20th Paragraph IV Disputes Conference

Sterne Kessler was pleased to sponsor the 20th Paragraph IV Disputes Conference. Director JC Rozendaal was also be a speaker in “The Economics of Pharmaceutical Patents in 2024: Understanding How the Next Ledge of the Patent Cliff Will Reshape PIV Strategy” session during the event.

Panel Overview

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 explored the seismic economic implications of this latest patent cliff statistic as well as its effects on Hatch-Waxman litigation. They also examined 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 included:

• 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 Alzheimer’s disease