Mr Justice Gerard Hogan dissented from the Court of Appeal’s majority in a dispute over supplementary patent protection for a cholesterol medicine, concluding that Merck Sharp & Dohme Corp. should receive an interlocutory injunction against Clonmel Healthcare Limited.
The judgment, delivered on 12 June 2018, concerns Merck’s claim that a supplementary protection certificate (SPC) covered its ezetimibe and simvastatin combination product, Inegy, until 1 April 2019. Clonmel, a generic medicines manufacturer, disputed the certificate’s validity and maintained that its planned launch after another certificate expired on 16 April 2018 would not infringe any subsisting right. Hogan J said the validity of the certificate was central to the case: if valid, Clonmel’s launch would amount to infringement; if invalid, Merck would have no right to an injunction.
Hogan J noted that the Court had to decide the interlocutory application quickly, while the disputed certificate was close to expiry. He considered it unlikely that the underlying patent dispute could reach a full trial in time. He also said an SPC carried a presumption of validity and that damages would not adequately remedy infringement if the certificate proved valid.
The judge assessed the evidence provisionally. Merck argued that its patent covered a novel combination of ezetimibe and statins; Clonmel disputed that this was an invention protected by the patent. Hogan J referred to expert evidence that the combination could improve cholesterol reduction and reduce the statin dose, while noting that the issue remained contested. The patent claims, he said, specifically identified simvastatin as one of the possible cholesterol biosynthesis inhibitors. On the material before him, he was not persuaded that Clonmel had shown the SPC to be invalid, while stressing that matters could change at a full hearing.
Hogan J concluded that the balance of least injustice favoured granting Merck the interlocutory relief it sought and allowing the appeal. This was his dissenting view. The supplied extract does not state the majority’s reasoning or the Court’s operative order, so it does not establish that the injunction was granted by the Court as a whole. The dispute over the certificate’s ultimate validity remained for determination at trial.