2022 Agenda
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Day 1 - Wednesday, September 21, 2022
Day 2 - Thursday, September 22, 2022
Day 1 - Wednesday, September 21, 2022
| 8:00 |
Opening Remarks Ryan M. Daniel  Linda Friedlieb |
| 8:15 |
LIVE AUDIENCE POLLING60 Minutes on Patents, Politics and Policy: An Analysis of Proposed Hatch- Waxman Reform Measures Anita Varma  Anna Brook Ryan M. Daniel This session will consider current and proposed legislation, as well as other potentially impactful measures which may influence on Paragraph IV litigation. Topics of discussion will include:
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| 9:15 |
§101 and §112Skinny Labeling: The Future of Carveouts and the Analyzing the Influence of GSK v. Teva on Competition David Abramowitz  Aziz Burgy  Gregory A. Morris
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| 10:15 |
Networking Coffee Break |
| 10:45 |
The Relationship Between Written Description and Enablement Post-Biogen v. Mylan: Best Practices for Strengthening or Invalidating Patent Claims John T. Bennett  Mary C. Till Moderator: William A. Rakoczy As demonstrated by the Federal Circuit’s recent denial of Biogen’s petition for en banc review in Biogen International GmbH et al. v. Mylan Pharmaceuticals Inc., written description and enablement requirements have perplexed patent practitioners for years. The dissent demonstrates opposing views at the Federal Circuit and among the bar as to §112 and signals that the Supreme Court may grant cert.
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| 11:45 |
Is Your Case Dead in the Water? Redefining What Is Patent-Eligible Subject Matter Post-American Axle v. Neapco John L. Abramic  Paul Browning  Brian P. Murray This session will review the latest developments and e most impactful cases from the last 12 months in 101 jurisprudence and review the Court’s attempt to resolve the “bitter divide” of patent subject matter eligibility.
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| 12:45 |
Networking Luncheon |
| 2:00 |
VENUE WAR ROOM: Knowing, How, When, and Where to Plan Your Attack Based on Current Trends in MDL with Joint Defense Groups Caryn Borg-Breen  Dan Hoang With the latest rulings on venue, deciding where to file your case is mission critical. In this session, our panelists will consider the proper venue for Hatch-Waxman cases and address the unanswered question of what constitutes “actions related to the ANDA submission”. Topics of discussion will include:
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| 3:00 |
Diversity, Equity & InclusionImplicit Bias in Life Sciences IP: How to Promote and Implement Bias-Reducing Strategies Robin Evans  Jamie L. Lucia Linda Friedlieb Implicit bias refers to the unconscious attitudes or stereotypes that affect our understanding, actions, and decisions. In this interactive session, our panelists will introduce the topic of implicit bias in pharmaceutical patent litigation, share bias-reducing strategies, and will invite attendees to share their thoughts and perceptions on implicit bias. Topics of discussion will include:
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| 4:00 |
Afternoon Refreshment Break |
| 4:15 |
MAGISTRATE TOWN HALLUnderstanding the Roles of the Magistrate Judges and Local Counsel in Paragraph IV Proceedings Hon. Douglas E. Arpert  Hon. Christopher J. Burke Moderator: Jeffrey R. Gargano This panel will explore the intricacies of local rules and offer solutions to your most rigid Paragraph IV pickles.
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| 5:15 |
VIEW FROM THE FEDERAL BENCHDistrict Court Judges on the Present State of Paragraph IV Litigation: Filing Trends, Counterclaims Settlements and Timings Hon. Colm F. Connolly  Hon. Stanley R. Chesler  Hon. Joshua Wolson Moderator: Anne Shea Gaza 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. |
| 6:15 |
Cocktail Reception |
Day 2 - Thursday, September 22, 2022
| 8:00 |
Opening Remarks |
| 8:15 |
REGULATORY THINK TANKAnalyzing the Impact of the Latest FDA Initiatives on Generic Drug Access and Hatch-Waxman Litigation Kurt Karst  Brian Stone
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| 9:15 |
THE PTAB LIVE!The APJs Speak on Practice, Policy, and Procedure in the World of Pharmaceutical Patent Validity Changes Jacqueline Bonilla  Hon. Susan Mitchell  Hon. Grace Obermann Moderator: Carolyn Blessing
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| 10:15 |
Networking Coffee Break |
| 10:45 |
The Interplay of Co-Pending IPR Proceedings: Winning Strategies for Navigating the District Court and Inter Partes Review Scott Weidenfeller  Cary Miller  Hon. Teresa “Terry” Stanek Rea  Arlene Chow
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| 12:00 |
Networking Luncheon |
| 1:00 |
Restrictions on Reverse-Payment Settlements: Non-Monetary Settlements and Provisions Relating to FTC/DOJ review Huong Nguyen  Andrew Berdon  Anil Patel
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| 2:00 |
INTERNATIONALCross-Border Business Considerations in a Hatch-Waxman Scenario: The Global Approach to Pharmaceutical Patent Litigation Mary Morry  Dominick A. Conde  Andrea Tiglio When considering cross-border biopharmaceutical patent matters, there are multiple factors in play. It is critical to understand the patent landscape in the relevant countries, the differences in patent laws in various jurisdictions, and the timing of litigation. Topics of discussion will include:
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| 3:00 |
Refreshment Break |
| 3:15 |
OTDP and Patent Terms: The Interplay Between Obviousness-Type Double Patenting, Pattern Terms Extension and Patent Term Adjustment Post-Ex Parte Cellect Jeremy Lowe  Kevin E. Noonan  Steven J. Horowitz In Ex Parte Cellect, the PTAB considered the appropriateness of an OTDP rejection of two related patents that had different expiration dates due to PTA. The patent whose term had been extended was found invalid – sending shivers down the spine of patent owners everywhere. With a contradictory decision delivered by the CAFC, practitioners are left with two opposing schools of thought. The present case will either expand or contract the Gilead precedent on this issue of first impression, and consider whether the doctrine is statutory or equitable. |
| 4:15 |
Revisiting Damages in an At-Risk Launch Scenario: Questions of Remedies and ValuationAlejandro Menchaca  Matt Murphy  Merritt D. Westcott
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| 5:15 |
ETHICSEthical Considerations for the Hatch-Waxman Practitioner: Discovery, Privilege, and Professional Responsibility Tanzina Chowdhury  Shashank Upadhye There is an ethical obligation as well as a fiduciary duty to protect the interest of your client – and Hatch-Waxman litigation has no exception to this general premise In this interactive session, our leaders will review common ethical challenges faced by Hatch-Waxman practitioners. Attendees will then reflect critically on hypothetical situations posed by the panelists, discuss in groups, and then review their conclusions.
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| 6:15 |
Conference Concludes |