As of 1 January 2025 some changes to UK Supplementary Protection Certificate (SPC) practice will come into force in relation to human medicines.  The UKIPO has issued some helpful guidance on these changes, which can be found here.  These changes to SPC practice in the UK are part of the wider so-called “Windsor Framework”, which aims to protect the long-term supply of human medicines to Northern Ireland.

Under current (pre-2025) practice, it is possible to file a UK SPC application based on a centralised EU Marketing Authorisation (MA) for the purposes of Northern Ireland and then to file the relevant UK Medicines and Healthcare products Agency (MHRA) MA documents later to meet the requirements for the UK SPC to be extended to Great Britain also.

A key upcoming change is that (with a small temporary exception – discussed below) as of 1 January 2025 it will no longer be possible to file new UK SPC applications on the basis of a centralized EU MA.  With a small temporary exception, as of 1 January 2025 SPC applications in the UK may be based only on a MA that is valid for the UK, issued by the UK MHRA.

The above-mentioned exception is that you may still file a SPC application after 1 January 2025 that relies on a centralized EU MA if (i) the centralized EU MA was granted before 1 January 2025, (ii) the six month application deadline for filing the SPC application is set by the grant of the MA rather than the grant of the basic patent, and (iii) the deadline mentioned in (ii) is after 1 January 2025.  In practice, this means that a centralized EU MA would be one granted between 1 July 2024 and 31 December 2024, and the SPC application filing deadline would be no later than 30 June 2025.  In this “exception” situation, for the SPC to actually come into force it would be necessary to have a UK MA also, which would need to be filed at the UKIPO at the appropriate time.

As of 1 January 2025, the deadline for filing a SPC application will be six months from the grant of the earliest UK, GB or NI MA or six months from the grant of the basic patent, whichever is later. This means that the deadline for applying for a UK SPC may be different from the deadline for applying for a SPC in EU countries.

Centralised EU MAs may still have some relevance to UK SPCs as the term of a UK SPC will still be calculated based on the earliest MA for the product in the European Economic Area (EEA), if that MA predates the corresponding UK MA.

The UKIPO guidance (link above) also provides some useful comments on paediatric extensions.  From 1 January 2025 it will no longer be possible to rely on a centralised authorisation to support a paediatric extension request.  Requests for paediatric extensions filed before 1 January 2025 will continue to be assessed by the UKIPO on the basis of the current (pre-2025) law, and the UKIPO guidance provides more details in this regard. Granted UK paediatric extensions will continue to rely on the current law.

The upshot of the change in practice is that, procedurally, applying for SPCs in the UK should become more straightforward.

The information in this article is necessarily of a general nature and is given by way of guidance only; specific legal advice should be sought on any particular matter. While this article has been prepared carefully to ensure that all information is correct at the time of publication, Dehns accepts no responsibility for any damage or loss suffered as a result of any inadvertent inaccuracy. Information contained herein should not, in whole or part, be published, reproduced or referred to without prior approval. Any such reproduction should be credited to Dehns.