The Impact of Brexit on Pharmaceutical Patents & SPCs in the UK

Dr James Stones, Anna Hatt and Harry O'Brien | May 2021

A recent paper in the British Journal of Pharmacy from the University of Huddersfield Press discusses the implications of Brexit on patents and supplementary protection certificates (SPCs).

The overall message from the authors is that UK pharmaceutical companies wishing to obtain European patents will be able to do so in the same way as they did before Brexit. Meanwhile, the long held dream of achieving a new simpler and cheaper patent system across Europe has suffered a huge setback after the UK government made clear it would no longer take part in such a system; a symptom of pursuing a “hard Brexit”.

For SPCs, there are changes which have caused undesired effects, even though EU law for SPCs has more or less been imported into UK statute. Some changes may be beneficial for pharmaceutical companies wishing to extend their protection for their products in the UK. For example, obtaining a six month paediatric extension of a UK SPC now only requires UK regulatory approval, rather than EU regulatory approval. 

On the other hand, the issues with Northern Ireland continue to pose a headache due to the jurisdiction of EU law, meaning that UK SPCs are now territorial depending on where marketing authorisations are obtained. In the news just recently, evidence of a hard border for medicines has recently come to light with the availability of a new cancer treatment that is available in Great Britain, but currently not in Northern Ireland:

https://www.belfasttelegraph.co.uk/news/northern-ireland/ni-protocol-pre...

What will be interesting to see in the long term is how pharmaceutical companies will make use of the SPC new manufacturing waiver for generics, allowing stockpiling and export of SPC protected medicines outside of the UK and EU. Also, with the UK no longer bound by the Court of Justice of the European Union, how will UK case law begin to diverge from EU case law? And will this benefit, or hinder, UK pharmaceutical companies?

Click on the link below to read the open access article:

https://www.bjpharm.org.uk/article/id/896/