Regulatory changes in the European Union in relation to supplementary protection certificates: centralised examination procedure and creation of a unitary SPC

Abstract

The supplementary protection certificate for medicinal products (hereinafter, SPC) is an industrial property right under EU law which allows the period of market exclusivity granted by patents on certain innovations in the biomedical sector to be extended by up to five years. In this sense, the main objective of these patents is to compensate for the significant gap in patent protection for these products resulting from the lengthy mandatory trials and tests to which they must be subjected in order to obtain the marketing authorisation established by the regulatory framework. As a reminder, although the unitary patent entered into force in June 2023 streamlining patent protection in the participating Member States, the SPC protection resulting from the unitary patent would continue to be regulated at national level along the lines of the current regulatory framework. Therefore, an applicant wishing to extend the protection provided by a unitary patent would need to comply with the national legislation in each Member State. This being the case, and as can be easily deduced, this legislative treatment is open to criticism and leads to disparity of results. In this context, the European Commission's Proposal, following the Intellectual and Industrial Property Action Plan 2020, presented a set of legislative measures for patents in April 2023, in which four proposals on SPCs were integrated in order to harmonise patent protection in the common market, two of them being draft Regulations specifically aimed at reforming the currently fragmented SPC regime for plant protection products. The first, therefore, introduces a unitary SPC which should provide uniform protection in all Member States where the unitary patent applies. In the event that the unitary patent is not applied, the second proposal seeks to harmonise national procedures for the granting of SPCs. Accordingly, the designated central examination authority would be the European Union Intellectual Property Office (EUIPO), which would work closely with national IP offices in assessing SPC applications. To sum up, this article analyses the potential impact of these proposals on access to medicines, the administrative burden for applicants and the cost for national health systems alongside the centralised procedure for obtaining national certificates.