Amgen Inc. v. Sanofi

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Supreme Court of the United States
Amgen Inc. v. Sanofi
Term: 2022
Important Dates
Argued: March 27, 2023
Decided: May 18, 2023
Outcome
affirmed
Vote
9-0
Majority
Chief Justice John Roberts • Clarence Thomas • Samuel Alito • Sonia Sotomayor • Elena Kagan • Neil Gorsuch • Brett Kavanaugh • Amy Coney Barrett • Ketanji Brown Jackson

Amgen Inc. v. Sanofi is a case that was decided by the Supreme Court of the United States on May 18, 2023, during the court's October 2022-2023 term. The case was argued before the Supreme Court of the United States on March 27, 2023. In a 9-0 opinion, the court affirmed the judgment of the United States Court of Appeals for the Federal Circuit, holding that Amgen's two patent applications failed to satisfy 35 U.S.C. §112(a)'s enablement clause.

HIGHLIGHTS
  • The issue: The case concerned concerns enablement under the Patent Act. Click here to learn more about the case's background.
  • The questions presented: "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)."[1]
  • The outcome: The court affirmed the judgment of the United States Court of Appeals for the Federal Circuit, holding that Amgen's two patent applications failed to satisfy 35 U.S.C. §112(a)'s enablement clause.


    • The case came on a writ of certiorari to the United States Court of Appeals for the Federal Circuit. To review the lower court's opinion, click here.

    Timeline

    The following timeline details key events in this case:

    Background

    Pharmaceutical company Amgen holds patents for monoclonal antibodies that lower LDL cholesterol (sometimes called bad cholesterol). In 2014, Amgen sued Sanofi, in the U.S. District Court for the District of Delaware. In the suit, Amgen claimed that Sanofi committed a number of patent infringements. Sanofi argued that the patents were invalid because they did not meet 35 U.S.C. §112(a), also known as the enablement requirement, which required a patent to outline the invention with enough detail that a skilled artisan would be able to make and use the invention. Both the district court and the U.S. Court of Appeals for the Federal Circuit, which Amgen appealed to, ruled in Sanofi's favor.[4][5][6]

    Questions presented

    The petitioner presented the following questions to the court:[1]

    Questions presented:
    “ 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).[7] ”

    Oral argument

    Audio

    Audio of oral argument:[8]




    Transcript

    Transcript of oral argument:[9]

    Outcome

    In a 9-0 opinion, the court affirmed the judgment of the United States Court of Appeals for the Federal Circuit, holding that Amgen's two patent applications failed to satisfy 35 U.S.C. §112(a)'s enablement clause. Justice Neil Gorsuch delivered the opinion of the court.[10]

    Opinion

    In the court's majority opinion, Justice Neil Gorsuch wrote:[10]

    “ With these principles in mind, we return to claims 19 and 29 of the ’165 patent and claim 7 of the ’741 patent. In doing so, we do not doubt that Amgen’s specification enables the 26 exemplary antibodies it identifies by their amino acid sequences. Even Sanofi concedes that description is enough to allow a person skilled in the art to make and use those embodiments. See Tr. of Oral Arg. 68. But the claims before us sweep much broader than those 26 antibodies. And we agree with the lower courts that Amgen has failed to enable all that it has claimed, even allowing for a reasonable degree of experimentation.

    [7]

    		”
    —Justice Neil Gorsuch

    Text of the opinion

    Read the full opinion here.

    October term 2022-2023

    See also: Supreme Court cases, October term 2022-2023

    The Supreme Court began hearing cases for the term on October 3, 2022. The court's yearly term begins on the first Monday in October and lasts until the first Monday in October the following year. The court generally releases the majority of its decisions in mid-June.[11]


    See also

    External links

    Footnotes

    1. ↑ 1.0 1.1 U.S. Supreme Court, "21-757 AMGEN INC. V. SANOFI QUESTIONS PRESENTED," Cert. granted November 4, 2022
    2. ↑ U.S. Supreme Court, "Amgen Inc. v. Sanofi On Petition for a Writ of Certiorari to the United States Court of Appeals for the Federal Circuit," filed November 18, 2021
    3. ↑ U.S. Court of Appeals for the Federal Circuit, Amgen Inc. v. Sanofi, Aventisub LLC, decided February 11, 2021
    4. ↑ U.S. Supreme Court, "Amgen Inc., Amgen Manufacturing,Limited, And Amgen USA, Inc.,Petitioners, V. Sanofi, Ventisub LLC, FKA Aventis Pharmaceuticals Inc., Regeneron Pharmaceuticals, Inc., and Sanofi-Aventis U.S. LLC," March 20, 2023
    5. ↑ SCOTUSblog, "Court to decide how specific a patent disclosure must be," March 23, 2023
    6. ↑ SCOTUSblog, "Amgen Inc. v. Sanofi," March 28, 2023
    7. ↑ 7.0 7.1 Note: This text is quoted verbatim from the original source. Any inconsistencies are attributable to the original source.
    8. ↑ Supreme Court of the United States, "Oral Argument - Audio," argued March 27,2023
    9. ↑ Supreme Court of the United States, "Oral Argument - Transcript," argued March 27,2023
    10. ↑ 10.0 10.1 U.S. Supreme Court, "Amgen Inc. et al. v.. Sanofi et al. Certiorari to The United States Court," May 18, 2023
    11. ↑ SupremeCourt.gov, "The Supreme Court at Work: The Term and Caseload," accessed January 24, 2022
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