Federal Circuit Revives Amarin’s Case Over Alleged Infringement by Hikma’s Generic Drug Labels


The Federal Circuit on Tuesday revived litigation accusing Hikma Pharmaceuticals USA Inc. of inducing physicians to infringe patents held by Amarin Pharma Inc. This case revolves around the generic production of Amarin’s widely-known cardiovascular drug, Vascepa.

At the center of the lawsuit are the so-called “skinny labels” used by generic drug manufacturers. These labels omit certain patented uses of a drug, theoretically allowing generics to be sold without infringing on existing patents. Amarin contends that Hikma’s labels still lead to patent infringement by indirectly prompting doctors to use their generic versions in unauthorized ways.

This development is significant in the ongoing debate over the balance between encouraging pharmaceutical innovation and allowing access to cost-effective generics. For more details on the case, visit the article at Law360.