Federally Funded Research, the Bayh-Dole Act, and the COVID Vaccine Race, by John Aubrey Douglass, CSHE 3.21 (February 2021)

This essay discusses the world of federally funded intellectual property (IP) before and after the Bayh-Dole Act and its impact on the world of science and commerce, before then exploring the complicated debates over ownership of the science behind the life-saving COVID-19 vaccines that will bring normalcy back to the world. Before 1980, federally funded science in the U.S. was largely focused on meeting the Cold War national defense needs of a nation in a science and technology race with the Soviet Union. The 1980 Bayh-Dole Act initiated in earnest the recognition that the advancement of national ecosystems of science was also vital for global economic competitiveness. The act allowed university generated IP with federal grants to be owned and licensed by universities for commercial purposes. Before, the federal government retained ownership of IP. The result was a transformation in how universities researchers viewed the research and IP they generated, leading to start-up companies and supporting a revolution in biotech and other emerging areas of science. Although many research-intensive universities already had technology transfer offices, these now proliferated. Universities generated policies on IP ownership, including a policy in which any profits resulting from patents and licenses are shared between the researcher, the department or school they belong to, and the university. Universities and other nonprofits were also required to reinvest Bayh–Dole patent revenues in science research and education, generating substantial resources to new research projects. But the success of the Bayh-Dole Act, and the discoveries it helped generate, also contributed to an increasingly complicated world of IP ownership. The act and similar legislation, as well as federal funding, contributed to the foundational science that led to the variety of COVID-19 vaccines. Its provisions also raise questions about the role, and ownership, of federally funded research that made the vaccine possible. The new Biden administration has put a priority on production and distribution of COVID vaccines, but it may later attempt to control the price and profits of pharmaceutical companies under the “march-in” rights reserved to the federal government. At the same time, the emergence of “vaccine nationalism,” in which nations and drug makers prioritize control of IP and production of vaccines for their own population, is testing the ability of the world to effectively respond to the virus as it mutates. In the aftermath of the COVID pandemic, the strengths and weaknesses of the IP world set out by the Bayh-Dole Act will be debated and focused on two questions: who profited from the pandemic and at what global public expense?