanism 

The SPC Regulations clearly aim at supporting pharmaceutical and agrochemical innovation in the 
EU299. While the economic literature provides vast empirical evidence in support of positive impacts 
of IP rules on R&D activities, it is nonetheless not possible to infer direct causal relationships 
between the implementation of an SPC system in a particular jurisdiction and an actual change in 
research and development activities in that area. For example, IQVIA (2021) shows a positive 

297   https://www.wipo.int/edocs/mdocs/classifications/en/cws_7/cws_7_23.pdf 
298   https://www.wipo.int/export/sites/www/standards/en/pdf/07-07-01.pdf 
299 Recitals 2 to 5 of Regulation (EC) 469/2009, Recitals 3 to 5 of Regulation (EC) 1610/96.  

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correlation between the strength of IP protection300 and the number of clinical trials (“countries with 
a strong IP index have higher levels of clinical research activities on average”301, see: Figure 26 
below), but the level of granularity of the analysis concerning the IP rules does not allow to 
distinguish the impact of rules on SPC or patent term restoration (PTR)302. As a consequence, 
although the above research supports the basic claim in favour of relevance of strong IP protection in 
the sector, it is not SPC/PTR-specific303.  

Figure 26: Strength of IP framework and the number of clinical trials per million inhabitants (2014-2020) 

Source:  The  Impact  of  Pharmaceutical  IP  Provisions  in  EU  Free  Trade  Agreements,  IQVIA  Institute  for  Human  Data 
Sciences, November 2021. 

The main difficulty in identifying the direct effects of the SPC/PTR on innovation intensity in the 
jurisdiction(s), where such rules are introduced also stems from the fact that patent holders can seek 
such extended protection irrespective of the country where the R&D or manufacturing of the novel 
product took place. In other words, the SPC Regulations do not differentiate between EU-based 
companies and their foreign competitors304. The same “geographic” neutrality towards innovators 
applies for example to the Japanese or US patent extension terms305. Such architecture of the 
SPC/PTR rules reflects the core nature of the pharmaceutical industry, which is by no means a global 
one. In view of the above, it is evident that the consequences of the current the SPC regime do not 
concern the Single Market only. They stretch beyond the EU borders and must be evaluated from 
such perspective, as well.  

300 Measured by the IP index of the Global Innovation Policy Centre (GIPC), U.S. Chamber 2021 
International IP Index. 
301 The Impact of Pharmaceutical IP Provisions in EU Free Trade Agreements, IQVIA Institute for Human 
Data Sciences, November 2021. 
302 Patent term restoration (PTR) is a term used in USA and Japan to describe extension of patent right 
equivalent to European SPC. 
303 Although the authors argue that „The combination of RDP and PTR provisions has the strongest effect 
on R&D and clinical research”, Idem, p. 27. 
304 Which is in clear contrast to for example local manufacturing requirements contained in the SPC 
manufacturing waiver.  
305 Most developed countries (e.g. the US, JP and others) have similar patent extension regimes 
incentivising the development of new products. For more details see: MPI study (2018), p. 603-617. 

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In pharmaceuticals, this is confirmed by productivity data, where an ever-increasing back catalogue 
of effective medicines, and a shift towards more complex conditions that has increased the 
complexity of clinical trials and failure rates. Figure 27 illustrates the decreasing productivity index. 
As mentioned above, a common hypothesis to explain this trend is that more stringent requirements 
to gain marketing authorisation have increased the costs of clinical trials.  

Figure 27: Clinical Productivity Index and elements of productivity indexed to 2010 values 

Source: Global Trends in R&D: Overview through 2021. IQVIA institute for Human Data Science, February 2022.  

Similar patterns can be observed in the plant protection sector, where as mentioned earlier, the 
major companies invested around 7-10% of their annual sales in R&D over the last 50 years306. Yet, 
according to a study by Deloitte307 the agrochemicals industry has experienced declining revenues 
and margins that were primarily due to:  

-  Longer  product-development  cycles:  the  average  development  period  for  a  new  PPP 
has  increased  from  8.3  years  in  1995  to  11.3  years  in  2010-2015  (see:  Table  45 
below).  

Table 45: Time to develop a new crop protection product 

Source:  Evolution  of  the  Crop  Protection  Industry  since  1960,  Phillips  McDougall,  November  2018  (from  Phillips 
McDougall, 2016), p.8. 

-  Escalating  costs:  the  overall  R&D  costs  for  a  new  PPP  increased  from  USD  152 

million in 1995 to USD 286 million in 2010-2014 (see: Figure 28, below). 

306 Evolution of the Crop Protection Industry since 1960, Phillips McDougall, November 2018. 
307 The future of agrochemicals | Capturing value through innovation, resourcefulness, and digital alchemy, 
Deloitte, 2019, p.4.  

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Figure 28: Discovery and development costs of a new crop protection product 

Source: Evolution of the Crop Protection Industry since 1960, Phillips McDougall, November 2018, p.8. 

Consequences - Hampered joint cross-country public procurement 

According to available data on public procurement, “medical equipment, pharmaceuticals and 
personal care products” accounted for around 14.1% of contracts below EUR 200 million covered by 
the EU public procurement Directives and were characterised by very high share of indirect308 cross-
border procurement309. Namely, as much as 50.2% of such awards in 2016-2019 were won by local 
subsidiaries of foreign firms, accounting for 61.3% of the total value of procurement under division 
33 of CPV310. The propensity to indirect cross-border procurement in CPV33 (medical equipment, 
pharmaceuticals and personal care products) was actually the highest among all sectors311. However, 
although it confirms the multinational character of the sector (supply side), the above data in 
principle concern calls for tender launched by contracting authorities from a single Member State 
(demand side), as different from a cross-country joint procurement. Unfortunately, calls for tender 
for pharmaceuticals involving two or more countries do not occur very often, although especially in 
case of small countries, it could leverage their market power by pooling volumes and/or address 
various concerns in terms of security of supply. 

How likely is the problem to persist? 

The medicine market is expected to grow at 3–6% CAGR through 2026, reaching about USD 1.8 
trillion in 2026, including spending on COVID-19 vaccines312 (see: Figure 29 below).  

308 Companies located in the same country as the contracting authority but controlled by companies in a 
foreign country 
309 Study on the measurement of cross-border penetration in the EU public procurement market, Prometeia 
SpA, European Commission, DG for Internal Market, Industry, Entrepreneurship and SMEs, 2021, p.65.  
310 Common Procurement Vocabulary (CPV) is a single classification system for public procurement aimed 
at standardising the references used by contracting authorities and entities to describe the subject of 
procurement contracts. 
311 Prometeia SpA (2021), p.65.  
312 IQVIA, The Global Use of Medicines 2022: Outlook to 2026, 2022, p.2. 

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Figure 29: Global medicine market size and growth 2011-2026 [USD billion, constant] 

Source: IQVIA Market Prognosis, September 2021, IQVIA Institute, November 2021  

C.  Evidence  supporting  section  6  (impacts),  except  for  the  cost-benefit 

analysis313 

The choice of the examination authority 

Table 46: Key elements impacting the choice between the EUIPO/EMA/EFSA and EPO 

EU body? 
Legal basis 

Supervision by the 
European 
Parliament?  
Decisions subject to 
review of the CJEU? 

EUIPO/EMA/EFSA 
Yes 
Art. 118 (unitary SPC) and Art. 114 
(centralised procedure) 
(codecision) 
Yes 

EPO 
No 
Probably Art. 352 (unanimity of 
the Council, and mere consent by 
the EP) 
No 

Yes 

No (to the EPO´s Board of Appeal, 
instead) 

Table 47: Public Consultations results: Which granting authority would you favour to grant and register a unitary SPC? Q38 
(to Originators), Q30 (to follow-on manufacturers), Q10 (to other public authorities). 

Agree answers only* 

Originators 

Follow-on 
manufacturers 

EU Intellectual Property Office 
European Patent Office 
A new EU agency 
European Medicines Agency 
EU countries' patent offices (e.g. virtual office 
approach or mutual recognition with reference 
offices, under EU rules) 
None of the above, please indicate your alternative 
preference 

No. of answers 

1% 
6% 
1% 
1% 
86% 

4% 

69 

2% 
48% 
38% 
0% 
7% 

5% 

50 

Ministries and 
other public 
authorities 
0% 
20% 
0% 
40% 
20% 

20% 

5 

313 The background data supporting cost-benefit analysis presented in section 6 of the impact assessment is 
provided in Annexes 5D to 5G. 

EN 

117 

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* the residual to 100% is the number of those disagreeing.  
Note: ”Don’t know“ and No answer not taken into account. Not all groups of respondents have received this question. 
Source: Public Consultations on Evaluation of SPC 

Figure 30: Allensbach survey on the choice of examination authority (question 70) 

The choice of linguistic regime – advantages and disadvantages 

As mentioned in sections 6.2 to 6.5, the table below identifies advantages and disadvantages per 
each linguistic regime with regards to selected steps of the centralised SPC procedure. The columns 
define selected actions in the SPC examination process, where a particular linguistic settings could 
have significant impacts on the objectives of this initiative defined in Section 4.  

Table 48: Advantages and disadvantages of each linguistic regime for a centralised SPC procedure (PO3 to PO5)  

Application for the SPC 
(standard form314) and 
filing of 3rd parties 
observations 

Procedure at the single authority 
(working language(s)) 

Transmission of the 
examination results to NPOs 
(ONLY in PO3 and PO4) 

Applicant (firm) 

Examination authority  

Examination authority and NPOs 

Linguisti
c regime 

Parties 
concerned 

314 A standard form for an SPC application would be agreed and translated into the languages of each 
linguistic regime (one-off cost). 

EN 

118 

EN 

 
 
 
 
 
                                                           
Application for the SPC 
(standard form314) and 
filing of 3rd parties 
observations 
(0) Although acceptable for 
the industry (as indicated in 
the public consultation, 
stakeholders usually 
communicate in EN), but 
there would be access 
barriers for non-EN 
speaking firms, such as 
smaller follow-on 
producers. 
(++) High cost-effectiveness 
(translation costs to one 
language only, if at all). 
(+ + +) Fully accessible for 
all stakeholders.  
(+ + +) Very high cost-
effectiveness (no translation 
costs315 as submission in the 
native language of the 
applicant always 
possible316). 

- 

- 
- 

(+) Reasonably accessible 
for stakeholders. 
(+ +) High cost-
effectiveness (translation 
costs to one language only, 
if at all). 

(+ +) Accessible for the 
prevailing majority of 
stakeholders. 
(++) High cost-effectiveness 
(translation costs to one 
language only, if at all). 

Linguisti
c regime 

English 
only (EN) 

Any 
official 
language 
of the EU 

EN, FR or 
DE (any 
language 
of the EPO 
linguistic 
regime ) 

EN, FR, 
DE, IT or 
ES (any of 
the 
languages 
used by 
EUIPO) 

Procedure at the single authority 
(working language(s)) 

(+ + +) Minimum cost (no translation 
costs for the EA).  
(+ + +) Facilitated exchange of expertise, 
streamlined administrative processes 
within the EA and w.r.t.:  
- the recruitment of members of the BoA  
- the working of BoA;  
- the recruitment of formality officers and 
setting up of a VNE.  

Transmission of the 
examination results to NPOs 
(ONLY in PO3 and PO4) 

(+++) Minimum cost (no translation 
costs for the EA). 
(++) Facilitated exchange of 
expertise, fast and streamlined 
administrative processes for the EA, 
but necessitate more effort from 
NPOs (if acceptable).  

(- - -) High translation costs, need for 
additional administrative staff with 
specific language skills. 
(- - -) Exchange of expertise difficult due 
to number of languages, cumbersome 
administrative processes, within the EA 
and w.r.t.: 
- the recruitment of members of the BoA 
(very challenging if not impossible); 
- the working of the BoA; 
- the recruitment of formality officers and 
setting up of a VNE. 
(+ +) High cost-effectiveness (reasonable 
translation costs,) 
(+ +) Facilitated exchange of expertise, 
acceptable level of linguistic impact on 
the complexity of administrative 
processes within the EA and w.r.t.:  
- the recruitment of members of the BoA;  
- the working of the BoA; 
- the recruitment of formality officers and 
setting up of a VNE. 
(+) Positive cost-effectiveness (moderate 
translation costs) 
(+ +) Facilitated exchange of expertise, 
acceptable level of linguistic impact on 
the complexity of administrative 
processes within the EA and w.r.t.:  
- the recruitment of members of the BoA;  
- the working of the BoA; 
- the recruitment of formality officers and 
setting up of a VNE. 

(Any official language of the EU, 
within the languages relevant to the 
requested SPC coverage) 
(0) Neutral cost-effectiveness 
(significant translation costs for the 
EA and delays) 
(- -) Very limited exchange of 
expertise, but respects the linguistic 
regime of each NPOs. 

(+ +) High cost-effectiveness 
(reasonable translation costs, 
acceptable level of linguistic impact 
on the complexity of proceedings).  
(+ +) Facilitated exchange of 
expertise, but the linguistic regime 
of majority of NPOs is not 
respected. 

(+) Positive cost-effectiveness 
(moderate translation costs, some 
negative impacts on the delays and 
complexity of proceedings due to 
number of languages). 
(+ +) Facilitated exchange of 
expertise, but the linguistic regime 
of majority of NPOs is not respected 

315 As mentioned earlier, it is assumed that EP and MA are always available in the language of the country 
for which the SPC is requested, as MA is published in all EU languages and the EP have been validated in 
the requested countries. 
316 If an SPC application for the same product covered several MS, it could be submitted in one language 
with several attachments (PE and MA) for each language of the the countries where the protection is sought. 

