No. 24-889

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

Lower Court: Federal Circuit
Docketed: 2025-02-19
Status: Granted
Type: Paid
CVSGAmici (4)Relisted (3) Experienced Counsel
Tags: carve-out generic-drugs hatch-waxman-act induced-infringement patent-infringement skinny-label
Key Terms:
Copyright Patent TradeSecret
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

2026-02-18
Joint Appendix submitted.
2026-02-18
Brief of Hikma Pharmaceuticals USA Inc. and Hikma Pharmaceuticals PLC submitted.
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
Brief amicus curiae of United States filed.
2025-12-05
Amicus brief of United States of America submitted.
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 Hikma Pharmaceuticals USA Inc. and Hikma Pharmaceuticals PLC submitted.
2025-06-02
Reply of petitioners Hikma Pharmaceuticals USA Inc., et al. filed. (Distributed)
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 to extend the time to file a response from April 21, 2025 to May 15, 2025, submitted to The Clerk.
2025-04-04
Motion of Amarin Pharma, Inc., et al. for an extension of time submitted.
2025-03-21
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
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
Charles DuanAmerican University Washington College of Law, Amicus
Amarin Pharma, Inc., et al.
Michael Robert HustonPerkins Coie LLP, Respondent
Association for Accessible Medicines
Matthew S. HellmanJenner & Block LLP, Amicus
Hikma Pharmaceuticals USA Inc. and Hikma Pharmaceuticals PLC
Charles Bennett KleinWinston & Strawn LLP, Petitioner
United States of America
D. John SauerSolicitor General, Amicus