Source: EURLEX
Language: en
Format: md

**Council of the**
**European Union**

**Interinstitutional File:**

**2023/0130(COD)**

**COVER NOTE**

**Brussels, 28 April 2023**
**(OR. en)**

**8894/23**

**PI 56**
**PHARM 68**
**COMPET 385**
**MI 353**
**IND 207**
**IA 89**
**CODEC 748**

From: Secretary-General of the European Commission, signed by Ms Martine
DEPREZ, Director

date of receipt: 27 April 2023

To: Ms Thérèse BLANCHET, Secretary-General of the Council of the
European Union

No. Cion doc.: COM(2023) 231 final

Subject: Proposal for a REGULATION OF THE EUROPEAN PARLIAMENT AND
OF THE COUNCIL on the supplementary protection certificate for
medicinal products (recast)

Delegations will find attached document COM(2023) 231 final.

Encl.: COM(2023) 231 final

8894/23 AF/ps
### COMPET.1 EN

EUROPEAN

COMMISSION

Brussels, 27.4.2023
COM(2023) 231 final

2023/0130 (COD)

Proposal for a

**REGULATION OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL**

**on the supplementary protection certificate for medicinal products (recast)**

(Text with EEA relevance)

{SEC(2023) 172 final} - {SWD(2023) 117 final} - {SWD(2023) 118 final} 
{SWD(2023) 119 final}

## **EN EN**

**EXPLANATORY MEMORANDUM**

**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 years [1] . 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 manner [2] .

This proposal aims to simplify the EU’s SPC system as regards national SPCs for medicinal
products, as well as improve its transparency and efficiency. This initiative was announced in
the Commission work programme for 2022 as initiative number 16 under Annex II (REFIT
initiatives) [3] .

Regulation (EC) No 469/2009 provides for SPCs for medicinal products (both human and
veterinary medicinal products) to be granted at a national level on the basis of national
applications, on a country-by-country basis. Similarly, Regulation (EC) No 1610/96 provides
for SPCs for plant protection products. Together these two measures constitute the EU’s SPC
regime. As Regulation (EC) No 469/2009 has been amended several times, and since further
amendments are to be made, that Regulation should, in the interest of clarity, be recast, which
is the **first objective of this proposal** (and of the parallel proposal on PPPs (COM(2023)
223).

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

1 An additional 6-month period of protection is available, subject to specific conditions, for medicinal
products for use in the paediatric population, as defined by Regulation (EC) 1901/2006.
2 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
the UP system. For updates and more information, see:

                                              -                                               -                                               -                                               https://ec.europa.eu/growth/industry/strategy/intellectual property/patent protection eu/unitary
patent_en.
3 –
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%3A9fb5131e30e9-11ec-bd8e-01aa75ed71a1.0001.02/DOC_2&format=PDF#page=9).

## EN 1 EN

products and PPPs, SPC protection is only available at national level. At the same time, there
is a centralised procedure for granting European patents and a centralised procedure for
obtaining marketing authorisations for medicinal products. In the same vein, the
pharmaceutical strategy for Europe (COM(2020) 761 final) emphasised the importance of
investing in R&D 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 Council [4] and the European Parliament [5] have called on
the Commission to correct these deficiencies.

Therefore, a **second objective of this proposal** is to introduce a centralised procedure for
granting SPCs for medicinal products. This would allow applicants to obtain SPCs in the
respective designated Member States subject to marketing authorisations having been granted
in/for each of them, by filing a single ‘centralised SPC application’ that would undergo a
single centralised examination procedure.

While that examination would be conducted by a centralised authority, the actual grant of
SPCs would be done by the respective national offices of the designated Member States,
based on a positive opinion from the central examination authority. The opinion of the central
examination authority would be binding upon the national offices of the designated Member
States.

A parallel proposal (COM(2023) 223), with similar provisions to this one for medicinal
products [6], concerns SPCs for PPPs.

**•** **Consistency with existing policy provisions in the policy area**

The core substantive features of the proposed centralised procedure – i.e. the conditions for

–
obtaining certificates, as well as their legal effect are the same as those of the existing SPC
regime. This proposal introduces new procedural provisions as regards the centralised
examination and is not intended to modify the scope nor the effect of the rights conferred by
national SPCs currently granted according to Regulation (EC) No 469/2009. The same new
procedural provisions are also inserted in the above-mentioned parallel proposal on SPCs for
PPPs (COM(2023) 223).

At the same time, parallel proposals are being made to create unitary certificates for medicinal
products (cf. COM(2023) 222) and for PPPs (cf. COM(2023) 221). Applications for these
unitary 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.

4 Council conclusions on intellectual property policy of 10 November 2020
https://www.consilium.europa.eu/media/46671/st-12750-2020-init.pdf.
5 European Parliament, Committee on Legal Affairs, Report on an intellectual property action plan to
support the EU’s recovery and resilience (2021/2007(INI)),
https://www.europarl.europa.eu/doceo/document/A-9-2021-0284_EN.html.
6 Human and veterinary medicinal products.

## EN 2 EN

This table explains the purposes of the four related proposals:

|Medicinal products|Col2|Plant protection products|
|---|---|---|
|**PROPOSAL 1** <br>Regulation on the SPC for medicinal<br>products (recast)| Art. 114<br>TFEU|**PROPOSAL 2** <br>Regulation on the SPC for plant<br>protection products (recast)|
|**PROPOSAL 3** <br>Regulation on the unitary SPC for<br>medicinal products| Art. 118<br>TFEU|**PROPOSAL 4** <br>Regulation on the unitary SPC for<br>plant protection products|

Moreover, it should be noted that nothing will prevent national SPCs as defined in Regulation
(EC) No 469/2009 and in Chapter II of this proposal from being granted on the basis of a
unitary patent as the basic patent.

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 supplementary protection
certificates, includes a new initiative on compulsory licensing and legislation on standardessential 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 COVID-19 pandemic has underlined the importance of having a strong and balanced IP
system to provide the necessary incentives to develop new treatments and vaccines that
patients will have access to. It has also highlighted the need for transparent and easily
accessible information on the status of IP rights, including SPCs, to facilitate potential
collaborations, licensing and freedom-to-operate analyses [7] . Patents and SPCs are key to
supporting the EU in its efforts to build a European Health Union and to other related
initiatives such as the new European Health Emergency Preparedness and Response Authority
(HERA) [8], EU FAB [9] and the pharmaceutical strategy for Europe.

The proposed centralised procedure is therefore fully consistent with the existing
pharmaceutical legislation and with other relevant legislation, in particular the European
patent with unitary effect ('unitary patent') as set out in Regulation (EU) No 1257/2012, and
the related Agreement on a Unified Patent Court (UPCA). The unitary patent system will
enter into force on 1 June 2023.

In addition, this proposal is fully compatible with Regulation (EC) No 1901/2006 on
medicinal products for paediatric use, which provides for a possible ‘paediatric extension’ of
SPCs for medicinal products under specific conditions.

7 Discussions in this regard have been taken to the World Intellectual Property Organisation (WIPO),
where national/regional patent offices were invited to share information on their collaborations with
publicly accessible databases of patent status information concerning medicines and vaccines, such as
MedsPaL. See: WIPO, Standing Committee on the Law of Patents, 32 [nd] session, SCP/32/7, 2020.
8 –
European Commission, Commission Communication HERA Incubator: Anticipating together the
threat of COVID-19 variants, COM/2021/78, 2021.
9 European Commission, ‘Questions and answers : HERA incubator – Anticipating together the threat of
COVID-19 variants’, 2021 (https://ec.europa.eu/commission/presscorner/detail/en/qanda_21_642).

## EN 3 EN

Moreover, this proposal complements the pharmaceutical strategy for Europe and its intention
to promote both innovation in medicines and better access to them, including the related
legislative changes that are contemplated as regards regulatory protections ( _[OP, please add a_
_reference to the ongoing reform of the pharmaceutical legislation]_ ).

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**

This proposal is based on Article 114(1) of the Treaty on the Functioning of the European
Union on the single (or ‘internal’) market. This is the same legal basis used for Regulations
(EC) No 469/2009 and (EC) No 1610/96 (previously Articles 100a, and then 95, respectively,
of the Treaty establishing the European Community, as it then was). It is once again necessary
to have recourse to Article 114 to adapt the EU SPC regime in the light of how the existing
system has been applied. Even though SPCs are already harmonised, 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
face [10] . Hence, by its nature, action at EU level is also justified to ensure the smooth
functioning of the single market for innovative medicinal 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**

The objectives underlying the proposal can only be achieved at Union level. The Union-wide
approach implemented by the centralised procedure envisaged in this proposal will ensure that
the applicable rules and procedures are consistent across the Union, ensuring legal certainty
for all relevant market participants.

**•** **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.

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

## EN 4 EN

**•** **Choice of the instrument**

As the current SPC legislation is only governed by regulations, no other instrument can be
envisioned for recasting the existing EU SPC legislation (Regulations (EC) No 469/2009 and
(EU) No 2019/933) and introducing a centralised procedure.

