FDA-PTO Roundtable

Please join us as we host a conference in response to several recent letters sent by the Acting Commissioner of Food and Drugs and Members of Congress to the Patent and Trademark Office concerning drug-related patents and pharmaceutical pricing. Pending approval, the attendees from the federal government include Drew Hirshfeld, performing the functions and duties of the Director of the PTO, Linda Horner, Administrative Patent Judge and Senior Legal Advisor at the PTO, Maryll Toufanian, FDA Director of Generic Drug Policy, and Grail Sipes, Deputy Director for Regulatory Policy at the FDA’s Center for Drug Evaluation and Research. In addition, former PTO Directors Andrei Iancu and David Kappos and former Acting PTO Director Teresa Stanek Rea will participate. The roundtable will also include participants from academia, industry, law firms, and trade organizations.

The topics that will be discussed include:

  • Introduction to FDA/PTO Intersection: The Hatch-Waxman Act
  • Patent Infringement Suits and the FDA
  • Strategies in Pharmaceutical and Biologic Patenting
  • Transparency—Orange and Purple Book Listings
  • Post Grant Review/Inter Partes Review
  • FDA and PTO Coordination and Collaboration
  • FDA and PTO Roles in Drug Marketing and Pricing

Speakers

Michael Abramowicz, Oppenheim Professor of Law, Senior Associate Dean, George Washington Law School

Rebeccca Eisenberg, Robert and Barbara Luciano Professor of Law, University of Michigan Law School

Karin Hessler, Vice President, IP Policy and Deputy General Counsel, Association for Accessible Medicines

Drew Hirshfeld, Performing the functions and duties of the Under Secretary of Commerce for Intellectual Property and Director of the USPTO

Christopher Holman, Professor of Law, University of Missouri Kansas City School of Law

Linda Horner, Administrative Patent Judge, Senior Legal Advisor, USPTO

Andrei Iancu, Partner, Irell & Manella LLP; Former Under Secretary of Commerce and Director of the USPTO 

Thomas Jenkins, Head of Global IP Litigation at Viatris

David Kappos, Partner, Cravath, Swaine & Moore LLP; Former Under Secretary of Commerce and Director of the USPTO

Dmitry Karshtedt, Associate Professor of Law, George Washington Law School

Otto Licks, Founding Partner, Licks Attorneys

Brian Malkin, Partner, McDermott Will & Emery; Former Regulatory Counsel at the FDA

Emily Morris, David L. Brennan Endowed Chair, Associate Professor, and Associate Director of the Center for Intellectual Property Law & Technology, University of Akron School of Law

Arti Rai, Elvin R. Latty Professor of Law, Duke Law; Former head of the Office of Policy and International Affairs at the USPTO

Teresa Rea, Partner, Crowell & Moring, Former Acting Director of the USPTO

Derrick Rowe, Senior Patent Counsel, GSK

Corey Salsberg, Vice President, Global Head IP Affairs, Novartis

Ameet Sarpatwari, Assistant Professor of Medicine at Harvard Medical School and the Assistant Director of the Program On Regulation, Therapeutics, And Law (PORTAL)

Hans Sauer, Deputy General Counsel and Vice President for Intellectual Property, Biotechnology Innovation Organization

Grail Sipes, Deputy Director for Regulatory Policy, Center for Drug Evaluation and Research, FDA

Richard Torczon, Senior Counsel, Wilson Sonsini Goodrich & Rosati, former Administrative Patent Judge

Maryll Toufanian, Director, Office of Generic Drug Policy, FDA

John Whealan, Associate Dean for Intellectual Property Law, George Washington Law School

Janet Woodcock, Acting Commissioner of Food and Drugs

Patricia Zettler, Associate Professor of Law, Ohio State Law School


Agenda

1:00 – 1:05 PM Welcome

1:05 – 1:15 PM Introduction to FDA/PTO Intersection: The Hatch-Waxman Act

1:15 – 2:30 PM Roundtable Discussion (Part 1)

  • 1:15 – 1:30 PM Patent Infringement Suits and the FDA
  • 1:30 – 2:15 PM Strategies in Pharmaceutical and Biologic Patenting
  • 2:15 – 2:30 PM Transparency—Orange/Purple Book Listings

2:30 – 3:00 PM Break

3:00 – 4:30 PM Roundtable Discussion (Part 2)

  • 3:00 – 3:15 PM Post Grant Review/Inter Partes Review
  • 3:15 – 3:45 PM FDA and PTO Coordination and Collaboration
  • 3:45 – 4:15 PM FDA and PTO Roles in Drug Marketing and Pricing
  • 4:15 – 4:30 PM Closing Thoughts

Notes

Currently the event will be 100% virtual for attendees and speakers. We are closely monitoring health requirements and will follow GWU protocols regarding in-person programming.

Questions? Contact Delphine Harper via email