All change for UK SPCs

Since Brexit, the UK has had a somewhat confusing situation regarding medicinal marketing authorisations (MAs) and supplementary protection certificates (SPCs) with respect to their effects in Great Britain (authorised by the UK MHRA) and Northern Ireland (authorised either by the MHRA or the EU EMA).

As of 1 January 2025, however, the changes agreed under the Windsor Framework will greatly simplify matters. From this date, any new MAs will be issued by the UK MHRA, and will be effective across the whole of the UK - that is, both Great Britain and Northern Ireland. The EU EMA will not have any effect in Northern Ireland.

Existing EU EMAs will also cease to have effect in Northern Ireland, and previous GB-only MHRA authorisations will extend to NI. 

In most cases, any relevant SPCs will automatically alter their geographical scope to correspond with the MA - that is, GB-only SPCs will now cover NI as well. However, where a separate NI authorisation existed before 1 January 2025 (granted either by the MHRA or the EMA), it is necessary to notify the UKIPO of this within 6 months of the grant of the MA, or the SPC will not have effect in NI. If an MA is only granted in NI (and not in GB), then the SPC will not come into force, unless a UK MA is granted before patent expiry.

Going forward, the process will simply rely on UK-wide MAs, although the SPC term will still be determined by the date of the first MA in either the UK or the EEA.

This is a complex and niche area of law, and SPC guidance continues to evolve in light of CJEU and UK decisions, so please do contact us if further details would be helpful.