The Bayh-Dole Act has been imperative to the development of the United States’ dynamic pharma-biotech sector. However, the use of march-in rights under the Bayh- Dole Act has remained controversial. On the one hand, there is the idea of market equilibrium with a need to secure health care for the public. Many believe march-in rights should be used to create this balance by regulating the pricing of drugs that were developed using federally funded research. On the other hand, some advocates recognize that the current relationship between public-sector institutions and business as the developers of basic research, and private-sector biotechnology companies as the producers has proven to be fruitful. Thousands of patents have been issued since the execution of the Bayh-Dole Act in 1980. These advocates fear that the expansion of march-in right usage would result in a chilling effect that destroys the progress made in pharma-biotech research and development.
This Article analyzes “march-in rights” under Section 203 of the Bayh-Dole Act by examining how individuals have attempted to use them and why in over 42 years of existence, march-in rights have never been invoked. It further addresses the current political climate surrounding the regulation of drug pricing and describes the potential consequences of improperly using march-in rights to lower drug prices.
Don't Tread on My IP Rights: A Law and Economics Analysis of "March-In Rights" Under the Bayh-Dole Act,
71 Clev. St. L. Rev.
available at https://engagedscholarship.csuohio.edu/clevstlrev/vol71/iss1/7