**3.** **RESULTS** **OF** **EX-POST** **EVALUATIONS,** **STAKEHOLDER**
**CONSULTATIONS** **AND** **IMPACT** **ASSESSMENTS**

**•** **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
companies recoup their R&D investments. Although the SPC Regulations provide a common
framework within the EU, they are administered at 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 generics. 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 generics manufacturers.

An evaluation of the SPC manufacturing waiver, which is an exception introduced by
Regulation (EU) 2019/933, which amended Regulation (EC) No 469/2009, and is included in
this proposal, will be undertaken in the near future (as foreseen in Article 21a of Regulation
(EC) No 469/2009).

**•** **Stakeholder consultations**

The Commission conducted a public consultation during the evaluation of the SPC regime
(between 12 October 2017 and 4 January 2018) [11] . 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).

**•** **Collection and use of expertise**

The study [12] 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). The additional Max Planck Institute study completed in
2022 [13] provides a deeper analysis of the design of a centralised procedure.

11
https://ec.europa.eu/docsroom/documents/29464
12 https://ec.europa.eu/docsroom/documents/29524
13 https://op.europa.eu/en/publication-detail/-/publication/94cb20ea-2ff0-11ed-975d01aa75ed71a1/language-en

## EN 5 EN

**•** **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:

–
Option 0: No policy change.

–
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 nonbinding 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 nonbinding. 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

## EN 6 EN

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.

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 holders of European patents to obtain several (national) SPCs across the EU through
a centralised procedure would represent a considerable simplification compared to the current
situation in which national SPCs need to be applied for and granted separately in each
Member State. The proposed new centralised procedure is expected to result in significant
reductions in costs and administrative burden for applicants, and in improved legal certainty
and transparency, including for third parties (e.g. makers of generics).

In addition, as regards medicinal products, this proposal will result in a single SPC Regulation
instead of three, as would have resulted from proposing the creation of a centralised procedure
through a stand-alone Regulation while leaving the existing Regulation (EC) No 469/2009 (as
amended by Regulation (EU) 2019/933) unaffected. In other words, this proposal – that will
recast and repeal Regulation (EC) No 469/2009, which was amended by Regulation (EU) No
2019/933 – will achieve a ‘one in, two out’ outcome.

**•** **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 the grant of an intellectual property right and where necessary
for third parties, by providing for the procedural conditions for the examination, opposition
and appeal 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. Oppositions to applications may also be
filed by third parties.

In addition, a national office may decide to not grant an SPC, despite a positive examination
opinion, in certain narrowly defined situations, namely where material circumstances in that
Member State have changed since the filing of the centralised application (such as the basic
patent being no longer in force). 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 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. Where
national SPCs are granted by national offices on the basis of a positive opinion, third parties
will also be able to challenge their validity before the respective national courts or other
competent bodies, as already possible today pursuant to Regulation (EC) No 469/2009.

## EN 7 EN

As further explained below under ‘Basic patent’, legal certainty concerns call for closing the
national route when SPC protection is sought for a given product, where the conditions are

–
fulfilled for the centralised procedure i.e., in such a case, the filing of separate national
applications before national offices should be prohibited. This is intended to avoid
divergences between national decisions as such divergences would be avoided by using the
centralised procedure, and to prevent users from filing national SPC applications only before
national offices whose examination practice is less rigorous. This practice is akin to forum
shopping and undermines the SPC system. Applicants may seek to file weak applications at
national level in the hope of receiving SPCs from more lenient offices.

Conversely, as further explained below under ‘Unitary SPC’, this proposal does not exclude
centralised SPC applications designating one or more Member States participating in the
unitary patent system, potentially resulting in national SPCs being granted in these Member
States, as long as double protection is excluded, even where the conditions are met for the
grant of a unitary SPC.

A comparison of these two proposed measures does not show any unjustified difference of
treatment. Indeed, there may be cases where an applicant, while holding a unitary patent, has
no interest in obtaining SPCs in all the Member States which that patent covers, and therefore
that applicant should not be forced to apply for a unitary SPC, even if the conditions thereof
were fulfilled. On the other hand, the closing of the national route for the centralised
procedure never creates an obligation to designate all Member States for which the centralised
procedure can be used in given circumstances, as the applicant is free to choose which
Member States should be designated.

**4.** **BUDGETARY** **IMPLICATIONS**

This proposal will have no impact on the EU budget, since the system will remain fully selffunded 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
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).

**5.** **OTHER** **ELEMENTS**

**•** **Implementation plans and monitoring, evaluation and reporting arrangements**

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

## EN 8 EN

**•** **Detailed explanation of the specific provisions of the proposal**

_**Overall structure of the proposal**_

Chapter I of the proposal includes definitions and other general provisions.

Chapter II of the proposal includes most of the existing provisions of Regulation (EC) No
469/2009 regarding national applications for certificates, filed at national offices [14] (as
amended by Regulation (EU) 2019/933), without changing their substance, except for minor
technical adaptations that bring the recast regulation up to current drafting standards and
ensure better alignment with certain provisions of the corresponding proposal on plant
protection products (COM(2023) 223), derived from Regulation (EC) No 1610/96.

Chapter III includes new provisions defining the new centralised procedure.

Chapter IV contains final provisions, including the repeal of Regulation (EC) No 469/2009.

_**Basic patent**_

The existing SPC Regulations do not impose any limitation on the types of (‘basic’) patents
on which a national SPC application must rely, which may thus be: (1) a national patent
resulting from either a national patent application or from a European patent application; or
(2) a unitary patent (a ‘European patent with unitary effect’). To remove any residual legal
uncertainty, the option to rely on this second type of patent will be clarified through minor
amendments, in the recitals of this proposal, that explicitly refer to unitary patents. In this
respect it should be noted that paragraph 21 of the explanatory memorandum of the first
proposal for a Council Regulation concerning the creation of a supplementary protection
certificate for medicinal products (COM(90)101) envisaged that ‘ _when use is made of the_
_European procedure to obtain a Community patent,_ _it will likewise be necessary that the_
_certificate can apply equally to medicinal products protected by a Community patent_ ’ (now
referred to as a ‘European patent with unitary effect’ or, more informally, a ‘unitary patent’).

It is proposed that applications for SPCs filed under the new centralised procedure (Chapter
III of this proposal) must be based on European patents only as 'basic patents', including a
European patent with unitary effect. This will facilitate the examination of centralised SPC
applications because the filing and examination of a European patent application, if positive,
results in the grant of a European patent having, with a few exceptions, identical claims for all
designated countries, which is required for unitary patents.

Moreover, today most inventions, and in particular medicinal products, patented in the EU are
protected by European patents, which are granted only as the result of a thorough examination
procedure, and not by national patents, which in several Member States are not subject to an
in-depth substantive examination.

Therefore, under the proposed centralised procedure, allowing centralised SPC applications to
be based on national patents would be more demanding as regards the examination of such
applications, as it would be necessary to examine separately, for each of the designated
Member States, whether the product concerned is indeed protected by each of the respective
national patents in force, which will not necessarily have the same claims. This may also
affect legal certainty.

14 More precisely, filed with the competent industrial property office of the Member State concerned,
unless another authority was designated for that purpose.

## EN 9 EN

A requirement that the claims of the basic (European) patent must be identical for all Member
States designated in a centralised SPC application would make it easier to examine the
application. However, the cases where a European patent includes two or more sets of claims
for different Member States are quite rare, and it is very exceptional that there are more than
two sets of claims. For this reason, this proposal does not include a requirement that the
claims of the basic patent must be identical for all Member States designated in a centralised
SPC application.

In those situations where a centralised application could be filed, namely where the basic
patent is a European patent and the marketing authorisation is a centralised one, the choice
could have been made to also allow applicants to file national SPC applications. Based on the
findings of the evaluation completed in 2020, which revealed discrepancies between the
granting practices of various national offices, this might have resulted, however, in applicants
applying for certificates in Member States with less strict examination standards, to avoid
filing a centralised application that may be rejected due to a stricter examination. Such a
situation would be detrimental to consistency and legal certainty, could promote forum
shopping, and would result in a higher total workload across the EU from examining
applications. To avoid these drawbacks, it is considered preferable to examine applications
under the centralised procedure in all cases where the conditions for using this procedure are
met. Accordingly, this proposal requires that a national SPC application, filed in a Member
State, be rejected where the requirements for filing a centralised application are fulfilled
(‘closing of the national route’).

_**Examination/granting authority**_

Under the proposed centralised procedure, a central examination authority will carry out a
substantive examination of a centralised 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 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 centralised 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 centralised SPC application
after its publication.

_**Examination procedure and remedies**_

After examining the centralised SPC application, the central examination authority will issue
an examination opinion stating, for each of the designated Member States, whether a national
SPC fulfilling the applicable criteria (and in the first place those defined in Article 3) should
be granted or refused. The applicant can file an appeal against a negative or partly negative
opinion (as further explained below).

## EN 10 EN

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.

The opinion (including where amended following an opposition) will then be transmitted to
the national offices of each of the designated Member States. Where the opinion is positive
the designated Member States will grant a national SPC in accordance with their national
rules, e.g. as regards publication, registration in relevant databases and the payment of annual
(renewal) fees, unless circumstances have changed, such as the basic patent no longer being in
force in a certain Member State. Subject to the outcome of any appeal before the Boards of
Appeal or the EU courts, if the examination opinion is negative, the national office concerned
must reject the application.

