Technological and Patent Evolution of Murine Monoclonal Antibodies

Abstract

Among the pharmaceutical products targeted for patent protection, monoclonal antibodies stand out. Technological advances involving monoclonal antibodies aim to minimize detrimental human immune responses to antibodies (e.g., human anti-murine antibodies [HAMA]) and increase the binding affinity of antibodies to their antigen, making them more specific for their therapeutic target. This work evaluates the main technological advances pertaining to monoclonal antibodies, from the creation of technology for the immortalization of cells to generate hybridomas through the generation of chimeric and humanized antibodies by genetic engineering techniques, phage display technology, and transgenic mice. It also aims to provide an overview of commercially available and patented murine monoclonal antibodies and to correlate the main players, markets, and therapeutic uses for which the antibodies were developed. The study of mMAB (murine monoclonal antibodies) proved to be of great importance to understand how the development of these antibodies and their protection by patents affects their therapeutic use in cancer patients, in diagnostics, to treat inflammation, etc. The United States (US), Japan (JP), France (FR), and China (CN) constitute potential markets for these protected technological advances. Among current usage trends of three murine monoclonal antibodies whose patents have expired, the use of generic and/or biosimilar is evidenced, as well as the use of these assets to guarantee the protection of new products, new associated processes (e.g., new combinations, associations, or dosage forms), or new processes. The newest market trends related to patent protection in this technological area incorporate the use of monoclonal antibody fragments.