§101 and §112

Skinny Labeling: The Future of Carveouts and the Analyzing the Influence of GSK v. Teva on Competition

September 21, 2022 9:15am

David Abramowitz

David Abramowitz
Locke Lord LLP

Aziz Burgy
Axinn, Veltrop & Harkrider LLP

Gregory A. Morris
O’Melveny & Myers LLP

  • 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