11 Jul 2023
Hatch-Waxman Safe Harbor Checklist
This checklist discusses the applicability of the drug development safe harbor provision of the Hatch-Waxman Act that creates a broad exemption from patent infringement liability for drug-research activities.
Related Content
- Biosimilars and the Biologics Price Competition and Innovation Act (BPCIA)
Understand the litigation process set up by the BPCIA to facilitate resolution of patent disputes between reference product sponsors and biosimilar manufacturers.
- Plaintiff's Interrogatories in Hatch-Waxman Patent Litigation (Brand to Generic)
Draft interrogatories designed for use by an innovator patent owner as a starting point in preparing interrogatories for service on a generic challenger accused of infringement under the Hatch-Waxman Act.
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