Explanatory Memorandum to COM(2023)221 - Unitary supplementary protection certificate for plant protection products - Main contents
Please note
This page contains a limited version of this dossier in the EU Monitor.
| dossier | COM(2023)221 - Unitary supplementary protection certificate for plant protection products. |
|---|---|
| source | COM(2023)221  |
| date | 27-04-2023 |
1. CONTEXT OF THE PROPOSAL
• Reasons for and objectives of the proposal
Supplementary protection certificates (SPCs) are sui generis intellectual property (IP) rights that extend the 20-year term of patents for medicinal or plant protection products (PPPs) by up to 5 years1. They aim to offset the loss of effective patent protection due to the compulsory and lengthy testing required in the EU for the regulatory marketing authorisation of these products.
The unitary patent will enter into force on 1 June 2023, allowing for a single patent that covers all participating Member States in a unitary manner2.
This proposal aims to simplify the EU’s SPC system, as well as improve its transparency and efficiency, by creating a unitary certificate for plant protection products. This initiative was announced in the Commission work programme for 2022 as initiative number 16 under Annex II (REFIT initiatives)3.
Regulation (EC) No 1610/96 provides for SPCs for plant protection products (‘PPPs’), at a national level, to be granted by national patent offices on the basis of national applications, on a country-by-country basis. Similarly, Regulation (EC) No 469/2009 provides for SPCs for medicinal products. Together these two measures constitute the EU’s SPC regime.
As confirmed by the evaluation carried out in 2020 (SWD(2020)292 final), today’s purely national procedures for granting SPCs involve separate examination proceedings (in parallel or subsequent) in Member States. This entails duplication of work, resulting in high costs and more often discrepancies between Member States in decisions to grant or refuse SPCs including in litigation before national courts. Inconsistency between Member States in decisions to grant or refuse SPCs is the single reason most often cited by national courts for preliminary references to the Court of Justice of the European Union on the application of the EU’s SPC regime. The current purely national procedures, therefore, lead to significant legal uncertainty.
The Commission’s intellectual property action plan of November 2020 (COM(2020) 760 final), which builds on the SPC evaluation, highlighted the need to tackle the remaining fragmentation of the EU’s intellectual property system. The plan noted that, for medicinal products and PPPs, SPC protection is only available at national level. At the same time, there is a centralised procedure for granting European patents.
In addition, many of the arguments made in the pharmaceutical strategy for Europe (COM(2020) 761 final) as regards SPCs for medicinal products are also applicable to SPCs for plant protection products. That Strategy emphasised the importance of investing in R&D to create innovative medicines. The strategy stressed, however, that the differences between Member States in the implementation of intellectual property regimes, especially for SPCs, lead to duplications and inefficiencies that affect the competitiveness of the pharmaceutical industry. Both the Council4 and the European Parliament5 have called on the Commission to correct these deficiencies.
Additionally, there is a clear need to complement the unitary patent (‘European patent with unitary effect’) by a unitary SPC. Indeed, while a unitary patent may be extended by national SPCs, this approach is not optimal in the sense that the unitary protection conferred by a unitary patent would then, after patent expiry, be complemented by a plurality of legally independent national SPCs, without any unitary dimension anymore.
The grant of a unitary SPC could be requested by filing an application that would then be subjected to the same centralised examination procedure also applicable to ‘centralised SPC applications’ defined in a parallel proposal (COM(2023) 223) with a view to the grant of national SPCs in the Member States designated in the centralised applications. An applicant will have the possibility of filing a ‘combined’ centralised SPC application in which he/she would request the grant of both a unitary SPC (for those Member States in which the basic patent has unitary effect) and national SPCs (for other Member States).
• Consistency with existing policy provisions in the policy area
The core substantive provisions applicable to the unitary certificates to which this proposal relates – i.e. the conditions for obtaining a unitary certificate – are the same as those of the existing SPC regime, while this proposal creates a unitary SPC to be granted following examination by a central authority, which relies on the same substantive rules, with minor modifications, as the centralised procedure for the grant of national certificates established in the parallel proposal COM(2023) 223. This ensures consistency across the whole SPC reform package, especially in the event of a ‘combined’ application requesting the grant of both a unitary certificate and national certificates, as explained below.
