Biologic drugs, many of which are antibodies, represent an increasing share of the pharmaceutical market. In recent years, numerous broad functional patent claims directed at therapeutic antibodies have come under attack for failing to satisfy the written description and enablement requirements. The proper scope of these requirements has divided the biopharmaceutical industry. In its latest decision on this topic, Amgen Inc. et al. v. Sanofi, Aventisub LLC et al., ___ F.3d ___, No. 2020-1074 (Fed. Cir. Feb. 11, 2021), the Federal Circuit affirmed the invalidity of claims directed to therapeutic antibodies, noting that “functional claim limitations … pose high hurdles in fulfilling the enablement requirement.”
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