Agenda
Please Note: For those attending via livestream, Track 2 will be the only track available.
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Day 1 - Tuesday, April 26, 2022
Day 2 - Wednesday, April 27, 2022
Day 1 - Tuesday, April 26, 2022
7:00 |
Breakfast and Registration |
8:00 |
Co-Chairs’ Opening Remarks![]() Lars Taavola ![]() Stephanie Donahue Co-Chairs’ opening remarks. |
8:15 |
60 Minutes on Patents, Politics, Policies, and Pricing: Patent Listing Statutes, “Buy America” Policies and Executive Orders, and Recent Hatch-Waxman and BPCIA Amendments Transforming PIV Disputes![]() Jay R. Deshmukh ![]() Andrei Iancu ![]() Nicholas Groombridge ![]() Joseph Reisman, Ph.D.
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9:15 |
Holistic Litigation Strategies for Strengthening or Defeating a Written Description Invalidity Defense![]() John Haberman ![]() Steven M. Coyle ![]() Matthew Pearson ![]() Kevin S. Prussia Moderator:![]() Vanessa Yen
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10:15 |
Networking Break |
10:45 |
FTC Keynote![]() Beckey Egeland FTC keynote. |
11:15 |
The Future of Inducement Claims in the Hatch-Waxman Context: Reconciling the Demarcation Between Describing an Infringing Use and Encouraging That Use in a Label![]() Huong T. Nguyen ![]() Abigail Struthers ![]() April Abele Isaacson ![]() Sanya Sukduang Moderator:![]() Aaron S. Lukas
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12:15 |
Networking Luncheon |
1:45 |
The Costs and the Consequences of Determining Venue Post-Valeant v. Mylan: Coordinating Multiple ANDA Suits through MDLs![]() David L. Anstaett ![]() Steven Maslowski ![]() Mark Rubinshtein, Ph.D. Moderated by:![]() Jeanna M. Wacker
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2:45 |
Networking Break |
3:00 |
Breakout SessionsTrack 1: The Business of PIV Disputes (available to in-person delegates only)Cross-Border Business Considerations in a Hatch-Waxman Scenario: Masterfully Managing Global Litigation
Track 1 - Speakers![]() Henry H. Gu ![]() Deepro R. Mukerjee ![]() Kevin Zive Track 2 - Speakers![]() Honorable Christopher J. Burke ![]() Chad Landmon ![]() Carolyn Blessing
Track 1: The Business of PIV Disputes — Cross-Border Business Considerations in a Hatch-Waxman Scenario: Masterfully Managing Global Litigation
Track 2: The Practice of PIV Disputes — Advanced Pleadings Drafting: Choosing Claims and Defenses Wisely
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3:45 |
Breakout SessionsTrack 1: The Business of PIV Disputes (available to in-person delegates only)The Cost and Worth of a Patent: The Economics of a Paragraph IV Challenge
Track 1 - Speakers![]() Donna Meuth ![]() Bruce M. Wexler ![]() Richard J. Berman Track 2 - Speakers![]() Jovial Wong ![]() Alyson Wooten
Track 1: The Business of PIV Disputes — The Cost and Worth of a Patent: The Economics of a Paragraph IV Challenge
Track 2: The Practice of PIV Disputes — Mastering the Use of Experts in Parallel Proceedings
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4:30 |
Networking Break |
4:45 |
View from the Bench: The Federal Judges Speak on Paragraph IV Litigation![]() Honorable Julien Xavier Neals ![]() Honorable Joshua Wolson Moderated by:![]() Rachel L. Pernic Waldron ![]() Gregory A. Morris Distinguished jurists with some of the liveliest Paragraph IV litigation dockets in the country will examine decision-making practices employed by the judicial system and provide sage advice for both patent holders and patent challengers. These federal judges will identify the impediments to resolving such multifaceted contests and provide you with solutions to your most unyielding Paragraph IV predicaments. |
6:00 |
Cocktail Reception |
