No. 21-757

Amgen Inc., et al. v. Sanofi, et al.

Lower Court: Federal Circuit
Docketed: 2021-11-22
Status: Judgment Issued
Type: Paid
CVSGAmici (33)Response RequestedRelisted (4) Experienced Counsel
Tags: 35-usc-112 claim-construction claim-scope enablement enablement-requirement invention-disclosure judicial-review patent patent-law statutory-interpretation undue-experimentation written-description
Key Terms:
Patent JusticiabilityDoctri
Latest Conference: 2022-11-04 (distributed 4 times)
Question Presented (AI Summary)

Whether enablement is a question of fact or law

Question Presented (OCR Extract)

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: 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 to cumulatively identify and make all or nearly all embodiments of the invention without substantial “‘time and effort,’” Pet. App. 14a (emphasis added). (i)

Docket Entries

2023-06-20
Judgment issued.
2023-05-18
Adjudged to be AFFIRMED. Gorsuch, J., delivered the <a href = 'https://www.supremecourt.gov/opinions/22pdf/21-757_2d8f.pdf'>opinion</a> for a unanimous Court.
2023-03-27
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.)
2023-03-16
Two copies of model exhibits from the record on appeal received from counsel for petitioners.
2023-03-06
Reply of petitioners Amgen Inc., et al. filed. (Distributed)
2023-02-27
Sealed records received electronically from the U.S.D.C.-Delaware. The remaining record is available on PACER.
2023-02-21
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.
2023-02-21
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.
2023-02-21
Record received from the U.S.C.A.-Federal Circuit. The record is available on PACER, except for confidential materials which were transmitted electronically.
2023-02-13
CIRCULATED
2023-02-10
Brief amici curiae of Eli Lilly and Company, et al. filed. (Distributed)
2023-02-10
Brief amicus curiae of Association for Accessible Medicines filed. (Distributed)
2023-02-10
Brief amicus curiae of Fresenius Kabi USA, LLC filed. (Distributed)
2023-02-10
Brief amicus curiae of United States filed. (Distributed)
2023-02-10
Brief amici curiae of Small and Medium Biotechnology Companies filed. (Distributed)
2023-02-10
Brief amici curiae of Arnold Ventures, et al. filed. (Distributed)
2023-02-10
Brief amicus curiae of Unified Patents, LLC filed. (Distributed)
2023-02-10
Brief amici curiae of Genentech, Inc., AstraZeneca Pharmaceuticals LP, Bayer AG, Gilead Sciences, Inc., and Johnson & Johnson filed. (Distributed)
2023-02-10
Brief amici curiae of Law Professors Joshua D. Sarnoff, et al. filed. (Distributed)
2023-02-10
Brief amicus curiae of Pfizer Inc. filed. (Distributed)
2023-02-10
Brief amici curiae of Intellectual Property Law Professors and Scholars filed. (Distributed)
2023-02-10
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.
2023-02-10
Brief amicus curiae of Public Interest Patent Law Institute filed. (Distributed)
2023-02-10
Brief amicus curiae of American Intellectual Property Law Association filed. (Distributed)
2023-02-10
Brief amicus curiae of Viatris Inc. filed. (Distributed)
2023-02-10
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)
2023-02-09
Brief amicus curiae of Professor Robin Feldman filed. (Distributed)
2023-02-03
Brief of respondents Sanofi, et al. filed.
2023-02-03
