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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An attack on Hikma’s skinny-label generic version of Vascepa by originator Amarin, claiming induced infringement of patents protecting a cardiovascular indication, has been dismissed in the US.
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.