Page:Amgen Inc. v. Sanofi.pdf/3

Syllabus

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