In addition to this proposal, parallel proposals are being made to create a centralised procedure for the grant of national certificates for medicinal products (COM(2023) 231), a centralised procedure for the grant of national certificates for plant protection products (COM(2023) 223), and a unitary certificate for medicinal products (cf. COM(2023) 222). Applications for all of these certificates would undergo the same centralised examination procedure described in this proposal, especially in the event of ‘combined’ applications that request both a unitary certificate and national certificates, as explained below. This ensures complete consistency across the whole SPC reform package.
Contents
- This table explains the purposes of the four related proposals:
- Regulation on the SPC for medicinal products (recast)
- Regulation on the SPC for plant protection products (recast)
- Regulation on the unitary SPC for medicinal products
- Regulation on the unitary SPC for plant protection products
- The following options were identified:
| Medicinal products | Plant protection products | |
| PROPOSAL 1 | Art. 114 TFEU 🡪 | PROPOSAL 2 |
| PROPOSAL 3 | Art. 118 TFEU 🡪 | PROPOSAL 4 |
In contrast to the proposal regarding the unitary SPC for medicinal products, this proposal foresees some minor differences as regards the conditions for grant and introduces some changes made necessary by specific features of the marketing authorisations for plant protection products.
The proposed creation of a unitary SPC will be fully compatible with the unitary patent system, under Regulation (EU) No 1257/2012 and the Agreement on a Unified Patent Court (UPCA).
In addition, as this was also the case for Regulation (EC) No 1610/96, this proposal is compatible with the agrochemical EU legislation.
Finally, this proposal is part of the ‘EU patent package’ announced in 2023 which, besides the revision, modernisation and introduction of a system for unitary SPCs, includes a new initiative on compulsory licensing and legislation on standard-essential patents. The proposal also complements the unitary patent system, which is a major step towards the completion of the single market for patents.
• Consistency with other Union policies
The proposed centralised procedure is fully consistent with the existing legislation relating to agrochemical products and with other relevant legislation. This includes the European patent with unitary effect ('unitary patent') as set out in Regulation (EU) No 1257/2012, and the related UPCA. The unitary patent system will enter into force on 1 June 2023.
Finally, the SPC reform and the other initiatives listed in the intellectual property action plan contribute to the broader innovation strategy of the EU.
2. LEGAL BASIS, SUBSIDIARITY AND PROPORTIONALITY
• Legal basis
The current proposal is based on the first subparagraph of Article 118 of the Treaty on the Functioning of the European Union, which is the only treaty provision suitable for the creation of unitary IP rights as it allows for measures for the creation of European intellectual property rights to provide uniform protection of intellectual property rights throughout the Union and for the setting up of centralised Union-wide authorisation, coordination and supervision arrangements.
Article 118 was introduced by the Treaty on the Functioning of the European Union (TFEU) and provides an express legal base for EU-wide intellectual property rights. It is also the legal basis for Regulation (EU) No 1257/2012 of the European Parliament and of the Council implementing enhanced cooperation in the area of the creation of unitary patent protection.
Together with the parallel proposal relating to a centralised procedure for the grant of national certificates (COM(2023) 223), this proposal addresses the fragmentation of the existing SPC regime, implemented at a purely national level: despite the fact that SPCs are already harmonised – and indeed defined – by EU law, there are still cases where some Member States have granted SPCs while identical applications have been refused in others, or been granted with a different scope. SPC applicants thus face diverging decisions across the EU on the same product, while incurring costs for applying and maintaining SPCs in several Member States. Consequently, further EU action is needed to address these issues and can, unlike national intervention by Member States, ensure a consistent EU-wide framework, and reduce the total costs and burden of fees to be paid in multiple Member States. Further EU-level action would strengthen the integrity of the single market by providing a centralised, balanced and transparent SPC system across the EU, and mitigate the negative consequences of redundant and potentially diverging procedures that applicants face6. Hence, by its nature, action at EU level is also justified to ensure the smooth functioning of the single market for innovative plant protection products that are subject to marketing authorisations. EU-level action would also allow innovative and follow-on manufacturers to reap the benefits of an efficient intellectual property framework in the relevant product markets.
