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

April 19, 2023 11:15am

Chad A. Landmon
Axinn, Veltrop & Harkrider LLP

Jason Leonard
McDermott Will & Emery

Kevin S. Prussia
Wilmer Cutler Pickering Hale and Dorr LLP

Jeanna M. Wacker
Kirkland & Ellis LLP


Michael Sitzman
DLA Piper

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