After the grant of SPCs at a national level, third parties will still be able to initiate invalidity
proceedings before the body responsible under national law for the revocation of the
corresponding basic patents, or the competent courts of the Member States, including the
Unified Patent Court, as applicable. The same applies to a possible counterclaim for a
declaration of invalidity of an SPC.

_**Marketing authorisations concerned**_

It is proposed that only a centralised marketing authorisation (as defined in Regulation (EC)
No 726/2004 and in Regulation (EU) No 2019/6) could serve as the basis for a centralised
SPC application for medicinal products made under the centralised procedure proposed in
Chapter III. Today, most medicinal products are authorised under that centralised marketing
authorisation procedure. A centralised SPC application based on national marketing
authorisations, such as those granted under the decentralised or mutual recognition
procedures, would have significant drawbacks. These would include a bigger examination
workload, potential differences between the various national marketing authorisations granted
for the product concerned in different Member States, including language issues.

_**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
469/2009 for the existing national SPC regimes or the new centralised procedure, since:

– the case law [15] on SPCs is progressively converging, and steadily reducing
uncertainty about the interpretation of the SPC regime [16], while further amendments

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

## EN 11 EN

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).

_**New recitals**_

It was noted that there were no relevant recitals in Regulation (EC) No 469/2009 that could
assist in interpretation of Article 3. Accordingly, certain recitals concern the conditions in
Article 3 for the grant of SPCs, and incorporate the case law of the Court of Justice. The aim
is to ensure consistency. In particular the judgements in cases C‑ 121/17 and C-673/18
interpret Article 3(a) and 3(d) of Regulation (EC)No 469/2009, 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(90)101) for what became Council Regulation 1768/92/EEC, i.e. the predecessor of
Regulation (EC) No 469/2009, remain fully relevant today and should continue to be used as
a guide to interpretation, where relevant. This includes the objective that _only one certificate_
_may be granted for any one product, a product being understood to mean an active substance_
_in the strict sense. Minor changes to the medicinal product such as a new dose, the use of a_
_different salt or ester or a different pharmaceutical form will not lead to the issue of a new_
_certificate_ .

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 could be appropriate to consider that the protection conferred by a
certificate on a product extends to the therapeutically equivalent derivatives of the product.

For biological products, the application of the rules, both as regards the conditions for grant
and the effects of a certificate, should take into account the fact that minor differences may be
unavoidable between a subsequent biosimilar and the product initially authorised, given the
nature of biological products.

_**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 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)

## EN 12 EN

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.

_**Appeals**_

Decisions of the central examination authority are subject to appeal. This also applies to a
negative (or partly negative) examination opinion issued by the central examination authority,
an appeal could be filed by an applicant before the central examination authority, during a
limited period after the issuance of the examination opinion. 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 also 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 medicinal products and PPPs together, and introducing third-party observations
should help keep the number of appeals at a very low level.

_**Fees**_

An application fee and possibly other procedural fees, such as the fee for oppositions and
appeals, will have to be paid to the central examination authority. For national SPCs granted
under the centralised procedure, renewal fees would have to be paid to the national patent
offices of all the Member States where such certificates have been granted. This would differ,
however, for unitary certificates granted under the parallel proposals COM(2023) 222 and
COM(2023) 221, whereby the examination authority shall charge application and annual
(renewal) fees. The level of fees to be paid to the central examination authority will be set in
an implementing act.

_**Financial transfers between the central authority and national patent offices (NPOs)**_

As the procedural fees paid by applicants to the central examination authority may not be
sufficient to cover the costs incurred by that authority under the new centralised procedure, it
is necessary to ensure that a fraction of the renewal fees collected by national offices for SPCs
granted on the basis of the centralised procedure will be transferred to the central examination
authority. This already happens between national patent offices and the European Patent
Office (EPO) in respect of renewal fees for European patents. At the same time, it is
necessary to ensure that those national offices that participate in the new centralised procedure
as regards the substantive examination of centralised SPC applications are properly
remunerated for their participation.

_**Litigation**_

Whether it was obtained under today's current national procedures or under the newly
proposed centralised procedure, an SPC based on an European patent, including a unitary
patent, will be able to be litigated before the body responsible under national law for the

## EN 13 EN

revocation of the corresponding basic patent, which is typically a national court, and may
also, for those Member States participating in the unitary patent system (i.e. that have ratified
the UPCA), be the Unified Patent Court (‘UPC’) where the applicable conditions are fulfilled
(cf. Article 3(b) of the UPCA, together with Article 2(g) and Article 32) [17] .

_**National aspects**_

As the proposed centralised procedure results in the grant of national certificates (SPCs),
many existing national requirements and procedures, currently applicable to the SPCs applied
for nationally, will be equally applicable to the certificates granted under the proposed
centralised procedure. This relates in particular to publication requirements, national registers,
the payment of renewal fees and the SPC manufacturing waiver introduced by Regulation
(EU) 2019/933 and the paediatric extension defined in Regulation (EC) No 1901/2006.

No changes are proposed to the judicial procedures applicable to nationally granted SPCs,
whether granted on the basis of a national application or of a centralised application, e.g. as
regards revocation and enforcement, subject to the provisions of the UPCA, for its parties,
where applicable. In other words, invalidity actions and infringement actions may be brought
before the UPC also in respect of a nationally granted SPC based on a European patent,
subject to the applicable conditions, in particular the requirement that neither the patent nor
the SPC has been opted-out from the jurisdiction of the UPC.

_**Extension of SPCs for paediatric medicinal products**_

SPC applicants and holders should be able to use the centralised SPC granting procedure to
apply for extensions of SPCs for paediatric medicinal products, under the conditions currently
provided for by Regulation (EC) No 1901/2006.

_**Unitary SPCs**_

A parallel proposal (COM(2023) 222) is intended to create a unitary SPC for medicinal
products. This unitary certificate would be available only on the basis of a European patent
with unitary effect (‘unitary patent’), as a basic patent, and would exert its effects uniformly
in all the Member States in which the basic patent has unitary effect (17 initially).

The procedure for the centralised filing and examination of applications for such unitary
certificates would be the same _mutatis mutandis_ as the centralised procedure set out in this
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. This ‘combined’ application
would undergo a single examination procedure, ruling out any discrepancies, and
considerably reducing costs and the administrative burden for applicants. For the sake of
clarity, this proposal does not exclude centralised SPC applications designating one or more
Member States participating in the unitary patent system, as long as no unitary SPC is
simultaneously requested in such a case.

17 Where the related basic patent or the SPC itself has not been opted-out from the competence of the UPC
and where no action has already been brought before a national court (as far as those Member States in
which the patent has unitary effect are concerned).

## EN 14 EN

 469/2009 (adapted)
2023/0130 (COD)

Proposal for a

**REGULATION OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL**

**on the supplementary protection certificate for medicinal products (recast)**

(Text with EEA relevance)

THE EUROPEAN PARLIAMENT AND THE COUNCIL OF THE EUROPEAN UNION,

Having regard to the Treaty ~~establishing the European Community~~  on the Functioning of
the European Union , and in particular Article ~~95~~  114(1)  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 Committee [18],

Having regard to the opinion of the Committee of the Regions [19],

Acting in accordance with the ordinary legislative procedure,

Whereas:

 469/2009 recital 1 (adapted)

~~Council Regulation (EC) No 1768/92 of 18 June 1992 concerning the creation of a~~
~~supplementary protection certificate for medicinal products has been substantially amended~~
~~several times~~ ~~[2][0]~~ ~~. In the interests of clarity and rationality the said Regulation should be~~
~~codified.~~

18 OJ C […], […], p. […].
19 OJ C […], […], p. […].
20 ~~See Annex I.~~

## EN 15 EN

 469/2009 recital 2

(2) Pharmaceutical research plays a decisive role in the continuing improvement in public
health.

 469/2009 recital 3 (adapted)

(3) Medicinal products, ~~especially~~  in particular  those that are the result of long,
costly research will not continue to be developed in the ~~Community~~  Union  ~~and~~
~~in Europe~~ unless they are covered by favourable rules that provide for sufficient
protection to encourage such research.

 469/2009 recital 4 (adapted)

(4) ~~At the moment,~~ ~~Tth~~ e period that elapses between the filing of an application for a
patent for a new medicinal product and  the  authorisation to place the medicinal
product on the market makes the period of effective protection under the patent
insufficient to cover the investment put into the research.

 469/2009 recitals 5 and 6
(adapted)

(5)  That ~~~~ ~~This~~ situation leads to a lack of protection which penalises pharmaceutical
research  and there is ~~~~ ~~. There exists~~ a risk ~~of~~  that  research centres
situated in the Member States  relocate  ~~relocating~~ to countries that offer greater
protection.

 469/2009 recital 7 (adapted)

(6) A uniform solution at ~~Community~~  Union  level should be provided for, thereby
preventing the heterogeneous development of national laws leading to further
disparities which would be likely to create obstacles to the free movement of
medicinal products within the ~~Community~~  Union  and thus directly affect the
functioning of the internal market.

22 See Annex I.

## EN 16 EN

(7) Therefore, the provision of a supplementary protection certificate  (‘certificate’) 
granted, under the same conditions, by each of the Member States at the request of the
holder of a national  patent  or European patent , with or without unitary
effect,  relating to a medicinal product for which marketing authorisation has been
granted is necessary. ~~A regulation is therefore the most appropriate legal instrument.~~

## EN 17 EN

 469/2009 recital 9 (adapted)

(15) The duration of the protection granted by the certificate should be such as to provide
adequate effective protection. For this purpose, the holder of both a patent and a
certificate should be able to enjoy an overall maximum of 15 years of exclusivity from
the time the medicinal product in question first obtains  an  authorisation to be
placed on the market in the ~~Community~~  Union  .

(16) All the interests at stake, including those of public health, in a sector as complex and
sensitive as the pharmaceutical sector should nevertheless be taken into account. For
~~this~~  that  purpose,  it should not be possible to grant a  ~~the~~ certificate
~~cannot be granted~~ for a period exceeding  5  years. The protection granted
should furthermore be strictly confined to the product which obtained authorisation to

 469/2009 recital 11

## EN 18 EN

## EN 19 EN

## EN 20 EN

## EN 21 EN

## EN 22 EN

 2019/933 recital 5 (adapted)

(43) ~~Those circumstances put makers of generics and biosimilars established in the Union~~
~~at a significant competitive disadvantage in comparison with makers based in third~~
~~countries that offer less or no protection. The Union should strike~~ ~~Aa~~ balance
 should be struck  between restoring a level playing field between ~~those~~ makers
 of generics and biosimilars established in the Union and makers based in third
countries that offer less or no protection  and ensuring that the essence of the
exclusive rights of holders of certificates (‘certificate holders’) is guaranteed in
relation to the Union market.

 2019/933 recital 8 (adapted)

~~such~~ M ~~ma~~ kers  of generics and biosimilars established in the Union should be
allowed  to make and store products, or medicinal products containing those
products, in a Member State for a defined period pending the expiry of the certificate,
for the purpose of entering the market of any Member State upon expiry of the
corresponding certificate, thereby helping those makers to compete effectively in the

 2019/933 recital 9 (adapted)

(45) In those specific and limited circumstances, and in order to create a level playing field
between makers established in the Union and third-country makers, it is appropriate to
provide for an exception to the protection conferred by a certificate so as to allow the
making of a product, or a medicinal product containing that product, for the purpose of
export to third countries or of storing, and any related acts in the Union strictly
necessary for that making or for the actual export or the actual storing  (‘related
acts’) , where such acts would otherwise require the consent of  the  ~~a~~
certificate holde ~~r~~ ~~(‘related acts’).~~ For instance, such related acts could include ~~:~~
 the  possessing, ~~;~~ offering to supply, ~~;~~ supplying, ~~;~~ importing, ~~;~~ using or

## EN 23 EN

synthesising  of  an active ingredient for the purpose of making a medicinal
product. ~~; or~~  They could also consist of  temporary storing or advertising  of
the product  for the exclusive purpose of export to third-country destinations. ~~That~~
 The  exception should also apply to related acts performed by third parties who
are in a contractual relationship with the maker.

 2019/933 recital 10 (adapted)

(46) The exception should apply to a product, or a medicinal product containing that
product, protected by a certificate ~~. It~~  and  should cover the making of the
product protected by  the  ~~a~~ certificate in the territory of a Member State and the
making of the medicinal product containing that product.

 2019/933 recital 11

(47) The exception should not cover placing a product, or a medicinal product containing
that product, which is made for the purpose of export to third countries or of storing
with a view to EU day-one entry, on the market of a Member State where a certificate
is in force, either directly or indirectly after export, nor should it cover re-importation
of such a product, or medicinal product containing that product, into the market of a
Member State in which a certificate is in force. Moreover, it should not cover any act
or activity carried out for the purpose of import of products, or medicinal products
containing those products, into the Union merely for the purposes of repackaging and
re-exporting. In addition, the exception should not cover any storing of products, or
medicinal products containing those products, for any purposes other than those set
out in this Regulation.

(48) By limiting the scope of the exception to  the  making  of a product, or a
medicinal product containing that product,  for the purpose of export outside the
Union or to making for the purpose of storing, and to acts strictly necessary for such
making or for the actual export or the actual storing, the exception ~~provided for in this~~
~~Regulation should~~  will  not conflict with the normal exploitation of the product,
or the medicinal product containing that product, in the Member State in which the
certificate is in force, namely with the core exclusive right of the certificate holder to
make that product for the purpose of placing it on the Union market during the term of
the certificate. In addition, that exception should not unreasonably prejudice the
legitimate interests of the certificate holder, whilst taking account of the legitimate
interests of third parties.

 2019/933 recital 13 (adapted)

(49) Effective and proportionate safeguards should apply in relation to the exception in
order to increase transparency, to help the ~~holder of a~~ certificate  holder to 

## EN 24 EN

enforce its protection in the Union and check compliance with ~~the conditions set out in~~
this Regulation, and to reduce the risk of illicit diversion onto the Union market during
the term of the certificate.

(50) ~~This Regulation should~~  To ensure better transparency and legal certainty, it is
necessary to  impose an information obligation on the maker, namely the person
established in the Union, on whose behalf the making of a product, or a medicinal
product containing that product, for the purpose of export or storing, is carried out. ~~It~~
~~is possible that the maker directly carries out the making~~  That obligation should

 2019/933 recital 18

be the responsibility of the maker established in the Union to verify that protection
does not exist or has expired in a country of export, or whether that protection is
subject to any limitations or exemptions in that country.

## EN 25 EN

(52) ~~This Regulation should impose~~ ~~c~~ Certain due diligence requirements  should be

the relevant certificate  will  ~~would,~~ therefore, be entitled to enforce its rights
under the certificate, while having due regard to the general obligation, provided for in
Directive 2004/48/EC of the European Parliament and of the Council [29], not to engage
in abusive litigation.

 2019/933 recital 21 (adapted)

in this Regulation  should be without prejudice to labelling requirements of third
countries.

 2019/933 recital 22

(54) Any act not covered by the exception provided for in this Regulation should remain
within the scope of the protection conferred by a certificate. Any diversion onto the
Union market, during the term of the certificate, of any product, or any medicinal
product containing that product, made under the exception, should remain prohibited.

29 Directive 2004/48/EC of the European Parliament and of the Council of 29 April 2004 on the
enforcement of intellectual property rights (OJ L 157, 30.4.2004, p. 45).

## EN 26 EN

(55) This ~~Regulation~~  exception  is without prejudice to other intellectual property
rights that could protect other aspects of a product, or a medicinal product containing
that product. This ~~Regulation~~  exception  does not affect the application of Union
acts that aim to prevent infringements, and facilitate enforcement, of intellectual
property rights, including Directive 2004/48/EC and Regulation (EU) No 608/2013 of
the European Parliament and of the Council [30] ~~[(7)]~~ .

(56) This ~~Regulation~~  exception  does not affect the rules on the unique identifier,
provided for in Directive 2001/83/EC of the European Parliament and of the
Council [31] . The maker should ensure that any medicinal product made for the purpose
of export ~~, pursuant to this Regulation,~~ does not bear an active unique identifier within

However, under that Delegated Regulation, the requirement to carry such an active
unique identifier applies to medicinal products intended to be placed on the market of

(57) This ~~Regulation~~  exception  does not affect the application of Directive ~~s~~
~~2001/82/EC and~~ 2001/83/EC and Regulation (EU) 2019/6, in particular the
requirements relating to the manufacturing authorisation of medicinal products made
for export. This includes compliance with the principles and guidelines of good
manufacturing practices for medicinal products and using only active substances
which have been manufactured in accordance with good manufacturing practices for
active substances and distributed in accordance with good distribution practices for
active substances.

30 Regulation (EU) No 608/2013 of the European Parliament and of the Council of 12 June 2013
concerning customs enforcement of intellectual property rights and repealing Council Regulation (EC)
No 1383/2003 ( OJ L 181, 29.6.2013, p. 15 ).
31 Directive 2001/83/EC of the European Parliament and of the Council of 6 November 2001 on the
Community code relating to medicinal products for human use (OJ L 311, 28.11.2001, p. 67).
32 Commission Delegated Regulation (EU) 2016/161 of 2 October 2015 supplementing Directive
2001/83/EC of the European Parliament and of the Council by laying down detailed rules for the safety
features appearing on the packaging of medicinal products for human use (OJ L 32, 9.2.2016, p. 1).

