Event Title
The Rise of Regulatory Exclusivities
Panel
Panel 1: IP and the Future of Medicine
Moderator
George Randels, Professor of Religious Studies, University of the Pacific
Description
In recent years FDA-administered exclusivities have proliferated and become more robust. From the perspective of brand-name firms, exclusivities have been superior to patents in view of ease of enforcement and effective lack of contestability. Yet historically these advantages were balanced by their modest term of protection, for regulatory exclusivities would most often predecease corresponding patent rights. Newer forms of regulatory exclusivity, particularly given their additive nature, may now feature terms that rival those of patents. This potential policy choice holds substantial consequences for both public health and the intellectual property landscape. In these relatively early days of regulatory exclusivities, we stand in a position to calibrate these proprietary rights before expectations have settled and international norms have been established.
Location
Pacific McGeorge School of Law, Lecture Hall, 3200 Fifth Ave., Sacramento, CA
The Rise of Regulatory Exclusivities
Pacific McGeorge School of Law, Lecture Hall, 3200 Fifth Ave., Sacramento, CA
In recent years FDA-administered exclusivities have proliferated and become more robust. From the perspective of brand-name firms, exclusivities have been superior to patents in view of ease of enforcement and effective lack of contestability. Yet historically these advantages were balanced by their modest term of protection, for regulatory exclusivities would most often predecease corresponding patent rights. Newer forms of regulatory exclusivity, particularly given their additive nature, may now feature terms that rival those of patents. This potential policy choice holds substantial consequences for both public health and the intellectual property landscape. In these relatively early days of regulatory exclusivities, we stand in a position to calibrate these proprietary rights before expectations have settled and international norms have been established.
Speaker Bio
Jay Thomas is Professor of Law at Georgetown University in Washington, DC. Jay previously served as law clerk to Chief Judge Helen Nies of the US Court of Appeals for the Federal Circuit. He has also served as a Visiting Fellow at the Congressional Research Service, where he advised members of Congress and their staff regarding legislation pertaining to the patent and food and drug laws. At the US Patent and Trademark Office, he was appointed the inaugural Edison Visiting Fellow and also Instructor at the Patent Academy. He has previously served on the faculty of George Washington University, and also on the visiting faculties of Cornell University and the University of Tokyo.
Jay has served as a research fellow at the Max Planck Institute in Munich, Germany; and the Institute of Intellectual Property in Tokyo, Japan. He has been appointed as Special Master in US patent litigation and has testified as an expert witness in numerous patent and antitrust proceedings. He currently is a member of the Patent Challenge Committee of Askeladden, Inc. He has authored numerous articles and six books on the subject of intellectual property, including Pharmaceutical Patent Law (3d ed. 2015).