The Software IP Report
Federal Circuit Affirms Grant of Summary Judgement Relating to Invalidity for Lack of Enablement Using Amgen Reasoning: Baxalta Inc. v. GenenTech, Inc.
In Baxalta Inc. v. GenenTech, Inc., No. 2022-1461 (Fed. Cir. Sep. 20, 2023), Baxalta Inc. and Baxalta
GmbH (“Baxalta”) appealed from the U.S. District Court for the District of Delaware a grant of summary
judgement that claims 1-4, 19, and 20 of U.S. Patent No. 7,033,590 (“the ‘590 patent”) are invalid for
lack of enablement. The Federal Circuit affirmed. Baxalta sued Genentech alleging Genentech’s
Hemlibra product infringed the ‘590 patent. After the district court’s claim construction of the terms
“antibody” and “antibody fragment,” the parties stipulated to non-infringement subject to appeal. On a
prior appeal, the Federal Circuit vacated the judgement of non-infringement and remanded due to the
district court erroneously excluding bispecific antibodies. On remand, Genentech moved for summary
judgment of invalidity of claims 1-4, 19, and 20.
The ‘590 patent relates to providing a means to treat Hemophilia A, a blood clotting disorder. Blot clots
are formed through a series of enzymatic activations known as the coagulation cascade. A “key step” of
the cascade includes an enzyme known as Factor VIIIa complexes with another enzyme known as
activated Factor IXa to activate Factor X. Hemophilia A is a disorder where the activity of Factor VIII is
functionally absent, thereby impeding the coagulation cascade and the body’s ability to effectively form
blood clots. The ’590 patent seeks to provide alternative ways to treat Hemophilia A in patients who
develop Factor VIII inhibitors. The ’590 patent discloses the amino acid sequences of eleven antibodies
that bind to Factor IX/IXa and increase the procoagulant activity of Factor IXa. The written description
states that a skilled artisan may use well-known antibody engineering techniques to transform the
resulting antibody into different structural formats.
Independent claim 1 is representative of the ‘590 patent:
- An isolated antibody or antibody fragment thereof that binds Factor IX or Factor IXa and
increases the procoagulant activity of Factor IXa.
Summary judgement rulings are reviewed under the law of the regional circuit. In this case, the Third
Circuit reviews de novo. Junker v. Med Components, Inc., 25 F.4th 1027, 1032 (Fed. Cir. 2022). Summary
judgement is appropriate when drawing all reasonable inferences in the non-movements favor, there is
no genuine issue of material fact and the movant is entitled to judgment as a matter of law. Anderson v.
Liberty Lobby, Inc., 477 U.S. 242, 255 (1986).
With regard to enablement, a patent’s specification must describe the invention and “the manner and
process of making and using it, in such full, clear, concise, and exact terms as to enable any person
skilled in the art to which it pertains … to make and use the same.” 35 U.S.C. § 112(a). In Amgen Inc. v.
Sanofi, the Supreme Court stated that “the specification much enable the full scope of the invention as
defined by its claims,” allowing for “a reasonable amount of experimentation.” 598 U.S. 594, 610-12
(2023) Enablement is a question of law. Because there is a presumption of validity of patents, lack of
enablement must be proven by clear and convincing evidence. ALZA Corp. v. Andrx Parms., LLC, 603 F.3d
935, 940 (Fed. Cir. 2010).
Baxalta argued that summary judgment of invalidity for lack of enablement was improper because
skilled artisans can obtain the full scope of claimed antibodies without undue experimentation and
skilled artisans can make and identify new claimed antibodies using the routine process disclosed in the
‘590 patent. According to Baxalta, the routine process does not amount to undue experimentation. The
Federal Circuit disagreed in light of Amgen.
The Court stated that the facts of the present case are materially indistinguishable from those of Amgen.
Claim 1 of the ‘590 patent covers all antibodies that (1) bind to Factor IX/IXa; and (2) increase the
procoagulant activity of Factor IXa. “There are millions of potential candidate antibodies” but the
specification only discloses amino acid sequences for eleven antibodies with the two claimed functions.
Just like in Amgen, the ‘590 patent includes a roadmap that directs skilled artisans to engage in the same
iterative, trial-and-error process the inventors followed to discover the eleven antibodies they elected to
disclose.
Additionally, the Court stated that it is undisputed that ‘590 patent contained no disclosures with a
common quality that would allow a skilled artisan to predict which antibodies will perform the claimed
functions. Amgen made clear that mere instructions, without more, is not enough to enable a broad
genus of claims like at issue here.
Accordingly, the Federal Circuit held that the ‘590 patent failed to teach a skilled artisan how to make
and use the full scope of the claimed antibodies without reasonable experimentation and affirmed the
district court’s of summary judgment that the claims at issue were