NIH has paused patenting of discoveries, slowing their use in developing treatments

STAT News – Friday, March 7, 2025
By Megan Molteni

Clampdowns on external communications and new contracts at the National Institutes of Health by President Trump’s administration — which have effectively slowed the flow of grant funding to a trickle — are also blocking the agency from sharing research materials with collaborators and taking crucial steps to ensure the discoveries its own scientists are making can later be used in the development of drugs and vaccines.

For the past five weeks, employees at NIH technology transfer offices have been barred from filing new patent applications and been restricted from licensing existing ones, according to emails obtained by STAT and interviews with current and former NIH employees.

On Jan. 29, the NIH’s acting director, Matthew Memoli, sent an email to senior agency officials instructing them to pause all technology transfer discussions with outside parties and not negotiate any new agreements. The NIH often contracts with law firms to handle patent-related work for inventions that arise from research funded by NIH or conducted in-house. The memo advised that agreements in place prior to Jan. 20 could move forward, but that “new patents should not be pursued during the pause,” Memoli wrote, adding that he believed the pause would be “short.”

However, the pause on new patent proceedings is still in place, according to NIH employees who spoke on the condition of anonymity because they were not authorized to discuss the matter publicly.

Larisa Gearhart-Serna, a patent specialist at the National Institute of Allergies and Infectious Disease, was one of a half-dozen or so tech transfer employees let go from that division on Feb. 14, when the Trump administration terminated thousands of probationary employees — people who had been hired in the previous one to two years — across public health and science agencies. She’d done similar work previously at the National Cancer Institute, and after a stint in academia, had been hired in December to help take on intellectual property portfolios that had been neglected due to short-staffing at NIAID.

“Being such a huge place of research, there was so much going on and a lot was already falling through the cracks,” Gearhart-Serna said. “That’s the biggest thing I’m worried about now.”

The NIH’s various technology transfer offices protect the intellectual property of discoveries made at NIH and at the Centers for Disease Control and Prevention and license those inventions to pharmaceutical, medical device, and biotechnology companies for further development into commercial products. In 2023, the NIH filed 187 patent applications, had 87 U.S. patents awarded, and issued 273 licenses on existing patents, according to its annual report.

One former NIH technology transfer employee, who was also laid off on Feb. 14, told STAT they were instructed to leave any emails from law firms or licensees — including those with existing contracts with the agency — unanswered.

According to an email obtained by STAT, Surekha Vathyam, the head of NIAID’s technology transfer office, informed employees in late January of a process to request exemptions in cases where existing patents were in danger of missing critical deadlines with the U.S. Patent and Trademark Office. But given the volume of such deadlines, Gearhart-Serna said her team had to prioritize those in imminent threat of being abandoned if no action was taken. In many cases, they opted for the temporary solution of filing for short-term extensions because exemptions were difficult to come by. “I don’t even want to think about all the extension fees we could be paying right now,” she said.

She’s particularly haunted by one exemption she was unable to obtain — to push through a new patent on vaccine components developed by an NIAID researcher to combat a rapidly spreading infection that already poses a huge threat in the U.S. “These are things that could actually be moved forward into a clinical trial,” Gearhart-Serna said. “But without patent protection, their development — and the ability to respond swiftly to this growing public health concern — remains uncertain.”

A short-term pause in such activities during the transition to a new administration is not unprecedented, said Kevin Noonan, a partner at the law firm McDonnell Boehnen Hulbert & Berghoff, who is also a co-author of the Patent Docs blog. And it might even be more expected in this transition, because of changes to the NIH’s licensing process the Biden administration made on its way out the door.

On Jan. 10, Biden officials released new guidelines for those seeking to license inventions made at the NIH, requiring potential licensees to develop extensive plans to make any resulting products accessible and affordable to the public. The new guidelines echoed a similar attempt by the NIH in the mid-’90s to mandate that any products resulting from its licenses must be sold at a “reasonable price.” That policy was abandoned after it proved unsuccessful in bringing down drug prices and led to a huge decline in NIH licensing instead.

“So I think that this is just more of a ‘don’t do anything while we figure it out’ move,” said Noonan. “And I don’t think that it’s entirely unjustified.”

But, the longer the disruptions go on, the more potential there is for the public to lose out on taxpayer-funded biomedical discoveries and for America to give up its edge on the international stage. “Clearly the longer you wait, the more bad things can happen, and I don’t think there’s any desire for that,” Noonan said. “Given the tumultuous history of the last six weeks, it makes sense to be wary of this, but I’m not sure we have any evidence one way or another that this is going to be a good thing or a bad thing. It’s just something we have to watch out for.”

In addition to filing and licensing patents, these offices also negotiate the transfer of massive amounts of biomedical data and research materials in and out of NIH, including unique human cell lines, animal models of disease, and chemical reagents useful to both academic and industry researchers. They also facilitate clinical trial agreements — contracts between the NIH and outside entities conducting tests of experimental new treatments and vaccines. Some of these activities resumed last week, according to the NIH employees who spoke on the condition of anonymity. Restrictions on licensing were also largely lifted.

The NIH did not respond to STAT’s questions about why new patent filings remain stalled or when the pause will be lifted.

Gearhart-Serna worries about her former colleagues getting stretched thin and all the NIH scientists, particularly the vaccine researchers she worked most closely with, whose discoveries are currently locked in an intellectual property purgatory. She also wonders about the wider potential harm to the whole biomedical research enterprise.

“Bench to bedside is such a complicated ladder — no company or university or even the federal government has all the expertise needed to get it from point A to point B,” she said. “It’s absolutely mind-boggling to take away so many rungs of that ladder and think that someone will still be able to climb it.”

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