Explanatory Memorandum to COM(2023)231 - Supplementary protection certificate for medicinal products (recast) - Main contents
Please note
This page contains a limited version of this dossier in the EU Monitor.
| dossier | COM(2023)231 - Supplementary protection certificate for medicinal products (recast). |
|---|---|
| source | COM(2023)231 |
| date | 27-04-2023 |
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 regards national SPCs for medicinal products, as well as improve its transparency and efficiency. This initiative was announced in the Commission work programme for 2022 as initiative number 16 under Annex II (REFIT initiatives)3.
Regulation (EC) No 469/2009 provides for SPCs for medicinal products (both human and veterinary medicinal products) to be granted at a national level on the basis of national applications, on a country-by-country basis. Similarly, Regulation (EC) No 1610/96 provides for SPCs for plant protection products. Together these two measures constitute the EU’s SPC regime. As Regulation (EC) No 469/2009 has been amended several times, and since further amendments are to be made, that Regulation should, in the interest of clarity, be recast, which is the first objective of this proposal (and of the parallel proposal on PPPs (COM(2023) 223).
As confirmed by the evaluation carried out in 2020 (SWD(2020)292 final), today’s purely national procedures for granting SPCs involve separate examination proceedings (in parallel or subsequent) in Member States. This entails duplication of work, resulting in high costs and more often discrepancies between Member States in decisions to grant or refuse SPCs including in litigation before national courts. Inconsistency between Member States in decisions to grant or refuse SPCs is the single reason most often cited by national courts for preliminary references to the Court of Justice of the European Union on the application of the EU’s SPC regime. The current purely national procedures, therefore, lead to significant legal uncertainty.
The Commission’s intellectual property action plan of November 2020 (COM(2020) 760 final), which builds on the SPC evaluation, highlighted the need to tackle the remaining fragmentation of the EU’s intellectual property system. The plan noted that, for medicinal 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 Council4 and the European Parliament5 have called on the Commission to correct these deficiencies.
Therefore, a second objective of this proposal is to introduce a centralised procedure for granting SPCs for medicinal products. This would allow applicants to obtain SPCs in the respective designated Member States subject to marketing authorisations having been granted in/for each of them, by filing a single ‘centralised SPC application’ that would undergo a single centralised examination procedure.
While that examination would be conducted by a centralised authority, the actual grant of SPCs would be done by the respective national offices of the designated Member States, based on a positive opinion from the central examination authority. The opinion of the central examination authority would be binding upon the national offices of the designated Member States.
A parallel proposal (COM(2023) 223), with similar provisions to this one for medicinal products6, concerns SPCs for PPPs.
• Consistency with existing policy provisions in the policy area
The core substantive features of the proposed centralised procedure – i.e. the conditions for obtaining certificates, as well as their legal effect – are the same as those of the existing SPC regime. This proposal introduces new procedural provisions as regards the centralised examination and is not intended to modify the scope nor the effect of the rights conferred by national SPCs currently granted according to Regulation (EC) No 469/2009. The same new procedural provisions are also inserted in the above-mentioned parallel proposal on SPCs for PPPs (COM(2023) 223).
At the same time, parallel proposals are being made to create unitary certificates for medicinal products (cf. COM(2023) 222) and for PPPs (cf. COM(2023) 221). Applications for these unitary certificates would undergo the same centralised examination procedure described in this proposal, especially in the event of ‘combined’ applications that request both a unitary certificate and national certificates, as explained below. This ensures complete consistency across the whole SPC reform package.
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 |
Moreover, it should be noted that nothing will prevent national SPCs as defined in Regulation (EC) No 469/2009 and in Chapter II of this proposal from being granted on the basis of a unitary patent as the basic patent.
