Brexit: what does Boris Johnson have to say about SPCs?

Fortunately nothing at all,  but after the UK's exit from normality we've been asked what impact there will be on SPCs in the UK?

As SPCs are granted in the UK under an EU regulation, which will no longer apply after Brexit, in the future it will be necessary for the UK to enact legislation to create some form of equivalent protection. Presumably this will not be at the top of the list of priorities for our new PM, and possibly we will adopt the current EU legislation into UK law, but without appeal to the CJEU for obvious reasons.  The possibility remains that any new protection could be of a different scope, but this seems an unlikely outcome given that there will apparently be some other things to do as well.  After Brexit the UK courts will not be bound by the existing CJEU decisions, or be able to refer questions on SPCs to the CJEU, and we may have divergent opinions on similar legal issues between the UK and EU as we move forward.  Given the view of some of the UK judges on the opinions of the CJEU, this could be rather interesting.

There will also need to be a new mechanism for extending the SPC term after appropriate paediatric studies, assuming the UK looks to maintain equivalent protection with the rest of the EU.

SPCs already granted by the UKIPO should be unaffected, but could potentially have a different validity if the law that applies to them is interpreted differently by a court free from the constraints of CJEU decisions.

Finally, this will all have to be subject to any new or transitional approval regime, given that the EMA may cease to have any jurisdiction in the UK.

All in all, Brexit has placed the UK in a position that arguably is more complex than SPC case law….and that's saying something.

Rob and Catherine