The George Washington University Law School hosted an FDA-PTO roundtable on January 21, bringing together experts from a wide range of backgrounds to discuss the complex relationship between drug patents and the cost and availability of pharmaceutical products. Panelists included current and former government officials, industry professionals, and academics specializing in patent law and public health.
The timely event was organized in response to President Biden's Executive Order on Promoting Competition in the American Economy, issued July 9, 2021, as well as several subsequent letters sent last fall by the Acting Commissioner of Food and Drugs and Members of Congress to the Acting Director of the Patent and Trademark Office concerning the impact of drug-related patents on pharmaceutical pricing.
While the Omicron surge in Washington, D.C. forced a shift from an in-person to a Zoom webinar format, it also allowed more than 200 participants to listen remotely to the insights provided by the more than 20 expert panelists.
“We were pleased to host this premier roundtable spotlighting timely issues at the intersection of the FDA and the PTO,” said Dean Dayna Bowen Matthew. “GW Law plays a vital role in bringing together preeminent scholars, government officials, and industry leaders for important discussions that help forge solutions to important issues impacting our nation and our world. Programs like this one are a shining example of our law school’s influence and impact both within and outside the legal academy.”
Senior Associate Dean Michael Abramowicz and David Kappos, a partner at Cravath, Swaine & Moore and former PTO Director, welcomed the panelists and attendees to the roundtable for a lively and informed discussion, co-moderated by Associate Dean for IP Law John Whealan and Teresa Rea, a partner at Crowell & Moring and former PTO Acting Director.
The panelists’ contributions of insights, data, divergent perspectives, and difficult questions helped participants gain a more comprehensive view of the challenges and interests at stake. Among the many topics addressed were the value and cost of secondary pharmaceutical patents, the challenges of assessing Orange Book listings by the FDA, and the interaction between the timing of drug patenting and the challenges of drug development and approval.
The conference also included discussion of numerous relevant scholarly articles as well as constructive proposals for facilitating better collaboration between the FDA and PTO. Finally, the roundtable highlighted key areas where better channels of communication are needed between these critically important government agencies. The members of the roundtable planning committee, which included GW Law’s Associate Dean for Intellectual Property Law John Whealan and Professor Dmitry Karshtedt, produced a final report for both agencies that summarized the entire four-hour discussion.
“Starting from our initial discussions about this event, I had envisioned a thoughtful, balanced discussion conducted by knowledgeable experts, exploring multiple sides of the life sciences-IP intersection,” said Mr. Kappos, who served as a member of the planning committee. “As the actual event unfolded, the level of discourse and participation so textured as to create four hours of magic. The results far exceeded my expectations!”
For additional information about the event, including the entire list of speakers and topics, visit here.