The recent efforts to reinterpret the 1980 Bayh-Dole Act's provisions—specifically the "March-in" rights—are not just attacks on a piece of legislation but on the very foundation of university-led innovation that sustains the United States' global leadership in technology and medicine. The efforts of the CPAC Foundation's Center for Regulatory Freedom, our partners in the Coalition Against Socialized Medicine, and our allies working to protect Bayh-Dole, clearly must have been doing something right, because in recent weeks those working to undermine the act have gone on the offensive--challenging us and our allies in social media, and publishing articles trying to shift the narrative.
Helen Santoro’s recent article for Lever (and republished at Jacobin), is but one example, particularly targeting how universities like UCLA profit from federally funded research, like the cancer drug Xtandi. However, this criticism overlooks the fundamental benefits of the Act, especially for Historically Black Colleges and Universities (HBCUs) and their crucial role in fostering academic and community growth.
The Bayh-Dole Act was a legislative milestone that transformed the landscape of federally funded research by allowing universities, small businesses, and non-profits to own patents on their innovations. This pivotal change facilitated a surge in technology transfer activities and has been crucial in translating academic research into real-world applications. Universities can patent discoveries made with federal funding and then license these patents to the private sector, creating a revenue stream that sustains further research and educational excellence.
Critics of the Act, like Santoro, argue that it encourages universities to prioritize profits over public good, particularly in the context of pharmaceutical pricing. However, such critiques miss the broader picture of the Act’s impact. The revenue generated from these patents is a lifeline for many institutions, particularly smaller colleges and HBCUs, which often operate with limited budgets. This income supports further scientific research, academic programs, and scholarships, contributing to a cycle of innovation and education that benefits society at large.
David Kappos, a staunch defender of intellectual property rights and a key figure in shaping modern patent policy, has emphasized the importance of the Bayh-Dole Act in maintaining a vibrant national economy centered on innovation. According to Kappos, the ability to secure patent rights on federally funded research encourages private sector investment in potentially risky but high-reward areas. This is not just about creating profits but about bringing scientific breakthroughs to the market where they can have real impact.
For example, the development of Xtandi involved significant investment in terms of money and research hours, which was made possible only through the incentives provided by the Bayh-Dole Act. The revenue UCLA has earned from Xtandi is reinvested into the university, funding research facilities and academic scholarships that might otherwise be unaffordable. This model is especially crucial for HBCUs, which have historically been underfunded compared to other institutions. The ability to patent and license inventions provides these schools with a financial boost that can be transformative, promoting not only further research but also greater educational opportunities for traditionally marginalized communities.
Moreover, the current debates around "March-in" rights—a provision that allows universities and research institutions that receive federal seed monies to license patents to third parties under specific circumstances—are particularly contentious. Critics pushing for a broader interpretation of these rights argue that it would help reduce drug prices. However, such a move could also undermine the financial model that has enabled university research to flourish. Kappos points out that broadening march-in rights to control prices was explicitly excluded from the Act's provisions, as it would introduce significant uncertainty into the patent licensing process, deterring private investment and stifling innovation.
It's important to consider what is at stake if the Bayh-Dole Act is undermined. Without the revenue from patent licensing, universities might struggle to fund research at current levels, potentially slowing the pace of scientific discovery. This is particularly critical for HBCUs and smaller institutions, where such funds play an outsized role in resource allocation.
The Bayh-Dole Act has been a cornerstone of America's innovation economy, particularly benefiting universities and research institutions, including HBCUs. Any efforts to reinterpret its provisions must carefully consider the potential impacts not just on drug prices but on the health of the institutions that drive American innovation. The ongoing success stories of universities turning research into real-world solutions affirm that those defending the Act's original intent are indeed on the right path. As the debate continues, it is crucial that the academic and broader communities understand the stakes involved and advocate for policies that support sustainable innovation and access to advancements in healthcare.
