2023 Agenda
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Day 1 - Wednesday, April 19, 2023
Day 2 - Thursday, April 20, 2023
Day 1 - Wednesday, April 19, 2023
7:00 |
Breakfast and Registration |
8:00 |
Chairs’ Opening Remarks![]() Honorable Kathleen M. O’Malley (Ret.) ![]() Neema Kumar ![]() Serena Farquharson Torres |
8:15 |
A View from Capitol HillPatents, Politics and Policies: Understanding Impact of The Inflation Reduction Act on Hatch-Waxman Litigation![]() Michael P. Kahn ![]() David J. Kappos ![]() David Korn Moderator:![]() William James
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9:15 |
SUPREME COURT UPDATEAmgen v. Sanofi: Understanding How the Supreme Court May Re-Shape §112![]() Matthew A. Pearson ![]() Emily J. Greb ![]() Eric Stone ![]() Richard C. Pettus Moderator:![]() Vishal C. Gupta In November of 2022, The U.S. Supreme Court granted cert. in Amgen v. Sanofi, but strangely denied cert. in Juno v. Kite, a case with remarkably similar questions presented. At the time of press, Juno petitioned the Court for rehearing, arguing that the grant of cert. in Amgen warrants reconsideration. The fate of §112 hangs in the balance leaving Hatch-Waxman practitioners wondering how this will impact litigation strategies. Topics of discussion will include:
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10:30 |
FEDERAL CIRCUIT FIRESIDE CHATA Conversation with the Federal Circuit![]() Honorable Leonard P. Stark Interviewed by:![]() Honorable Kathleen M. O’Malley (Ret.) |
11:00 |
Morning Networking Break |
11:15 |
Skinny Labeling and the Infringement of Repurposed Patents: Winning Strategies, New Approaches to Carve Outs, and Induced Infringement of Method Claims![]() Chad A. Landmon ![]() Jason Leonard ![]() Kevin S. Prussia ![]() Jeanna M. Wacker Moderator:![]() Michael Sitzman The battle over the common generic carve-out has made its way to the White House. The Supreme Court has asked the Solicitor General to weigh in on the matter of carve outs. The industry ponders the implications of the pending opinion on pharmaceutical patents as well as the practice of patent law. In this session, points of discussion will include:
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12:15 |
Networking Luncheon
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1:45 |
§101 in the Balance: Comparing Current Requirements with Proposed Reforms for Patent Subject Matter Eligibility![]() Ryan Hagglund ![]() John Kirkland ![]() Noah M. Leibowitz ![]() Rashad Morgan ![]() Whitney Meier Howard The Supreme Court’s denial of cert. in American Axle & Manufacturing, Inc. v. Neapco Holdings LLC, 967 F.3d 1285 (Fed. Cir. 2020) contributes to the history of uncertainty surrounding patent eligible subject matter determinations. The case has also spurred debate over whether the current state of play advances or harms innovation. The Federal Courts, the USPTO, and Congress have responded to this the uncertainty in several ways, including proposed legislation. In this session, points of discussion will include:
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2:45 |
Networking Break |
3:00 |
The Practice of PIV DisputesTrack 1 — International IP Risks: Effectively Managing a Global Pharmaceutical IP Litigation Strategy
Track 1![]() Deepro R. Mukerjee ![]() Kevin Zive Track 2![]() Honorable Christopher J. Burke ![]() Pilar G. Kraman Track 3![]() Ryan M. Daniel ![]() Stephanie Donahue ![]() James P. Leeds ![]() Aaron Pereira Track 1 — International IP Risks: Effectively Managing a Global Pharmaceutical IP Litigation Strategy
Track 2 — Joint Defense Groups: A Risk Benefit Analysis for the Hatch-Waxman Practitioner
Track 3 — Closed Door Executive Meeting with ACI’S Hatch-Waxman Series Advisory BoardLimited to 24 participants (12 brand; 12 generic) by invitation- only, this unique, interactive discussion will provide an exclusive and intimate networking and benchmarking opportunity that will shed light on the expectations of in-house counsel from their law firm partners. It is also a vehicle for other in-house counsel to benchmark their current “3C’s” strategies with those of the Board.
