Amgen Inc. v. Sanofi
598 U.S. 594 (2023)
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Rule of Law:
Under the Patent Act's enablement requirement, 35 U.S.C. § 112(a), if a patent claims an entire class of products by their function, the specification must enable a person skilled in the art to make and use the full scope of the claimed invention without undue experimentation.
Facts:
- Pharmaceutical companies Amgen and Sanofi each developed antibody-based drugs to reduce LDL cholesterol by inhibiting a protein called PCSK9.
- The antibodies function by binding to a specific 15-amino-acid region of PCSK9 (the 'sweet spot') and blocking PCSK9 from degrading LDL receptors.
- In 2011, both companies received patents covering their specific drug's antibody, identified by its unique amino acid sequence.
- In 2014, Amgen obtained two additional patents claiming the entire genus of antibodies that perform two functions: 1) binding to specific residues on PCSK9, and 2) blocking PCSK9 from binding to LDL receptors.
- Amgen's patent specification identified the amino acid sequences for 26 antibodies that performed these functions.
- To enable the creation of other antibodies in the claimed class, which could number in the millions, Amgen disclosed two methods: a 'roadmap' for screening antibodies and 'conservative substitution' for modifying known antibodies.
- Sanofi's competing drug, Praluent, also uses an antibody that performs the two functions claimed in Amgen's 2014 patents.
Procedural Posture:
- Amgen Inc. sued Sanofi for patent infringement in the U.S. District Court for the District of Delaware (the trial court of first instance).
- Sanofi asserted as a defense that Amgen's patent claims were invalid for failing to meet the enablement requirement of 35 U.S.C. § 112.
- The district court granted Sanofi judgment as a matter of law, concluding the patent claims at issue were not enabled.
- Amgen, as the appellant, appealed the district court's decision to the U.S. Court of Appeals for the Federal Circuit.
- The Federal Circuit affirmed the district court's judgment, agreeing that Amgen's claims were invalid for lack of enablement.
- The U.S. Supreme Court granted Amgen's petition for a writ of certiorari to review the Federal Circuit's decision.
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Issue:
Does a patent satisfy the Patent Act's enablement requirement when it claims an entire genus of antibodies by their function but only discloses the amino acid sequences for a small number of examples and provides general methods for discovering others through trial and error?
Opinions:
Majority - Gorsuch
No. A patent does not satisfy the enablement requirement when it claims a vast genus of antibodies by their function but fails to teach a person skilled in the art how to make and use the full scope of that genus without undue experimentation. The patent bargain requires that in exchange for a monopoly, the inventor must provide a full disclosure of the invention. Merely providing a few examples and a research plan for trial-and-error discovery of other members of the genus is insufficient. The Court reasoned that 'the more one claims, the more one must enable.' Relying on precedents like O'Reilly v. Morse and The Incandescent Lamp Patent, the Court found Amgen's claims analogous to attempts to patent a functional result rather than a specific invention. Amgen defined the claimed antibodies by what they do, not by their structure or a 'general quality' that would reliably allow a skilled artisan to create them. The 'roadmap' and 'conservative substitution' methods were not a form of enablement but rather research assignments that required 'painstaking experimentation,' akin to a 'hunting license' which is not what the enablement requirement demands.
Analysis:
This unanimous decision reinforces a robust enablement standard for patent law, particularly for broad, functional genus claims common in biotechnology and pharmaceuticals. The ruling clarifies that patent protection does not extend to an entire functional class of substances based on the discovery of a few examples and a method for finding more. This decision will likely compel inventors to file narrower claims tailored to what they have actually invented and can describe, potentially curbing attempts to monopolize future discoveries in a research area. It significantly impacts patent prosecution strategy, encouraging more concrete disclosures over speculative, functional claiming in unpredictable arts.
