The document is a formal letter submitted on behalf of several prominent organizations representing universities, academic medical centers, and technology managers, in response to the U.S. Food and Drug Administration’s (FDA) public meeting regarding the Hatch-Waxman Amendments. The letter addresses concerns raised about the interpretation of the Bayh-Dole Act’s “march-in” rights, cautioning against an expanded use of these rights beyond Congress’s original intent. Specifically, the organizations argue that broadening march-in rights to address drug pricing, rather than limited nonuse or unreasonable use of federally funded inventions, could discourage private sector engagement in licensing university-derived technologies. They point out that such a shift risks undermining medical innovation and public health benefits by deterring companies from the costly and risky process of commercializing academic discoveries.
The letter underscores the Bayh-Dole Act’s significant role in promoting the commercialization of federally funded innovation by enabling universities to transfer research to the private sector under suitable terms, leading to widespread benefits in public health and economic growth. Statistical evidence is provided to illustrate the Act’s positive impact, including increased patenting, startups, and economic output. The authors note that the statute does not mandate specific pricing controls and that previous federal attempts to impose pricing clauses resulted in diminished industry collaboration, as experienced by the National Institutes of Health (NIH) in the 1990s. Instead, they contend that practical application, not pricing, should remain the standard for march-in rights usage. The letter concludes with a willingness to remain engaged with the FDA on issues of innovation, access, and public benefit.
