Day 1

Co-Chair’s Opening Remarks

Guy Donatiello
Senior Vice President, Intellectual Property
Endo Pharmaceuticals

Josephine Liu
Vice President of IP, North America

Fireside Chat with The Federal Circuit: Quarantine Edition

Hon. Kathleen M. O’Malley
United States Circuit Judge

Interviewed By:

Hon. Mary Pat Thynge
Chief Magistrate Judge
United States Federal District Court, District of Delaware

Finding Solutions to COVID-Related Pharmaceutical Patent Litigation Delays: Addressing Brand and Generic Concerns in the District Courts and at the PTAB

Chad A. Landmon
Axinn, Veltrop & Harkrider LLP

Mira Atanassova Mulvaney
Kirkland & Ellis LLP

  • Examining how COVID-19 is causing havoc on ANDA litigation timetables established under Hatch-Waxman
  • Exploring brand name and generic concerns about the probability and consequences of potentially tolling the 30-month stay in light of COVID court delays
  • Assessing whether measures taken by the District of New Jersey and Delaware have been successful in mitigating COVID-19-related interruptions to ANDA litigation
  • Looking at measures taken by the PTO relative to the extension of PTAB filings and proceedings under the CARES Act
    • how this has impacted IPR proceedings as they relate to parallel proceedings and related stays
  • Analyzing whether the use of virtual media, such as tele-conferencing or web-related activity has been useful in mitigating litigation disruption
  • Understanding the economic and business impact of COVID -related ANDA and other patent litigation delays on:
    • Patent rights
    • Generic entry/180-day exclusivity

Morning Break
Spotlight on the USPTO: Gauging the Impact of the Global Pandemic on the Patent Office and PTAB

Hon. Jacqueline D. Wright Bonilla (invited)
Deputy Chief Administrative Patent Judge
Patent Trial and Appeal Board
U.S. Patent and Trademark Office

Interviewed By:

Hon. Teresa Rea
Crowell & Moring LLP
Former Acting Under Secretary of Commerce for Intellectual Property and Former Acting Director of the United States Patent and Trademark Office

CASE STUDY on Mitsubishi Tanabe Pharma Corp. v. Zydus Inc. Collaboration and COVID-19: Extending the Hatch-Waxman Automatic Stay

Donna Meuth
Associate General Counsel, IP

Bruce M. Wexler
Paul Hastings LLP

Lunch Break

Welcome to the Virtual Courtroom: Navigating Paragraph IV Litigating from Home

Part I: Virtual Discovery

Ryan M. Daniel
Chief Patent Counsel
Region North America

Fresenius Kabi USA, LLC

Guy Donatiello
Senior Vice President, Intellectual Property
Endo Pharmaceuticals

Gregory A. Morris
Honigman LLP

While courts were already exploring virtual media for procedures such as conference calls, scheduling meetings, etc., the coronavirus forced traditional litigation into the virtual forum. Further, there is every indication given the efficiency as well as cost saving aspects of virtual litigation, that this trend may continue well after the time of a COVID cure. This working group will help you navigate this brave new world as it applies to ANDA litigation.

Part II: The Impact to Motion Practice

Eric. I Abraham
Hill Wallack LLP

William C. Baton
Saul Ewing Arnstein & Lehr

Stephanie L. Donahue
Senior Director, Patent Litigation

Part III: Virtual Trial and Adjudication

Christopher H. Strate
Gibbons P.C.

Virtual Cocktail Hour
Conference Concludes