On June 4, 2026, the Supreme Court of the United States decided Hikma Pharmaceuticals v. Amarin Pharma, elaborating on the standard for satisfying the “active steps” requirement for a claim for induced patent infringement under 35 U.S.C. § 271(b) . The Court held that, to proceed past a motion to dismiss, the patentee must plausibly allege that the accused infringer actively encouraged infringing uses, not merely that the end user or direct infringer could have plausibly read the alleged statements or acts as instructions or invitations to infringe. Rather, the necessary inducement must be clear to the relevant audience and affirmative.
Hikma Pharmaceuticals arose from a patent dispute between two drug manufacturers: Amarin Pharma, Inc. (Amarin) — the manufacturer of brand-name Vascepa, with the active ingredient icosapent ethyl — and Hikma Pharmaceuticals USA Inc. (Hikma), a generic drug manufacturer. In 2016, Hikma submitted a new drug application for generic icosapent ethyl. Federal law permits generic manufacturers to market generic versions of brand-name drugs already approved by the FDA, but generic manufacturers may be subject to liability if they “actively induce[] infringement of a [brand manufacturer’s] patent.” 35 U.S.C. § 271(b).
Amarin brought an induced-infringement claim against Hikma, alleging that statements on its generic iscosapent ethyl “skinny label,” or abbreviated label for a generic drug, actively induced infringement of Amarin’s patent. The district court granted Hikma’s motion to dismiss, and the Federal Circuit reversed.
An induced infringement claim involves three elements: (1) a third party or end user directly infringes on the patent, (2) the inducer knows that the induced acts constitute patent infringement, and (3) the inducer took “active steps . . . to encourage direct infringement.” Slip Opinion at 8 (quotation marks omitted). The Supreme Court’s decision concerned the third element. The Court held that, to sufficiently plead the third element of an induced infringement claim, “[t]he central question is whether Amarin plausibly alleged that Hikma actively encouraged infringing uses, not merely whether doctors could plausibly read the alleged statements as instructions to infringe.” Slip Opinion at 2. The Court held that because Amarin insufficiently pled the third element, it failed to state a claim for induced infringement.
Under prior Supreme Court and Federal Circuit precedent, inducement cannot be based only on “vague language combined with speculation about how others may act.” Slip Opinion at 10 (cleaned up). Inducement can be “implicit or explicit,” but it “must be clear to the relevant audience and affirmative.” Id. (cleaned up). Here, the Court held that Amarin’s allegations fell short of the requirement to plead that Hikma took any affirmative steps to encourage infringement. Several of the statements had an obvious alternative explanation: Hikma was complying with federal labeling requirements or standard industry practice. And the Court held that the remaining statements involved omissions or vague statements, none of which is sufficient to show affirmative steps to encourage infringement.
Justice Jackson delivered the opinion for a unanimous Court.
Law clerk Grace Rybak contributed to this client alert.
