Following a 20-year patent, a supplementary protection certificate (SPC) can be applied for for medicines or crop protection products. This provides additional protection for up to 5 years. In addition, to be allowed to market a medicine or crop protection product, an authorization is required from the European Medicines Agency or the national authorities. This requires research into possible side effects and risks to human health and the environment. The patent is already pending during this research, but the product is not yet on the market. The extension of the protection by an SPC compensates for this.
The impact of Brexit on SPCs
Although SPCs are governed by EU law (in particular by EC Regulation No 469/2009), SPC applications are currently processed by national patent offices, and are thus still very much a national affair to begin with. In the UK SPC applications are handled by the Intellectual Property Office (IPO). The consequences of Brexit on the SPC granting procedure are expected to be small, as the relevant EU law will simply be implemented in new UK law. No major changes in the SPC practice are therefore expected.
In summary:
- Authorisations from the European Medicines Agency (EMA) will be converted into equivalent UK authorisations on 1 January 2021. This is done at the Medicines and Healthcare products Regulatory Agency (MHRA).
- Pediatric extensions will remain available from 1 January 2021 and will be determined based on equivalent provisions in the UK’s Human Medicines Regulations 2012. The process of applying for an extension will remain the same. It will be no longer necessary to provide evidence of authorizations covering the product across the European economic area (EEA).
- The manufacturing waiver was introduced to the EU SPC system as of 4 April 2019. The waiver will be retained from 1 January 2021 but additional fixes are needed to make sure it works correctly.
- The procedure for applying for an SPC will remain the same from 1 January 2021. Information on both the UK marketing authorization and the earliest marketing authorization for the product in the EEA, if it predates the UK authorization, still needs to be provided.
- Existing SPCs will remain in effect after exit day. SPCs granted but not yet in force will come into force at the end of the associated patent term as normal. Pending SPC applications will continue to progress and it is not necessary to refile.
- After exit day, it will no longer be possible for UK courts to make references to the Court of Justice of the European Union (CJEU) for interpretation of the SPC legislation and other retained EU law.
- Judgments of the CJEU that were issued before exit day will continue to apply to the retained EU law. The amendments made by the Patents Regulations are written to have the same meaning as the original EU legislation, so that existing case law on its interpretation still applies.
- After exit day, UK courts will continue to apply pre-Brexit CJEU case law in any SPC actions. SPC examiners will also take into account of the relevant CJEU case law applicable before exit day. They will examine SPC applications on that basis.
- UK courts will not be required to follow judgments of the CJEU issued after exit day, as these will not be binding. They may be taken into account, but it will be for the court to determine the extent to which the post-exit case law applies. This will also apply to hearings before the IPO on SPC-related matters.
