A Supplementary Protection Certificate (SPC) provides an additional period of protection for patented pharmaceutical products and agrochemicals after patent expiry. A UK SPC is a UK national right, which up to 31 December 2020 was governed by EU law. From 1 January 2021 this ceased to be the case, although equivalent provisions have largely been transposed into UK law. See in particular the Patents (Amendment) (EU Exit) Regulations 2019. Following the end of the implementation period, a UK SPC remains a valid UK IP right, and all existing rights and licences remain in force in the UK. Pending UK SPC applications also continue to be assessed on the same criteria as before and it is possible to file new applications.
The duration of an SPC in the UK is calculated based on the first authorisation to place the product on the market in the territory of the UK or the EEA. The same term of protection as before Brexit thus remains applicable. At present, the SPC manufacturing waiver will apply for export outside of the UK and EU, with stockpiling for sale in the UK or EU permitted within the final 6 months of the SPC term. It is still possible to apply for a 6 month extension to SPCs which protect medicines that have been tested for paediatric use. The same deadline (2 years before SPC expiry) and other conditions apply as previously. The only exception is that it is no longer necessary to provide evidence of authorisations covering the product across the EEA.
Significantly, however, even after Brexit, Northern Ireland (NI) remains subject to EU regulatory laws, whereas the rest of the UK (Great Britain; GB) is free to diverge. Three types of marketing authorisation are therefore possible:
UK(NI) – compliant with EU law, e.g. granted by EMA
UK(GB) – compliant with GB law only
UK – compliant with both
This does not mean separate SPCs. Rather, a single SPC is granted based on whichever NI, GB or UK authorisation the applicant holds when applying. If the SPC enters into force with MA covering only NI or GB, the SPC has the same geographical limit. However, up to entry into force of the SPC (i.e. expiry of the basic patent), the applicant can file additional MAs to make up a complete set and cover the whole UK. In practice, this complexity may not arise for some time. The UK medicines agency (MHRA) has indicated that it intends to recognise EMA marketing authorisations unilaterally in the UK for at least two years from January 2021.
Finally, the significant body of CJEU case law relating to SPCs that existed prior to 31 December 2020 has been directly imported into UK law. Deviation may be possible where a UK court (currently only the Supreme Court) deems that “it appears right to do so”. There is no requirement for UK courts to follow new CJEU case law, but they can “have regard to [it] so far as it is relevant”. The UK is also in principle free to devise its own, separate SPC regulation, for example to include protection for medical devices or auxiliary substances that are also subject to regulatory approval. However, this is unlikely to be a priority and Northern Ireland considerations will still apply.
SPCs remain available post-Brexit on effectively the same terms as before. A product must be protected by a basic patent in force and must be subject to a valid marketing authorisation covering (at least part of) the UK. This must be the first marketing authorisation for the product.
Please contact the J A Kemp SPC team or your usual J A Kemp adviser if you have any general queries or would like to assess specific implications for your business.