BREXIT: Supplementary protection certificates (SPCs)

Supplementary protection certificates (SPCs) are intellectual property rights. They were introduced to encourage innovation by compensating for the long time needed to obtain authorization to put products on the market. Importantly, they apply only to specific pharmaceutical and plant protection products that have been authorized by regulatory authorities. These products must also be covered by a patent. These so-called patent extensions take effect when the patent expires. They can last up to five years. Moreover, SPCs follow from European Union law. They derive from specific regulations, such as Regulations (EC) 469/2009 and 1610/96.

Importantly, SPCs are not granted as EU-wide rights, but rather as national rights. Therefore, the UK and the EU didn’t need to agree on the creation of a comparable right. This ensures the continued protection of existing SPCs in the UK post-Brexit. SPCs granted before Brexit will therefore continue to exist and take effect at the end of the relevant patent term. Additionally, the Withdrawal Agreement will ensure that pending SPC applications will be examined under the current framework.

After Brexit, i.e. from January 1st, 2021, any new SPC application in the UK will be dealt with under equivalent UK domestic law. For the most part this will cause only limited change. This is because the current EU provisions will be mostly retained in UK domestic law. However, only certain references to EU directives and EU agencies will be replaced by UK equivalents. In addition, there may be implications for extensions of SPC durations for pediatric medicines. There may also be implications for generic and biosimilar producers seeking to export medicines covered by SPCs.

Although the wording of the EU and UK law on SPCs will be nearly identical, it is nonetheless expected that the interpretation thereof may diverge in the future. Currently, the interpretation of the SPC Regulation is heavily shaped by the Court of Justice of the European Union (CJEU). Notably, the UK courts have previously often indicated that the tests provided by the CJEU to determine compliance with the SPC Regulation are unclear. They believe that different tests would be preferable. In addition, the European Commission issued its report on the evaluation of the SPC Regulations on 25 November 2020. This may lead to important changes to the system. These changes will not necessarily be applied in the UK.

For further assistance on this topic or how Brexit will impact your Intellectual Property rights, do not hesitate to contact our experts.

Written by Stijn Lagaert

European and Belgian Patent Attorney

European Patent Litigator

View expert