SPCs after Brexit
11
Feb
2020
UK SPC system remains unchanged following UK’s departure from the European Union

The UK left the European Union on 31st January 2020. Under the terms of the Withdrawal Agreement ratified by the UK Government and the EU, the UK entered into a transition period lasting until 31st December 2020 (this period can be extended by up to two years upon agreement between the UK and EU). During the transition period, the UK will continue to apply EU law and will be treated as if it were still a member state.

There will be no changes to the UK’s SPC regime during the transition period. Patent holders can continue to apply for SPCs for pharmaceutical and plant protection products in the same way as before. All SPC applications filed in the UK before the end of the transition period, whether before or after Brexit, will continue to be examined in the same way and will provide the same rights once granted. The same applies for paediatric extensions to SPCs.

After expiry of the transition period, the UK’s SPC regime is likely to remain largely the same. Any changes are expected to be minor, and to date the UK Government has not announced any substantive changes to the SPC system. As before, a UK patent granted by the UKIPO or the EPO and a marketing authorisation (MA) for the UK will be required. Suitable MAs include those granted by the Medicines and Healthcare products Regulatory Agency (MHRA) in the UK, as well as those issued by the EU before the end of the transition period (which will be converted to UK MAs on 1st January 2021). Paediatric extensions to SPCs will also be available as before (it will no longer be necessary to provide evidence that the product has been approved in all EU states).

There is no change to the high quality advice that Carpmaels & Ransford can provide in relation to SPCs. We will continue to be able to provide advice on SPC filing strategies across Europe, to file and prosecute SPC applications in the UK, and to coordinate local counsel to file and prosecute SPC applications in the EU and other countries in Europe (such as Switzerland) as before.