• Subsidiarity
EU action is necessary to provide a unitary SPC for the unitary patent. An EU IP right (such as a unitary SPC) can only be created by the EU. National legislation cannot achieve this objective, as it is not able to provide for unitary protection, and the objectives underlying this proposal can thus only be achieved at Union level. The Union-wide approach implemented by the centralised procedure for the grant of national certificates and unitary SPCs will ensure that the applicable rules and procedures are consistent across the Union — at least insofar as the Member States participating in the unitary patent system are concerned —, ensuring legal certainty for all relevant market participants. Moreover, the unitary SPC is an autonomous IP right, applying independently of any national system. Consequently, EU action is needed to create a new unitary SPC complementing the unitary patent.
• Proportionality
This initiative does not go beyond what is necessary to achieve the identified objectives. Its scope is limited to those aspects that Member States cannot achieve satisfactorily on their own and where EU action can produce better results, e.g. in terms of consistent decisions on SPC applications to reduce administrative burdens and costs, and improve transparency and legal certainty.
• Choice of the instrument
The instrument choice is an EU regulation establishing a unitary SPC. No other instrument can be envisioned for creating a unitary IP right.
3. RESULTS 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 a national level. This fragmentation leads to high costs and imposes an administrative burden on applicants (especially SMEs) and national administrations. It also leads to legal uncertainty, as the scope of protection can differ across the EU. This has a negative impact on SPC users and makers of follow-on products. These negative effects are amplified by a lack of transparency, especially from a cross-border perspective, making it difficult to trace what SPC protection exists for which products in which Member States. This affects both SPC holders and manufacturers of follow-on products.
• Stakeholder consultations
The Commission conducted a public consultation during the evaluation (between 12 October 2017 and 4 January 2018). In addition, the Max Planck Institute study mentioned below included a survey of stakeholders in the Member States, conducted in 2017 by the Allensbach Institute (‘the Allensbach survey’), which included several questions on the operation of the current (national) SPC regimes. Moreover, from 8 March to 5 April 2022 interested parties could provide feedback to Commission’s Call for Evidence. For further information, see Annex 2 of the impact assessment (SWD(2023) 118).
Most of the respondents to the Allensbach survey consultation (conducted by the Allensbach Institute and included in the 2018 study by the Max Planck Institute (MPI))7 and to the public consultation organised by the Commission endorse the creation of a Unitary SPC. Answers to Question 69 of the Allensbach survey show that there is wide support for a unitary SPC, and that from all categories of respondents. The same can be said of the replies to the questions relating to the unitary SPC included in the public consultation ‘on Supplementary Protection Certificates and patent research exemption for sectors whose products are subject to regulated market authorisations’ that was conducted from 12 October 2017 to 4 January 2018.8
Moreover, from 8 March to 5 April 2022 interested parties could provide feedback to Commission’s Call for Evidence. For further information, see Annex 2 of the Impact Assessment.
• Collection and use of expertise
The study9 carried out in 2018 by the Max Planck Institute on the legal aspects of SPCs in the EU (especially Chapter 22) provides key findings on the operation of the current SPC regime (for medicinal products). In particular that study included a survey among stakeholders in the EU Member States (2017), conducted by the Allensbach Institute10, which included several questions relating to a possible unitary SPC in addition to the many questions relating to the operation of the current (national) SPC regimes.
• Impact assessment
An impact assessment was carried out and submitted to the Regulatory Scrutiny Board in late 2022 and, after resubmission, received a positive opinion on 16 December 2022 (SWD(2023) 118).
