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, plant health legislation, plant health product

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   EUROPEAN COMMISSION  Brussels, 27.4.2023  COM(2023) 221 final 2023/0126 (COD)  Proposal for a REGULATION OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL on the unitary supplementary protection certificate for plant protection products (Text with EEA relevance) {SEC(2023) 172 final} - {SWD(2023) 117 final} - {SWD(2023) 118 final} - {SWD(2023) 119 final}  
 
EXPLANATORY MEMORANDUM 

1. 

• 

CONTEXT OF THE PROPOSAL 

Reasons for and objectives of the proposal 

Supplementary protection certificates (SPCs) are  sui  generis intellectual property (IP) rights 
that extend the 20-year term of patents for medicinal or plant protection products (PPPs) by 
up to 5 years1. 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  unitary  patent  will  enter  into  force  on  1  June  2023,  allowing  for  a  single  patent  that 
covers all participating Member States in a unitary manner2. 

This proposal aims to simplify the EU’s SPC system, as well as improve its transparency and 
efficiency,  by  creating  a  unitary  certificate  for  plant  protection  products.  This  initiative  was 
announced  in  the  Commission  work  programme  for  2022  as  initiative  number  16  under 
Annex II (REFIT initiatives)3. 

Regulation  (EC)  No  1610/96  provides  for  SPCs  for  plant  protection  products  (‘PPPs’),  at  a 
national level, to be granted by national patent offices on the basis of national applications, on 
a  country-by-country  basis.  Similarly,  Regulation  (EC)  No  469/2009  provides  for  SPCs  for 
medicinal products. Together these two measures constitute the EU’s SPC regime. 

As  confirmed  by  the  evaluation  carried  out  in  2020  (SWD(2020)292  final),  today’s  purely 
national procedures for granting SPCs involve separate examination proceedings (in parallel 
or subsequent) in Member States. This entails duplication of work, resulting in high costs and 
more  often  discrepancies  between  Member  States  in  decisions  to  grant  or  refuse  SPCs 
including  in  litigation  before  national  courts.  Inconsistency  between  Member  States  in 
decisions to grant or refuse SPCs is the single reason most often cited by national courts for 
preliminary references to the Court of Justice of the European Union on the application of the 
EU’s SPC regime. The current purely national procedures, therefore, lead to significant legal 
uncertainty. 

The  Commission’s  intellectual  property  action  plan  of  November  2020  (COM(2020) 760 
final),  which  builds  on  the  SPC  evaluation,  highlighted  the  need  to  tackle  the  remaining 
fragmentation  of  the  EU’s  intellectual  property  system.  The  plan  noted  that,  for  medicinal 
products and PPPs, SPC protection is only available at national level. At the same time, there 
is a centralised procedure for granting European patents.  

In  addition,  many  of  the  arguments  made  in  the  pharmaceutical  strategy  for  Europe 
(COM(2020) 761 final)  as regards SPCs  for medicinal  products  are  also  applicable to  SPCs 
for plant protection products. That Strategy emphasised the importance of investing in R&D 

1 

2 

3 

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. 
The  unitary  patent  (UP)  is  a  legal  title  that  will  provide  uniform  protection  across  all  participating 
countries on a one-stop-shop basis. As of April 2023, 17 Member States are expected to participate in 
see: 
updates 
the 
https://ec.europa.eu/growth/industry/strategy/intellectual-property/patent-protection-eu/unitary-
patent_en. 
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). 

information, 

system. 

more 

and 

For 

UP 

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to create innovative medicines. The strategy stressed, however, that the differences between 
Member  States  in  the  implementation  of  intellectual  property  regimes,  especially  for  SPCs, 
lead  to  duplications  and  inefficiencies  that  affect  the  competitiveness  of  the  pharmaceutical 
industry. Both the Council4 and the European Parliament5 have called on the Commission to 
correct these deficiencies. 

Additionally,  there  is  a  clear  need  to  complement  the  unitary  patent  (‘European  patent  with 
unitary effect’) by a unitary SPC. Indeed, while a unitary patent may be extended by national 
SPCs,  this  approach  is  not  optimal  in  the  sense  that  the  unitary  protection  conferred  by  a 
unitary  patent  would  then,  after  patent  expiry,  be  complemented  by  a  plurality  of  legally 
independent national SPCs, without any unitary dimension anymore. 

The  grant  of  a  unitary  SPC  could  be  requested  by  filing  an  application  that  would  then  be 
subjected to the same centralised examination procedure also applicable to ‘centralised SPC 
applications’  defined  in  a  parallel  proposal  (COM(2023)  223)  with  a  view  to  the  grant  of 
national SPCs in the Member States designated in the centralised applications. An applicant 
will have the possibility of filing a ‘combined’  centralised SPC application  in  which he/she 
would request  the  grant of both  a unitary SPC  (for those Member States  in  which the basic 
patent has unitary effect) and national SPCs (for other Member States). 

• 

Consistency with existing policy provisions in the policy area 

The  core  substantive  provisions  applicable  to  the  unitary  certificates  to  which  this  proposal 
relates  – i.e. the conditions  for obtaining a unitary  certificate  – are the same as  those of the 
existing  SPC  regime,  while  this  proposal  creates  a  unitary  SPC  to  be  granted  following 
examination  by  a  central  authority,  which  relies  on  the  same  substantive  rules,  with  minor 
modifications, as the centralised procedure for the grant of national certificates established in 
the parallel proposal COM(2023) 223. This ensures consistency across the whole SPC reform 
package,  especially  in  the  event  of  a  ‘combined’  application  requesting  the  grant  of  both  a 
unitary certificate and national certificates, as explained below. 

In  addition  to  this  proposal,  parallel  proposals  are  being  made  to  create  a  centralised 
procedure  for  the  grant  of  national  certificates  for  medicinal  products  (COM(2023)  231),  a 
centralised  procedure  for  the  grant  of  national  certificates  for  plant  protection  products 
(COM(2023)  223),  and  a  unitary  certificate  for  medicinal  products  (cf.  COM(2023)  222). 
Applications  for  all  of  these  certificates  would  undergo  the  same  centralised  examination 
procedure described in this proposal, especially in the event of ‘combined’ applications that 
request  both  a  unitary  certificate  and  national  certificates,  as  explained  below.  This  ensures 
complete consistency across the whole SPC reform package. 

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on 

intellectual 

conclusions 

Council 
https://www.consilium.europa.eu/media/46671/st-12750-2020-init.pdf. 
European  Parliament,  Committee  on  Legal  Affairs,  Report  on  an  intellectual  property  action  plan  to 
(2021/2007(INI)), 
support 
https://www.europarl.europa.eu/doceo/document/A-9-2021-0284_EN.html.  

10  November 

resilience 

recovery 

property 

policy 

EU’s 

2020 

and 

the 

of 

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This table explains the purposes of the four related proposals:  

Medicinal products 

PROPOSAL 1 

Regulation on the SPC for medicinal 
products (recast) 

PROPOSAL 3 

Regulation on the unitary SPC for 
medicinal products 

 Art. 114 
TFEU  

 Art. 118 
TFEU  

Plant protection products 

PROPOSAL 2 

Regulation on the SPC for plant 
protection products (recast) 

PROPOSAL 4 

Regulation on the unitary SPC for 
plant protection products 

In  contrast  to  the  proposal  regarding  the  unitary  SPC  for  medicinal  products,  this  proposal 
foresees  some  minor  differences  as  regards  the  conditions  for  grant  and  introduces  some 
changes  made  necessary  by  specific  features  of  the  marketing  authorisations  for  plant 
protection products. 

The  proposed  creation  of  a  unitary  SPC  will  be  fully  compatible  with  the  unitary  patent 
system, under Regulation (EU) No 1257/2012 and the Agreement on a Unified Patent Court 
(UPCA). 

In  addition,  as  this  was  also  the  case  for  Regulation  (EC)  No  1610/96,  this  proposal  is 
compatible with the agrochemical EU legislation. 

Finally, this proposal is part of the ‘EU patent package’ announced in 2023 which, besides the 
revision,  modernisation  and  introduction  of  a  system  for  unitary  SPCs,  includes  a  new 
initiative on compulsory licensing and legislation on standard-essential patents. The proposal 
also complements the unitary patent system, which is a major step towards the completion of 
the single market for patents. 

• 

Consistency with other Union policies 

The proposed centralised procedure is fully consistent with the existing legislation relating to 
agrochemical products and with other relevant legislation. This includes the European patent 
with  unitary  effect  ('unitary  patent')  as  set  out  in  Regulation  (EU)  No  1257/2012,  and  the 
related UPCA. The unitary patent system will enter into force on 1 June 2023. 

Finally, the SPC reform and the other initiatives listed in the intellectual property action plan 
contribute to the broader innovation strategy of the EU. 

2. 

• 

LEGAL BASIS, SUBSIDIARITY AND PROPORTIONALITY 

Legal basis 

The  current  proposal  is  based  on  the  first  subparagraph  of  Article  118  of  the  Treaty  on  the 
Functioning  of  the  European  Union,  which  is  the  only  treaty  provision  suitable  for  the 
creation of unitary IP rights as it 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. 

Article 118 was introduced by the Treaty on the Functioning of the European Union (TFEU) 
and provides an express legal base for EU-wide intellectual property rights. It is also the legal 
basis  for  Regulation  (EU)  No  1257/2012  of  the  European  Parliament  and  of  the  Council 
implementing enhanced cooperation in the area of the creation of unitary patent protection. 

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Together with the parallel proposal relating to a centralised procedure for the grant of national 
certificates (COM(2023) 223), this proposal addresses the fragmentation of the existing SPC 
regime,  implemented  at  a  purely  national  level:  despite  the  fact  that  SPCs  are  already 
harmonised  –  and  indeed  defined  –  by  EU  law,  there  are  still  cases  where  some  Member 
States  have  granted  SPCs  while  identical  applications  have  been  refused  in  others,  or  been 
granted with a different scope. SPC applicants thus face diverging decisions across the EU on 
the same product, while incurring costs for applying and maintaining SPCs in several Member 
States.  Consequently,  further  EU  action  is  needed  to  address  these  issues  and  can,  unlike 
national intervention by Member States, ensure a consistent EU-wide framework, and reduce 
the  total  costs  and  burden  of  fees  to  be  paid  in  multiple  Member  States.  Further  EU-level 
action would strengthen the integrity of the single market by providing a centralised, balanced 
and  transparent  SPC  system  across  the  EU,  and  mitigate  the  negative  consequences  of 
redundant  and  potentially  diverging  procedures  that  applicants  face6.  Hence,  by  its  nature, 
action at EU level is also justified to ensure the smooth functioning of the  single market for 
innovative  plant  protection  products  that  are  subject  to  marketing  authorisations.  EU-level 
action  would  also  allow  innovative  and  follow-on  manufacturers  to  reap  the  benefits  of  an 
efficient intellectual property framework in the relevant product markets. 

• 

Subsidiarity 

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  EU.  National  legislation  cannot  achieve  this 
objective, as it is not able to provide for unitary protection, and the objectives underlying this 
proposal can thus only be achieved at Union level. The Union-wide approach implemented by 
the  centralised  procedure  for  the  grant  of  national  certificates  and  unitary  SPCs  will  ensure 
that the applicable rules and procedures are consistent across the Union — at least insofar as 
the Member States participating in the unitary patent system are concerned —, ensuring legal 
certainty for all relevant market participants. Moreover, the unitary SPC is an autonomous IP 
right,  applying independently of any national  system. Consequently, EU  action is  needed to 
create a new unitary SPC complementing the unitary patent. 

• 

Proportionality 

This initiative does not go beyond what is necessary to achieve the identified objectives. Its 
scope is limited to those aspects that Member States cannot achieve satisfactorily on their own 
and where EU action can produce better results, e.g. in terms of consistent decisions on SPC 
applications to reduce administrative burdens and costs, and improve transparency and legal 
certainty. 

• 

Choice of the instrument 

The  instrument  choice  is  an  EU  regulation  establishing  a  unitary  SPC.  No  other  instrument 
can be envisioned for creating a unitary IP right. 

3. 

• 

RESULTS 
CONSULTATIONS AND IMPACT ASSESSMENTS 

EX-POST 

EVALUATIONS, 

OF 

STAKEHOLDER 

Ex-post evaluations and fitness checks of existing legislation 

An  evaluation  of  the  SPC  regime  was  carried  out  in  2020  (SWD(2020) 292).  It  found  that 
SPCs promote innovation and the availability of new medicines and PPPs because they help 

6 

Case C-58/08 ECLI:EU:C:2010:321. 

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companies recoup their R&D investments. Although the SPC Regulations provide a common 
framework within the EU, they are administered at a national level. This fragmentation leads 
to  high  costs  and  imposes  an  administrative  burden  on  applicants  (especially  SMEs)  and 
national administrations. It also leads to legal uncertainty, as the scope of protection can differ 
across the EU. This  has  a negative impact  on SPC users and makers of follow-on products. 
These negative effects are amplified by a lack of transparency, especially from a cross-border 
perspective,  making  it  difficult  to  trace  what  SPC  protection  exists  for  which  products  in 
which  Member  States.  This  affects  both  SPC  holders  and  manufacturers  of  follow-on 
products. 

• 

Stakeholder consultations 

The Commission conducted a public consultation during the evaluation (between 12 October 
2017  and  4  January  2018).  In  addition,  the  Max  Planck  Institute  study  mentioned  below 
included a survey of stakeholders in the Member States, conducted in 2017 by the Allensbach 
Institute (‘the Allensbach survey’), which included several questions on the operation of the 
current  (national)  SPC  regimes.  Moreover,  from  8  March  to  5  April  2022  interested  parties 
could  provide  feedback  to  Commission’s  Call  for  Evidence.  For  further  information,  see 
Annex 2 of the impact assessment (SWD(2023) 118). 

Most of the respondents to the Allensbach survey consultation (conducted by the Allensbach 
Institute and included in the 2018 study by the Max Planck Institute (MPI))7 and to the public 
consultation organised by the Commission endorse the creation of a Unitary SPC. Answers to 
Question 69 of the Allensbach survey show that there is wide support for a unitary SPC, and 
that from all categories of respondents. The same can be said of the replies to the questions 
relating to the unitary SPC included in the public consultation ‘on Supplementary Protection 
Certificates and patent research exemption for sectors whose products are subject to regulated 
market authorisations’ that was conducted from 12 October 2017 to 4 January 2018.8 

Moreover,  from  8  March  to  5  April  2022  interested  parties  could  provide  feedback  to 
Commission’s  Call  for  Evidence.  For  further  information,  see  Annex  2  of  the  Impact 
Assessment. 

Collection and use of expertise 

• 
The study9 carried out in 2018 by the Max Planck Institute on the legal aspects of SPCs in the 
EU (especially Chapter 22) provides key findings on the operation of the current SPC regime 
(for medicinal products). In particular that study included a survey among stakeholders in the 
EU  Member  States  (2017),  conducted  by  the  Allensbach  Institute10,  which  included  several 
questions relating to a possible unitary SPC in addition to the many questions relating to the 
operation of the current (national) SPC regimes. 

• 

Impact assessment 

An impact assessment was carried out and submitted to the Regulatory Scrutiny Board in late 
2022 and, after resubmission, received a positive opinion on 16 December 2022 (SWD(2023) 
118). 

The following options were identified: 

– 

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Option 0: No policy change. 

https://ec.europa.eu/docsroom/documents/29524 
https://ec.europa.eu/docsroom/documents/29464   
https://ec.europa.eu/docsroom/documents/29524 
https://ec.europa.eu/docsroom/documents/29524/attachments/4/translations/en/renditions/native 

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– 

– 

– 

– 

– 

Option  1:  Guidelines  for  the  application  of  the  current  SPC  regimes.  This  option 
would  provide  common  guidelines/recommendations  to  national  patent  offices 
(NPOs) on the application of the SPC Regulation, building on their experience and 
the case law of the Court of Justice of the European Union (CJEU). These guidelines 
would  also  recommend  common  rules  for  the  publication  and  accessibility  of  SPC 
information in national registers. 

