Precedential and Key Federal Circuit Opinions

1.  BAXALTA INCORPORATED v. GENENTECH, INC. [OPINION] (2022-1461, 9/20/2023) (Moore, Clevenger, and Chen)

Moore, C.J. The Court affirmed a district court’s grant of summary judgment that claims were invalid for lack of enablement. Claim 1 of the asserted patent “cover[ed] all antibodies that (1) bind to Factor IX/IXa; and (2) increase the procoagulant activity of Factor IXa.” There were “millions of potential candidate antibodies,” but “the written description disclose[d] the amino acid sequences for only eleven antibodies with the two claimed functions.” It was “undisputed that to practice the full scope of the claimed invention, skilled artisans must make candidate antibodies and screen them to determine which ones perform the claimed functions.” The patent did “not disclose any common structural (or other) feature delineating which antibodies will bind to Factor IX/IXa and increase procoagulant activity from those that will not.” The Court held that, under Amgen, “such random trial-and-error discovery, without more, constitutes unreasonable experimentation that falls outside the bounds required by § 112(a).”

1.  ELECKTA LIMITED v. ZAP SURGICAL SYSTEMS, INC. [OPINION] (2021-1985, 9/21/2023) (Reyna, Stoll, and Stark)

Reyna, J. The Court affirmed an IPR decision by the PTAB finding certain claims unpatentable as obvious. First, the Court found “substantial support for the Board’s finding that a person of ordinary skill in the art would have been motivated to make the proposed combination.” Second, the Court held “the Board made a sufficient, implicit finding that a skilled artisan would have had a reasonable expectation of success in combining the prior art references,” holding that the Court could “reasonably discern that the Board considered and implicitly addressed reasonable expectation of success based on the arguments and evidence presented to the Board on motivation to combine.” Although “requiring less than an explicit statement may appear to be in tension” with the APA, which requires the Board to “explain” its decisions “with sufficient precision,” the Court held that “there is no such tension where the Board makes an implicit finding on reasonable expectation of success by considering and addressing other, intertwined arguments, including … a motivation to combine.” Lastly, the Court concluded that the Board’s finding that a skilled artisan would have had a reasonable expectation of success in combining the references was supported by substantial evidence.