Supreme Court Decides Amgen Inc. v. Sanofi

On May 18, 2023, the U.S. Supreme Court decided Amgen Inc. v. Sanofi, No. 21-757, affirming the decisions below and holding that Amgen’s relevant patent claims were invalid under the Patent Act’s enablement requirement, 35 U.S.C. § 112(a), because the patents failed to describe the invention in a way that would enable any person skilled in the art to make and use the invention.

The Constitution vests in Congress the power to “promote the Progress of Science and useful Arts, by securing for limited Times to Authors and Inventors the exclusive Right to their respective Writings and Discoveries.” Art. I, § 8, cl. 8. The Patent Act exercises this authority and provides a limited monopoly to any applicant who “invented or discovered any useful art, manufacture, . . . or device, or any improvement therein not before known or used.” The statute, however, ensures through its enablement requirement that the public will have the full benefit of the invention or discovery after the expiration of the patent term by requiring the applicant to deposit with the Secretary of State a “written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art . . . to make and use the same.” 35 U.S.C. §112(a). Citing 170 years of precedent, the Court reiterated the “simple statutory command” that “the [patent’s] specification must enable the full scope of the invention as defined by its claims.”

At issue in the decision is the validity of two 2014 patents received by Amgen related to the creation of antibodies to treat patients with high LDL cholesterol. Amgen and Sanofi are pharmaceutical companies that each developed drugs to reduce levels of LDL cholesterol. Amgen’s patents claim a monopoly over all antibodies that (1) bind to specific amino acids on a naturally occurring protein known as PCSK9, and (2) block PCSK9 from impairing the body’s mechanism for removing LDL cholesterol from the bloodstream. Soon after receiving these patents, Amgen sued Sanofi for infringement. Sanofi argued that the patents were invalid as a matter of law under Section 112 of the Patent Act because they sought to claim for Amgen’s exclusive use potentially millions more antibodies than the 26 Amgen had taught scientists to make. The district court ruled for Sanofi, and the Federal Circuit affirmed.

The Supreme Court affirmed the lower courts, holding that Amgen’s claims did not satisfy the enablement requirement. The Court focused on the methods required by the two patents in question and stressed that while Amgen had identified 26 antibodies that bind to PCSK9 and block it from binding to LDL receptors, its claims covered potentially millions more undisclosed antibodies that perform these same functions. The Court concluded that neither of the two methods Amgen had outlined for generating additional antibodies enabled a person skilled in the art to do so reliably as required by Section 112 of the Patent Act.

Justice Gorsuch delivered the opinion for a unanimous Court.