Hikma Pharmaceuticals USA Inc. v. Amarin Pharma

Questions presented

SCOTUS records, cert granted 16 Jan 2026

1. Congress passed the Hatch-Waxman Act "[t]o facilitate the approval of generic drugs as soon as patents allow." Caraco Pharm. Labs., Ltd. v. Novo Nordisk A/S, 566 U.S. 399, 405 (2012). Recognizing that many drugs are approved for both patented and unpatented uses, Congress sought to ensure "that one patented use will not foreclose marketing a generic drug for other unpatented ones." Id. at 415. The statutory mechanism is a "skinny label": Generic drugmakers "carve out" patented uses from their labels, leaving only instructions to use generic drugs for their unpatented uses. See 21 U.S.C. § 355(j)(2)(A)(viii). Congress designed this carve-out mechanism to encourage competition and to protect generic drugmakers from allegations that marketing a generic drug for an unpatented use "actively induces infringement." 35 U.S.C. § 271(b). After all, active inducement requires "clear expression or other affirmative steps taken to foster infringement"-there is no "liability when a defendant merely sells a commercial product suitable for some lawful use." Metro-Goldwyn- Mayer Studios Inc. v. Grokster, Ltd., 545 U.S. 913, 936-937 & n.11 (2005). The questions presented are:
2. When a generic drug label fully carves out a patented use, are allegations that the generic drugmaker calls its product a "generic version" and cites public information about the branded drug (e.g., sales) enough to plead induced infringement of the patented use?
3. Does a complaint state a claim for induced infringement of a patented method if it does not allege any instruction or other statement by the defendant that encourages, or even mentions, the patented use?

Opinion summary

Etalia.ai summary of the majority opinion

The dispute was over whether Hikma Pharmaceuticals actively induced infringement of Amarin’s method-of-use patents for Vascepa by marketing a generic icosapent ethyl product with a skinny label, website statements, patient materials, and press releases. The Court, in an opinion by Justice Jackson, held that Amarin failed to state a claim under 35 U.S.C. § 271(b). The Court said induced infringement requires direct infringement, knowledge, and active steps to encourage infringement, and that active steps must be affirmative conduct, not ordinary product distribution or vague statements combined with speculation. Applying that standard, the Court found Hikma’s statements had innocent explanations, such as statutory label requirements and standard industry practice, and that omissions could not support liability. The remaining statements were too vague to plausibly allege that Hikma deliberately encouraged infringement. The Court reversed the Federal Circuit and remanded.