The Court of Appeal has upheld the High Court’s decision to revoke a supplementary protection certificate held by Merck Sharp & Dohme Corp. for a combination of ezetimibe and simvastatin, while rejecting Clonmel Healthcare Limited’s separate challenge to the certificate under another provision of EU law.
The judgment, delivered by Ms Justice Costello on 24 February 2021, concerns a certificate for the combination marketed as Inegy. The High Court had found the certificate invalid under Articles 3(a) and 3(c) of the EU Supplementary Protection Certificate Regulation, but rejected Clonmel Healthcare’s argument that it also breached Article 3(d). Both parties appealed the parts of that decision adverse to them.
On Article 3(a), Merck argued that the combination was protected by its patent because both ingredients were expressly mentioned in the patent claims. The Court of Appeal rejected that argument and dismissed the appeal. It held that the relevant question was whether the product fell under the invention covered by the patent. Although ezetimibe was one of the patent’s novel compounds, simvastatin was already known at the patent’s priority date and had been the subject of a separate patent and certificate. The court agreed with the High Court that naming the combination in a claim did not, by itself, make it an invention covered by the patent.
The court also dismissed Merck’s Article 3(c) appeal. The parties agreed that the product identified for Article 3(c) had to be the same product found protected under Article 3(a). The court accepted the High Court’s conclusion that the protected product was ezetimibe alone, rather than the ezetimibe-simvastatin combination. Ezetimibe had already been the subject of an earlier certificate for Ezetrol.
Clonmel Healthcare argued that the earlier Ezetrol authorisation was already an authorisation for ezetimibe and simvastatin together, because one approved use required ezetimibe to be administered with a statin. The Court of Appeal rejected that challenge and dismissed Clonmel Healthcare’s appeal under Article 3(d). It found that Ezetrol’s authorised product contained ezetimibe alone; the requirement to use it with a statin concerned how the medicine was used, not the ingredients of the authorised product. The Inegy authorisation was therefore the first authorisation for the combination product.
The court said the case would be listed for a short hearing on the costs of the two appeals at a date to be notified to the parties.