Record requested from the U.S.C.A. for the Federal Circuit.
2023-01-31
SET FOR ARGUMENT on Monday, March 27, 2023.
2023-01-17
Motion to dispense with printing the joint appendix filed by petitioner GRANTED.
2023-01-05
Response to motion from petitioners Amgen Inc., et al. filed.
2023-01-03
Brief amici curiae of High Tech Inventors Alliance, et al. in support of neither party filed.
2023-01-03
Brief amici curiae of Alliance of U.S. Startups and Inventors for Jobs (USIJ), et al. (1/5/2023) filed.
2023-01-03
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.
2023-01-03
Brief amicus curiae of AbbVie Inc. filed.
2023-01-03
Brief amicus curiae of Chemistry and the Law Division of the American Chemical Society filed.
2023-01-03
Brief amici curiae of Diversified Researchers and Innovators filed.
2023-01-03
Brief amicus curiae of National Association of Patent Practitioners, Inc. filed.
2023-01-03
Brief amici curiae of Intellectual Property Professors filed.
2023-01-03
Brief amicus curiae of New York Intellectual Property Law Association in support of neither party filed.
2023-01-03
Brief amicus curiae of Intellectual Property Law Association of Chicago in support of neither party filed.
2023-01-03
Brief amicus curiae of The Fynder Group, Inc. d/b/a Nature’s Fynd filed.
2023-01-03
Brief amici curiae of REGENXBIO Inc., et al. in support of neither party filed.
2023-01-03
Brief amicus curiae of Instil Bio, Inc. filed.
2023-01-03
Brief amicus curiae of GlaxoSmithKline plc filed.
2023-01-03
Brief amicus curiae of Intellectual Property Owners Association in support of neither party filed.
2022-12-27
Brief of petitioners Amgen Inc., et al. filed.
2022-12-22
Motion to dispense with printing the joint appendix filed by petitioners Amgen Inc., et al.
2022-12-15
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.
2022-12-13
Motion for an extension of time to file the briefs on the merits filed.
2022-12-01
Blanket Consent filed by Petitioner, Amgen Inc., et al.
2022-11-29
Blanket Consent filed by Respondent, Sanofi, et al.
2022-11-04
Petition GRANTED limited to Question 2 presented by the petition.
2022-10-31
DISTRIBUTED for Conference of 11/4/2022.
2022-10-05
DISTRIBUTED for Conference of 10/28/2022.
2022-10-04
Supplemental brief of petitioners Amgen Inc., et al. filed. (Distributed)
2022-09-21
Brief amicus curiae of United States filed.
2022-04-18
The Solicitor General is invited to file a brief in this case expressing the views of the United States.
2022-03-29
DISTRIBUTED for Conference of 4/14/2022.
2022-03-28
Reply of petitioners Amgen Inc., et al. filed. (Distributed)
2022-03-14
Brief of respondents Sanofi, et al. in opposition filed.
2022-01-14
Motion to extend the time to file a response is granted and the time is extended to and including March 14, 2022.
2022-01-12
Motion to extend the time to file a response from February 10, 2022 to March 14, 2022, submitted to The Clerk.
2022-01-11
Response Requested. (Due February 10, 2022)
2022-01-05
DISTRIBUTED for Conference of 1/21/2022.
2021-12-22
Brief amici curiae of Intellectual Property Professors filed.
2021-12-22
Brief amicus curiae of GlaxoSmithKline plc filed.
2021-12-22
Brief amici curiae of Association of University Technology Managers, Inc., et al.
2021-11-18
Petition for a writ of certiorari filed. (Response due December 22, 2021)

