Exercising Bayh-Dole March-in Rights Would Handicap COVID-19 Innovation
By Fred Reinhart
Scientists across America are working hard to develop treatments for and vaccines against COVID-19. Unfortunately, several activist groups are making their jobs harder.
Doctors Without Borders is urging governments to seize the patents on any coronavirus therapies that benefited from taxpayer-funded research. Universities Allied for Essential Medicines is making a similar push. These groups claim that such steps are necessary to prevent industry price gouging.
Their efforts are misguided. Confiscating patents would damage the innovation ecosystem that has generated breakthrough therapies and enabled scientists to work so quickly on COVID-19.
Several firms have already pledged to make coronavirus treatments widely accessible. Gilead says it will donate enough doses of its experimental antiviral remdesivir to treat 140,000 seriously ill patients. And Johnson & Johnson promises that if its vaccine proves effective, it will provide 1 billion doses at cost.
Despite these actions, activist groups still want the government to seize patents outright or to exercise the "march-in" rights detailed in the Bayh-Dole Act of 1980. To see why such action would backfire, consider how the drug development process currently works.
The federal government funds much of the country's basic scientific research. University and nonprofit labs receive relatively small federal grants to investigate unanswered questions.
These investigations often don't lead anywhere. But sometimes academic scientists discover crucial insights. The Bayh-Dole Act allows them to patent their findings and license them to private companies, which have the resources to turn the insights into tangible products.
The Bayh-Dole Act has played a role in the creation of almost 300 new vaccines and drug therapies, including breakthrough treatments for human papillomavirus, hepatitis B, HIV, and Crohn's disease.
Before the law was enacted, the government retained ownership of patents filed by academic institutions that received federal grants. But before 1980, the government licensed fewer than 5 percent of its 28,000 research patents to private firms. Universities have done a much better job of licensing patents than the government ever did. In 2018 alone, academic institutions issued 9,350 licenses to commercialize their discoveries.
Bayh-Dole could soon play a role in the production of lifesaving coronavirus therapies. Consider Moderna, a biotech firm that's already conducting human trials for its coronavirus vaccine. According to the firm's website, its intellectual property estate includes "licenses to pioneering discoveries from Harvard University and the University of Pennsylvania."
Researchers are also studying potential COVID-19 therapies at several U.S. universities.
These institutions will likely license any discoveries to private-sector firms -- unless politicians stifle this cooperation by misapplying Bayh-Dole's "march-in" rights. That provision allows the government to force the relicense of patents in rare instances, such as when a firm has licensed a patent but deliberately not commercialized it.
No administration has ever employed the Bayh-Dole march-in rights for that purpose -- and for good reason. Doing so would undermine America's innovation ecosystem. After licensing university patents, private firms spend enormous sums on additional research and development.
If the government could arbitrarily march in and seize intellectual property, investors would hesitate to fund the research that has brought us so many innovations. There would be far fewer partnerships and licensing deals between companies and universities. And that would inevitably slow the development and reduce the availability of new treatments and vaccines, hurting patients everywhere.
Fred Reinhart is a past president of AUTM with 35 years of experience in academic technology transfer at the University of Massachusetts, New England Medical Center, Wayne State University, and the University of Michigan. This piece originally ran in STAT News.
