Hikma Pharmaceuticals USA, Inc. v. Amarin Pharma Inc. (Patent infringement)

Send us Fan MailIn a unanimous opinion by Justice Jackson, the Supreme Court held that Amarin failed to plausibly allege that Hikma actively induced infringement of Amarin’s patented cardiovascular-use methods for Vascepa. Although Hikma marketed a generic version of the drug using an FDA-approved “skinny label” that omitted the patented cardiovascular indication, Amarin argued that various statements in Hikma’s labeling, website, patient materials, and press releases nevertheless encouraged doctors to prescribe the drug for the patented use. The Court rejected that theory, emphasizing that inducement under 35 U.S.C. §271(b) requires affirmative, purposeful steps designed to encourage infringement, not merely statements that could conceivably lead someone to infringe. Many of Hikma’s challenged statements reflected legal requirements or standard industry practices, while others were omissions or vague references that did not plausibly show an intent to promote infringing use. Because Amarin’s allegations relied on speculation and attenuated chains of inference rather than concrete acts encouraging infringement, the complaint failed to state a claim, and the Court reversed the Federal Circuit’s decision allowing the suit to proceed.Support the show