Insights

Rethinking Bayh-Dole Compliance in a Changing Federal Landscape

  • Bloomberg Law

The U.S. Commerce Department’s scrutiny of Harvard University’s patents — and its explicit focus on Bayh-Dole compliance — signals a potentially consequential shift in how federally funded intellectual property may be evaluated and enforced going forward. 1 At issue is not only a single institution’s practices, but a decades-old innovation model that underpins technology transfer across U.S. universities and research institutions.

At the center of this debate is the Bayh-Dole Act of 1980, which allows universities, nonprofits, and small businesses to retain ownership of inventions arising from federally funded research, subject to certain reporting obligations and government rights. 2 The statute is widely credited with catalyzing the commercialization of academic research by enabling institutions to license patents to industry partners; a framework that has shaped the modern technology transfer ecosystem.

Federal Scrutiny and the Harvard Case

According to Bloomberg Law, the Commerce Department has demanded that Harvard demonstrate compliance with Bayh-Dole requirements, including detailed disclosures regarding subject inventions, licensing activities, and reporting practices. 1 The government has also raised the prospect of exercising so-called “march-in rights,” a statutory mechanism that allows federal agencies, under limited circumstances, to grant additional licenses or assert control over patents tied to federally funded research.

While march-in rights have existed for more than four decades, they have never been formally exercised to revoke or reassign a university patent. 3 Nonetheless, the public invocation of these rights introduces uncertainty into long-standing assumptions about the stability of university-held patent rights.

Implications for the Innovation Ecosystem

Legal and higher-education observers have noted that increased scrutiny of Bayh-Dole compliance could have ripple effects well beyond Harvard. 3 4 Industry licensees may become more cautious if they perceive heightened regulatory risk associated with university-owned patents.

Broader interpretations of Bayh-Dole obligations could alter how institutions manage invention disclosures, patent prosecution, and licensing negotiations. 4

Federal oversight of Bayh-Dole compliance has historically emphasized institutional reporting practices and administrative controls. 5 6

Practical Responses from Technology Transfer Offices

Given the critical role of federally funded technologies, many technology transfer offices are already responding proactively.

  • Internal compliance reviews are being expanded to ensure accurate identification and reporting of subject inventions.
  • Greater attention is being paid to Government Support Clauses (GSCs) in patent filings.
  • Cross-functional coordination between research administration, legal, and technology transfer teams is increasing.

Looking Ahead

Bayh-Dole compliance is receiving renewed attention at the highest levels, and institutions strengthening compliance frameworks will be better positioned moving forward.


Footnotes

1 Bloomberg Law, Trump’s Attack on Harvard’s Patents Hits at Decades-Old IP Model (2025). 

2 35 U.S.C. §§ 200–212 (Bayh-Dole Act). ?

3 U.S. Department of Commerce, NIST, Bayh-Dole Act Regulations, 37 C.F.R. Part 401.

4 Higher Ed Dive, What’s at Stake as the Trump Administration Targets Harvard’s Patents (2025).

5 U.S. Government Accountability Office, Technology Transfer: Administration of the Bayh-Dole Act by Research Institutions

6 Congressional Research Service, The Bayh-Dole Act: Selected Issues in Patent Policy and the Commercialization of Technology