The Trump administration’s recent threat to exercise the Bayh-Dole Act’s march-in rights against Harvard University represents a watershed moment in the federal government’s oversight of patents arising from federally funded research.

This unprecedented regulatory escalation has sent ripples of concern throughout the higher education community and industry alike, revealing a new era marked by uncertainty over patent ownership and licensing agreements. For businesses that partner with universities, this uncertainty threatens to chill collaborative innovation by undermining the foundation of predictability essential to long-term success.

The Background: The Bayh-Dole Act

Enacted in 1980, the Bayh-Dole Act fundamentally reshaped the landscape of academic innovation by granting universities the right to retain ownership of inventions developed with federal funding. This statute was designed to spur the transfer of groundbreaking academic discoveries to industry for practical application, fueling the growth of start-ups, driving technology commercialization and ultimately benefiting the public through new products and services. For more than four decades, the Bayh-Dole Act has underpinned a thriving ecosystem where research institutions and private companies collaborate with clear expectations around intellectual property rights and licensing dynamics.

According to AUTM, since 1996, academic technology transfer resulted in more than 580,000 inventions disclosed, more than 149,000 patents granted and more than 19,000 start-ups created, supporting 6.5 million jobs and contributing $1.9 trillion to U.S. gross industrial output. This impact extends deeply into local economies, where universities’ technology-transfer activities have driven significant employment growth and economic development in their surrounding communities.

The impact is especially visible in local and state economies. In Colorado, for example, university-driven tech transfer created more than 400 start-ups between 1998 and 2023 and led to more than 8,200 invention disclosures and 1,600 patents issued. In Delaware, life sciences start-ups and patented technologies have established the state as a leading biotech hub, with significant local job creation and direct contributions to state GDP.

Yet, the Trump administration has embarked on a highly aggressive path that would undermine the economic benefits of the Bayh-Dole Act by threatening to invoke the act’s march-in provisions, signaling its intent to compel universities to license patents under government-directed terms and even indicating a willingness to seize those patents. Historically, march-in rights have been considered a last resort in extreme cases, not a routine enforcement tool. This new posture upends decades of predictability, igniting fears among industry partners and university technology-transfer offices that the regulatory ground could shift beneath their feet at any moment.

U.S. Secretary of Commerce Howard Lutnick has also said that the federal government should receive 50 percent of patent revenue from inventions arising out of federally funded university research. While university-held patents contribute significantly to innovation and economic growth, the average revenue from patent licensing varies widely—many universities earn modest amounts, with a small number of technologies generating the bulk of revenue.

March-In Rights and Patent Ownership: What’s Changed?

The Bayh-Dole Act’s march-in rights were designed to enable the government to intervene only when certain conditions warranted, such as when a patent holder fails to take action to make the invention available to the public, to address unmet public health needs, or meet domestic manufacturing demands. In the 45 years since the Bayh-Dole Act was passed, these provisions have never before been exercised. Yet the administration required Harvard to submit exhaustive records of federally funded patents, along with proof of manufacturing and commercialization compliance. This aggressive scrutiny marks a paradigm shift from supportive stewardship to assertive oversight.

In an environment where billions in federal research dollars fuel university discoveries, this intervention raises serious questions about the future security of intellectual property created through federally funded research.

Why Businesses Hate Uncertainty: The Chilling Effect

Industry collaborators value clarity, stability and risk mitigation when licensing university inventions or entering research partnerships. The trust that a negotiated license grants exclusive or protected rights is paramount. Regulatory uncertainties—such as the threat of government march-in actions—introduce significant risk into this equation, increasing transaction costs and dampening corporate willingness to invest in the costly, lengthy process of commercialization. In addition, industry partners may now increase their scrutiny of university compliance with Bayh-Dole requirements during due diligence processes, imposing greater administrative pressure on universities to demonstrate full and timely compliance with their disclosure and commercialization obligations.

Companies may delay or forgo entering partnerships if regulatory uncertainties threaten to disrupt their rights or planned revenue streams; additionally, the reputational toll on universities subjected to regulatory investigation could damage their attractiveness to future collaborators, creating a self-reinforcing cycle of diminished innovation partnerships. The practical outcomes of this climate of increased regulatory scrutiny are profound: slowed innovation pipelines, reduced industry funding for academic research and fewer ventures aimed at bringing university-derived technologies to market. Over time, this could stifle the very ecosystem that Bayh-Dole was meant to nurture.

The New Regulatory Reality: Compliance Scrutiny and Strategic Responses

Responding to the government’s demands, university technology-transfer offices face unprecedented pressure to meticulously inventory patents, prove manufacturing compliance and demonstrate active commercialization efforts—tasks that require major administrative effort. The expectation of enhanced reporting and compliance monitoring elevates operational burdens on universities while simultaneously casting a shadow of uncertainty over every collaborative deal.

Adherence to these increased regulatory demands may not insulate universities from further government intervention. The cloud of possible march-in or patent seizure threats looms indefinitely, making it difficult for universities to assure industry partners of reliable, stable ownership and licensing terms.

This growing risk complicates technology-transfer operations, potentially pushing universities to adopt more conservative approaches with their intellectual property to avoid drawing regulatory intervention—an approach that could severely restrain innovation.

Innovation at Risk: The Need for Policy Clarity

The Bayh-Dole Act was crafted to promote technology transfer and public benefit through a carefully calibrated balance of government oversight and private negotiation. Over the past 45 years, it has enabled remarkable advances and created multisector partnerships grounded in clear rules and mutual benefit.

The Trump administration’s enforcement posture, amplified by proposals for government sharing in patent revenue, exposes a fault line in the collective understanding of where public investment yields the greatest return. Decades of history and overwhelming economic data reveal that America’s edge in global innovation thrives on an ecosystem that turns patents into jobs, companies and local prosperity.

To maintain the United States’ exceptional position as a global innovation leader, it is essential that policymakers reaffirm a clear, consistent and predictable patent system governing federally funded inventions. Upholding this system will ensure the continued flourishing of public-private partnerships that have driven decades of breakthrough discoveries and economic growth.

Jonathan Stone is national chair of the research institutions and higher education industry team at the legal firm Quarles & Brady.

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