In early December, the Biden administration announced a proposed framework under the Bayh-Dole Act that would allow the government to seize patent rights on products developed with any federal funding if they don’t agree with the price, using the “march-in” provision. Not only does this unjustified use of “march-in” ignore decades of precedent and previous failed attempts by the NIH to force so-called “reasonable pricing” clauses into partnership agreements but it threatens to chill the lifesaving innovation made possible by public-private collaboration. In response, innovation leaders, small business advocates, and other experts have voiced significant concerns about the proposed framework:
- “The Biden administration is poised to weaken U.S. innovation and competitiveness. The plan to seize patents at will jeopardizes countless entrepreneurial firms and the jobs they create.” – Karen Kerrigan, president & CEO, Small Business & Entrepreneurship Council
- "If government leaders break decades of precedent by codifying this march-in proposal, no patent licensing agreement will be safe. Without security for hard-earned intellectual property rights, it will become exponentially more difficult for startups and inventors to secure funding for their innovations. Our economy will take a hit. And we will all lose out on potentially life-changing inventions.” – Chris Israel, director, Alliance of U.S. Startups & Inventors for Jobs
- “I am very concerned that this development could kill the golden goose that we have built for decades and undo our efforts to uplift innovators from all backgrounds.” – Almesha L. Campbell, Ph.D., assistant vice president for research and economic development at Jackson State University and chair, Association of University Technology Managers (AUTM)
- “This will chill investment. This will chill innovation. While it may have been expected to be directed at drug prices, it actually is agnostic to technology. This ruling affects all federally funded research.” – Jon Soderstrom, former managing director, Yale Ventures
- “The plan is not only of dubious legality, but it would also complicate — and seriously undermine — the historic innovation pipeline created by the very law under which the administration proposes to act.” – Lamar Smith, former U.S. Representative (R-TX)
- “Misusing Bayh-Dole’s march-in clauses as a de facto price control would obliterate private firms’ willingness to license and commercialize discoveries from universities and other federally funded research institutions. All taxpayer-funded research, no matter how promising, could become tainted overnight.” – Peter J. Pitts, president and co-founder, Center for Medicine in the Public Interest
Since the Bayh-Dole Act became law in 1980, our innovation ecosystem has flourished to the tune of over 200 new medications and vaccines being brought to market through licensing and public-private partnerships.
Policymakers must re-evaluate whether they want to take us back to a time when nearly 28,000 patented inventions were gathering dust on government shelves. Instead, our leaders should prioritize patients and their families who stand to lose the most from chilling lifesaving collaboration and innovation.
