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Filko, M.S., J.D., is a litigator and USPTO-registered patent attorney. For over 20 years, Filko has been extensively involved in all aspects of contested patent matters and licensing disputes, bolstered by his solid foundation in chemistry and biotechnology. He has first-chaired proceedings and won in every venue of importance: the PTAB, federal district courts, and the Federal Circuit. Filko also has experience handling arbitrations under the American Arbitration Association (AAA) and with pre-litigation work having handled comprehensive preparatory investigations for numerous blockbuster drugs.

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.”

Continue Reading U.S. Federal Circuit Continues To Pressure BioPharma For More When It Comes To Functional Claims