Scientific Research and the Experimental Use Privilege in Patent Law

Publication Date: October 2004

Publisher: Library of Congress. Congressional Research Service

Author(s):

Research Area: Law and ethics; Science and technology

Type:

Abstract:

Congress has identified research and development (R&D) as important contributors to technological progress. The performance of R&D may have intellectual property ramifications, however. To the extent that researchers use patented inventions without authorization, they may face infringement liability. Although the courts recognize an exception to patent infringement known as the "experimental use privilege," this judicially created doctrine has been described as very narrow and rarely applied. In particular, the experimental use privilege applies only to uses done for amusement, to satisfy idle curiosity or for strictly philosophical inquiry. This doctrine does not excuse uses that are in keeping with the accused infringer's business objectives.

In 2002, the U.S. Court of Appeals for the Federal Circuit applied these principles in the case of Madey v. Duke University. The court held that the experimental use privilege does not apply to activities that are "in keeping with the alleged infringer's legitimate business" -- even though the business of the defendant, Duke University, was nonprofit research. This ruling has raised concerns among some representatives of universities and research institutions, who fear that their basic R&D activities will subject them to patent infringement lawsuits.

Competing views have arisen over the significance of the Madey v. Duke University case. Some commentators believe that a limited experimental use privilege may best encourage technological advancement by rewarding successful researchers with robust patent rights. Others argue that the restricted nature of the experimental use privilege may in fact limit researcher access to state-of-the-art technologies and thus discourage further technological development. Still others assert that this issue is not of great practical importance, as few patent owners will likely file costly and time-consuming lawsuits against researchers who are not making commercially important uses of patented inventions.

The judicially created, "common law" experimental use privilege is complemented by a limited statutory experimental use privilege for patents on pharmaceuticals, medical devices, and certain other products regulated by the Food and Drug Administration. This provision, enacted as part of the 1984 HatchWaxman Act, applies to firms seeking to market generic equivalents of brand-name products. In addition, Congress has enacted other intellectual property legislation that incorporates provisions shielding researchers from infringement liability.

Should congressional interest continue in this area, a variety of options are available. If the current scope of the common law experimental use privilege is deemed to be appropriate, then no action need be taken. Alternatively, Congress could enact legislation confirming the limited experimental use privilege recognized in Madey v. Duke University and predecessor cases. Introduction of a broader form of the experimental use privilege into U.S. patent law is an additional possibility. The report will be updated if events warrant such action.