Syllabus

NOTE: Where it is feasible, a syllabus (headnote) will be released, as is being done in connection with this case, at the time the opinion is issued. The syllabus constitutes no part of the opinion of the Court but has been prepared by the Reporter of Decisions for the convenience of the reader. See United States v. Detroit Timber & Lumber Co., 200 U. S. 321, 337.

SUPREME COURT OF THE UNITED STATES

Syllabus

AMGEN INC. ET AL. v. SANOFI ET AL. CERTIORARI TO THE UNITED STATES COURT OF APPEALS FOR THE FEDERAL CIRCUIT

No. 21–757. Argued March 27, 2023—Decided May 18, 2023 This case concerns patents covering antibodies engineered by scientists that help reduce levels of low-density lipoprotein (LDL) cholesterol, sometimes called bad cholesterol because it can lead to cardiovascular disease, heart attacks, and strokes. To treat patients with high LDL cholesterol, scientists explored how antibodies might be used to inhibit PCSK9—a naturally occurring protein that binds to and degrades LDL receptors responsible for extracting LDL cholesterol from the blood- stream. Two pharmaceutical companies—Amgen and Sanofi—each developed a PCSK9-inhibiting drug. In 2011, Amgen obtained a pa- tent for the antibody employed in its drug, and Sanofi received one covering the antibody used in its drug. Each patent describes the rel- evant antibody by its unique amino acid sequence. The dispute in this case concerns two additional patents Amgen obtained in 2014 that re- late back to the company’s 2011 patent. These later-issued patents purport to claim for Amgen “the entire genus” of antibodies that (1) “bind to specific amino acid residues on PCSK9,” and (2) “block PCSK9 from binding to [LDL receptors].” 872 F. 3d 1367, 1372. As part of its submission to the patent office, Amgen identified the amino acid sequences of 26 antibodies that perform these two functions. Amgen then described two methods—one Amgen called “the roadmap” and a second it called “conservative substitution”—that scientists could use to make other antibodies that perform the binding-and-blocking functions described in the claims. After Amgen obtained the 2014 patents, it sued Sanofi for infringe- ment. Sanofi replied that it was not liable to Amgen for infringement because Amgen’s relevant claims were invalid under the Patent Act’s “enablement” requirement. That provision requires a patent applicant to describe the invention “in such full, clear, concise, and exact terms 2 AMGEN INC. v. SANOFI

Syllabus

as to enable any person skilled in the art . . . to make and use the [in- vention].” 35 U. S. C. §112(a). Sanofi characterized the methods Amgen outlined for generating additional antibodies as amounting to little more than a trial-and-error process of discovery, and thus con- tended that Amgen’s patents failed to meet the enablement require- ment because they sought to claim for Amgen’s exclusive use poten- tially millions more antibodies than the company had taught persons skilled in the art to make. Both the district court and the Federal Cir- cuit sided with Sanofi. Held: The courts below correctly concluded that Amgen failed “to enable any person skilled in the art . . . to make and use the [invention]” as defined by the relevant claims. Pp. 7–19. (a) The patent “bargain” describes the exchange that takes place when an inventor receives a limited term of “protection from competi- tive exploitation” in exchange for bringing “new designs and technolo- gies into the public domain through disclosure” for the benefit of all. Bonito Boats, Inc. v. Thunder Craft Boats, Inc., 489 U. S. 141, 150. From the Patent Act’s beginnings, Congress has sought to ensure the be