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AAM Warns Of Dangerous Precedent In Vascepa 'Skinny Label' Case

Files Amicus Brief In Support Of Hikma Over Amarin Induced Infringement Claims

Executive Summary

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.

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A controversial ruling revolving around labelling carve-outs that saw Teva hit with $235m in damages over its generic rival to GSK’s Coreg has been upheld after being reheard by the US Court of Appeals for the Federal Circuit. However, the court sought to counter the suggestion that its decision upends the Hatch-Waxman framework’s labelling carve-out provisions.

Hikma Fails To Nix Vascepa Induced Infringement Case Early On

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.

Latest Vascepa Lawsuit Plunges Hikma Into Induced Infringement Battle

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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