EN 

119 

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Application for the SPC 
(standard form314) and 
filing of 3rd parties 
observations 

(not possible)  
It would dissuade (or 
practically block) the 
submission of SPC 
applications.  
It would dissuade (or 
practically block) the filing 
of observations. 

- 

- 

Procedure at the single authority 
(working language(s)) 

(- - -) Very low cost-effectiveness 
(significant translation costs, need for 
additional administrative staff with 
specific language skills). 
(- - -) Exchange of expertise difficult due 
to number of languages, cumbersome 
administrative processes, within the EA 
and w.r.t.: 
- the recruitment of members of the BoA 
(very challenging if not impossible in 
view of linguistic requirements)  
- the working of the BoA; 
- the recruitment of formality officers and 
setting up of a VNE (extremely difficult, 
if not unfeasible). 

Transmission of the 
examination results to NPOs 
(ONLY in PO3 and PO4) 

(not possible) 
The translation into more languages 
than selected languages relevant to 
the requested SPC coverage would 
generate redundant costs (serves no 
purpose). 

The translation costs would 
be borne by the applicant. 

The translation costs of would be borne 
by the examination authority. 

The translation costs would be 
borne by the examination authority. 

Linguisti
c regime 

All official 
languages 
of the EU 
(or of the 
enhanced 
cooperatio
n area)  

Parties 
bearing 
the 
translatio
n costs 

Note: EA - the examination authority; VNE - a virtual network of examiners (i.e. a pool of SPC examiners delegated from 
NPOs); BoA – Board of Appeals. 

The choice of linguistic regime – translation costs for the applicants  

Table 49 below estimates the yearly cost of translations borne by SPC applicants under the current 
regime (two scenarios – SPC coverage sought in 27 Member States or 17 Member States of the 
enhanced cooperation) and the newly proposed centralised filing. If the SPC was to be submitted 
centrally, the cost of translation of the application from applicant’s own language to the working 
language of the examination office would amount to 17 400 EUR yearly (100 SPC applications yearly 
* 2 pages per applications * 87 EUR/ page). This would be roughly 7.5% of costs borne by firms 
currently, when they seek an SPC protection in 27 Member States (translations to 23 official EU 
languages317 * 58 application * 2 pages per application * 87 EUR/page).  

In case of no translation requirements in the centralised procedure (the applications are accepted in 
any of the EU official languages), the translation cost to firms would drop to zero. 

317 24 official EU languages, less the applicant’s own language.  

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Table  49:  Estimated  annual  EU  wide  translation  costs  for  firms  –  comparison  of  current  situation  and  a  centralised 
submission 

Note: Number of SPC applications to be submitted = number of countries * 58 (average yearly number of SPC submitted in 
2014-2021 per country); Number of SPC applications to be translated before submission = number of languages into which 
an  SPC  application  needs  to  be  translated  *  58  (average  yearly  number  of  SPC  submitted  in  2014-2021  per  country). 
Assumptions  –  number  of  SPC  applications  per  year  in  the  centralised  system:  100;  number  of  pages  per  an  SPC 
application: 2; Translation cost per page: 87 EUR. 

The typical cost of translation per product in case of submission in 27 Member States would be EUR 4 
002 (i.e. 23 languages * 2 pages * EUR 87 per page) and EUR 2 436 in case of submission in the 
current 17 UP Member States (i.e. 14 languages * 2 pages * EUR 87 per page).  

The choice of linguistic regime – translation costs for the examination authority 

The below cost estimate is based on the assumption that, the SPC applicants or 3rd parties wishing to 
file written observations can use any official EU language in order to submit documents to the 
examination authority. This being said, Table 50 and Table 51 below present such costs incurred in 
the following stages of the centralised SPC procedure:  

- 
reception of an SPC application (any EU official language), 
-  publication of the SPC application (all EU official languages), 
- 
- 

reception of third parties written observations (any EU language), 
transmission of the SPC dossier to NPOs (all EU official languages where the SPC is 
sought318), 

-  publication of the SPC examination results (all EU languages). 

Furthermore, the number of SPC applications submitted per year in the new centralised procedure is 
expected to be 100 (as it was the case for the estimate of firm’s translation costs). The SPC 
procedures are expected to be quite contentious, therefore three scenarios concerning the number 
of 3rd parties interventions are considered, ranging from 50% of SPC being subject to reactions from 
other stakeholders to 100% of SPC receiving written observations. The expected number of written 
observations per SPC procedure is three. This number is based on the assumption that half of future 

318 Table 50 is based on an upper bound scenario of a coverage sought in 27 Member States. 

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121 

EN 

SPC sought in 27 MSSPC sought in UP-17 MSCentralised filing yes, for all except for the SPC application languageyes, for all except for the SPC application languageyesNumber of Offices for which an SPC application needs to be submitted27171Number of languages into which an SPC application needs to be translated231411566986100133481210026681624200232 116 €         141 288 €         17 400 €           4 002 €2 436 €174 €Translation cost per productCombined translation costs for firms - yearly estimatesScopeIs the SPC application to be translated (application language is NOT the working language of the NPO or EA)? TOTAL cost of translationSPC applicationNumber of SPC applications to be submitted Number of SPC applications to be translated before submission Number of pages for translation (2 per SPC application) 
 
 
                                                           
generic competitors319 would address such observations concerning medicinal products that they 
may consider producing.  

Table 50: Translation costs for the examination authority under the centralised SPC procedure – reception of documents 

Notes: Assumptions – number of SPC applications per year in the centralised system: 100; number of pages to be translated 
per SPC application: 2; number of pages to be translated per written observations dossier: 10; Translation cost per page: 
87 EUR. 

Two steps of the procedure are to be published: i) information that an SPC request has been received 
by the examination office and it fulfils basic admissibility conditions (including some key elements of 
its contents to enable the submission of written observations) and ii) the summary of results of the 
SPC examination procedure (this publication may be less detailed than what is transmitted to the 
parties concerned and/or NPOs in PO3 and PO4), yet it should contain all necessary elements to 
allow the follow-on producers make their decisions with regards to potential market entry.  

It shall be noted that the transmission of the SPC examination outcome to NPOs (foreseen under PO3 
and PO4) has the highest impact on the overall translation costs for the examination authority 
(around EUR 2 million). It would be therefore highly recommended to agree that the SPCs dossiers 
passed to NPOs are not translated into all languages, but transferred and processed in the 
examination procedural language only. 

319 “Within three years following the LoE [loss of exclusivity], the ratio of generic companies to originators 
is about 6:1.” (source: Pharmaceutical sector Inquiry (2009), p. 74).  

EN 

122 

EN 

yes-100%yes-50%no-0%100500Number of pages to be translated (2 per SPC application)200100017 400 €                    8 700 €                       - €                           yes-100%yes-50%no-0%100% of SPCs will receive 3 observation dossiers300150075% of SPCs will receive 3 observation dossiers225113050% of SPCs will receive 3 observation dossiers150750Ranges taken for the estimate3001130Number of pages to be translated (10 per observations dossier)300011250261 000 €                  97 875 €                    - €                           Documents received need to be translated to the EA working language?Cost of translationCost of translationTranslation  of written observations into the EA working language (1 translation per observation dossier), in case of:Reception of 3rd parties written observationsSteps in the administrative procedure Actions to be undertaken by the EANumber of documents to be translated and the cost of translationReception of an SPC applicationTranslation into the EA working language for admissibility inspection (1 translation per SPC application)Documents received need to be translated to the EA working language? 
 
 
 
                                                           
Table 51: Translation costs for the examination authority under the centralised SPC procedure – publication of documents 
(upper bound for 27 Member States) 

Notes: Assumptions – number of SPC applications per year in the centralised system: 100; number of languages: 23 (i.e. 24 
languages, less 1 language of the dossier); number of pages to be translated per published SPC application: 2 (although the 
published version of the application may be abridged due to the removal of sensitive information, the same number of pages 
is  kept);  number  of  pages  to  be  translated  per  SPC  dossier  before  transmission  to  NPOs:  10;  number  of  pages  to  be 
translated per SPC examination dossier to be published (only key elements of the complete file submitted to the NPOs): 2; 
Translation cost per page: 87 EUR. 

Table 52: SPC maintenance fees and their estimated share in the NPOs revenues from patent maintenance   

Source: Renewal fees for granted patents from “EPO Financial Statements 2021”, p. 61; shares – own calculations based on 
renewal fees collected from NPOs websites in March 2022 multiplied by average yearly number of SPC filed, as presented in 
Figure 1.  

EN 

123 

EN 

Steps in the SPC administrative procedure Number of documents to be translated Number of pages per documentNumber of pages to be translatedCost of translationPublication of an abridged SPC application230024600              400 200 € Transmission of the SPC dossier to NPOs230010230002 001 000 €          Publication of the SPC examination results230024600400 200 €             CountryRenewal fees for granted patents in 2021 ['000 EUR]Share of SPC fees in renewal fees for granted patents (application)Share of SPC fees in renewal fees for granted patents (maintenance)AT25 142                                0.1%0.9%BE10 810                                0.1%0.5%BG2 272                                  0.6%3.4%CY1 113                                  0.4%3.3%CZ6 206                                  0.2%1.0%DE218 360                             0.0%0.1%DK10 657                                0.2%0.4%EE1 533                                  0.3%1.8%EL4 236                                  0.4%2.5%ES22 618                                0.2%0.9%FI10 520                                0.3%0.5%FR77 771                                0.1%0.1%HR740                                     1.7%10.5%HU6 396                                  0.6%1.1%IE7 513                                  0.1%0.4%IT45 653                                0.1%0.2%LT1 287                                  0.4%1.2%LU1 661                                  0.1%1.5%LV1 210                                  0.4%1.9%MT370                                     0.8%1.8%NL44 168                                0.1%0.3%PL5 272                                  0.1%1.4%PT6 098                                  0.5%0.9%RO3 573                                  0.8%1.9%SE16 474                                0.3%0.7%SI1 737                                  1.2%7.4%SK2 584                                  0.3%3.2%535 974                             0.1%0.4% 
 
 
 
 
The choice of linguistic regime – languages of applications to the German NPO. 

Based on the geographical distribution of applications submitted to the German NPO in 2010-2022 
(as described in Annex 5B) we can estimate which languages are most frequently used. It is assumed 
that all non-EU applicants would apply in one of the official EU languages – most often it is English, 
but in case of Canada it could be also English or French, and for Switzerland: French, German or 
Italian, etc. The language distribution resulting from the above analysis is presented in Table 53 (the 
columns refer to variations in the use of a second or third language). 

Table 53: Estimated language distribution of applications to German NPO in 2010-2022 

Language 

English 
French 
German 
Italian 
Dutch 
Danish 
Swedish 
Spanish 

Total 
Share of English, French and German 

Using 1st language 

Using 2nd language* 

57.8% 
20.0% 
11.5% 
1.5% 
2.2% 
2.8% 
2.4% 
1.1% 
99.3% 
89.3% 

56.9% 
4.6% 
23.4% 
1.5% 
6.5% 
2.8% 
2.6% 
1.1% 
99.5% 
84.9% 

Using 3rd *or in 
absence 2nd language 
56.9% 
4.6% 
16.2% 
13.1% 
2.2% 
2.8% 
2.6% 
1.1% 
99.5% 
77.7% 

* if available 
Note: Ranges depict variation due to existence of second or third language in some countries that could potentially be used. 
Assumptions: The assumption was that all non-EU applicants would apply in one of EU languages – most often English, but 
for e.g. for Canada in English or French, and for Switzerland: French, German or Italian. 
Source: Own estimation based on German NPO data. 

Consequently, between 78% and 90% of applications have historically been filed in English, German 
and French. These findings are in line with the MPI (2022) study, which analysed the use of languages 
at the EPO and concluded that up to 65% of patent applications between 2016 and 2020 were 
submitted in English, up to 14% in German and up to 5% in French.320 

320 MPI (2022), page 13. It must be noted however that EPO has three official languages: English, French 
and German, and a European application can be filed in any language under Art 14(1) EPC. However, it 
must be translated into one of the official EPO languages, if it was filed in any other language. 

EN 

124 

EN 

 
 
 
 
 
                                                           
Background information concerning impacts on the follow-on products entry 

Figure 31: Share of generics in the total pharmaceutical market, 2019 (or nearest year) 

Source: Source: OECD Health Statistics 2021 (https://stat.link/uyjgok) 

EN 

125 

EN 

 
 
 
 
 
Figure 32: Time-to entry of follow-on medicines over 1 to 48 months after the loss of exclusivity (LoE), by country - number 
of medicines that were previously covered by any type of protection 

Source: In-house analysis based on IQVIA data covering molecules with the loss of exclusivity from 01/2010 onwards. 

EN 

126 

EN 

 
 
 
 
 
 
In the context of this initiative, the impact of a hypothetical shortening of the regulatory protection 
by two years was estimated (Table 54 below), showing that the share of SPC would increase by 
roughly 5% from 49.6%321 currently to 54.9% of molecules. 

Table 54: SPC as the last protection to expire – comparison between the current situation and a hypothetical shortening of 
the duration of regulatory protection by two years  

Molecules322 

Molecule-country pairs 

Number 

% 

Number 

% 

342 

Current length of the RP 
(8+2) 
Shorter length of the RP 
(6+2) 
Source: In-house analysis based on IQVIA data covering molecules with the loss of exclusivity from 01/2010 onwards; only 
EMA-matched molecules were taken into account. 

3 253 

3 644 

49.6  

54.9  

31.6 

35.4 

379 

Yet, it seems more adequate to perform such analysis at the level of country-molecule pairs, as the 
same molecule may have different SPC status across different Member States. In such case the SPC 
share would increase from roughly 32% to 35.4% if the regulatory protection was shortened by two 
years. Nonetheless, the above analysis also shows that irrespective of the unit of measure chosen, in 
2/3 of cases (or roughly ½ of molecules), the SPC is not the last protection measure to expire and 
thus does not have a decisive influence on generic entry. 

