The U.S. Department of Commerce’s National Institute of Standards and Technology (NIST) is proposing rules changes that would reaffirm our understanding of the Bayh-Dole Act and encourage commercial development of new medical innovations. Here’s what BIO has to say about the proposal.
As background, the bipartisan 1980 Bayh-Dole Act:
- Empowers universities, small businesses, and non-profit institutions to take ownership of inventions made with federally funded research, so they can license these inventions for further R&D and public use.
- Encourages the private-sector investment needed to turn basic government-funded research into tested and approved products that benefit Americans.
The success of the Bayh-Dole Act is clear. The law fueled a vibrant innovation sector that, between 1996 and 2017, led to the development of more than 200 new drugs and vaccines and 5.9 million jobs, among other successes.
But some want the federal government to wrongly use it to “march in” and seize the patents on these drugs, sending “a chilling message to companies in every industry—don’t bother investing billions of R&D dollars to turn federally funded inventions into real-life, market-ready products, since the government will just steal the fruit of your labor,” wrote David Winwood, an expert in university technology transfer, in The Washington Times last year.
BIO’s recommendations to NIST in a nutshell:
- Clearly state that “march-in rights” will only be exercised based on the four specific grounds spelled out in the initial act.
- Clearly state that “march-in-rights” will only be exercised after sufficient factfinding, and only when there is no other way to ensure that a patent is used effectively.
“The policy embodied in the Bayh-Dole Act delivers an excellent return to the taxpayers on their investment,” says BIO. “In the response to the COVID-19 pandemic alone, of the more than 840 unique active compounds currently in development today, approximately half are being developed by companies based here in the United Sates.”
Read BIO’s full submission to NIST.
Want to know what’s in the COVID-19 pipeline? Check out the BIO COVID-19 Therapeutic Development Tracker.