The Court of Appeal has dismissed Mylan’s appeal against an interlocutory injunction protecting Merck Sharp & Dohme’s Janumet product. The injunction restrains Mylan from offering, marketing or using products containing sitagliptin and metformin, or importing or stocking them for those purposes, until judgment in the substantive action or the expiry of the relevant supplementary protection certificate on 7 April 2023, whichever comes first.
The appeal concerned SPC 2008/024, which covers Janumet, a combination of sitagliptin and metformin. Mylan contends that the certificate is invalid and that it is free to launch a generic version. The underlying validity dispute was not decided in this appeal.
The High Court granted the injunction on 20 January 2023. It found that there was a fair question to be tried and that damages would not be a full or adequate remedy for either side. The balance of potential irreparable harm did not decisively favour either party. The trial judge concluded that the balance of justice favoured an injunction, relying on the certificate’s presumption of validity and Mylan’s failure to take steps to clear the way for a generic launch.
Mylan argued that the trial judge should have assessed the strength of its invalidity case. It relied, among other matters, on a German patent court decision that found the sitagliptin and metformin combination was not a separate invention disclosed by the patent. Merck disputed that assessment and argued that the combination was identified in the patent claims.
Delivering judgment on 14 March 2023, Mr Justice Haughton said the legal tests governing the relevant EU rules on supplementary protection certificates remained unclear while preliminary references to the Court of Justice of the European Union were pending. In those circumstances, the Court of Appeal said it could not meaningfully assess the parties’ competing arguments at this interim stage. It also said the court should not conduct a mini-trial on the patent’s meaning, and that the German decision was under appeal and did not establish a wider European trend.
The appeal court held that the trial judge was entitled to give weight to the SPC’s presumption of validity and Mylan’s failure to clear the way. It dismissed the appeal. The ruling leaves the injunction in place within its stated limits; it does not determine whether the SPC is ultimately valid.