Finally, this proposal is part of the ‘EU patent package’ announced in 2023 which, besides the revision, modernisation and introduction of a system for unitary supplementary protection certificates, includes a new initiative on compulsory licensing and legislation on 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 analyses7. Patents and SPCs are key to supporting the EU in its efforts to build a European Health Union and to other related initiatives such as the new European Health Emergency Preparedness and Response Authority (HERA)8, EU FAB9 and the pharmaceutical strategy for Europe.
The proposed centralised procedure is therefore fully consistent with the existing pharmaceutical legislation and with other relevant legislation, in particular the European patent with unitary effect ('unitary patent') as set out in Regulation (EU) No 1257/2012, and the related Agreement on a Unified Patent Court (UPCA). The unitary patent system will enter into force on 1 June 2023.
In addition, this proposal is fully compatible with Regulation (EC) No 1901/2006 on medicinal products for paediatric use, which provides for a possible ‘paediatric extension’ of SPCs for medicinal products under specific conditions.
Moreover, this proposal complements the pharmaceutical strategy for Europe and its intention to promote both innovation in medicines and better access to them, including the related legislative changes that are contemplated as regards regulatory protections ([OP, please add a reference to the ongoing reform of the pharmaceutical legislation]).
Finally, the SPC reform and the other initiatives listed in the intellectual property action plan contribute to the broader innovation strategy of the EU.
2. LEGAL BASIS, SUBSIDIARITY AND PROPORTIONALITY
• Legal basis
This proposal is based on Article 114(1) of the Treaty on the Functioning of the European Union on the single (or ‘internal’) market. This is the same legal basis used for Regulations (EC) No 469/2009 and (EC) No 1610/96 (previously Articles 100a, and then 95, respectively, of the Treaty establishing the European Community, as it then was). It is once again necessary to have recourse to Article 114 to adapt the EU SPC regime in the light of how the existing system has been applied. Even though SPCs are already harmonised, there are still cases where some Member States have granted SPCs while identical applications have been refused in others or been granted with a different scope. SPC applicants thus face diverging decisions across the EU on the same product, while incurring costs for applying and maintaining SPCs in several Member States. Consequently, further EU action is needed to address these issues and can, unlike national intervention by Member States, ensure a consistent EU-wide framework, and reduce the total costs and burden of fees to be paid in multiple Member States. Further EU-level action would strengthen the integrity of the single market by providing a centralised, balanced and transparent SPC system across the EU, and mitigate the negative consequences of redundant and potentially diverging procedures that applicants face10. Hence, by its nature, action at EU level is also justified to ensure the smooth functioning of the single market for innovative medicinal products that are subject to marketing authorisations. EU-level action would also allow innovative and follow-on manufacturers to reap the benefits of an efficient intellectual property framework in the relevant product markets.
• Subsidiarity
The objectives underlying the proposal can only be achieved at Union level. The Union-wide approach implemented by the centralised procedure envisaged in this proposal will ensure that the applicable rules and procedures are consistent across the Union, ensuring legal certainty for all relevant market participants.
• Proportionality
This initiative does not go beyond what is necessary to achieve the identified objectives. Its scope is limited to those aspects that Member States cannot achieve satisfactorily on their own and where EU action can produce better results, e.g. in terms of consistent decisions on SPC applications to reduce administrative burdens and costs, and improve transparency and legal certainty.
• Choice of the instrument
As the current SPC legislation is only governed by regulations, no other instrument can be envisioned for recasting the existing EU SPC legislation (Regulations (EC) No 469/2009 and (EU) No 2019/933) and introducing a centralised procedure.
3. RESULTS OF EX-POST EVALUATIONS, STAKEHOLDER CONSULTATIONS AND IMPACT ASSESSMENTS
• Ex-post evaluations and fitness checks of existing legislation
An evaluation of the SPC regime was carried out in 2020 (SWD(2020) 292). It found that SPCs promote innovation and the availability of new medicines and PPPs because they help companies recoup their R&D investments. Although the SPC Regulations provide a common framework within the EU, they are administered at national level. This fragmentation leads to high costs and imposes an administrative burden on applicants (especially SMEs) and national administrations. It also leads to legal uncertainty, as the scope of protection can differ across the EU. This has a negative impact on SPC users and makers of generics. These negative effects are amplified by a lack of transparency, especially from a cross-border perspective, making it difficult to trace what SPC protection exists for which products in which Member States. This affects both SPC holders and generics manufacturers.
