Paragraph IV Disputes

ACI is honored to have this panel of distinguished jurists who were actively involved in Paragraph IV cases from the start to provide a retrospective look at the Hatch-Waxman Act. Join us as these legends detail the law’s original intents, pivotal milestones, and future trajectories. They will outline how this landmark legislation has shaped the pharmaceutical industry and patent litigation for brands and generics.

Join us for a look back at the past year’s most important developments impacting small molecule drugs, including groundbreaking court decisions, pivotal regulatory and policy changes, and major industry shifts.

Session leaders will offer insights how these developments are changing the practice of Hatch-Waxman Litigation. Topics of discussion will include:

• The Biden Administration’s new stance on drug pricing and march-in rights
• Analyzing recent actions to control prescription drug prices in the U.S., including the potential impact of using march-in rights under the Bayh-Dole Act
• FTC’s approach to drug listings in the orange book and the evolution of pay-for-delay
• Exploring the intensified scrutiny and investigations
• Examining recent listing and relisting of drugs in the Orange Book
• Understanding how this is influencing the dynamics of drug patenting and market exclusivity
• The evolution of USPTO-FDA Collaboration
• Taking stock of the evolving partnership and understanding the impact on patent prosecution and regulatory approvals
• §101 legislation and the impact on patent eligibility
• Assessing the latest legislative proposals regarding §101, focusing on the potential effects on the patentability of small molecules
• Global policy shifts
• Understanding the implications of the new TRIPS waiver and the WIPO’s disclosure proposals on international pharmaceutical patent protection and licensing
• Implications of GSK v. Teva on section viii carve-outs for small molecules
• Examining the current landscape for small molecule patent strategies and litigation

By 2026, nearly 400 small molecule drugs – including at least a half dozen of blockbuster status and blockbuster revenue are set to go off patent. This panel will explore the seismic economic implications of this latest patent cliff statistic as well as its effects on Hatch-Waxman litigation. Join us as we examine the current challenges and opportunities relative to the complexities of the looming patent cliff, pipeline replenishment, and the strategies brands and generics are employing to navigate these challenges. Points of discussion will include:

• It’s not 1984 anymore…
  • Understanding why this latest patent cliff is different than others
• The economic impact of the patent cliff
• Potential revenue loss and market share shifts
• Strategies for scaling today’s patent cliff
  • Extending patent life, managing patent portfolios, and navigating legal challenges in a competitive market
• Assessing the impact of the cliff on Paragraph IV practice: to sue or not to sue?
• The role of AI, automation, and digital transformation in creating new opportunities considering patent cliff challenges
• Understanding the influence of new and evolving regulation on pharma patenting strategies and the broader implications for access and pricing
• Predicting long-term shifts in pharma IP management based on cliff dynamics
• The evolving landscape of pharmaceutical innovation: recent trends and breakthroughs in research, advancements in obesity treatment and discoveries in Alzherimer’s disease

The IRA has far-reaching effects on big pharma. This session will detail the ripple effect of drug pricing reforms patent portfolio management, life cycle management and litigation

• Evaluating the potential impact of the IRA on pharmaceutical patent litigation
• Examining possible patent perils during IRA price negotiation
  • What happens when a patent holder’s product is selected for negotiation before or during litigation?
  • What is the impact on recoverable damages in an at-risk launch scenario?
  • Assessing the impact on coordination and discovery
• Exploring how the IRA can encourage settlement of infringement litigation
• Practical strategies for safeguarding IP value when your drug is selected for negotiation

This session will outline the evolving landscape of §112 in Hatch-Waxman litigation, illustrated by the Supreme Court’s decision in Amgen v. Sanofi, and the Federal Circuit’s pending decision in In re: Xencor.

• Analyzing the impact of the Supreme Court’s decision in Amgen on the enablement requirement for broad genus claims and the resulting impact to patent portfolios
• Discussing potential outcomes of the Xencor case and how it could reshape the use and viability of MPF claims on antibody patents
• Exploring best practices in claim drafting relative to Amgen and Xencor
  • Broad protection v. sufficient disclosure
• Assessing how these cases influence Hatch-Waxman strategies, especially for ANDA filers

This session will enhance the synergy between in-house legal teams and their law firm counterparts. Session leaders will explore effective communication strategies, share best practices for aligning business goals, and provide you with actionable insights into building stronger partnerships, managing expectations, and fostering a collaborative environment that supports the unique legal needs of Hatch-Waxman practitioners.

• Detailing the impact of AI on life sciences IP and Hatch-Waxman litigation
  • Discovering how AI is revolutionizing drug discovery and development
  • Understanding new challenges and opportunities for IP protection and litigation under Hatch-Waxman
• Predicting AI’s role in patentability matters, data protection, and its influence on future litigation

Limited to 25 in-house attendees, 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 Advisory Board.

• “Cost”, will offer insights on the monitoring of legal spend and balancing a budget
• “Competency”, will provide best practices for overcoming talent limitations with demonstrable advice
• “Communication”, will engage attendees in the art of communicating value and fostering collaboration between corporate legal counsel  and outside

This session will provide you with effective strategies for managing and maximizing the value of your patent portfolio. Session leaders will provide insights into winning techniques for strategic patent management. Whether navigating patent lifecycles or exploring innovative expansion to your portfolio, you will be empowered with the tools required for successful portfolio optimization.

This session will explore the evolving landscape of litigation funding and alternative fee arrangements in Hatch-Waxman litigation, especially considering recent judicial scrutiny on hidden funding sources. Session leaders will discuss how these developments impact Hatch-Waxman litigation strategies and the importance of transparency in funding arrangements.

District Court Judges are at the forefront of shaping the landscape of pharmaceutical IP law. During this can’t-miss roundtable, distinguished District Court Judges will share their unique perspectives, illuminating the delicate balance between patent holders, generic drug manufacturers, and public interest.