No. 24-889
Hikma Pharmaceuticals USA Inc., et al. v. Amarin Pharma, Inc., et al.
Tags: carve-out generic-drugs hatch-waxman-act induced-infringement patent-infringement skinny-label
Latest Conference:
2026-01-16
(distributed 3 times)
Question Presented (from Petition)
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?
Question Presented (AI Summary)
QP: 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 enough to plead induced infringement of the patented use?
Docket Entries
2026-04-13
Reply of petitioners Hikma Pharmaceuticals USA Inc. et al. filed. (Distributed)
2026-04-13
Reply of Hikma Pharmaceuticals USA Inc. and Hikma Pharmaceuticals PLC submitted.
2026-03-30
CIRCULATED
2026-03-27
Brief amici curiae of AbbVie Inc., et al. filed. (Resubmitted) (Distributed)
2026-03-27
Amicus brief of American Intellectual Property Law Association submitted.
2026-03-27
Amicus brief of Sanofi submitted.
2026-03-27
Amicus brief of Regeneron Pharmaceuticals, Inc. submitted.
2026-03-27
Amicus brief of Pharmaceutical Research and Manufacturers of America and Biotechnology Innovation Organization submitted.
2026-03-27
Amicus brief of AbbVie Inc. and Bristol-Myers Squibb Company submitted.
2026-03-27
Amicus brief of Former Federal Circuit Chief Judge Paul R. Michel and Scholars of Law and Economics submitted.
2026-03-27
Brief amicus curiae of Regeneron Pharmaceuticals, Inc. filed. (Distributed)
2026-03-27
Brief amici curiae of The Academic Medical Centers filed. (Distributed)
2026-03-27
Brief amici curiae of Pharmaceutical Research and Manufacturers of America, et al. filed. (Distributed)
2026-03-27
Brief amicus curiae of Sanofi filed. (Distributed)
2026-03-27
Brief amici curiae of Academic Medical Centers filed. (Distributed)
2026-03-27
Brief amicus curiae of American Intellectual Property Law Association filed. (Distributed)
2026-03-27
Brief amici curiae of AbbVie Inc., et al. filed. (Resubmitted - March 27, 2026) (Distributed)
2026-03-27
Brief amici curiae of Former Federal Circuit Chief Judge Paul R. Michel, et al. filed. (Distributed)
2026-03-23
Motion of the Solicitor General for leave to participate in oral argument as amicus curiae and for divided argument GRANTED.
2026-03-20
Brief of respondents Amarin Pharma, Inc., et al. filed.
2026-03-20
Brief of Amarin Pharma, Inc., et al. submitted.
2026-03-09
Brief amici curiae of Patent Law Professors Paul R. Gugliuzza and Jacob S. Sherkow in support of neither party filed.
2026-03-09
Amicus brief of Intellectual Property Owners Association submitted.
2026-03-09
Amicus brief of Licensing Executives Society (USA and Canada), Inc. submitted.
2026-03-09
Amicus brief of The Public Interest Patent Law Institute submitted.
2026-03-09
Brief amicus curiae of Intellectual Property Owners Association filed.
2026-03-09
Brief amicus curiae of The Public Interest Patent Law Institute filed.
2026-03-09
Brief amicus curiae of Licensing Executives Society (USA and Canada), Inc. filed.
2026-03-09
Brief amici curiae of Patent Law Professor Paul R. Gugliuzza, et al. filed.
2026-03-09
Brief amicus curiae of The Public Interest Patent Law Institute in support of neither party filed.
2026-03-09
Brief amicus curiae of Licensing Executives Society (USA and Canada), Inc. in support of neither party filed.
2026-03-09
Brief amicus curiae of Intellectual Property Owners Association in support of neither party filed.
2026-03-05
Brief amicus curiae of New York Intellectual Property Law Association filed.
2026-03-05
Brief amicus curiae of New York Intellectual Property Law Association in support of neither party filed.
2026-03-05
Amicus brief of New York Intellectual Property Law Association submitted.
2026-02-26
Motion of the Solicitor General for leave to participate in oral argument as amicus curiae and for divided argument filed.
2026-02-26
Motion of United States of America for leave to participate in oral argument and for divided argument submitted.
2026-02-25
Brief for the United States as Amicus Curiae Supporting Petitioners of United States of America submitted.
2026-02-25
Brief amicus curiae of United States filed.
2026-02-25
Amicus brief of Association for Accessible Medicines submitted.
2026-02-25
Amicus brief of Former Congressman Henry A. Waxman submitted.
2026-02-25
Brief amicus curiae of Public Citizen filed.
2026-02-25
Brief amicus curiae of The Association For Accessible Medicines filed.
2026-02-25
Brief amicus curiae of Former Congressman Henry A. Waxman filed.
2026-02-25
Brief amicus curiae of Association for Accessible Medicines filed.
2026-02-25
Amicus brief of Public Citizen submitted.
2026-02-25
Sealed 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.
2026-02-24
Brief amicus curiae of Shashank Upadhye filed.
