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Amgen Inc. v. Sanofi

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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

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