Table 55: Estimated (theoretical) lost benefits from longer SPC protection caused by its unitary application in million EUR, 
compared to the overall spending on pharmaceuticals by country based on COFOG 2020 data 

General government expenditure on 
medical products, appliances and 
equipment in 2020 
[million EUR] 

        4 624.4  
        3 696.1  
           460.1  
        1 793.6  
           208.9  
        1 683.0  
      34 955.0  
      60 200.0  
      16 955.0  
           202.5  
           439.0  
        1 247.4  
        7 247.0  
        1 293.5  
           479.0  
        3 696.7  

Estimated 
average 
difference in 
2010-2021  
[%] 
         0.033  
         0.005  
         0.139  
         0.077  
         0.101  
         0.094  
         0.027  
         0.027  
         0.011  
         0.248  
         0.096  
         0.000  
         0.015  
         0.049  
         0.046  
         0.026  

Estimated lost benefits  
[million EUR] 

                  1.5    
                  0.2    
                  0.6    
                  1.4    
                  0.2    
                  1.6    
                  9.4    
                16.5    
                  1.8    
                  0.5    
                  0.4    
                  0.0    
                  1.1    
                  0.6    
                  0.2    
                  1.0    

AUSTRIA 
BELGIUM 
BULGARIA 
DENMARK 
ESTONIA 
FINLAND 
FRANCE 
GERMANY 
ITALY 
LATVIA 
LITHUANIA 
LUXEMBOURG 
NETHERLANDS 
PORTUGAL 
SLOVENIA 
SWEDEN 

321 Commission services in the impact assessment accompanying the proposal for a revision of Regulation 
(EC) No 726/2004 estimate that SPC is the last protection measure to expire in 48 % of molecules, based on 
a basket of 217 products selected based on IQVIA Ark Patent intelligence data where the loss of protection 
was between 2016–2024 in four countries: FR, DE, IT and ES. 
322 A molecule is identified as positive if it was covered by an SPC in at least one Member State. 

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Source:  In-house  analysis  based  on  IQVIA  data  covering  molecules  with  the  loss  of  exclusivity  from  01/2010  onwards; 
Eurostat COFOG - general government spending on medical products, appliances and equipment, extracted on 04.08.22. 

    139 181.2  

                37.0    

D.  Cost  analysis  supporting  section  6  (impacts)  –  the  central  authority  and 

reference office’s perspective 

The  assumption  of  new  functions  by  any  of  the  considered  authorities  (reference  offices  in 
case of PO2, or central authority in case of PO3-5) would involve additional costs. 

The below analysis is based on estimates provided by the EUIPO reflecting their experience 
with managing EU Trademarks and Designs. The presented cost estimate is expected to be in 
the same range regardless of which of the considered bodies takes the new role. 

Central examination authority: one-off costs (PO3-5) 

In  order  to  prepare  for  the  new  role  the  examination  authority  would  have  to  incur  the 
following set-up expenses: 

Table 56: Set up costs of the central authority (FTE and EUR). 

Cost item: 
Evaluate and appoint examiners from NPOs 
Guidelines and work instructions 
Set up collaborative working methods 
Set-up quality controls  
Templates 
Training 
Set up case management/distribution system 
Set up Board of Appeals at the EU level (PO4-5, and PO4+5) 
IT (analysis, design, quality control and development) 

Total PO3 
Total PO4, PO5, and PO4+5 

FTE* 
1.0 
1.0 
1.9 
1.0 
0.5 
1.0 
0.5 
0.5 
3.9 
10.6 
11.1 

Cost (EUR thousands) 
124.8  
124.8  
249.5  
124.8  
62.4  
124.8  
62.4  
62.4  
512.0  
1 385.3 
1 447.7 

* FTE – full time equivalent  
Assumptions: Number of SPCs per year: 100, salary of FTE: EUR 131 000 (average EUIPO salary for 2021-2022 based on 
its budget)323 
Source: In-house analysis based on EUIPO estimates. 

Set-up costs for all three options involve: the evaluation and appointment of examiners from 
NPOs that would conduct substantive examination of applications, preparation of guidelines 
and work instructions, as well as collaborative methods and quality controls in order to ensure 
a  consistent  approach  to  the  SPC  examination.  It  would  further  involved  the  creation  of 
common  templates  for  applicants  and  examiners,  training  of  all  involved  in  new  working 
methods  and  the  creation  of  a  case  management  system.  The  bulk  share  of  one-off  costs 
would  be  devoted  to  creation  of  an  IT  system  for  processing  SPC  data.  Additional  cost  for 
PO4-5 is connected with the setting up of a Board of Appeals. 

323 https://euipo.europa.eu/ohimportal/en/transparency-portal/economic/office-budget  

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Administrative processing 
of the SPC applications 
Examiners remuneration 
(examination + revision) 
BoA appeal 
EGC/ECJ 
Recordals** 
IT maintenance 

The IT system for SPC is expected to contain the following features: 

  Front office: i) (e-submission) with: a standard e-form for SPC filing, validation of the 
Market  Authorisation (EMA), validation of the base patent  (EPO), sourcing of other 
structured information, if necessary; ii) publication and search functions. 

  Register: register of SPCs. 
  Back Office: data management, fees management, documents management.  
  Virtual Network: ensuring the exchange of data with NPOs for SPC examinations. 
For the purpose of subsequent calculations, the setup cost is expected to be depreciated over 
10 years period according to the number of applications received each year324. 

Central examination authority: recurrent costs (PO3-5) 

The  running  costs  of  dealing  with  SPCs  is  expected  to  consist  of  the  following  items 
(excluding translations). 

Table 57: Recurrent costs of the central authority (FTE and EUR). 

Cost item: 

FTE* 

Cost (EUR thousands) 

PO3 
0.5 

PO4 
0.5 

PO5  
0.5 

PO4+5 
0.5 

PO3 
 66 

PO4 
 66 

PO5 
 66 

PO4+5 
 66 

4.8 

5.7 

5.7 

6.7 

 624 

 749 

 749 

 873 

3.8 
1.9 
0.48 
0.45 
12.9 
* FTE – full time equivalent, **an entry in the SPC register  
Assumptions: Number of SPCs per year: 100, salary of FTE: EUR 131 000 (average EUIPO salary for 2021-2022 based on 
its budget)325 
Source: In-house analysis based on EUIPO estimates. 

 499 
 250 
 62 
 59 
1 684 

 499 
 250 
 62 
 59 
1 809 

3.8 
1.9 
0.48 
0.45 
13.8 

 59 
 748 

 59 
 873 

0.5 
5.7 

0.5 
6.7 

Total  

The recurring costs for PO3 would involve administrative processing of the SPC applications, 
remuneration  of  examiners  from  NPOs326  and  maintenance  of  IT  systems.  PO4  would  have 
higher examiners’ cost, as they would also handle reviews (a second examiner or a panel of 
examiners would be asked to  look  at  a contested case). The  cost  items  under PO5 cover an 
appeal process at the Board of Appeals and handle potential litigations in CJEU327, as well as 
processing entries into the SPC register (recordials). 

The  combination  of  PO4  and  PO5  takes  the  cost  of  the  latter,  but  with  more  examiners,  as 
foreseen under PO4. 

324 For instance if over 10 year period 1 000 SPC applications will arrive, cost of handling each application 
will include 1/1 000 of total set up cost. 
325 https://euipo.europa.eu/ohimportal/en/transparency-portal/economic/office-budget  
326 Under the assumption that an SPC examination would take up to 10 working days and there are 100 
examinations per year in PO3. In PO4 and PO5, the estimate is based on 120 cases to take into account an 
additional workload, related to re-examination of the file that may be requested. Finally, 140 in PO4+5 
reflects a potential need to involve examiners from UP and non-UP Member States to deal with appeals. 
327 We expect up to 5 referrals to CJEU a year (out of approximately 20 rejections for 100 applications). The 
number of referrals reported by MPI (2022) in Table 5.5, p. 79 for years 2012-2020 was doubled to reflect a 
potentially higher share of negative opinions covering all 17 UP-MS. 

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Translation costs (PO2-5) 

Additionally,  the  publication  of  SPC  applications  and  examination  results  in  all  24  EU 
languages  and  the  possibility  to  submit  written  observations  in  any  language  (proposed  for 
transparency reasons in PO3-5) would create a fixed translation cost per SPC application. The 
translation  of  an  examination  dossier  to  languages  of  the  Member  States  where  an  SPC  is 
sought  (PO2-5)  would create variable translation  costs. These were analysed earlier (Annex 
5C) and are summarised in the table below: 

Table 58: SPC translations costs per option 

Pages 

Languages  Costs per SPC 

Publication of SPC application in all EU languages  
(PO3, 4, 4+5) 
Written observations*  
(PO3, 4, 4,+5) 
Publication SPC examination result in all EU languages 
(PO3, 4, 4,+5) 

2 

30 

2 

23 

1 

23 

(EUR) 
4 002 

2 610 

4 002 

Annual cost 
(EUR million) 
0.4 

0.26 

0.4 

Total fixed translation cost per SPC application 

1.06 

10 

Examination dossier translation for NPOs**  
(PO2, 3, 4 and 4+5) 
Note: there are 24 official languages, so at maximum an applications needs to be translated into the remaining 23. 
* Assumption that an SPC will receive three 10-page-long observations that need to be translated in to working language of 
the examination authority; ** variable dependent on the number of Member States designated by the applicant, in case of 
options where national NPO is granting an SPC. 
Assumptions: Number of SPCs per year: 100, cost of one page translation EUR 87 by professional translator 
Source: In-house analysis  

870 to 20 010 

0.09 to 2 

1 to 23 

Application fee 

As changes proposed under this initiative should be self-financing, the minimum fees charged 
should at least cover all additional costs. The above cost analysis also shows that almost all 
recurrent costs (except for the IT maintenance) are generated during the pre-grant phase, thus 
it  would  seem  logical  to  recover  them  in  the  application  fee  (as  opposed  to  annual 
maintenance fees, which are charged after the SPC is granted).  

In case of PO2 the additional cost would consist of the translation of the examination dossier 
for  the  designated  NPOs.  Consequently,  the  reference  office  could  charge  a  variable 
translation  fee  of  between  EUR  870  (1  Member  State)  and  20  000  (27  Member  States) 
depending on the number of countries/languages chosen328.  

In  case  of  PO3-5  and  PO4+5,  the  application  fee  could  be  composed  of  a  fixed  component 
matching the recurrent cost, depreciation and the fixed translation cost amounting to EUR 19 
500 (PO3), EUR 20 800 (PO4), EUR 28 900 (PO5) and EUR 30 100 (PO4+5). For PO3-4 a 
variable  component  of  between  EUR  870  and  20  000  (27  Member  States)  would  cover  the 
translation  cost  and  depend  on  the  number  of  countries/languages  chosen.  For  PO4+5,  in 

328 This cost might be reduced if NPOs agreed to receive examination dossier in e.g. one working language. 
However this might not always be legally possible, thus for the purpose of this analysis we assume 
translation for each designated NPO. 

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cases where an EU-wide coverage is sought, an additional translation fee could be necessary 
to cover non-UP Member States (currently 10) which would amount to EUR 8 700329.  

Table 59: Minimum SPC application fees to cover authority’s new cost for SPC protection in the whole EU (EUR) 

PO2 
x* 
20 000 
Total  20 000 

Fixed fee 
Variable translation fee (27 MS)** 

PO3 
19 500 
20 000 
39 500 
* No new fee, this would be a fee charged already by the NPO; ** variable dependent on the number of Member States 
designated by the applicant, in case of options where national NPO is granting an SPC. 
Assumptions: Number of SPCs per year: 100, fixed cost depreciated over 10 years. 
Source: In-house analysis based on EUIPO estimates. 

PO4+5 
30 100 
8 700329 
38 800 

PO4 
20 800 
20 000 
40 800 

PO5 
28 900 

28 900 

Maintenance Fee 

While  for  PO3-4  the  central  authority  could  only  charge  an  application  fee,  for  PO5  and 
PO4+5 the costs could be recuperated via both the application and annual maintenance fees. 
This possibility could be used to make the centralised procedure more attractive to applicants, 
as the national application fees are currently lower than those proposed above and for an EU-
wide protection - they amount to around EUR 8 800 (plus EUR 183 000 in maintenance fees 
for a five-year-long SPC protection in the whole EU). There are however, drawbacks of such 
an  approach.  With  an  application  fee  not  covering  all  examination  cost,  there  could  be  an 
incentive for the authority to be more lenient towards granting SPCs, as only for granted SPCs 
the full cost could be recovered. Alternatively, to recover the full cost in case applications are 
rejected (historically around 20% national SPC were rejected), the maintenance fee should be 
higher  as  the  cost  is  spread  over  a  lower  number  of  successful  applicants.  Finally,  with 
maintenance  fees  the  central  authority  can  run  into  deficit  during  the  first  years  of  the  new 
system, as there would not be enough SPCs to collect the fees (see: Table 60 below).330 

Table 60: Base for maintenance fees collection over a decade 

2 

Year 
Applications 
Granted SPC 
No. of SPC for which maintenance fee can be 
collected 
Assumptions: 100 SPC applications per year; 80% grant rate; five year long duration of an SPC.  
Source: In-house analysis. 