Option 2: Mutual recognition of national decisions. This would enable applicants to 
file an SPC application with a designated NPO, known as the reference office, whose 
decision would be recognised by all other NPOs. 

Option 3: Centralised filing and examination of SPC applications, resulting in a non-
binding opinion. This would create a central authority for filing SPC applications in 
the EU, which would examine applications and issue an opinion on whether or not to 
grant  an  SPC.  NPOs  could  follow  this  opinion  or,  alternatively,  conduct  their  own 
examination. Therefore, the decision on granting SPC protection would be kept at the 
national level. Only holders of a European patent – and, for medicinal products, of a 
centralised marketing authorisation – could use this system. 

Option  4:  Centralised  filing  and  examination  of  SPC  applications,  resulting  in  a 
binding  opinion.  This  is  identical  to  option  3,  but  NPOs  would  have  to  follow  the 
opinion. Therefore, while decisions on granting SPC protection would still be taken 
by national offices, the outcome of these decisions would be determined by a central 
authority. 

Option 5: A ‘unitary SPC’ complementing the unitary patent. The central authority, 
in addition to examining applications, would grant a ‘unitary SPC’ to applicants with 
a  European  patent  with  unitary  effect.  The  unitary  SPC  would  be  valid  only  in  the 
territory of the (initially 17) Member States party to the UPCA. 

These  options  would  not  replace  national  SPCs,  but  would  provide  alternative  routes  to 
obtaining SPC protection across the EU. 

A  combination  of  options  4  and  5  constitutes  the  preferred  choice.  It  would  provide  for  a 
centralised procedure that could result in  the grant of national SPCs in some or all Member 
States,  and/or  of  a  unitary  SPC  (covering  those  Member  States  in  which  the  basic  unitary 
patent  has  effect).  When  deciding  on  who  should  act  as  the  examination  authority,  several 
criteria were considered: accountability (in particular, to the European Parliament), alignment 
with the EU’s overarching political values and current policy priorities, and experience with 
substantive SPC assessment. It is therefore proposed that the EU Intellectual Property Office 
(EUIPO) should become the central examination authority, supported by national offices. 

Option  1,  on  guidelines  for  examining  national  SPC  applications,  would  not  be  sufficient 
alone to  overcome discrepancies between national  practices,  as the  guidance would be non-
binding. Nevertheless, in the context of the preferred options 4 and 5, EUIPO should develop 
guidelines that reflect its practice. These guidelines would be of practical use both to officials 
in  charge  of  the  SPC-related  procedures  and  to  their  users,  including  professional  advisers 
who  assist  applicants  (e.g.  by  offering  examples).  This  guidance  would  take  stock  of  the 
practices developed by the examination panels, especially since they will include examiners 
from several different Member States, to improve consistency between examination practices 
under  the  new  centralised  procedure.  Moreover,  national  offices  may  also  benefit  from 
guidelines  developed  by  the  examination  authority  for  their  own  (national)  examination 
procedures. 

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Option  2  may  not  provide  enough  predictability,  as  some  reference  offices  could  be  more 
lenient  than  others,  thus  leading  to  ‘forum  shopping’,  while  Option  3  alone  would  allow 
offices to re-examine the SPC application, and has thus the potential to result in divergences 
on  the  decision  to  grant  or  refuse  an  SPC,  leading  to  further  fragmentation  in  the  single 
market. 

• 

Regulatory fitness and simplification 

Enabling unitary patent holders to obtain through a single procedure a unitary SPC able to be 
enforced  centrally  in  all  relevant  Member  States  represents  a  considerable  simplification 
compared to the current situation in which national SPCs need to be applied for and enforced 
separately  in  each  Member  State,  while  noting  that  SPCs  based  on  European  patents  (also 
non-unitary ones) will be able to be enforced before the Unified Patent Court (‘UPC’) once it 
is operating11. 

• 

Fundamental rights 

This proposal will have no impact on fundamental rights, especially since it is not proposed to 
alter  the  substantive  features  of  the  existing  SPC  regimes  (e.g.  conditions  for  grant,  scope, 
effects).  The  initiative  is  consistent  with  the  Charter  of  Fundamental  Rights,  as  it  offers 
greater  legal  certainty  to  applicants  for  unitary  certificates,  and  where  necessary  for  third 
parties, by providing for the procedural conditions for the examination, opposition, appeal and 
invalidity actions before the centralised authority. 

In particular, where a centralised examination opinion is negative, the applicant may file an 
appeal before the Boards of Appeal of the EUIPO. 

Moreover, examiners from national offices will play a key role in the centralised examination 
procedure  and  participate  in  the  substantive  examination  of  the  application,  as  well  as  may 
take part in opposition and invalidity proceedings. 

On the other hand, third parties will be able to submit observations during the examination of 
a centralised application, and to initiate an opposition against an examination opinion. After a 
unitary SPC is  granted by  the Office, third parties will also  be able to  challenge its validity 
before  the  Office.  Counterclaims  for  a  declaration  of  invalidity  may  be  raised  in  the 
competent court of a Member State. 

4. 

BUDGETARY IMPLICATIONS 

This proposal will have no impact on the EU budget, since the system will remain fully self-
funded by applicants’ fees, as is already the case for the existing SPCs regimes governed by 
Regulations  (EC)  No  469/2009  and  (EC)  No  1610/96,  and  will  be  implemented  by  the 
examination  authority,  the  EUIPO.  The  necessary  set-up  costs  of  the  tasks  conferred  to  the 
EUIPO,  including  the  costs  of  new  digital  systems,  will  be  financed  from  the  EUIPO’s 
accumulated  budgetary  surplus.  A  breakdown  of  the  budgetary  impact  on  the  examination 
authority is provided in Annex 5D of the impact assessment. 

The financial impacts on Member States (national offices) will also remain low. Indeed, while 
the  number  of  SPCs  applied  for  each  year  is  likely  to  increase,  it  is  quite  low  for  the  time 
being, even in large Member States. For instance, in 2017, 70 SPC applications were filed in 
Germany and 72 in France. The largest number of applications (95) were filed in Ireland. The 
average cost  varies  by country.  Based on current average coverage (20  Member States) and 

11 

To some extent at least, during the transitional period during which non-unitary European patents will 
still be able to be litigated before national courts. 

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duration (3.5  years), SPC protection for a given product  would cost  around EUR 98 500 on 
average.  In  order  to  cover  all  27  Member  States  for  5  years  one  would  pay  nearly 
EUR 192 000 in total (not including any fees charged by patent lawyers). For a breakdown of 
the costs, see Annex 5B of the impact assessment (SWD(2023) 118 ).  

Moreover it may be expected that only some  plant protection products will be eligible for a 
unitary certificate in the first years of operation of the unitary patent system, considering that 
not all European patents will have unitary effect (which will be a prerequisite for applying for 
a unitary certificate). 

5. 

• 

OTHER ELEMENTS 

Implementation plans and monitoring, evaluation and reporting arrangements 

It is envisaged that an evaluation will be carried out every 5 years. 

• 

Detailed explanation of the specific provisions of the proposal 

Overall structure of the proposal 

The  proposal  is  structured  similarly  to  the  current  SPC  Regulations  and  in  particular  to  a 
parallel proposal relating to the unitary certificate for medicinal products  (COM(2023) 222). 
It first sets out general provisions on SPCs followed by procedural provisions. 

Coherence with the parallel proposal relating to medicinal products 

This proposal is similar to the one presented in parallel regarding unitary SPCs for medicinal 
products  (COM(2023)  222),  with  a  limited  number  of  adaptations  directly  linked  to  the 
intrinsic  differences  between  medicinal  products  and  plant  protection  products,  regarding  in 
particular  marketing  authorisations  (as  there  are  no  centralised  marketing  authorisations  for 
plant  protection  products).  Moreover  the  ‘SPC  manufacturing  waiver’  introduced  into 
Regulation  (EC)  No  469/2009  by  Regulation  (EU)  2019/933  only  applies  to  SPCs  for 
medicinal products and therefore does not need to be reflected in this new Regulation. 

Basic patent 

It is proposed that a unitary SPC must be based on a European patent with unitary effect only 
(as the ‘basic patent’), which would ensure that its claims are identical for all Member States 
it covers, and would avoid the risk of the basic patent being revoked, or lapsing, for one or 
some  of  these  Member  States.  In  this  respect  it  should  be  noted  that  paragraph  28  of  the 
explanatory memorandum of the proposal for a European Parliament and Council Regulation 
(EC)  concerning  the  creation  of  a  supplementary  protection  certificate  for  plant  protection 
products (COM(94)579) already envisaged that ‘when use is made of the European procedure 
to  obtain  a  Community  patent,  it  will  be  all  the  more  necessary  for  the  certificate  to  apply 
equally to plant protection products protected by a Community patent’ (now referred to as a 
‘European patent with unitary effect’ or, more informally, a ‘unitary patent’). 

Allowing  unitary  SPCs  to  be  based  on  national  patents,  or  even  on  non-unitary  European 
patents, would be more demanding insofar as the examination of such applications would be 
concerned,  as  it  would  be  required  to  examine  separately,  for  each  of  the  Member  States 
concerned,  if  the  product  concerned  is  indeed  protected.  This  would  also  raise  language 
issues, and affect legal certainty. 

Examination/granting authority 

Under this proposal, a central examination authority will carry out a substantive examination 
of a unitary SPC application, especially as regards the conditions for grant defined in Article 3 
of  the  existing  SPC  Regulations.  The  Commission  proposes  that  the  EUIPO  should  be  the 

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central examination authority, in particular because it is an EU agency and therefore part of 
the EU legal order. 

After  assessing  the  formal  admissibility  of  the  unitary  SPC  application,  the  central 
examination authority would entrust the substantive examination of the application to a panel. 
This  panel  would  be  made  up  of  a  member  of  that  central  authority  and  two  qualified 
examiners, experienced in SPC matters, from two different national patent offices in Member 
States.  Before designating  examiners qualified to examine SPC issues, these national  patent 
offices will have agreed, through an ad hoc agreement with the central examination authority, 
to participate in this centralised examination system. Competencies and skills in SPC matters 
are  scarce  and  qualified  SPC  examiners  can  be  found  today  in  national  patent  offices. 
Moreover, the relatively low number of products  for which SPC applications are made each 
year  (less  than  100)  justifies  making  recourse  to  existing  qualified  examiners  in  Member 
States, as opposed to creating an entirely new body of experts. During the examination, third 
parties may submit their observations on the validity of a certain unitary SPC application after 
its publication. 

Examination procedure and remedies 

After examining the application, the central examination authority will issue an examination 
opinion  stating  whether  the  application  fulfils  the  applicable  criteria  (and  in  the  first  place 
those  defined  in  Article  3).  The  applicant  can  file  an  appeal  against  a  negative  opinion  (as 
further explained below). 

In order to account for the need to have a complete system of remedies and avoid the need for 
third parties challenging a positive examination opinion in national courts which would then 
in  turn  have  to  make  reference  to  the  EU  Courts,  third  parties  will  be  able  to  challenge  a 
positive  (or  partly  positive)  opinion  by  initiating  an  opposition  procedure  during  2  months 
after  the  publication  of  the  examination  opinion.  Such  an  opposition  may  result  in  the 
examination opinion being amended. 

Challenges  against  the  examination  opinion  can  be  appealed  to  the  Boards  of  Appeal,  and 
subsequently to the General Court and, possibly, ultimately before the Court of Justice subject 
to the system of leave to appeal under Articles 170a and following of the Rules of Procedure 
of  the  Court  of  Justice,  or  under  the  review  procedure  in  accordance  with  Article  256, 
paragraph 2, TFEU, Article 62 of the Statute of the Court and Articles 191 and following of 
the Rules of Procedure of the CJEU. 

On the basis of the examination opinion (as possibly amended following an opposition), the 
EUIPO will either grant a unitary SPC, or reject the application for it, subject to the outcome 
of any appeal before the Boards of Appeal of the EU courts. 

After the grant of a unitary SPCs, third parties will be able to initiate invalidity proceedings 
(actions for a declaration of invalidity) before the Office. Here as well, related decisions may 
be appealed to the Boards of Appeal, and may end up before the General Court. 

Counterclaims  for  a  declaration  of  invalidity  could  be  raised  in  the  competent  court  of  a 
Member  State  (including  the  Unified  Patent  Court  where  the  applicable  conditions  are  met, 
subject to a suitable amendment of the UPCA). 

Marketing authorisations concerned 

Given  that  there  is  a  zonal  system  of  marketing  authorisations  for  PPPs  in  the  EU  and  that 
only  national  marketing  authorisations  exist  for  PPPs,  the  requirement  for  a  centralised 
authorisation, included in the parallel proposal (COM(2023) 222) creating a unitary certificate 

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for  medicinal  products,  cannot  be  applied  in  this  Regulation.  Therefore,  national  marketing 
authorisations will be allowed to serve as basis for the grant of unitary certificates for PPPs. 

Since the marketing authorisations granted in respect of a given plant protection product may 
have slightly different scopes in different Member States, it will be important to clarify that a 
unitary  certificate  will  confer  protection  to  the  product  identified  in  the  related  application 
only to the extent that the product is duly covered by the marketing authorisations granted in 
each of the relevant Member States (i.e. those in which the basic patent has unitary effect). 

Moreover,  since  marketing  authorisations  for  a  given  plant  protection  product  are  usually 
granted at different dates in different Member States, it may happen that, at the date of filing 
the unitary certificate application12, authorisations have been granted in some of the Member 
States in which the basic patent has unitary effect, but not in all of them. Since this situation is 
expected to be frequent, the traditional requirement for the availability of valid authorisations 
at the date of filing of the application would often make it impossible to fulfil the conditions 
for the grant of a unitary certificate on a PPP. 

To address  this situation, it is  proposed  to  allow  the  grant  of  a unitary  certificate  for a PPP 
provided  that  two  conditions  are  fulfilled  in  respect  of  marketing  authorisations,  as  a 
derogation from the above-mentioned traditional requirement: 

– 

– 

at  the  date  of  filing  of  the  application,  it  is  only  required  that  marketing 
authorisations have been applied for in each of the Member States in which the basic 
patent has unitary effect, but 

before the end of the examination process, marketing authorisations must have been 
granted in each of these Member States. At the same time it would be required that 
the examination process  does not  end  earlier than 18 months  from  the  filing of the 
application,  to  increase  the  likelihood  that  the  ‘missing’  marketing  authorisations 
may have been granted by then. 

In addition, it is necessary to consider that in certain cases marketing authorisations may still 
not  be  available  (granted),  before  the  end  of  the  examination  process,  in  all  of  the  Member 
States  in  which  the  basic  patent  has  unitary  effect  –  which  is  a  real  risk  considering  the 
complexity and thus duration of the authorisation procedures. 

In such a case it is proposed that a unitary certificate will be granted, but will not have effect 
in a Member State (in which the basic patent has unitary effect) in which no authorisation was 
granted  before  the  end  of  the  examination  process.  In  such  an  exceptional  situation,  the 
suspended  effect  in  a  certain  Member  State  could  resume  where  a  ‘missing’  authorisation 
would be granted after the grant of the unitary certificate but – for legal certainty reasons  –
before the expiry of the basic patent, subject to a proper re-examination of that authorisation 
by the Office. 

12 

or  of  filing  a  ‘combined’  application  including  a  request  for  the  granting  of  a  unitary  certificate  in 
addition to the designation of additional Member States. 

