Hatch-Waxman Litigation Update

The Drug Price Competition and Patent Term Restoration Act of 1984, more commonly known as the Hatch-Waxman Act, amended the Federal Food, Drug, and Cosmetic Act and the Patent Act in order to speed the introduction of lower-cost generic drugs into the marketplace, while at the same time preserving the rights of pharmaceutical patentees and compensating them for market time lost satisfying the U.S. Food and Drug Administration’s (FDA) safety and efficacy requirements.

The Hatch-Waxman Act establishes a mechanism for prospective manufacturers of a generic drug to challenge an extant patent covering an FDA-approved drug by filing an Abbreviated New ...