Leaving Room for Research: The Historical Treatment of the Common Law Research Exemption in Congress and the Courts, and its Relationship to Biotech Law and Policy
By Maureen E. Boyle
In this article, Maureen Boyle argues that the common law research exemption from patent infringement claims must be clearly defined to protect basic scientific research, particularly in the field of biotechnology.
Boyle surveys the history of the common law research exemption, starting with Justice Story’s 1813 view that the use of patented inventions for noncommercial experimentation was protected under the Patent Act of 1793. Boyle then uses the Bayh-Dole Act of 1980, which places a burden on universities to commercialize federally-funded research, to show that in the age of biotechnology the line between commercial and noncommercial research is blurred. Moreover, she criticizes the Federal Circuit for obscuring the distinction further. In Madey v. Duke University, 307 F.3d 1351, 1352 (Fed. Cir. 2002), the Federal Circuit held that even noncommercial experimentation in a university setting served to further universities’ business objectives of attracting students, faculty, and research grants. Thus, the Federal Circuit effectively eliminated the common law research exemption.
Drawing on the text and legislative history of the Transgenic Animal Patent Reform Act of 1988 and the Patent Competitiveness and Technological Innovation Act of 1990, Boyle demonstrates that Congress continues to believe there is a robust common law research exemption to patent infringement claims. Boyle argues that this disconnect between Congress and the judiciary leaves universities and researchers with no clear guidance regarding the use of patented inventions in basic noncommercial research. Boyle stresses that legal ambiguity on the subject has a chilling effect on beneficial biotechnology research and proposes a number of solutions, including a liability rule for patent infringement, a fair use factor-based exemption, a number of licensing options, and statutory exemption to the Patent Act of 1953.