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Substantive features of the SPC regime 

This reform does not intend to modify, nor further clarify in view of the relevant case law of 
the  Court  of  Justice,  the  substantive  features  currently  laid  down  in  Regulation  (EC)  No 
1610/96 for the existing national SPC regimes or the new centralised procedure, including as 
regards its application to unitary SPCs, since: 

– 

– 

the  case  law13  on  SPCs  is  progressively  but  effectively  converging,  and  steadily 
reducing  uncertainty  about  the  interpretation  of  the  SPC  regime14,  while  further 
amendments  might  trigger  new  fluctuations  and  uncertainty  as  regards  the  proper 
interpretation of the amended rules; 

respondents  to  the  Allensbach  survey  did  not  call  for  Article  3  of  the  SPC 
Regulations  to  be amended (question 48) even if they  consider that the case law is 
unclear in some respects (question 46). 

That being said,  considering that there are national discrepancies in the interpretation of the 
rule  defining  the  duration  of  a  European  patents,  which  may  result  in  a  one-day  difference, 
there is a need to clarify that rule insofar as its application to unitary SPCs is concerned. 

New recitals 

Certain  recitals  concern  the  conditions  (as  set  out  in  Article  3)  for  the  grant  of  SPCs  and 
incorporate  the  case  law  of  the  Court  of Justice.  The  aim  is  to  assist  ensure  consistency.  In 
particular the judgements in cases C‑121/17 and C-673/18 interpret Article 3(1)(a) and 3(1)(d) 
of the current SPC Regulation, respectively, and should be considered settled case law. This is 
also the case for judgement C-471/14, whereby the date of the first marketing authorisation in 
the Union, within the meaning of Article 13, is the date on which notification of the decision 
granting the authorisation was given to the addressee of the decision. 

The  requirement  that  the  product  should  be  protected  by  the  basic  patent  means  that  the 
product  should  fall  within  the  scope  of  one  or  more  claims  of  that  patent,  as  properly 
interpreted  at  the  basic  patent’s  filing  date.  This  also  includes  situations  where  the  product 
corresponds to  a general functional definition used by one of the claims of the basic patent, 
and necessarily comes within the scope of the invention covered by that patent, even if it is 
not indicated in individualised form as a specific embodiment in the patent, provided that it is 
specifically identifiable from the patent. 

Many  general  objectives  set  out  in  the  Explanatory  Memorandum  of  the  proposal 
(COM(94)579) for what became Council Regulation (EC) No 1610/96, remain fully relevant 
today,  and  should  continue  to  be  used  as  a  guide  to  interpretation,  where  relevant.  This 
includes the objective that  if a certificate has already been granted for the active substance 
itself, a new certificate may not be granted for that active substance, whatever changes may 
have been made regarding other features of  the  plant protection product  (use of  a different 
salt, different excipients, different presentation, etc.). 

Furthermore, as regards the rights conferred by a certificate, the certificate confers the same 
protection as the basic patent, but only protects the product covered by the authorisation, for 
all pharmaceutical uses authorised, until the expiry of the basic patent. 

As  regards  the  rights  conferred  by  a  certificate,  and  in  line  with  the  earlier  statements 
regarding derivatives, it is appropriate to consider that the protection conferred by a certificate 

13 
14 

For a full list of cases, see Table 5.5. of the second MPI study.  
Further  clarifications  are,  however,  necessary  in  certain  areas  as  indicated  by  two  referrals  in  2022, 
cases C-119/22 and C-149/22. 

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on a product extends to the derivatives of that product that are equivalent to the product from 
a phytosanitary perspective. 

Finally, it remains fully justified to require, as already stated in the Explanatory Memorandum 
of  the  proposal  (COM(94)579)  for  what  became  Council  Regulation  (EC)  No  1610/96,  that 
only the first authorisation to place the product on the market in the Member State in which 
the  application  is  lodged  is  taken  into  account  for  the  purposes  of  the  Regulation.  In  other 
words, this ‘first authorisation’ requirement should be applied on a country-by-country basis. 

Language regime 

This Regulation envisages the possibility of filing a centralised SPC application in any official 
EU  language.  In  this  regard,  the  amount  of  text  in  an  SPC  application  is  extremely  small, 
especially compared to patents and that this would not present a burden for applicants. Certain 
matters  would  not  require  any  translation,  such  as  the  identification  of  the  basic  patent  and  
the  relevant  marketing  authorisation,  the  relevant  dates,  and  the  identification  of  the 
applicant(s)  and  the  product  concerned.  The  translation  costs  are,  therefore,  expected  to  be 
considerably lower than would be the case for patent applications. See the impact assessment 
(SWD(2023) 118) for an exact calculation. 

Appeal 

Decisions  of  the  central  examination  authority  are  subject  to  appeal.  This  also  applies  to  a 
negative examination opinion issued by the central examination authority, against which the 
applicant  may  file  an  appeal.  This  also  applies  to  other  decisions  of  that  authority;  for 
instance,  the  decision  relating  to  an  opposition  may  be  appealed  by  any  of  its  parties.  An 
appeal may result in the examination opinion being amended. 

In  the  event  of  a  ‘combined’  SPC  application  as  referred  to  below  –  namely  an  SPC 
application which requests  the  grant of  a unitary  SPC and also  of national  SPCs  –, such an 
appeal  would  be  applicable  to  the  (common)  examination  opinion  relating  to  the  combined 
SPC application. 

The appeal would take place before the Boards of Appeal of the EUIPO. Members from the 
Boards  of  Appeal  should  be  appointed  in  accordance  with  Article  166  (5)  of  Regulation 
2017/1001.  These  members  may  also  be  national  examiners,  but  they  may  not  be  the  same 
examiners already involved in the examination of the centralised applications or applications 
for unitary certificates. 

In  terms  of  workload,  SPC  applications  are  made  for  less  than  100  products  each  year  on 
average,  for  both  medicinal  products  and  PPPs,  and  introducing  third-party  observations 
should help keep the number of appeals at a very low level. 

Fees  and  financial  transfers  between  the  central  authority  and  national  patent  offices 
(NPOs) 

An  application  fee  and  possibly  other  procedural  fees,  such  as  the  fee  for  a  review  or  an 
appeal,  and  annual  (renewal)  fees,  will  have  to  be  paid  by  applicants  to  the  central 
examination authority. The level of fees to be paid to the central examination authority will be 
set in an implementing act. 

It  would  be  appropriate  that  a  fraction  of  the  renewal  fees  paid  by  unitary  SPC  holders  be 
transferred to the national patent offices15 of the Member States in which unitary SPCs have 
legal  effect  (as  already  planned  in  respect  of  renewal  fees  for  unitary  patents).  At  the  same 

15 

Or any other national authority competent for the grant of SPCs. 

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time, it is necessary to ensure that those national offices that participate in the new procedure 
as regards the substantive examination of unitary SPC applications are properly remunerated 
for their participation. 

Litigation 

It is intended that a unitary SPC will be able to be litigated before the body responsible under 
national  law  for  the  revocation  of  the  corresponding  basic  patent.  It  is  expected  that  the 
definition  of  SPCs  present  in  the  UPCA  will  be  amended  to  include  unitary  SPCs  as  well. 
Such amendment may be based on Article 87(2) of the UPCA. 

Centralised procedure for the grant of national SPCs 

A  parallel  proposal  (COM(2023)  223)  is  intended  to  create  a  centralised  procedure  for  the 
filing  and  examination  of  ‘centralised  SPC  applications’,  able  to  result  in  the  grant  (at  a 
national  level)  of  national  SPCs  in  the  Member  States  designated  in  that  application.  This 
procedure  would  be  available  potentially  for  all  Member  States,  and  only  on  the  basis  of  a 
European patent as basic patent. 

It  is  proposed that the procedure for the filing and examination of unitary  SPC applications 
would  be  the  same  (mutatis  mutandis)  as  the  centralised  procedure  defined  in  the  above-
mentioned  parallel  proposal.  In  this  manner,  a  ‘combined’  SPC  application  could  possibly 
include both a request for the grant of a unitary SPC (for the Member States covered by the 
basic  patent)  and  a  request  for  the  grant  of  national  SPCs  in  other  Member  States.  That 
‘combined’  application  would  undergo  a  single  examination  procedure,  ruling  out  any 
discrepancies, and considerably reducing costs and administrative burden for applicants. 

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2023/0126 (COD) 

Proposal for a 

REGULATION OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL 

on the unitary supplementary protection certificate for plant protection products 

(Text with EEA relevance) 

THE EUROPEAN PARLIAMENT AND THE COUNCIL OF THE EUROPEAN UNION, 

Having  regard  to  the  Treaty  on  the  Functioning  of  the  European  Union,  and  in  particular 
Article 118, first paragraph, thereof, 

Having regard to the proposal from the European Commission, 

After transmission of the draft legislative act to the national parliaments, 
Having regard to the opinion of the European Economic and Social Committee16, 
Having regard to the opinion of the Committee of the Regions17, 

Acting in accordance with the ordinary legislative procedure, 

Whereas: 

(1) 

(2) 

(3) 

(4) 

Phytopharmaceutical research plays a decisive role in the  continuing improvement in 
agriculture.  Plant  protection  products,  in  particular those  that  are  the  result  of  long, 
costly research will not continue to be developed in the Union unless they are covered 
by favourable rules that provide for sufficient protection to encourage such research. 

The period that elapses between the filing of an application for a patent for a new plant 
protection product and the authorisation to place that product on the market makes the 
period of effective protection under the patent insufficient to cover the investment put 
into the research. 

Uniform patent and supplementary protection within the internal market, or at least a 
significant  part  thereof,  should  feature  amongst  the  legal  instruments  which 
agrochemical undertakings have at their disposal to enhance their competitiveness. 

In  its  Communication  of  25  November  2020  entitled  ‘Making  the  most  of  the  EU’s 
innovative  potential  –  An  intellectual  property  action  plan  to  support  the  EU’s 
recovery  and  resilience’18,  the  Commission  highlighted  the  need  to  tackle  the 
remaining  fragmentation  of  the  Union’s  intellectual  property  system.  In  that 
Communication,  the  Commission  noted  that,  for  medicinal  products  and  plant 
protection  products,  supplementary  protection  is  only  available  at  national  level.  At 
the  same  time,  there  is  a  centralised  procedure  for  granting  European  patents.  In 

16 
17 
18 

OJ C […], […], p. […]. 
OJ C […], […], p. […]. 
COM(2020)760 final. 

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(5) 

(6) 

(7) 

(8) 

addition, the ‘unitary patent’ as laid down in Regulation (EU) No 1257/201219 enters 
into  force  on  1  June  2023  in  respect  for  all  Member  States  having  ratified  the 
Agreement on a Unified Patent Court (‘UPC’). 

Regulation (EU) No 1257/2012 has created the possibility to provide unitary patents. 
However,  Regulation  (EU)  No  1257/2012  does  not  provide  for  a  unitary 
supplementary protection certificate (‘unitary certificate’). 

In  the  absence  of  a  unitary  certificate,  a  unitary  patent  could  only  be  extended  by 
applying  for  several  national  certificates  in  each  Member  State  where  protection  is 
sought,  preventing  the  holder  of  a  unitary  patent  from  obtaining  unitary  protection 
during  the  whole  combined  protection  period  conferred  by  that  unitary  patent  and 
subsequently by these certificates. Therefore, a unitary certificate for plant protection 
products  should  be  created,  that  would  allow  a  unitary  patent  to  be  extended  in  a 
unitary  manner.  Such  a  unitary  certificate  should  be  applied  for  on  the  basis  of  a 
unitary basic patent and would have the same legal effects as national certificates in all 
Member States in which that basic patent has unitary effect. The main feature of such 
a unitary certificate should be its unitary character. 

A  unitary  certificate  should  provide  uniform  protection  and  have  equal  effect  in  all 
Member States where the basic patent it relies upon has unitary  effect, except  in  the 
case  of  temporary  suspension  of  the  effect  to  allow  for  marketing  authorisations 
granted  at  different  times.  Consequently,  a  unitary  certificate  should  only  be 
transferred or revoked, or expire, in respect of all those Member States. 

Regulation [COM(2023) 223] replaces Regulation (EC) No 1610/96 of the European 
Parliament and of the Council20, and includes new provisions establishing a centralised 
procedure  for  the  examination  of  supplementary  protection  certificates  for  plant 
protection products. 

(9) 

Considering that certain Member States have not yet joined the unitary patent system, 
certificates granted by national patent offices should remain available. 

(10)  To  avoid  discrimination  between  applicants  for  certificates  under  Regulation 
[COM(2023) 223] and for unitary certificates under this Regulation, and distortions of 
the  internal  market,  the  same  substantive  rules  should  apply,  with  appropriate 
adaptations,  to  certificates  under  Regulation  [COM(2023)  223]  and  to  unitary 
certificates, in particular as regards the conditions for grant of a certificate, as well as 
the duration and effects of a certificate. 

(11) 

In particular, the duration of the protection granted by a unitary certificate should be 
identical to the duration provided for as regards national certificates under Regulation 
[COM(2023) 223]; namely, the holder of both a unitary patent and a unitary certificate 
should be able to enjoy an overall maximum of 15 years of exclusivity from the time 
the plant protection product in question first obtains an authorisation to be placed on 
the market in the Union. Since the unitary certificate would take effect at the expiry of 
the basic patent, and in order to  take into account  discrepancies in  national  practices 

19 

20 

Regulation (EU) No 1257/2012 of the European Parliament and of the Council of 17 December 2012 
implementing enhanced cooperation in the area of the creation of unitary patent protection (OJ L 361, 
31.12.2012, p. 1). 
Regulation (EC) No 1610/96 of the European Parliament and of the Council of 23 July 1996 concerning 
the creation of a supplementary protection certificate for plant protection products (OJ L 198, 8.8.1996, 
p. 30). 

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regarding  the  date  of  expiry  of  a  patent  which  may  result  in  1-day  differences,  this 
Regulation should clarify when exactly the protection conferred by a unitary certificate 
should take effect. 

(12)  Regulation (EU) No 2017/1001 of the European Parliament and of the Council21 has 
established,  under  its  Article  2,  a  European  Union  Intellectual  Property  Office  (‘the 
Office’). In the interest of the internal market, and due to the autonomous nature of the 
unitary  certificate,  its  examination  and  grant  procedure  should  be  carried  out  by  a 
single  examining  authority.  This  can  be  achieved  by  giving  the  Office  the  task  of 
examining both applications for unitary certificates in accordance with this Regulation 
and  Regulation  [COM(2023)  222]  and  centralised  applications  for  certificates  under 
Regulations [COM(2023) 231] and [COM(2023) 223]. 

(13) 

In  the  absence  of  a  centralised  marketing  authorisation,  marketing  authorisations  are 
granted  at  a  national  level.  Accordingly,  authorisations  in  respect  of  a  given  plant 
protection  product  may  have  a  slightly  different  scope  in  different  Member  States. 
Nevertheless,  a  unitary  certificate  should  confer  protection  to  that  plant  protection 
product  only  to  the  extent  that  it  is  duly  covered  by  the  marketing  authorisations 
granted in each of the Member States in which the basic patent has unitary effect. 

(14)  The  fact  that  marketing  authorisations  in  respect  of  a  given  plant  protection  product 
may  be  granted  at  different  dates  in  different  Member  States  would  in  many  cases 
make the grant of a unitary certificate for a given plant protection product impossible, 
if it was  required that  authorisations  must have  been  granted in  all  relevant  Member 
States – i.e. those in which the basic patent has unitary effect – by the time of the filing 
of the application. An applicant should therefore be allowed to file an application for a 
unitary certificate where marketing authorisations have been applied for in all relevant 
Member  States,  provided  that  such  authorisations  are  granted  before  the  end  of  the 
examination process – which for that reason should not be completed earlier than  18 
months from the filing of the application. Where no authorisation has been granted in 
a  relevant  Member  State  before  the  completion  of  the  examination,  the  unitary 
certificate  should  not  have  any  effect  in  respect  of  that  Member  State  until  a  valid 
authorisation is granted in that Member State. However, that suspensory effect should 
be  lifted  where  an  outstanding  authorisation  is  granted  after  the  grant  of  the  unitary 
certificate  but  –  to  ensure  legal  certainty  –  before  the  expiry  of  the  basic  patent, 
following  a  request  to  that  end  by  the  holder  of  the  unitary  certificate,  subject  to  a 
verification of that request by the Office. 

