Patents on biomedical research tools—technological inputs to experimentation—may inhibit scientific inquiry and the development of life-enhancing treatments. 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 are resorting to a new paradigm of patent regulation 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 share resulting patented inventions widely 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,” institutions are embedding policy objectives in quid pro quos with individual recipients of research support. This model allows public institutions to effectuate norms favoring wide dissemination of research technologies as well as provides considerably more freedom to operate than traditional regulation. 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.
- patent law,
- biomedical research,
- private ordering,
Available at: http://works.bepress.com/peter_lee/2/