- 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 unitary patent holders to obtain through a single procedure a unitary SPC able to be enforced centrally in all relevant Member States represents a considerable simplification compared to the current situation in which national SPCs need to be applied for and enforced separately in each Member State, while noting that SPCs based on European patents (also non-unitary ones) will be able to be enforced before the Unified Patent Court (‘UPC’) once it is operating11.
• Fundamental rights
This proposal will have no impact on fundamental rights, especially since it is not proposed to alter the substantive features of the existing SPC regimes (e.g. conditions for grant, scope, effects). The initiative is consistent with the Charter of Fundamental Rights, as it offers greater legal certainty to applicants for unitary certificates, and where necessary for third parties, by providing for the procedural conditions for the examination, opposition, appeal and invalidity actions before the centralised authority.
In particular, where a centralised examination opinion is negative, the applicant may file an appeal before the Boards of Appeal of the EUIPO.
Moreover, examiners from national offices will play a key role in the centralised examination procedure and participate in the substantive examination of the application, as well as may take part in opposition and invalidity proceedings.
On the other hand, third parties will be able to submit observations during the examination of a centralised application, and to initiate an opposition against an examination opinion. After a unitary SPC is granted by the Office, third parties will also be able to challenge its validity before the Office. Counterclaims for a declaration of invalidity may be raised in the competent court of a Member State.
4. BUDGETARY IMPLICATIONS
This proposal will have no impact on the EU budget, since the system will remain fully self-funded by applicants’ fees, as is already the case for the existing SPCs regimes governed by Regulations (EC) No 469/2009 and (EC) No 1610/96, and will be implemented by the examination authority, the EUIPO. The necessary set-up costs of the tasks conferred to the EUIPO, including the costs of new digital systems, will be financed from the EUIPO’s accumulated budgetary surplus. A breakdown of the budgetary impact on the examination authority is provided in Annex 5D of the impact assessment.
The financial impacts on Member States (national offices) will also remain low. Indeed, while the number of SPCs applied for each year is likely to increase, it is quite low for the time being, even in large Member States. For instance, in 2017, 70 SPC applications were filed in Germany and 72 in France. The largest number of applications (95) were filed in Ireland. The average cost varies by country. Based on current average coverage (20 Member States) and duration (3.5 years), SPC protection for a given product would cost around EUR 98 500 on average. In order to cover all 27 Member States for 5 years one would pay nearly EUR 192 000 in total (not including any fees charged by patent lawyers). For a breakdown of the costs, see Annex 5B of the impact assessment (SWD(2023) 118 ).
Moreover it may be expected that only some plant protection products will be eligible for a unitary certificate in the first years of operation of the unitary patent system, considering that not all European patents will have unitary effect (which will be a prerequisite for applying for a unitary certificate).
5. OTHER ELEMENTS
• Implementation plans and monitoring, evaluation and reporting arrangements
It is envisaged that an evaluation will be carried out every 5 years.
• Detailed explanation of the specific provisions of the proposal
Overall structure of the proposal
The proposal is structured similarly to the current SPC Regulations and in particular to a parallel proposal relating to the unitary certificate for medicinal products (COM(2023) 222). It first sets out general provisions on SPCs followed by procedural provisions.
Coherence with the parallel proposal relating to medicinal products
This proposal is similar to the one presented in parallel regarding unitary SPCs for medicinal products (COM(2023) 222), with a limited number of adaptations directly linked to the intrinsic differences between medicinal products and plant protection products, regarding in particular marketing authorisations (as there are no centralised marketing authorisations for plant protection products). Moreover the ‘SPC manufacturing waiver’ introduced into Regulation (EC) No 469/2009 by Regulation (EU) 2019/933 only applies to SPCs for medicinal products and therefore does not need to be reflected in this new Regulation.