(15)  An applicant should also be allowed to lodge a ‘combined application’ that would also 
include the designation of Member States, other than those in which the basic patent 
has unitary effect, in which the grant of national certificates would be requested as set 
out  in  Regulation  [COM(2023) 223]. Such a combined application should undergo a 
single examination procedure. 

(16) 

In  such  an  event,  double  protection  by  both  a  unitary  certificate  and  a  national 
certificate – whether obtained on the basis of a national application or of a centralised 
application – should be excluded in any Member State. 

(17)  One of the conditions for the grant of a certificate should be that the product should be 
protected by the basic patent, in the sense that the product should fall within the scope 

21 

Regulation  (EU)  2017/1001  of  the  European  Parliament  and  of  the  Council  of  14  June  2017  on  the 
European Union trade mark (OJ L 154, 16.6.2017, p. 1). 

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16 

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of one or more claims of that patent, as interpreted by the person skilled in the art by 
the description of the patent on its filing date. This should not necessarily require that 
the  active  substance  of  the  product  be  explicitly  identified  in  the  claims.  Or,  in  the 
event  of  a  preparation,  this  should  not  necessarily  require  that  each  of  its  active 
substances  be  explicitly  identified  in  the  claims,  provided  that  each  of  them  is 
specifically identifiable in the light of all the information disclosed by that patent. 

(18)  To  avoid  overprotection,  it  should  be  provided  that  no  more  than  one  certificate, 
whether  national  or  unitary,  may  protect  the  same  product  in  a  Member  State. 
Therefore it should be required that the product, or any derivative such as salts, esters, 
ethers,  isomers, mixtures of isomers, or complexes, equivalent  to  the product  from  a 
phytosanitary  perspective,  should  not  have  already  been  the  subject  of  a  prior 
certificate,  either  alone  or  in  combination  with  one  or  more  additional  active 
ingredients, whether for the same application or for a different one. 

(19)  Within  the  limits  of  the  protection  conferred  by  the  basic  patent,  the  protection 
conferred by a unitary certificate should extend only to the product, namely the active 
substance  or  combinations  thereof,  covered  by  the  authorisation  to  place  it  on  the 
market  and  for  any  use  of  the  product  as  a  plant  protection  product  that  has  been 
authorised before the expiry of the unitary certificate. 

(20)  To ensure balanced protection, however, a unitary certificate should entitle its holder 
to  prevent  a  third  party  from  manufacturing  not  only  the  product  identified  in  the 
unitary  certificate  but  also  derivatives  of  that  product,  such  as  salts,  esters,  ethers, 
isomers,  mixtures  of  isomers,  or  complexes,  equivalent  to  the  product  from  a 
phytosanitary perspective, even where such derivatives are not explicitly mentioned in 
the product description on the unitary certificate. There is therefore a need to consider 
that  the  protection  conferred  by  the  unitary  certificate  extends  to  such  equivalent 
derivatives, within the limits of the protection conferred by the basic patent. 

(21)  As a further measure to ensure that no more than one certificate may protect the same 
product in any Member State, the holder of more than one patent for the same product 
should not be granted more than one certificate for that product. However, where two 
patents protecting the product are held by two holders, one certificate for that product 
should be allowed to be granted to each of those holders, where they can demonstrate 
that they are not economically linked. Furthermore, no certificate should be granted to 
the  proprietor  of  a  basic  patent  in  respect  of  a  product  which  is  the  subject  of  an 
authorisation held by a third party, without that party’s consent. 

(22)  As regards unitary certificate applications for plant protection products, the condition 
for  grant  relating  to  the  authorisation  being  the  first  one  should  be  fulfilled  on  a 
country-by-country basis. 

(23)  To ensure alignment with the rules applicable to unitary patents, a unitary certificate as 
an object of property should be dealt with, in its entirety and in all Member States in 
which  it  has  effect,  as  a  national  certificate  of  the  Member  State  determined  in 
accordance with the law that applies to the basic patent. 

(24)  To guarantee a fair and transparent process, ensure legal certainty and reduce the risk 
of  subsequent  validity  challenges,  third  parties  should  have  the  possibility,  after  the 
publication  of  the  unitary  certificate  application,  to  submit  within  3  months 
observations to the Office while the centralised examination is being performed. These 
third parties allowed to submit observations should also include Member States. This, 
however, should not  affect  the rights  of third parties to  initiate subsequent  invalidity 

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proceedings before the Office. These provisions are necessary to ensure involvement 
of third parties both before and after the grant of certificates. 

(25)  The examination of an application for a unitary certificate should be conducted, under 
supervision  of  the  Office,  by  an  examination  panel  including  one  member  of  the 
Office as well as two examiners employed by the national patent offices. This would 
ensure that optimal use be made of expertise in supplementary protection certificates 
matters,  located  today  at  national  offices  only.  To  ensure  an  optimal  quality  of  the 
examination,  suitable  criteria  should  be  laid  down  in  respect  of  the  participation  of 
specific examiners in the procedure, in particular as regards qualification and conflicts 
of interest. 

(26)  The  Office  should  examine  the  application  for  a  unitary  certificate  and  issue  an 
examination opinion. That opinion should state the reasons for which it is positive or 
negative. 

(27)  To  safeguard  third  parties’  procedural  rights  and  ensure  a  complete  system  of 
remedies,  third  parties  should  be  able  to  challenge  an  examination  opinion,  by 
initiating opposition proceedings within a short duration following the publication of 
that opinion, and that opposition may result in that opinion being amended. 

(28)  After the completion of the examination of a unitary certificate application, and after 
the time limits for appeal and opposition have expired, or, the case being, after a final 
decision on the merits has been issued, the Office should implement the examination 
opinion by granting a unitary certificate or rejecting the application, as applicable. 

(29)  Where the applicant or another party is adversely affected by a decision of the Office, 
the  applicant  or  that  party  should  have  the  right,  subject  to  a  fee,  to  file  within  2 
months an appeal  against  the decision, before  a  Board of Appeal  of the  Office. This 
also  applies  to  the  examination  opinion,  that  may  be  appealed  by  the  applicant. 
Decisions of that Board of Appeal should, in turn, be amenable to actions before the 
General  Court,  which  has  jurisdiction  to  annul  or  to  alter  the  contested  decision.  In 
case of a combined application including the designation of additional Member States 
with a view to the grant of national certificates, a common appeal may be filed. 

(30)  When appointing members of the Boards of Appeal in matters regarding applications 
for unitary certificates, their prior experience in supplementary protection certificate or 
patent matters should be taken into account. 

(31)  Any  person  may  challenge  the  validity  of  a  unitary  certificate  by  lodging  with  the 

Office an application for a declaration of invalidity. 

(32)  The Office should have the possibility to charge a fee for the application for a unitary 
certificate, as well as other procedural fees such as those for oppositions, appeals and 
invalidity.  The  fees  charged  by  the  Office  should  be  laid  down  by  an  implementing 
act. 

(33)  Annual fees in respect of unitary certificates  (also known as renewal fees) should be 
paid to the Office, which should retain a part of them to cover the expenses generated 
by carrying out tasks in relation to the grant of unitary certificates while the remaining 
part  would  be  shared  with  those  Member  States  in  which  unitary  certificates  have 
effect. 

(34)  To  ensure  transparency,  a  register  should  be  set  up  that  can  serve  as  a  single  access 
point providing information on applications for unitary certificates as well as granted 

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unitary  certificates  and  their  status.  The  register  should  be  available  in  all  official 
languages of the Union. 

(35)  For  the  tasks  conferred  on  the  Office  under  this  Regulation,  the  languages  of  the 
Office should be all official languages of the Union, to enable actors across the Union 
to easily apply for unitary certificates or submit third party observations and result in 
optimal transparency for all stakeholders across the Union.  The Office should accept 
verified translations, into one of the official languages of the Union, of documents and 
information. The Office may, if appropriate, use verified machine translations. 

(36)  Financial provision should be made to ensure that competent national authorities that 
participate  in  the  centralised  procedure  are  adequately  remunerated  for  their 
participation. 

(37)  The necessary set-up costs related to  the tasks conferred to  the Office, including the 
costs  of  new  digital  systems,  should  be  financed  from  the  Office’s  accumulated 
budgetary surplus. 

(38) 

(39) 

In order to supplement certain non-essential elements of this Regulation, the power to 
adopt  acts,  in  accordance  with  Article  290  of  the  Treaty  on  the  Functioning  of  the 
European Union, should be delegated to the Commission in respect of: (i) specifying 
the content and form of the notice of appeal and the content and the form of the Boards 
of  Appeal’s  decision,  (ii)  specifying  the  details  concerning  the  organisation  of  the 
Boards  of  Appeal  in  proceedings  relating  to  certificates,  (iii)  specifying  the  rules  on 
the means of communication, including the electronic means of communication, to be 
used  by  the  parties  to  proceedings  before  the  Office  and  the  forms  to  be  made 
available by the Office, (iv) setting out the detailed arrangements for oral proceedings, 
(v) setting out the detailed arrangements for the taking of evidence, (vi) setting out the 
detailed  arrangements  for  notification,  (vii)  specifying  the  details  regarding  the 
calculation and duration of time limits and (viii) setting out the detailed arrangements 
for the resumption of proceedings. It is of particular importance that the Commission 
carry  out  appropriate  consultations  during  its  preparatory  work,  including  at  expert 
level, and that those consultations be conducted in accordance with the principles laid 
down in the Interinstitutional Agreement on Better Law-Making of 13 April 2016.22 In 
particular,  to  ensure  equal  participation  in  the  preparation  of  delegated  acts,  the 
European  Parliament  and  the  Council  receive  all  documents  at  the  same  time  as 
Member  States'  experts,  and  their  experts  systematically  have  access  to  meetings  of 
Commission expert groups dealing with the preparation of delegated acts. 

In  order  to  ensure  uniform  conditions  for  the  implementation  of  this  Regulation, 
implementing  powers  should  be  conferred  on  the  Commission  as  regards:  (i)  the 
application  forms  to  be  used;  (ii)  rules  on  procedures  relating  to  the  filing,  and 
procedures  regarding  the  way  in  which  examination  panels  examine  centralised 
applications and prepare examination opinions, as well as the issuance of examination 
opinions by the Office, (iii) the criteria in the ways the examination panels are to be set 
up, and the criteria for the selection of examiners, (iv) the amounts of the applicable 
fees to be paid to the Office, (v) specifying the maximum rates for costs essential to 
the  proceedings  and  actually  incurred  by  the  successful  party,  and  (vi)  rules  on  the 
financial  transfers  between  the  Office  and  Member  States,  the  amounts  of  these 
transfers, and the remuneration to be paid by the Office regarding the participation of 

22 

Interinstitutional Agreement between the European Parliament, the Council of the European Union and 
the European Commission on Better Law-Making (OJ L 123, 12.5.2016, p. 1). 

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competent national authorities. Those powers should be exercised in accordance with 
Regulation (EU) No 182/2011 of the European Parliament and of the Council23. 

(40)  The  Commission  should  regularly  report  on  the  operation  of  this  Regulation,  in 

coordination with that required in Regulation [COM(2023) 223]. 

(41)  This Regulation respects the fundamental rights and observes the principles recognised 
in  particular  by  the  Charter  of  Fundamental  Rights  of  the  European  Union  (‘the 
Charter’). The rules in this Regulation should be interpreted and applied in accordance 
with  those  rights  and  principles.  In  particular,  this  Regulation  seeks  to  ensure  full 
respect for the right to property and the right to health care and the right to an effective 
remedy in Articles 17 and 47 of the Charter. 

(42)  Since the objectives of this Regulation cannot be sufficiently achieved by the Member 
States  but  can  rather,  by  reason  of  the  autonomous  nature  of  the  unitary  SPC  being 
independent from national systems, be better achieved at Union level, the Union may 
adopt measures, in accordance with the principle of subsidiarity as set out in Article 5 
of the Treaty on European Union. In accordance with the principle of proportionality 
as set out in that Article, this Regulation does not go beyond what is necessary in order 
to achieve those objectives. 

(43)  The  European  Data  Protection  Supervisor  was  consulted  in  accordance  with 
Article 42(1) of Regulation (EU) 2018/172524 and delivered an opinion on XXX [OP, 
please add reference once available]. 

(44)  Provision  should  be  made  for  appropriate  arrangements  to  facilitate  a  smooth 
implementation  of  the  rules  provided  for  in  this  Regulation.  To  allow  for  sufficient 
time for the Office to prepare the operational set-up and launch of the procedure to be 
used for the grant of unitary certificates, as set out in this Regulation, the application 
of this Regulation should be deferred, 

HAVE ADOPTED THIS REGULATION: 

Article 1 

Subject matter 

This Regulation lays down rules on the unitary supplementary protection certificate (‘unitary 
certificate’) for plant protection products protected by  a European patent  with  unitary  effect 
and  subject,  prior  to  being  placed  on  the  market  as  a  plant  protection  product,  to  an 
administrative authorisation procedure as laid down in Regulation (EC) No 1107/2009 of the 
European Parliament and of the Council25. 

23 

24 

25 

Regulation  (EU)  No  182/2011  of  the  European  Parliament  and  of  the  Council  of  16  February  2011 
laying down the rules and general principles concerning mechanisms for control by the Member States 
of the Commission's exercise of implementing powers (OJ L 55, 28.2.2011, p. 13). 
Regulation (EU) 2018/1725 of the European Parliament and of the Council of 23 October 2018 on the 
protection of natural persons with regard to the  processing of personal data by the Union institutions, 
bodies, offices and agencies and on the free movement of such data, and repealing Regulation (EC) No 
45/2001 and Decision No 1247/2002/EC (OJ L 295, 21.11.2018, p. 39). 
Regulation  (EC)  No  1107/2009  of  the  European  Parliament  and  of  the  Council  of  21  October  2009 
concerning  the  placing  of  plant  protection  products  on  the  market  and  repealing  Council  Directives 
79/117/EEC and 91/414/EEC (OJ L 309 24.11.2009, p. 1). 

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Article 2 

Definitions 

For the purposes of this Regulation, the following definitions shall apply: 

(1) 

‘plant protection products’ means active substances and preparations containing one 
or more active substances, put up in the form in which they are supplied to the user, 
intended to: 

(a) 

(b) 

(c) 

protect  plants  or  plant  products  against  all  harmful  organisms  or  prevent  the 
action of such organisms, in so far as such substances or preparations are not 
otherwise defined below; 

influence the life processes of plants, other than as a nutrient (e.g. plant growth 
regulators); 

preserve plant products, in so far as such substances or products are not subject 
to special Council or Commission provisions on preservatives; 

(d)  destroy undesirable plants; 

(e) 

destroy parts of plants, check or prevent undesirable growth of plants; 

(2) 

(3) 

(4) 

(5) 

(6) 

(7) 

(8) 

(9) 

‘substances’ means chemical elements and their compounds, as they occur naturally 
or  by  manufacture, 
the 
manufacturing process; 

inevitably  resulting  from 

including  any 

impurity 

‘active  substances’  means  substances  or  micro-organisms  including  viruses,  having 
general or specific action: 

(a) 

 against harmful organisms;  

(b)  or on plants, parts of plants or plant products; 

‘preparations’ means mixtures or solutions composed of two or more substances, of 
which  at  least  one  is  an  active  substance,  intended  for  use  as  plant  protection 
products; 

‘plants’ means live plants and live parts of plants, including fresh fruit and seeds; 

‘plant  products’  means products  in  the  unprocessed  state  or  having  undergone  only 
simple  preparation  such  as  milling,  drying  or  pressing,  derived  from  plants,  but 
excluding plants themselves; 

‘harmful organisms’ means pests of plants or plant products belonging to the animal 
or plant kingdom, and also viruses, bacteria and mycoplasmas and other pathogens; 

‘product’ means the active substance or combination of active substances of a plant 
protection product; 

'European  patent'  means  a  patent  granted  by  the  European  Patent  Office  (‘EPO’) 
under  the  rules  and  procedures  laid  down  in  the  European  Patent  Convention26 
('EPC'); 

(10) 

‘unitary  patent’  means  a  European  patent  which  benefits  from  unitary  effect  in  the 
Member  States  participating  in  the  enhanced  cooperation  laid  down  in  Regulation 
(EU) No 1257/2012; 

26 

Convention on the Grant of European Patents of 5 October 1973, as revised on 17 December 1991 and 
on 29 November 2000. 

