Speaking Engagements April 29, 2025  |  10:30 AM - 11:30 AM ET

ACI 21st Annual Paragraph IV Disputes 2025

The Altman Building
135 West 18th Street
New York, NY 10011

Speakers

Alan B. Clement

Tuesday, April 29 • 10:30 – 11:30 a.m. ET

Troutman Pepper Locke is proud to sponsor ACI’s Paragraph IV Disputes Conference on April 29-30, 2025.

Partner Alan Clement will be speaking on “Charting the Evolving Boundaries of the Safe Harbor 35 USC § 271 in View of Recent Case Law,” on April 29 at 10:30 a.m.

The panel will cover:

  • Determining what is and is not shielded by the safe harbor following the Federal Circuit decision on Edwards Lifesciences Corp. v. Meril Life Sciences Pvt. Ltd.
    • Analyzing the broad interpretation of the term ‘solely’ for regulatory purposes and the implications for patent enforcement.
    • Exploring Brand and Generic perspectives on the scope of conduct covered by the safe harbor.
  • Examining where safe harbor defenses are holding up and where they are being defeated.
    • Allel Biotechnology & Pharm v. Regeneron Pharm.
    • Protecting third party manufacturing activities for the purposes of filing an ANDA.
    • Comparing the US safe harbors for drug development with other key jurisdictions.