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
Huong T. Nguyen
General Counsel & Compliance Officer
Fosun Pharma USA Inc.
Abigail Struthers
Partner
Arnold & Porter Kaye Scholer LLP
April Abele Isaacson
Partner
Kilpatrick Townsend & Stockton LLP
Sanya Sukduang
Partner
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