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(11) 

(12) 

(13) 

'basic patent' means a unitary patent which protects a product as such, a preparation, 
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 unitary certificate;  

'centralised  application'  means an  application  made  before  the  European  Union 
Intellectual  Property  Office  (‘the  Office’)  pursuant  to  Chapter  III  of  Regulation 
[COM(2023) 223] with a view to the grant of certificates, for the product identified 
in the application, in the designated Member States; 

‘competent  national  authority’  means  the  national  authority  that  is  competent,  in  a 
given Member State, for the grant of certificates and for the rejection of applications 
for certificates. 

Article 3 

Conditions for obtaining a unitary certificate 

1. 

A unitary certificate shall be granted by the Office on the basis of a basic patent if, in 
each of the Member States in which that basic patent has unitary effect, at the date of 
the application, all of the following conditions are fulfilled: 

(a) 

(b) 

(c) 

(d) 

the product is protected by that basic patent in force; 

a  valid  authorisation  to  place  the  product  on  the  market  as  a  plant  protection 
product has been granted in accordance with Regulation (EC) No 1107/2009; 

the  product  has  not  already  been  the  subject  of  a  certificate,  nor  of  a  unitary 
certificate; 

the  authorisation  referred  to  in  point  (b)  is  the  first  authorisation  to  place  the 
product on the market as a plan protection product. 

2. 

The holder of more than one patent for the same product shall not be granted more 
than  one  certificate  or  unitary  certificate  for  that  product  for  any  given  Member 
State. 

Where  two  or  more  applications,  whether  national  or  centralised  applications  for 
certificates, or applications for unitary certificates, concerning the same product and 
submitted  by  two  or  more  holders  of  different  patents  are  pending  for  a  given 
Member State, one certificate or unitary certificate for that product may be granted to 
each  of  those  holders,  where  they  are  not  economically  linked,  by  a  competent 
national authority or by the Office, as applicable. 

3. 

A unitary certificate shall also be granted for a given plant protection product if the 
following conditions are fulfilled: 

(a) 

at the date of the application, in each of the Member States in which the basic 
patent has unitary effect, an authorisation to place the product on the market as 
a plant protection product has been applied for in accordance with Regulation 
(EC)  No  1107/2009,  but  an  authorisation  has  not  yet  been  granted  in  at  least 
one of these Member States; 

(b)  before  the  examination  opinion  is  adopted,  valid  authorisations  have  been 
granted  in  each  of  the  Member  States  in  which  the  basic  patent  has  unitary 
effect. 

4. 

Where  the  condition  set  out  in  paragraph  3,  point  (a),  is  fulfilled,  the  examination 
opinion shall not be adopted earlier than 18 months after the application was filed. 

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5. 

By  way  of  derogation  from  paragraph  3,  where  only  the  condition  set  out  in 
paragraph  3,  point  (a),  is  fulfilled  in  respect  of  a  Member  State  in  which  the  basic 
patent  has  unitary  effect,  a  unitary  certificate  shall  be  granted,  but  shall  not  have 
effect in that Member State. 

Where a unitary certificate is granted in accordance with the first subparagraph,  the 
applicant may submit to the Office a marketing authorisation subsequently granted in 
that Member State before the expiry of the basic patent, together with a request for 
the effect of the unitary certificate to resume in that Member State. The Office shall 
assess  whether  the  conditions  set  out  in  paragraph  1  are  fulfilled  in  respect  of  that 
Member State, and shall issue a decision on whether the effect shall resume. 

Article 4 

Scope of the protection 

Within the limits of the protection conferred by the basic patent, the protection conferred by a 
unitary certificate shall extend only to the product covered, in each of the Member States in 
which that basic patent has unitary effect, by an authorisation to place the corresponding plant 
protection product on the market and for any use of the product as a plant protection product 
that has been authorised before the expiry of the unitary certificate. 

Article 5 

Effects of the unitary certificate 

1. 

2. 

1. 

2. 

The unitary certificate shall confer the same rights  as  conferred by the basic patent 
and shall be subject to the same limitations and the same obligations, in all Member 
States in which the basic patent has unitary effect. 

A  unitary  certificate  shall  have  a  unitary  character.  It  shall  provide  uniform 
protection and shall have equal effect in all Member States in which the basic patent 
has unitary effect. The unitary certificate may only be limited, transferred or revoked, 
or lapse, in respect of all those Member States. 

Article 6 

Entitlement to the unitary certificate 

The  unitary  certificate  shall  be  granted  to  the  holder  of  the  basic  patent  or  to  the 
successor in title of that holder. 

Notwithstanding paragraph 1, where a basic patent has been granted in respect of a 
product  that  is  the  subject  of  an  authorisation  held  by  a  third  party,  a  unitary 
certificate  for  that  product  shall  not  be  granted  to  the  holder  of  the  basic  patent 
without the consent of that third party. 

Article 7 

The unitary certificate as an object of property 

A unitary certificate or an application for a unitary certificate as an object of property shall be 
treated in  its  entirety,  in each Member State in  which the basic patent  has  unitary  effect, in 
accordance with the national law applicable to the basic patent as an object of property.   

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Article 8 

Application for a unitary certificate 

1. 

2. 

The application for a unitary certificate shall be lodged within 6 months of the date 
on  which  the  first  authorisation  referred  to  in  Article  3(1),  point  (b),  to  place  the 
product  on  the  market  as  a  plant  protection  product  was  granted  in  one  of  the 
Member States in which the basic patent has unitary effect. 

Notwithstanding  paragraph  1,  where  an  authorisation  to  place  the  product  on  the 
market  are  granted  in  a  Member  State  in  which  the  basic  patent  has  unitary  effect, 
before  unitary  effect  is  attributed  to  the  basic  patent,  the  application  for  a  unitary 
certificate  shall  be  lodged  within  6  months  of  the  date  on  which  unitary  effect  is 
attributed to the basic patent. 

Content of the application for a unitary certificate 

1. 

The application for a unitary certificate shall contain the following: 

Article 9 

(a) 

 a  request  for  the  grant  of  a  unitary  certificate,  stating  the  following 
information: 

(i) 

the name and address of the applicant; 

(ii) 

if  the applicant has  appointed a representative, the name and address  of 
that representative; 

(iii) 

the number of the basic patent and the title of the invention; 

(iv) 

the number and date of the first authorisation to place the product on the 
market, as referred to in Article 3(1), point (b), and, if this authorisation 
is not the first authorisation for placing the product on the market in the 
Union, the number and date of that authorisation; 

(a) 

 a copy of the authorisation to place the product on the market, as referred to in 
Article  3(1),  point  (b),  in  which  the  product  is  identified,  containing  in 
particular  the  number  and  date  of  the  authorisation  and  the  summary  of  the 
product  characteristics  listed  in  Part  A,  Section  1,  points  1.1  to  1.7,  of 
Commission Regulation 283/201327 or Part B, Section 1, points 1.1 to 1.4.3, of 
that Regulation or in equivalent national laws of the Member State in which the 
application was lodged; 

(b)  where the authorisation referred to in point (b) is not the first authorisation for 
placing  the  product  on  the  market  as  a  medicinal  product  in  the  Union, 
information regarding the identity of the product thus authorised and the legal 
provision under which the authorisation procedure took place, together with a 
copy  of  the  notice  publishing  the  authorisation  in  the  appropriate  official 
publication or, in the absence of such a notice, any other document proving that 
the  authorisation  has  been  issued,  the  date  on  which  it  was  issued  and  the 
identity of the product authorised. 

27 

Commission Regulation (EU) No 283/2013 of 1 March 2013 setting out the data requirements for active 
substances, in accordance with Regulation (EC) No 1107/2009 of the European Parliament  and of the 
Council concerning the placing of plant protection products on the market (OJ L 093 3.4.2013, p. 1). 

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2. 

The  application  referred  to  in  this  Article  shall  be  filed  by  using  a  specific 
application form. 

The Commission is empowered to adopt implementing acts laying down rules on the 
application form to be used. Those implementing acts shall be adopted in accordance 
with the examination procedure referred to in Article 50. 

Lodging of an application for a unitary certificate 

The application for a unitary certificate shall be lodged with the Office. 

Article 10 

Article 11 

Examination of the admissibility of a centralised application for a unitary certificate 

1. 

The Office shall examine the following: 

(a)  whether the application for a unitary certificate complies with Article 9; 

(b)  whether the application complies with Article 8; 

(c)  whether the application fee referred to in Article 29(1) has been paid within the 

prescribed period. 

2. 

3. 

4. 

Where  the  centralised  application  does  not  satisfy  the  requirements  referred  to  in 
paragraph 1, the Office shall request the applicant to take the measures necessary to 
satisfy those requirements, and shall set a deadline for such compliance. 

Where the fee referred to in paragraph 1, point (c), has not been paid or has not been 
paid in full, the Office shall inform the applicant accordingly. 

If the applicant does not satisfy the requirements referred to in paragraph 1 within the 
deadline  referred  to  in  paragraph  2,  the  Office  shall  reject  the  application  for  a 
unitary certificate. 

 Article 12 

Publication of the application 

If the application for a unitary certificate complies with Article 11(1), the Office shall publish 
the application in the Register. 

Article 13 

Examination of the application for a unitary certificate 

1. 

2. 

3. 

The  Office  shall  assess  the  application  on  the  basis  of  all  the  conditions  in  Article 
3(1), for all Member States in which the basic patent has unitary effect. 

Where  the  application  for  a  unitary  certificate  and  the  product  to  which  it  relates 
comply with Article 3(1) for each of the Member States referred to in paragraph 1, 
the Office shall issue a reasoned positive examination opinion in respect of the grant 
of a unitary certificate. The Office shall notify that opinion to the applicant. 

Where the application for a unitary certificate and the product to which it relates does 
not comply with Article 3(1) in respect of one or more of those Member States, the 

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4. 

5. 

1. 

2. 

3. 

4. 

5. 

1. 

2. 

3. 

4. 

Office shall issue a reasoned negative examination opinion on the grant of a unitary 
certificate. The Office shall notify that opinion to the applicant. 

The examination opinion shall be translated in the official languages of all Member 
States  in  which  the  basic  patent  has  unitary  effect.  The  Office  may  use  verified 
machine translation to that effect. 

The  Commission  is  empowered  to  adopt  implementing  acts  laying  down  rules  on 
procedures  relating  to  the  filing,  and  procedures  regarding  the  way  in  which 
examination  panels  examine  applications  for  unitary  certificates  and  prepare 
examination opinions, as well as the issuance of examination opinions by the Office. 
Those  implementing  acts  shall  be  adopted  in  accordance  with  the  examination 
procedure referred to in Article 50. 

Article 14 

Observations by third parties 

Any  natural  or  legal  person  may  submit  written  observations  to  the  Office 
concerning  the  eligibility  for  supplementary  protection  of  the  product  to  which  the 
application  relates,  in  one  or  more  of  the  Member  States  in  which  the  basic  patent 
has unitary effect. 

A natural  or legal  person that has  submitted the written observations  in  accordance 
with paragraph 1 shall not be a party to the proceedings. 

Third party observations shall be submitted within 3 months after publication of the 
application in the Register. 

Any observations by a third party shall be submitted in writing in one of the official 
languages of the Union and state the grounds on which they are based. 

Any  observations  by  a  third  party  shall  be  notified  to  the  applicant.  The  applicant 
may comment on the observations within a time limit set by the Office. 

Article 15 

Opposition 

Within a period of 2 months following the publication of the examination opinion in 
respect  of  an  application  for  a  unitary  certificate,  any  person  (‘opponent’)  may  file 
with the Office a notice of opposition to that opinion. 

Opposition may only be filed on the grounds that one or more of the conditions set 
out in Article 3 are not fulfilled for one or more of the Member States in which the 
basic patent has unitary effect. 

Opposition  shall  be  filed  in  writing,  and  shall  specify  the  grounds  on  which  it  is 
made. It shall not be considered as duly filed until the opposition fee has been paid. 

The notice of opposition shall contain: 

(a) 

the references of the unitary certificate application against which opposition is 
filed, the name of its holder, and the identification of the product; 

(b) 

the particulars of the opponent and, where applicable, of its representative; 

(c) 

a statement of the extent to which the examination opinion is opposed, and of 
the grounds on which the opposition is based. 

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5. 

6. 

7. 

1. 

9. 

10. 

11. 

12. 

13. 

1. 

2. 

The  opposition  shall  be  examined  by  an  opposition  panel  set  up  by  the  Office  in 
accordance with the rules applicable to  examination panels as referred to in Article 
17.  However,  the  opposition  panel  shall  not  include  any  examiner  previously 
involved in the examination panel that examined the unitary certificate application. 

If  the  opposition  panel  notes  that  the  notice  of  opposition  does  not  comply  with 
paragraphs 2, 3 or 4, it shall reject the opposition as inadmissible, and communicate 
this to opponent, unless these deficiencies have been remedied before expiry of the 
opposition filing period referred to in paragraph 1. 

The  decision  to  reject  an  opposition  as  inadmissible  shall  be  communicated  to  the 
holder  of  the  unitary  certificate  application,  together  with  a  copy  of  the  notice  of 
opposition. 

A notice of opposition shall be inadmissible where a previous appeal relating to the 
same  subject  matter  and  cause  of  action  has  been  adjudicated  on  its  merits  by  the 
Office, and the decision of the Office on that appeal has acquired the authority of a 
final decision. 

Where  the  opposition  is  not  rejected  as  inadmissible,  the  Office  shall  promptly 
transmit the notice of opposition to the applicant, and shall publish it in the Register. 
If  several  notices  of  opposition  have  been  filed,  the  Office  shall  promptly 
communicate them to the other opponents. 

The  Office  shall  issue  a  decision  on  the  opposition  within  6  months,  unless  the 
complexity of the case requires a longer period. 

If  the  opposition  panel  considers  that  no  ground  for  opposition  prejudices  the 
maintenance of the examination opinion, it shall reject the opposition, and the Office 
shall mention this in the Register. 

If  the  opposition  panel  considers  that  at  least  one  ground  for  opposition  prejudices 
the maintenance of the examination opinion, it shall adopt an amended opinion, and 
the Office shall mention this in the Register. 

The Commission is empowered to adopt delegated acts in accordance with Article 49 
to  supplement  this  Regulation  by  specifying  the  details  of  the  procedure  for  filing 
and examining an opposition. 

Article 16 

Role of competent national authorities 

On a request made to the Office, any competent national authority may be appointed 
by  the  Office  as  a  participating  office  in  the  examination  procedure.  Once  a 
competent  national  authority  is  appointed  in  accordance  with  this  Article,  that 
authority shall designate one or more examiners to be involved in the examination of 
one or more applications for unitary certificates. 

