In the recent case of Amgen Inc. v. Sanofi, Aventisub LLC, the Federal Circuit affirmed the district court’s invalidation of certain of Amgen’s antibody patent claims, concluding that the claims were not “enable[d]” under 35 U.S.C. § 112. This decision establishes that it is more difficult to satisfy the enablement requirement for antibody claims that use functional language to describe the antibody. (The court granted Amgen’s motion to extend the deadline for filing a petition for panel rehearing and/or rehearing en banc until April 14, 2021. See id., Order (March 8, 2021).)
Siegmund (“Sige”) Gutman is chair of the Life Sciences Patent Practice, a partner in the Litigation Department, and a member of the Patent Law and Intellectual Property Groups.
Sige is an accomplished patent litigator, frequently representing clients before trial and appellate courts, as well as arbitration panels. In the life sciences area, his practice focuses on developing and executing market exclusivity and freedom-to-operate strategies, including patent office and FDA regulatory strategies, for leading biologics, pharmaceutical, biotechnology, and medical device clients. He has extensive experience successfully litigating biologic drug patent and Hatch-Waxman cases, and has frequently spoken and written about issues relating to biosimilars and generic drugs. Sige’s background combines a graduate degree in molecular and cell biology and biophysical chemistry with more than 20 years of industry experience, including serving as senior patent litigation counsel for Amgen, the world’s largest biotechnology company.
He advises clients on patent matters involving a wide range of technologies, including therapeutic proteins such as monoclonal antibodies, antibody-drug conjugates, nucleic acids, gene therapy, stem cells, expression systems, screening methodologies, purification processes, DNA microarrays, small molecules and polymer chemistry.
Sige also has extensive experience in inter-partes patent office actions, including oppositions, and providing strategic patent counseling, including addressing product life cycle management and patent portfolio development issues, as well as preparing third-party patent landscape analyses.
Prior to joining Proskauer, Sige was a partner at another Am Law 100 firm.
While in graduate school, Sige worked on elucidating the 3-D structure of an auto-catalytic RNA using molecular biological, biochemical and biophysical techniques. He also previously worked for a major manufacturer of photocopiers and printers, where he helped develop novel color toner particles using electrochemical, photochemical and polymer chemical techniques.