Drug discovery and the impact of the safe harbor provision of the Hatch- Waxman Act.
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.
Goodson
Susanne H
SH
Fish & Richardson P.C., 222 Delaware Avenue, P.O. Box 1114, Wilmington, DE 19801, USA. shg@fr.com
D000818:Animals; D017277:Drug Approval; D055808:Drug Discovery / Q000331:legislation & jurisprudence*; D006801:Humans; D010330:Patents as Topic / Q000331:legislation & jurisprudence*; D014481:United States; D014486:United States Food and Drug Administration