Basic patent
It is proposed that a unitary SPC must be based on a European patent with unitary effect only (as the ‘basic patent’), which would ensure that its claims are identical for all Member States it covers, and would avoid the risk of the basic patent being revoked, or lapsing, for one or some of these Member States. In this respect it should be noted that paragraph 28 of the explanatory memorandum of the proposal for a European Parliament and Council Regulation (EC) concerning the creation of a supplementary protection certificate for plant protection products (COM(94)579) already envisaged that ‘when use is made of the European procedure to obtain a Community patent, it will be all the more necessary for the certificate to apply equally to plant protection products protected by a Community patent’ (now referred to as a ‘European patent with unitary effect’ or, more informally, a ‘unitary patent’).
Allowing unitary SPCs to be based on national patents, or even on non-unitary European patents, would be more demanding insofar as the examination of such applications would be concerned, as it would be required to examine separately, for each of the Member States concerned, if the product concerned is indeed protected. This would also raise language issues, and affect legal certainty.
Examination/granting authority
Under this proposal, a central examination authority will carry out a substantive examination of a unitary SPC application, especially as regards the conditions for grant defined in Article 3 of the existing SPC Regulations. The Commission proposes that the EUIPO should be the central examination authority, in particular because it is an EU agency and therefore part of the EU legal order.
After assessing the formal admissibility of the unitary SPC application, the central examination authority would entrust the substantive examination of the application to a panel. This panel would be made up of a member of that central authority and two qualified examiners, experienced in SPC matters, from two different national patent offices in Member States. Before designating examiners qualified to examine SPC issues, these national patent offices will have agreed, through an ad hoc agreement with the central examination authority, to participate in this centralised examination system. Competencies and skills in SPC matters are scarce and qualified SPC examiners can be found today in national patent offices. Moreover, the relatively low number of products for which SPC applications are made each year (less than 100) justifies making recourse to existing qualified examiners in Member States, as opposed to creating an entirely new body of experts. During the examination, third parties may submit their observations on the validity of a certain unitary SPC application after its publication.
Examination procedure and remedies
After examining the application, the central examination authority will issue an examination opinion stating whether the application fulfils the applicable criteria (and in the first place those defined in Article 3). The applicant can file an appeal against a negative opinion (as further explained below).
In order to account for the need to have a complete system of remedies and avoid the need for third parties challenging a positive examination opinion in national courts which would then in turn have to make reference to the EU Courts, third parties will be able to challenge a positive (or partly positive) opinion by initiating an opposition procedure during 2 months after the publication of the examination opinion. Such an opposition may result in the examination opinion being amended.
Challenges against the examination opinion can be appealed to the Boards of Appeal, and subsequently to the General Court and, possibly, ultimately before the Court of Justice subject to the system of leave to appeal under Articles 170a and following of the Rules of Procedure of the Court of Justice, or under the review procedure in accordance with Article 256, paragraph 2, TFEU, Article 62 of the Statute of the Court and Articles 191 and following of the Rules of Procedure of the CJEU.
On the basis of the examination opinion (as possibly amended following an opposition), the EUIPO will either grant a unitary SPC, or reject the application for it, subject to the outcome of any appeal before the Boards of Appeal of the EU courts.
After the grant of a unitary SPCs, third parties will be able to initiate invalidity proceedings (actions for a declaration of invalidity) before the Office. Here as well, related decisions may be appealed to the Boards of Appeal, and may end up before the General Court.
Counterclaims for a declaration of invalidity could be raised in the competent court of a Member State (including the Unified Patent Court where the applicable conditions are met, subject to a suitable amendment of the UPCA).
Marketing authorisations concerned
Given that there is a zonal system of marketing authorisations for PPPs in the EU and that only national marketing authorisations exist for PPPs, the requirement for a centralised authorisation, included in the parallel proposal (COM(2023) 222) creating a unitary certificate for medicinal products, cannot be applied in this Regulation. Therefore, national marketing authorisations will be allowed to serve as basis for the grant of unitary certificates for PPPs.
Since the marketing authorisations granted in respect of a given plant protection product may have slightly different scopes in different Member States, it will be important to clarify that a unitary certificate will confer protection to the product identified in the related application only to the extent that the product is duly covered by the marketing authorisations granted in each of the relevant Member States (i.e. those in which the basic patent has unitary effect).
