Amgen Inc. v. Sanofi

Docket No.	Op. Below	Argument	Opinion	Vote	Author	Term
21-757	Fed. Cir.	Mar 27, 2023	May 18, 2023	9-0	Gorsuch	OT 2022

Holding: Amgen's two patent applications purporting to cover all antibodies that bind and block the PCSK9 receptor involved in LDL cholesterol metabolism fail to satisfy the Patent Act's enablement clause, see 35 U.S.C. § 112(a).

Judgment: Affirmed, 9-0, in an opinion by Justice Gorsuch on May 18, 2023.

SCOTUSblog Coverage

Supreme Court rules invalid Amgen's patent on cholesterol-lowering drug (Eric M. Fraser, May 19, 2023)
Court concerned about scope of patent covering millions of antibodies (Eric M. Fraser, March 29, 2023)
Court to decide how specific a patent disclosure must be (Eric M. Fraser, March 23, 2023)
Court schedules final two argument sessions of 2022-23 term (Amy Howe, January 31, 2023)
Justices grant review in cases on patents, trademarks, and water rights for Native Americans (Amy Howe, November 4, 2022)
Intellectual property and Navajo water rights (John Elwood, November 2, 2022)
Court declines to hear death-row inmate's claim of juror's racial bias, prompting dissent from liberal justices (Amy Howe, April 18, 2022)

