Amgen Inc. v. Sanofi
598 U.S. 594 (2023)
Rule of Law:
To satisfy the enablement requirement of 35 U.S.C. § 112(a), a patent's specification must enable a person skilled in the art to make and use the full scope of the claimed invention. The more a patent claims, particularly when claiming an entire functional genus, the more it must enable without requiring undue experimentation.
Facts:
- Scientists explored using antibodies to inhibit PCSK9, a naturally occurring protein that degrades LDL receptors, as a treatment for high cholesterol.
- Two pharmaceutical companies, Amgen and Sanofi, each developed distinct PCSK9-inhibiting drugs employing unique antibodies with their own specific amino acid sequences.
- In 2011, both Amgen and Sanofi obtained patents for their respective specific antibodies, described by their unique amino acid sequences.
- In 2014, Amgen obtained two additional patents that claimed the entire genus of antibodies defined by a two-part functional test: (1) binding to specific amino acid residues on PCSK9, and (2) blocking PCSK9 from binding to LDL receptors.
- In its patent submission, Amgen identified the amino acid sequences for only 26 antibodies that performed these functions.
- To enable the creation of other antibodies within the claimed genus, Amgen's patent described two methods: a 'roadmap' for screening potential antibodies and 'conservative substitution' for modifying known antibodies.
- The class of antibodies claimed by Amgen could potentially encompass millions of distinct antibody sequences beyond the 26 that were specifically disclosed.
Procedural Posture:
- Amgen Inc. sued Sanofi in the U.S. District Court for the District of Delaware for patent infringement.
- Sanofi defended by arguing that the asserted patent claims were invalid for failing the enablement requirement of 35 U.S.C. § 112.
- The district court granted judgment as a matter of law to Sanofi, concluding that the claims were not enabled.
- Amgen, as appellant, appealed the decision to the U.S. Court of Appeals for the Federal Circuit.
- The Federal Circuit affirmed the district court's judgment, holding that no reasonable factfinder could conclude Amgen had enabled the full scope of its claims.
- The Supreme Court of the United States granted Amgen's petition for a writ of certiorari.
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Issue:
Do patent claims covering an entire functional genus of antibodies satisfy the Patent Act's enablement requirement when the specification only discloses the amino acid sequences for a small number of exemplary antibodies and provides general methods for discovering others?
Opinions:
Majority - Justice Gorsuch
No. The patent claims fail to satisfy the enablement requirement because the specification does not enable a person skilled in the art to make and use the full scope of the claimed invention. Amgen claimed a vast genus of antibodies defined by their function but only provided the specific structures for 26 examples. The 'roadmap' and 'conservative substitution' methods are not enabling; they amount to little more than a 'research assignment' or a 'hunting license,' requiring skilled artisans to engage in the same kind of 'painstaking experimentation' and 'trial-and-error' discovery that Amgen itself undertook. Citing precedents like O'Reilly v. Morse and The Incandescent Lamp Patent, the Court affirmed that an inventor cannot claim a monopoly over an entire functional class without teaching how to reliably achieve that function across the class, thus failing to uphold the public's side of the patent 'bargain.'
Analysis:
This unanimous decision strongly reaffirms the 'full scope' enablement standard, particularly for broad functional claims in unpredictable fields like biotechnology. The ruling discourages inventors from claiming a monopoly over an entire class of solutions to a problem when they have only identified a few specific examples. It will likely compel patent applicants to file narrower claims that are more commensurate with what their specification actually teaches, potentially altering patent strategy in the pharmaceutical and biotech industries by requiring more comprehensive disclosure to support broad functional claims.
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