Merck Serono SA v The Comptroller-General of Patents, Designs and Trade Marks

A Court of Justice judgment interpreting retained EU law generally applies ex tunc, unless the Court of Justice itself expressly limits its temporal effect. National courts cannot create a retrospective exception based on legitimate expectations or legal certainty where no competent authority made a relevant representation.

The ruling in Santen was expressed in general terms and displaced the approach in Neurim. A later marketing authorisation for a new therapeutic application of an active ingredient is not the first authorisation for that product where the ingredient has previously been authorised for a different therapeutic application. The UKIPO must therefore refuse an SPC application that fails Article 3(d) of the Regulation (EC) 469/2009.

Merck applied to the UKIPO for an SPC for cladribine, relying on a patent concerning its use in treating highly active relapsing remitting multiple sclerosis and an MA for MAVENCLAD.

Earlier MAs existed for cladribine products used to treat hairy cell leukaemia. The Hearing Officer rejected the application under Article 3(d) of the Regulation (EC) 469/2009, applying the Court of Justice’s judgment in Santen. Merck appealed, arguing that Santen should be distinguished, should operate only prospectively, or should not defeat its legitimate expectation arising from Neurim.

The central issues were the temporal effect of Santen and whether reliance on the earlier interpretation could require the grant of an SPC.

1. Appeal dismissed. The appeal was by way of review. It would succeed if the Hearing Officer’s decision was wrong, including because of an error of law, applying the approach in Axogen.
2. Santen was a general ruling on Article 3(d). It was not confined to its facts. The Court of Justice had squarely considered whether to reverse Neurim and did so. The differences relied upon by Merck did not provide a basis for distinguishing Santen.
3. The ordinary rule is that an interpretation by the Court of Justice clarifies the meaning of EU law from the time of its entry into force. Under Denkavit Italiana and Dansk Industrie, a temporal limitation is exceptional and may be imposed only by the Court of Justice in the judgment concerned. Santen contained no such limitation and therefore applied ex tunc.
4. Legitimate expectations could not alter that conclusion. Elmeka concerned a representation by a competent administrative authority. No such representation was made by the courts or the UKIPO. Reliance on the former interpretation of substantive law could not create a right to a property right contrary to the Regulation.
5. Applying Santen, the MAVENCLAD MA was not the first UK authorisation for cladribine as a medicinal product because earlier MAs existed for the same active ingredient. The application consequently failed Article 3(d), and Article 10(2) required rejection.

• High Court (Patents Court): Merck’s appeal was dismissed.
• UK Intellectual Property Office: In decision BL O/0484/23 dated 26 May 2023, the Hearing Officer rejected the SPC application under Article 3(d) of the Regulation (EC) 469/2009.