An evaluation of the SPC manufacturing waiver, which is an exception introduced by Regulation (EU) 2019/933, which amended Regulation (EC) No 469/2009, and is included in this proposal, will be undertaken in the near future (as foreseen in Article 21a of Regulation (EC) No 469/2009).
• Stakeholder consultations
The Commission conducted a public consultation during the evaluation of the SPC regime (between 12 October 2017 and 4 January 2018)11. In addition, the Max Planck Institute study mentioned below included a survey of stakeholders in the Member States, conducted in 2017 by the Allensbach Institute ('the Allensbach survey'), which included several questions on the operation of the current (national) SPC regimes. Moreover, from 8 March to 5 April 2022 interested parties could provide feedback to Commission’s Call for Evidence. For further information, see Annex 2 of the impact assessment (SWD(2023) 118).
• Collection and use of expertise
The study12 carried out in 2018 by the Max Planck Institute on the legal aspects of SPCs in the EU (especially Chapter 22) provides key findings on the operation of the current SPC regime (for medicinal products). The additional Max Planck Institute study completed in 202213 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).
- 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 generics).
In addition, as regards medicinal products, this proposal will result in a single SPC Regulation instead of three, as would have resulted from proposing the creation of a centralised procedure through a stand-alone Regulation while leaving the existing Regulation (EC) No 469/2009 (as amended by Regulation (EU) 2019/933) unaffected. In other words, this proposal – that will recast and repeal Regulation (EC) No 469/2009, which was amended by Regulation (EU) No 2019/933 – will achieve a ‘one in, two out’ outcome.
• Fundamental rights
This proposal will have no impact on fundamental rights, especially since it is not proposed to alter the substantive features of the existing SPC regimes (e.g. conditions for grant, scope, effects). The initiative is consistent with the Charter of Fundamental Rights as it offers greater legal certainty to applicants for the grant of an intellectual property right and where necessary for third parties, by providing for the procedural conditions for the examination, opposition and appeal before the centralised authority.
In particular, where a centralised examination opinion is negative, the applicant may file an appeal before the Boards of Appeal of the EUIPO. Oppositions to applications may also be filed by third parties.
In addition, a national office may decide to not grant an SPC, despite a positive examination opinion, in certain narrowly defined situations, namely where material circumstances in that Member State have changed since the filing of the centralised application (such as the basic patent being no longer in force). Moreover, examiners from national offices will play a key role in the centralised examination procedure and participate in the substantive examination of the application, as well as may take part in opposition proceedings.
On the other hand, third parties will be able to submit observations during the examination of a centralised application, and to initiate an opposition against an examination opinion. Where national SPCs are granted by national offices on the basis of a positive opinion, third parties will also be able to challenge their validity before the respective national courts or other competent bodies, as already possible today pursuant to Regulation (EC) No 469/2009.
As further explained below under ‘Basic patent’, legal certainty concerns call for closing the national route when SPC protection is sought for a given product, where the conditions are fulfilled for the centralised procedure – i.e., in such a case, the filing of separate national applications before national offices should be prohibited. This is intended to avoid divergences between national decisions as such divergences would be avoided by using the centralised procedure, and to prevent users from filing national SPC applications only before national offices whose examination practice is less rigorous. This practice is akin to forum shopping and undermines the SPC system. Applicants may seek to file weak applications at national level in the hope of receiving SPCs from more lenient offices.
Conversely, as further explained below under ‘Unitary SPC’, this proposal does not exclude centralised SPC applications designating one or more Member States participating in the unitary patent system, potentially resulting in national SPCs being granted in these Member States, as long as double protection is excluded, even where the conditions are met for the grant of a unitary SPC.
