The Court of Appeal has dismissed Merck Sharp & Dohme Corporation’s appeal over the refusal to temporarily stop Clonmel Healthcare Limited selling a generic version of Inegy in Ireland. The court did not decide whether the supplementary protection certificate at the centre of the dispute was valid; that issue remains for a substantive hearing.
Clonmel launched its ezetimibe and simvastatin combination product on 17 April 2018, one day after an earlier certificate covering ezetimibe alone expired. MSD says its separate certificate for the combination protects Inegy until 1 April 2019 and that Clonmel’s sales infringe its rights. Clonmel disputes this, arguing the certificate was invalid. Both sides raised serious questions for trial, the Court of Appeal said.
The High Court refused an interlocutory injunction on 27 April 2018. The trial judge considered that MSD had shown a serious issue to be tried, but concluded that damages would adequately remedy its loss if it ultimately won. The Court of Appeal reviewed that refusal; it was not deciding the underlying patent dispute.
MSD argued that Clonmel’s pricing, reported as 92 per cent below Inegy’s, could force lasting price reductions, damage relations with pharmacists and affect prices in other markets. It also pointed to possible effects on staff and parallel imports. The appeal court said any lost profit from wrongful marketing could be measured and recovered as damages, and found MSD had not shown that damages would be inadequate.
The court also considered the likely effect of an injunction on Clonmel. It said the injunction application was likely to determine the practical outcome before a full trial, given the certificate’s approaching expiry and the expected timetable. Clonmel’s potential loss of first-mover advantage and future market share would be difficult to assess reliably if an injunction were later found to have been wrongly granted. On the evidence, the court considered Clonmel likely to suffer the greater uncompensatable disadvantage.
The Court of Appeal held that MSD had not met the heavy burden required to show that the High Court judge had erred in principle or exercised discretion unreasonably. It dismissed the appeal, leaving the refusal of interim relief in force. The court made no final ruling on the certificate’s validity or whether Clonmel infringed it; those matters were left for trial.