The Trump administration’s threat to take control of Harvard University’s patents risks upending a decades-old partnership between the federal government and research universities that backers say has fueled inventions and cemented US technological dominance.
Commerce Secretary Howard Lutnick gave Harvard until Sept. 5 to prove its compliance with the 1980 Bayh-Dole Act, which allows universities to own intellectual property for technology invented with the aid of government money. His letter announcing the investigation—which references an intent to exercise “march-in rights"—opened a new front against the university in a fight over more than $2 billion in frozen federal funding.
March-in rights allow federal agencies to control licensing of a university or nonprofit’s grant-funded inventions—a right the government has never ultimately exercised.
“The Bayh-Dole statute has been a huge benefit for American taxpayers, and universities and commercial firms,” said Robert Merges, co-founder of UC Berkeley’s Center for Law and Technology. “It’s been a win-win-win, and threatening to undermine the stability of that system, especially if it’s just part of a campaign against a single institution, just is, to me, a risky strategy.”
Progressives and members of Congress have urged prior administrations to wield the authority to address the high prices of certain drugs. But Lutnick’s missive has a different flavor, targeting thousands of patents covering inventions across the technology spectrum, according to “tech transfer” professionals and attorneys who work with universities on patent licensing issues.
“The real motive is the administration’s animus toward Harvard and to higher education generally, but it’s a dangerous game to play because of the collateral damage,” said Alfonso Garcia Chan of Cahill Gordon & Reindel, who’s represented universities in IP litigation.
Bayh-Dole allows universities that rely on federal funding for research to own the patents linked to the inventions their exploration yields. They can then license the IP to companies to commercialize the innovations, which generates money for both while bringing the technology to the public.
The scope of Lutnick’s Harvard inquiry could create a chilling effect if companies view those patents as more susceptible to federal intervention, Chan said.
“Companies may be very hesitant to transact or license with the university if they know that their exclusivity from that license can be taken away by the government,” Chan said.
The Commerce Department didn’t respond to a request for comment. Harvard’s response to the letter called the investigation “unprecedented” and “retaliatory” and said the university is committed to compliance.
History
Advocates for patent collaboration between the government and higher education said research achievements of the Bayh-Dole system are significant.
Supportive groups have highlighted a 3D virtual colonoscopy procedure and the honeycrisp apple as university breakthroughs it produced.
Before the law, companies were reluctant to use patents connected to government grants, said Stephen Susalka, the CEO of AUTM, which advocates for expanded commercial development of university inventions.
“There was this concern and a phrase called ‘contaminated by federal funding,’” he said. “A lot of those inventions never went forward.”
The number of patents granted to universities soared to 2,369 in 1997, from just 294 in 1976, according to a 2012 Harvard paper citing National Bureau of Economic Research data.
The top 100 universities were granted 6,700 patents in 2024, according to the National Academy of Inventors. Harvard was seventh on that list and says it owns more than 5,800 patents in total.
The federal government’s march-in rights can be exercised under four circumstances, including noncompliance with domestic manufacturing preferences or health and safety needs. Under President Joe Biden, there was a push to allow it to address unaffordable prices. But tech transfer advocates have always sought a more cautious approach, arguing excessive enforcement could discourage companies from licensing grant-funded inventions from universities.
“There’s always concerns about using march-in rights outside of the statute,” Susalka said. “It potentially puts this dark cloud on this early-stage technology that’s hard to commercialize in the first place.”
University research funding from industry typically hovers between 5% and 30%, which is “minuscule” compared to federal dollars, according to DJ Nag, the president of patent monetization firm Innovaito, who has helped several universities patent their inventions. Federally funded research and development expenditures for higher education amounted to $60 billion in fiscal year 2023, according to the National Center for Science and Engineering Statistics.
Different Approach
Lutnick’s letter demanded Harvard provide a comprehensive list of patents stemming from federally funded research, proof of its compliance, and licensing details. The Commerce Department hasn’t publicly announced any petitions to agencies funding Harvard’s research, but his letter says he’s “initiating the ‘march-in’ process.”
That departs from usual legal mechanisms for the government to ensure compliance, according to Joe Allen, a former committee staffer for the law’s co-author, late former Sen. Birch Bayh (D-Ind.), and executive director of the Bayh-Dole Coalition, a group dedicating to defending the law.
Normally, “an inquiry about compliance with Bayh-Dole is about a particular circumstance, not a university’s entire portfolio of federally funded inventions,” Allen said.
Federal agencies can audit recipients of grant money and the companies that license patents obtained with federal support, he added, but it “must be done fairly” to maintain confidence there’s no disparate treatment.
Typically, the march-in process is initiated with a petition to the agency funding the research. There’ve been less than a dozen publicized petitions for march-in rights use, some of which resulted in investigations but none of which prevailed, according to Allen.
The march-in process “is not simple nor fast,” Allen added, and agencies must allow the grant recipient and licensee the right to appeal.
For now, universities should make sure they’re fully compliant with Bayh-Dole requirements to avoid any opening to challenge their IP or disrupt their government-funded research, Nag said.
“Can universities shift away from the federal funding?” he said. “My short answer is absolutely not.”
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