USA Trends and Developments Contributed by: Ed Haug, Andrew Wasson and Wan Chieh (Jenny) Lee, Haug Partners LLP
provides little guidance as to what type of devic - es are encompassed by the claims and how the devices would function. Citing to Amgen, the Federal Circuit concluded that “[h]ere, much is claimed and little is enabled” and affirmed the rejections of the claims as lacking enablement. Although this first post-Amgen decision from the Federal Circuit is non-precedential, it pro - vides a first glimpse that the ramifications of the Supreme Court’s holding in Amgen may extend beyond antibody technologies. Shortly after Starett, the Court of Appeals for the Federal Circuit, in a precedential deci - sion, extended the Supreme Court’s analysis from Amgen beyond antibodies technologies to invalidate a method of treatment claim that functionally claimed clinical results (Medytox, Inc. v Galderma S.A., 71 F.4th 990 (Fed Cir 2023)). In Medytox, Inc. v Galderma S.A., the claims at issue are directed to a method for treating glabellar lines using an animal-protein- free botulinum toxin composition that “requires a responder rate at 16 weeks after the first treat - ment of 50% or greater.” The specification pro - vided three examples of responder rates above 50% at 16 weeks: 52%, 61% and 62%. During proceedings before the Board, the patent chal - lenger provided expert testimony indicating that achieving the claimed 16-week responder rates is unpredictable, and that one skilled in the art would not have been able to achieve responder rates significantly higher than the exemplified 62% responder rate using the claimed animal- protein-free botulinum toxin formulations with - out undue experimentation (Galderma S.A. v Medy-Tox, Inc., 2021 Pat. App. LEXIS 4717 (PTAB 2021)). Relying on Amgen’s explanation that “[t]he more one claims, the more one must enable”, the Federal Circuit affirmed the Board’s finding that “the arguments and evidence were insufficient to demonstrate enablement to a
skilled artisan because said artisan “would not have been able to achieve” responder rates higher than the limited examples provided in the specification” (Medytox, Inc., 71 F.4th at 999). It was not a long wait to see the impact of Amgen in a subsequent antibody decision. In Baxalta Inc. v Genentech, Inc., the Federal Circuit affirmed the district court’s summary judgment of inva - lidity of claims reciting an isolated antibody that binds Factor IX or Factor IXa and increases the procoagulant activity of Factor IXa for lacking enablement (Baxalta Inc. v Genentech, Inc., 81 F.4th 1362 (Fed Cir 2023)). The specification in Baxalta describes eleven antibodies with the two claimed functions and a hybridoma-and-screen - ing process for identifying additional antibodies that meet the claimed functions. In rejecting the hybridoma-and-screening process as ena - bling disclosure, the Federal Circuit noted that “Amgen makes clear that such an instruction, without more, is not enough to enable the broad functional genus claims at issue here.” Here, the court was looking for additional guidance from the specification, such as common delineating features or explanation of why the disclosed antibodies worked, to identify which antibodies would perform the claimed functions, but did not find such guidance in the specification. In view of the lack of any additional guidance in the specification, the court concluded that “[t]he facts of this case are materially indistinguishable from those in Amgen.” The Federal Circuit stated that the trial and error testing necessitated by the specification “leaves the public no better equipped to make and use the claimed antibod - ies than the inventors were” when they set out to discover them. While the court in Baxalta relied on Amgen as the basis for its holding of invalid - ity, the Federal Circuit clarified that Amgen did
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