4 
100  100  100  100 
80 
320  400  400  400 

1 
100  100 
80 
80 

3 
100 
80 
240 

80 
160 

80 

80 

80 

5 

6 

7 

8 
100 
80 
400 

9 
100 
80 
400 

10 
100 
80 
400 

Table 61 below presents the total minimum maintenance fee for a given application  fee and 
SPC duration to  cover authority’s  cost  during ten  years’ time in  case of  the combination of 
PO4 and PO5. 

Table 61: Minimum maintenance fee by the level of application fee and SPC duration allowing the authority to break even 
during a ten-year-long period 

Application fee:  0 
u
P C
1 
d
S

n
48 600 
o

a
r

i
t

5 000 
42 300 

10 000 
36 100 

15 000 
29 800 

20 000 
23 600 

25 000 
17 300 

30 000 
11 100 

35 000 
4 800 

38 800 
 0 

329 However for those applicants that do not wish or cannot obtain a unitary SPC but seek a central 
examination resulting in a bundle of national SPC, the translation fee for EU wide protection would amount 
to EUR 20 000. 
330 This only applies if fees are set to break even. In case of higher fees the authority may cover all cost 
from year one, and produce significant surpluses over longer run 

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2 

3 

3.5 

4 

5 

51 100 

54 000 

55 700 

57 100 

60 700 

44 500 

47 000 

48 600 

49 800 

52 900 

38 000 

40 100 

41 400 

42 400 

45 100 

31 400 

33 100 

34 200 

35 100 

37 300 

24 800 

26 200 

27 000 

27 700 

29 500 

18 200 

19 200 

19 900 

20 400 

21 600 

11 600 

12 300 

12 700 

13 000 

13 800 

5 100 

5 300 

5 500 

5 700 

6 000 

 0 

 0 

 0 

 0 

 0 

Note: Total maintenance fee due for the SPC duration; numbers rounded to 100s  
Assumptions: 100 SPC applications per year; 80% grant rate;  
Source: In-house analysis. 

As shown above, a split into an application and maintenance fee increases the total fee level to 
cover  the  authority  costs.  From  the  perspective  of  successful  applicant  it  would  be  more 
advantageous if there was no maintenance fee but just an application fee. 

Number of applications impact on costs and fees 

The  number  of  SPC  applications  submitted  under  the  centralised  procedure  would  most 
probably not immediately reach 100 (i.e. the assumed number of applications per year used as 
a reference throughout this impact assessment). Firstly, stakeholders need to become familiar 
with the new system and start using it. Secondly, it would also take some time before the first 
SPC under the newly proposed procedures is granted, due to the time necessary to complete 
the  entire  process  (e.g.  the  examination  via  a  group  of  experts,  third  party  observations, 
efficiency  of  instruments  and  institutions  involved  in  the  process  e.g.  issuing  of  European 
patents with unitary effect).  

The table below estimates the minimum level of application fee (assuming this is the only fee 
collected) to cover the central authority costs, depending on the number of years before the annual 
number of applications received reaches 100. 

Table 62:  Minimum  level  of SPC  application fees  to  cover  authority’s  cost,  depending on the  length  of period  before  100 
applications per year is reached (EUR). 

Run-up period length 

10 years 
5 years 
2 years 
1 year 
Assumptions: fixed cost depreciated over 10 year,.20% refusal rate 
Source: In-house analysis based on EUIPO estimates. 

Number 
of 
applicatio
ns during 
10 years 
550 
800 
950 
1 000 

Applicati
on fee 
(EUR) 

40 000 
39 200 
38 900 
38 800 

(1st year 10, 2nd 20, 3rd 30 … 10th 100 applications) 
(1st year 20, 2nd 40, 3rd 60… 5th and following 100 applications) 
(1st year 50, 2nd and following 100 applications) 
(1st year and following 100 applications) 

The  longer  it  takes  to  reach  100  applications  annually,  the  lower  the  overall  number  of 
applications  during  the  10  year  period,  and  consequently  the  higher  share  of  fixed  costs 
(depreciation  of  one-off  expenses)  per  application.  As  a  result,  longer  run-up  period  (or  the 
less  applications  received)  would  increase  the  minimum  application  fee  necessary  to  cover 
authority’s costs. 

Maximum fee level 

The above discussion aimed at identifying the minimum fee level to cover  new costs of the 
central authority (notwithstanding the fact that an agreement can be reached at a later stage to 
fix the actual fee at a higher level). 

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The  SPC  fee  could  be  modelled  on  the  approach  used  for  the  European  patent  (EPC/UPC) 
where  the  EPO  fees  reflect  fees  charged  by  the  four  largest  Member  States  in  terms  of  the 
number of patent applications. For instance,  among UP  Member States,  the highest  average 
number of applications for period 2014-2021 was recorded in DE, IT, FR and NL. The sum of 
application fees of these four amounts to around EUR 1 770 and the sum of maintenance fees 
for  a  five-year  long  protection  amounts  to  EUR  36 460.  The  sum  of  these  two  components 
would  result  in  a  total  fee  of  EUR  38 230.  This  fee  is  very  similar  to  the  minimum  fee 
calculated for PO4+5, much above the fee proposed for PO5 and slightly below PO3 and PO4 
minimum fees. 

In  case  we  took  all  Member  States  into  account,  the  top  four  countries  in  terms  of  SPC 
applications  would  be:  DE,  ES,  IT  and  FR.  The  level  of  fees  due  in  those  four  countries 
altogether  is  around  EU  42 250  (i.e.  EUR  1 750  for  application  and  EUR  40 500  for 
maintenance).  This  fee  is  slightly  above  the  minimum  fees  calculated  for  PO3,  PO4  and 
PO4+5, and much higher than the fee estimated for PO5.  

Maximum fee: the next section “Cost analysis for the SPC applicant” calculates the total cost 
for  an  applicant  (including  besides  the  central  authority  fees,  also  fees  collected  by  NPOs, 
attorney remuneration or own translation  costs).  It  could  be argued that the maximum  fee a 
central authority could charge to remain an attractive option for applicants should not make 
the  total  application  cost  higher  than  in  the  baseline.  The  table  below  calculates  such 
maximum central authority fee for all options for two combinations in the number of Member 
States  and  SPC  duration:  i)  27  Member  States  and  an  SPC  lasting  five  years  and  ii)  20 
Member States and the current average duration of an SPC of 3.5 years. 

Table  63:  Maximum  total  fee  of  PO3  to  PO5  and  PO4+5  in  respect  of  selected  combinations  of  SPC  duration  and  MS 
covered (EUR) 

PO3 
54 000 
39 500 

PO4 
64 800 
47 500 

PO5 
151 300 
114 100 

PO4+5 
175 900 
121 300 

27 MS, five-year-long SPC 
20 MS, 3.5 year-long SPC 
Note: Based on total applicants fee calculation from Annex 5E. Maximum fee calculated as follows: Baseline total cost to 
applicants (of obtaining SPC protection in selected MS and of selected duration) minus fees paid to NPOs (application and 
maintenance), attorney fees and own translation costs. 
Source: In-house analysis using NPO fee data and EUIPO cost estimates. 

As  indicated  above,  a  combination  of  PO4+5  offers  the  greatest  flexibility  in  terms  of  the 
maximum fee setup, while PO3 offers the narrowest price range.  

The table below presents the maximum fee for PO4+5 for all combinations of the number of 
Member  States  covered  and  years  of  SPC  duration.  It  also  marks  in  red  all  combinations 
where the authority’s cost per SPC is higher than the maximum fee and in green where it is 
lower. 

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Table 64: Maximum total fee of PO4+5 in respect of SPC duration and MS covered 

  SPC duration 
Years =>     1 

d
e
r
e
v
o
c

s
e
t
a
t
S
r
e
b
m
e
M

1 

2 

3 

4 

5 

6 

7 

8 

9 

10 

11 

12 

13 

14 

15 

16 

17 

18 

19 

20 

21 

22 

23 

24 

25 

26 

27 

1 400 

4 900 

8 500 

12 100 

15 600 

19 200 

22 700 

26 300 

29 900 

33 400 

36 800 

40 400 

43 900 

47 300 

50 900 

54 400 

58 000 

60 600 

63 100 

65 700 

68 300 

70 800 

73 200 

75 800 

78 400 

80 900 

83 500 

2 
2 600 

7 300 

12 100 

16 900 

21 600 

26 400 

31 200 

35 900 

40 700 

45 400 

50 000 

54 800 

59 500 

64 100 

68 900 

73 600 

78 400 

81 000 

83 500 

86 100 

88 700 

91 200 

93 600 

96 200 

98 800 

101 300 

103 900 

3 
3 900 

10 000 

16 100 

22 300 

28 400 

34 500 

40 600 

46 700 

52 800 

58 900 

64 800 

70 900 

77 100 

83 000 

89 100 

95 200 

101 300 

103 800 

106 300 

108 800 

111 300 

113 700 

116 100 

118 500 

121 000 

123 500 

126 000 

3.5 
4 700 

11 500 

18 400 

25 300 

32 100 

39 000 

45 800 

52 700 

59 600 

66 400 

73 100 

80 000 

86 800 

93 500 

100 400 

107 200 

114 100 

116 500 

118 900 

121 300 

123 700 

126 100 

128 400 

130 800 

133 200 

135 600 

138 000 

4 
5 400 

13 000 

20 700 

28 300 

35 900 

43 500 

51 100 

58 700 

66 300 

73 900 

81 400 

89 000 

96 600 

104 000 

111 600 

119 200 

126 800 

129 200 

131 500 

133 800 

136 200 

138 500 

140 700 

143 000 

145 300 

147 700 

150 000 

5 
7 100 

16 400 

25 700 

34 900 

44 200 

53 500 

62 800 

72 000 

81 300 

90 600 

99 700 

109 000 

118 200 

127 300 

136 600 

145 900 

155 200 

157 300 

159 300 

161 400 

163 500 

165 600 

167 500 

169 600 

171 700 

173 800 

175 900 

Note: Based on total applicants fee calculation from Annex 5E. Maximum fee calculated as follows: Baseline total cost to 
applicants minus fees paid to NPOs (application and maintenance), attorney fees and own translation costs. The most 
common combination of Member States coverage and SPC duration is marked with a red box. Red background denotes 
combinations where the maximum fee does not cover all cost of the authority. 
Assumptions: For PO5 and PO4+5  from 1 to 17 Member States covered are assumed to be UP Member States and above 
non-UP Member States.  
Source: In-house analysis using NPO fee data and EUIPO cost estimates. 

E.  Cost  analysis  supporting  section  6  (impacts)  –  the  SPC  applicant’s 

perspective 

Full cost of obtaining EU-wide SPC protection for five years 

The  overall  costs  of  application  are  of  primary  importance  for  the  applicants.  Besides  fees 
paid to NPOs, these also include other costs such as: IP attorney fees, translation costs, time 
and internal firm’s resources spent on dealing with different procedural requirements of each 
NPO. 

The  table  below  summarises  the  total  cost  for  obtaining  SPC  protection  covering  all  27 
Member States for a period of five years that would be borne by applicants across all options. 
EN 

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The  overview  is  based  on  minimum  fees  that  cover  additional  costs  for  authorities  in  each 
option (as presented in Annex 5D). 

Table 65: Total cost for an applicant of obtaining a five-year-long SPC protection in the whole EU (EUR) 

NPO application fee 
NPO translation fee 
EA application fee  
EA translation fee 

Total application fee 
NPO maintenance fees 
EA maintenance fees  

Total maintenance fee 
for 5 years 
Application+ 5 years 
maintenance fee 

PO0 

PO1 

PO2 

PO3 

PO4 

PO5 

PO4+5 

8 800 
 0 
 0 
 0 
8 800 
183 000 
 0 
183 000 

8 800 
 0 
 0 
 0 
8 800 
183 000 
 0 
183 000 

 400 
20 000 
 0 
 0 
20 400 
183 000 
 0 
183 000 

 0 
 0 
19 500 
20 000 
39 500 
183 000 
 0 
183 000 

 0 
 0 
20 800 
20 000 
40 800 
183 000 
 0 
183 000 

3 000 
 0 
28 900 
 0 
31 900 
71 900 
 0 
71 900 

 0 
 0 
30 100 
8 700 
38 800 
71 900 
 0 
71 900 

191 800 

191 800 

203 400 

222 500 

223 800 

103 800 

110 700 

Translation costs 
Agent/attorneys’ fees 

4 000 
54 000 
249 800 
Total 
100% 
% baseline 
EA – examination/central authority 
Note: fees as calculated in Annex 5D; numbers rounded to nearest 100s. 5 years maintenance fee not discounted. 
Source: In-house analysis using NPO fee data and EUIPO cost estimates. 

 0 
2 000 
225 800 
90% 

 200 
2 000 
205 600 
82% 

 0 
12 800 
235 300 
94% 

4 000 
54 000 
249 800 
100% 

1 600 
22 000 
127 400 
51% 

 0 
2 000 
112 700 
45% 

In the baseline (PO0), applicants need to translate SPC application documents into an official 
language of each NPO, file them with the 27 NPOs following national forms and rules (most 
likely  with  the  help  of  a  local  attorney),  pay  27  application  fees  and,  when  the  SPCs  are 
granted, also pay 27 annual national maintenance fees over several years. PO1 is identical in 
terms of costs and procedures when compared with the baseline.  

In  case  of  PO2,  applicants  would  need  to  deal  with  just  one  reference  office  and  pay  one 
application fee. Although the application and maintenance fees are higher than in the baseline 
by  6%  (due  to  an  estimated  additional  translation  fee  charged  by  the  reference  office),  the 
applicant would need to pay the attorney fees just once, instead of 27 and could save on own 
translation  costs  (i.e.  translation  of  the  application  to  just  one  reference  office/language 
instead of 23 languages that are used by 27 NPOs). The maintenance fees would be collected 
by each NPO and stay the same as in the baseline. Overall savings of PO2 would amount to 
around  18%  in  comparison  with  the  baseline.  As  discussed  in  section  6,  if  all/some  NPOs 
refrained  from  requesting  translations  of  the  examination  dossier  the  savings  could  be  even 
higher  (respectively  25%  if  all  NPOs  accepted  dossier  without  translations  and  22%  if  half 
would do so – data not presented in the table). 

