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Amgen Inc. v. 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.

10 F. 4th 1016, affirmed. 

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

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