Patenting Genetic Therapies–An International Perspective

Panel

Panel 1: IP and the Future of Medicine

Moderator

George Randels, Professor of Religious Studies, University of the Pacific

Description

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.

Speaker Bio

Jorge L. Contreras is a Professor of Law at the University of Utah, with an adjunct appointment in the Department of Human Genetics. He has written and spoken extensively on the institutional structures of intellectual property, technical standardization and biomedical research. He has previously served as Co-Chair of the National Conference of Lawyers and Scientists (NCLS), and as a member of NIH’s Council of Councils, the Advisory Council of NIH’s National Center for the Advancement of Translational Sciences (NCATS), the National Advisory Council for Human Genome Research (NACHGR) and the National Academy of Science’s (NAS) Committee on IP Management in Standard-Setting Processes. At the University of Utah, he serves on the Scientific Advisory Board of the Utah Genome Project, the Executive Steering Committee of the Center for Clinical & Translational Science and the Oversight Board of the Veterans Administration Genealogy Project. Professor Contreras’s work and commentary has appeared in a range of scientific, policy and legal publications including Science, Nature, Nature Biotechnology, Annual Review of Genomics and Human Genetics, Trends in Genetics, American Journal of Bioethics, JAMA, Georgetown Law Journal, Washington Law Review, University of Illinois Law Review, North Carolina Law Review, American University Law Review, Health Matrix, Berkeley Technology Law Journal, and Harvard Journal of Law and Technology. Together with James Cuticchia, he edited the first book on the law of bioinformatics, Bioinformatics Law: Legal Issues for Computational Biology in the Post-Genome Era(Chicago: ABA Publishing, 2013), and has won numerous awards and honors for his scholarship and teaching. He holds degrees from Rice University (B.A., BSEE) and Harvard Law School (JD).

Location

Pacific McGeorge School of Law, Lecture Hall, 3200 Fifth Ave., Sacramento, CA

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Apr 5th, 8:10 AM Apr 5th, 9:10 AM

Patenting Genetic Therapies–An International Perspective

Pacific McGeorge School of Law, Lecture Hall, 3200 Fifth Ave., Sacramento, CA

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.