In  PO3,  applicants  would  address  just  one  central  authority  that  collects  application  fees. 
Nevertheless that fee would be around 4.5 times higher than the application fees collected by 
27 NPOs in the baseline. Altogether, the application fees and maintenance fees (collected as 
currently by the NPOs) would be 16% higher than in the baseline. However, applicants would 
be  saving on attorney’s and own translation fees. The attorney fees are estimated at EUR 12 
800 to take account of a potential need for national representations in case an applicant would 
like to challenge the negative opinion (it can only do so at national level in this option). The 
latter is based on an assumption of 20% negative opinions. Taking all the above elements into 
account, PO3 produces 6% savings on all costs in comparison with the baseline. 

EN 

135 

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In  case  of  PO4,  the  application  fee  is  slightly  higher  than  in  PO3,  however  applicants  can 
benefit from the central review system thus can save on national attorney fees, as well as on 
own  translations  since  the  application  could  be  submitted  in  all  EU  languages).  Overall 
savings of PO4 amount to 10% of the baseline. 

The centralised procedure envisaged under PO5 would cover only 17 UP-Member States thus 
to obtain an EU-wide protection, applicants would need to file additional SPC applications in 
ten non-UP Member States to complement the one filed with the central authority. This entails 
own  translations  and  attorney  representation  before  11  authorities.  In  line  with  the  earlier 
assumptions, all cost of the central authority are covered by the application fee, therefore the 
only maintenance fees that a successful applicant would need to pay are the national fees to 
each of the ten non-UP NPOs. The above combination produces a very significant saving of 
around 50% in comparison to the baseline. In the future, with more Member States joining the 
UPCA, the savings of this option would be even higher, reaching up to 88% of the baseline in 
case of all EU countries joining (estimation not presented in the table above).  

In  case  of  combination  of  PO4+5,  applicants  would  be  in  contact  only  with  the  central 
authority to  obtain one unitary SPC for 17 UP  Member States and ten national SPC for the 
remaining  countries.  The  application  fee  would  be  higher  than  in  PO5  mainly  due  to 
translation cost needed when the examination dossier is transmitted to the ten non-UP NPOs. 
As  only  one  attorney  might  be  required  and  there  would  be  no  own  translation  fees,  this 
option  produces  the  largest  savings  of  up  to  55%  when  compared  to  the  baseline  costs.  If 
however, an applicant is not able to apply for a unitary SPC (e.g. because it does not have an 
European patent with unitary effect), this option would be similar to PO4, albeit with higher 
fees  (needed  to  cover  for  additional  infrastructure  of  PO5,  such  as  a  fully-fledged  Board  of 
Appeals), thus producing savings of just 6% in comparison to the baseline (data not shown). 
Therefore the ultimate savings of this option would depend on the take-up of the unitary SPC 
versus  just  the  central  procedure  leading  to  national  SPC.  It  is  expected  that  at  least  in  the 
initial year(s) the balance would be toward the latter, but with the rollout of unitary patents, 
the former (unitary SPC applications) should be more prominent. Consequently the savings of 
this options would be in the range of 6 to 55% of the baseline. 

Option producing the most savings – sensitivity analysis 

From the analysis above we can conclude that the option with the highest saving potential for 
obtaining SPC protection covering the whole EU, lasting for the maximum term of five years 
is PO4+5. 

The table below looks at the most cost efficient option (taking into account all applicant costs 
for the whole duration of an SPC), in case less than 27 Member States are designated and/or 
when SPC protection is shorter than five years331. 

331 Under the assumption that in case of PO5 and PO4+5 from 1 to 17 Member States covered are UP 
Member States and above non-UP Member States. 

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Table  66:  The  most  cost  efficient  option  depending  on  the  number  of  Member  States  covered  and  SPC  duration  
(% of baseline cost in brackets). 

  SPC duration 
Years =>     1 

2 

3 

1  PO0 (100%) 

PO0 (100%) 

PO0 (100%) 

3.5 
PO0 (100%) 

4 

5 

PO0 (100%) 

PO0 (100%) 

2  PO2 (92%) 

3  PO2 (79%) 

4  PO2 (73%) 

5  PO2 (69%) 

6  PO2 (67%) 

7  PO2 (65%) 

8  PO2 (63%) 

9  PO2 (62%) 

10  PO2 (62%) 

11  PO2 (59%) 

12  PO2 (59%) 

13  PO2 (58%) 

14  PO2 (56%) 

15  PO2 (56%) 

16  PO5 (55%) 

17  PO5 (52%) 

d
e
r
e
v
o
c

s
e
t
a
t
S
r
e
b
m
e
M

PO2 (94%) 

PO2 (85%) 

PO2 (80%) 

PO2 (77%) 

PO2 (75%) 

PO2 (74%) 

PO2 (73%) 

PO2 (72%) 

PO5 (65%) 

PO5 (59%) 

PO5 (54%) 

PO5 (50%) 

PO5 (47%) 

PO5 (44%) 

PO5 (41%) 

PO5 (38%) 

PO2 (95%) 

PO2 (88%) 

PO2 (84%) 

PO2 (82%) 

PO2 (81%) 

PO5 (73%) 

PO5 (63%) 

PO5 (56%) 

PO5 (51%) 

PO5 (46%) 

PO5 (42%) 

PO5 (39%) 

PO5 (36%) 

PO5 (34%) 

PO5 (32%) 

PO5 (30%) 

PO2 (96%) 

PO2 (89%) 

PO2 (86%) 

PO2 (84%) 

PO5 (75%) 

PO5 (65%) 

PO5 (56%) 

PO5 (50%) 

PO5 (45%) 

PO5 (41%) 

PO5 (38%) 

PO5 (35%) 

PO5 (32%) 

PO5 (30%) 

PO5 (28%) 

PO5 (27%) 

PO2 (96%) 

PO2 (90%) 

PO2 (87%) 

PO5 (82%) 

PO5 (68%) 

PO5 (58%) 

PO5 (51%) 

PO5 (45%) 

PO5 (41%) 

PO5 (37%) 

PO5 (34%) 

PO5 (31%) 

PO5 (29%) 

PO5 (27%) 

PO5 (25%) 

PO5 (24%) 

PO2 (97%) 

PO2 (92%) 

PO5 (84%) 

PO5 (67%) 

PO5 (56%) 

PO5 (48%) 

PO5 (42%) 

PO5 (37%) 

PO5 (33%) 

PO5 (30%) 

PO5 (28%) 

PO5 (26%) 

PO5 (24%) 

PO5 (22%) 

PO5 (21%) 

PO5 (20%) 

18  PO4+5 (53%) 

PO4+5 (41%) 

PO4+5 (33%) 

PO4+5 (30%) 

PO4+5 (28%) 

PO4+5 (24%) 

19  PO4+5 (53%) 

PO4+5 (43%) 

PO4+5 (36%) 

PO4+5 (33%) 

PO4+5 (31%) 

PO4+5 (27%) 

20  PO4+5 (53%) 

PO4+5 (44%) 

PO4+5 (37%) 

PO4+5 (35%) 

PO4+5 (33%) 

PO4+5 (30%) 

21  PO4+5 (53%) 

PO4+5 (45%) 

PO4+5 (39%) 

PO4+5 (37%) 

PO4+5 (36%) 

PO4+5 (33%) 

22  PO4+5 (53%) 

PO4+5 (46%) 

PO4+5 (41%) 

PO4+5 (39%) 

PO4+5 (38%) 

PO4+5 (36%) 

23  PO4+5 (53%) 

PO4+5 (46%) 

PO4+5 (42%) 

PO4+5 (41%) 

PO4+5 (40%) 

PO4+5 (38%) 

24  PO4+5 (53%) 

PO4+5 (47%) 

PO4+5 (44%) 

PO4+5 (42%) 

PO4+5 (41%) 

PO4+5 (40%) 

25  PO4+5 (53%) 

PO4+5 (48%) 

PO4+5 (45%) 

PO4+5 (44%) 

PO4+5 (43%) 

PO4+5 (42%) 

26  PO4+5 (53%) 

PO4+5 (49%) 

PO4+5 (46%) 

PO4+5 (45%) 

PO4+5 (44%) 

PO4+5 (44%) 

27  PO4+5 (53%) 

PO4+5 (49%) 

PO4+5 (47%) 

PO4+5 (46%) 

PO4+5 (46%) 

PO4+5 (45%) 

Note: Based on fees as calculated in Annex 5D. The most common combination of Member States coverage and SPC 
duration is marked with a red box 
Assumptions: For PO5 and PO4+5 from 1 to 17 Member States covered are assumed to be UP Member States and above 
non-UP Member States.  
Source: In-house analysis using NPO fee data and EUIPO cost estimates. 

Based on the duration/coverage combinations and assuming that each combination is equally 
likely, the baseline (PO0) is the least expensive option in 4% of cases – when SPC is sought 
in just one Member State, irrespective of SPC duration. PO2 is the least expensive choice in 
22% of duration/coverage combinations (producing in those cases an average saving of 22% 
in comparison to baseline). PO2 is especially beneficial when the SPC duration is shorter (e.g. 
for  1  year-long  SPCs,  PO2  is  the  best  choice  for  up  to  15  Member  States  covered).  PO5 
(understood as unitary SPC in 17 UP Member States and national SPC via the national route 
in  the remaining ones) is the least  costly choice  in  37% of cases (average savings of  56%), 
when only UP countries are covered. The combination of PO4+5 is the least expensive option 
as  well  in  37%  of  cases  (average  savings  of  58%),  when  on  top  of  unitary  SPC  for  17  UP 
countries, a central procedure is used to obtain national SPCs in the remaining ones.  

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From earlier research we know, however, that currently SPC protection is sought most often 
in 20 Member States and lasts for 3.5 years. In this case the combination PO 4+5 is the least 
expensive one, reducing cost of the baseline by 65%. 

Savings of the preferred option– sensitivity analysis 

The  table  below  presents  total  costs  for  applicants  of  applying  and  maintaining  SPC  of 
different duration and Member States coverage as percentage of cost of the baseline, in case 
the combination of PO4+5 is selected. 

Table 67: PO4+5 costs for applicant as percentage of baseline cost depending on the number of Member States covered and 
SPC duration. 

  SPC duration 
Years =>     1 

d
e
r
e
v
o
c

s
e
t
a
t
S
r
e
b
m
e
M

1 

2 

3 

4 

5 

6 

7 

8 

9 

10 

11 

12 

13 

14 

15 

16 

17 

18 

19 

20 

21 

22 

23 

24 

25 

26 

27 

948% 

462% 

306% 

228% 

182% 

152% 

130% 

113% 

101% 

91% 

83% 

76% 

70% 

65% 

61% 

57% 

54% 

53% 

53% 

53% 

53% 

53% 

53% 

53% 

53% 

53% 

53% 

2 
700% 

343% 

228% 

170% 

136% 

113% 

97% 

85% 

75% 

68% 

62% 

57% 

52% 

49% 

45% 

42% 

40% 

41% 

43% 

44% 

45% 

46% 

46% 

47% 

48% 

49% 

49% 

3 
541% 

267% 

177% 

132% 

106% 

88% 

75% 

66% 

59% 

53% 

48% 

44% 

41% 

38% 

35% 

33% 

31% 

33% 

36% 

37% 

39% 

41% 

42% 

44% 

45% 

46% 

47% 

3.5 
480% 

237% 

157% 

118% 

94% 

78% 

67% 

59% 

52% 

47% 

43% 

39% 

36% 

34% 

31% 

29% 

28% 

30% 

33% 

35% 

37% 

39% 

41% 

42% 

44% 

45% 

46% 

4 
432% 

213% 

142% 

106% 

85% 

71% 

60% 

53% 

47% 

42% 

39% 

35% 

33% 

30% 

28% 

26% 

25% 

28% 

31% 

33% 

36% 

38% 

40% 

41% 

43% 

44% 

46% 

5 
353% 

175% 

116% 

87% 

69% 

58% 

50% 

43% 

39% 

35% 

32% 

29% 

27% 

25% 

23% 

22% 

20% 

24% 

27% 

30% 

33% 

36% 

38% 

40% 

42% 

44% 

45% 

Note: Based on fees as calculated in Annex 5D. The most common combination of Member States coverage and SPC 
duration is marked with a red box 
Assumptions: For PO5 and PO4+5 from 1 to 17 Member States covered are assumed to be UP Member States and above 
non-UP Member States.  
Source: In-house analysis using NPO fee data and EUIPO cost estimates. 

The  combination  of  PO4+5  produces  savings  in  comparison  to  the  baseline  in  81%  of 
considered  Member States/SPC duration combinations.  On average the costs are lower than 
the baseline by 53%. The option always produces savings when ten or more Member States 

EN 

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are covered. In case of the most common SPC duration of 3.5 years, the option is beneficial 
for covering five or more Member States. 

In  the  remaining  19%  of  cases,  PO4+5  is  more  expensive  than  the  baseline  by  on  average 
260%. It is always more expensive when up to three Member States are covered by an SPC.  

F.  Evidence supporting section 6 (impacts) – quantification of impacts on NPOs 

As regards one-off costs the NPOs under PO1 and PO2 would need to develop a common SPC 
database. The cost of an EU-wide database is estimated at EUR 0.5 million; if shared equally between 
all NPOs it would amount to around EUR 19 000 per NPO. For the annual cost calculations below we 
will assume that these costs are depreciated over ten years adding EUR 1 900 to the annual cost of 
each NPO. Additionally, the annual database maintenance cost is estimated at EUR 59 000 EU wide, 
or EUR 2 200 per NPO. 

