The Future of Inducement Claims in the Hatch-Waxman Context: Reconciling the Demarcation Between Describing an Infringing Use and Encouraging That Use in a Label

April 26, 2022 11:15am

Huong T. Nguyen
General Counsel & Compliance Officer
Fosun Pharma USA Inc.

Abigail Struthers
Arnold & Porter Kaye Scholer LLP

April Abele Isaacson
Kilpatrick Townsend & Stockton LLP

Sanya Sukduang
Cooley LLP


Aaron S. Lukas
Co-Chair, Hatch-Waxman & Biologics Practice
Cozen O’Connor

  • Analyzing whether a skinny label alone is enough to preclude induced infringement allegations
  • Reviewing the implications of recent decisions for induced infringement
    • Anticipating the impact of recent decisions on claim drafting and the availability of generic drugs
  • Devising strategic considerations of label language for inducement infringement
    • What considerations should patent owners keep in mind when labeling drugs?
  • Reviewing the approval of generic drug labeling
    • On what basis will FDA determine the scope of an appropriate carve-out?
    • Must FDA review the patent to ensure the only information carved out is covered by the patent?
    • Is the interpretation of the patent claims subject only to a jury’s interpretation?
  • Assessing the flurry of follow-on cases in the courts