The Court of Appeal has refused Merck Sharp & Dohme Corp an interlocutory injunction that would have stopped Clonmel Healthcare Limited selling its generic version of Inegy until trial of the companies’ dispute over a supplementary protection certificate (SPC).
In a judgment delivered on 12 June 2018, Mr Justice Michael Peart said the court was deciding only whether to grant temporary relief. It did not determine whether the SPC was valid or whether Clonmel’s product infringed Merck’s rights. The High Court had refused the injunction on 27 April, finding a serious question to be tried but considering damages an adequate remedy for Merck. Its detailed reasons were not available when the urgent appeal was heard, so the Court of Appeal exercised its own discretion on the evidence before it.
Merck argued that its exclusive rights over the combination of ezetimibe and simvastatin lasted until 1 April 2019 under the Combi-SPC. Clonmel disputed the certificate’s validity and said its launch, on 17 April 2018, after expiry of a separate certificate covering ezetimibe, did not infringe any continuing right.
The court found a fair and serious issue for trial but declined to resolve the technical validity dispute at the interim stage. It said Merck’s product was likely to be effectively blocked by Clonmel’s generic, which was being sold at 92 per cent below Merck’s price. Merck also claimed possible effects from parallel imports, international price referencing and damage to its market position.
However, the court accepted Clonmel’s submission that the market was stable and that the remaining SPC period was short. The market for Inegy was worth about €8 million a year, according to sales figures cited by Clonmel. The court concluded that Merck’s losses during the remaining term could be calculated and recovered under Clonmel’s undertaking as to damages if Merck ultimately succeeded. It also held that damages would not adequately compensate Clonmel if an injunction prevented it from gaining the first-mover advantage as the first generic on the market.
Merck also criticised Clonmel for not disclosing its launch date in correspondence before the launch. Justice Peart said such conduct could be relevant when weighing convenience, but it did not justify an injunction where damages were an adequate remedy. He made no concluded finding on Merck’s allegations about Clonmel’s conduct.
The appeal was refused. The underlying dispute over the certificate’s validity remained to be decided in the proceedings.