Drug Discovery and the Impact of the Safe Harbor Provision of the Hatch-Waxman Act

Susanne      H. Goodson

Abstract

Many facets of drug discovery involve the use of patented materials and methods, subjecting the researcher to potential liability from infringement of the underlying patents. Enacted in 1984, the Hatch-Waxman Act established a “safe harbor” for activities that would otherwise constitute infringement of a patented invention, if those activities were “solely for uses reasonably related to the development and submission of information under a Federal law which regulates the manufacture, use, or sale of drugs or veterinary biological products”. This article examines the major court decisions interpreting the scope of the safe harbor and their application to various activities in drug development.

Keywords: Research tools, Merck, AbTox, Eli Lilly, Proveris, Safe Harbor Provision, Hatch-Waxman Act, Federal law, Investigational New Drug Applica-tion, New Drug Ap-plication, Patent Term Restoration Act, Abbreviated New Drug, flurazepam, Federal Food, Drug, and Cosmetic Act, hybridoma tech-nology, FDCA, PHS Act, Federal Circui, FDA regulation, Arg-Gly-Asp, RGD, Merck's preclinical experimentation, ANDA, EMD 121974, v3 receptors, angio-matrigel test, FDA's guidelines, U.S. Patent No. 4,879,237, U.S. Patent No. 4,789,734, IC50 or EC50