2026-02-24
Amicus brief of Shashank Upadhye submitted.
2026-02-23
Record received from the United States Court of Appeals for the Federal Circuit. The record is electronic and is available on PACER.
2026-02-23
Brief amici curiae of 76 Scholars filed.
2026-02-23
Record requested from the United States Court of Appeals for the Federal Circuit.
2026-02-18
Brief of Hikma Pharmaceuticals USA Inc. and Hikma Pharmaceuticals PLC submitted.
2026-02-18
Joint Appendix submitted.
2026-02-18
Brief of petitioners Hikma Pharmaceuticals USA Inc., et al. filed.
2026-02-18
Joint appendix filed. (Statement of costs filed)
2026-02-11
SET FOR ARGUMENT on Wednesday, April 29, 2026.
2026-01-16
Petition GRANTED.
2026-01-12
DISTRIBUTED for Conference of 1/16/2026.
2025-12-23
Letter of Hikma Pharmaceuticals USA Inc. and Hikma Pharmaceuticals PLC filed.
2025-12-23
Supplemental brief of respondents Amarin Pharma, Inc., et al. filed. (Distributed)
2025-12-23
Letter of Hikma Pharmaceuticals USA Inc. and Hikma Pharmaceuticals PLC submitted.
2025-12-23
Supplemental Brief of Amarin Pharma, Inc., et al. submitted.
2025-12-23
DISTRIBUTED for Conference of 1/9/2026.
2025-12-05
Amicus brief of United States of America submitted.
2025-12-05
Brief amicus curiae of United States filed.
2025-06-23
The Solicitor General is invited to file a brief in this case expressing the views of the United States.
2025-06-03
DISTRIBUTED for Conference of 6/18/2025.
2025-06-02
Reply of petitioners Hikma Pharmaceuticals USA Inc., et al. filed. (Distributed)
2025-06-02
Reply of Hikma Pharmaceuticals USA Inc. and Hikma Pharmaceuticals PLC submitted.
2025-05-15
Brief of respondents Amarin Pharma, Inc., et al. in opposition filed.
2025-05-15
Brief of Amarin Pharma, Inc., et al. in opposition submitted.
2025-04-07
Motion to extend the time to file a response is granted and the time is further extended to and including May 15, 2025.
2025-04-04
Motion of Amarin Pharma, Inc., et al. for an extension of time submitted.
2025-04-04
Motion to extend the time to file a response from April 21, 2025 to May 15, 2025, submitted to The Clerk.
2025-03-21
Brief amicus curiae of Association for Accessible Medicines filed.
2025-03-21
Amicus brief of Association for Accessible Medicines submitted.
2025-03-20
Brief amici curiae of 30 Scholars of Law, Economics, and Medicine filed.
2025-03-20
Brief amici curiae of 30 Scholars of Law, et al. filed.
2025-03-05
Motion to extend the time to file a response is granted and the time is extended to and including April 21, 2025.
2025-03-04
Motion to extend the time to file a response from March 21, 2025 to April 21, 2025, submitted to The Clerk.
2025-03-04
Motion of Amarin Pharma, Inc., et al. for an extension of time submitted.
2025-02-14
Petition for a writ of certiorari filed. (Response due March 21, 2025)
2025-01-03
Application (24A652) granted by The Chief Justice extending the time to file until February 14, 2025.
2024-12-27
Application (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.
Attorneys
30 Scholars of Law, Economics, and Medicine
Abbvie Inc.
Jonathan S. Massey — Massey & Gail LLP, Amicus
Amarin Pharma, Inc., et al.
Michael Robert Huston — Perkins Coie LLP, Respondent
American Intellectual Property Law Association
Barbara A. Fiacco — Foley Hoag, Amicus
Association for Accessible Medicines
Matthew S. Hellman — Jenner & Block LLP, Amicus
William McGinley Jay — Goodwin Procter, LLP, Amicus
Former Congressman Henry A. Waxman
William Barnett Schultz — Zuckerman Spaeder LLP, Amicus
Former Federal Circuit Chief Judge Paul R. Michel and Scholars of Law and Economics
Gregory Andrew Castanias — Jones Day, Amicus
Hikma Pharmaceuticals USA Inc. and Hikma Pharmaceuticals PLC
Charles Bennett Klein — Winston & Strawn LLP, Petitioner
Intellectual Property Owners Association
Licensing Executives Society (USA and Canada), Inc.
New York Intellectual Property Law Association
Patent Law Professors Paul R. Gugliuzza and Jacob S. Sherkow
Pharmaceutical Research and Manufacturers of America and Biotechnology Innovation Organization
Public Citizen
Regeneron Pharmaceuticals, Inc.
Sanofi
Zachary D. Tripp — Weil, Gotshal & Manges LLP, Amicus
Shashank Upadhye
Shashank S. Upadhye — Upadhye Tang LLP, Amicus
The Academic Medical Centers
Ronald Edmund Cahill — Barnes & Thornburg, Amicus
The Public Interest Patent Law Institute
United States of America
D. John Sauer — Solicitor General, Amicus