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3:45 |
The Business of PIV DisputesTrack 1 — The Cost and Worth of a Patent: The Economics of a Paragraph IV Challenge
Track 1![]() Jonathan Davies ![]() Isaac S. Ashkenazi Track 2![]() Kathleen Gersh ![]() Kurt Karst Track 1 — The Cost and Worth of a Patent: The Economics of a Paragraph IV Challenge
Track 2 — Best Practices for Utilizing FDA’s Citizen Petition Process to Achieve Market Exclusivity
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4:30 |
Networking Break |
4:45 |
View from the Bench: Spotlight on PIV Litigation in DE and NJ![]() Honorable Stanley R. Chesler ![]() Honorable Mitchell Goldberg ![]() Honorable Maryellen Noreika ![]() Honorable Joshua Wolson Moderator:![]() Jonathan B. Turpin |
6:00 |
Cocktail Reception
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Day 2 - Thursday, April 20, 2023
7:15 |
Breakfast and Registration |
8:00 |
Chairs’ Opening Remarks![]() Honorable Kathleen M. O’Malley (Ret.) ![]() Neema Kumar ![]() Serena Farquharson Torres |
8:15 |
FOCUS ON FDAGDUFA III User Fees, Guidances, and MAPPs – User Fee Reauthorization Riders and New Litigation with FDA![]() Christopher Pruitt ![]() Brian Stone ![]() Maryll W. Toufanian Moderator:![]() David B. Abramowitz
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9:00 |
Part II: What Every PIV Litigator Needs to Know about the USPTO- FDA Collaboration and the Efforts to Promote Competition![]() Christopher Pruitt ![]() Brian Stone ![]() Maryll W. Toufanian Moderator:![]() Daniel G. Brown President Biden and Congress have applied pressure on USPTO and FDA to change patent policies to keep drug prices down and promote competition. The two agencies are exploring initiatives, as the Order required USPTO and FDA to identify inter-agency goals for collaboration. Areas of collaboration to be discussed will include:
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9:30 |
Morning Networking Break |
10:00 |
The Business of PIV DisputesTrack 1 — Legal Spend Management: Best Practices for Budgeting Pharmaceutical IP Litigation – Monitoring Legal Spend and Balancing the Budget
Track 1![]() Peter Waibel ![]() Douglas H. Carsten Track 2![]() Andrew Cochran ![]() Vikram Mathrani ![]() Ted Mathias Track 1 — Legal Spend Management: Best Practices for Budgeting Pharmaceutical IP Litigation – Monitoring Legal Spend and Balancing the Budget
Track 2 — Revisiting Damages in an At-Risk Launch Scenario: Questions of Remedies and Valuation
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10:45 |
The Business of PIV DisputesTrack 1 — The Essential Skills In-House Counsel Require: Communicating Value and Collaboration
Track 1![]() Donna Meuth ![]() Kevin M. Nelson Track 2![]() Mira A. Mulvaney ![]() Mary Morry ![]() Preston K. Ratliff II Track 1 — The Essential Skills In-House Counsel Require: Communicating Value and Collaboration
Track 2 — Patent Reissue and Reexamination: Strategies for Correcting Errors and Determining When to Pursue
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11:30 |
ANTITRUST MATTERS IN THE SETTLEMENT OF PIV DISPUTESFTC KEYNOTE![]() Beckey Egeland |
12:00 |
Networking Luncheon |
1:45 |
Reverse-Payment Settlements: Demystifying the Current State of Pharmaceutical Litigation Settlements in the Hatch-Waxman Context![]() Julia Chapman ![]() Benjamin M. Greenblum ![]() Kurt Mathas ![]() Robert Milne ![]() Alyson Wooten
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2:45 |
THE PATENT TRIAL AND APPEAL BOARD THINK TANKThe APJs Speak on Practice, Policy, and Procedure in the World of Pharmaceutical Patent Validity Changes![]() Honorable Jacqueline Bonilla ![]() Honorable Susan Mitchell ![]() Honorable Grace Obermann Co-Moderators:![]() John J. Molenda ![]() Gregory A. Morris
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3:45 |
Networking Break |
4:00 |
Preparing for Parallel Proceedings: Maneuvering through the District Court and Inter Partes Review![]() Angie Verrecchio ![]() Andrew D. Cohen ![]() Gerald J. Flattmann, Jr. Moderator:![]() Daniel J. Minion
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5:00 |
CYBERSECURITYCybersecurity and Information Security Concerns for Hatch-Waxman Litigators: Practical and Ethical Considerations![]() Shashank Upadhye Attorneys oversee myriad of sensitive information daily, and confidentiality is a core tenet of the legal profession. Now, more than ever before, cybersecurity must be an ever-present priority for Hatch-Waxman practitioners. This session will offer best practices for protecting your clients’ information, identify the main risks specific to the life sciences and intellectual property, and provide proven strategies on optimizing your firm’s cybersecurity approach that you can immediately implement. |
6:00 |
Conference Concludes |