Amgen Inc. v. Sanofi

by Supreme Court of the United States

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.

After Amgen obtained the 2014 patents, it sued Sanofi for infringement. 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 as to enable any person skilled in the art … to make and use the [invention].” 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 contended that Amgen’s patents failed to meet the enablement requirement because they sought to claim for Amgen’s exclusive use potentially millions more antibodies than the company had taught persons skilled in the art to make. Both the district court and the Federal Circuit 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 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.

This Court has addressed the enablement requirement many times, and its decisions in O’Reilly v. Morse, 15 How. 62, The Incandescent Lamp Patent, 159 U. S. 465, and Holland Furniture Co. v. Perkins Glue Co., 277 U. S. 245, reinforce the simple statutory command: If a patent claims an entire class of processes, machines, manufactures, or compositions of matter, the patent’s specification must enable a person skilled in the art to make and use the entire class. In Morse, for example, the Court held that one of the claims in Morse’s patent for a telegraphic system was “too broad, and not warranted by law.” 15 How., at 113. The problem was that the claim covered all means of achieving telegraphic communication, yet Morse’s specification did not describe how to make or use them all. See id., at 113–117. In Incandescent Lamp, inventors of an “electric lamp” with an “incandescing conductor” made of “carbonized paper” claimed that a lamp created by Thomas Edison infringed their patent because it used bamboo as a conductor. The Court sided with Edison because the rival inventors, rather than confining their claim to carbonized paper, “made a broad claim for every fibrous and textile material.” 159 U. S., at 472. That broad claim “might” have been permissible, the Court allowed, if the inventors had disclosed “a quality common” to fibrous and textile substances that made them “peculiarly” adapted to incandescent lighting, but they did not. Ibid. Finally, in Holland Furniture, a company that had developed a starch glue that was similar enough to animal glue to be used for wood veneering included a claim in its patent covering all “starch glue which, [when] combined with about three parts or less … of water, will have substantially the same properties as animal glue.” 277 U. S., at 251. The specification described the key input—the “starch ingredient”—in terms of its “use or function” rather than its “physical characteristics or chemical properties.” Id., at 256. The problem, as the Court put it, was that “[o]ne attempting to use or avoid the use of [the] discovery as so claimed and described functionally could do so only after elaborate experimentation” with different starches. Id., at 257.

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 insists that its claims are nevertheless enabled because scientists can make and use every functional antibody if they simply follow the “roadmap” or “conservative substitution.” These two approaches, however, amount to little more than two research assignments. The “roadmap” merely describes step-by-step Amgen’s own trial-and-error method for finding functional antibodies. Not much different, “conservative substitution” requires scientists to make substitutions to the amino acid sequences of antibodies known to work and then test the resulting antibodies to see if they do too.

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.

Gorsuch, J., delivered the opinion for a unanimous Court.

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