Attorneys

AbbVie Inc.
Jonathan S. MasseyMassey & Gail LLP, Amicus
Jonathan S. MasseyMassey & Gail LLP, Amicus
Alliance of U.S. Startups and Inventors for Jobs and and Innovation Alliance
Robert P. TaylorRPT Legal Strategies PC, Amicus
Robert P. TaylorRPT Legal Strategies PC, Amicus
American Intellectual Property Law Association
James D. Crowne[Self employed], Amicus
James D. Crowne[Self employed], Amicus
Amgen Inc., et al.
Jeffrey Alan LamkenMoloLamken LLP, Petitioner
Jeffrey Alan LamkenMoloLamken LLP, Petitioner
Arnold Ventures, The National Center for Health Research, Dr. Aaron S. Kesselheim, Dr. Eliot A. Brinton, Dr. Michael S. Doyle, and Dr. Jerry Avorn
Lauren A. DegnanFish & Richardson, P.C., Amicus
Lauren A. DegnanFish & Richardson, P.C., Amicus
Association for Accessible Medicines
Matthew S. HellmanJenner & Block LLP, Amicus
Matthew S. HellmanJenner & Block LLP, Amicus
Chemistry and the Law Division of the American Chemical Society
Justin James HasfordFinnegan Henderson Farabow Garrett and Dunner, LLP, Amicus
Justin James HasfordFinnegan Henderson Farabow Garrett and Dunner, LLP, Amicus
diversified researchers and innovators
Jeffrey P. KushanSidley Austin LLP, Amicus
Jeffrey P. KushanSidley Austin LLP, Amicus
Eli Lilly and Company, Ipsen Bioscience, Inc. and Innovent Biologics, Inc.
Katherine Ann HelmDechert LLP, Amicus
Katherine Ann HelmDechert LLP, Amicus
Fresenius Kabi USA, LLC
Michael Neil LloydSchiff, Hardin, & Waite, Amicus
Michael Neil LloydSchiff, Hardin, & Waite, Amicus
Genentech, Inc., AstraZeneca Pharmaceuticals LP, Bayer AG, Gilead Sciences, Inc., and Johnson & Johnson
Melanie Lynn BostwickOrrick, Herrington & Sutcliffe LLP, Amicus
Melanie Lynn BostwickOrrick, Herrington & Sutcliffe LLP, Amicus
GSK PLC
John M. DesmaraisDesmarais LLP, Amicus
John M. DesmaraisDesmarais LLP, Amicus
High Tech Inventors Alliance and The Computer & Communications Industry Association
John D. VandenbergKlarquist Sparkman, LLP, Amicus
John D. VandenbergKlarquist Sparkman, LLP, Amicus
Instil Bio, Inc.
John Randolph LabbeMarshall, Gerstein & Borun LLP, Amicus
John Randolph LabbeMarshall, Gerstein & Borun LLP, Amicus
Intellectual Property Law Association of Chicago
Charles W. ShifleyBanner & Witcoff, Ltd., Amicus
Charles W. ShifleyBanner & Witcoff, Ltd., Amicus
Intellectual Property Law Professors and Scholars
Edgar H. HaugHaug Partners, LLP, Amicus
Edgar H. HaugHaug Partners, LLP, Amicus
Intellectual Property Owners Association
Vanessa Y. YenKing & Spalding LLP, Amicus
Vanessa Y. YenKing & Spalding LLP, Amicus
Intellectual Property Professors
Mark A. LemleyStanford Law School, Amicus
Mark A. LemleyStanford Law School, Amicus
Law Professors Joshua D. Sarnoff, Sharon K. Sandeen, and Ana Santos Rutschman
Jeremy P. OczekBond, Schoeneck & King, PLLC, Amicus
Jeremy P. OczekBond, Schoeneck & King, PLLC, Amicus
National Association of Patent Practitioners, Inc.
Louis James HoffmanHoffman Patent Firm, Amicus
Louis James HoffmanHoffman Patent Firm, Amicus
New York Intellectual Property Law Association
Melvin C. GarnerLeason Ellis LLP, Amicus
Melvin C. GarnerLeason Ellis LLP, Amicus
Pfizer Inc.
Amit Hasit ThakoreWhite & Case LLP, Amicus
Amit Hasit ThakoreWhite & Case LLP, Amicus
Professor Robin Feldman
Gideon Alexander SchorCenter for Innovation, UC Law San Francisco, Amicus
Gideon Alexander SchorCenter for Innovation, UC Law San Francisco, Amicus
Public Interest Patent Law Institute
Nina Kosana SrejovicGeorgetown University Law Center, Amicus
Nina Kosana SrejovicGeorgetown University Law Center, Amicus
Regenxbio Inc., IGM Biosciences, Inc., Adaptive Phage Therapeutics, Inc.
William G. JenksJenks IP Law, Amicus
William G. JenksJenks IP Law, Amicus
Sanofi, et al.
Paul D. ClementClement & Murphy, PLLC, Respondent
Paul D. ClementClement & Murphy, PLLC, Respondent
Sir Gregory Paul Winter and Interested Scientists
Sophie Feifei WangChoate Hall & Stewart LLP, Amicus
Sophie Feifei WangChoate Hall & Stewart LLP, Amicus
Small and Medium Biotechnology Companies
Mark Andrew PerryWeil, Gotshal & Manges, LLP, Amicus
Mark Andrew PerryWeil, Gotshal & Manges, LLP, Amicus
The Fynder Group, Inc. d/b/a Nature’s Fynd
Matthew James DowdDowd Scheffel PLLC, Amicus
Matthew James DowdDowd Scheffel PLLC, Amicus
Unified Patents, LLC
Lisa Marie FerriMayer Brown LLP, Amicus
Lisa Marie FerriMayer Brown LLP, Amicus
United States
Elizabeth B. PrelogarSolicitor General, Amicus
Elizabeth B. PrelogarSolicitor General, Amicus
Viatris Inc.
Steffen Nathanael JohnsonWilson Sonsini Goodrich & Rosati, Amicus
Steffen Nathanael JohnsonWilson Sonsini Goodrich & Rosati, Amicus