Helpful summary by the UK Intellectual Property Office of the changes to how the supplementary protection certificate (SPC) system in the UK will operate in light of Brexit.
- No action is needed for SPCs that have already been granted.
- Applications filed before 1 January 2021 will continue unaffected save that, where a UK SPC application was based on a marketing authorisation (MA) granted by the European Medicines Agency, SPC applicants may be asked to provide information on the converted UK authorisations.
- From 1 January 2021, MAs may cover the UK as a whole, Great Britain (GB) only, or Northern Ireland (NI) only. A UK SPC application can be filed based on any UK MA and its protection will cover the same territory as the MA (i.e. UK / GB / NI), plus any extension granted before the SPC comes into effect, provided the extension is notified to the UK IPO (i) within six months of the additional authorisation; and (ii) before the SPC takes effect.
- The duration of a UK SPC will be based on the date of the earliest MA in the UK or EEA.
- The six-month paediatric extension will also still be available.
From 1 January 2021, an SPC application can be filed based on any marketing authorisation which allows the patented product to be placed on the market in any part of the UK. If that application meets the statutory requirements, an SPC will be granted. The protection provided by that SPC will cover the same territory as its marketing authorisation (for example, if the marketing authorisation is for Northern Ireland only, the protection will also cover Northern Ireland only). If a further valid marketing authorisation for the same product covering another part of the UK is granted before the SPC takes effect, then the protection provided by the SPC can be expanded to cover the additional territory.