The presentation by Robert Hardy at the 2005 AUTM meeting examines the implications of the Madey v. Duke University decision, particularly its significant impact on university-based research and the application of the experimental use defense in patent law. The Federal Circuit’s ruling in Madey v. Duke held that the experimental use defense is extremely narrow and does not generally apply to research conducted at universities if such activities further the legitimate business objectives of the institution, regardless of whether or not that institution is non-profit. The court emphasized that acts in furtherance of the university’s mission—such as attracting research funding, increasing reputation, and educating students—are not exempt, and the experimental use defense is limited only to activities performed solely for amusement, idle curiosity, or strictly philosophical inquiry.
The presentation further details the potential effects of the ruling, including increased administrative and financial burdens on universities and a potential chilling effect on research activities. Surveys and workshops involving major research institutions and associations were conducted to assess the real-world impact, including the frequency of infringement notifications, changes in research practices, and economic costs. Data collected indicate a noticeable but steady level of infringement claims directed at universities, primarily from the industry sector and especially concerning biomedical research. While the majority of universities reported little practical change to their research activities, a significant minority incurred notable costs or reconsidered research directions. The findings point to a heightened risk environment post-Madey, prompting calls for better risk management and consideration of possible legislative action to introduce a statutory research exemption.
