Hikma Pharmaceuticals USA Inc. v. Amarin Pharma, Inc., No. 24-889

Argued on Apr 29 2026.

For petitioners: Charles B. Klein, Washington, D. C.; and Malcolm L. Stewart, Deputy Solicitor General, Department of Justice, Washington, D. C. (for United States, as amicus curiae.) For respondents: Michael R. Huston, Phoenix, Ariz.

Question Presented:

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: 1. 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? 2. 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?

Oral Argument Links: