Opinions and Editorials

Apr. 3, 2020

Morning Consult: How the Bayh-Dole Act Facilitates Development of Coronavirus Therapies by Stephen Ezell

As the urgency of finding a treatment and vaccine for the coronavirus accelerates, dozens of American biomedical companies, startups and universities are rushing to develop COVID-19 therapeutics. There’s a good chance the Bayh-Dole Act will play a critical behind-the-scenes role in facilitating these efforts.

Congress passed the bipartisan Bayh-Dole Act in 1980 to give universities and nonprofit research institutions such as Battelle Memorial Institute, Sloan Kettering and Mass General Hospital rights to the intellectual property they generate from federally funded research. The Economist hailed the act as “possibly the most inspired piece of legislation to be enacted in America over the past half-century,” and that judgment proved to be correct. The law has since stimulated a tremendous amount of innovation, unlocking the potential of inventions and discoveries that in many cases had been sitting untapped on national laboratory or university shelves.

Prior to the Bayh-Dole Act, when the federal government retained ownership of the innovations it funded, very few were ever commercially produced. Only 390 patents were awarded to universities the year the act was passed. But in 2017, that number had increased to nearly 7,500. In fact, more than 100,000 patents have been issued to U.S. universities or nonprofit research institutes between 1996 and 2017, resulting in more than 420,000 inventions and 13,000 startup companies formed.

In the life sciences, Bayh-Dole enables universities to secure IP rights — often in the form of patents for molecular compounds or biotechnological processes — which they in turn often license to startups and bigger biopharmaceutical companies. Over 200 new drugs and vaccines have been developed through public-private partnerships facilitated in part by the Bayh-Dole Act since its enactment in 1980. These medicines treat conditions ranging from Crohn’s disease to hepatitis B, HIV/AIDS and HPV, among many others. In contrast, not one drug was created from federally funded research under the technology-transfer regime that existed prior to Bayh-Dole.

Today, there’s a direct link between the Bayh-Dole Act and the quest to develop a COVID-19 therapeutic. For instance, Moderna, the company that has come the furthest toward developing a vaccine — with Phase 1 clinical trials already underway in Seattle — credits the pivotal role of patents in the field of messenger RNA and associated mRNA delivery technologies, which it licensed from Harvard and the University of Pennsylvania.