Source: EURLEX
Language: en
Format: md

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

**Interinstitutional File:**

**2023/0128(COD)**

**COVER NOTE**

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

**8887/23**

**PI 55**
**PHARM 67**
**COMPET 383**
**MI 351**
**IND 204**
**IA 88**
**CODEC 746**

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) 223 final

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

Delegations will find attached document COM(2023) 223 final.

Encl.: COM(2023) 223 final

8887/23 BM/ps
### COMPET.1 EN

EUROPEAN

COMMISSION

Brussels, 27.4.2023
COM(2023) 223 final

2023/0128 (COD)

Proposal for a

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

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

(Text with EEA relevance)

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

## **EN EN**

**EXPLANATORY MEMORANDUM**

**1.** **CONTEXT** **OF** **THE** **PROPOSAL**

**•** **Reasons for and objectives of the proposal**

Supplementary protection certificates (SPCs) are _sui generis_ intellectual property (IP) rights
that extend the 20-year term of patents for medicinal or plant protection products (PPPs) by
up to 5 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 plant
protection 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 1610/96 provides for SPCs for plant protection products, to be granted at
a national level on the basis of national applications, on a country-by-country basis. Similarly,
Regulation (EC) No 469/2009 provides for SPCs for medicinal products. Together these two
measures constitute the EUs SPC regime. As amendments are to be made to Regulation (EC)
No 1610/96, that Regulation should be recast, which is the **first objective of this proposal,**
and of a similar parallel proposal regarding medicinal products (COM(2023) 231).

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

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

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) No 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

In addition, many of the arguments made in the pharmaceutical strategy for Europe
(COM(2020) 761 final) as regards SPCs for medicinal products are also applicable to SPCs
for PPPs. That Strategy 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 PPPs. 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 granting 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.

**•** **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 1610/96. The same new
procedural provisions are also inserted in the above-mentioned parallel proposal on SPCs for
medicinal products (COM(2023) 231).

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

## 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 1610/96 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 proposed centralised procedure is fully consistent with the existing legislation relating to
agrochemical products and with other relevant legislation. This includes the _European patent_
_with unitary effect_ ('unitary patent') as set out in Regulation (EU) No 1257/2012, and the
related Agreement on a Unified Patent Court (UPCA). The unitary patent system will enter
into force on 1 June 2023.

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

**2.** **LEGAL** **BASIS,** **SUBSIDIARITY** **AND** **PROPORTIONALITY**

**•** **Legal basis**

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 (Articles 100a, and then 95, respectively, of the
Treaty establishing the European Community, as it then was), and it is once again necessary
to have recourse to Article 114 in order to adapt the EU SPC regime in the light of how the
existing system has been applied. Despite the fact that SPCs are already harmonised – and
indeed defined – by EU law, there are still cases where some Member States have granted
SPCs while identical applications have been refused in others, or been granted with a different
scope. SPC applicants thus face diverging decisions across the EU on the same product, while
incurring costs for applying and maintaining SPCs in several Member States. Consequently,
further EU action is needed to address these issues and can, unlike national intervention by
Member States, ensure a consistent EU-wide framework, and reduce the total costs and
burden of fees to be paid in multiple Member States. Further EU-level action would
strengthen the integrity of the single market by providing a centralised, balanced and

## EN 3 EN

transparent SPC system across the EU, and mitigate the negative consequences of redundant
and potentially diverging procedures that applicants face [6] . Hence, by its nature, action at EU
level is also justified to ensure the smooth functioning of the single market for innovative
plant protection products that are subject to marketing authorisations. EU-level action would
also allow innovative and follow-on manufacturers to reap the benefits of an efficient
intellectual property framework in the relevant product markets.

**•** **Subsidiarity**

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.

**•** **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 (Regulation (EC) No 1610/96) 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 follow-on products. These
negative effects are amplified by a lack of transparency, especially from a cross-border
perspective, making it difficult to trace what SPC protection exists for which products in
which Member States. This affects both SPC holders and manufacturers of follow-on
products.

