Toelichting bij COM(2023)222 - Aanvullende beschermingscertificaat met eenheidswerking voor geneesmiddelen - Hoofdinhoud
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| dossier | COM(2023)222 - Aanvullende beschermingscertificaat met eenheidswerking voor geneesmiddelen. |
|---|---|
| bron | COM(2023)222  |
| 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 well as improve its transparency and efficiency, by creating a unitary certificate for medicinal 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 469/2009 provides for SPCs for medicinal products (both human and veterinary medicinal products), 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 1610/96 provides for SPCs for plant protection 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 and a centralised procedure for obtaining marketing authorisations for medicinal products.
In the same vein, the pharmaceutical strategy for Europe (COM(2020) 761 final) emphasised the importance of investing in R&D to create innovative medicines. The strategy stressed, however, that the differences between Member States in the implementation of intellectual property regimes, especially for SPCs, lead to duplications and inefficiencies that affect the competitiveness of the pharmaceutical industry. Both the Council 4 and the European Parliament 5 have called on the Commission to correct these deficiencies.
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) 231) 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) 231. 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 plant protection products (cf. COM(2023) 221). 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.
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 |
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 already the case for Regulation (EC) No 469/2009, this proposal is compatible with the pharmaceutical EU legislation, including Regulation 1901/2006 on medicinal products for paediatric use, which provides for a possible ‘paediatric extension’ of SPCs for medicinal products, under specific conditions.
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 COVID-19 pandemic has underlined the importance of having a strong and balanced IP system to provide the necessary incentives to develop new treatments and vaccines that patients will have access to. It has also highlighted the need for transparent and easily accessible information on the status of IP rights, including SPCs, to facilitate potential collaborations, licensing and freedom-to-operate analyses 6 . Patents and SPCs are key to supporting the EU in its efforts to build a European Health Union and to other related initiatives such as the new European Health Emergency Preparedness and Response Authority (HERA) 7 , EU FAB 8 and the pharmaceutical strategy for Europe.
In addition, this proposal complements the pharmaceutical strategy for Europe and its intention to promote both innovation in medicines and better access to them, including the related legislative changes that are contemplated as regards regulatory protections ([OP, please add a reference to the ongoing reform of the pharmaceutical legislation]).
Finally, 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 plant protection 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 and financial transfers between the central authority and national patent offices (NPOs)
- Litigation
- Extension of unitary SPCs for paediatric medicinal products
- Centralised procedure for the grant of national SPCs
•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) 231), 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 face 9 . Hence, by its nature, action at EU level is also justified to ensure the smooth functioning of the single market for innovative medicinal products that are subject to marketing authorisations. EU-level action would also allow innovative and follow-on manufacturers to reap the benefits of an efficient intellectual property framework in the relevant product markets.
•Subsidiarity
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.
•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 generics. These negative effects are amplified by a lack of transparency, especially from a cross-border perspective, making it difficult to trace what SPC protection exists for which products in which Member States. This affects both SPC holders and generics manufacturers.
An evaluation of the SPC manufacturing waiver, which is an exception introduced by Regulation (EU) 2019/933, which amended Regulation (EC) No 469/2009, and is included in this proposal, will be undertaken in the near future (as foreseen in Article 21a of Regulation (EC) No 469/2009).
•Stakeholder consultations
The Commission conducted a public consultation during the evaluation (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)) 10 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 11 .
Moreover, from 8 March to 5 April 2022 interested parties could provide feedback to Commission’s Call for Evidence 12 . For further information, see Annex 2 of the Impact Assessment.
•Collection and use of expertise
The study 13 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 Institute 14 , 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.
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 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 operating 15 .
•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 could be raised in the competent court of a Member State.
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 medicinal 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).
•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
The proposal is structured similarly to the current SPC Regulations and in particular to a parallel proposal relating to the unitary certificate for plant protection products (COM(2023) 221). It first sets out general provisions on SPCs followed by procedural provisions. It also ensures alignment with certain provisions of the corresponding proposal relating to plant protection products (COM(2023) 223), derived from Regulation (EC) No 1610/96.
Furthermore, this proposal would amend:
–Regulation (EU) 2017/1001, that lays down the tasks carried out by the Office (see below under ‘Examination/granting authority’), to ensure that the Office will be able to implement the procedures envisaged in the context of the present reform of the SPC regime,
–Regulation (EC) No 1901/2006, to ensure that the paediatric extension it established will also be applicable in respect of unitary SPCs for medicinal products; and
–Regulation (EU) No 608/2013, to ensure that the customs measures it established will also be applicable in respect of unitary SPCs (for medicinal products under this proposal, and for plant protection products under the parallel proposal for plant protection products).
