The Supreme Court allowed Merck Sharp & Dohme Corporation’s appeal in its dispute with Clonmel Healthcare Limited over a generic version of Inegy, a cholesterol medicine. It said an interlocutory injunction ought to have been granted when the application was considered in April 2018, but did not grant one in the appeal because the relevant supplementary protection certificate (SPC) had expired and Merck had agreed not to seek an injunction if successful.
The appeal concerned SPC No. 2005/2001, which Merck said protected the combination of simvastatin and ezetimibe in Inegy until 1 April 2019. Clonmel argued that the SPC was invalid. It launched its generic product on 17 April 2018, after a separate SPC covering ezetimibe expired. The Supreme Court said there was a serious issue to be tried about the contested SPC’s validity; it did not determine that issue in this appeal.
Merck had obtained an interim injunction ex parte from the High Court. A later High Court judge refused an interlocutory injunction, and the Court of Appeal majority upheld that refusal. The Supreme Court examined whether an injunction should have been granted on the circumstances as they stood at the original application in April 2018. The parties had agreed the appeal could be decided on that basis, without updating evidence about events after Clonmel’s launch.
Writing for the court, O’Donnell J. said the injunction assessment requires a flexible evaluation of the balance of convenience or justice. Whether damages would adequately compensate either party is central, but the availability of damages does not by itself require refusal of an injunction. The court must consider the circumstances and the risk of injustice to both sides.
The judge considered the parties’ potential losses finely balanced. If the SPC was valid, Merck’s rights included excluding competitors until expiry and planning for the market after that date. If it was invalid, Clonmel could lose the first-mover advantage it sought by launching early. The SPC remained legally effective unless and until declared invalid, and the court considered that Clonmel had not taken steps to clarify the validity issue before launch. It concluded Clonmel’s case had not been shown to be strong enough to outweigh the factors favouring an injunction.
O’Donnell J. said that, had the matter remained live, he would have allowed the appeal against the High Court and Court of Appeal orders and granted an interlocutory injunction, subject to Merck’s undertaking in damages and a speedy trial on validity. But the SPC had expired before the appeal hearing, and Merck had conceded it would not seek an injunction. The court therefore simply allowed the appeal. It did not rule on the SPC’s validity or make a current injunction order.