**•** **Stakeholder consultations**

The Commission conducted a public consultation during the evaluation of the SPC regime
(between 12 October 2017 and 4 January 2018) [7] . 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

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

7 https://ec.europa.eu/docsroom/documents/29464

## EN 4 EN

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 carried out in 2018 by the Max Planck Institute on the legal aspects of SPCs in the
EU [8] (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 [9]
provides a deeper analysis of the design of a centralised procedure.

**•** **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.

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

## EN 5 EN

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
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 follow-on products).

Moreover, since this proposal will recast and repeal Regulations (EC) No 1610/96, it will
achieve a ‘one in, one 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 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.

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

## EN 6 EN

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 (EU) No 1610/96.

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.

**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.

**•** **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
1610/96 regarding national applications for certificates, filed at national offices [10], without
changing their substance, except for minor technical adaptations that bring the recast
regulation up to current drafting standards.

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

## EN 7 EN

Chapter III includes new provisions defining the new centralised procedure. That Section is
further described below.

Chapter IV contains final provisions, including the repeal of Regulation (EC) No 1610/96.

_**Coherence with the parallel proposal relating to medicinal products**_

This proposal is extremely similar to the one presented in parallel regarding SPCs for
medicinal products (COM(2023) 231), with a limited number of changes directly linked to the
intrinsic differences between medicinal products and plant protection products, regarding in
particular marketing authorisations (as there are no centralised marketing authorisations for
plant protection products). Moreover the ‘SPC manufacturing waiver’ introduced into
Regulation (EC) No 469/2009 by Regulation (EU) 2019/933 only applies to SPCs for
medicinal products and therefore does not need to be reflected in this new (recast) version of
Regulation (EC) No 1610/96.

_**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 28 of the explanatory memorandum of the proposal
for a European Parliament and Council Regulation (EC) concerning the creation of a
supplementary protection certificate for plant protection products (COM(94)579) envisaged
that ‘ _when use is made of the European procedure to obtain a Community patent, it will be all_
_the more necessary for the certificate to apply equally to plant protection products protected_
_by a Community patent’_ (now referred to as a ‘European patent with unitary effect’ (or, more
informally, a ‘unitary patent’).

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 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.

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

## EN 8 EN

claims of the basic patent must be identical for all Member States designated in a centralised
SPC application.

_**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).

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.

## EN 9 EN

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 (‘UPC’), as applicable. The same applies to a possible counterclaim for
a declaration of invalidity of an SPC.

_**Marketing authorisations concerned**_

Given that there is a zonal system of marketing authorisation for PPPs in the EU and that only
national marketing authorisations exist for PPPs, the requirement for a centralised
authorisation, included in the parallel proposal (COM(2023) 231) which creates a centralised
procedure for the grant of certificates for medicinal products, cannot be applied in this
Regulation, applicable to PPPs. Therefore, national marketing authorisations will be allowed
to serve as basis for the grant of certificates for PPPs under the centralised procedure laid
down in this Regulation.

Moreover, since marketing authorisations for a given plant protection product are often
granted at different dates in different Member States, it may happen that, at the date of filing a
centralised application for certificates, authorisations have been granted in some of the
designated Member States but not in all of them. Since this situation is expected to be
frequent, the traditional requirement for the availability of valid authorisations at the date of
filing of the application would often severely restrict the number of Member States that could
be validly designated in a centralised application for certificates for a certain PPP.

To address this situation, it is proposed to allow the grant of certificates for a PPP, through the
centralised procedure, when two conditions are fulfilled in respect of marketing
authorisations, as a derogation from the above-mentioned traditional requirement:

–
at the date of filing of the application, it is only required that marketing
authorisations have been _applied for_ in each of the designated Member States, but

– before the end of the examination process, authorisations must have been _granted_ in
each of the designated Member States. At the same time, it would be required that
the examination process does not end earlier than 18 months from the filing of the
application, to increase the likelihood that the ‘missing’ authorisations may have
been granted by then. Where this condition is not met in one of the designated
Member States, however, the examination proceedings would be suspended until the

–
‘missing’ authorisation is possibly granted, provided that for legal certainty reasons

–
this takes place before the expiry of the basic patent.