A comparison of these two proposed measures does not show any unjustified difference of treatment. Indeed, there may be cases where an applicant, while holding a unitary patent, has no interest in obtaining SPCs in all the Member States which that patent covers, and therefore that applicant should not be forced to apply for a unitary SPC, even if the conditions thereof were fulfilled. On the other hand, the closing of the national route for the centralised procedure never creates an obligation to designate all Member States for which the centralised procedure can be used in given circumstances, as the applicant is free to choose which Member States should be designated.
4. BUDGETARY IMPLICATIONS
This proposal will have no impact on the EU budget, since the system will remain fully 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).
5. OTHER ELEMENTS
• Implementation plans and monitoring, evaluation and reporting arrangements
It is envisaged that an evaluation will be carried out every 5 years.
• Detailed explanation of the specific provisions of the proposal
Overall structure of the proposal
Chapter I of the proposal includes definitions and other general provisions.
Chapter II of the proposal includes most of the existing provisions of Regulation (EC) No 469/2009 regarding national applications for certificates, filed at national offices14 (as amended by Regulation (EU) 2019/933), without changing their substance, except for minor technical adaptations that bring the recast regulation up to current drafting standards and ensure better alignment with certain provisions of the corresponding proposal on plant protection products (COM(2023) 223), derived from Regulation (EC) No 1610/96.
Chapter III includes new provisions defining the new centralised procedure.
Chapter IV contains final provisions, including the repeal of Regulation (EC) No 469/2009.
Basic patent
The existing SPC Regulations do not impose any limitation on the types of (‘basic’) patents on which a national SPC application must rely, which may thus be: (1) a national patent resulting from either a national patent application or from a European patent application; or (2) a unitary patent (a ‘European patent with unitary effect’). To remove any residual legal uncertainty, the option to rely on this second type of patent will be clarified through minor amendments, in the recitals of this proposal, that explicitly refer to unitary patents. In this respect it should be noted that paragraph 21 of the explanatory memorandum of the first proposal for a Council Regulation concerning the creation of a supplementary protection certificate for medicinal products (COM(90)101) envisaged that ‘when use is made of the European procedure to obtain a Community patent, it will likewise be necessary that the certificate can apply equally to medicinal products protected by a Community patent’ (now referred to as a ‘European patent with unitary effect’ or, more informally, a ‘unitary patent’).
It is proposed that applications for SPCs filed under the new centralised procedure (Chapter III of this proposal) must be based on European patents only as basic patents, including a European patent with unitary effect. This will facilitate the examination of centralised SPC applications because the filing and examination of a European patent application, if positive, results in the grant of a European patent having, with a few exceptions, identical claims for all designated countries, which is required for unitary patents.
Moreover, today most inventions, and in particular medicinal products, patented in the EU are protected by European patents, which are granted only as the result of a thorough examination procedure, and not by national patents, which in several Member States are not subject to an in-depth substantive examination.
Therefore, under the proposed centralised procedure, allowing centralised SPC applications to be based on national patents would be more demanding as regards the examination of such applications, as it would be necessary to examine separately, for each of the designated Member States, whether the product concerned is indeed protected by each of the respective national patents in force, which will not necessarily have the same claims. This may also affect legal certainty.
A requirement that the claims of the basic (European) patent must be identical for all Member States designated in a centralised SPC application would make it easier to examine the application. However, the cases where a European patent includes two or more sets of claims for different Member States are quite rare, and it is very exceptional that there are more than two sets of claims. For this reason, this proposal does not include a requirement that the claims of the basic patent must be identical for all Member States designated in a centralised SPC application.
