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

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: SCOTUS Oral Argument Page Transcript PDF Docket Links: SCOTUS Docket Page Question Presented Petition for a Writ of Certiorari (White Br.) Brief in Opposition (Orange Br.) Reply Brief in Support of Petition (Tan Br.) Cert. Stage Brief of the United States (Green Br.) Petitioner's Brief on the Merits (Blue Br.) Merits Stage Brief of the United States (Green Br.) Respondent's Brief on the Merits (Red Br.) Petitioner's Reply Brief on the Merits (Yellow Br.) Chapters: (00:00:00) Case Call (00:00:05) ORAL ARGUMENT OF CHARLES B. KLEIN (00:11:20) ORAL ARGUMENT OF MALCOLM L. STEWART (00:28:12) ORAL ARGUMENT OF MICHAEL R. HUSTON (00:57:08) REBUTTAL ARGUMENT OF CHARLES B. KLEIN Disclosure, Disclaimer, and Credits: Independent feed. NOT affiliated with the Supreme Court of the United States or any other entity. Audio files from and links to the Supreme Court of the United States' website. Image credit to Ian Hutchinson, https://unsplash.com/photos/U8WfiRpsQ7Y