## EN 27 EN

(58) To safeguard the rights of certificate holders, the exception provided for in this
Regulation should not apply to a certificate that ~~has~~  had  already taken effect at
the date of entry into force of ~~this~~ Regulation  (EU) 2019/933 of the European
Parliament and of the Council  . ~~In order tT~~ o ensure that the rights of certificate
holders are not excessively restricted, the exception should apply to certificates that
are applied for on or after the date of entry into force of ~~this~~ Regulation  (EU) No
2019/933  . Given that a certificate takes effect at the end of the lawful term of the
basic patent, which can be a relatively long time after the date of filing of the
application for the certificate, ~~and in order to achieve the aim of this Regulation,~~ it is
justified that  the exception set out in  this Regulation also ~~cover~~  covers ,
over a certain period of time, a certificate that was applied for before the date of entry
into force of ~~this~~ Regulation  (EU) No 2019/933 , but ~~has~~  had  not yet
taken effect before that date, irrespective of whether or not that certificate was granted
before that date. The exception  applied  ~~should apply,~~ therefore, from 2 July
2022 to a certificate that ~~takes~~  took  effect from the date of entry into force of
~~this~~ Regulation  (EU) No 2019/933  . The concept of ‘certain period of time’ for
each individual certificate that takes effect after the date of entry into force of  that
 ~~this~~ Regulation should ensure that the exception ~~is~~  be  applied, on a
progressive basis, to such a certificate, depending on the date on which it ~~takes~~
 took  effect and on its duration. Such application of the exception would allow
the holder of a certificate that ~~has~~  had  been granted, but that ~~has~~  had  not
yet taken effect by the date of the entry into force of ~~this~~ Regulation
 (EU) 2019/933 , a reasonable period of transition to adapt to the changed legal
context, while at the same time ensuring that makers of generics and biosimilars can
benefit effectively, without excessive delay, from the exception.

 2019/933 recital 27 (adapted)

(59) ~~Typically, an applicant for a certificate files an application at approximately the same~~
~~date in each Member State of filing. However, due to differences in national~~
~~procedures for the examination of applications, the date of grant of the certificate~~
~~might vary significantly from one Member State to another, thereby creating~~
~~disparities in the legal situation of the applicant in the Member States in which the~~
~~certificate was applied for. Introducing~~ ~~t~~ The exception  should apply  on the
basis of the date of the filing of the application for a certificate ~~would, therefore~~,  in
order to  promote uniformity and limit the risk of disparities.

## EN 28 EN

## EN 29 EN

~~13 April 2016 on Better Law-Making, that evaluation should be based on the five~~
~~criteria of effectiveness, efficiency, relevance, coherence and added value and should~~
~~provide the basis for impact assessments of possible further measures.~~ That evaluation
should take into account, on the one hand, exports to outside the Union, and on the
other  hand , the effects of storing on the swifter entry of generics and especially
biosimilars into markets in the Union as soon as possible after a certificate expires.
Such regular evaluation should also address the effects of this ~~Regulation~~
 exception  on the making of generics and biosimilars in the Union by makers of
generics and biosimilars established in the Union. In that context, it  is ~~~~ ~~would be~~
important to ascertain whether making that was previously taking place outside of the
Union ~~would be~~  are being  moved to within Union territory. In particular, 
the  ~~that~~ evaluation should review the effectiveness of the exception in the light of
the aim to restore a global level playing field for makers of generics and biosimilars in
the Union.  The evaluation  ~~It~~ should also study the impact of the exception on
research and production of innovative medicines in the Union by certificate holders
and consider the balance between the different interests at stake, in particular as
regards public health, public expenditure and, in  that  ~~this~~ context, access to
medicines within the Union. It should also study whether the period provided for as
regards the making of generics and biosimilars for the purpose of storing is sufficient
to achieve the objective of EU day-one entry, including its effects on public health.
 The Commission should also regularly evaluate the centralised procedure. 

## EN 30 EN

(68) This Regulation respects fundamental rights and observes the principles recognised by

should maintain the core rights of the certificate, by limiting the exception provided
for in this Regulation to the making of a product, or a medicinal product containing
that product, only for the purpose of export outside the Union or for the purpose of
storing for a limited period of time with a view to entry into the Union market upon
expiry of the protection, and to the acts strictly necessary for such making or for the
actual export or the actual storing. In the light of those fundamental rights and
principles, the exception provided for in this Regulation does not go beyond what is
necessary and appropriate in the light of the overall objective of this Regulation, which
is to promote the competitiveness of the Union by avoiding relocation and allowing
makers of generics and biosimilars established in the Union to compete, on the one
hand, on fast-growing global markets where protection does not exist or has already
expired, and on the other, on the Union market upon expiry of the certificate. ~~Indeed, it~~
~~is necessary to benefit from the positive economic effects arising from the exception,~~
~~as otherwise the Union would risk substantially weakening its position as a hub for~~
~~pharmaceutical development and manufacturing. It is, therefore, appropriate to~~
~~introduce that exception in order to increase the competitive position of makers of~~
~~generics and biosimilars established in the Union in third countries whose markets are~~
~~in any event open to competition, whilst leaving the scope and duration of the~~
~~protection granted by the certificate in the Union untouched. The appropriateness of~~
~~the measure is further ensured by providing for appropriate safeguards regulating the~~
~~use of the exception. This Regulation should allow sufficient time for public~~
~~authorities to put in place the necessary arrangements to receive and publish~~

## EN 31 EN

HAVE ADOPTED THIS REGULATION:

CHAPTER I

 GENERAL PROVISIONS 

_Article_ ~~_2_~~ _1_

~~_**Scope**_~~  _**Subject matter**_ 

~~Any~~ ~~product~~  This Regulation lays down rules on the supplementary protection certificate
(‘certificate’) for medicinal products  protected by a patent in the territory of a Member
State and subject, prior to being placed on the market as a medicinal product, to an
administrative authorisation procedure as laid down in Directive 2001/83/EC ~~of the European~~
~~Parliament and of the Council of 6 November 2001 on the Community code relating to~~
~~medicinal products for human use~~ ~~[(6)]~~ , Regulation (EC) No 726/2004  or ~~Directive~~
~~2001/82 of the European Parliament and of the Council 6 November 2001 on the Community~~
~~code relating to veterinary medicinal products (7)~~ Regulation (EU) 2019/6 ~~may, under the~~
~~terms and conditions provided for in this Regulation, be the subject of a certificate~~ .

## EN 32 EN

 469/2009 (adapted)

_Article_ ~~_1_~~ _2_

_**Definitions**_

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

(1) ‘medicinal product’ means any substance or combination of substances presented for
treating or preventing disease in human beings or animals and any substance or
combination of substances which may be administered to human beings or animals
with a view to making a medical diagnosis or to restoring, correcting or modifying
physiological functions in humans or in animals;

(2) ‘product’ means the active ingredient or combination of active ingredients of a
medicinal product;

(3) ‘basic patent’ means a patent which protects a product as such, a process to obtain a
product or an application of a product, and which is designated by its holder for the
purpose of the procedure for grant of a certificate;

~~‘certificate’ means supplementary protection certificate;~~

(4) ‘application for an extension of the duration’ means an application for an extension
of the duration of the certificate pursuant to Article 13(3) of this Regulation and
Article 36 of Regulation (EC) No 1901/2006 ~~of 12 December 2006 on medicinal~~
~~products for paediatric use~~ [37] ;

 2019/933 Art. 1 pt. 1

(5) ‘maker’ means the person, established in the Union, on whose behalf the making of a
product, or a medicinal product containing that product, for the purpose of export to
third countries or for the purpose of storing, is carried out.

37 Regulation (EC) No 1901/2006 of the European Parliament and of the Council of 12 December 2006 on
medicinal products for paediatric use and amending Regulation (EEC) No 1768/92, Directive
2001/20/EC, Directive 2001/83/EC and Regulation (EC) No 726/2004 (OJ L 378, 27.12.2006, p. 1) OJ
L 378, 27.12.2006, p. 1.

## EN 33 EN

_Article 3_

_**Conditions for obtaining a certificate**_

1. A certificate shall be granted if, in the Member State in which the application
referred to in Article 7 is submitted and at the date of that application , all of the
following conditions are fulfilled  :

(a) the product is protected by a basic patent in force;

(b) a valid authorisation to place the product on the market as a medicinal product
has been granted in accordance with Directive 2001/83/EC,  Regulation (EC)
No 726/2004  or ~~Directive 2001/82/EC~~ Regulation (EU) 2019/6, as
appropriate;

(c) the product has not already been the subject of a certificate;

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

## EN 34 EN

 469/2009 (adapted)

_Article 4_

 _**Scope**_  ~~_**Subject matter o**_~~ _**f**_  _**the**_  _**protection**_

Within the limits of the protection conferred by the basic patent, the protection conferred by a
certificate shall extend only to the product covered by the authorisation to place the
corresponding medicinal product on the market and for any use of the product as a medicinal
product that has been authorised before the expiry of the certificate.

 933/2019 Art. 1 pt. 2 (adapted)

_Article 5_

_**Effects of the certificate**_

1. ~~Subject to the provisions of Article 4,~~ ~~Tt~~ he certificate shall confer the same rights as
conferred by the basic patent and shall be subject to the same limitations and the
same obligations.