_**Substantive features of the SPC regime**_

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

– the case law [11] on SPCs is progressively converging, and steadily reducing
uncertainty about the interpretation of the SPC regime [12], while further amendments
might trigger new fluctuations and uncertainty as regards the proper interpretation of
the amended rules;

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

## EN 10 EN

–
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 CJEU case
law is unclear in some respects (question 46).

_**New recitals**_

It was noted that there were no relevant recitals in Regulation (EC) No 1610/96 that could
assist in interpretation of Article 3. Accordingly, certain recitals concern the conditions (as set
out in Article 3) for the grant of SPCs and incorporate the case law of the Court of Justice.
The aim is to ensure consistency. In particular the judgements in cases C‑ 121/17 and C673/18 interpret Article 3(1)(a) and 3(1)(d) of the current SPC Regulation, respectively, and
should be considered settled case law. This is also the case for judgement C-471/14, whereby
the date of the first marketing authorisation in the Union, within the meaning of Article 13, is
the date on which notification of the decision granting the authorisation was given to the
addressee of the decision.

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

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

Furthermore, as regards the rights conferred by a certificate, _the certificate confers the same_
_protection as the basic patent, but only protects the product covered by the authorisation, for_
_all pharmaceutical uses authorised, until the expiry of the basic patent_ .

As regards the rights conferred by a certificate, and in line with the earlier statements
regarding derivatives, it is appropriate to consider that the protection conferred by a certificate
on a product extends to the derivatives of that product that are equivalent to the product from
a phytosanitary perspective.

_**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 authorisations, the relevant dates, and the identification of the applicant(s)
and the product concerned. The translation costs are, therefore, expected to be considerably
lower than would be the case for patent applications. See the impact assessment (SWD(2023)
118) for an exact calculation.

_**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,

## EN 11 EN

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 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
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

## EN 12 EN

the UPCA), be the Unified Patent Court where the applicable conditions are fulfilled (cf.
Article 3(b) of the UPCA, together with Article 2(g) and Article 32) [13] .

_**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
and the payment of renewal fees.

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.

_**Unitary SPCs**_

A parallel proposal (COM(2023) 221) is intended to create a unitary SPC for plant protection
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.

13 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 13 EN

 1610/96 (adapted)
2023/0128 (COD)

Proposal for a

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

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

(Text with EEA relevance)

THE EUROPEAN PARLIAMENT AND THE COUNCIL OF THE EUROPEAN UNION,

Having regard to the Treaty  on the Functioning of the European Union , and in
particular Article ~~100a~~  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 [14],

Having regard to the opinion of the Committee of the Regions [15],

Acting in accordance with the ordinary legislative procedure,

Whereas:

 1610/96 recital 1

(2) Research into plant protection products contributes to the continuing improvement in
the production and procurement of plentiful food of good quality at affordable prices.

14 OJ C […], […], p. […].
15 OJ C […], […], p. […].

## EN 14 EN

 1610/96 recital 2

(3) Plant protection research contributes to the continuing improvement in crop
production.

 1610/96 recital 3 (adapted)

(4) Plant protection products, especially those that are the result of long, costly research,
will continue to be developed in the ~~Community~~  Union  ~~and in Europe~~ if they
are covered by favourable rules that provide for sufficient protection to encourage
such research.

 1610/96 recital 4

(5) The competitiveness of the plant protection sector, by the very nature of the industry,
requires a level of protection for innovation which is equivalent to that granted to
medicinal products by Regulation (EC) No 469/2009 of the European Parliament and
of the Council [18] _[OP, please insert new Regulation reference to COM(2023)_
_231]_ ~~Council Regulation (EEC) No 1768/92 of 18 June 1992 concerning the creation~~
~~of a supplementary protection certificate for medicinal products~~ ~~[(][3)]~~ ~~.~~

 1610/96 recital 5 (adapted)

(6) ~~at the moment,~~ T ~~th~~ e period that elapses between the filing of an application for a
patent for a new plant protection product and  the  authorisation to place the said
plant protection product on the market makes the period of effective protection under
the patent insufficient to cover the investment put into the research and to generate the
resources needed to maintain a high level of research.

