Latest Vascepa Lawsuit Plunges Hikma Into Induced Infringement Battle
Amarin Files Over Icosapent Ethyl Capsules And Cardiovascular Indication Patents
Hikma has pushed back against a further attempt by Amarin to counter its US generic version of Vascepa, this time via a fresh lawsuit claiming that the generic induces infringement of patents protecting cardiovascular indications for which the brand is approved but which are carved out of the generic label.
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By allowing Amarin’s allegation of induced infringement against Hikma over its generic version of Vascepa to proceed, a US court is jeopardizing the ‘skinny label’ system that allows generics to carve out patented indications from their labels under the Hatch-Waxman framework, according to the AAM.
In a suit closely watched by industry, a US district magistrate judge found that Amarin had at least stated a plausible claim in its case accusing Hikma and US healthcare insurance provider Health Net of induced infringement of Vascepa method-of-use patents, which Hikma has carved out of its generic label.
Dr Reddy’s has shaken up the market for generic Vascepa in the US by launching its own icosapent ethyl capsules to compete with Hikma’s generic and the Amarin brand, hot on the heels of the Supreme Court’s rejection of the originator’s attempt to overturn a Federal Circuit decision invalidating six Vascepa patents.