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

608 U. S. ___ (2026) · 6/04/26

Amarin has failed to state a claim for actively inducing infringement of its brand-name drug’s patented uses in violation of 35 U. S. C. §271(b), so its complaint cannot withstand Hikma’s motion to dismiss.

Once the Food and Drug Administration (FDA) has approved a new drug, federal law authorizes other manufacturers to seek approval for marketing generic versions so long as they do not infringe on any patented uses. All 50 states and the District of Columbia permit (or require) medical providers to substitute the brand-name drug with the cheaper generic version. Still, generic manufacturers may be subject to liability under federal law if they actively induce infringement of the brand manufacturer’s patent. See 35 U. S. C. §271(b). Amarin Pharma, Inc. developed Vascepa, a drug containing the…

Held: Amarin has failed to state a claim for active inducement in violation of §271(b), so its complaint cannot withstand Hikma’s motion to dismiss. The central question is whether Amarin plausibly alleged that Hikma actively encouraged infringing use, not merely whether doctors could plausibly read the alleged statements as instructions to infringe. Pp. 7–14. (a) A claim for active inducement of infringement under §271(b) requires three elements: direct infringement by a third party, Limelight Networks, Inc. v. Akamai Technologies, Inc., 572 U. S. 915, 920–921; knowledge that “the induced…