The Supreme Court handed down its decision in Amgen v. Sanofi today. In Justice Gorsuch’s unanimous opinion, the Court held that the scope of the claims at issue were much broader than the 26 expressly disclosed antibodies. The Court sees these claims as being like (“bear more than a passing resemblance”) the claims held to be invalid 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. The Supreme Court handed down its decision in Amgen v. Sanofi today, affirming the Federal Circuit's decision below in a unanimous opinion by Justice Gorsuch.

The opinion relies heavily on its own precedent that was heavily cited by both parties in their briefs and arguments, including 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. In the Court's view, the statute plainly requires that "[i]f 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." The Court is careful to address some of the concerns raised by Amgen and its amici regarding that the burdens the disclosure requirements would imposed taken to its extreme could inhibit innovation in the biotech and pharma arts. In this regard, the Court states "[a]ll this is not to say a specification always must describe with particularity how to make and use every single embodiment within a claimed class." But the enablement requirement requires, for example, that the specification also discloses "some general quality . . . running through" the class that gives it "a peculiar fitness for the particular purpose," as in Incandescent Lamp, and situations where there is some adaptation or testing is needed does not make the disclosure "necessarily inadequate," as in Wood v. Underhill, 5 How. 1, 4– 5. Under Minerals Separation, Ltd. v. Hyde, 242 U. S. 261, 270–271, the opinion states that "[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."

Amgen's claims fail this test, the Court holding that the scope of the claims at issue were much broader than the 26 expressly disclosed antibodies. The Court sees these claims as being like ("bear more than a passing resemblance") the claims in Morse, Incandescent Lamp, and Holland Furniture that were held to be invalid. The Court understands Amgen's claims to attempt to "monopolize an entire class of things defined by their function" even though that class was must broader ("a vast number") of antibodies. Nor was Amgen's disclosure of a "roadmap" for obtaining other antibodies or reference to "conservative substitutions" persuasive, the Court considering these to "amount to little more than two research assignments."

The decision certainly solidifies the Federal Circuit's trend of limiting claim scope much more closely to what is expressly disclosed and the Court's affirmance of the insufficiency of relying on conservative substitutions will have consequences extending much more broadly than to antibody claims. Further discussions of the implications will be provided in later posts.