The rebirth of epitope-based patent claims

Article type: Review Article

Authors: Storz, Ulrich

Affiliations: Michalski Hüttermann & Partner Patentanwälte mbB, Düsseldorf, Germany | E-mail: st@mhpatent.de

Correspondence: [*] Corresponding author: Michalski Hüttermann & Partner Patentanwälte mbB, Düsseldorf, Germany. E-mail: st@mhpatent.de.

Abstract: BACKGROUND: 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. OBJECTIVE: This article tries to explain the patentability issues related to epitope-based patent claims. METHODS: For this purpose, an overview is given on the respective legal provisions and court decisions. RESULTS: The study reveals that the respective patentability standards are constantly changed by courts and lawmakers. CONCLUSIONS: Companies developing therapeutic antibodies or T cell receptors need to consider these developments in their strategic planning.

Keywords: Antibodies, T cell receptors, patent, epitope

DOI: 10.3233/HAB-240006

Journal: Human Antibodies, vol. 32, no. 2, pp. 35-49, 2024