UK Court of Appeal reaffirms no UK SPC for second medical use

Summary

Merck Serono sought a supplementary protection certificate (“SPC”) for a product that had previously been authorised for a different use. The Comptroller-General rejected Merck Serono’s application, a decision which was also upheld by the UK Patents Court.

The Court of Appeal was asked to determine whether it should follow the CJEU’s decision in Santen or depart from it thereby granting a SPC for a second medical use in Merck Serono’s favour. The appeal was dismissed, as the Court of Appeal concluded that it could not depart from Santen because it was retained EU case law that had already been applied post-transition by the Court of Appeal.

Background 

In 2018, Merck Serono applied for a SPC for cladribine on the back of EP(UK)1 827 461 (the “Patent”), accompanied by a 2017 marketing authorisation for a product called MAVENCLAD. The Patent relates to the use of cladribine for the treatment of multiple sclerosis. 

Cladribine had twice previously been authorised for the treatment of hairy cell leukaemia (LEUSTAT and LETAK). The Comptroller’s Hearing Officer concluded that Merck Serono’s SPC application must fail because it did not satisfy Art. 3(d) of the SPC Regulation, i.e. it was not the first authorisation to place that product (or more specifically a product containing cladribine) on the market. The Comptroller effectively followed the CJEU’s decision in Santen C-673/18. On appeal to the Patents Court, Michael Tappin KC dismissed the appeal.

The Court of Appeal was consequently asked to determine whether Santen was wrongly decided. But a prior question to this was whether it was even open to the court to depart from it given its decision in Newron Pharmaceuticals v The Comptroller [2024] EWCA 1471 which approved and applied Santen (albeit that the precise point in issue was different and the court had not been asked to exercise its power to depart from retained/assimilated EU case law).

Central to these proceedings is the relationship between second medical use patents and SPCs, and the decision in Neurim C-130/11. In that case, the CJEU concluded that a SPC could be issued for the same product if the intended use of such (based on a new marketing authorisation) was taken into account, having focused on the purpose of the SPC Regulation to encourage pharmaceutical research. This approach was overruled in Santen where the CJEU confirmed that the correct interpretation of the SPC Regulation was that SPCs could not be granted in such circumstances. In Newron, the Court of Appeal rejected the teleological approach in Neurim and applied Santen. 

Key issues and findings

The Court of Appeal held that although there is the power to depart from CJEU decisions in certain circumstances, this was not one of them.

Paragraph 4 of the European Union (Withdrawal) Act 2018 (Relevant Court (Retained EU Case Law) Regulations 2020 says:

(1) A relevant court is not bound by any retained EU case law except as provided in paragraph (2). 

(2) A relevant court is bound by retained EU case law so far as there is post-transition case law which modifies or applies that retained EU case law and which is binding on the relevant court.”

Therefore, in accordance with paragraph 4(2) ), Santen was retained EU case law that had already been applied post-transition by the Court of Appeal in Newron (as part of the ratio decidendi). The Court of Appeal could not depart from it since it is bound by its own earlier decisions and none of the recognised exceptions to this principle applied.  Further, even if the court had not been bound by Newron, on analysis of the case-law and the policy underpinning the grant of an SPC, it was not considered appropriate to depart from Santen in any event. 

Arnold LJ’s additional judgment explains that the post-Brexit UK (assimilated) SPC Regulation has not been relevantly amended and it “follows that it remains the will of Parliament that the legislation should continue to be harmonised with that of the EU”. In those circumstances, “the UK courts should continue to interpret the legislation in harmony with the Court of Justice unless convinced that [its] interpretation is wrong”. Arnold LJ also comments that there “is no realistic prospect” of the CJEU reversing Santen (which, given the importance of the issue had been heard by the Grand Chamber) and that Merck Serono did not provide any academic or judicial evidence of criticism of Santen in support of its case. 

Commentary

This decision confirms the Court of Appeal’s position on the divisive issue of SPCs based on new (patent protected) authorised uses for a previously authorised active ingredient. It also more generally confirms that the UK courts should continue to interpret the current (assimilated) SPC Regulation in harmony with the CJEU unless convinced that the interpretation is wrong.

Note that new SPC related legislation came into force in the UK on 1 January 2025, dealing with the changes to the types of marketing authorisation of medicines that are now available in the UK (see MHRA guidance)  as a result of the Windsor Framework.

Case: Merck Serono SA v Comptroller-General of Patents, Designs, and Trade Marks [2025] EWCA Civ 45