Hatch-Waxman Patent Litigation Strategies

July 2020

This practice note discusses strategies that counsel for brand-name and generic drug companies may employ in pharmaceutical patent litigation under the Drug Price Competition and Patent Term Restoration Act of 1984, commonly known as the Hatch-Waxman Act. It focuses on litigating infringement and validity of active pharmaceutical ingredient (API), formulation, and treatment patents using court decisions as a guide to what works and what doesn’t for each side in Hatch-Waxman litigation.

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