The  Office  and  the  competent  national  authority  shall  conclude  an  administrative 
agreement  before  that  competent  national  authority  is  appointed  as  participating 
office as referred to in paragraph 1. 

The agreement shall specify the rights and obligations of the parties, in particular the 
formal  undertaking  by  the  competent  national  authority  concerned  to  comply  with 
this Regulation as regards the examination of applications for unitary certificates.  

EN 

27 

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3. 

4. 

5. 

1. 

2. 

3. 

4. 

5. 

The  Office  may  appoint  a  competent  national  authority  as  a  participating  office  as 
referred to in paragraph 1 for 5 years. That appointment may be extended for further 
periods of 5 years. 

The Office shall, before appointing a  competent  national authority, or extending its 
appointment,  or  before  any  such  appointment  expires,  hear  the  competent  national 
authority concerned. 

Each  competent  national  authority  appointed  under  this  Article  shall  provide  the 
Office  with  a  list  identifying  the  individual  examiners  who  are  available  for 
participation  in  examination,  opposition  and  invalidity  proceedings.  Each  such 
competent national authority shall update that list in the event of a change. 

Article 17 

Examination panels 

The assessments under Articles 13, 15 and 22 shall be conducted by an examination 
panel including one member of the Office as well as two examiners as referred to in 
Article  16(1)  from  two  different  participating  competent  national  authorities,  under 
supervision of the Office. 

Examiners  shall  be  impartial  in  the  exercise  of  their  duties  and  shall  declare  to  the 
Office any real or perceived conflict of interest upon their designation. 

When setting up an examination panel, the Office shall ensure the following: 

(a) 

geographical balance amongst the participating offices;  

(b) 

the respective workload of the examiners is taken into account; 

(c) 

no  more  than  one  examiner  employed  by  a  competent  national  authority 
making  use  of  the  exemption  set  out  in  Article  10(5)  of  Regulation 
[COM(2023) 223]. 

The  Office  shall  publish  a  yearly  overview  of  the  number  of  procedures,  including 
those  for  examination,  opposition,  appeal  and  invalidity,  each  competent  national 
authority participated in. 

The Commission is empowered to adopt implementing acts to determine the criteria 
in the ways the panels are to be set up, and the criteria for the selection of examiners. 
Those  implementing  acts  shall  be  adopted  in  accordance  with  the  examination 
procedure referred to in Article 50. 

Article 18 

Grant of a unitary certificate or rejection of the application for a unitary certificate 

After  the  period  during  which  an  appeal  or  an  opposition  may  be  filed  has  expired  without 
any appeal nor opposition being filed, or after a final decision on the merits has been issued, 
the Office shall take one of the following decisions: 

(a)  where  the  examination  opinion  is  positive,  the  Office  shall  grant  a  unitary 

certificate; 

(b)  where  the  examination  opinion  is  negative,  the  Office  shall  reject  the 

application for a unitary certificate. 

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Article 19 

Duration of the unitary certificate 

1. 

2. 

The  unitary  certificate  shall  take  effect  at  the  end  of  the  lawful  term  of  the  basic 
patent, namely on the twentieth anniversary of the filing date of the application for 
that patent, for a period equal to the period which elapsed between the date on which 
the application for the basic patent was lodged and the date of the first authorisation 
to place the product on the market in the Union, reduced by a period of 5 years. 

The duration of the unitary certificate may not exceed 5 years from the date on which 
it takes effect. 

Article 20 

Expiry of the unitary certificate 

1. 

The unitary certificate shall lapse in any of the following events: 

(a) 

at the end of the period provided for in Article 19; 

(b) 

if the unitary certificate holder surrenders it; 

(c) 

if the annual fee laid down in accordance with Article 29(3) is not paid in time. 

2. 

Where  the  authorisation  to  place  the  product  on  the  market  in  accordance  with 
Regulation (EC) No 1107/2009 is withdrawn in a Member State in which the basic 
patent  has  unitary  effect,  the  certificate  shall  cease  to  have  effect  in  that  Member 
State. This may be decided by the Office of its own motion or at the request of a third 
party. 

Article 21 

Invalidity of the unitary certificate 

The unitary certificate shall be invalid in any of the following events: 

(a) 

the certificate was granted contrary to Article 3; 

(b) 

the basic patent has lapsed before its lawful term expires; 

(c) 

the basic patent is revoked or limited to the extent that the product for which 
the unitary certificate was granted would no longer be protected by the claims 
of the basic patent or, after the basic patent has expired, grounds for revocation 
exist which would have justified such revocation or limitation. 

Article 22 

Action for a declaration of invalidity 

1. 

2. 

3. 

Any person may file with the Office an application for a declaration of invalidity of a 
unitary certificate. 

An application for a declaration of invalidity may only be filed on the grounds that 
one or more of the conditions set out in Article 21 are not fulfilled for one or more of 
the Member States in which the basic patent has unitary effect. 

An  application  for  a  declaration  of  invalidity  shall  be  filed  in  writing,  and  shall 
specify the grounds on which it is made. It shall not be considered as duly filed until 
the related fee has been paid. 

EN 

29 

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4. 

The application for a declaration of invalidity shall contain: 

(a) 

(b) 

(c) 

the references of the unitary certificate against which that application is filed, 
the name of its holder, and the identification of the product; 

the particulars of the person referred to in paragraph 1 (‘applicant’) and, where 
applicable, of its representative; 

a  statement  of  the  grounds  on  which  the  application  for  a  declaration  of 
invalidity is based. 

The application for a declaration of invalidity shall be examined by an invalidation 
panel  set  up  by  the  Office  in  accordance  with  the  rules  applicable  to  examination 
panels.  However,  the  invalidation  panel  shall  not  include  any  examiner  previously 
involved in  the examination panel  that examined the unitary  certificate  application, 
nor,  the  case  being,  any  examiner  involved  in  possible  related  opposition 
proceedings, nor in related appeal proceedings. 

An  application  for  a  declaration  of  invalidity  shall  be  inadmissible  where  an 
application relating to the same subject matter and cause of action, and involving the 
same  parties,  has  been  adjudicated  on  its  merits,  either  by  the  Office  or  by  a 
competent  court  as  referred  to  in  Article 24,  and  the  decision  of  the  Office  or  that 
court on that application has acquired the authority of a final decision. 

If the invalidation panel notes that the application for a declaration of invalidity does 
not comply with paragraphs 2, 3 or 4, it shall reject that application as inadmissible, 
and communicate this to applicant. 

The  decision  to  reject  an  application  for  a  declaration  of  invalidity  as  inadmissible 
shall be communicated to the holder of the unitary certificate, together with a copy of 
that application. 

Where the application for a declaration of invalidity is not rejected as inadmissible, 
the  Office  shall  promptly  transmit  that  application  to  the  holder  of  the  unitary 
certificate,  and  shall  publish  it  in  the  Register.  If  several  applications  for  a 
declaration  of  invalidity  have  been  filed,  the  Office  shall  promptly  communicate 
them to the other applicants. 

The  Office  shall  issue  a  decision  on  the  application  for  a  declaration  of  invalidity 
within 6 months, unless the complexity of the case requires a longer period. 

If  the  examination  of  the  application  for  a  declaration  of  invalidity  reveals  that  the 
one  or  more  of  the  conditions  set  out  in  Article  21  are  met,  the  unitary  certificate 
shall  be  declared  invalid.  Otherwise  the  application  for  a  declaration  of  invalidity 
shall be rejected. The outcome shall be mentioned in the Register. 

The unitary certificate shall be deemed not to have had, as from the outset, the effects 
specified in this Regulation, to the extent that it has been declared invalid. 

The Commission is empowered to adopt delegated acts in accordance with Article 49 
to  supplement  this  Regulation  by  specifying  the  details  of  the  procedure  governing 
the declaration of invalidity. 

5. 

1. 

7. 

8. 

9. 

10. 

11. 

12. 

13. 

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30 

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1. 

2. 

3. 

4. 

5. 

6. 

Article 23 

Counterclaim for the invalidity of a certificate 

A counterclaim for a declaration of invalidity may only be based on the grounds for 
invalidity set out in Article 21. 

The competent court of a Member State shall reject a counterclaim for a declaration 
of invalidity if a decision taken by the Office relating to the same subject matter and 
cause of action and involving the same parties has already become final. 

If  the  counterclaim  is  brought  in  a  legal  action  to  which  the  holder  of  the  unitary 
certificate  is  not  already  a  party,  that  holder  shall  be  informed  thereof  and  may  be 
joined as a party to the action in accordance with the conditions applicable before the 
competent court. 

The competent court of a Member State with which a counterclaim for a declaration 
of  invalidity  of  the  unitary  certificate  has  been  filed  shall  not  proceed  with  the 
examination  of  the  counterclaim,  until  either  the  interested  party  or  the  court  has 
informed the Office of the date on which the counterclaim was filed. The Office shall 
record  that  information  in  the  Register.  If  an  application  for  a  declaration  of 
invalidity of the unitary certificate had already been filed before the Office before the 
counterclaim was filed, the court shall be informed thereof by the Office and stay the 
proceedings  until  the  decision  on  the  application  is  final  or  the  application  is 
withdrawn. 

Where  the  competent  court  of  a  Member  State  has  given  a  judgment  which  has 
become final on a counterclaim for a declaration of invalidity of a unitary certificate, 
a copy of the judgment shall be sent to the Office without delay, either by the court 
or  by  any  of  the  parties  to  the  national  proceedings.  The  Office  or  any  other 
interested  party  may  request  information  about  such  transmission.  The  Office  shall 
mention  the  judgment  in  the  Register  and  shall  take  the  necessary  measures  to 
comply with its operative part. 

The competent court hearing a counterclaim for a declaration of invalidity may stay 
the proceedings on application by the holder of a unitary certificate and after hearing 
the  other  parties  and  may  request  the  defendant  to  submit  an  application  for  a 
declaration of invalidity to the Office within a time limit which it shall determine. If 
the application is not made within the time limit, the proceedings shall continue; the 
counterclaim  shall be deemed withdrawn. Where the competent  court of a Member 
State stays the proceedings it may order provisional and protective measures for the 
duration of the stay. 

Article 24 

Notification of lapse or invalidity 

Where  the  unitary  certificate  lapses  in  accordance  with  Article  20(1),  point  (b)  or  (c),  or 
Article  20(2),  or  is  invalid  in  accordance  with  Article  21  and  22,  the  Office  shall  promptly 
publish a notification thereof. 

EN 

31 

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1. 

2. 

3. 

4. 

5. 

6. 

7. 

8. 

1. 

2. 

Article 25 

Conversion 

Where  the  unitary  effect  of  the  basic  patent  is  revoked  while  the  application  for  a 
unitary certificate is still pending, the holder of that application may, subject to a fee, 
request  the  conversion  of  that  application  into  a  centralised  application  for 
certificates. 

Where the unitary effect of the basic patent is revoked after the unitary certificate has 
been  granted,  the  holder  of  that  certificate  may,  subject  to  a  fee,  request  the 
conversion of that unitary certificate into national certificates. 

A  request  for  conversion  may  be  filed  with  the  Office  within  3  months  after 
notification of the revocation of the unitary effect of the basic patent. 

A request for conversion, as well as its outcome, shall be published in the Register. 

The Office shall check whether the conversion requested fulfils the conditions set out 
in this Article, together with the formal conditions specified in the implementing act 
adopted  pursuant  to  paragraph  8.  If  the  conditions  governing  the  request  are  not 
fulfilled, the Office shall notify the applicant of the deficiencies.  If the deficiencies 
are not remedied within a period to be specified by the Office, the Office shall reject 
the  request  for  conversion.  Where  the  conversion  fee  has  not  been  paid  within  the 
relevant period of 3 months, the Office shall inform the applicant that the request for 
conversion is deemed not to have been filed. 

Where  a  request  under  paragraph  1  complies  with  paragraph  5,  the  Office  shall 
convert  the  application  for  a  unitary  certificate  into  a  centralised  application  for 
certificates  designating  the  Member  States  in  which  the  basic  patent  had  unitary 
effect. In the event of a combined application, the designation of the Member States 
in which the basic patent had unitary effect shall be added to the designation of other 
Member States already included in the combined application. 

Where  a  request  under  paragraph  2  complies  with  paragraph  5,  the  Office  shall 
transmit  the  request  for  conversion  to  the  competent  national  authorities  of  each 
Member State in which the basic patent had unitary effect and for which the request 
has  been  found  admissible.  The  competent  national  authorities  shall  take  decisions 
accordingly. 

The Commission shall adopt implementing acts specifying the details to be contained 
in a request for conversion of the for a unitary certificate or unitary certificate into a 
centralised  application  for  certificates  or  national  certificates.  Those  implementing 
acts  shall  be  adopted  in  accordance  with  the  examination  procedure  referred  to  in 
Article 50. 

Article 26 

Appeals 

Any party to proceedings under this Regulation, adversely affected by a decision of 
the  Office,  including  the  adoption  of  an  examination  opinion,  may  appeal  the 
decision to the Boards of Appeal. 

The  filing  of  the  appeal  shall  have  suspensive  effect.  A  decision  of  the  Office  that 
has not been contested shall take effect on the day following the date of expiry of the 
appeal period referred to in paragraph 3. 

EN 

32 

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3. 

4. 

5. 

6. 

7. 

8. 

1. 

2. 

3. 

Notice of appeal shall be filed in writing at the Office within 2 months of the date of 
notification of the decision. The notice shall be deemed to have been filed only when 
the fee for appeal has been paid. In case of an appeal, a written statement setting out 
the grounds of appeal shall be filed within 4 months of the date of notification of the 
decision. 

Following an examination of admissibility of the appeal, the Boards of Appeal shall 
decide on the merits of the appeal. 

Where  an  appeal  results  in  a  decision  which  is  not  in  line  with  the  examination 
opinion, the decision of the Boards may annul or alter the opinion. 

An action may be brought before the General Court of the European Union against a 
decision of the Boards of Appeal in relation to appeals, within 2 months of the date 
of  notification  of  that  decision,  within  2  months  of  the  date  of  notification  of  that 
decision,  on  grounds  of  infringement  of  an  essential  procedural  requirement, 
infringement of the Treaty on the Functioning of the European Union, infringement 
of  this  Regulation  or  of  any  rule  of  law  relating  to  their  application  or  misuse  of 
power.  The  action  shall  be  open  to  any  party  to  proceedings  before  the  Board  of 
Appeal adversely affected by its decision. The General Court shall have jurisdiction 
to annul or to alter the contested decision. 

The decisions of the Boards of Appeal shall take effect on the day following the date 
of expiry of the period referred to  in  paragraph  6 or, if an action has been brought 
before  the  General  Court  within  that  period,  as  from  the  date  following  the  day  of 
dismissal of such action or of dismissal of any appeal filed with the Court of Justice 
of  the  European  Union  against  the  decision  of  the  General  Court.  The  Office  shall 
take the necessary measures to comply with the judgement of the General Court or, 
in the event of an appeal against that judgement, the Court of Justice. 

The Commission is empowered to adopt delegated acts in accordance with Article 49 
to  supplement  this  Regulation  by  specifying  the  content  and  form  of  the  notice  of 
appeal referred to in paragraph 3, the procedure for the filing and examination of an 
appeal and the content and the form of the Boards of Appeal’s decision referred to in 
paragraph 4. 

Article 27 

Boards of Appeal 

In  addition  to  the  powers  conferred  upon  it  by  Article  165  of  Regulation  (EU) 
2017/1001,  the  Boards  of  Appeal  instituted  by  that  Regulation  shall  be  responsible 
for deciding on appeals against decisions of the Office taken on the basis of Article 
26(1). 

