§101 and §112
Skinny Labeling: The Future of Carveouts and the Analyzing the Influence of GSK v. Teva on Competition
Locke Lord LLP
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