A functional genus claim must be enabled across its full scope, and a research plan is not enablement

2023-05-18Supreme Court

Amgen Inc. v. Sanofi, 598 U.S. 594, No. 21-757 (May 18, 2023) (Gorsuch, J., for a unanimous Court), affirming the United States Court of Appeals for the Federal Circuit

United States Patent Nos. 8,829,165 and 8,859,741 claim every antibody that binds a "sweet spot" of 15 of the 692 amino acids on the PCSK9 protein and blocks PCSK9 from binding to LDL receptors. The specifications disclose the amino acid sequences of 26 such antibodies and describe two methods for finding more: a "roadmap" of generating candidate antibodies and screening them for the claimed functions, and "conservative substitution" of amino acids in a known working antibody. The district court held claims 19 and 29 of the '165 patent and claim 7 of the '741 patent not enabled under Section 112 of Title 35 of the United States Code as a matter of law, and the Federal Circuit affirmed. The Supreme Court affirmed in a unanimous opinion by Justice Gorsuch. Reading Morse, Incandescent Lamp and Holland Furniture together, the Court held that where a patent "claims an entire class of processes, machines, manufactures, or compositions of matter," the specification must enable a skilled artisan to make and use the entire class. A specification "may call for a reasonable amount of experimentation," and need not describe every embodiment if it discloses "some general quality" of the class, but the two methods here "amount to little more than two research assignments," and "Amgen has failed to enable all that it has claimed, even allowing for a reasonable degree of experimentation."

What it changesA claim to any model "trained to" produce an output or any architecture "configured to" reach a result is a functional genus, and this decision says the specification must enable the whole genus, not the two or three networks the team built. A specification that discloses one trained model and a recipe for finding others by trial and error is the roadmap the Court rejected. The response is to claim what was actually shown to work, with the architecture, the training objective, the data pipeline and the inference mechanism recited as limitations; to put the general quality that makes the class work into the specification in words an engineer can apply; and to keep the broad functional claim as one claim among several rather than the one the portfolio depends on. Enablement is now the invalidity argument of choice against broad software claims that survive Section 101, and a review of issued claims should ask whether the specification enables everything they cover.

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Burbage Law is the practice of Jon Burbage, a registered patent attorney. 342 United States patents have issued from applications he wrote; the full list is on the Patents page. More about Jon Burbage.

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