2. By way of derogation from paragraph 1, the certificate ~~referred to in paragraph 1~~
shall not confer protection against certain acts which would otherwise require the
consent of the ~~holder of the certificate (‘~~ the certificate holder ~~’),~~ if  all of  the
following conditions are met:

(a) the acts comprise  any of the following  :

(i) the making of a product, or a medicinal product containing that product,
for the purpose of export to third countries; ~~or~~

(ii) any related act that is strictly necessary for the making, in the Union,
referred to in point (i), or for the actual export; ~~or~~

(iii) the making, no earlier than  6  ~~six~~ months before the expiry of the

certificate, of a product, or a medicinal product containing that product,
for the purpose of storing it in the Member State of making, in order to
place that product, or a medicinal product containing that product, on the

## EN 35 EN

market of Member States after the expiry of the corresponding
certificate; ~~or~~

(iv) any related act that is strictly necessary for the making, in the Union,

referred to in point (iii), or for the actual storing, provided that such
related act is carried out no earlier than  6  ~~six~~ months before the
expiry of the certificate.

(b) the maker, through appropriate and documented means, notifies the authority
referred to in Article 9(1) in the Member State in which that making is to take
place, and informs the certificate holder, of the information  referred to 
~~listed~~ in paragraph 5 ~~of this Article~~ no later than  3  ~~three~~ months before
the start date of the making in that Member State, or no later than  3 
~~three~~ months before the first related act, prior to that making, that would
otherwise be prohibited by the protection conferred by a certificate, whichever
is the earlier;

(c) if the information  referred to  ~~listed~~ in paragraph 5 of this Article
changes, the maker notifies the authority referred to in Article 9(1) and informs
the certificate holder, before those changes take effect;

(d) in the case of products, or medicinal products containing those products, made
for the purpose of export to third countries, the maker ensures that a logo, in
the form set out in Annex ~~-Ia~~ II, is affixed to the outer packaging of the
product, or the medicinal product containing that product, referred to in point
(a)(i) of this paragraph, and, where feasible, to its immediate packaging;

(e) the maker complies with paragraph 9 of this Article and, if applicable, with
Article 12(2).

3. ~~The exception laid down referred to in pP~~ aragraph 2 shall not apply to any act or
activity carried out for the import of products, or medicinal products containing those
products, into the Union merely for the purpose of repackaging, re-exporting or
storing.

4. The information provided to the certificate holder for the purposes of paragraph 2,
points (b) and (c), ~~of paragraph 2~~ shall be used exclusively for the purposes of
verifying whether the requirements of this Regulation have been met and, where
applicable, initiating legal proceedings for non-compliance.

5. ~~The information to be provided by the maker fF~~ or the purposes of paragraph 2, point
(b), ~~of paragraph 2~~  the maker shall provide all of the following information 
~~shall be as follows~~ :

(a) the name and address of the maker;

(b) an indication of whether the making is for the purpose of export, for the
purpose of storing, or for the purpose of both export and storing;

(c) the Member State in which the making and, if applicable, also the storing is to
take place, and the Member State in which the first related act, if any, prior to
that making is to take place;

(d) the number of the certificate granted in the Member State of making, and the
number of the certificate granted in the Member State of the first related act, if
any, prior to that making; ~~and~~

## EN 36 EN

(e) for medicinal products to be exported to third countries, the reference number
of the marketing authorisation, or the equivalent of such authorisation, in each
third country of export, as soon as it is publicly available.

6. For the purposes of notification to the authority under paragraph 2, points (b) and (c),
~~of paragraph 2,~~ the maker shall use the standard form for notification ~~contained~~
 set out  in Annex ~~-Ia~~ III.

7. Failure to ~~comply with the requirements of~~  provide the information referred to in
 paragraph 5, point (e), ~~of paragraph 5~~ with regard to a third country shall only
affect exports to that  third  country, and those exports shall ~~, therefore,~~ not
benefit from the exception  laid down in paragraph 2  .

8. The maker shall ensure that medicinal products made pursuant to paragraph 2, point
(a) (i), ~~of paragraph 2~~ do not bear an active unique identifier within the meaning of
~~Commission~~ Delegated Regulation (EU) 2016/161 ~~[39]~~ ~~.~~

9. The maker shall ensure, through appropriate and documented means, that any person
in a contractual relationship with the maker ~~who~~  that  performs acts falling
under paragraph 2, point (a), ~~of paragraph 2~~ is fully informed and aware of  all of
 the following:

(a) that those acts are subject to paragraph 2;

(b) that the placing on the market, import or re-import of the product, or the
medicinal product containing that product, referred to in paragraph 2, point
(a)(i), ~~of paragraph 2~~ or the placing on the market of the product, or the
medicinal product containing that product, referred to in paragraph 2, point
(a)(iii), ~~of paragraph 2~~ could infringe the certificate referred to in  that 
paragraph ~~2~~ where, and for as long as, that certificate applies.

10. Paragraph 2 shall apply to certificates that are applied for on or after 1 July 2019.

Paragraph 2 shall also apply to certificates that have been applied for before 1 July
2019 and that take effect on or after that date. Paragraph 2 shall only apply to such
certificates from 2 July 2022.

Paragraph 2 shall not apply to certificates that have taken effect before 1 July 2019.

_Article 6_

_**Entitlement to the certificate**_

1. The certificate shall be granted to the holder of the basic patent or ~~his~~  to the 
successor in title  of that holder  .

39 ~~Commission Delegated Regulation (EU) 2016/161 of 2 October 2015 supplementing Directive~~
~~2001/83/EC of the European Parliament and of the Council by laying down detailed rules for the safety~~
~~features appearing on the packaging of medicinal products for human use (OJ L 32, 9.2.2016, p. 1).';~~

## EN 37 EN

_Article 7_

_**Application for a certificate**_

1. The application for a certificate shall be lodged within  6  ~~six~~ months of the
date on which the authorisation referred to in Article 3(1), point (b), to place the
product on the market as a medicinal product was granted.

2. Notwithstanding paragraph 1, where the authorisation to place the product on the
market is granted before the basic patent is granted, the application for a certificate
shall be lodged within  6  ~~six~~ months of the date on which the patent is granted.

3. The application for an extension of the duration may be ~~made~~  lodged at the same
time  when lodging the application for a certificate or when the application for the
certificate is pending and the appropriate requirements of Article 8(1), point (d), or
Article 8(2), respectively, are fulfilled.

4. The application for an extension of the duration of a certificate already granted shall
be lodged not later than  2  ~~two~~ years before the expiry of the certificate.

~~Notwithstanding paragraph 4, for five years following the entry into force of Regulation (EC)~~
~~No 1901/2006, the application for an extension of the duration of a certificate already granted~~
~~shall be lodged not later than six months before the expiry of the certificate.~~

_Article 8_

_**Content of the application for a certificate**_

1. The application for a certificate shall contain  the following  :

(a) a request for the grant of a certificate, stating in particular:

(i) the name and address of the applicant;

(ii) if  the applicant  ~~he~~ has appointed a representative, the name and
address of  that  ~~the~~ 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  ~~Community,~~ the number and date of that
authorisation;

## EN 38 EN

(b) 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 Article 11 of Directive 2001/83/EC or Article
35 ~~14~~ of ~~Directive 2001/82/EC~~ Regulation (EU) 2019/6;

(c)  where  ~~if~~ 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  ~~Community,~~ 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

(d) where the application for a certificate for a medicinal product includes a
request for an extension of the duration:

(i) a copy of the statement indicating compliance with an agreed completed
paediatric investigation plan as referred to in Article 36(1) of Regulation
(EC) No 1901/2006;

(ii) where necessary, in addition to the copy of the authorisation to place the
product on the market as referred to in point (b), proof of possession of
authorisations to place the product on the market of all other Member
States, as referred to in Article 36(3) of Regulation (EC) No 1901/2006.

2. Where an application for a certificate is pending, an application for an extension of
the duration in accordance with Article 7(3) shall include the particulars referred to
in paragraph 1, point (d), of this Article and a reference to the application for a
certificate already filed.

3. The application for an extension of the duration of a certificate already granted shall
contain the particulars referred to in paragraph 1, point (d), and a copy of the
certificate already granted.

4. Member States may provide that a fee is to be payable upon application for a
certificate and upon application for the extension of the duration of a certificate.

_Article 9_

_**Lodging of an application for a certificate**_

1. The application for a certificate shall be lodged with the competent industrial
property office of the Member State which granted the basic patent or on whose
behalf it was granted and in which the authorisation referred to in Article 3(1), point
(b), to place the product on the market was obtained, unless the Member State
designates another authority for  that ~~~~ ~~the~~ purpose.

The application for an extension of the duration of a certificate shall be lodged with
the competent authority of the Member State concerned.

2. Notification of the application for a certificate shall be published by the authority
referred to in paragraph 1. The notification shall contain ~~at least~~  all of  the
following information:

## EN 39 EN

(a) the name and address of the applicant;

(b) the number of the basic patent;

(c) the title of the invention;

(d) the number and date of the authorisation to place the product on the market,
referred to in Article 3(1), point (b), and the product identified in that
authorisation;

(e) where relevant, the number and date of the first authorisation to place the
product on the market in the  Union  ~~Community~~ ;

(f) where applicable, an indication that the application includes an application for
an extension of the duration.

3. Paragraph 2 shall apply to the notification of the application for an extension of the
duration of a certificate already granted or where an application for a certificate is
pending. The notification shall additionally contain an indication of the application
for an extended duration of the certificate.

