Facts of the Case

Provided by Oyez

Amarin sells icosapent ethyl as Vascepa, which the FDA approved in 2012 for severe hypertriglyceridemia and in 2019 for a patented cardiovascular-risk indication. Hikma won approval for a generic version with a "skinny label" that carved out the patented cardiovascular use, but its press releases called the product a "generic version" of Vascepa and cited Vascepa's sales figures, which were driven mostly by the patented indication. Amarin sued for induced infringement; the District of Delaware dismissed the complaint, but the Federal Circuit reversed.

Questions

  1. When a generic drug manufacturer excludes a patented use from its label, can it still be liable for inducing infringement if it calls its product a "generic version" of the brand-name drug and cites publicly available information about the brand-name drug's sales?

  2. Can a patent infringement complaint survive dismissal if it does not allege that the defendant made any statement specifically instructing or encouraging the patented use?

Conclusions

  1. On June 4, 2026, the U.S. Supreme Court unanimously held in Hikma Pharmaceuticals USA Inc. v. Amarin Pharma, Inc. that a generic drug manufacturer does not actively induce patent infringement under 35 U.S.C. §271(b) when its communications consist only of legally required labeling, standard industry language, omissions, and vague statements lacking an affirmative purpose of encouraging the patented use.