A  Board  of  Appeal  in  matters  regarding  unitary  certificates  shall  consist  of  three 
members,  at  least  two  of  whom  are  legally  qualified.  Where  the  Board  of  Appeal 
considers  that  the  nature  of  the  appeal  so  requires,  it  may  call  up  to  two  further 
members for that case. 

There  shall  be  no  Grand  Board  as  referred  to  in  Article  165  (2),  (3)  and  (4),  and 
Article  167(2)  of  Regulation  (EU)  2017/1001  in  matters  regarding  unitary 
certificates.  Decisions  taken  by  a  single  member  as  under  Article  165  (2)  of 
Regulation (EU) 2017/1001 shall not be possible. 

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4. 

Members  of  the  Boards  of  Appeal  in  matters  regarding  unitary  certificates  shall  be 
appointed in accordance with Article 166 (5) of Regulation (EU) 2017/1001. 

Article 28 

Delegation of power regarding the Boards of Appeal 

The  Commission  is  empowered  to  adopt  delegated  acts  in  accordance  with  Article  49  to 
supplement  this  Regulation  by  specifying  the  details  concerning  the  organisation  of  the 
Boards of Appeal in proceedings relating to unitary certificates under this Regulation. 

Article 29 

Fees 

1. 

2. 

3. 

4. 

The Office shall charge a fee for an application for a unitary certificate. 

The  Office  shall  charge  a  fee  for  appeals,  for  oppositions,  for  applications  for  a 
declaration of invalidity and for conversions. 

The unitary certificate shall be subject to the payment of annual maintenance fees to 
the Office. 

The Commission is empowered to adopt implementing acts determining the amounts 
of the fees charged by the Office, the time limits within which they have to be paid,   
and the ways in which they are to be paid. Those implementing acts shall be adopted 
in accordance with the examination procedure referred to in Article 50. 

Article 30 

Combined applications 

An application for a unitary certificate may be included in a combined centralised application 
in  which  the  applicant  also  requests  the  grant  of  national  certificates,  in  the  designated 
Member States, in accordance with the centralised procedure under Regulation [COM(2023) 
223]. In that case, Article 38 of that Regulation shall apply. 

Article 31 

Language  

1. 

2. 

All documents and information sent to the Office in respect of the procedures under 
this Regulation shall be in one of the official languages of the Union. 

For  the  tasks  conferred  on  the  Office  under  this  Regulation,  the  languages  of  the 
Office  shall  be  all  the  official  languages  of  the  Union  in  accordance  with  Council 
Regulation No 128. 

28 

Council Regulation No 1 determining the languages to be used by the European Economic Community 
(OJ 17, 6.10.1958, p. 385).  

EN 

34 

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1. 

2. 

1. 

Article 32 

Communications to the Office 

Communications addressed to the Office may be effected by electronic means. The 
Executive  Director  shall  determine  to  what  extent  and  under  which  technical 
conditions those communications may be submitted electronically. 

The Commission is empowered to adopt delegated acts in accordance with Article 49 
to  supplement 
the  means  of 
communication, including the electronic means of communication, to be used by the 
parties  to  proceedings  before the Office and the forms  to  be made available by the 
Office. 

this  Regulation  by  specifying 

the  rules  on 

Article 33 

Register 

As  regards  applications  for  unitary  certificates  for  plant  protection  products,  the 
Register set up under Article 35 of Regulation [COM(2023) 231]29 shall include, for 
each  unitary  certificate,  or  application  for  a  unitary  certificate,  the  following 
information, as applicable: 

(a) 

(b) 

the name and address of the applicant or certificate holder; 

the name and business address of the representative, other than a representative 
as referred to in Article 36(3); 

(c) 

the application as well as its date of lodging and date of publication; 

(d)  whether the application relates to a medicinal product or to a plant protection 

(e) 

(f) 

(g) 

(h) 

(i) 

product; 

the number of the basic patent; 

an identification of the product for which a unitary certificate is requested; 

the numbers and dates of the authorisations to place the product on the market 
referred  to  in  Article  3(1),  point  (b),  and  an  identification  of  the  product 
identified in each of them; 

the  number  and  date  of  the  first  authorisation  to  place  the  product  on  the 
market in the Union; 

the date and a summary of the examination opinion of the Office in respect of 
each of the Member States in which the basic patent has unitary effect; 

(j)  where applicable, the number and the duration of the unitary certificate; 

(k)  where applicable, the filing of an opposition, and the outcome of the opposition 
proceedings, including where applicable a summary of the revised examination 
opinion; 

(l)  where  applicable,  the  filing  of  an  appeal,  and  the  outcome  of  the  appeal 
proceedings, including where applicable a summary of the revised examination 
opinion; 

29 

Regulation of the European Parliament and of the Council on the supplementary protection certificate 
for medicinal products [COM(2023) 231]. 

EN 

35 

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(m)  where  applicable,  a  mention  that  a  certificate  has  lapsed  or  was  declared 

invalid; 

(n)  where applicable, any decision regarding the geographical scope of the unitary 
certificate,  in  respect  of  a  derogation  under  Article  3,  paragraph  5  or  under 
Article 20, paragraph 2; 

(o)  where applicable, the filing of an application for a declaration of invalidity and, 

once available, the outcome of the related proceedings; 

(p)  where  applicable,  information  relating  to  a  request  for  conversion,  and  its 

outcomes; 

(q) 

information on the payment of annual fees. 

The  Register  shall  contain  changes  to  the  information  referred  to  in  paragraph  1, 
including transfers, each accompanied by the date of recording of such entry. 

The Register and information referred to in paragraphs 1 and 2 shall be available in 
all official languages of the Union. The Office may use verified machine translation 
for the information to be published in the register. 

The  Executive  Director  of  the  Office  may  determine  that  information  other  than 
those referred to in paragraphs 1 and 2 shall be entered in the Register. 

The Office shall collect, organise, make public and store the information referred to 
in  paragraphs  1  and  2,  including  any  personal  data,  for  the  purposes  laid  down  in 
paragraph  7.  The  Office  shall  keep  the  Register  easily  accessible  for  public 
inspection. 

The Office shall provide certified or uncertified extracts from the Register on request 
and on payment of a fee. 

The  processing  of  the  data  concerning  the  entries  set  out  in  paragraphs  1  and  2, 
including any personal data, shall take place for the purposes of: 

(a) 

administering the applications  and unitary  certificates  in accordance with  this 
Regulation and the acts adopted pursuant to it; 

(b)  maintaining  the  Register  and  making  it  available  for  inspection  by  public 

authorities and economic operators; 

(c) 

producing  reports  and  statistics  enabling  the  Office  to  optimise  its  operations 
and improve the functioning of the system. 

All  the  data,  including  personal  data,  concerning  the  entries  in  paragraphs  1  and  2 
shall be considered to be of public interest  and may be  accessed by any third party 
free of charge. For reasons of legal certainty, the entries in the Register shall be kept 
for an indefinite period of time. 

Article 34 

Database 

In addition to the obligation to keep a Register, the Office shall collect and  store in 
an  electronic  database  all  the  particulars  provided  by  applicants  or  any  other  third 
party observations pursuant to this Regulation or acts adopted pursuant to it. 

The  electronic  database  may  include  personal  data,  beyond  those  included  in  the 
Register, to the extent that such particulars are required by this Regulation or by acts 

2. 

3. 

4. 

5. 

6. 

7. 

8. 

1. 

2. 

EN 

36 

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adopted pursuant to it. The collection, storage and processing of such data shall serve 
the purposes of: 

(a) 

(b) 

administering  the  applications  and/or  certificate  registrations  as  described  in 
this Regulation and in acts adopted pursuant to it; 

accessing  the  information  necessary  for  conducting  the  relevant  proceedings 
more easily and efficiently; 

(c) 

communicating with the applicants and other third parties; 

(d)  producing  reports  and  statistics  enabling  the  Office  to  optimise  its  operations 

and improve the functioning of the system. 

The  Executive  Director  shall  determine  the  conditions  of  access  to  the  electronic 
database and the manner in which its contents, other than the personal data referred 
to  in  paragraph 2 of this Article but  including those listed in  Article 33(3), may be 
made available in machine-readable form, including the charge for such access. 

Access  to  the  personal  data  referred  to  in  paragraph  2  shall  be  restricted  and  such 
data  shall  not  be  made  publicly  available  unless  the  party  concerned  has  given  his 
express consent. 

All  data  shall  be  kept  indefinitely.  However,  the  party  concerned  may  request  the 
removal of any personal data from the database after 18 months from the expiry of 
the  unitary  certificate  or,  the  case  being,  the  closure  of  the  relevant  inter  partes 
procedure.  The  party  concerned  shall  have  the  right  to  obtain  the  correction  of 
inaccurate or erroneous data at any time. 

Article 35 

Transparency  

Regulation  (EC)  No  1049/2001  of  the  European  Parliament  and  of  the  Council30 
shall apply to documents held by the Office. 

The  Management  Board  of  the  Office  shall  adopt  detailed  rules  for  applying 
Regulation (EC) No 1049/2001 in the context of this Regulation. 

Decisions taken by the Office under Article 8 of Regulation (EC) No 1049/2001 may 
be  challenged  through  the  European  Ombudsman  or  form  the  subject  of  an  action 
before the Court of Justice of the European Union, under the conditions laid down in 
Articles 228 and 263 TFEU respectively. 

The processing of personal data by the Office shall be subject to Regulation (EC) No 
45/2001 of the European Parliament and of the Council31. 

Regulation (EC) No 1049/2001 of the European Parliament and of the Council of 30 May 2001 regarding public access to 
European Parliament, Council and Commission documents (OJ L 145, 31.5.2001, p. 43). 
Regulation (EC) No 45/2001 of the European Parliament and of the Council of 18 December 2000 on the protection of 
individuals  with  regard  to  the  processing  of  personal  data  by  the  Community  institutions  and  bodies  and  on  the  free 
movement of such data (OJ L 8, 12.1.2001, p. 1). 

3. 

4. 

5. 

1. 

2. 

3. 

4. 

30 

31 

EN 

37 

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Article 36 

Representation 

1. 

2. 

3. 

4. 

Natural  or  legal  persons  having  neither  their  domicile  nor  their  principal  place  of 
business  or  a  real  and  effective  industrial  or  commercial  establishment  in  the 
European Economic Area shall be represented before the Office in accordance  with 
this Article in all proceedings provided for by this Regulation, other than the filing of 
an application for a unitary certificate. 

Natural or legal persons having their domicile or principal place of business or a real 
and  effective  industrial  or  commercial  establishment  in  the  Union  may  be 
represented before the Office by an employee. 

An  employee  of  a  legal  person  may  also  represent  other  legal  persons  which  are 
economically linked with the legal person being represented by that employee. 

The second subparagraph also  applies where those other legal  persons have neither 
their domicile nor their principal place of business nor a real and effective industrial 
or commercial establishment within the Union. 

Employees who represent natural or legal persons shall, at the request of the Office 
or, where appropriate, of the party to the proceedings, file with the Office a signed 
authorisation for insertion in the files. 

A common representative shall be appointed where there is more than one applicant 
or more than one third party acting jointly. 

Only  a  practitioner  established  in  the  Union,  entitled  to  act  as  a  professional 
representative in patent matters before a national patent office or the European Patent 
Office, or a lawyer authorised to practise before the courts or tribunals of a Member 
State, may represent natural or legal persons before the Office. 

Article 37 

Supplementary Protection Certificates Division 

A Supplementary Protection Certificate Division  (‘SPC Division’) shall be set up within the 
Office  and,  in  addition  to  the  responsibilities  under  Regulations  [COM(2023)  231]  and 
[COM(2023) 223], shall be responsible for implementing the tasks set out in this Regulation 
and in Regulation [COM(2023) 222], including in particular: 

(a) 

(b) 

receiving  and  supervising  the  examination  of  applications  for  unitary 
certificates, appeals and observations by third parties; 

adopting  examination  opinions  on  behalf  of  the  Office  in  relation  to 
applications for unitary certificates; 

(c) 

deciding on oppositions against examination opinions; 

(d)  deciding on applications for a declaration of invalidity; 

(e) 

processing conversion requests; 

(f)  maintaining the Register and the database. 

EN 

38 

  EN 

1. 

2. 

3. 

1. 

2. 

3. 

4. 

Article 38 

Decisions and communications of the Office  

Decisions of the Office under this Regulation shall include examination opinions and 
shall state the reasons on which they are based. They shall be based only on reasons 
or evidence on which the parties concerned have had an opportunity to present their 
comments. Where oral proceedings are held before the Office, the decision may be 
given orally. Subsequently, the decision or opinion shall be notified in writing to the 
parties. 

Any  decision,  opinion,  communication  or  notice  from  the  Office  under  this 
Regulation shall indicate the SPC Division and the relevant panel as well as the name 
or the names of the examiners responsible. It shall be signed by these examiners, or, 
instead of a signature, carry a printed  or stamped seal of the Office. The Executive 
Director  may  determine  that  other  means  of  identifying  the  SPC  Division  and  the 
name  of  the  examiners  responsible,  or  an  identification  other  than  a  seal,  may  be 
used  where  decisions  or  other  communications  are  transmitted  by  any  technical 
means of communication. 

Decisions  of  the  Office  under  this  Regulation  which  are  open  to  appeal  shall  be 
accompanied by a written communication indicating that any notice of appeal is to be 
filed  in  writing  at  the  Office  within  2  months  of  the  date  of  notification  of  the 
decision in question. That communication shall also draw the attention of the parties 
to  the provisions laid down in  Article 26. The parties may not  plead  any  failure on 
the part of the Office to communicate the availability of appeal proceedings. 

Article 39 

Oral proceedings 

If the Office  considers that  oral  proceedings would  be expedient they shall be held 
either at the instance of the Office or at the request of any party to the proceedings. 

Oral  proceedings  before  an  examination  panel,  opposition  panel  or  invalidity  panel 
shall not be public. 

Oral  proceedings  before  the  Boards  of  Appeal,  including  delivery  of  the  decision 
and, as the case may be, of a revised opinion, shall be public, unless the Boards of 
Appeal decide otherwise in cases where admission of the public could have serious 
and unjustified disadvantages, in particular for a party to the proceedings. 

The Commission is empowered to adopt delegated acts in accordance with Article 49 
to  supplement  this  Regulation  by  setting  out  the  detailed  arrangements  for  oral 
proceedings. 

Article 40 

Taking of evidence 

1. 

In any proceedings before the Office, the means of giving or obtaining evidence shall 
include the following: 

(a) 

hearing the parties; 

(b) 

requests for information; 

(c) 

the production of documents and items of evidence; 

EN 

39 

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(d) 

 hearing witnesses; 

(e) 

(f) 

 opinions by experts; 

statements in writing sworn or affirmed or having a similar effect under the law 
of the State in which the statement is drawn up. 

The  relevant  panel  may  commission  one  of  its  members  to  examine  the  evidence 
adduced. 

If the Office or the relevant panel considers it necessary for a party, witness or expert 
to give evidence orally, it shall issue a summons to the  person concerned to appear 
before it. The period of notice provided in such summons shall be at least 1 month, 
unless they agree to a shorter period. 

The parties shall be informed of the hearing of a witness or expert before the Office. 
They shall have the right to be present and to put questions to the witness or expert. 

The  Executive  Director  shall  determine  the  amounts  of  expenses  to  be  paid, 
including advances, as  regards the costs of taking of evidence as referred to  in this 
Article. 

The Commission is empowered to adopt delegated acts in accordance with Article 49 
to supplement this Regulation by setting out the detailed arrangements for the taking 
of evidence. 

Article 41 

Notification 

The Office shall, as a matter of course, notify those concerned of decisions, including 
opinions, summonses and of any notice or other communication from which a time 
limit  is  reckoned,  or  of  which  those  concerned  are  to  be  notified  under  other 
provisions  of  this  Regulation  or  of  acts  adopted  pursuant  to  this  Regulation,  or  of 
which notification has been ordered by the Executive Director. 

