The rebirth of epitope-based patent claims.

Abstract

Patent protection of therapeutic antibodies and T cell receptors is an important tool to enable the path to the market. In view of the substantial spendings for R&D and regulatory approval, sponsors expect exclusivity for their drug for a given period of time. Different categories exist to protect therapeutic antibodies and T cell receptors. One of these categories are epitope-based patent claims, with regard to which in the different jurisdictions, different patentability standards exist, which, furthermore, are constantly changed by courts and lawmakers. This article tries to explain the patentability issues related to epitope-based patent claims. For this purpose, an overview is given on the respective legal provisions and court decisions. The study reveals that the respective patentability standards are constantly changed by courts and lawmakers. Companies developing therapeutic antibodies or T cell receptors need to consider these developments in their strategic planning.