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Hikma Pharmaceuticals USA Inc., et al. v. Amarin Pharma, Inc., et al.
Paid petition · United States Court of Appeals for the Federal Circuit, No. 2023-1169 · judgment June 25, 2024
Before the decision, well below the 4.1% base rate, with no standout signals pointing toward a grant.
Questions 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-GoldwynMayer Studios Inc. v. Grokster, Ltd., 545 U.S. 913, 936-937 & n.11 (2005). The questions presented are:
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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?
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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?
Counsel of record
For petitioner
Charles Bennett Klein
Winston Taylor LLP
For respondent
Michael Robert Huston
Perkins Coie LLP
Case
Conference history
Distributed for 3 conferences
Amicus briefs
3 cert-stage · 18 merits
(11 supporting pet./neither, 7 respondent)
Linked docket
24A652
Argument & decision
Argued April 29, 2026 — Charles B. Klein · Michael R. Huston. Audio and transcript
Decided June 4, 2026. Opinion by Jackson.
Proceedings
- Jul 06 2026Judgment Issued.
- Jun 04 2026Judgment REVERSED and case REMANDED. Jackson, J., delivered the opinion for a unanimous Court.
- Apr 29 2026Argued. 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.
- Apr 13 2026Reply of petitioners Hikma Pharmaceuticals USA Inc. et al. filed. (Distributed)
- Mar 30 2026CIRCULATED
- Mar 27 2026Amicus brief of AbbVie Inc. not accepted for filing. (To be resubmitted - March 27, 2026)
- Mar 27 2026Brief amici curiae of AbbVie Inc., et al. filed. (Resubmitted) (Distributed)
- Mar 27 2026Brief amici curiae of Former Federal Circuit Chief Judge Paul R. Michel, et al. filed. (Distributed)
- Mar 27 2026Brief amicus curiae of Regeneron Pharmaceuticals, Inc. filed. (Distributed)
- Mar 27 2026Brief amici curiae of Academic Medical Centers filed. (Distributed)
- Mar 27 2026Brief amici curiae of Pharmaceutical Research and Manufacturers of America, et al. filed. (Distributed)
- Mar 27 2026Brief amicus curiae of Sanofi filed. (Distributed)
- Mar 27 2026Brief amicus curiae of American Intellectual Property Law Association filed. (Distributed)
- Mar 23 2026Motion of the Solicitor General for leave to participate in oral argument as amicus curiae and for divided argument GRANTED.
- Mar 20 2026Brief of respondents Amarin Pharma, Inc., et al. filed.
- Mar 09 2026Brief amicus curiae of The Public Interest Patent Law Institute in support of neither party filed.
- Mar 09 2026Brief amicus curiae of Intellectual Property Owners Association in support of neither party filed.
- Mar 09 2026Brief amicus curiae of Licensing Executives Society (USA and Canada), Inc. in support of neither party filed.
- Mar 09 2026Brief amici curiae of Patent Law Professors Paul R. Gugliuzza and Jacob S. Sherkow in support of neither party filed.
- Mar 05 2026Brief amicus curiae of New York Intellectual Property Law Association filed.
- Feb 26 2026Motion of the Solicitor General for leave to participate in oral argument as amicus curiae and for divided argument filed.
- Feb 25 2026Sealed material received electronically from the United States District Court for the District of Delaware and available with the Clerk. The remainder of the record is electronic and is available on PACER.
- Feb 25 2026Brief amicus curiae of United States filed.
- Feb 25 2026Brief amicus curiae of Public Citizen filed.
- Feb 25 2026Brief amicus curiae of Association for Accessible Medicines filed.
- Feb 25 2026Brief amicus curiae of Former Congressman Henry A. Waxman filed.
- Feb 24 2026Brief amicus curiae of Shashank Upadhye filed.
- Feb 23 2026Record requested from the United States Court of Appeals for the Federal Circuit.
- Feb 23 2026Brief amici curiae of 76 Scholars filed.
- Feb 23 2026Record received from the United States Court of Appeals for the Federal Circuit. The record is electronic and is available on PACER.
- Feb 18 2026Brief of petitioners Hikma Pharmaceuticals USA Inc., et al. filed.
- Feb 18 2026Joint appendix filed. (Statement of costs filed)
- Feb 11 2026SET FOR ARGUMENT on Wednesday, April 29, 2026.
- Jan 16 2026Petition GRANTED.
- Jan 12 2026DISTRIBUTED for Conference of 1/16/2026.
- Dec 23 2025DISTRIBUTED for Conference of 1/9/2026.
- Dec 23 2025Supplemental brief of respondents Amarin Pharma, Inc., et al. filed. (Distributed)
- Dec 23 2025Letter of Hikma Pharmaceuticals USA Inc. and Hikma Pharmaceuticals PLC filed.
- Dec 05 2025Brief amicus curiae of United States filed.
- Jun 23 2025The Solicitor General is invited to file a brief in this case expressing the views of the United States.
- Jun 03 2025DISTRIBUTED for Conference of 6/18/2025.
- Jun 02 2025Reply of petitioners Hikma Pharmaceuticals USA Inc., et al. filed. (Distributed)
- May 15 2025Brief of respondents Amarin Pharma, Inc., et al. in opposition filed.
- Apr 07 2025Motion to extend the time to file a response is granted and the time is further extended to and including May 15, 2025.
- Apr 04 2025Motion to extend the time to file a response from April 21, 2025 to May 15, 2025, submitted to The Clerk.
- Mar 21 2025Brief amicus curiae of Association for Accessible Medicines filed.
- Mar 20 2025Brief amici curiae of 30 Scholars of Law, Economics, and Medicine filed.
- Mar 05 2025Motion to extend the time to file a response is granted and the time is extended to and including April 21, 2025.
- Mar 04 2025Motion to extend the time to file a response from March 21, 2025 to April 21, 2025, submitted to The Clerk.
- Feb 14 2025Petition for a writ of certiorari filed. (Response due March 21, 2025)
- Jan 03 2025Application (24A652) granted by The Chief Justice extending the time to file until February 14, 2025.
- Dec 27 2024Application (24A652) to extend the time to file a petition for a writ of certiorari from January 15, 2025 to February 14, 2025, submitted to The Chief Justice.