The High Court has temporarily restrained Mylan companies from marketing or using generic products containing sitagliptin and metformin in Ireland before 7 April 2023, when a supplementary protection certificate held by Merck Sharp & Dohme LLC (MSD) is due to expire.
Mr Justice Mark Sanfey granted the interlocutory injunction on 20 January 2023. The order applies until judgment in the substantive case, the certificate’s expiry, or further order of the court. It does not decide whether the certificate is valid. That question remains for trial.
The certificate, numbered 2008/024, covers the sitagliptin and metformin combination marketed by MSD as Janumet, a medicine used to treat type 2 diabetes. MSD argued that an early generic launch would erode its market and undermine the protection it says the certificate provides. Mylan disputed the certificate’s validity and counterclaimed for its revocation. The companies had obtained Irish marketing authorisations and reimbursement prices for generic products, but MSD’s application concerned the risk of launch before the certificate expired.
The judge said there was a fair question to be tried. He considered that damages would not fully remedy potential harm to either side: MSD could lose control of its protected market, while Mylan could lose the opportunity to be the first generic supplier. He found that neither party’s potential irreparable harm decisively outweighed the other’s.
The court also considered uncertainty over the legal test for whether a combination product is protected by a basic patent. In a separate case involving a different medicine, the Supreme Court had referred questions about the EU supplementary protection certificate rules to the Court of Justice of the European Union. Justice Sanfey concluded that this uncertainty meant Mylan’s case for invalidity could not, at this preliminary stage, be treated as strong enough to displace the certificate’s presumption of validity.
The judge also noted that Mylan had not taken steps in Ireland to establish the certificate’s invalidity before these proceedings. He treated that failure to “clear the way” as a factor supporting preservation of the existing position. The injunction was granted pending a full determination; it is not a final ruling on infringement or validity.
The judgment’s postscript recorded later European interim decisions, including Finnish orders restraining Mylan and other defendants from launching before expiry. The judge said that information did not alter his conclusions.