Toelichting bij COM(2023)223 - Aanvullende beschermingscertificaat voor gewasbeschermingsmiddelen (herschikking) - Hoofdinhoud
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dossier | COM(2023)223 - Aanvullende beschermingscertificaat voor gewasbeschermingsmiddelen (herschikking). |
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bron | COM(2023)223 ![]() |
datum | 27-04-2023 |
•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.
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.
This table explains the purposes of the four related proposals:
Medicinal products | Plant protection products | |
PROPOSAL 1 Regulation on the SPC for medicinal products (recast) | ← Art. 114 TFEU → | PROPOSAL 2 Regulation on the SPC for plant protection products (recast) |
PROPOSAL 3 Regulation on the unitary SPC for medicinal products | ← Art. 118 TFEU → | PROPOSAL 4 Regulation on the unitary SPC for 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 standard-essential patents. The proposal also complements the unitary patent system, which is a major step towards the completion of the single market for patents.
•Consistency with other Union policies
The proposed centralised procedure is fully consistent with the existing legislation relating to agrochemical products and with other relevant legislation. This includes the European patent with unitary effect ('unitary patent') as set out in Regulation (EU) No 1257/2012, and the related 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.
Inhoudsopgave
- 2.LEGAL BASIS, SUBSIDIARITY AND PROPORTIONALITY
- 3.RESULTS OF EX-POST EVALUATIONS, STAKEHOLDER CONSULTATIONS AND IMPACT ASSESSMENTS
- 4.BUDGETARY IMPLICATIONS
- 5.OTHER ELEMENTS
- Overall structure of the proposal
- Coherence with the parallel proposal relating to medicinal products
- Basic patent
- Examination/granting authority
- Examination procedure and remedies
- Marketing authorisations concerned
- Substantive features of the SPC regime
- New recitals
- Language regime
- Appeals
- Fees
- Financial transfers between the central authority and national patent offices (NPOs)
- Litigation
- National aspects
- Unitary SPCs
•Legal basis
This proposal is based on Article 114 i 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 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.
•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 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 non-binding opinion. This would create a central authority for filing SPC applications in the EU, which would examine applications and issue an opinion on whether or not to grant an SPC. NPOs could follow this opinion or, alternatively, conduct their own examination. Therefore, the decision on granting SPC protection would be kept at the national level. Only holders of a European patent – and, for medicinal products, of a centralised marketing authorisation – could use this system.
–Option 4: Centralised filing and examination of SPC applications, resulting in a binding opinion. This is identical to option 3, but NPOs would have to follow the opinion. Therefore, while decisions on granting SPC protection would still be taken by national offices, the outcome of these decisions would be determined by a central authority.
–Option 5: A ‘unitary SPC’ complementing the unitary patent. The central authority, in addition to examining applications, would grant a ‘unitary SPC’ to applicants with a European patent with unitary effect. The unitary SPC would be valid only in the territory of the (initially 17) Member States party to the UPCA.
These options would not replace national SPCs, but would provide alternative routes to obtaining SPC protection across the EU.
A combination of options 4 and 5 constitutes the preferred choice. It would provide for a centralised procedure that could result in the grant of national SPCs in some or all Member States, and/or of a unitary SPC (covering those Member States in which the basic unitary patent has effect). When deciding on who should act as the examination authority, several criteria were considered: accountability (in particular, to the European Parliament), alignment with the EU’s overarching political values and current policy priorities, and experience with substantive SPC assessment. It is therefore proposed that the EU Intellectual Property Office (EUIPO) should become the central examination authority, supported by national offices.
Option 1, on guidelines for examining national SPC applications, would not be sufficient alone to overcome discrepancies between national practices, as the guidance would be non-binding. Nevertheless, in the context of the preferred options 4 and 5, EUIPO should develop guidelines that reflect its practice. These guidelines would be of practical use both to officials in charge of the SPC-related procedures and to their users, including professional advisers who assist applicants (e.g. by offering examples). This guidance would take stock of the practices developed by the examination panels, especially since they will include examiners from several different Member States, to improve consistency between examination practices under the new centralised procedure. Moreover, national offices may also benefit from guidelines developed by the examination authority for their own (national) examination procedures.
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 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.
This proposal will have no impact on the EU budget, since the system will remain fully self-funded by applicants’ fees, as is already the case for the existing SPCs regimes governed by Regulations (EC) No 469/2009 and (EC) No 1610/96, and will be implemented by the examination authority, the EUIPO. The necessary set-up costs of the tasks conferred to the EUIPO, including the costs of new digital systems, will be financed from the EUIPO’s accumulated budgetary surplus. A breakdown of the budgetary impact on the examination authority is provided in Annex 5D of the impact assessment.
The financial impacts on Member States (national offices) will also remain low. Indeed, while the number of SPCs applied for each year is likely to increase, it is quite low for the time being, even in large Member States. For instance, in 2017, 70 SPC applications were filed in Germany and 72 in France. The largest number of applications (95) were filed in Ireland. The average cost varies by country. Based on current average coverage (20 Member States) and 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).
•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
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.
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.
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.
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: i 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 claims of the basic patent must be identical for all Member States designated in a centralised SPC application.
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.
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.
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.
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.
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;
–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).
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 C-673/18 interpret Article 3(1)(a) and 3(1)(d) of the current SPC Regulation, respectively, and should be considered settled case law. This is also the case for judgement C‑471/14, whereby the date of the first marketing authorisation in the Union, within the meaning of Article 13, is the date on which notification of the decision granting the authorisation was given to the addressee of the decision.
The requirement that the product should be protected by the basic patent means that the product should fall within the scope of one or more claims of that patent, as properly interpreted at the basic patent’s filing date. This also includes situations where the product corresponds to a general functional definition used by one of the claims of the basic patent, and necessarily comes within the scope of the invention covered by that patent, even if it is not indicated in individualised form as a specific embodiment in the patent, provided that it is specifically identifiable from the patent.
Many general objectives set out in the Explanatory Memorandum of the proposal (COM(94)579) for what became Council Regulation (EC) No 1610/96, remain fully relevant today, and should continue to be used as a guide to interpretation, where relevant. This includes the objective that if a certificate has already been granted for the active substance itself, a new certificate may not be granted for that active substance, whatever changes may have been made regarding other features of the plant protection product (use of a different salt, different excipients, different presentation, etc.).
Furthermore, as regards the rights conferred by a certificate, the certificate confers the same protection as the basic patent, but only protects the product covered by the authorisation, for all pharmaceutical uses authorised, until the expiry of the basic patent.
As regards the rights conferred by a certificate, and in line with the earlier statements regarding derivatives, it is appropriate to consider that the protection conferred by a certificate on a product extends to the derivatives of that product that are equivalent to the product from a phytosanitary perspective.
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.
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 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.
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.
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.
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 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 .
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.
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.
🡻 1610/96 (adapted)