In those situations where a centralised application could be filed, namely where the basic patent is a European patent and the marketing authorisation is a centralised one, the choice could have been made to also allow applicants to file national SPC applications. Based on the findings of the evaluation completed in 2020, which revealed discrepancies between the granting practices of various national offices, this might have resulted, however, in applicants applying for certificates in Member States with less strict examination standards, to avoid filing a centralised application that may be rejected due to a stricter examination. Such a situation would be detrimental to consistency and legal certainty, could promote forum shopping, and would result in a higher total workload across the EU from examining applications. To avoid these drawbacks, it is considered preferable to examine applications under the centralised procedure in all cases where the conditions for using this procedure are met. Accordingly, this proposal requires that a national SPC application, filed in a Member State, be rejected where the requirements for filing a centralised application are fulfilled (‘closing of the national route’).
Examination/granting authority
Under the proposed centralised procedure, a central examination authority will carry out a substantive examination of a centralised SPC application, especially as regards the conditions for grant defined in Article 3 of the existing SPC Regulations. The Commission proposes that the EUIPO should be the central examination authority, in particular because it is an EU agency and therefore part of the EU legal order.
After assessing the formal admissibility of the centralised SPC application, the central examination authority would entrust the substantive examination of the application to a panel. This panel would be made up of a member of that central authority and two qualified examiners, experienced in SPC matters, from two different national patent offices in Member States. Before designating examiners qualified to examine SPC issues, these national patent offices will have agreed, through an ad hoc agreement with the central examination authority, to participate in this centralised examination system. Competencies and skills in SPC matters are scarce and qualified SPC examiners can be found today in national patent offices. Moreover, the relatively low number of products for which SPC applications are made each year (less than 100) justifies making recourse to existing qualified examiners in Member States, as opposed to creating an entirely new body of experts. During the examination, third parties may submit their observations on the validity of a certain centralised SPC application after its publication.
Examination procedure and remedies
After examining the centralised SPC application, the central examination authority will issue an examination opinion stating, for each of the designated Member States, whether a national SPC fulfilling the applicable criteria (and in the first place those defined in Article 3) should be granted or refused. The applicant can file an appeal against a negative or partly negative opinion (as further explained below).
In order to account for the need to have a complete system of remedies and avoid the need for third parties challenging a positive examination opinion in national courts which would then in turn have to make reference to the EU Courts, third parties will be able to challenge a positive (or partly positive) opinion by initiating an opposition procedure during 2 months after the publication of the examination opinion. Such an opposition may result in the examination opinion being amended.
Challenges against the examination opinion can be appealed to the Boards of Appeal, and subsequently to the General Court and, possibly, ultimately before the Court of Justice subject to the system of leave to appeal under Articles 170a and following of the Rules of Procedure of the Court of Justice, or under the review procedure in accordance with Article 256, paragraph 2, TFEU, Article 62 of the Statute of the Court and Articles 191 and following of the Rules of Procedure of the CJEU.
The opinion (including where amended following an opposition) will then be transmitted to the national offices of each of the designated Member States. Where the opinion is positive the designated Member States will grant a national SPC in accordance with their national rules, e.g. as regards publication, registration in relevant databases and the payment of annual (renewal) fees, unless circumstances have changed, such as the basic patent no longer being in force in a certain Member State. Subject to the outcome of any appeal before the Boards of Appeal or the EU courts, if the examination opinion is negative, the national office concerned must reject the application.
After the grant of SPCs at a national level, third parties will still be able to initiate invalidity proceedings before the body responsible under national law for the revocation of the corresponding basic patents, or the competent courts of the Member States, including the Unified Patent Court, as applicable. The same applies to a possible counterclaim for a declaration of invalidity of an SPC.
Marketing authorisations concerned
It is proposed that only a centralised marketing authorisation (as defined in Regulation (EC) No 726/2004 and in Regulation (EU) No 2019/6) could serve as the basis for a centralised SPC application for medicinal products made under the centralised procedure proposed in Chapter III. Today, most medicinal products are authorised under that centralised marketing authorisation procedure. A centralised SPC application based on national marketing authorisations, such as those granted under the decentralised or mutual recognition procedures, would have significant drawbacks. These would include a bigger examination workload, potential differences between the various national marketing authorisations granted for the product concerned in different Member States, including language issues.
