Antibody Patenting: Meeting Written Description and Obviousness Requirements, U.S. and European Perspectives

Description

Patent applicants frequently employ functional claims to provide broad protection for antibody inventions. However, in Amgen v. Sanofi, the Federal Circuit called into question the USPTO's practice of granting claims that define antibodies by their ability to bind to a newly characterized antigen.

Under prevailing law, to meet the written description requirement, an application must disclose the claimed invention in such detail that a person of ordinary skill would understand the inventors possessed the full scope of the claimed invention at the time of filing. After Amgen v. Sanofi, it may be more difficult to obtain some antibody claims, particularly if it will no longer suffice to characterize the antigen bound by the claimed antibody.

A patent specification must provide a sufficient number of representative examples or a structure-function relationship across the full scope of the claimed genus. What those concepts entail and how to satisfy them for antibody-based technologies is the subject of current debate.

Antibody claims also encounter similar problems in Europe, with the EPO taking a strict view on what makes a new antibody inventive and sufficiently disclosed. In 2021, the EPO updated the influential Guidelines for Examination in the European Patent Office, definitively setting out important aspects of its approach to examining claims directed to antibodies. These guidelines were further revised in March 2022, reflecting the dynamic developments in this field of technology and the necessary evolution of strategies to obtain adequate patent protection.

Biotech companies, universities, and others are scrambling to determine how to protect their antibody patents on both sides of the Atlantic.

Listen as our authoritative panel of patent attorneys examines the patentability requirements in the USPTO and EPO for claiming a broad genus of antibodies, recent case law that could impact those claims, and how to protect antibody inventions amid recent developments. Our panel will discuss best practices on what and how much data to include in a patent application to support claims of differing scope, the extent to which post-filing data can be relied on to support the claims, and how examiners are being instructed to examine antibody inventions.