In Baxalta Incorporated v. Genentech, Inc. 2022-1461 (Fed. Cir. September 20, 2023), this case addresses the enablement requirement in view of the Supreme Court's recent decision in Amgen Inc. v. Sanofi, 598 U.S. 594 (2023).
Background
Baxalta Inc. and Baxalta GmbH (collectively "Baxalta") sued Genentech Inc. ("Genentech") for infringement of US Pat. No. 7,033,590 ("the '590 patent").
The asserted claims of the '590 patent are drawn to antibodies (or antibody derivatives) for treating Hemophilia. Representative of the asserted claims, independent claim 1 of the '590 patent recites "[a]n isolated antibody or antibody fragment thereof that binds Factor IX or Factor IXa and increases the procoagulant activity of Factor IXa."
On remand, the district court granted summary judgement for Genentech based on a finding that the asserted claims of the '590 patent were invalid for lack of enablement.
Baxalta appealed.
Issue
Did the specification of the '590 patent enable the "full scope" of the claimed antibodies without undue experimentation?
Holding
The specification of the '590 patent did not enable the "full scope" of the claimed antibodies without undue experimentation because: (1) "[t]here are millions of potential candidate antibodies [covered by the asserted claims] ... but the written description discloses the amino acid sequences for only eleven antibodies with the two claimed functions;" and (2) any roadmap contained in the specification of the '590 patent to make or use undisclosed antibodies "simply 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" – which the Supreme Court previously held to be insufficient to satisfy the enablement requirement in Amgen Inc. v. Sanofi, 598 U.S. 594 (2023).
Reasoning
The Federal Circuit based its enablement analysis on the recent Supreme Court decision in Amgen.
In Amgen, the asserted patents claimed all antibodies that (1) bind to specific amino acid residues on a protein known as PCSK9; and (2) block PCSK9 from binding to LDL receptors. The Federal Circuit noted that similar to the '590 patent, "[t]he full scope of the claims [in Amgen] covered potentially millions of antibodies, but the specification only disclosed the amino acid sequences of twenty-six antibodies that performed the two claimed functions." The specification in Amgen included a "roadmap" that skilled artisans could follow to make and use undisclosed antibodies. The specification in Amgen also indicated that skilled artisans could employ a technique known as "conservative substitution" to make and use undisclosed antibodies.
The Supreme Court held that Amgen's roadmap and the disclosed conservative substitution methods "amount[ed] to little more than two research assignments" and failed to enable the full scope of the claims. Amgen, at 612–15. Namely, the Supreme Court reasoned that Amgen's roadmap "merely describes step-by-step Amgen's own trial-and-error method for finding functional antibodies—calling on scientists to create a wide range of candidate antibodies and then screen each to see" which practice the claims. Id. at 614. Relatedly, the Supreme Court found the conservative substitution method simply "requires scientists to make substitutions to the amino acid sequences of antibodies known to work and then test the resulting antibodies to see if they do too—an uncertain prospect given the state of the art." Id.
The Federal Circuit found the facts from this case "materially indistinguishable from those in Amgen." Namely, the Federal Circuit found that "[j]ust like the roadmap rejected by the Supreme Court in Amgen, the '590 patent's roadmap simply 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."
Addressing the Supreme Court's suggestion in Amgen that methods like a roadmap or conservative substitution might be sufficient for enablement where a patent discloses "a quality common to every functional embodiment" – the Federal Circuit further noted that the '590 patent included no such disclosures "that would allow a skilled artisan to predict which antibodies will perform the claimed functions." Instead, the Federal Circuit found that "[t]he only guidance the patent provides is 'to create a wide range of candidate antibodies and then screen each to see which happen to bind' to Factor IX/IXa and increase procoagulant activity." (citing Amgen, at 614).
Addressing one of Baxalta's attempts to distinguish from Amgen, the Federal circuit further stated that "[e]ven accepting as true that skilled artisans will generate at least one claimed antibody each time they follow the disclosed process, this does not take the process out of the realm of the trial-and-error approaches rejected in Amgen. Amgen made clear that § 112(a) requires inventors to enable the 'full scope' of the claimed invention without unreasonable experimentation... Here, it is 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... This is the definition of trial and error and leaves the public no better equipped to make and use the claimed antibodies than the inventors were when they set out to discover the antibodies over which they now have an exclusive right." (emphasis added) (citing Amgen at 610-612).
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