The American Conference Institute (ACI) will be holding its 17th Annual Paragraph IV Disputes Conference on April 26-27, 2022, at the Intercontinental Hotel in New York City. The conference starts each day at 8:00 am and ends at 6:00 pm on April 26th and 5:30 pm on April 27th. Two workshops are offered on April 25th, starting at 9:30 am and 1:30 pm.
The conference will open with an introduction by Co-Chairs Stephanie Donahue from Sanofi-Aventis and Lars Taavola from Mallinckrodt Pharmaceuticals. This will be followed by an opening panel featuring Andre Iancu, former Director of the USPTO and partner at Irell & Mandela LLP, Jay R. Deshmukr from Kasowitz Benson Torres, and Nicholas Groombridge from Paul, Weiss, Rifkin Wharton & Garrison LLP. There will also be a keynote from Beckey Egeland from the Federal Trade Commission.
ACI faculty will give presentations on:
• Holistic Litigation Strategies for Strengthening or Defeating a Written Description Invalidity Defense, featuring a discussion of Biogen Int'l GmbH v. Mylan Pharmaceuticals
• The Future of Inducement Claims in the Hatch-Waxman Context: Reconciling the Demarcation Between Describing and Infringing Use and Encouraging That Use in a Label
• The Costs and the Consequences of Determining Venue Post-Valeant v. Mylan: Coordinating Multiple ANDA Suits through MDLs
• Brand and Generic Perspectives on the Latest FDA Initiatives Impacting Pharmaceutical Patents
• Restrictions on Reverse-Payment Settlements: Non-Monetary Settlements and Expert Testimony on the Merits
• A Parallel Proceedings Think Tank: Winning Strategies for Navigating the District Court and Inter Partes Review (IPR)
• Restrictions on Reverse-Payment Settlements: Non-Monetary Settlements and Expert Testimony on the Merits
• The Ethical Practice of Paragraph IV Litigation: New Developments Impacting Professional Responsibility in the Hatch-Waxman Arena
Breakout sessions will discuss several aspects on the Business and Practice of Paragraph IV Disputes involving cross-border business considerations, advanced pleadings drafting, the economics of Paragraph IV challenges, the use of expert witnesses in parallel proceedings, monitoring legal spending and budgets, seeking damages and value calculations assessments, communicating value and coordination between corporate and outside counsel, and a risk-benefit analysis of joint defense groups.
Conferees will hear from judges from each of the relevant tribunals. The Honorable Kathleen M. O’Malley from the Federal Circuit will be interviewed by the Honorable Mary Pat Thynge, Chief Magistrate Judge of the U.S. District Court of Delaware. There will be a View from the Bench, featuring the Honorable Julien Xavier Neals of the U.S. District Court of New Jersey and the Honorable Mitchell S. Goldberg of the U.S. District Court of Pennsylvania, moderated by Rachel L. Pernic Waldron from Rakoczy Molino Mazzochi Siwik LLP and Gregory A. Morris from Honigman LLP. The Honorable Jacqueline Write Bonilla, Deputy Chief Administrative Patent Judge at the PTAB will discuss Practice, Policy, and Procedure in the World of Pharmaceutical Patent Validity Changes. A cocktail reception will follow the Judges' remarks on April 26th.
The workshops offered on April 25th are Workshop A, Comparative Analysis of Drug Patent Linkage Systems in China and the United States, and Workshop B, Diversity, Equity, and Inclusion: Implementing Change and Expanding Innovation. Workshop A will be presented by Jiazhong (Jason) Luo of Duane Morris LLP and Ningling Wang of Finnegan, Henderson, Farabow, Garrett & Dunner LLP. Workshop B will be presented by Mira A. Mulvaney of Eli Lilly & Co. and Serena Farquharson-Torres of Bristol Myers Squibb. The workshops are available as in-person events only.
An agenda for the conference and additional information regarding the workshops can be found here. A complete brochure for this conference, including an agenda, detailed descriptions of conference sessions, list of speakers, and registration form can be obtained here.
The registration fee for the in-person conference is $2,395 (paid registration by April 26th), with a special in-house counsel rate of $1,895. The livestream virtual conference fees are $2,095,and $1,595 for in-house counsel. Workshop A is an additional $600 and Workshop B is an additional $400. Patent Docs readers are entitled to a 10% discount off of registration using discount code D10-896-896EX03. Those interested in registering for the conference can do so here, by e-mailing [email protected], or by calling 1-888-224-2480.
Patent Docs is a media partner of ACI's 17th Annual Paragraph IV Disputes Conference.
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