The Patentability of Genetic Therapies: CAR-T and Medical Treatment Exclusions Around The World

Abstract

More than eighty countries, including the members of the European Patent Convention, the United States, Canada, New Zealand, China, Japan, and India, currently exclude or limit the patentability of methods of medical treatment. CAR-T and other recent gene and cell therapies, which operate based on the extraction of genetic or cellular material from a patient, the alteration of such material, and the reintroduction of such material to the patient’s body, should, under most or all of these legal regimes, be considered medical treatments that are thus excluded from patentability, or as to which patent enforcement is limited. Accordingly, we urge national patent offices to update their examination procedures and practices to take these patentability limitations into account, and to publish guidance clearly explaining this approach to applicants.

Keywords: CAR-T, gene therapy, cell therapy, patent, medical treatment, European Patent Convention