_Article 10_

_**Grant of the certificate or rejection of the application for a certificate**_

1. Where the application for a certificate and the product to which it relates meet the
conditions laid down in this Chapte ~~rRegulation,~~ the authority referred to in Article
9(1) shall grant the certificate.

2. The authority referred to in Article 9(1) shall, subject to paragraph 3  of this
Article , reject the application for a certificate if the application or the product to
which it relates does not meet the conditions laid down in this Chapte ~~rRegulation~~ .

3. Where the application for a certificate does not meet the conditions laid down in
Article 8, the authority referred to in Article 9(1) shall ask the applicant to rectify the
irregularity, or to settle the fee, within a stated time.

4. If the irregularity is not rectified or the fee is not settled under paragraph 3 within the
stated time, the authority shall reject the application.

5. Member States may provide that the authority referred to in Article 9(1) is to grant
certificates without verifying that the conditions laid down in Article 3(1), points (c)
and (d), are met.

6. Paragraphs 1 to 4 shall apply _mutatis mutandis_ to the application for an extension of
the duration.

_Article 11_

_**Publication**_

1.  The authority referred to in Article 9(1) shall publish, as soon as possible, 
n ~~No~~ tification of the fact that a certificate has been granted ~~shall be published by the~~
~~authority referred to in Article 9(1)~~ . The notification shall contain ~~at least~~  all of 
the following information:

(a) the name and address of the holder of the certificate;

(b) the number of the basic patent;

## EN 40 EN

(c) the title of the invention;

(d) the number and date of the authorisation to place the product on the market
referred to in Article 3 (1), point (b), and the product identified in that
authorisation;

(e) where relevant, the number and date of the first authorisation to place the
product on the market in the  Union  ~~Community~~ ;

(f) the duration of the certificate.

2.  The authority referred to in Article 9(1) shall publish, as soon as possible, 
n ~~No~~ tification of the fact that the application for a certificate has been rejected ~~shall~~
~~be published by the authority referred to in Article 9(1).~~ The notification shall
contain at least the information listed in Article 9(2).

3. Paragraphs 1 and 2 shall apply to the notification of the fact that an extension of the
duration of a certificate has been granted or of the fact that the application for an
extension has been rejected.

 2019/933 Art. 1 pt. 3

4. The authority referred to in Article 9(1) shall publish, as soon as possible, the
information listed in Article 5(5), together with the date of notification of that
information. It shall also publish, as soon as possible, any changes to the information
notified in accordance with Article 5(2), point (c) ~~of Article 5(2)~~ .

 933/2019 Art. 1 pt. 4 (adapted)

_Article 12_

_**Fees**_

1. Member States may require that the certificate be subject to the payment of annual
fees.

2. Member States may require that the notifications to in Article 5(2), points (b) and (c),
~~of Article 5(2) b~~ e subject to the payment of a fee.

_Article 13_

_**Duration of the certificate**_

1. The certificate shall take effect at the end of the lawful term of the basic patent for a
period equal to the period which elapsed between the date on which the application
for a basic patent was lodged and the date of the first authorisation to place the
product on the market in the  Union  ~~Community,~~ reduced by a period of  5
 ~~five~~ years.

## EN 41 EN

2. Notwithstanding paragraph 1, the duration of the certificate may not exceed  5 
~~five~~ years from the date on which it takes effect.

3. The periods laid down in paragraphs 1 and 2  of this Article  shall be extended
by  6  ~~six~~ months in the case where Article 36 of Regulation (EC) No
1901/2006 applies. In that case, the duration of the period laid down in paragraph 1
of  that  ~~this~~ Article may be extended only once.

~~Where a certificate is granted for a product protected by a patent which, before 2 January~~
~~1993, had its term extended or for which such extension was applied for, under national law,~~
~~the term of protection to be afforded under this certificate shall be reduced by the number of~~
~~years by which the term of the patent exceeds 20 years.~~

_Article 14_

_**Expiry of the certificate**_

The certificate shall lapse  in any of the following events  :

(a) at the end of the period provided for in Article 13;

(b) if the certificate holder surrenders it;

(c) if the annual fee laid down in accordance with Article 12 is not paid in time;

(d) if and as long as the product covered by the certificate may no longer be placed
on the market following the withdrawal of the appropriate authorisation or
authorisations to place on the market in accordance with Directive 2001/83/EC
or ~~Directive 2001/82/EC~~ Regulation (EU) 2019/6.

 For the purposes of point (d),  ~~Tt~~ he authority referred to in Article 9(1) ~~of this Regulation~~
may decide on the lapse of the certificate either of its own motion or at the request of a third
party.

_Article 15_

_**Invalidity of the certificate**_

1. The certificate shall be invalid  in any of the following events  ~~if:~~

(a)  the certificate  ~~it~~ was granted contrary to ~~the provisions of~~ 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 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.

2. Any person may submit an application or bring an action for a declaration of
invalidity of the certificate before the body responsible under national law for the
revocation of the corresponding basic patent , or before a competent court of a
Member State  .

## EN 42 EN

_Article 16_

_**Revocation of an extension of the duration of a certificate for a medicinal product**_

1. The extension of the duration may be revoked if it was granted contrary to ~~the~~
~~provisions of~~ Article 36 of Regulation (EC) No 1901/2006.

2. Any person may submit an application for revocation of the extension of the duration
 granted under this Chapter  to the body responsible under national law for the
revocation of the corresponding basic patent.

_Article 17_

_**Notification of lapse or invalidity**_

1. If the certificate lapses in accordance with ~~point (b), (c) or (d) of~~ Article 14, points
(b), (c) or (d), or is invalid in accordance with Article 15,  the authority referred to
in Article 9(1) shall publish  notification thereof ~~shall be published by the~~
~~authority referred to in Article 9(1)~~ .

2. If the extension of the duration is revoked in accordance with Article 16,  the
authority referred to in Article 9(1) shall publish  notification thereof ~~shall be~~
~~published by the authority referred to in Article 9(1).~~

_Article 18_

_**Appeals**_

1. The decisions of the authority referred to in Article 9(1) or of the bodies referred to in
Article 15(2) and Article 16(2) taken under this ~~Regulation~~ Chapter shall be open to the same
appeals as those provided for in national law against similar decisions taken in respect of
national patents.

 469/2009 (adapted)

_Article 19_

_**Procedure**_

1. In the absence of procedural provisions in this Regulation, the procedural provisions
applicable under national law to the corresponding basic patent shall apply to the
certificate, unless the national law lays down special procedural provisions for
certificates.

2. Notwithstanding paragraph 1, the procedure for opposition to the grant ~~ing~~ of a
certificate shall be excluded.

## EN 43 EN

_Article 20_

_**Scope of the centralised application**_

4. Articles 1 to 7 and 13 to 18 shall apply to centralised applications.

5. The centralised application shall be lodged by using a specific application form.

_Article 21_

_**Content of the centralised application**_

The centralised application shall contain the following:

(b) the information referred to in Article 8(1).

_Article 22_

_**Examination of the admissibility of a centralised applicatio**_ _n_

1. The Office shall examine the following:

(a) whether the centralised application complies with Article 21;

(b) whether the centralised application complies with Article 7;

## EN 44 EN

_Article 23_

_**Publication of the centralised application**_

_Article 24_

_**Examination of the centralised application**_

_Article 25_

_**Observations by third parties**_

## EN 45 EN

_Article 26_

_**Opposition**_

4. The notice of opposition shall contain:

(b) the particulars of the opponent and, where applicable, of its representative;

## EN 46 EN

_Article 27_

_**Role of competent national authorities**_

_Article 28_

_**Examination panels**_

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

(a) geographical balance amongst the participating offices;

## EN 47 EN

(b) the respective workload of the examiners is taken into account;

_Article 29_

_**Appeals**_

## EN 48 EN

_Article 30_

_**Boards of Appeal**_

_Article 31_

_**Delegation of power regarding the Boards of Appeal**_

_Article 32_

_**National implementation of a centralised examination opinion**_

## EN 49 EN

_Article 33_

_**Centralised application for an extension of the duration of certificates**_

_Article 34_

_**Fees**_

2. The Office shall charge a fee for an appeal, and for an opposition.

4. Article 12 shall apply to certificates granted under this Chapter.

_Article 35_

_**Register**_

(a) the name and address of the applicant or certificate holder;

## EN 50 EN

(c) the application as well as its date of lodging and date of publication;

(f) the designated Member States;

(g) the number of the basic patent;

(h) an identification of the product for which certificates are requested;

(l) where applicable, the duration of the certificates to be granted;

## EN 51 EN

_Article 36_

_**Database**_

(c) communicating with the applicants and other third parties;

## EN 52 EN

_Article 37_

_**Transparency**_

_Article 38_

_**Representation**_

## EN 53 EN

_Article 39_

_**Combined applications**_

_Article 40_

_**Supplementary Protection Certificates Division**_

## EN 54 EN

(c) deciding on oppositions against examination opinions;

(d) maintaining the register and the database.

