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San Juan Puerto Rico
19 April 20233 minute read

18th Annual Paragraph IV Disputes Conference

Wednesday, April 19 – Thursday, April 20, 2023

New York, New York

ACI’s 18th Annual Paragraph IV Disputes Conference is the most prestigious conference shaping the law, policy, and proceedings of Paragraph IV litigation. Featuring leaders from brand and generic drug companies, judges, government officials, and litigators, this event will provide an unparalleled forum for discussions and presentation on both economic and legal takeaways for every aspect of the evolving Hatch-Waxman litigation. The conference not only highlights hot topics, but it also emphasizes recent court cases and filings and industry trends.

Agenda and Registration

Featured Moderator: Michael Sitzman

Skinny Labeling and the Infringement of Repurposed Patents: Winning Strategies, New Approaches to Carve Outs, and Induced Infringement of Method Claims

Wednesday April 19 – 11:15 am EDT 

DLA Piper partner, Michael Sitzman, will be moderating this panel. 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:

  • Evaluating the impact of GSK v. Teva, Amarin v. Hikma and their progeny on proving induced infringement
    • Analyzing recent court treatment
    • Types of evidence to demonstrate inducement
    • Pre-launch v. post-launch
  • Distinguishing between skinny labels and partial labels
  • Explaining the patentability of further medical use inventions
  • Strategies for claim drafting in view of these decisions
    • Reevaluating claim and label language
  • Detailing what every patent owner needs to consider when labeling FDA-approved products
    • Best practices for aligning patent claims with the label
    • Considerations for multiple approved indications