The Impact of the Bayh-Dole Act on Genetic Research and Development: Evaluating the Arguments and Empirical Evidence

Abstract

This book chapter summarizes the theoretical arguments for and against patenting upstream genetic research and vesting presumptive patent ownership in the recipients of federally funded genetic research, with a view to determining who should bear the burden of proof on specific aspects of these two questions. The chapter also evaluates the weight of the empirical evidence concerning each question made available between 2004 and 2007, with a view to determining how that evidence seems to preponderate. While neither the theoretical arguments nor the empirical evidence are likely to put an end to the fractious debate over these issues, both the theoretical arguments and the empirical evidence to date clearly seem to preponderate in favor of the proponents of patenting upstream genetic research and vesting presumptive patent ownership in the recipients of federally funded genetic research. Indeed, very little empirical evidence has been produced to date to support the argument that granting patents on the results of “upstream” genetic research undermines the norms of the biological research community or retards biomedical innovation, technology transfer, or the development of downstream commercial products and processes. To the contrary, the preponderance of the empirical evidence produced to date seems to suggest that, by vesting presumptive patent ownership in the recipients of federally funded genetic research, the Bayh-Dole Act is indeed achieving not only its statutory purpose but also the larger, constitutionally mandated requirement that the U.S. patent system “promote the Progress of Science and the useful Arts.”

Keywords: genetic research, patent ownership, legal issues in biomedical innovation, technology transfer, Bayh-Dole Act