(Forslag) Europaparlaments- og rådsforordning (EU) …/… om ensartede supplerende beskyttelsessertifikater for legemidler og om endring av forordning (EU) 2017/1001, forordning (EU) 2006/1901 og forordning (EU) 2013/608
(Proposal) Regulation (EU) …/… of the European Parliament and of the Council on the unitary supplementary certificate for medicinal products, and amending Regulation (EU) 2017/1001, Regulation (EC) No 1901/2006 as well as Regulation (EU) No 608/2013
Dansk departementsnotat offentliggjort 22.9.2023
BAKGRUNN (fra Kommisjonsforslaget)
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).
Justis- og beredskapsdepartementet