UK Court of Appeal: No SPCs for 2nd Medical Uses
18 February 2025
The UK Court of Appeal (CoA) recently issued its ruling in Merck Serono v Comptroller, confirming that supplementary protection certificates (SPCs) are not available for second medical uses of pharmaceutically active products.
The case concerned Merck’s SPC application for cladribine, used to treat multiple sclerosis. The UK Patent Office, in accordance with Article 3(d) of the relevant SPC Regulation (EC) No. 469/2009, rejected the application due to an existing earlier marketing authorisation for cladribine used to treat leukaemia. This rejection was upheld by the English High Court and subsequently appealed to the CoA.
The CoA held that (i) it was bound by its earlier decision in Newron Pharmaceuticals v Comptroller, which applied the post-Brexit retained CJEU case law of Santen C-673/18 in rejecting the grant of an SPC in similar circumstances, and (ii) even if it was not bound, it would still have maintained the rejection as the application of Santen brought coherence to the SPC regulation and reduced legal uncertainty for stakeholders. The CoA emphasised that the aim of the SPC regime was to balance the commercial interests of pharmaceutical companies with public health needs. The decision emphasises the importance of consistent interpretation of the SPC regulation in line with EU case law, despite the UK’s departure from the EU several years ago.
The story may not be over, as Merck may seek to appeal the decision to the UK Supreme Court. We await to see what, if any, further developments occur in this area.
Adrian Tombling and Bradley Wilson
Life Sciences & Chemistry group
This publication is a general summary of the law. It should not replace legal advice tailored to your specific circumstances.
© Withers & Rogers LLP February 2025
