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Two Years Later: The Effect of Madey v. Duke on Infringement By University Researchers

By Robert W. Esmond, Ph.D. and Robert A. Schwartzman, Ph.D.
November 09, 2004

In 2002, Duke University attempted to avoid liability for patent infringement by invoking the common law experimental research exception to patent infringement. In a landmark decision, the U.S. Court of Appeals for the Federal Circuit rejected Duke University's argument that its infringing research activities should be exempt from liability under this exception. Madey v. Duke Univ., 307 F.3d 1351 (Fed. Cir. 2002).

This decision led a number of commentators to proclaim that the experimental use doctrine has been eliminated, that patent holders will now aggressively pursue licensing with researchers and embolden their enforcement efforts, and that there will be a great chill on research efforts. University administrators complained that it would be impossible for them to monitor the activities of their research personnel for possible infringement.

Now that 2 years have passed, it is time to step back and see what effect this decision has had on enforcement efforts by patent holders. But first, it is useful to discuss the four major exceptions to patent infringement that might be relied upon by universities to avoid liability for infringement: the common law experimental use exception, the statutory clinical research exception under 35 U.S.C. '271(e)(1), and sovereign immunity protection for state schools and institutions. A fourth exemption under 28 U.S.C. '1498(a) provides that the patent owner must sue the government if the infringement occurred under a government contract.

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