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Amgen Inc. v. Sanofi, Aventisub LLC

 
DOCKET NO.
21-757
OP. BELOW
Fed. Cir.
SUBJECT
Patent

Question(s) 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:”

  1. “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.”
  2. “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).”

 

Posts About this Case

Date
Proceedings and Orders
November 18, 2021
Petition for a writ of certiorari filed. (Response due December 22, 2021)
December 22, 2021
Brief amici curiae of Association of University Technology Managers, Inc., et al.
December 22, 2021
Brief amicus curiae of Glaxosmithkline Plc filed.
December 22, 2021
Brief amici curiae of Intellectual Property Professors filed.
January 5, 2022
DISTRIBUTED for Conference of 1/21/2022.
January 11, 2022
Response Requested. (Due February 10, 2022)
January 12, 2022
Motion of Sanofi, et al. for an extension of time submitted.
January 14, 2022
Motion to extend the time to file a response is granted and the time is extended to and including March 14, 2022.
March 14, 2022
Brief of Sanofi, et al. in opposition submitted.
March 28, 2022
Reply of Amgen Inc., et al. submitted.
March 29, 2022
DISTRIBUTED for Conference of 4/14/2022.
April 18, 2022
The Solicitor General is invited to file a brief in this case expressing the views of the United States.
September 21, 2022
Brief amicus curiae of United States filed.
October 4, 2022
Supplemental Brief of Amgen Inc., et al. submitted.
October 5, 2022
DISTRIBUTED for Conference of 10/28/2022.
October 31, 2022
DISTRIBUTED for Conference of 11/4/2022.
November 4, 2022
Petition GRANTED limited to Question 2 presented by the petition.
November 29, 2022
Consent to the filing of amicus briefs received from counsel for Sanofi, et al. submitted.
December 1, 2022
Blanket Consent filed by Petitioner, Amgen Inc., et al.
December 13, 2022
Motion of Amgen Inc., et al. for an extension of time submitted.
December 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.
December 22, 2022
Motion of Amgen Inc., et al. to dispense with joint appendix submitted.
December 27, 2022
Brief of Amgen Inc., et al. submitted.
January 3, 2023
Amicus brief of Intellectual Property Professors submitted.
January 3, 2023
Amicus brief of Instil Bio, Inc. submitted.
January 3, 2023
Amicus brief of GlaxoSmithKline plc submitted.
January 3, 2023
Amicus brief of Intellectual Property Owners Association submitted.
January 3, 2023
Amicus brief of Regenxbio Inc., IGM Biosciences, Inc., Adaptive Phage Therapeutics, Inc. submitted.
January 3, 2023
Amicus brief of Chemistry and the Law Division of the American Chemical Society submitted.
January 3, 2023
Amicus brief of High Tech Inventors Alliance and The Computer & Communications Industry Association submitted.
January 3, 2023
Motion of Chemistry and the Law Division of the American Chemical Society for leave to participate in oral argument and for divided argument submitted.
January 3, 2023
Amicus brief of National Association of Patent Practitioners, Inc. submitted.
January 3, 2023
Amicus brief of Intellectual Property Law Association of Chicago submitted.
January 3, 2023
Amicus brief of AbbVie Inc. submitted.
January 3, 2023
Amicus brief of Alliance of U.S. Startups and Inventors for Jobs and and Innovation Alliance submitted.
January 3, 2023
Amicus brief of Association of University Technology Managers, Inc., Biogen Inc., Bristol-Myers Squibb Company, Corning Incorporated, Merck Sharp & Dohme Corp., and St. Jude Children’s Research Hospital, Inc. submitted.
January 3, 2023
Amicus brief of AbbVie Inc. submitted.
January 3, 2023
Amicus brief of Alliance of U.S. Startups and Inventors for Jobs and and Innovation Alliance submitted.
January 5, 2023
Response of Amgen Inc., et al. to motion submitted.
January 17, 2023
Motion to dispense with printing the joint appendix filed by petitioner GRANTED.
January 31, 2023
SET FOR ARGUMENT on Monday, March 27, 2023.
February 3, 2023
Record requested from the U.S.C.A. for the Federal Circuit.
February 3, 2023
Brief of Sanofi, et al. submitted.
February 9, 2023
Amicus brief of Professor Robin Feldman submitted.
February 10, 2023
Amicus brief of American Intellectual Property Law Association submitted.
February 10, 2023
Amicus brief of Law Professors Joshua D. Sarnoff, Sharon K. Sandeen, and Ana Santos Rutschman submitted.
February 10, 2023
Amicus brief of Sir Gregory Paul Winter and Interested Scientists submitted.
February 10, 2023
Amicus brief of Intellectual Property Law Professors and Scholars submitted.
February 10, 2023
Amicus brief of Pfizer Inc. submitted.
February 10, 2023
Amicus brief of Eli Lilly and Company, Ipsen Bioscience, Inc. and Innovent Biologics, Inc. submitted.
February 10, 2023
Amicus brief of Genentech, Inc., AstraZeneca Pharmaceuticals LP, Bayer AG, Gilead Sciences, Inc., and Johnson & Johnson submitted.
February 10, 2023
Amicus brief of Small and Medium Biotechnology Companies submitted.
February 10, 2023
Amicus brief of Unified Patents, LLC submitted.
February 10, 2023
Amicus brief of Fresenius Kabi USA, LLC submitted.
February 10, 2023
Amicus brief of Association for Accessible Medicines submitted.
February 10, 2023
Amicus brief of Public Interest Patent Law Institute submitted.
February 10, 2023
Amicus brief of Viatris Inc. submitted.
February 10, 2023
Amicus brief of United States submitted.
February 10, 2023
Motion of United States for leave to participate in oral argument and for divided argument submitted.
February 10, 2023
Amicus brief of Arnold Ventures, The National Center for Health Research, Dr. Aaron S. Kesselheim, Dr. Eliot A. Brinton, Dr. Michael S. Doyle, and Dr. Jerry Avorn submitted.
February 13, 2023
CIRCULATED
February 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.
February 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.
February 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.
February 27, 2023
Sealed records received electronically from the U.S.D.C.-Delaware. The remaining record is available on PACER.
March 6, 2023
Reply of petitioners Amgen Inc., et al. filed. (Distributed)
March 16, 2023
Two copies of model exhibits from the record on appeal received from counsel for petitioners.
March 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.)
May 18, 2023
Adjudged to be AFFIRMED. Gorsuch, J., delivered the opinion for a unanimous Court.
June 20, 2023
Judgment issued.