Notification  may  be  effected  by  different  means,  including  electronic  means.  The 
details regarding electronic means shall be determined by the Executive Director. 

Where  notification  is  to  be  effected  by  public  notice,  the  Executive  Director  shall 
determine how the public notice is to be given and shall fix the beginning of the  1-
month  period  on  the  expiry  of  which  the  document  shall  be  deemed  to  have  been 
notified. 

The Commission is empowered to adopt delegated acts in accordance with Article 49 
to  supplement  this  Regulation  by  setting  out  the  detailed  arrangements  for 
notification. 

Article 42 

Time limits 

Time  limits  shall  be  laid  down  in  terms  of  full  years,  months,  weeks  or  days. 
Calculation  shall  start  on  the  day  following  the  day  on  which  the  relevant  event 
occurred. The duration of time limits shall be no less than 1 month and no more than 
6 months.  

2. 

3. 

4. 

5. 

6. 

1. 

2. 

3. 

4. 

1. 

EN 

40 

  EN 

2. 

3. 

4. 

5. 

1. 

2. 

3. 

4. 

1. 

The Executive Director shall determine, before the commencement of each calendar 
year, the days on which the Office is not open for receipt of documents or on which 
ordinary post is not delivered in the locality in which the Office is located.  

The Executive Director shall determine the duration of the period of interruption in 
the case of a general interruption in the delivery of post in the Member State where 
the  Office  is  located  or,  in  the  case  of  an  actual  interruption  of  the  Office's 
connection to admitted electronic means of communication.  

If  an  exceptional  occurrence,  such  as  a  natural  disaster  or  strike,  interrupts  or 
interferes  with  proper  communication  from  the  parties  to  the  proceedings  to  the 
Office  or  vice-versa,  the  Executive  Director  may  determine  that  for  parties  to  the 
proceedings  having  their  residence  or  registered  office  in  the  Member  State 
concerned  or  who  have  appointed  a  representative  with  a  place  of  business  in  the 
Member State concerned all time limits that otherwise would  expire on or after the 
date of commencement of such occurrence, as determined by the Executive Director, 
shall  extend  until  a  date  to  be  determined  by  the  Executive  Director.  When 
determining  that  date,  the  Executive  Director  shall  assess  when  the  exceptional 
occurrence  comes  to  an  end.  If  the  occurrence  affects  the  seat  of  the  Office,  such 
determination of the Executive Director shall specify that it applies in respect of all 
parties to the proceedings.  

The Commission is empowered to adopt delegated acts in accordance with Article 49 
to supplement this Regulation by specifying the details regarding the calculation and 
duration of time limits. 

Article 43 

Correction of errors and manifest oversights 

The Office shall correct any linguistic errors or errors of transcription and manifest 
oversights  in  its  decisions,  including  opinions,  or  technical  errors  in  publishing 
information in the Register, of its own motion or at the request of a party.  

Where  the  Office  has  made  an  entry  in  the  Register  or  taken  a  decision  which 
contains  an  obvious  error  attributable  to  the  Office,  it  shall  ensure  that  the  entry  is 
cancelled or the decision is revoked. The cancellation of the entry in the Register or 
the revocation of the decision shall be effected within 1 year of the date on which the 
entry was made in the Register or that decision was taken, after consultation with the 
parties to the proceedings. 

The Office shall keep records of any such corrections or cancellations. 

Corrections and cancellations shall be published by the Office. 

Article 44 

Restitutio in integrum 

The applicant for or holder of a unitary certificate, or any other party to proceedings 
before the Office under this Regulation, who, in spite of all due care required by the 
circumstances having been taken, was unable to  comply  with  a time limit  vis-à-vis 
the  Office  shall,  upon  application,  have  his  rights  re-established  if  the  obstacle  to 
compliance  has  the  direct  consequence,  by  virtue  of  the  provisions  of  this 
Regulation, of causing the loss of any right or means of redress. 

EN 

41 

  EN 

2. 

3. 

4. 

5. 

The application for re-establishment shall be filed in writing within 2 months of the 
removal of the obstacle to compliance with the time limit. The omitted act shall be 
completed  within  this  period.  The  application  shall  only  be  admissible  within  the 
year immediately following the expiry of the unobserved time limit.  

The application for re-establishment shall state the grounds on which it is based and 
shall set out the facts on which it relies. It shall not be deemed to be filed until the fee 
for re-establishment of rights has been paid. 

The SPC Division, or where applicable the Boards of Appeal, shall decide upon the 
application. 

This  Article shall  not  be  applicable  to  the  time  limits  referred  to  in  paragraph 2  of 
this Article, or in Article 15(1) and (3). 

Article 45 

Interruption of proceedings 

1. 

Proceedings before the Office under this Regulation shall be interrupted: 

(a) 

(b) 

(c) 

in  the  event  of  the  death  or  legal  incapacity  of  the  applicant  or  of  the  person 
authorised by national law to act on behalf of the applicant. To the extent that 
that  death  or  incapacity  does  not  affect  the  authorisation  of  a  representative 
appointed  under  Article  36,  proceedings  shall  be  interrupted  only  on 
application by such representative; 

in the event of the applicant being prevented, for legal reasons resulting from 
action  taken  against  his  property,  from  continuing  the  proceedings  before  the 
Office; 

in  the  event  of  the  death  or  legal  incapacity  of  the  representative  of  the 
applicant, or of that representative being prevented, for legal reasons resulting 
from action taken against his property, from continuing the proceedings before 
the Office. 

Proceedings before the Office shall be resumed as soon as the identity of the person 
authorised to continue them has been established. 

The Commission is empowered to adopt delegated acts in accordance with Article 49 
to  supplement  this  Regulation  by  setting  out  the  detailed  arrangements  for  the 
resumption of proceedings before the Office. 

Article 46 

Costs 

The  losing  party  in  opposition  proceedings  and  proceedings  for  a  declaration  of 
invalidity,  including  in  related  appeal  proceedings,  shall  bear  the  fees  paid  by  the 
other party. The losing party shall also bear all costs incurred by the other party that 
are  essential  to  the  proceedings,  including  travel  and  subsistence  and  the 
remuneration of a representative, within the maximum rates set for each category of 
costs in the implementing act to be adopted in accordance with paragraph 7. The fees 
to be borne by the losing party shall be limited to the fees paid by the other party in 
those proceedings. 

2. 

3. 

1. 

EN 

42 

  EN 

2. 

3. 

4. 

5. 

6. 

7. 

8. 

Where each party succeeds on some and fails on other heads, or if reasons of equity 
so  dictate,  the  SPC  Division  or  Board  of  Appeal  shall  decide  a  different 
apportionment of costs. 

Where  proceedings  are  terminated  the  costs  shall  be  at  the  discretion  of  the  SPC 
Division or Board of Appeal. 

Where the parties conclude before the SPC Division or Board of Appeal a settlement 
of  costs  differing  from  that  provided  for  in  paragraphs 1  to  3,  the  body  concerned 
shall take note of that agreement. 

The  SPC  Division  or  Board  of  Appeal  shall  fix  the  amount  of  the  costs  to  be  paid 
pursuant to paragraphs 1 to 3 of this Article when the costs to be paid are limited to 
the fees paid to the Office and the representation costs. In all other cases, the registry 
of the Board of Appeal or SPC Division shall fix, on request, the amount of the costs 
to  be  reimbursed.  The  request  shall  be  admissible  only  for  the  period  of  2  months 
following the date on which the decision for which an application was made for the 
costs  to  be  fixed  becomes  final  and  shall  be  accompanied  by  a  bill  and  supporting 
evidence. For the costs of representation an assurance by the representative that the 
costs that have been incurred shall be sufficient. For other costs, it shall be sufficient 
if their plausibility is established. Where the amount of the costs is fixed pursuant to 
the first sentence of this paragraph, representation costs shall be awarded at the level 
laid  down  in  the  implementing  act  adopted  pursuant  to  paragraph 7  of  this 
Article and irrespective of whether they have been actually incurred. 

Decisions on the fixing of costs adopted in  accordance with paragraph 5 shall state 
the reasons on which they are based, and may be reviewed by a decision of the SPC 
Division  or  Board  of  Appeal  on  a  request  filed  within  1  month  of  the  date  of 
notification of the awarding of costs. It shall not be deemed to be filed until the fee 
for reviewing the amount of the costs has been paid. The SPC Division or the Board 
of Appeal, as the case may be, shall take a decision on the request for a review of the 
decision on the fixing of costs without oral proceedings. 

The  Commission  shall  adopt  implementing  acts  specifying  the  maximum  rates  for 
costs  essential  to  the  proceedings  and  actually  incurred  by  the  successful  party. 
Those  implementing  acts  shall  be  adopted  in  accordance  with  the  examination 
procedure referred to in Article 50. 

When specifying the maximum rates with respect to travel and subsistence costs, the 
Commission  shall  take  into  account  the  distance  between  the  place  of  residence  or 
business of the party, representative or witness or expert and the place where the oral 
proceedings  are  held,  the  procedural  stage  at  which  the  costs  have  been  incurred, 
and,  as  far  as  costs  of  representation  are  concerned,  the  need  to  ensure  that  the 
obligation  to  bear  the  costs  may  not  be  misused  for  tactical  reasons  by  the  other 
party.  In  addition,  subsistence  expenses  shall  be  calculated  in  accordance  with  the 
Staff  Regulations  of  Officials  of  the  Union  and  the  Conditions  of  Employment  of 
Other  Servants  of  the  Union,  laid  down  in  Council  Regulation  (EEC,  Euratom, 
ECSC)  No  259/6832.  The  losing  party  shall  bear  the  costs  for  one  party  in  the 
proceedings only and, where applicable, one representative only.  

32 

Regulation  (EEC,  Euratom,  ECSC)  No  259/68  of  the  Council  of  29  February  1968  laying  down  the 
Staff  Regulations  of  Officials  and  the  Conditions  of  Employment  of  Other  Servants  of  the  European 

EN 

43 

  EN 

                                                 
 
1. 

2. 

3. 

4. 

1. 

2. 

3. 

4. 

Article 47 

Enforcement of decisions fixing the amount of costs 

Any final decision of the Office fixing the amount of costs shall be enforceable. 

Enforcement shall be governed by the rules of civil procedure in force in the Member 
State in the territory of which it is carried out. Each Member State shall designate a 
single authority responsible for verifying the authenticity of the decision referred to 
in paragraph 1 and shall communicate its contact details to the Office, the Court of 
Justice  and  the  Commission.  The  order  for  enforcement  shall  be  appended  to  the 
decision by that authority, with the verification of the authenticity of the decision as 
the sole formality 

When these formalities have been completed on application by the party concerned, 
the  latter  may  proceed  to  enforcement  in  accordance  with  the  national  law,  by 
bringing the matter directly before the competent authority. 

Enforcement may be suspended only by a decision of the Court of Justice. However, 
the courts of the Member State concerned shall have jurisdiction over complaints that 
enforcement is being carried out in an irregular manner. 

Article 48 

Financial provisions 

The expenses incurred by the Office in carrying out the additional tasks given to it in 
accordance with this Regulation shall be covered by the procedural fees to be paid to 
it  by  applicants  and  by  a  fraction  of  the  annual  fees  paid  by  the  holders  of  unitary 
certificates, while the remainder of the annual fees shall be shared with the Member 
States  in  accordance  with  the  number  of  unitary  certificates  having  legal  effect  in 
each of them. The fraction of the annual fees to be shared with Member States shall 
initially  be  set  at  a  certain  value  but  shall  be  reviewed  every  5  years,  in  such  a 
manner  as  to  achieve  financial  sustainability  for  the  activities  carried  out  by  the 
Office  under  this  Regulation  as  well  as  under  Regulations  [COM(2023)  231], 
[COM(2023) 223] and [COM(2023) 222]. 

For the purposes of paragraph 1, the Office shall keep an account of the annual fees 
paid to it by holders of unitary certificates in force in the respective Member States. 

The expenses incurred by a competent national authority participating in proceedings 
under this Chapter shall be covered by the Office and shall be paid annually, on the 
basis of the number of proceedings in  which that competent  national  authority was 
involved during the preceding year. 

The Commission is empowered to adopt implementing acts laying down rules on the 
financial  transfers  between  the  Office  and  Member  States,  the  amounts  of  these 
transfers, and the remuneration to be paid by the Office regarding the participation of 
competent  national  authorities  referred  to  in  paragraph  3.  Those  implementing  acts 
shall be adopted in accordance with the examination procedure referred to in Article 
50. 

Commission and instituting special measures temporarily applicable to officials of the Commission (OJ 
L 56, 4.3.1968, p. 1.)’ 

EN 

44 

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5. 

1. 

2. 

3. 

4. 

5. 

6. 

1. 

2. 

Article  12  of  Regulation  (EU)  No  1257/2012  shall  apply  to  the  annual  fees  due  in 
respect of unitary certificates. 

Article 49 

Exercise of the delegation 

The  power  to  adopt  delegated  acts  is  conferred  on  the  Commission  subject  to  the 
conditions laid down in this Article. 

The power to adopt delegated acts referred to in  Articles 15(13), 22(13), 26(8), 28, 
32(2), 39(4), 40(6), 41(4), 42(5) and 45(3) shall be conferred on the Commission for 
an indeterminate period of time from XXX [OP please insert the date = date of entry 
into force]. 

The  delegation  of  power  referred  to  in  Articles  15(13),  22(13),  26(8),  28,  32(2), 
39(4),  40(6),  41(4),  42(5)  and  45(3)  may  be  revoked  at  any  time  by  the  European 
Parliament or by the Council. A decision to revoke shall put an end to the delegation 
of the power specified in that decision. It shall take effect on the day following the 
publication of the decision in the Official Journal of the European Union or at a later 
date specified therein. It shall not affect the validity of any delegated acts already in 
force. 

Before adopting a delegated act, the Commission shall consult experts designated by 
each  Member  State 
the 
in  accordance  with 
Interinstitutional Agreement of 13 April 2016 on Better Law-Making. 

the  principles 

laid  down 

in 

As soon as it adopts a delegated act, the Commission shall notify it simultaneously to 
the European Parliament and to the Council. 

A delegated act adopted pursuant to Articles 15(13), 22(13), 26(8), 28, 32(2), 39(4), 
40(6),  41(4),  42(5)  and  45(3)  shall  enter  into  force  only  if  no  objection  has  been 
expressed either by the European Parliament or by the Council within a period of two 
months of notification of that act to the European Parliament and the Council or if, 
before the expiry of that period, the European Parliament and the Council have both 
informed the Commission that they will not object. That period shall be extended by 
two months at the initiative of the European Parliament or of the Council. 

Article 50 

Committee procedure 

The  Commission  shall  be  assisted  by  a  Committee  on  Supplementary  Protection 
Certificates established by Regulation [COM(2023) 231]. That committee shall be a 
committee within the meaning of Regulation (EU) No 182/2011. 

Where  reference  is  made  to  this  paragraph,  Article  5  of  Regulation  (EU)  No 
182/2011 shall apply. 

Article 51 

Evaluation 

By xxxxxx [OP, please insert: five years after the date of application], and every five years 
thereafter, the Commission shall evaluate the implementation of this Regulation. 

EN 

45 

  EN 

Article 52 

Entry into force and application 
This  Regulation  shall  enter  into  force  on  XXX  [OP  –  please  insert  the  date  -  the  20th  day 
following its publication in the Official Journal of the European Union]. 
It shall apply from xxxxx [OP please insert first day of the 12th month after the date of entry 
into force]. 

This Regulation shall be binding in its entirety and directly applicable in all Member States. 

Done at Brussels, 

For the European Parliament 
The President 

For the Council 
The President 

EN 

46 

  EN