In case of all options but PO1, NPOs could see their annual SPC application fee income reduced as 
such fee would be paid to either the reference office(s) (PO2) or to the newly established central 
authority (PO3 to PO5 and PO4+5). The extent of the income loss would depend on the uptake of the 
centralised procedure. The below figures present the most extreme situation where all 100 SPC 
applications are submitted via the central procedure. Figures are based on the SPC application and 
maintenance cost per Member State concerned presented in Table 69. It is also assumed that SPC 
protection is sought in all EU Member States for the maximum protection period of five years.  

Table 68: SPC fee schedule per NPO in 2022 (EUR). 

SPC application 
363 
200 
256 
100 
195 
300 
403 
105 
250 
528 
500 
520 
398 
657 
95 
404 
115 
20 
120 
116 
544 
120 
430 
500 
986 
420 
166 
 8,811  
 326  

AT* 
BE* 
BG* 
CY 
CZ 
DE* 
DK* 
EE* 
EL 
ES 
FI* 
FR* 
HR 
HU 
IE 
IT* 
LT* 
LU* 
LV* 
MT* 
NL* 
PL 
PT* 
RO 
SE* 
SI* 
SK 
Total 
Average 

EN 

1st renewal 

2nd renewal 

3rd renewal 

4th renewal 

5th renewal 

3 448 
750 
1 534 
780 
1 170 
3 290 
686 
630 
1 400 
2 715 
900 
950 
2 391 
1 147 
468 
1 011 
347 
430 
550 
268 
2 000 
1 314 
861 
1 200 
1 971 
2 504 
1 660 
 36,374  
 1 347  

3 864 
800 
1 790 
820 
1 248 
3 650 
686 
630 
1 500 
3 806 
900 
950 
2 789 
1 310 
468 
1 011 
347 
440 
550 
280 
2 200 
1 314 
915 
1 300 
1 971 
3 004 
1 992 
 40,534  
 1 501  

4 282 
850 
2 045 
860 
1 326 
4 120 
686 
630 
1 800 
5 007 
900 
950 
3 188 
1 473 
468 
1 011 
347 
450 
550 
291 
2 400 
1 314 
969 
1 400 
1 971 
3 404 
2 324 
 45,015  
 1 667  

2 611 
650 
1 023 
700 
1 014 
2 650 
686 
630 
1 200 
820 
900 
950 
1 594 
819 
468 
1 011 
347 
410 
550 
245 
1 600 
1 314 
753 
1 000 
1 971 
1 702 
996 
 28,613  
 1 060  

3 029 
700 
1 278 
740 
1 092 
2 940 
686 
630 
1 300 
1 722 
900 
950 
1 992 
982 
468 
1 011 
347 
420 
550 
256 
1 800 
1 314 
807 
1 100 
1 971 
2 102 
1 328 
 32,416  
 1 201  

139 

EN 

 
 
 
Note: for non-euro countries, amounts converted to EUR using ECB exchange rates of mid 2022; * UP-MS;  
Source: In-house analysis based on NPO websites. 

The maximum application fee revenue loss for PO5 is estimated at EUR 0.58 million EU-wide, or on 
average of EUR 34 100 for the 17 UP-MS NPOs. In case of PO2, applicants will always apply to one 
“reference office” NPO – thus all remaining NPOs would lose on average EUR 32 300 with an EU wide 
loss of EUR 0.84 million. As explained in the option description/analysis the reference office is 
expected to collect an additional translation fee that should cover the translation cost, thus is 
expected to have no impact on the financial position of that office. In case of PO3, PO4 and PO4+5 all 
application income of around EUR 32 600 per NPO is lost amounting to EUR 0.88 million EU wide. 

In case of PO3 to PO5 and PO4+5 the central authority is going to rely on experts from the willing 
NPOs to conduct SPC examinations in exchange for remuneration. These transfers332 from the central 
authority to the participating NPOs are estimated at EUR 0.62 million for PO3, EUR 0.75 million (PO4 
and PO 5) and EUR 0.87 million (PO4+5).  

In case of PO5 and PO4+5 the NPOs in the 17 UP-MS may also lose SPC maintenance fee income. The 
maximum annual loss from the fifth year from activation of the new system333 is estimated at EUR 
0.5 million per NPO, amounting to EUR 8.9 million EU wide. The real maintenance fee loss will be 
determined by the demand for the unitary SPC (which among others will be driven by the demand of 
pharmaceutical and PPP companies for European patents with unitary effect). 

Combining all of the above, NPOs income would be least affected by PO1 (cost of EUR 4 100 per 
annum per NPO and EUR 0.1 million EU-wide). PO3 and PO4 would reduce the NPOs bottom line by 
around EUR 9 500 and EUR 4 900 per NPO respectively (assuming equal transfers from the central 
authority to the NPOs) or EUR 0.26 million and EUR 0.13 million EU-wide respectively. PO2 would 
reduce NPOs revenues by on average EUR 36 400 per NPO and EUR 0.95 million for the whole EU. 
The highest impact of around EUR 0.5 million per NPO or around EUR 8.7 million to 8.9 million EU-
wide could come from PO5 and PO4+5 respectively, mainly driven by the loss of the SPC 
maintenance fee by the 17 UP-MS. Nevertheless, these losses do not seem significant when 
compared to other sources of NPOs revenue. For instance, they account for just 0.02% (PO1 and 
PO4), 0.05% (PO3), 0.2% (PO2) or 1.6% (PO5 and PO4+5) of NPOs income on patent renewal fees. 
The table below provides a summary of all discussed monetary impacts. 

Table 69: Maximum impact on NPOs – income losses and new costs in case of an EU-wide five year long SPC protection 
(EUR). 

PO1 

PO2 

PO3 

PO4 

PO4+5 

PO5 
(only 17 
UP-MS 
affected) 

One off costs 
Database development (all NPOs) 
Database development (per NPO) 

Recurrent (EU wide) costs and fee losses 
application fee loss (annual) 
maintenance fee loss (17 UP-MS only, annual) 

 512 000 
 19 000 

 512 000 
 19 000 

  0 
  0 

  0 
  0 

  0 
  0 

  0 
  0 

  0 
  0 

 840 000 
  0 

 880 000 
  0 

 880 000 
  0 

 580 000 
8 888 000 

 880 000 
8 888 000 

332 For calculations see: Annex 5D above. 
333 As explained earlier (see Table 60) only from the fifth year the full impact of the proposed changes on 
maintenance fees collection could be observed. 

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Database maintenance (annual) 
Database one-off cost depreciation over 10 years 
(annual) 
New translation costs for the PO2 reference 
office(s) only 
Benefits (EU wide)  
Additional Translation fee (PO2 only) 
Examiners remuneration from the central 
authority 

Net result 

Net result as % of PO0 total EU27 SPC 
revenue (100 SPC, 5 years protection) 
Net result as % of NPOs patent annual renewal 
fees collected in 2021 of EUR 536 million 
(PO5: EUR 337 million) 

Recurrent (per NPO) costs and fee losses 
application fee loss (annual) 
maintenance fee loss (17 UP-MS only, annual) 
Database maintenance  
Database depreciation over 10 years (annual) 
New translation costs for the PO2 reference 
office(s) only 
Benefits (per NPO) 
Additional Translation fee (PO2 only) 
Examiners remuneration from the central 
authority (assuming equal distribution among 
NPOs) 

PO1 

PO2 

PO3 

PO4 

PO4+5 

PO5 
(only 17 
UP-MS 
affected) 

 59 000 
 51 200 

 59 000 
 51 200 

2 000 000 

2 000 000 

 623 800 

 748 600 

 748 600 

 873 300 

- 110 200 
0.7% 

- 950 200 
6.1% 

- 256 200 
1.7% 

- 131 400 
0.8% 

-8 719 400 
56.2% 

-8 894 700 
57.3% 

0.02% 

0.18% 

0.05% 

0.02% 

2.6% 

1.66% 

  0 
  0 
 2 200 
 1 900 

 32 300 
  0 
 2 200 
 1 900 
 2 000 000 

2 000 000 

 32 600 
  0 
  0 

 32 600 
  0 
  0 

34 100 
 522 800 
  0 

 32 600 
 522 800 
  0 

 23 100 

 27 700 

 44 000 

 32 300 

Net results 

- 4 100 

- 36 400 

- 9 500 

- 4 900 

- 512 900 

- 523 100 

Note: Table presents maximum potential impacts; maintenance fee loss from fifth year of new system operation; numbers 
rounded. Assumptions: 100 SPC applications per year, 80 SPC granted and maintained for five years. 
Source: In-house analysis using NPO fee data and EUIPO cost estimates. Renewal fees for granted patents from “EPO 
Financial Statements 2021”, p. 61. 

G.  Evidence supporting section 6 (impacts) – the EU-wide costs and savings per 

stakeholder 

The tables below summarise the quantifiable impacts of the considered policy options on different 
stakeholders. The effects are calculated under the assumption of a five-year-long SPC duration and 
EU-wide coverage. Costs include both additional expenditures and loss of income. Savings include 
both cost savings and additional income.  

It should be noted that not all impacts are quantifiable. Quantification was possible for objective 3 
“Reduce cost of applying and maintaining SPC protection” – and concerns originators, patent offices 
and IP agents. The quantification of objective 2 “Facilitate SPC monitoring” concerning follow-on 
(generic/biosimilar) manufacturers and healthcare sector to the extent possible is presented below. 
The quantification of objective 1 “Increase predictability and legal certainty of SPC protection in the 
EU” concerning originators, follow-on manufacturers and health sector was not possible. To 
understand the full impact of options on objectives 1 and 2, please refer to the qualitative 
description provided throughout chapter 6 and the comparison of options against all criteria 
presented in chapter 7 of the main text of this impact assessment. 

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Table 70: EU-wide quantifiable annual additional cost (including additional expenditures and loss of income) and additional 
benefits (including cost savings and additional income) in comparison to the baseline by policy option in case of an EU wide, 
five year long SPC protection from the fifth year of the new system (EUR). 

Originators/ 
SPC applicants 

Follow-on 
(generic/ 
biosimilar) 
manufacturers 

Healthcare 
sector, patients 
and users of 
PPPs 

Patent offices 
(NPOs)  

IP agents/ 
attorneys 

Total 

5 200 000 

0 
0 
  0 

0 
0 
  0 

-5 200 000 

1 080 000 
1 080 000 

12 000 000 
12 000 000 

 110 200 
0 
- 110 200 

  0 
1 080 000 
1 080 000 

3 070 000 
4 520 000 
1 450 000 

2 950 200 
2 000 000 
- 950 200 

  0 
1 080 000 
1 080 000 

1 160 000 
5 580 000 
4 420 000 

  0 
12 000 000 
12 000 000 

9 310 200 
20 660 000 
11 349 800 

  0 
12 000 000 
12 000 000 

 110 200 
13 080 000 
12 969 800 

PO1 
∆ costs 
∆ benefits 
net 
PO2 
∆ costs 
∆ benefits 
net 
PO3 
∆ costs 
∆ benefits 
net 
PO4 
∆ costs 
∆ benefits 
net 
PO5 
∆ costs 
∆ benefits 
net 
PO4+5 
∆ costs 
∆ benefits 
net 
Note: Table presents maximum potential impacts. Based on minimum fees as calculated in Annex 5D; NPO costs from Annex 
5F (NPO fee data and EUIPO cost estimates) and healthcare impacts from section 6.6.2; numbers rounded. 
Assumptions: 100 SPC applications per year, 80 SPC granted; EUR 40 000 – cost of accessing private SPC database; EUR 
2 000 - SPC attorney fee.  
Source: In-house analysis. 

2 310 000 
12 328 000 
10 018 000 

3 000 000 
14 488 000 
11 488 000 

37 000 000 
37 680 000 
 680 000 

37 000 000 
38 080 000 
1 080 000 

  0 
12 000 000 
12 000 000 

9 280 000 
19 428 600 
10 148 600 

  0 
12 000 000 
12 000 000 

51 978 000 
58 312 600 
6 334 600 

54 968 000 
65 441 300 
10 473 300 

8 070 000 
18 223 800 
10 153 800 

9 468 000 
 748 600 
-8 719 400 

9 768 000 
 873 300 
-8 894 700 

3 200 000 
5 600 000 
2 400 000 

  0 
1 080 000 
1 080 000 

  0 
7 556 000 
7 556 000 

 880 000 
 748 600 
- 131 400 

 880 000 
 623 800 
- 256 200 

-5 200 000 

-4 120 000 

-5 200 000 

-3 200 000 

5 200 000 

4 120 000 

5 200 000 

3 200 000 

Table  71:  Individual  quantifiable  annual  additional  cost  (including  additional  expenditures  and  loss  of  income)  and 
additional benefits (including cost savings and additional income) per entity affected in comparison to the baseline by policy 
option in case of an EU wide, five year long SPC protection (EUR). 

