Supreme Court of the United States · Official docket →
Amgen Inc., et al. v. Sanofi, et al.
Paid petition · United States Court of Appeals for the Federal Circuit, No. 2020-1074 · judgment February 11, 2021
Before the decision, modestly above the 4.1% base rate. The model weighted this up for counsel who has won certiorari before, a Federal Circuit decision below, and a business petitioner.
Questions presented
Section 112 of the Patent Act provides that a patent's "specification shall contain a written description of the invention, and of the manner and process of making and using it," sufficient "to enable any person skilled in the art * * * to make and use the" invention. 35 U.S.C. § 112(a). The requirement that the specification teach skilled artisans "to make and use" the invention is referred to as the "'enablement'" requirement. Markman v. Westview Instruments, Inc., 517 U.S. 370, 379 (1996). The questions presented are:
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Whether enablement is "a question of fact to be determined by the jury," Wood v. Underhill, 46 U.S. (5 How.) 1, 4 (1846), as this Court has held, or "a question of law that [the court] review[s] without deference," Pet. App. 6a, as the Federal Circuit holds.
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Whether enablement is governed by the statutory requirement that the specification teach those skilled in the art to "make and use" the claimed invention, 35 U.S.C. § 112, or whether it must instead enable those skilled in the art "to reach the full scope of claimed embodiments" without undue experimentation-i.e., to cumulatively identify and make all or nearly all embodiments of the invention without substantial "'time and effort,'" Pet.App. 14a (emphasis added). LIMITED TO QUESTION 2 PRESENTED BY THE PETITION
Counsel of record
For petitioner
Jeffrey Alan Lamken
MoloLamken LLP
For respondent
Paul D. Clement
Clement & Murphy, PLLC
Case
Conference history
Distributed for 4 conferences
Amicus briefs
4 cert-stage · 30 merits
(14 supporting pet./neither, 16 respondent)
Argument & decision
Argued March 27, 2023 — Jeffrey A. Lamken · Paul D. Clement. Audio and transcript
Decided May 18, 2023. Opinion by Gorsuch.
Proceedings
- Jun 20 2023Judgment issued.
- May 18 2023Adjudged to be AFFIRMED. Gorsuch, J., delivered the opinion for a unanimous Court.
- 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.)
- Mar 16 2023Two copies of model exhibits from the record on appeal received from counsel for petitioners.
- Mar 06 2023Reply of petitioners Amgen Inc., et al. filed. (Distributed)
- Feb 27 2023Sealed records received electronically from the U.S.D.C.-Delaware. The remaining record is available on PACER.
- 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 13 2023CIRCULATED
- 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 09 2023Brief amicus curiae of Professor Robin Feldman filed. (Distributed)
- Feb 03 2023Record requested from the U.S.C.A. for the Federal Circuit.
- Feb 03 2023Brief of respondents Sanofi, et al. filed.
- Jan 31 2023SET FOR ARGUMENT on Monday, March 27, 2023.
- Jan 17 2023Motion to dispense with printing the joint appendix filed by petitioner GRANTED.
- Jan 05 2023Response to motion from 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.
- Dec 27 2022Brief of petitioners Amgen Inc., et al. filed.
- Dec 22 2022Motion to dispense with printing the joint appendix filed by petitioners Amgen Inc., et al.
- 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 13 2022Motion for an extension of time to file the briefs on the merits filed.
- Dec 01 2022Blanket Consent filed by Petitioner, Amgen Inc., et al.
- Nov 29 2022Blanket Consent filed by Respondent, Sanofi, et al.
- Nov 04 2022Petition GRANTED limited to Question 2 presented by the petition.
- Oct 31 2022DISTRIBUTED for Conference of 11/4/2022.
- Oct 05 2022DISTRIBUTED for Conference of 10/28/2022.
- Oct 04 2022Supplemental brief of petitioners Amgen Inc., et al. filed. (Distributed)
- Sep 21 2022Brief amicus curiae of United States filed.
- Apr 18 2022The Solicitor General is invited to file a brief in this case expressing the views of the United States.
- Mar 29 2022DISTRIBUTED for Conference of 4/14/2022.
- Mar 28 2022Reply of petitioners Amgen Inc., et al. filed. (Distributed)
- Mar 14 2022Brief of respondents Sanofi, et al. in opposition filed.
- Jan 14 2022Motion to extend the time to file a response is granted and the time is extended to and including March 14, 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 11 2022Response Requested. (Due February 10, 2022)
- Jan 05 2022DISTRIBUTED for Conference of 1/21/2022.
- 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.
- Nov 18 2021Petition for a writ of certiorari filed. (Response due December 22, 2021)