When is patent infringement not patent infringement? Merck v Integra and the 'safe harbour'

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.