89 Pages Posted: 22 Oct 2008 Last revised: 25 May 2014
Date Written: October 22, 2008
Patents on biomedical research tools - technological inputs to experimentation - may inhibit scientific inquiry and the development of life-enhancing therapies. Various "public law" approaches to address this challenge, such as a common law experimental use exception to patent infringement, have achieved limited success. In the wake of these shortcomings, this Article argues that institutions that fund and support biomedical research are resorting to an underappreciated model of private ordering to resolve research holdup. Increasingly, federal and state agencies, universities, non-profits, and disease advocacy groups are conditioning vital research support on requirements that recipients of this support make resulting patented inventions widely available for noncommercial research purposes. In essence, these institutions are contractually constructing a biomedical research commons.
These efforts represent a significant shift towards "privatizing" patent regulation. Through a new model of "consideration-based patent regulation," public institutions are embedding policy objectives in contractual quid pro quos with individual recipients of research support. This model provides public institutions with considerable freedom to effectuate norms favoring wide dissemination of research technologies. This Article greets this development with cautious optimism, providing prescriptions for how public institutions may effectively manage the contractual construction of a biomedical research commons. It concludes by exploring the significant ramifications of this development for patent law, institutions, and theory.
Keywords: private ordering, norms, biomedical research, research tools, patent law, commons
Suggested Citation: Suggested Citation
Lee, Peter, Contracting to Preserve Open Science: Consideration-Based Regulation in Patent Law (October 22, 2008). Emory Law Journal, Vol. 58, p. 889, 2009; UC Davis Legal Studies Research Paper No. 153. Available at SSRN: https://ssrn.com/abstract=1288183