The Mouse as a Paradigm

No single research tool has played a more significant role in genetics and genomics research and development than the genetically engineered research mouse, so it is not surprising that no other research tool has so often been at the epicenter of tension between the ethos of sharing and the commercialization of intellectual property. The "mouse wars" over the p53 knockout mouse, the first patented transgenic mouse (the "Harvard Mouse"), and mice made with Cre-lox technology are historical milestones in the ongoing debate over whether the Bayh-Dole Act, federal policies and guidelines, and technology transfer practices in the research community are best serving the public interest in ensuring the accessibility of research tools. Given the leading part that genetically altered mice have played in this drama, the mouse is the obvious paradigm to study whether the intellectual property ownership incentives provided by Bayh-Dole have inhibited or promoted access to and utilization of mice as research tools. The Jackson Laboratory, as the national repository of genetically engineered mice, has a unique resource of more than 100 negotiated mouse distribution agreements with virtually every major biomedical research institution. The proposed research project will analyze this collection of agreements to determine past and current practices of mouse distribution, terms and conditions on the use of mice, the impact of patents and multiple intellectual property claims on access to mice, and whether intellectual property claims in mice promote, discourage or are a neutral factor in the research and development of mice. The project will review the mouse distribution licenses of each biomedical research institution that has contributed mice to The Jackson Laboratory's repository and evaluate how these licenses comport with the NIH Policies on Sharing Biomedical Research Resources, Sharing of Model Organisms for Biomedical Research, and Sharing and Distributing Mouse Resources. The project will examine whether the case of Madey v. Duke, which placed a legal cloud on the custom of experimental use (research) exemption, has had a measurable effect on how technology transfer offices in academia treat mice as intellectual property and how it impacts NIH policies. Finally, based on the project's research findings for the mouse as the paradigm, recommendations will be provided to NIH with respect to how it can improve its research tools policies so as to ensure that NIH grantees can more readily obtain research tools developed with federal funds.