_Article 41_

_**Languages**_

_Article 42_

_**Communications to the Office**_

_Article 43_

_**Decisions and communications of the Office**_

## EN 55 EN

_Article 44_

_**Oral proceedings**_

_Article 45_

_**Taking of evidence**_

(a) hearing the parties;

(b) requests for information;

(c) the production of documents and items of evidence;

(d) hearing witnesses;

(e) opinions by experts;

## EN 56 EN

_Article 46_

_**Notification**_

_Article 47_

_**Time limits**_

## EN 57 EN

_Article 48_

_**Correction of errors and manifest oversights**_

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

4. Corrections and cancellations shall be published by the Office.

_Article 49_

_**Restitutio in integrum**_

_Article 50_

_**Interruption of proceedings**_

1. Proceedings before the Office under this Chapter shall be interrupted:

## EN 58 EN

_Article 51_

_**Costs**_

## EN 59 EN

_Article 52_

_**Enforcement of decisions fixing the amount of costs**_

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

## EN 60 EN

_Article 53_

_**Financial provisions**_

 469/2009 (adapted)

~~_Article 20_~~

~~_Additional provisions relating to the enlargement of the Community_~~

~~Without prejudice to the other provisions of this Regulation, the following provisions shall~~
~~apply:~~

~~(a)~~ ~~any medicinal product protected by a valid basic patent and for which the first~~
~~authorisation to place it on the market as a medicinal product was obtained~~
~~after 1 January 2000 may be granted a certificate in Bulgaria, provided that the~~
~~application for a certificate was lodged within six months from 1 January 2007;~~

~~(b)~~ ~~any medicinal product protected by a valid basic patent in the Czech Republic~~
~~and for which the first authorisation to place it on the market as a medicinal~~
~~product was obtained:~~

~~(i)~~ ~~in the Czech Republic after 10 November 1999 may be granted a~~
~~certificate, provided that the application for a certificate was lodged~~
~~within six months of the date on which the first market authorisation was~~

~~obtained;~~

~~(ii)~~ ~~in the Community not earlier than six months prior to 1 May 2004 may~~
~~be granted a certificate, provided that the application for a certificate was~~

## EN 61 EN

~~lodged within six months of the date on which the first market~~
~~authorisation was obtained;~~

~~(c)~~ ~~any medicinal product protected by a valid basic patent and for which the first~~
~~authorisation to place it on the market as a medicinal product was obtained in~~
~~Estonia prior to 1 May 2004 may be granted a certificate, provided that the~~
~~application for a certificate was lodged within six months of the date on which~~
~~the first market authorisation was obtained or, in the case of those patents~~
~~granted prior to 1 January 2000, within the six months provided for in the~~
~~Patents Act of October 1999;~~

~~(d)~~ ~~any medicinal product protected by a valid basic patent and for which the first~~
~~authorisation to place it on the market as a medicinal product was obtained in~~
~~Cyprus prior to 1 May 2004 may be granted a certificate, provided that the~~
~~application for a certificate was lodged within six months of the date on which~~
~~the first market authorisation was obtained; notwithstanding the above, where~~
~~the market authorisation was obtained before the grant of the basic patent, the~~
~~application for a certificate must be lodged within six months of the date on~~
~~which the patent was granted;~~

~~(e)~~ ~~any medicinal product protected by a valid basic patent and for which the first~~
~~authorisation to place it on the market as a medicinal product was obtained in~~
~~Latvia prior to 1 May 2004 may be granted a certificate. In cases where the~~
~~period provided for in Article 7(1) has expired, the possibility of applying for a~~
~~certificate shall be open for a period of six months starting no later than 1 May~~
~~2004;~~

~~(f)~~ ~~any medicinal product protected by a valid basic patent applied for after 1~~
~~February 1994 and for which the first authorisation to place it on the market as~~
~~a medicinal product was obtained in Lithuania prior to 1 May 2004 may be~~
~~granted a certificate, provided that the application for a certificate was lodged~~
~~within six months from 1 May 2004;~~

~~(g)~~ ~~any medicinal product protected by a valid basic patent and for which the first~~
~~authorisation to place it on the market as a medicinal product was obtained~~
~~after 1 January 2000 may be granted a certificate in Hungary, provided that the~~
~~application for a certificate was lodged within six months from 1 May 2004;~~

~~(h)~~ ~~any medicinal product protected by a valid basic patent and for which the first~~
~~authorisation to place it on the market as a medicinal product was obtained in~~
~~Malta prior to 1 May 2004 may be granted a certificate. In cases where the~~
~~period provided for in Article 7(1) has expired, the possibility of applying for a~~
~~certificate shall be open for a period of six months starting no later than 1 May~~
~~2004;~~

~~(i)~~ ~~any medicinal product protected by a valid basic patent and for which the first~~
~~authorisation to place it on the market as a medicinal product was obtained~~
~~after 1 January 2000 may be granted a certificate in Poland, provided that the~~
~~application for a certificate was lodged within six months starting no later than~~
~~1 May 2004;~~

~~(j)~~ ~~any medicinal product protected by a valid basic patent and for which the first~~
~~authorisation to place it on the market as a medicinal product was obtained~~
~~after 1 January 2000 may be granted a certificate in Romania. In cases where~~
~~the period provided for in Article 7(1) has expired, the possibility of applying~~

## EN 62 EN

~~for a certificate shall be open for a period of six months starting no later than 1~~
~~January 2007;~~

~~(k)~~ ~~any medicinal product protected by a valid basic patent and for which the first~~
~~authorisation to place it on the market as a medicinal product was obtained in~~
~~Slovenia prior to 1 May 2004 may be granted a certificate, provided that the~~
~~application for a certificate was lodged within six months from 1 May 2004,~~
~~including in cases where the period provided for in Article 7(1) has expired;~~

~~(l)~~ ~~any medicinal product protected by a valid basic patent and for which the first~~
~~authorisation to place it on the market as a medicinal product was obtained in~~
~~Slovakia after 1 January 2000 may be granted a certificate, provided that the~~
~~application for a certificate was lodged within six months of the date on which~~
~~the first market authorisation was obtained or within six months of 1 July 2002~~
~~if the market authorisation was obtained before that date.~~

 2012 Act of Accession
(adapted)

~~(m) any medicinal product protected by a valid basic patent and for which the first~~

~~authorisation to place it on the market as a medicinal product was obtained~~
~~after 1 January 2003 may be granted a certificate in Croatia, provided that the~~
~~application for a certificate is lodged within six months from the date of~~
~~accession.~~

 469/2009 (adapted)

_Article 54_ ~~21~~

_**Transitional provisions**_

~~1.~~ ~~This Regulation shall not apply to certificates granted in accordance with the national~~
~~legislation of a Member State before 2 January 1993 or to applications for a~~
~~certificate filed in accordance with that legislation before 2 July 1992.~~

~~With regard to Austria, Finland and Sweden, this Regulation shall not apply to~~
~~certificates granted in accordance with their national legislation before 1 January~~
~~1995.~~

 2012 Act of Accession
(adapted)

~~2.~~ This Regulation shall apply to ~~supplementary protection~~ certificates granted in accordance
with the national legislation of  Czechia  ~~the Czech Republic,~~ Estonia, Croatia, Cyprus,
Latvia, Lithuania, Malta, Poland, Romania, Slovenia and Slovakia prior to their respective
date of accession.

## EN 63 EN

_Article 55_

_**Exercise of the delegation**_

_Article 56_

_**Committee procedure**_

## EN 64 EN

 2019/933 Art. 1 pt. 5 (adapted)

_Article 57_ ~~_21a_~~

_**Evaluation**_

1. No later than five years after the date referred to in Article 5(10), and every ~~five~~
 5  years thereafter, the Commission shall carry out an evaluation of Article 5(2) to (9)
and Article 11 in order to assess whether the objectives of those provisions have been
achieved, and present a report on the main findings to the European Parliament, the Council
and the European Economic and Social Committee. In addition to evaluating the impact of the
exception of making for the purpose of export, special account shall be taken of the effects of
making for the purpose of storing in order to place that product, or a medicinal product
containing that product, on the market of Member States after the expiry of the corresponding
certificate on access to medicines and on public health expenditure, and of whether the waiver
and in particular the period provided for in Article 5(2), point (a)(iii), ~~of Article 5(2)~~ is
sufficient to achieve the objectives referred to in Article 5, including public health.

_Article 58_

_**Transitional provisions for pending applications**_

 469/2009 (adapted)

_Article 59_ ~~_22_~~

_**Repeal**_

Regulation  (EC) No 469/2009  ~~(EEC) No 1768/92, as amended by the acts listed in~~
~~Annex I,~~ is repealed _._

References to the repealed Regulation shall be construed as references to this Regulation and
shall be read in accordance with the correlation table in Annex IV ~~II.~~

## EN 65 EN

 (adapted)

_Article 60_ ~~_23_~~

_**Entry into force**_  _**and application**_ 

This Regulation shall enter into force on the ~~20~~ ~~[t][h]~~  twentieth  day following its
publication in the _Official Journal of the European Union_ .

 469/2009

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

Done at Brussels,

_For the European Parliament_ _For the Council_
_The President_ _The President_

## EN 66 EN