 1610/96 recital 6

(7) This situation leads to a lack of protection which penalises plant protection research
and the competitiveness of the sector.

(8) One of the main objectives of the supplementary protection certificate
 (‘certificate’)  is to place European industry on the same competitive footing as
~~its North American and Japanese counterparts~~  third countries  .

18 Regulation (EC) No 469/2009 of the European Parliament and of the Council of 6 May 2009
concerning the supplementary protection certificate for medicinal products (OJ L 152, 16.6.2009, p. 1).

## EN 15 EN

 1610/96 recital 8 (adapted)

~~In its Resolution of 1 February 1993~~ ~~[19]~~ ~~on a Community programme of policy and action in~~
~~relation to the environment and sustainable development, the Council adopted the general~~
~~approach and strategy of the programme presented by the Commission, which stressed the~~
~~interdependence of economic growth and environmental quality. Improving protection of the~~
~~environment means maintaining the economic competitiveness of industry. Accordingly, the~~
~~issue of a supplementary protection certificate can be regarded as a positive measure in favour~~
~~of environmental protection.~~

 1610/96 recital 9 (adapted)

(9) 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 hinder the free movement of plant protection
products within the ~~Community~~  Union  and thus directly affect the functioning
of the internal market ~~; whereas this is in accordance with the principle of subsidiarity~~
~~as defined by Article 3b of the Treaty~~ .

(10) Therefore, there is a need to ~~create~~  provide for  a ~~supplementary protection~~
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 plant protection product for which marketing
authorisation has been granted. ~~is necessary; whereas a Regulation is therefore the~~

19 ~~Opinion of the European Parliament of 15 June 1995 (OJ C 166, 3. 7. 1995, p. 89), common position of~~
~~the Council of 27 November 1995 (OJ C 353, 30. 12. 1995, p. 36) and decision of the European~~
~~Parliament of 12 March 1996 (OJ C 96, 1. 4. 1996, p. 30).~~

## EN 16 EN

 1610/96 recital 11 (adapted)

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

## EN 17 EN

(18) All the interests at stake in a sector as complex and sensitive as plant protection ~~must~~
~~nevertheless~~  should  be taken into account. For this purpose, the certificate

 1610/96 recital 13 (adapted)

~~The certificate confers the same rights as those conferred by the basic patent; consequently,~~
~~where the basic patent covers an active substance and its various derivatives (salts and esters),~~
~~the certificate confers the same protection.~~

 1610/96 recital 14 (adapted)

~~The issue of a certificate for a product consisting of an active substance does not prejudice the~~
~~issue of other certificates for derivatives (salts and esters) of the substance, provided that the~~
~~derivatives are the subject of patents specifically covering them.~~

 1610/96 recital 15 (adapted)

~~A fair balance should also be stuck with regard to the determination of the transitional~~
~~arrangements. Such arrangements should enable the Community plant protection industry to~~
~~catch up to some extent with its main competitors, while making sure that the arrangements~~
~~do not compromise the achievement of other legitimate objectives concerning the agricultural~~
~~policy and environment protection policy pursued at both national and Community level.~~

 1610/96 recital 16 (adapted)

(19) Only action at ~~Community~~  Union  level will  allow ~~~~ ~~enable the objective,~~
~~which consists in~~ ensuring adequate protection for innovation in the field of plant
protection, while guaranteeing the proper functioning of the internal market for plant
protection products, to be attained effectively.

 1610/96, recital 17 (adapted)

(20) The detailed rules  referred to  in recitals 13, 14 and 15 ~~12, 13 and 14~~ and
 laid down in  in Article 4, Article 8 (1), point (c), and Article 17 (2) of this
Regulation are also valid, _mutatis mutandis_, for the interpretation in particular of
recital 9 and Articles 3 ~~,~~ and 4, Article 8 (1), point (c), and Article 17 of ~~Council~~
Regulation (EC) No 469/2009 [ _OP please insert new reference to COM(2023) 231_ ].