Moreover, since marketing authorisations for a given plant protection product are usually granted at different dates in different Member States, it may happen that, at the date of filing the unitary certificate application12, authorisations have been granted in some of the Member States in which the basic patent has unitary effect, but not in all of them. Since this situation is expected to be frequent, the traditional requirement for the availability of valid authorisations at the date of filing of the application would often make it impossible to fulfil the conditions for the grant of a unitary certificate on a PPP.
To address this situation, it is proposed to allow the grant of a unitary certificate for a PPP provided that two conditions are fulfilled in respect of marketing authorisations, as a derogation from the above-mentioned traditional requirement:
- at the date of filing of the application, it is only required that marketing authorisations have been applied for in each of the Member States in which the basic patent has unitary effect, but
- before the end of the examination process, marketing authorisations must have been granted in each of these Member States. At the same time it would be required that the examination process does not end earlier than 18 months from the filing of the application, to increase the likelihood that the ‘missing’ marketing authorisations may have been granted by then.
In addition, it is necessary to consider that in certain cases marketing authorisations may still not be available (granted), before the end of the examination process, in all of the Member States in which the basic patent has unitary effect – which is a real risk considering the complexity and thus duration of the authorisation procedures.
In such a case it is proposed that a unitary certificate will be granted, but will not have effect in a Member State (in which the basic patent has unitary effect) in which no authorisation was granted before the end of the examination process. In such an exceptional situation, the suspended effect in a certain Member State could resume where a ‘missing’ authorisation would be granted after the grant of the unitary certificate but – for legal certainty reasons –before the expiry of the basic patent, subject to a proper re-examination of that authorisation by the Office.
Substantive features of the SPC regime
This reform does not intend to modify, nor further clarify in view of the relevant case law of the Court of Justice, the substantive features currently laid down in Regulation (EC) No 1610/96 for the existing national SPC regimes or the new centralised procedure, including as regards its application to unitary SPCs, since:
- the case law13 on SPCs is progressively but effectively converging, and steadily reducing uncertainty about the interpretation of the SPC regime14, while further amendments might trigger new fluctuations and uncertainty as regards the proper interpretation of the amended rules;
- respondents to the Allensbach survey did not call for Article 3 of the SPC Regulations to be amended (question 48) even if they consider that the case law is unclear in some respects (question 46).
That being said, considering that there are national discrepancies in the interpretation of the rule defining the duration of a European patents, which may result in a one-day difference, there is a need to clarify that rule insofar as its application to unitary SPCs is concerned.
New recitals
Certain recitals concern the conditions (as set out in Article 3) for the grant of SPCs and incorporate the case law of the Court of Justice. The aim is to assist ensure consistency. In particular the judgements in cases C‑121/17 and C-673/18 interpret Article 3(1)(a) and 3(1)(d) of the current SPC Regulation, respectively, and should be considered settled case law. This is also the case for judgement C‑471/14, whereby the date of the first marketing authorisation in the Union, within the meaning of Article 13, is the date on which notification of the decision granting the authorisation was given to the addressee of the decision.
The requirement that the product should be protected by the basic patent means that the product should fall within the scope of one or more claims of that patent, as properly interpreted at the basic patent’s filing date. This also includes situations where the product corresponds to a general functional definition used by one of the claims of the basic patent, and necessarily comes within the scope of the invention covered by that patent, even if it is not indicated in individualised form as a specific embodiment in the patent, provided that it is specifically identifiable from the patent.
Many general objectives set out in the Explanatory Memorandum of the proposal (COM(94)579) for what became Council Regulation (EC) No 1610/96, remain fully relevant today, and should continue to be used as a guide to interpretation, where relevant. This includes the objective that if a certificate has already been granted for the active substance itself, a new certificate may not be granted for that active substance, whatever changes may have been made regarding other features of the plant protection product (use of a different salt, different excipients, different presentation, etc.).
