UK SPCs to return, but for second medical uses?

With the new unitary Supplementary Protection Certificate (SPC) and changes to EU supplementary protection certificates still in discussion, it would be easy to miss that the system of UK SPCs is also going through some changes.

As a result of the Northern Ireland Protocol, negotiated to deal with Brexit, Northern Ireland (NI) was aligned with certain EU regulatory laws that do not apply to Great Britain (GB). These had included the need to obtain marketing authorisations for medicinal products in NI compliant with EU law, whilst separate marketing authorisations could be obtained in GB, compliant with UK law. 

Although the UK had transferred the EU SPC Regulation 469/2009 to domestic law, the NI Protocol has had an impact on the form of SPCs: if the SPC enters into force with a marketing authorisation covering only one of GB or NI, the protection provided by the SPC extends only to that territory. But, up until the SPC comes into force, an applicant can submit an additional marketing authorisation to make the full complement, allowing protection to extend to the whole of the UK in a single SPC.

Subsequently, the Windsor Framework was agreed between the UK and the EU (effective on 1 October 2023), in which NI was returned to the UK regulatory regime for medicinal product authorisation.

As a result of this development, the UKIPO is now considering how the UK version of the SPC Regulation needs to be changed to reflect the Windsor Framework. With the end to division between GB and NI authorisations, the previous system of granting full UK SPCs in all cases is expected to return, phoenix like. 

Full details are yet to emerge, but the new legislation is expected to come into force in January 2025.

At about the same time, the English Court of Appeal will decide, in the Merck Serono case, on the question of whether SPCs in the UK can be granted for a second medical use of an active ingredient, when the second medical use authorisation is pre-dated by an authorisation for the ingredient per se.

The Patents Court considered itself bound, under legislation withdrawing the UK from the EU, to the Santen (C-673/18) ruling of the CJEU that answers ‘no’ to the above question.

The Court of Appeal is not so bound, however, and if earlier statements of the court at the time of the original Neurim SPC case are any guide, it may depart from the CJEU on this issue.