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

Patent applicants frequently employ functional language in claims to provide broad protection for antibody inventions. Under prevailing U.S. law, however, to satisfy the written description and enablement requirements, 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, and be able to make and use that full scope without undue experimentation. What those concepts entail and how to satisfy them for antibody-based technologies is the subject of current debate. After the Supreme Court’s decision in Amgen v. Sanofi, however, it may be more difficult to obtain some antibody claims, particularly if it will no longer suffice to characterize the claimed antibody by its various functions.

Claiming antibodies in Europe can also be challenging, with the EPO taking a strict view on what makes a new antibody inventive. 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 have been further revised since, and there have been several recent decisions from the EPO Boards of Appeal 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 when prosecuting before the USPTO and EPO, 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.