This proposal is extremely similar to the one presented in parallel regarding the unitary SPC for plant protection products (COM(2023) 221), 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). 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 needs to be reflected in this new Regulation, but not in the above-mentioned parallel proposal regarding unitary SPCs for plant protection products.
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 21 of the explanatory memorandum of the first proposal for a Council Regulation concerning the creation of a supplementary protection certificate for medicinal products (COM(90)101) already envisaged that ‘when use is made of the European procedure to obtain a Community patent, it will likewise be necessary that the certificate can apply equally to medicinal products protected by a Community patent’ (now referred to as a ‘European patent with unitary effect’ or, more informally, a ‘unitary patent’).
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.
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.
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 .
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).
It is proposed that only a centralised marketing authorisation (as defined in Regulation (EC) No 726/2004) can serve as a basis for an application for a unitary SPC for a medicinal product. Today, most medicinal products are authorised under that centralised marketing authorisation procedure. A unitary SPC application based on national marketing authorisations (such as those granted under the decentralised or mutual recognition procedures) would have significant drawbacks. These would include a bigger examination workload, potential differences between the various national marketing authorisations granted for the product concerned in different Member States, including language issues.
This reform does not intend to modify, nor further clarify in view of the relevant case law of the Court of Justice, the substantive features currently laid down in Regulation (EC) No 469/2009 for the existing national SPC regimes or the new centralised procedure, including as regards its application to unitary SPCs, since:
–the case law 16 on SPCs is progressively but effectively converging, and steadily reducing uncertainty about the interpretation of the SPC regime 17 , 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.
Certain recitals concern the conditions 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(a) and 3(d) of Regulation (EC)No 469/2009, respectively, and should be considered settled case law. This is also the case for judgement C471/14, whereby the date of the first marketing authorisation in the Union, within the meaning of Article 13, is the date on which notification of the decision granting the authorisation was given to the addressee of the decision.
The requirement that the product should be protected by the basic patent means that the product should fall within the scope of one or more claims of that patent, as properly interpreted at the basic patent’s filing date. This also includes situations where the product corresponds to a general functional definition used by one of the claims of the basic patent, and necessarily comes within the scope of the invention covered by that patent, even if it is not indicated in individualised form as a specific embodiment in the patent, provided that it is specifically identifiable from the patent.
Many general objectives set out in the Explanatory Memorandum of the proposal (COM(90)101) for what became Council Regulation 1768/92/EEC, i.e. the predecessor of Regulation (EC) No 469/2009, remain fully relevant today and should continue to be used as a guide to interpretation, where relevant. This includes the objective that only one certificate may be granted for any one product, a product being understood to mean an active substance in the strict sense. Minor changes to the medicinal product such as a new dose, the use of a different salt or ester or a different pharmaceutical form will not lead to the issue of a new certificate.
Furthermore, as regards the rights conferred by a certificate, the certificate confers the same protection as the basic patent, but only protects the product covered by the authorisation, for all pharmaceutical uses authorised, until the expiry of the basic patent.
As regards the rights conferred by a certificate, and in line with the earlier statements regarding derivatives, it could be appropriate to consider that the protection conferred by a certificate on a product extends to the therapeutically equivalent derivatives of the product.
For biological products, the application of the rules, both as regards the conditions for grant and the effects of a certificate, should take into account the fact that minor differences may be unavoidable between a subsequent biosimilar and the product initially authorised, given the nature of biological products.
This Regulation envisages the possibility of filing a centralised SPC application in any official EU language. In this regard, the amount of text in an SPC application is extremely small, especially compared to patents and this would not present a burden for applicants. Certain matters would not require any translation, such as the identification of the basic patent and the relevant marketing authorisation, the relevant dates, and the identification of the applicant(s) 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 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 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 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 offices 18 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.
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.
Unitary SPC applicants/holders should be able to apply before the central examination authority for extensions of unitary SPCs for paediatric medicinal products, under the conditions currently provided for by Regulation (EC) No 1901/2006 – which, therefore, needs to be amended so as to ensure that it also applies to unitary SPCs in addition to national SPCs.
A parallel proposal (COM(2023) 231) 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.