Correspondence: Karen I. Boyd, Fish & Richardson P.C., 500 Arguello St., Suite 500, Redwood City, CA 94063, USA. Tel: +1 650 839 5012; Fax: +1 650 839 5071. E-mail: boyd@fr.com

¹is a principal at Fish & Richardson P.C., specialising in life sciences patent litigation. She clerked for Chief Judge Paul R. Michel of the Federal Circuit. She received her master's degree in molecular biology from UCLA and her law degree from UC Berkeley's Boalt Hall. Ms Boyd has taught as an adjunct professor at Hastings College of the Law, teaching patent law and as an adjunct lecturer at Boalt Hall teaching Biotechnology and Chemical Patent Law.

Received 19 July 2006; Revised 19 July 2006.

Abstract

The Supreme Court recently ruled on the scope of the patent infringement 'safe harbour' of 35 U.S.C. §271(e)(1), which was passed by Congress in 1984 to allow generic drug manufacturers to test their drugs before the expiration of the patents that covered the drugs. The scope of the safe harbour has been interpreted by the courts to be much broader than that, and the Supreme Court confirmed the breadth of the exemption. The Supreme Court did not, however, address the application of the safe harbour to research tools, an issue of vast commercial importance. This paper traces the history of the safe harbour and the Merck v Integra decision, and explains the current state of the law and where the law may be going.