## EN 18 EN

## EN 19 EN

## EN 20 EN

## EN 21 EN

## EN 22 EN

## EN 23 EN

 1610/96 (adapted)

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 plant protection products  protected by a patent in the territory of a
Member State and subject, prior to being placed on the market as a plant protection product,
to an administrative authorisation procedure as laid down in ~~Article 4 of Directive~~
~~91/414/EEC~~ Regulation (EC) No 1107/2009 of the European Parliament and of the Council [26] ~~,~~
~~or pursuant to an equivalent provision of national law if it is a plant protection product in~~
~~respect of which the application for authorisation was lodged before Directive 91/414/EEC~~
~~was implemented by the Member State concerned, may, under the terms and conditions~~
~~provided for in this Regulation, be the subject of a certificate.~~

 1610/96 (adapted)

_Article_ ~~_1_~~ _2_

_**Definitions**_

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

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

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

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

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

(d) destroy undesirable plants; or

(e) destroy parts of plants, check or prevent undesirable growth of plants;

26 Regulation (EC) No 1107/2009 of the European Parliament and of the Council of 21 October 2009
concerning the placing of plant protection products on the market and repealing Council Directives
79/117/EEC and 91/414/EEC (OJ L 309 24.11.2009, p. 1).

## EN 24 EN

(2) ‘substances ~~’:~~  means  chemical elements and their compounds, as they occur
naturally or by manufacture, including any impurity inevitably resulting from the
manufacturing process;

(3) ‘active substances’ ~~:~~  means  substances or micro-organisms including viruses,
having general or specific action:

(a) against harmful organisms; or

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

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

(5) ‘plants ~~’:~~  means  live plants and live parts of plants, including fresh fruit and
seeds;

(6) ‘plant products’ ~~:~~  means  products in the unprocessed state or having undergone
only simple preparation such as milling, drying or pressing, derived from plants, but
excluding plants themselves ~~as defined in point 5;~~

(7) ‘harmful organisms’ ~~:~~  means  pests of plants or plant products belonging to the
animal or plant kingdom, and also viruses, bacteria and mycoplasmas and other
pathogens;

(8) ‘product ~~’:~~  means  the active substance ~~as defined in point 3~~ or combination of
active substances of a plant protection product;

(9) 'basic patent ~~':~~  means  a patent which protects a product ~~as defined in point 8~~ as
such, a preparation ~~as defined in point 4,~~ 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~~  the grant  of a certificate;

~~'certificate': the supplementary protection certificate;.~~

## EN 25 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 ~~Article 4 of Directive 91/414/EEC~~

(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 plant protection product.

2. The holder of more than one patent for the same product shall not be granted more
than one certificate for that product. However, where two or more applications
concerning the same product and emanating from two or more holders of different
patents are pending, one certificate for ~~this~~  that  product may be issued to each
of ~~these~~  those  holders , where they are not economically linked  .

_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 authorisations to place the
corresponding plant protection product on the market and for any use of the product as a plant
protection product that has been authorised before the expiry of the certificate.

_Article 5_

_**Effects of the certificates**_

~~Subject to Article 4,~~ ~~Tth~~ e certificate shall confer the same rights as conferred by the basic
patent and shall be subject to the same limitations and the same obligations.

## EN 26 EN

_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  .

_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 plant protection 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.

_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 has appointed a representative,  the name and
address of  that  ~~the~~ representative ~~, if any;~~

(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
~~Community~~  Union , the number and date of that authorisation;

(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 ~~Part A.I (points 1~~ ~~7) or B.I (points 1~~ ~~7) of~~

## EN 27 EN

~~Annex II to Directive 91/414/EEC~~, Part A, section 1, points 1.1 to 1.7 of the
Annex to Commission Regulation 283/2013 [28] or Part B, Section 1, points 1.1

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

2. Member States may provide that a fee is to be payable upon application for 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.

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:

(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 ~~Community~~  Union  .

_Article 10_

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

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.

28 Commission Regulation (EU) No 283/2013 of 1 March 2013 setting out the data requirements for active
substances, in accordance with Regulation (EC) No 1107/2009 of the European Parliament and of the
Council concerning the placing of plant protection products on the market (OJ L 93, 3.4.2013, p. 1).