Substantive features of the SPC regime
This reform does not intend to modify, nor further clarify in view of the relevant case law of the Court of Justice, the substantive features currently laid down in Regulation (EC) No 469/2009 for the existing national SPC regimes or the new centralised procedure, since:
- the case law15 on SPCs is progressively converging, and steadily reducing uncertainty about the interpretation of the SPC regime16, 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).
New recitals
It was noted that there were no relevant recitals in Regulation (EC) No 469/2009 that could assist in interpretation of Article 3. Accordingly, certain recitals concern the conditions in Article 3 for the grant of SPCs, and incorporate the case law of the Court of Justice. The aim is to ensure consistency. In particular the judgements in cases C‑121/17 and C-673/18 interpret Article 3(a) and 3(d) of Regulation (EC)No 469/2009, respectively, and should be considered settled case law. This is also the case for judgement C-471/14, whereby the date of the first marketing authorisation in the Union, within the meaning of Article 13, is the date on which notification of the decision granting the authorisation was given to the addressee of the decision.
The requirement that the product should be protected by the basic patent means that the product should fall within the scope of one or more claims of that patent, as properly interpreted at the basic patent’s filing date. This also includes situations where the product corresponds to a general functional definition used by one of the claims of the basic patent, and necessarily comes within the scope of the invention covered by that patent, even if it is not indicated in individualised form as a specific embodiment in the patent, provided that it is specifically identifiable from the patent.
Many general objectives set out in the Explanatory Memorandum of the proposal (COM(90)101) for what became Council Regulation 1768/92/EEC, i.e. the predecessor of Regulation (EC) No 469/2009, remain fully relevant today and should continue to be used as a guide to interpretation, where relevant. This includes the objective that only one certificate may be granted for any one product, a product being understood to mean an active substance in the strict sense. Minor changes to the medicinal product such as a new dose, the use of a different salt or ester or a different pharmaceutical form will not lead to the issue of a new certificate.
Furthermore, as regards the rights conferred by a certificate, the certificate confers the same protection as the basic patent, but only protects the product covered by the authorisation, for all pharmaceutical uses authorised, until the expiry of the basic patent.
As regards the rights conferred by a certificate, and in line with the earlier statements regarding derivatives, it could be appropriate to consider that the protection conferred by a certificate on a product extends to the therapeutically equivalent derivatives of the product.
For biological products, the application of the rules, both as regards the conditions for grant and the effects of a certificate, should take into account the fact that minor differences may be unavoidable between a subsequent biosimilar and the product initially authorised, given the nature of biological products.
Language regime
This Regulation envisages the possibility of filing a centralised SPC application in any official EU language. In this regard, the amount of text in an SPC application is extremely small, especially compared to patents and this would not present a burden for applicants. Certain matters would not require any translation, such as the identification of the basic patent and the relevant marketing authorisation, the relevant dates, and the identification of the applicant(s) and the product concerned. The translation costs are, therefore, expected to be considerably lower than would be the case for patent applications. See the impact assessment (SWD(2023) 118) for an exact calculation.
Appeals
Decisions of the central examination authority are subject to appeal. This also applies to a negative (or partly negative) examination opinion issued by the central examination authority, an appeal could be filed by an applicant before the central examination authority, during a limited period after the issuance of the examination opinion. This also applies to other decisions of that authority; for instance, the decision relating to an opposition may be appealed by any of its parties. An appeal may result in the examination opinion being amended.
In the event of a ‘combined’ SPC application as referred to below – namely an SPC application which requests the grant of a unitary SPC and also of national SPCs –, such an appeal would also be applicable to the (common) examination opinion relating to the combined SPC application.
The appeal would take place before the Boards of Appeal of the EUIPO. Members from the Boards of Appeal should be appointed in accordance with Article 166 (5) of Regulation 2017/1001. These members may also be national examiners, but they may not be the same examiners already involved in the examination of the centralised applications or applications for unitary certificates.
