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The Supreme Court's decision to grant certiorari in Amgen v. Sanofi is the first time in almost a hundred years that the Court has deigned to consider sufficiency of disclosure. ....
Sunday, February 14, 2021 While this recent Fed. Cir. decision – Amgen Inc. v. Sanofi, Appeal No. 2020-1074 (Fed. Cir., Feb. 11, 2021) seems predictable, given the fate of antibody claims that recite the target and the function of antibody binding thereto, there are a few interesting wrinkles to comment on. A Fed. Cir. panel of Judges Lourie, Prost and Hughes, Lourie writing, affirmed the district courts finding that Amgen’s claims failed the enablement test of s. 112. Evaluating the Wands factors there are seven of them to determine whether or not the claimed antibodies would require undue experimentation to locate ones falling within the scope of the claims, the panel relied on its fairly extensive precedent, most of it unfavorable to Amgen, and concluded that “lack of enablement [was found] due to the undue experimentation required to make and use the full scope of the claimed compounds that require a particular structure and functionality.” As the panel ....