The Misuse of the Bayh-Dole Act and the Folly of Price Controls on Drug Patents
This chapter in Bring Medicines to Life: How Intellecutal Property Enables Innovation in the Life Sciences analyzes and critiques the “price control theory of the Bayh-Dole Act,” demonstrating that this decades-long campaign to use the Bayh-Dole Act to impose price controls on drug patents is both statutorily unjustified and policy folly. First, it provides novel statutory analyses of the Bayh-Dole Act to show once again that the text, structure, and function of the march-in power in § 203 precludes the National Institutes of Health (NIH) from using it to grant licenses to generic drug companies to reduce prices of prescription drugs. Second, it addresses the economic errors underlying this price-control agenda even when the NIH is legally authorized in other provisions of the Bayh-Dole Act to impose conditions in its grant agreements and licenses, such as affordability mandates or reasonable price restrictions. Invoking this other statutory power in the Bayh-Dole Act, the Biden Administration adopted an “affordability” mandate in all licenses of NIH-owned patents in early 2025, and the Trump Administration officially implemented this policy on October 1, 2025. But this is policy folly. Contrary to conventional wisdom, almost all R&D funding for prescription drugs is from private sources. Given this economic data on drug R&D, a similar price-control policy adopted by the NIH failed. In 1989, the NIH adopted a “reasonable pricing” condition in its research grant agreements and licenses for any resulting prescription drug. This policy resulted in a collapse of NIH research agreements and licenses. NIH Director Varmus thus withdrew the “reasonable pricing” mandate in 1995, recognizing that it was contrary to the commercialization goals of the Bayh-Dole Act. The 2025 “affordability” mandate in NIH licenses will similarly undermine the commercialization of biomedical innovations created by NIH scientists. In sum, price controls on drug patents contravene the Bayh-Dole Act’s statutory text and function in harnessing the patent system as an engine of healthcare innovation through patent licensing and technology transfer.