Brexit – The Consequences for Pharmaceutical Patents and Supplementary Protection Certificates

Anna Louise Hatt,Harry Melville O'Brien,James Alexander Stones

doi:10.5920/bjpharm.896

Abstract

Now that the UK has left the EU, and the transition period following this departure is over, we have a clearer view on the implications of Brexit on intellectual property rights and the consequences for UK based pharmaceutical companies.  Although little has changed for UK applicants wishing to obtain a European patent via the European Patent Office, the UK’s withdrawal from the Unified Patent Court and Unitary Patent is a huge blow to the realisation of the long awaited Unitary Patent system.  Meanwhile, breaking away from the EU has also had effects on how UK pharmaceutical companies can apply for supplementary protection certificates (SPCs), with further intricacies due to the Northern Ireland Protocol.  The introduction of a new manufacturing waiver for medicinal products protected by SPCs in the UK and EU will allow pharmaceutical companies more leeway with regards to stockpiling and export provisions. Perhaps most interesting of all is how UK and EU laws will diverge over the following years, now that the UK is no longer under the jurisdiction of the Court of Justice of the European Union.

Highlights

On 31 December 2020, the transition period that followed the United Kingdom’s exit from the European Union ended and the UK officially became, in the eyes of the EU at least, a “third country”
With the UK still bound by EU law during the transition period, and with trade negotiations being decided at the eleventh hour, it has been difficult to ascertain fully the changes and effects of Brexit on intellectual property (IP) rights
With the UK still a member of the European Patent Convention (EPC), UK attorneys will still be in demand from pharmaceutical companies to best position their patent rights

Summary

INTRODUCTION

On 31 December 2020, the transition period that followed the United Kingdom’s exit from the European Union ended and the UK officially became, in the eyes of the EU at least, a “third country”. There are no significant changes to the current system of obtaining European or UK patents post-Brexit This is because the European Patent Office (EPO), which examines and grants European patents, is not an EU institution and does not fall within the jurisdiction of the CJEU. As a “hard Brexit” was pursued, the likelihood of the UK’s continued participation slowly started to erode and in February 2020, the UK government made clear that the UK would no longer take part in the UPC system due to the jurisdiction of the CJEU (UK 2021) This was a blow to both the UP/UPC and the UK pharmaceutical industry, especially as part of the central division of the UPC (hearing cases relating to chemistry, including pharmaceuticals and the life sciences) had been proposed to be based in London. The Bundestag have since voted on and approved the UPCA with the required votes (UPC 2020), as more challenges have since been filed at the German courts, it is still too early to say when (or whether) the UPC will get off the ground

CONCLUSIONS

CONFLICT OF INTEREST