Date	Proceedings and Orders (key to color coding)
11/18/2021	Petition for a writ of certiorari filed. (Response due December 22, 2021)
12/22/2021	Brief amici curiae of Association of University Technology Managers, Inc., et al.
12/22/2021	Brief amicus curiae of GlaxoSmithKline plc filed.
12/22/2021	Brief amici curiae of Intellectual Property Professors filed.
01/05/2022	DISTRIBUTED for Conference of 1/21/2022.
01/11/2022	Response Requested. (Due February 10, 2022)
01/12/2022	Motion to extend the time to file a response from February 10, 2022 to March 14, 2022, submitted to The Clerk.
01/14/2022	Motion to extend the time to file a response is granted and the time is extended to and including March 14, 2022.
03/14/2022	Brief of respondents Sanofi, et al. in opposition filed.
03/28/2022	Reply of petitioners Amgen Inc., et al. filed. (Distributed)
03/29/2022	DISTRIBUTED for Conference of 4/14/2022.
04/18/2022	The Solicitor General is invited to file a brief in this case expressing the views of the United States.
09/21/2022	Brief amicus curiae of United States filed.
10/04/2022	Supplemental brief of petitioners Amgen Inc., et al. filed. (Distributed)
10/05/2022	DISTRIBUTED for Conference of 10/28/2022.
10/31/2022	DISTRIBUTED for Conference of 11/4/2022.
11/04/2022	Petition GRANTED limited to Question 2 presented by the petition.
11/29/2022	Blanket Consent filed by Respondent, Sanofi, et al.
12/01/2022	Blanket Consent filed by Petitioner, Amgen Inc., et al.
12/13/2022	Motion for an extension of time to file the briefs on the merits filed.
12/15/2022	Motion to extend the time to file the briefs on the merits granted. The time to file the joint appendix and petitioners' brief on the merits is extended to and including December 27, 2022. The time to file respondents' brief on the merits is extended to and including February 3, 2023.
12/22/2022	Motion to dispense with printing the joint appendix filed by petitioners Amgen Inc., et al.
12/27/2022	Brief of petitioners Amgen Inc., et al. filed.
01/03/2023	Brief amicus curiae of Chemistry and the Law Division of the American Chemical Society filed.
01/03/2023	Brief amici curiae of Diversified Researchers and Innovators filed.
01/03/2023	Brief amicus curiae of National Association of Patent Practitioners, Inc. filed.
01/03/2023	Brief amici curiae of Intellectual Property Professors filed.
01/03/2023	Brief amicus curiae of New York Intellectual Property Law Association in support of neither party filed.
01/03/2023	Brief amicus curiae of Intellectual Property Law Association of Chicago in support of neither party filed.
01/03/2023	Brief amicus curiae of The Fynder Group, Inc. d/b/a Nature’s Fynd filed.
01/03/2023	Brief amici curiae of REGENXBIO Inc., et al. in support of neither party filed.
01/03/2023	Brief amicus curiae of Instil Bio, Inc. filed.
01/03/2023	Brief amicus curiae of GlaxoSmithKline plc filed.
01/03/2023	Brief amicus curiae of Intellectual Property Owners Association in support of neither party filed.
01/03/2023	Brief amicus curiae of AbbVie Inc. filed.
01/03/2023	Brief amici curiae of High Tech Inventors Alliance, et al. in support of neither party filed.
01/03/2023	Motion of Chemistry and the Law Division of the American Chemical Society for leave to participate in oral argument as amicus curiae, for divided argument, and for enlargement of time for oral argument filed.
01/03/2023	Brief amici curiae of Alliance of U.S. Startups and Inventors for Jobs (USIJ), et al. (1/5/2023) filed.
01/05/2023	Response to motion from petitioners Amgen Inc., et al. filed.
01/17/2023	Motion to dispense with printing the joint appendix filed by petitioner GRANTED.
01/31/2023	SET FOR ARGUMENT on Monday, March 27, 2023.
02/03/2023	Record requested from the U.S.C.A. for the Federal Circuit.
02/03/2023	Brief of respondents Sanofi, et al. filed.
02/09/2023	Brief amicus curiae of Professor Robin Feldman filed. (Distributed)
02/10/2023	Brief amicus curiae of Association for Accessible Medicines filed. (Distributed)
02/10/2023	Brief amicus curiae of Fresenius Kabi USA, LLC filed. (Distributed)
02/10/2023	Brief amicus curiae of United States filed. (Distributed)
02/10/2023	Brief amici curiae of Small and Medium Biotechnology Companies filed. (Distributed)
02/10/2023	Brief amici curiae of Arnold Ventures, et al. filed. (Distributed)
02/10/2023	Brief amicus curiae of Unified Patents, LLC filed. (Distributed)
02/10/2023	Brief amici curiae of Genentech, Inc., AstraZeneca Pharmaceuticals LP, Bayer AG, Gilead Sciences, Inc., and Johnson & Johnson filed. (Distributed)
02/10/2023	Brief amici curiae of Law Professors Joshua D. Sarnoff, et al. filed. (Distributed)
02/10/2023	Brief amicus curiae of Pfizer Inc. filed. (Distributed)
02/10/2023	Brief amici curiae of Eli Lilly and Company, et al. filed. (Distributed)
02/10/2023	Brief amici curiae of Intellectual Property Law Professors and Scholars filed. (Distributed)
02/10/2023	Motion of the Solicitor General for leave to participate in oral argument as amicus curiae, for divided argument, and for enlargement of time for oral argument filed.
02/10/2023	Brief amicus curiae of Public Interest Patent Law Institute filed. (Distributed)
02/10/2023	Brief amicus curiae of American Intellectual Property Law Association filed. (Distributed)
02/10/2023	Brief amicus curiae of Viatris Inc. filed. (Distributed)
02/10/2023	Brief amici curiae of Sir Gregory Paul Winter, et al. filed. (Feb. 15, 2023 - updated hard copies with page insert of enlarged Figures 1, 2 & 3). (Distributed)
02/13/2023	CIRCULATED
02/21/2023	Motion of the Solicitor General for leave to participate in oral argument as amicus curiae, for divided argument, and for enlargement of time for oral argument GRANTED.
02/21/2023	Motion of Chemistry and the Law Division of the American Chemical Society for leave to participate in oral argument as amicus curiae, for divided argument, and for enlargement of time for oral argument DENIED.
02/21/2023	Record received from the U.S.C.A.-Federal Circuit. The record is available on PACER, except for confidential materials which were transmitted electronically.
02/27/2023	Sealed records received electronically from the U.S.D.C.-Delaware. The remaining record is available on PACER.
03/06/2023	Reply of petitioners Amgen Inc., et al. filed. (Distributed)
03/16/2023	Two copies of model exhibits from the record on appeal received from counsel for petitioners.
03/27/2023	Argued. For petitioners: Jeffrey A. Lamken, Washington, D. C. For respondents: Paul D. Clement, Alexandria, Va.; and Colleen R. Sinzdak, Assistant to the Solicitor General, Department of Justice, Washington, D. C. (for United States, as amicus curiae.)
05/18/2023	Adjudged to be AFFIRMED. Gorsuch, J., delivered the opinion for a unanimous Court.
06/20/2023	Judgment issued.