UK Explains What Happens to SPCs and Patents After the Brexit Transition Period

Regulatory NewsRegulatory News | 30 January 2020 |  By 

With the official beginning of Brexit starting soon, the UK government on Thursday offered further information on supplementary protection certificates (SPCs) in a post-Brexit world.

The guidance explains how after the transition period that runs until the end of 2020, medicine authorizations from the European Medicines Agency will be converted into equivalent UK authorizations on 1 January 2021. 

SPCs, which extend the protection of patented active ingredients in pharmaceuticals by six months if pediatric testing has been done, will then be overseen by the UK.

“From 1 January 2021, the availability of this extension 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. You will still be able to make the request at the same time as filing the SPC application, or at any point up to 2 years before the SPC expires,” the guidance says.

However, a new law on the manufacturing waiver to the SPC system came into force in the UK after new patent regulations were made on 4 April 2019, so the government says that the law has not been fixed by those regulations so that it works correctly as UK law after the transition period. 

“A call for views on draft modifications to fix the manufacturing waiver law ran from 5 July to 9 August 2019. We are considering the final form of legislation to be laid before Parliament in light of these responses,” the guidance adds.

However, the requirements for getting an SPC, the duration of an SPC and the fees will not change on 1 January 2021, the guidance explains. In addition, UK courts will not be required to follow judgements of the Court of Justice of the European Union issued from 1 January 2021 onwards.

In terms of patent law, the changes are related to plant variety rights and security for costs, and the guidance says the UK will continue to be a participating state in the European Patent Convention and the conditions for patenting biotechnological inventions will remain in place. In addition, companies will continue to be able to obtain a compulsory licence for manufacturing a patented medicine to meet a specific health need in a developing country.

"UK, EU or third country businesses can continue to rely on the exceptions from patent infringement provided for various studies, trials and tests carried out on a pharmaceutical product," the guidance adds.



© 2022 Regulatory Affairs Professionals Society.

Discover more of what matters to you

No taxonomy