In terms of workload, SPC applications are made for less than 100 products each year on average, for medicinal products and PPPs together, and introducing third-party observations should help keep the number of appeals at a very low level.
Fees
An application fee and possibly other procedural fees, such as the fee for oppositions and appeals, will have to be paid to the central examination authority. For national SPCs granted under the centralised procedure, renewal fees would have to be paid to the national patent offices of all the Member States where such certificates have been granted. This would differ, however, for unitary certificates granted under the parallel proposals COM(2023) 222 and COM(2023) 221, whereby the examination authority shall charge application and annual (renewal) fees. The level of fees to be paid to the central examination authority will be set in an implementing act.
Financial transfers between the central authority and national patent offices (NPOs)
As the procedural fees paid by applicants to the central examination authority may not be sufficient to cover the costs incurred by that authority under the new centralised procedure, it is necessary to ensure that a fraction of the renewal fees collected by national offices for SPCs granted on the basis of the centralised procedure will be transferred to the central examination authority. This already happens between national patent offices and the European Patent Office (EPO) in respect of renewal fees for European patents. At the same time, it is necessary to ensure that those national offices that participate in the new centralised procedure as regards the substantive examination of centralised SPC applications are properly remunerated for their participation.
Litigation
Whether it was obtained under today's current national procedures or under the newly proposed centralised procedure, an SPC based on an European patent, including a unitary patent, will be able to be litigated before the body responsible under national law for the revocation of the corresponding basic patent, which is typically a national court, and may also, for those Member States participating in the unitary patent system (i.e. that have ratified the UPCA), be the Unified Patent Court (‘UPC’) where the applicable conditions are fulfilled (cf. Article 3(b) of the UPCA, together with Article 2(g) and Article 32)17.
National aspects
As the proposed centralised procedure results in the grant of national certificates (SPCs), many existing national requirements and procedures, currently applicable to the SPCs applied for nationally, will be equally applicable to the certificates granted under the proposed centralised procedure. This relates in particular to publication requirements, national registers, the payment of renewal fees and the SPC manufacturing waiver introduced by Regulation (EU) 2019/933 and the paediatric extension defined in Regulation (EC) No 1901/2006.
No changes are proposed to the judicial procedures applicable to nationally granted SPCs, whether granted on the basis of a national application or of a centralised application, e.g. as regards revocation and enforcement, subject to the provisions of the UPCA, for its parties, where applicable. In other words, invalidity actions and infringement actions may be brought before the UPC also in respect of a nationally granted SPC based on a European patent, subject to the applicable conditions, in particular the requirement that neither the patent nor the SPC has been opted-out from the jurisdiction of the UPC.
Extension of SPCs for paediatric medicinal products
SPC applicants and holders should be able to use the centralised SPC granting procedure to apply for extensions of SPCs for paediatric medicinal products, under the conditions currently provided for by Regulation (EC) No 1901/2006.
Unitary SPCs
A parallel proposal (COM(2023) 222) is intended to create a unitary SPC for medicinal products. This unitary certificate would be available only on the basis of a European patent with unitary effect (‘unitary patent’), as a basic patent, and would exert its effects uniformly in all the Member States in which the basic patent has unitary effect (17 initially).
The procedure for the centralised filing and examination of applications for such unitary certificates would be the same mutatis mutandis as the centralised procedure set out in this proposal. In this manner, a ‘combined’ SPC application could possibly include both a request for the grant of a unitary SPC (for the Member States covered by the basic patent) and a request for the grant of national SPCs in other Member States. This ‘combined’ application would undergo a single examination procedure, ruling out any discrepancies, and considerably reducing costs and the administrative burden for applicants. For the sake of clarity, this proposal does not exclude centralised SPC applications designating one or more Member States participating in the unitary patent system, as long as no unitary SPC is simultaneously requested in such a case.
🡻 469/2009 (adapted)