Originators/SPC 
applicants 

Number of 
affected 

Application: 100 firms 
Maintenance: 400 firms 

Follow-on 
(generic/ 
biosimilar) 
manufacturers 
300 firms 

Healthcare 
sector, patients 
and users of PPPs 

Patent offices (NPOs)  

At least 27 (one 
healthcare 
authority per MS) 

Up to 27 NPOs  
(except PO5 – 17 UP-MS 
NPOs) 

IP agents/ 
attorneys 

Up to 2 600 
cases (except 
PO3: 2 060; 
PO5: 1 600) 

0 

0 

 2 000 

Database 27 NPOs: 4 100 

27 NPOs: - 4 100 

Application fee loss 26 NPOs: 
32 300  
database cost 27 NPOs: 4 100 
Reduced SPC workload 

 - 36 400 

- 2 000 

Application fee loss 27 NPOs: 
32 600 
Examiners remuneration: 

 2 000 

PO1 
∆ costs 
∆ benefits 

net 
PO2 
∆ costs 

∆ benefits 

net 

PO3 
∆ costs 

0 
0 

0 

  0 
Monitoring:  
40 000 
 40 000 

  0 
Monitoring:  
40 000 
 40 000 

11 600 

  0 

  0 

Application: 55 800 
Maintenance: 0 
Application: 44 200 
Maintenance: 0 

Monitoring:  
40 000 
 40 000 

Monitoring:  
40 000 
 40 000 

30 700 

  0 

  0 

∆ benefits 

Application: 45 200 

Monitoring:  

Monitoring:  

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Originators/SPC 
applicants 

Maintenance: 0 
Application: 14 500 
Maintenance: 0 

Follow-on 
(generic/ 
biosimilar) 
manufacturers 
40 000 
 40 000 

Healthcare 
sector, patients 
and users of PPPs 

Patent offices (NPOs)  

IP agents/ 
attorneys 

40 000 
 40 000 

23 100 
27 NPOs: - 9 500 

net 

PO4 
∆ costs 

∆ benefits 

net 

PO5 
∆ costs 

32 000 

  0 

  0 

Application: 56 000 
Maintenance: 0 
Application: 24 000 
Maintenance: 0 

Monitoring:  
40 000 
 40 000 

Monitoring:  
40 000 
 40 000 

23 100 

  0 

- 2 000 

 2 000 

- 2 000 

 2 000 

Application fee loss 27 NPOs: 
32 600 
Examiners remuneration: 
27 700 
- 4 900 

Application fee loss 17 NPOs: 
34 100 
Maintenance fee loss 17 NPOs: 
522 800 
Examiners remuneration 17 
NPOs: 44 000 

- 512 900 

- 2 000 

 2 000 

Application fee loss 27 NPOs: 
32 600 
Maintenance fee loss 17 NPOs: 
522 800 
Examiners remuneration: 
32 300 

- 523 100 

- 2 000 

Higher medicines 
cost 17 UP-MS: 
 2 176 500  

Monitoring:  
25 200 
More innovative 
medicines:  
2 176 500 
25 200 

Higher medicines 
cost 17 UP-MS: 
 2 176 500 

Monitoring:  
40 000 
More innovative 
medicines:  
2 176 500 
40 000 

∆ benefits 

Application: 34 400 
Maintenance: 22 200 

Monitoring:  
 25 200 

net 

PO4+5 
∆ costs 

Application: 11 300 
Maintenance: 22 200 

25 200 

30 000 

  0 

∆ benefits 

Application: 56 000 
Maintenance: 22 200 

Monitoring:  
40 000 

net 

Application: 26 000 
Maintenance: 22 200 

 40 000 

Note: Table presents maximum potential impacts. Based on minimum fees as calculated in Annex 5D; NPO costs from Annex 
5F (NPO fee data and EUIPO cost estimates) and healthcare impacts from section 6.6.2; numbers rounded. 
Assumptions: 100 SPC applications per year, 80 SPC granted; EUR 40 000 – cost of accessing private SPC database; EUR 
2 000 - SPC attorney fee.  
Source: In-house analysis. 

The impact on SPC applicants was described in Annex 5E. It would concern around 100 new 
applicants annually and up to 400 SPC holders paying maintenance fees. PO5 and PO4+5 provide the 
highest benefits to the originators amounting to EUR 10 million and EUR 11.5 million respectively EU-
wide. This includes savings on both application cost (EUR 11 300 and EUR 26 000 per application 
respectively) and maintenance fees (EUR 22 200 per SPC holder annually for five years). Global 
benefits of PO2 are the third-highest and amount to EUR 4.4 million. They come from a reduction of 
application cost of EUR 44 200 per applicant. Benefits of PO3 and PO4 amount to EUR 1.5 million and 
EUR 2.4 million respectively and are explained by lower per-company application cost of EUR 14 500 
and EUR 24 000 respectively. Cost savings of PO1 are not expected, the benefits of that option are 
not quantifiable. It is important to note that the full benefits presented in the table would only 
materialise from the fifth year after the new system becomes operational.   

As regards the follow-on manufacturers, around 300334 would benefit annually from savings on the 
access to SPC data, estimated at around EUR 25 000 (PO5) to EUR 40 000 (PO2-4 and PO4+5) per 

334 „Within three years following the LoE [loss of exclusivity] the ratio of generic companies to originators 
is about 6:1” (source: Pharmaceutical sector Inquiry (2009), p. 74). With up to 50 molecules where 
competition emerges the estimated number of follow-on producers affected is 300. 

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firm335. The same savings are expected for the health sector where it is assumed that at least 27 
central purchasing bodies could benefit from the new system (a conservative estimate of one user 
per Member State, whereas the real number may be higher). Additionally, as discussed in 6.6.2, the 
healthcare systems in 17 UP-MS may bear higher cost of pharmaceutical purchases of up to EUR 37 
million per year EU-wide. As this can translate into additional R&D on medicines by innovators, the 
benefits on the health sector (due to more innovative medicines) are expected to increase by the 
corresponding amount.  

The NPOs cost was analysed in detail in section 5F. It would include the development and 
maintenance of a common database (PO1, PO2). Based on EUIPO experience, the cost of an EU wide 
database development is estimated at EUR 0.5 million, with EUR 59 000 of annual maintenance 
costs. If shared equally by each NPO it would amount to an annual expense of around EUR 4 100 per 
country (depreciation of database setup costs over 10 years and annual maintenance cost). NPOs 
could also experience various degree of loss of revenue due to a lower number of national SPC 
application fees collected (except for PO1), amounting to up to around EUR 32 300 (PO2 concerning 
all NPOs but the reference office(s)), EUR 32 600 (PO3-4 and PO4+5 concerning all NPOs) and EUR 34 
100 (PO5 and concerning only 17 UP-MS). Additionally, in case of PO5 and PO4+5 the 17 UP-MS may 
lose their maintenance fee income to the amount of EUR 0.5 million annually from the fifth year of 
the new system operation. NPOs contributing to the pool of experts conducting SPC examinations for 
the central authority will receive additional income (EU wide figures due to uncertainty which NPOs 
will participate) of EUR 0.6 million (PO3), EUR 0.75 million (PO4 and 5) and EUR 0.87 million (PO4+5). 

IP attorneys are expected to lose clients due to the introduction of some form of central procedure in 
PO2 to PO4+5 which reduces the need for national representation before each NPO. An average IP 
attorney fee was estimated at EUR 2 000336 per Member State per SPC application. In case of 
applicants seeking SPC protection in the whole EU for PO2, 4 and 4+5 the need for legal advice 
should diminish from 27 to 1 (with demand for legal assistance eliminated for up to 2 600 cases337), 
hence around EUR 5.2 million EU-wide loss in revenue in comparison to the baseline. In case of PO3, 
where there is no possibility to centrally appeal the evaluation outcome, it is assumed that legal 
representation for national appeals would be necessary in 20% of cases on average, hence it would 
trigger a lower loss of revenue of around EUR 4.1 million EU-wide (up to 2 060 cases affected338). In 
case of PO5, where applicants would need to apply for national SPCs in 10 non-UP Member States, 
the loss would be even lower and estimated at EUR 3.2 million EU-wide (need for IP assistance 
eliminated for around 1 600 cases339). 

335 Approximate cost of a yearly subscription to commercial database with SPC information (own market 
research). 
336 The estimated attorney fees take into account feedback received from the industry representatives and 
fall within the costs range reported by Fédération Internationale des Conseils en Propriété Intellectuelle 
FICPI (https://ficpi.org/system/files/FICPI_The_IP_Practitioner.pdf), taking into account the lower 
complexity of an SPC dossier, when compared with a patent file. 
337 No need for legal assistance in 26 countries time 100 applications per year 
338 Legal assistance potentially needed for applications to the central authority (100 cases) and for potential 
appeals in 20 cases in up to 27 Member states (up to 540 cases). Compared to the baseline (legal assistance 
needed for 100 applications in each of 27 NPO = 2 700 cases) the reduction in demand by up to 2 060 cases. 
339 Legal assistance needed for SPC applications to the central authority (100 cases) and to ten non-UP-MS 
(10 x 100 = 1 000 cases). Reduction of demand in comparison to baseline by 1 600 cases. 

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In case of PO1, the cost/benefits effects are uncertain and depend on the implementation of the 
voluntary guidelines by NPOs. For the remaining options the presented numbers depict the 
maximum effects under assumption that all 100 SPC applications annually will go through the new 
system and SPC protection will cover the whole EU for a duration of five years. The real impacts, 
however, would depend on the extent of use of the central procedure, the number of Member 
States covered by an SPC and its duration, and in case of PO5 and PO4+5 the demand for a unitary 
SPC. 

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ANNEX 6: SME TEST 

Small and medium-sized enterprises (SMEs)340 are often referred to as the backbone of the European 
economy, providing a potential source for jobs and economic growth. Also in the pharmaceutical 
sector, SMEs play a key role. They are the motor of innovation and play a major role in the 
development of new medicines for patients. Around 27% of new EMA-authorised medicines in the 
above period originated from SME341. Small and medium enterprises were responsible for 81% of the 
preclinical projects in the antibacterial pipeline.342 According to EMA, 53% of successful applications 
for marketing authorisation submitted by SME between 2005 and 2015 contained a new active 
substance and 42% of the medicines they developed were orphan medicines343 

The  potential  impacts  of  the  proposed  initiative  on  SMEs  have  therefore  been  considered; 
they are reported throughout the impact assessment and below in an aggregated format. 

This  impact  assessment  and  the  preferred  policy  option  have  taken  into  account  the 
pharmaceutical SMEs, and an SME-test has been conducted in line with the 4-steps foreseen 
in following: 

Step-1: Identification of affected businesses 

The  SPC  is  a  general  incentive  to  incentivise  investment  in  innovation  related  to  novel 
medicinal  and  plant  protection  products.  It  does  not  specifically  target  SME.  However, 
different types of SMEs are affected by the SPC protection, either because they are potential 
or actual users of the SPC system, or their businesses depend on the status of SPC protection 
of competing products. For the purpose of assessing the effects of this proposal, the following 
types  of  SMEs  active  in  the  medicinal  products  and  the  plant  protection  products  (PPPs) 
sectors can be distinguished: 

(1) SMEs engaging in R&D with a view to developing innovative pharmaceuticals and PPPs 

(i.e. potential future SPC holders). 

These  SMEs  are  potential  users  of  the  SPC.  Most  of  SPC  applicants  are  large 
corporations.  SMEs  accounted  for  at  least  8%  to  19%  of  the  SPC  holders  of  SPCs 
submitted to the German NPO in 2010-2021, whereas the SMEs share among the holders 
of EU-centralised marketing authorisation was around 13% in 2010-2012.  

In  the  field  of  pharmaceutical  innovation,  start-ups  and  SMEs  are  playing  an  important 
role, especially in the initial steps of innovation. The Commission’s pharmaceutical sector 
inquiry344  reported  that  approximately  25%  of  molecules  in  clinical  development  were 

340 SMEs are defined by the European Commission as having less than 250 persons employed. They should 
also have an annual turnover of up to EUR 50 million, or a balance sheet total of no more than EUR 43 
million - Commission Recommendation (2003/361/EC) of 6 May 2003 concerning the definition of micro, 
small and medium-sized enterprises and its subsequent amendments. 
341 https://www.ema.europa.eu/en/news/supporting-innovative-smes-major-drivers-new-pharmaceutical-
developments 
342 Theuretzbacher U, Outterson K, Engel A, Karlén A. The global preclinical antibacterial pipeline. Nat 
Rev Microbiol (2020) p. 278 
343 EMA, Report on the 10th anniversary of the SME initiative, EMA/155560/2016, 
https://www.ema.europa.eu/en/documents/report/report-10th-anniversary-sme-initiative_en.pdf p.8 
344 European Commission, Directorate General Competition Pharmaceutical Sector Inquiry, 2009, 
(https://ec.europa.eu/competition/sectors/pharmaceuticals/inquiry/staff_working_paper_part1.pdf) 

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acquired  from  other  companies,  including  SMEs.  This  shows  that  pharmaceutical 
companies are increasingly externalising their R&D. According to EBE, when the EMA 
analysed  the  origin  of  new  medicines,  27%  of  all  new  medicines,  and  61%  of  new 
medicines  for  orphan  indications  originated  from  SME.  Newer  figures  confirm  that 
significant  medical  innovation  comes  from  SMEs.  The  cumulative  figures  from  the 
EMA’s PRIME scheme345 indicate that 40% (39 out of 98) of PRIME applications granted 
by 2022 came from SMEs. 346  

The SMEs register, at 15 May 2022, of the EMA has 185 SMEs registered with a focus on 
new  formulations/delivery  methods,  and  124  SMEs  developing  complex  biologically 
derived proteins and peptides. We can observe a high number (236) of SMEs specialised 
in  orphan  treatments  (these  category  of  SMEs  especially  relies  on  orphan  incentives, 
under Regulation (EC) No 141/2000 on orphan medicinal products, for their investments 
in innovation). We can also observe a high number, 123, of SMEs specialised in paediatric 
treatments.  83  of  these  SMEs  are  also  involved  in  orphan  treatments,  with  37  of  them 
having less than 10 employees.  

