Court of Appeal upholds the High Court's decision to grant an interlocutory injunction restraining a generic drug manufacturer from infringing a Supplementary Protection Certificate (SPC) held by a pharmaceutical company for a diabetes medication combination. The original High Court ruling found that there was a fair question to be tried regarding the SPC's validity, and that damages would not be an adequate remedy for either party. The Court of Appeal agreed with the High Court's reliance on the presumption of validity of the SPC and the generic manufacturer's failure to clear the way for product launch, thus favoring the pharmaceutical company in the balance of justice.
Court of Appeal, interlocutory injunction, Supplementary Protection Certificate (SPC), generic drug manufacturer, pharmaceutical company, diabetes medication, sitagliptin, metformin, presumption of validity, balance of justice, invalidity claim, CJEU preliminary references, Article 3 of Regulation EC 469/2009, patent protection, market authorisation, "clearing the way", first mover advantage, identificatory test, qualitative test, Actavis v. Boehringer, Teva v. Gilead, CJEU ruling awaited, European Patent 1412357, invalidity proceedings, nullity action.