# Amgen Inc. v. Sanofi

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 bloodstream. Two pharmaceutical companies—Amgen and Sanofi—each developed a PCSK9-inhibiting drug. In 2011, Amgen obtained a patent for the antibody employed in its drug, and Sanofi received one covering the antibody used in its drug. Each patent describes the relevant antibody by its unique amino acid sequence. The dispute in this case concerns two additional patents Amgen obtained in 2014 that relate 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.
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 competitive exploitation” in exchange for bringing “new designs and technologies 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 benefit of this bargain for the public by requiring the patent applicant to deposit a “specification … so particular … as not only to distinguish the invention or discovery from other things before known and used, but also to enable a workman or other person skilled in the art or manufacture … to make, construct, or use the same.” 1 Stat. 110. Over time, Congress has left this “enablement” obligation largely intact.
All this is not to say a specification always must describe with particularity how to make and use every single embodiment within a claimed class. It may suffice to give an example if the specification also discloses “some general quality … running through” the class that gives it “a peculiar fitness for the particular purpose.” Incandescent Lamp, 159 U. S., at 475. Nor is a specification necessarily inadequate just because it leaves the skilled artist to engage in some measure of adaptation or testing. See, e.g., Wood v. Underhill, 5 How. 1, 4–5. A specification may call for a reasonable amount of experimentation to make and use a claimed invention, and reasonableness in any case will depend on the nature of the invention and the underlying art. See Minerals Separation, Ltd. v. Hyde, 242 U. S. 261, 270–271. Pp. 7–15.
(b) Turning to the patent claims at issue in this case, Amgen’s claims sweep much broader than the 26 exemplary antibodies it identifies by their amino acid sequences. Amgen has failed to enable all that it has claimed, even allowing for a reasonable degree of experimentation. Amgen’s claims bear more than a passing resemblance to the broadest claims in Morse, Incandescent Lamp, and Holland Furniture. While Amgen seeks to monopolize an entire class of things defined by their function—every antibody that both binds to particular areas of the sweet spot of PCSK9 and blocks PCSK9 from binding to LDL receptors—the record reflects that this class of antibodies does not include just the 26 that Amgen has described by their amino acid sequences, but a vast number of additional antibodies that it has not.
Amgen’s alternative arguments lack merit. Amgen first suggests that the Federal Circuit erred by conflating the question whether an invention is enabled with the question how long may it take a person skilled in the art to make every embodiment within a broad claim. But the Federal Circuit made clear that it was not treating as dispositive the cumulative time and effort required to make the entire class of antibodies. Amgen next argues that the Patent Act supplies a single, universal enablement standard, while the Federal Circuit applied a higher standard to Amgen’s claims that encompass an entire genus of embodiments defined by their function. The Court agrees in principle that there is one statutory enablement standard, but the Federal Circuit’s treatment in this case is entirely consistent with Congress’s directive and this Court’s precedents. Finally, while Amgen warns that a ruling against it risks destroying the incentives that lead to breakthrough inventions, since 1790 Congress has included an enablement mandate as one feature among many designed to achieve the balance it wishes to strike between incentivizing inventors and ensuring the public receives the full benefit of their innovations. In this case, the Court’s duty is to enforce the statutory enablement requirement according to its terms. Pp. 15–19.
987 F. 3d 1080, affirmed.
| | The current edition of this document derives from the electronic version of the "slip opinion" posted online by the Supreme Court of the United States the day the decision was handed down. It is not the final or most authoritative version. It is subject to further revision by the Court and should be replaced with the final edition when it is published in a print volume of the United States Reports. The Court's full disclaimer regarding slip opinions follows: |
| The "slip" opinion is the second version of an opinion. It is sent to the printer later in the day on which the "bench" opinion is released by the Court. Each slip opinion has the same elements as the bench opinion—majority or plurality opinion, concurrences or dissents, and a prefatory syllabus—but may contain corrections not appearing in the bench opinion. Caution: These electronic opinions may contain computer-generated errors or other deviations from the official printed slip opinion pamphlets. Moreover, a slip opinion is replaced within a few months by a paginated version of the case in the preliminary print, and—one year after the issuance of that print—by the final version of the case in a U. S. Reports bound volume. In case of discrepancies between the print and electronic versions of a slip opinion, the print version controls. In case of discrepancies between the slip opinion and any later official version of the opinion, the later version controls. (source: http://www.supremecourt.gov/opinions/slipopinions.aspx) ||
This work is in the public domain in the United States because it is a work of the United States federal government (see 17 U.S.C. 105).
Public domainPublic domainfalsefalse