IP  protection  is  very  important  for  these  SMEs.  The  EPO,  for  instance,  has  produced  a 
series of case studies on European SMEs347, including SMEs dealing with biotechnology, 
which are leveraging the power of patents and other IP rights to achieve business success. 
The resulting case studies illustrate how new and established SMEs have developed the IP 
management capabilities they need, and how they are using IP to their advantage. 

Often  large  corporations  hold  pharmaceuticals  in  their  portfolios  that  were  initially 
developed by start-ups. The latte are frequently purchased by large corporations to pursue 
the latest stages of clinical trials (which can be capital and human resources intensive) and 
regulatory approval of their medicines under development. 

(2) SMEs engaged in research supporting the development of biosimilars, and SMEs engaged 

in manufacturing activities related to generics and biosimilars. 

This  category  includes  companies  manufacturing  on  their  own  behalf  as  well  as 
companies  working  as  a  subcontractor  (e.g.  such  as  contract  development  and 
manufacturing organisations, ‘CDMOs’). 

According  to  Eurostat,  in  2015  in  the  EU28  there  were  3  724  SMEs  active  in 
pharmaceutical manufacturing, representing 88% of the firms and 22% of the workforce, 
in  the  pharmaceutical  sector.  This  includes  only  those  SMEs  whose  primary  activity  is 
pharmaceutical  manufacturing348,  and  does  not  necessarily  capture  SMEs  specialized  in 
other activities such as pharmaceutical R&D, commercialisation of generics or innovative 
products. 

The  SMEs  covered  by  point  (1)  are  the  direct  beneficiaries  of  the  proposal  as  they  are 
potential  users  of  the  SPC  system.  SMEs  under  point  (2)  are  expected  to  benefit  from  the 

345 Priority medicines, a scheme to enhance support for the development of medicines that target an unmet 
medical need. https://www.ema.europa.eu/en/human-regulatory/research-development/prime-priority-
medicines  
346 The register of the EMA’s SME office contains more than 1 500 companies with SMEs status registered 
as active in the pharmaceutical sector in the EEA. This is a sharp increase over recent years (10 times more 
SMEs than in 2006). There were 185 SMEs registered with a focus on new formulations/delivery methods, 
and 256 SMEs specialised in orphan treatments. 
347 https://www.epo.org/learning/materials/sme/innovation-case-studies/sme-case-studies.html  
348 It includes both SMEs manufacturing original as well as generic/biosimilar products.   

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greater legal certainty and transparency to be induced by this proposal, which would facilitate 
conduction of their business activities. 

Step-2: Consultations of SME Stakeholders 

This impact assessment has been elaborated paying due consideration to the input provided by 
stakeholders.  The  SME  angle  has  been  taken  into  account  throughout  the  consultation 
process,  bilateral  meetings,  and 
in 
seminars/round tables. 

the  Commission  services 

the  participation  of 

(1) Commission’s public consultation on SPCs  

This public consultation included a set of six specific sub-questionnaires for the six groups 
of  stakeholders,  including  (II)  originators  industry/associations  and  (III)  generics  and 
biosimilars industry/associations, both of which included SMEs. 

The questionnaires addressed to these industrial-related stakeholders (groups (II) and (III) 
above)  included  identification-related  questions  allowing  for  the  identification  of 
submissions  corresponding  to  start-ups  and  SMEs.  The  statistics  corresponding  to 
respondents identified as SME or start-up profiles are the following: 

-  Among  the  63  respondents  defining  themselves  as  mostly  manufacturers  of 
generics/biosimilars (group  III), 12 respondents  identified themselves as  an SME 
and  one  as  a  start-up.  All  of  the  13  respondents  deal  with  human  medicinal 
products, with one respondent also dealing with veterinary medicinal products and 
one with medical devices. 

-  Among  the  71  respondents  defining  themselves  as  mostly  originators  (group  II), 
only  2  respondents  identified  themselves  as  an  SME  involved  in  medicines 
biotechnology and one as a start-up in the field of biopesticides. 

In addition, as reflected in this impact assessment, several European pharmaceutical associations 
such as Medicines for Europe (representing generics and biosimilars) and ECPA, EFPIA and IFAH-
Europe (representing originators in the pharmaceutical and agrochemical sectors) conveyed the 
views of their start-ups and SME members in their submissions and accompanying letters sent to 
the Commission during the public consultation. A few national pharmaceutical associations with 
start-ups and SMEs-members also provided their views. In this regard, another industry 
association – EBE, which represents the interests of biopharmaceutical companies in Europe 
(60% of its members are SMEs), reported to the Commission as part of the SPC public 
consultation.  

(2) Max Planck Institute’s SPC stakeholders consultation  

Several  SMEs  and  universities  (in  total:  14  small-sized  companies,  20  medium-sized 
companies and 5 universities) replied to the consultation launched by Max Planck Institute 
in the context of their study on the SPC of 2018.  

(3) Participation of the Commission in round tables and seminars 

The  Commission  was  active  in  participating  in  events  organised,  or  co-organised,  by 
representatives of the pharmaceutical industry (including SMEs), as follows: 

- 8th SPC Experts meeting from the national patent offices, remote, 5 March 2021.  

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- Medicines for Europe Legal Affairs Committee - Exchange of Views with DG GROW 
on IP/Pharma Review, 23 February 2022 (remote). 

- Seminar organised by the University of Barcelona in collaboration with Farmaindustria 
(the Spanish association of originators), FARMATALK-Estrategia Farmacéutica Europea: 
retos y oportunidades para la industria farmacéutica europea, 1 March 2022 

- Videoconference with the Polish Association of Pharmaceutical Industry Employers, 11 
May 2022. 

-  Medicines  for  Europe  Legal  Affairs  Conference,  28-29  June  2022,  Sitges,  Barcelona 
(Spain). 

(4) Bilateral  meetings  of  the  Commission  representatives  with  pharmaceutical  industry 

representatives  

Commission  representatives  have  had  numerous  bilateral  meetings  with  representatives 
from the pharmaceutical and agrochemical industries, who conveyed the position of SMEs 
impacted by this initiative.  

(5) Letters sent by pharmaceutical and agrochemical associations, which also represent the 

interest of SMEs and start ups 

Following the publication of the SPC evaluation report (November 2020) and the Call for 
Evidence on the SPC (March 2022) international, European and national pharmaceutical 
associations  with  significant  members  representing  SME,  start-ups  and  universities  sent 
letters  to  the  Commission  stating  their  position  on  the  unitary  SPC  and  the  single  grant 
mechanism (following up also on the position provided by the SPC-holders, generics and 
biosimilar manufacturers during the Commission public consultation). These associations 
included Medicines for Europe, ECPA, EFPIA and IFAH-Europe. 

Step-3: Assessment of the impact on SMEs 

On  the  data  collection,  we  refer  to  the  previous  section.  The  impact  assessment  analyses  a 
number of policy options (from PO0 to PO5 plus the preferred option), which pay particular 
attention to, and have features especially relevant for, the SME-angle.  

As set out in section 5 and the table below, options PO2 and PO3, but especially both PO 4 
and PO 5, take into account the interests of innovative SMEs and SMEs dealing with generics 
and biosimilars. In particular, referring to the feedback from the public consultation as set out 
above, some options would address the points on simplification (e.g. less redundant steps in 
the  SPC  grant  procedures  in  the  EU,  accessible  and  pragmatic  linguistic  regime),  cost  of 
registration and maintenance of protection, and cost of monitoring SPC protection throughout 
the  EU.  The  impact  assessment  also  addresses  the  involvement  of  third  parties  in  the  grant 
procedure, a feature of significant important for SMEs in the generics/biosimilars sector. 

When considering the impact of the options on SMEs in detail (see table below), it must be 
borne  in  mind  that  many  SMEs  have  a  limited  financial  resources  and  are  thus  confronted 
with a significantly higher burden than larger pharmaceutical companies. The fragmentation 
and costs in the current system as identified above could best be reduced with the following 
options: 

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Table 72: Impacts of the policy options on SMEs 

Originators SMEs (potential SPC users) 

Generic/biosimilar SMEs 

PO 0: Baseline scenario: no 
action 

The  identified  problems  would  persist,  with 
greater impact on innovative SMEs. They have 
less financial and human capital resources than 
large  companies  to  pursue  SPC  protection  in 
multiple jurisdictions.  

The  problems  related  to  legal  uncertainty  would 
persist, with greater impact on generic/biosimilar 
SMEs.  They  have  less  financial  and  human 
capital 
follow-on 
than 
manufacturers to monitor the SPC protection, and 
scope  of  the  competing  innovative  product  in 
each jurisdiction. 

resources 

large 

PO 1: Guidelines 

As the impact of guidelines is likely to be limited and would only marginally improve the situation 
of the base-line scenario, the impact on SMEs of PO1 is as describe above for PO 0. 

PO 2: Mutual recognition  

it  would 

to 
This  option  would  bring  advantages 
innovative  SMEs, 
reduce 
as 
administrative fees and attorney fees related to 
the  filing  and  examination  (maintenance  fees 
would  remain  in  each  jurisdiction),  as  well  as 
limit  translation  costs  related  to  filing  and 
examination of SPC protection in the EU. 

PO 3: Centralised 
procedure resulting in a 
non-binging opinion 

PO 4: Centralised 
procedure resulting in a 
binding opinion 

it  would 

This  option  would  bring  advantages 
to 
reduce 
as 
innovative  SMEs, 
administrative fees and  attorney fees related to 
the  filing  and  examination  (maintenance  fees 
would  remain  in  each  jurisdiction),  as  well  as 
limit  translation  costs  related  to  filing  and 
examination of SPC protection in the EU. 

However,  SMEs  could  still  face  national  re-
examinations  of  the  SPC  file  resulting  in  legal 
uncertainty. 

it  would 

to 
This  option  would  bring  advantages 
innovative  SMEs, 
reduce 
as 
administrative fees and attorney fees related to 
the  filing  and  examination  (maintenance  fees 
would  remain  in  each  jurisdiction),  as  well  as 
limit  translation  costs  related  to  filing  and 
examination of SPC protection in the EU. 

Legal  uncertainty  linked  to  the  SPC  process 
would be significantly reduced. 

PO 5: Unitary SPC 

In  addition  to  the  advantages  of  PO  4  above, 
this  option  would  provide  additional  savings 
like a single annual maintenance fee to keep the 
protection in the EU.  

However, these benefits would be limited to the 
EU MS participating in the unitary patent. 

advantages 

to 
This  option  would  bring 
generic/biosimilar  SMEs  as  it  would  increase  of 
predictability  and  legal  certainty  regarding  SPC 
the  EU  (e.g.  divergent  SPC 
protection 
in 
outcomes  for 
the  same  product  would  be 
eliminated). 

However,  the  risk  of  having  reference  offices 
with  different  practice  would 
remain  and 
therefore  result  in  “forum  shopping”  for  SPC 
applicants  to  file  the  examination  procedure  in 
lenient offices. 

It  would  reduce  the  cost  and  administrative 
burden  of  monitoring  SPC  protection  in  the  EU, 
something 
for 
especially 
generic/biosimilar SMEs. 

challenging 

advantages 

This  option  would  bring 
to 
generic/biosimilar  SMEs  as  it  would  increase  of 
predictability  and  legal  certainty  regarding  SPC 
the  EU  (e.g.  divergent  SPC 
protection 
in 
outcomes  for 
the  same  product  would  be 
eliminated). 

However, the risk of divergent SPC outcomes for 
the same product would not be eliminated.  

It  would  reduce  the  cost  and  administrative 
burden  of  monitoring  SPC  protection  in  the  EU, 
something 
for 
Generic/biosimilar SMEs.  

challenging 

especially 

advantages 

This  option  would  bring 
to 
generic/biosimilar  SMEs  as  it  would  increase  of 
predictability  and  legal  certainty  regarding  SPC 
the  EU  (e.g.  divergent  SPC 
protection 
in 
the  same  product  would  be 
outcomes  for 
eliminated). Above all, the risk of divergent SPC 
outcomes  for 
the  same  product  would  be 
eliminated  therefore  adding  predictability  with 
regards 
legal 
certainty for the follow-on producers.  

to  possible  market  entry  and 

It  would  reduce  the  cost  and  administrative 
burden  of  monitoring  SPC  protection  in  the  EU, 
something 
for 
especially 
generic/biosimilar SMEs. 

challenging 

This  option  would  bring  advantages  as  PO4, 
however,  they  would  be  limited  to  the  EU  MS 
participating in the unitary patent. 

Preferred option: PO 4 
combined with PO 5  

I wold bring to SMEs the benefits of PO 5 above in  the EU MS participating in the unitary patent, 
and the advantages of PO 4 above in the non-participating ones. 

EN 

150 

EN 

 
 
 
 
Step-4: Minimising negative impacts on SMEs 

As  described  in  the  table  above,  the  preferred  option  would  ensure  more  registration 
savings/simplification  for  innovative  SMEs,  legal  certainty  (predictability,  consistency,  etc.) 
innovative  and  competing  generics/biosimilars  SMEs,  and  monitoring 
for  both 
savings/simplification 
competing 
generics/biosimilars SMEs compared to the other options. Contrary to this, option PO1 and, to 
some  extent,  PO  3  would  provide  limited  positive  effects  for  SMEs  vis-à-vis  the  base  line 
scenario, as the legal uncertainty would remain (in PO3 due to the non-binding character of 
the opinion issues by the examination authority).  

transparency) 

innovative 

for  both 

(more 

and 

Finally, the preferred option (a centralised SPC procedure and the unitary SPC) introduces features 
easy to comply with by SMEs as described in section 8. It would entail enhanced transparency and 
legal certainty in the SPC-protection of the pharmaceutical and agrochemical industries in the EU by 
comparison with the base line scenario. 

EN 

151 

EN