Furthermore, as regards the rights conferred by a certificate, the certificate confers the same protection as the basic patent, but only protects the product covered by the authorisation, for all pharmaceutical uses authorised, until the expiry of the basic patent.
As regards the rights conferred by a certificate, and in line with the earlier statements regarding derivatives, it is appropriate to consider that the protection conferred by a certificate on a product extends to the derivatives of that product that are equivalent to the product from a phytosanitary perspective.
Finally, it remains fully justified to require, as already stated in the Explanatory Memorandum of the proposal (COM(94)579) for what became Council Regulation (EC) No 1610/96, that only the first authorisation to place the product on the market in the Member State in which the application is lodged is taken into account for the purposes of the Regulation. In other words, this ‘first authorisation’ requirement should be applied on a country-by-country basis.
Language regime
This Regulation envisages the possibility of filing a centralised SPC application in any official EU language. In this regard, the amount of text in an SPC application is extremely small, especially compared to patents and that this would not present a burden for applicants. Certain matters would not require any translation, such as the identification of the basic patent and the relevant marketing authorisation, the relevant dates, and the identification of the applicant(s) and the product concerned. The translation costs are, therefore, expected to be considerably lower than would be the case for patent applications. See the impact assessment (SWD(2023) 118) for an exact calculation.
Appeal
Decisions of the central examination authority are subject to appeal. This also applies to a negative examination opinion issued by the central examination authority, against which the applicant may file an appeal. This also applies to other decisions of that authority; for instance, the decision relating to an opposition may be appealed by any of its parties. An appeal may result in the examination opinion being amended.
In the event of a ‘combined’ SPC application as referred to below – namely an SPC application which requests the grant of a unitary SPC and also of national SPCs –, such an appeal would be applicable to the (common) examination opinion relating to the combined SPC application.
The appeal would take place before the Boards of Appeal of the EUIPO. Members from the Boards of Appeal should be appointed in accordance with Article 166 (5) of Regulation 2017/1001. These members may also be national examiners, but they may not be the same examiners already involved in the examination of the centralised applications or applications for unitary certificates.
In terms of workload, SPC applications are made for less than 100 products each year on average, for both medicinal products and PPPs, and introducing third-party observations should help keep the number of appeals at a very low level.
Fees and financial transfers between the central authority and national patent offices (NPOs)
An application fee and possibly other procedural fees, such as the fee for a review or an appeal, and annual (renewal) fees, will have to be paid by applicants to the central examination authority. The level of fees to be paid to the central examination authority will be set in an implementing act.
It would be appropriate that a fraction of the renewal fees paid by unitary SPC holders be transferred to the national patent offices15 of the Member States in which unitary SPCs have legal effect (as already planned in respect of renewal fees for unitary patents). At the same time, it is necessary to ensure that those national offices that participate in the new procedure as regards the substantive examination of unitary SPC applications are properly remunerated for their participation.
Litigation
It is intended that a unitary SPC will be able to be litigated before the body responsible under national law for the revocation of the corresponding basic patent. It is expected that the definition of SPCs present in the UPCA will be amended to include unitary SPCs as well. Such amendment may be based on Article 87(2) of the UPCA.
Centralised procedure for the grant of national SPCs
A parallel proposal (COM(2023) 223) is intended to create a centralised procedure for the filing and examination of ‘centralised SPC applications’, able to result in the grant (at a national level) of national SPCs in the Member States designated in that application. This procedure would be available potentially for all Member States, and only on the basis of a European patent as basic patent.
It is proposed that the procedure for the filing and examination of unitary SPC applications would be the same (mutatis mutandis) as the centralised procedure defined in the above-mentioned parallel proposal. In this manner, a ‘combined’ SPC application could possibly include both a request for the grant of a unitary SPC (for the Member States covered by the basic patent) and a request for the grant of national SPCs in other Member States. That ‘combined’ application would undergo a single examination procedure, ruling out any discrepancies, and considerably reducing costs and administrative burden for applicants.