Day 2 - Wednesday, April 27, 2022
7:15 |
Breakfast and Registration |
8:00 |
Co-Chairs’ Opening Remarks![]() Lars Taavola ![]() Stephanie Donahue Co-Chairs’ opening remarks. |
8:15 |
Brand and Generic Perspectives on the Latest FDA Initiatives Impacting Pharmaceutical Patents![]() Maryll Toufanian ![]() David B. Abramowitz ![]() Kurt Karst ![]() Christopher Pruitt ![]() John Bennett
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9:30 |
Networking Break |
10:00 |
Federal Circuit Fireside Chat![]() Honorable Kathleen M. O’Malley (Ret.) Interviewed by:![]() Honorable Mary Pat Thynge |
10:30 |
Breakout SessionsTrack 1: The Business of PIV Disputes (available to in-person delegates only)Monitoring Legal Spend and Balancing the Budget
Track 1 - Speakers![]() Serge Ilin-Schneider ![]() David Silverstein ![]() Martin Wilson Track 2 - Speaker![]() Shashank Upadhye ![]() Robert McSorley
Track 1: The Business of PIV Disputes — Monitoring Legal Spend and Balancing the Budget
Track 2: The Practice of PIV Disputes — Seeking Damages and Assessing Value Calculations
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11:15 |
Breakout SessionsTrack 1: The Business of PIV Disputes (available to in-person delegates only)Communicating Value and Collaboration Between Corporate Legal and Outside Counsel
Track 1 - Speakers![]() Stephanie Donahue ![]() Colin Heitzmann ![]() Sam Deka ![]() Jeffrey Martin Track 2 - Speakers![]() Honorable Tonianne J. Bongiovanni ![]() Ryan M. Daniel ![]() Robert M. Vrana ![]() Luke T. Shannon
Track 1: The Business of PIV Disputes — Communicating Value and Collaboration Between Corporate Legal and Outside Counsel
Track 2: The Practice of PIV Disputes — Joint Defense Groups: A Risk Benefit Analysis for the Hatch-Waxman Practitioner
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12:00 |
Networking Luncheon |
1:15 |
Restrictions on Reverse-Payment Settlements: Non-Monetary Settlements and Expert Testimony on the Merits![]() Adam L. Perlman ![]() Saami Zain ![]() Sailesh Patel In April 2021, lawmakers from the House and Senate introduced legislation “targeting conduct that prevents competition.” Complicating matters further, several states have enacted laws meant to curb reverse-payment patent settlements – with no comparable statute at the federal level. This session will consider the economic implications of the resurgence of antitrust conundrums during drug development and launch, the competitive effects, and economic damages. Topics of discussion will include:
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2:15 |
The APJs Speak on Practice, Policy, and Procedure in the World of Pharmaceutical Patent Validity Changes![]() Honorable Jacqueline Wright Bonilla ![]() Honorable Michelle N. Ankenbrand Moderators:![]() John J. Molenda ![]() Elizabeth S. Weiswasser
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3:15 |
Parallel Proceedings Think Tank: Winning Strategies for Navigating the District Court and Inter Parte Review (IPR)![]() Peter Waibel ![]() Dan Minion ![]() Eric W. Dittmann ![]() Kathleen B. Carr Moderator:![]() Gerald J. Flattmann, Jr.
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4:15 |
Afternoon Break |
4:30 |
The Ethical Practice of Paragraph IV Litigation: New Developments Impacting Professional Responsibility in the Hatch-Waxman Arena![]() Mary J. Morry ![]() Chris Borello ![]() Mark E. Waddell ![]() David G. Conlin Moderated by:![]() Vishal C. Gupta This interactive skills session will identify common ethical dilemmas in Hatch-Waxman litigation and help you incorporate practices to avoid them. Points of discussion will include:
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5:30 |
Conference Concludes |