Amarin Pharma, Inc. v. Hikma Pharms. USA Inc

Authored by: Jeremy J. Gustrowsky

The Federal Circuit recently revived Amarin Pharma’s patent infringement case against Hikma Pharmaceuticals, clarifying when generic drug makers can be liable for inducing off-label use, even after carving out patented indications from their labels. Amarin, which markets Vascepa® (icosapent ethyl) for reducing cardiovascular risk, accused Hikma of inducing doctors to prescribe its generic version for the same patented use, despite Hikma’s “skinny label” that only listed treatment for severe hypertriglyceridemia.

The dispute centered on whether Hikma’s actions—such as press releases calling its product the “generic version” of Vascepa, website marketing in the broad “Hypertriglyceridemia” category, and references to sales figures mostly attributable to the patented use—amounted to active encouragement of off-label, infringing prescriptions. The district court had dismissed Amarin’s complaint, finding these actions insufficient as a matter of law. However, the Federal Circuit disagreed, emphasizing that at the early stage of litigation, courts must accept well-pleaded allegations as true and consider the totality of the circumstances.

The appellate court found it plausible that Hikma’s public statements and marketing materials could be seen by doctors as instructions or encouragement to prescribe the generic for the infringing cardiovascular indication. The court stressed that whether these communications actually induce infringement is a factual question that should not be decided on a motion to dismiss, before discovery and evidence are presented.

This decision underscores that generic manufacturers must be careful with their communications when marketing drugs under a skinny label. Even if the label omits patented uses, other marketing materials or public statements that suggest broader uses may expose generics to liability for induced infringement. The case will now proceed, allowing Amarin to try to prove its claims in court.