## EN 28 EN

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 application shall be rejected~~  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.

_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;

(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 ~~Community~~  Union  ;

(f) the duration of the certificate.

2.  The authority referred to in Article 9(1) shall publish, as soon as possible,  a
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).

_Article 12_

_**Annual**_ _**fees**_

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

_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

## EN 29 EN

product on the market in the ~~Community~~  Union , reduced by a period of
 5  ~~five~~ years.

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

3. For the purposes of calculating the duration of the certificate, account shall be taken
of a provisional first marketing authorisation only if it is directly followed by a
definitive authorisation concerning the same product.

_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 ~~Article 4 of Directive~~
~~91/414/EEC~~ Regulation (EC) No 1107/2009 or equivalent provisions of
national law , as applicable  .

 For the purposes of point (d),  t ~~Th~~ e 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  .

_Article 16_

_**Notification of lapse or invalidity**_

If the certificate lapses in accordance with 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)~~ .

## EN 30 EN

_Article 17_

_**Appeals**_

1. The decisions of the authority referred to in Article 9(1) or of the body referred to in
Article 15(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.

2. The decision to grant the certificate shall be open to an appeal aimed at rectifying the
duration of the certificate where the date of the first authorisation to place the
product on the market in the ~~Community~~  Union , contained in the application
for a certificate as provided for in Article 8, is incorrect.

_Article 18_

_**Procedure**_

1. In the absence of procedural provisions in this Regulation, the procedural provisions
applicable under national law to the corresponding basic patent and, where
appropriate, the procedural provisions applicable to the certificates referred to in
Regulation (EC) No 469/2009 ~~(EEC) No 1768/92~~ _[OP, please insert reference to_
_COM(2023) 231]_, shall apply to the certificate, unless 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.

_Article 19_

_**Scope of the centralised application**_

3. Articles 1 to 7 and 13 to 17 shall apply to centralised applications.

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

## EN 31 EN

_Article 20_

_**Content of the centralised application**_

The centralised application shall contain the following:

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

_Article 21_

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

1. The Office shall examine the following:

(a) whether the centralised application complies with Article 20;

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

_Article 22_

_**Publication of the centralised application**_

_Article 23_

_**Examination of the centralised application**_

## EN 32 EN

_Article 24_

_**Extended conditions for obtaining a certificate**_

(b) a valid authorisation was granted before the examination opinion is adopted.

_Article 25_

_**Observations by third parties**_

## EN 33 EN

_Article 26_

_**Opposition**_

4. The notice of opposition shall contain:

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

## EN 34 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;

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

## EN 35 EN

_Article 29_

_**Appeals**_

_Article 30_

_**Boards of Appeal**_

## EN 36 EN

_Article 31_

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

_Article 32_

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

## EN 37 EN

_Article 33_

_**Fees**_

1. The Office shall charge a fee for a centralised application for certificates.

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 34_

_**Register**_

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

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

(e) the designated Member States;

(f) the number of the basic patent;

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

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

## EN 38 EN

_Article 35_

_**Database**_

## EN 39 EN

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

_Article 36_

_**Transparency**_

## EN 40 EN

_Article 37_

_**Representation**_

_Article 38_

_**Combined applications**_

## EN 41 EN

_Article 39_

_**Supplementary Protection Certificates Division**_

(c) deciding on oppositions against examination opinions;

(d) maintaining the Register and the database.

_Article 40_

_**Languages**_

_Article 41_

_**Communications to the Office**_

_Article 42_

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

## EN 42 EN

_Article 43_

_**Oral proceedings**_

_Article 44_

_**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 43 EN

_Article 45_

_**Notification**_

_Article 46_

_**Time limits**_

## EN 44 EN

_Article 47_

_**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 48_

_**Restitutio in integrum**_

## EN 45 EN

_Article 49_

_**Interruption of proceedings**_

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

_Article 50_

_**Costs**_

## EN 46 EN

_Article 51_

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

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

## EN 47 EN

_Article 52_

_**Financial provisions**_

 1610/96 (adapted)

