In addition to the Pharmaceutical strategy for Europe[1], the European Commission adopted a new Action Plan for Intellectual Property[2] in November 2020, which is intended to support companies in protecting their intellectual property and envisaged to contribute to promoting the use of intellectual property rights by small and medium-sized enterprises (SMEs) and better enforcement of intellectual property rights through further measures.
The first article in the three-part series dealt with the proposed amendments to data protection and market protection in the proposals for new pharmaceutical legislation. This second article deals with the planned changes regarding supplementary protection certificates for medicinal products.
Supplementary protection certificates
The duration of the mandatory approval procedures for medicinal products prior to market launch is generally very long, meaning that sales of a new active ingredient can only begin several years after the patent application has been filed. As a rule, a large part of the patent protection period has therefore already expired before a drug is approved for sale. To ensure that the high research and development costs can be amortized and that the search for new active ingredients is worthwhile, the European legislator has provided further protection concepts in the form of data protection and market protection and the option of applying for a supplementary protection certificate. These are located in different areas of competence. The so-called data protection and market protection is subject to the Pharmaceutical Strategy, the amendments to supplementary protection certificates to the Action Plan for Intellectual Property. While data protection, the period of time during which an applicant cannot rely on the data in support of another marketing authorisation for the purposes of submitting an application, obtaining marketing authorisation or placing the product on the market, and market protection, the period of time during which generics, hybrid or biosimilars cannot be placed on the market, even if the medicinal product has already received a marketing authorisation, delay the access to the market, supplementary protection certificates effectively extend patent protection by up to five years and, if approved as a medicinal product in all EU states, by a further six months.
On April 27, 2023, the European Commission presented two proposals for Regulations on supplementary protection certificates for medicinal products.[3] The aim is to promote investment in new active substances that require long development times for approval and to create a transparent, efficient and pro-competitive SPC system.[4]
Status Quo
Supplementary protection certificates (or SPCs) are currently regulated in Regulation (EC) 469/2009. According to Art. 5 of the Regulation, they grant the same protection as the patent on which the SPC is based, but according to Article 4 of the Regulation, not for individual patent claims, but rather for a product in the form of a medicinal product authorized in the EU (patented active ingredient or combination of active ingredients), for up to five additional years after the expiry of patent protection (as well as an additional six-month extension for paediatric medicinal products according to Art. 36 of Regulation (EC) No. 1901/2006). They are currently only intended for pharmaceutical patents and therefore only grant protection for a specific purpose within the scope of the marketing authorization under pharmaceutical law. The term of the certificate is determined by the period between the patent application and the authorization of the medicinal product minus a period of five years, limited to a maximum of five years, see Art. 13 para. 1 and 2 Regulation 496/2009.
Supplementary protection certificates, even if they are based on a European (unitary) patent, are always granted by the national patent offices, i.e. in Germany by the DPMA, see Section 49a PatG. So far, there is no unitarySPC, only national SPCs, even for unitary patents. However, according to Art. 32 UPCA, the Unified Patent Court (UPC), which was created with effect from June 1, 2023, is responsible for disputes concerning an SPC on the basis of a European (unitary) patent (unless an opt-out has been declared).
Proposed new Regulation and the unitary protection certificate
In order to simplify the system for granting protection certificates, the Commission has proposed the creation of a unitary SPC[5] and the introduction of a centralized application obligation for SPCs for European (unitary) patents[6] . National applications for SPCs would then only be possible for national patents. A single examination office is to be created for unitary SPCs, which in turn can involve national authorities in the examination procedure. According to the proposal, the European Union Intellectual Property Office would assume this function.
Just as the existing protection certificates, the unitary SPC should also grant the same protection as the underlying patent, see Art. 5 para. 1 of the proposed Unitary SPC Regulation. As with the existing regulation for national protection certificates, the term of the unitary protection certificate is to be up to five years, thus enabling patent protection to be extended to 25 years. The calculation is to be carried out in accordance with Art. 10 (1) and (2) of the proposed Unitary SPC Regulation. The duration of the national SPCs is also not supposed to be changed and the existing six-month extension rule for paediatric medicinal products mentioned above is to continue to apply to the unitarySPC.[7]
A further asset of this granting concept wouldbe the possibility of a combined application in accordance with Art. 39 C of the Draft Unitary SPC Regulation. According to this, it should be possible to obtain a unitary SPC for all Member States in which the basic patent has unitary effect and national protection certificates for the other Member States in a single examination procedure.
While the Parliament made extensive changes to the Commission’s proposals for the revision of pharmaceutical legislation, it adopted the proposal to create the unitary SPC and the revision of the existing Regulation on SPCs with only a few, mostly formal (editorial) changes.[8]
SPC squatting
According to Art. 6 of Regulation 469/2009, it is currently possible, under certain circumstances, for a patent holder to apply for a protection certificate even if he is not the holder of the marketing authorization – even against the will of the marketing authorization holder. The existing ambiguities are now to be erased by the insertion of Art. 6 para. 2 of the two proposed regulations[9], which provides for the necessity of consent of the marketing authorization holder to the granting of the protection certificate.
Further procedure
It now remains to be seen whether the Regulations approved by the European Parliament on February 28, 2024 will be retained in the further ordinary legislative procedure.
[1] Regarding the Commission’s proposal and the European pharmaceutical strategy, we refer to previous blog posts (January 4, 2021 and March 8, 2023) as well as Stief/Grabow: Quo vadis pharmaceutical law – an overview of the revision of EU pharmaceutical legislation, PharmR 2023, 317 ff.
[2] Communication from the Commission to the European Parliament, the Council, the European Economic and Social Committee and the Committee of the Regions, Making the most of the EU’s innovation potential – An Intellectual Property Action Plan for the EU’s recovery and resilience, COM(2020) 760 final.
[3] COM(2023) 222 final and COM(2023) 231 final, hereinafter also referred to as “proposed regulations”.
[4] Commission Staff Working Document, Impact Assessment Report, SWD(2023) 118 final, 3, 4.
[5] Commission proposal COM(2023) 222 final.
[6] Art. 20 ff. COM(2023) 231 final.
[7] see Art. 20 (3) COM/2023/222 final.
[8] https://www.europarl.europa.eu/doceo/document/TA-9-2024-0097_EN.pdf.
[9] Commission proposal COM(2023) 222 final and COM(2023) 231 final.
