Antibody Patenting: U.S. and Asian Perspectives

Description

Patent applicants frequently employ functional claims to provide broad protection for antibody inventions. However, the Amgen v. Sanofi decision from 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.

Unlike the decision in Amgen, Japan and China will grant a patent for an antibody without producing an actual antibody, provided the antigen is structurally described and has some function.

To meet the support requirements, the JPO requires that the specification describe actual data relating to a claimed use. Japanese law does not permit post-filing data showing such activity to overcome a rejection if the specification does not include any data on activity. Chinese support and disclosure requirements are similar.

To obtain a granted claim on a new antibody to a known antigen, all jurisdictions generally require defining and claiming the antibody structurally. Japanese (JPO) and Chinese examiners (CNIPA) typically require the inclusion of the sequences of the antibody's six complementarity determining regions when claiming an antibody. Furthermore, outside the U.S., structural non-obviousness per se may be insufficient to claim an antibody even if defined by sequence, and it may be necessary to demonstrate that the antibody produces an unexpected technical effect or was produced using non-conventional techniques.

Listen as our authoritative panel of patent attorneys provides guidance on protecting design rights in the global marketplace. The panel will discuss the key differences between the patent laws in the U.S. and other countries that must be understood when developing a strong global IP strategy. The panel will offer best practices for U.S. companies on developing a global strategy.