Volume 598 U. S. Part 2 Pages 594–616

OFFICIAL REPORTS OF

THE SUPREME COURT May 18, 2023

Page Proof Pending Publication

REBECCA A. WOMELDORF reporter of decisions

NOTICE: This preliminary print is subject to formal revision before the bound volume is published. Users are requested to notify the Reporter of Decisions, Supreme Court of the United States, Washington, D.C. 20543, pio@supremecourt.gov, of any typographical or other formal errors. 594 OCTOBER TERM, 2022

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 Sanof—each de- veloped a PCSK9-inhibiting drug. In 2011, Amgen obtained a patent for the antibody employed in its drug, and Sanof received one covering the antibody used in its drug. Each patent describes the relevant anti- body by its unique amino acid sequence. The dispute in this case con- cerns two additional patents Amgen obtained in 2014 that relate back Page Proof Pending Publication to the company's 2011 patent. These later-issued patents purport to claim for Amgen “the entire genus” of antibodies that (1) “bind to spe- cifc 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 offce, Amgen identifed 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 an- tibodies that perform the binding-and-blocking functions described in the claims. After Amgen obtained the 2014 patents, it sued Sanof for infringe- ment. Sanof 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 as to enable any person skilled in the art . . . to make and use the [inven- tion].” 35 U. S. C. § 112(a). Sanof characterized the methods Amgen outlined for generating additional antibodies as amounting to little more than a trial-and-error process of discovery, and thus contended that Am- gen's patents failed to meet the enablement requirement because they sought to claim for Amgen's exclusive use potentially millions more anti- bodies than the company had taught persons skilled in the art to make. Both the district court and the Federal Circuit sided with Sanof. Cite as: 598 U. S. 594 (2023) 595

Syllabus Held: The courts below correctly concluded that Amgen failed “to enable any person skilled in the art . . . to make and use the [invention]” as defned by the relevant claims. Pp. 604–616. (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