Fresh From the Bench: Latest Precedential Patent Cases
CASE OF THE WEEK
Baxalta Inc. v. Genentech, Inc., Appeal No. 22-1461 (Fed. Cir. Sept. 20, 2023)
Our Case of the Week focuses on the enablement requirement. It’s the first case to come before the Federal Circuit following the Supreme Court’s decision on the issue earlier this year in Amgen Inc. v. Sanofi, 598 U.S. 495 (2023). Here, a panel of the Circuit unanimously found that broad claims to an entire class of antibodies were not fully enabled by the patent specification.
The patent concerns treatments for hemophilia A, a blood-clotting disorder. Blood clots are formed through a series of enzymatic activations, including a step wherein Factor VIII and Factor IX/Factor IXa complex to activate Factor X. For patients with hemophilia A, Factor VIII is functionally absent.
Baxalta’s ’590 patent discloses a treatment for hemophilia A, wherein certain antibodies allow Factor IXa to activate Factor X in the absence of Factor VIII.
The Federal Circuit affirmed an inter partes review decision of the Patent Trial and Appeal Board that found challenged claims of Elekta’s U.S. Patent No. 7,295,648 to be obvious. The Court held that in its findings concerning the prior art, the Board was not required to make an express “reasonable expectation of success” analysis separately from its “motivation to combine” analysis. The ’648 patent claimed a method and apparatus for delivering therapeutic radiation from a linear accelerator (“linac”) mounted on a rotating concentric ring structure:
At issue on appeal was whether a person of ordinary skill in the art would have been motivated to combine a prior art reference that disclosed a similar rotational apparatus for use in radiation imaging applications (such as X-ray) with a reference generally disclosing the use of a rotating linac to deliver radiation therapy. The Board found that a POSITA would be motivated to make the combination, for example rejecting petitioner ZAP’s arguments that the added weight of the linac and associated accuracy concerns would dissuade a POSITA from making the attempt, and noting that the prior art disclosed advantages to combining imaging and therapeutic irradiating functions in a single device. The Federal Circuit agreed, and also rejected ZAP’s argument that the Board failed to make any express “reasonable expectation of success” analysis. Rather, the Court re-affirmed precedent that “a finding of a reasonable expectation of success can be implicit,” for example “where the Board makes an implicit finding on reasonable expectation of success by considering and addressing other, intertwined arguments, including, as we hold today, a motivation to combine.” Because the Board’s express motivation to combine findings and related, implicit reasonable expectation of success findings were supported by substantial evidence, the Federal Circuit affirmed its decision that the challenged claims were unpatentable as obvious.