Hikma Pharmaceuticals USA Inc. v. Amarin Pharma, Inc.
Hikma Pharmaceuticals USA Inc. v. Amarin Pharma, Inc., No. 24-889 [https://www.supremecourt.gov/search.aspx?filename=/docket/docketfiles/html/public/24-889.html]
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 [https://www.supremecourt.gov/oral_arguments/audio/2025/24-889]
* Transcript PDF [https://www.supremecourt.gov/oral_arguments/argument_transcripts/2025/24-889_5ifl.pdf]
Docket Links:
* SCOTUS Docket Page [https://www.supremecourt.gov/search.aspx?filename=/docket/docketfiles/html/public/24-889.html]
* Question Presented [https://www.supremecourt.gov/qp/24-00889qp.pdf]
* Petition for a Writ of Certiorari (White Br.) [https://www.supremecourt.gov/DocketPDF/24/24-889/342837/20250214130639007_Petition%20for%20Certiorari%20-%20Hikma%20v%20Amarin.pdf]
* Brief in Opposition (Orange Br.) [https://www.supremecourt.gov/DocketPDF/24/24-889/358860/20250515112618670_24-889%20Brief%20in%20Opposition.pdf]
* Reply Brief in Support of Petition (Tan Br.) [https://www.supremecourt.gov/DocketPDF/24/24-889/362081/20250602120413875_Reply%20to%20Brief%20in%20Opposition%2024-889.pdf]
* Cert. Stage Brief of the United States (Green Br.) [https://www.supremecourt.gov/DocketPDF/24/24-889/386573/20251205145014514_24-889%20--%20Hikma%20Pharmaceuticals%20v.%20Amarin%20Pharma.pdf]
* Petitioner's Brief on the Merits (Blue Br.) [https://www.supremecourt.gov/DocketPDF/24/24-889/396643/20260218155808148_Brief%20for%20Petitioners%2024-889.pdf]
* Merits Stage Brief of the United States (Green Br.) [https://www.supremecourt.gov/DocketPDF/24/24-889/397318/20260225162016293_24-889_Hikma_Merits_Amicus.pdf]
* Respondent's Brief on the Merits (Red Br.) [https://www.supremecourt.gov/DocketPDF/24/24-889/390238/20251223120039390_24-889%20Supplemental%20Brief%20for%20Respondents.pdf]
* Petitioner's Reply Brief on the Merits (Yellow Br.) [https://www.supremecourt.gov/DocketPDF/24/24-889/404276/20260413134709097_Hikma%20v%20Amarin%20Petitioners%20Reply%20Brief%20No.%2024-889.pdf]
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 [https://unsplash.com/photos/U8WfiRpsQ7Y]