Hikma Pharmaceuticals USA Inc. v. Amarin Pharma

Amarin Pharma markets icosapent ethyl under the brand name Vascepa. In 2012, the FDA approved Vascepa for treating severe hypertriglyceridemia (the SH indication), which affects patients with blood triglyceride levels of at least 500 mg/dL. In 2019, following additional research and clinical trials, the FDA approved Vascepa for a second use: reducing cardiovascular risk in patients with triglyceride levels of at least 150 mg/dL (the CV indication). Amarin listed two patents covering the CV indication in the FDA’s Orange Book. In 2016, Hikma Pharmaceuticals submitted an Abbreviated New Drug Application seeking approval for a generic version of icosapent ethyl. When the CV indication was approved in 2019, Hikma filed a “section viii statement” seeking FDA approval only for the SH indication by “carving out” the patented CV indication from its label—creating a “skinny label.” The FDA approved Hikma’s ANDA in May 2020. Throughout 2020, Hikma issued press releases referring to its product as the “generic version” or “generic equivalent” of Vascepa, describing Vascepa as indicated “in part” for the SH indication, and citing Vascepa sales figures (over $1 billion annually) that were attributable primarily to the CV indication. Hikma also marketed its product on its website under the therapeutic category “Hypertriglyceridemia” and as “AB” rated, though with a disclaimer that it was approved for fewer indications than Vascepa. In November 2020, Amarin sued Hikma for induced infringement of its CV indication patents. The U.S. District Court for the District of Delaware granted Hikma’s motion to dismiss. The U.S. Court of Appeals for the Federal Circuit reversed, finding that Amarin’s allegations—based on Hikma’s skinny label combined with its press releases and marketing materials—plausibly stated a claim for induced infringement.