Bayh-Dole Coalition Statement on Biden Administration’s Proposed March-in Framework

Bayh-Dole Coalition Statement on Biden Administration’s Proposed March-in Framework

WASHINGTON, D.C. (December 7, 2023) — Today, the Biden administration’s Interagency Working Group for Bayh-Dole concluded its review of the federal government’s march-in authority under the 1980 Bayh-Dole Act. The Working Group’s findings indicate that “on the exercise of march-in rights…price can be a factor in determining that a drug or other taxpayer-funded invention is not accessible to the public,” along with other purely subjective criteria.

In response, Joseph P. Allen, Executive Director of the Bayh-Dole Coalition, released the following statement:

“The Bayh-Dole Coalition is saddened by the Biden administration’s proposed framework for march-in use. It casts a shadow of uncertainty over America’s innovation system.

“Since 1980, the Bayh-Dole Act has contributed almost $2 trillion to America’s economic growth, sustained over 6 million jobs, and brought thousands of life-changing products to market. For over 45 years, researchers and the investors who help commercialize federally-funded technologies had a shared understanding of how the law worked. All that is now in doubt.

“The proposed framework is a stark departure from the government’s long-standing interpretation of the Bayh-Dole Act. Earlier this year, the Biden administration rightly rejected activists’ petition to use the Bayh-Dole Act’s march-in authority on the basis of price to effectively control the cost of an already-commercialized medicine. The Obama administration rejected a similar petition in 2016. Abandoning this precedent now — as the Working Group specifies — would discourage critical public-private partnerships and prevent thousands of transformational discoveries from reaching consumers. Unfortunately, the guidelines open up other subjective criteria which undermine confidence that public sector research institutions can be reliable partners. That uncertainty puts our innovation system at risk just as we need it most.

“Ironically, the impact of this confusion will fall on the very entrepreneurial small companies that drive American innovation. They must rely on venture capital to exist, and the new guidelines will make potential investors wary of backing them when the government threatens to license their competitors under these vague guidelines. The resulting damage won’t be limited to drug development. So many nascent technologies to counter climate change, improve the environment, and address food insecurity are now at risk.

“Finally, this proposal directly contradicts the views of Americans on both sides of the aisle. An overwhelming majority of voters want to preserve the Bayh-Dole Act in its current form, according to a recent poll conducted by Morning Consult.

“At a time when our nation faces so many real crises, it makes little sense to create another by casting an unnecessary cloud of confusion over the Bayh-Dole Act. We implore the Biden administration to disregard the Working Group’s framework. The future of American innovation and economic competitiveness is at stake.”

About the Bayh-Dole Coalition: The Bayh-Dole Coalition is a diverse group of innovation-oriented organizations and individuals committed to celebrating and protecting the Bayh-Dole Act, as well as informing policymakers and the public of its many benefits.