#### ~~**TRANSITIONAL PROVISIONS**~~

~~_Article 19_~~

~~1. Any product which, on the date on which this Regulation enters into force, is protected by a~~
~~valid basic patent and for which the first authorization to place it on the market as a plant~~
~~protection product in the Community was obtained after 1 January 1985 under Article 4 of~~
~~Directive 91/414/EEC or an equivalent national provision may be granted a certificate.~~

## EN 48 EN

~~2. An application made under paragraph 1 for a certificate shall be submitted within six~~
~~months of the date on which this Regulation enters into force.~~

 2003 Act of Accession
(adapted)

~~_Article 19a_~~

~~_Provisions relating to the enlargement of the Community_~~

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

~~(a)~~

~~(1)~~ ~~(i) any plant protection 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~~
~~plant protection product was obtained 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,~~

~~(2)~~ ~~(ii) any plant protection 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~~
~~plant protection product was obtained in the Community not earlier than six~~
~~months prior to the date of accession 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;~~

~~(b)~~ ~~any plant protection product protected by a valid basic patent and for which the first~~
~~authorisation to place it on the market as a plant protection product was obtained in~~
~~Estonia prior to the date of accession 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 month period provided for in the Patents Act of~~
~~October 1999;~~

~~(c)~~ ~~any plant protection product protected by a valid basic patent and for which the first~~
~~authorisation to place it on the market as a plant protection product was obtained in~~
~~Cyprus prior to the date of accession 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;~~

~~(d)~~ ~~any plant protection product protected by a valid basic patent and for which the first~~
~~authorisation to place it on the market as a plant protection product was obtained in~~
~~Latvia prior to the date of accession 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 the date of~~
~~accession;~~

~~(e)~~ ~~any plant protection 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~~

## EN 49 EN

~~plant protection product was obtained in Lithuania prior to the date of accession may~~
~~be granted a certificate, provided that the application for a certificate is lodged within~~
~~six months of the date of accession;~~

~~(f)~~ ~~any plant protection product protected by a valid basic patent and for which the first~~
~~authorisation to place it on the market as a plant protection product was obtained~~
~~after 1 January 2000 may be granted a certificate in Hungary, provided that the~~
~~application for a certificate is lodged within six months of the date of accession;~~

~~(g)~~ ~~any plant protection product protected by a valid basic patent and for which the first~~
~~authorisation to place it on the market as a plant protection product was obtained in~~
~~Malta prior to the date of accession 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 the date of~~
~~accession;~~

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

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

~~(j)~~ ~~any plant protection product protected by a valid basic patent and for which the first~~
~~authorisation to place it on the market as a plant protection 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;~~

 2005 Act of Accession
(adapted)

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

~~(l)~~ ~~any plant protection product protected by a valid basic patent and for which the first~~
~~authorisation to place it on the market as a plant protection 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 for a~~
~~certificate shall be open for a period of six months starting no later than the date of~~
~~accession;~~

## EN 50 EN

 2012 Act of Accession
(adapted)

~~(m)~~ ~~any plant protection product protected by a valid basic patent and for which the first~~
~~authorisation to place it on the market as a plant protection 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.~~

 1610/96 (adapted)

_Article_ ~~_205_~~ _3_

 _**Transitional provisions**_ 

 2003 Act of Accession
(adapted)

~~1. In those Member States whose national law did not, on 1 January 1990, provide for the~~
~~patentability of plant protection products, this Regulation shall apply from 2 January 1998.~~
~~Article 19 shall not apply in those Member States.~~

 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.

_Article 54_

_**Exercise of the delegation**_

## EN 51 EN

_Article 55_

_**Committee procedure**_

_Article 56_

_**Evaluation**_



_Article 57_

_**Repeal**_

Regulation (EC) No 1610/96 is repealed.

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

## EN 52 EN

 1610/96 (adapted)

_Article_ ~~_215_~~ _8_

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

This Regulation shall enter into force on the  twentieth day following that of  ~~sixth~~
~~month after~~ its publication in the _Official Journal of the European_ ~~Communities~~
 _Union_  .

 1610/96

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 53 EN