Trump Admin Raises Odds Of 'March-In' On Harvard Patents

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Posted by AI on 2025-08-09 03:29:31 | Last Updated by AI on 2026-06-24 11:08:53

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The Trump administration has urged federal agencies to investigate whether Harvard University's patent rights on a promising coronavirus therapy should be waived to boost production of the drug for the pandemic, raising the stakes in a contentious legal battle with far-reaching implications for future crises.

The inquiry is being conducted under the march-in rights provision of the Bayh-Dole Act, which gives the Department of Justice (DOJ) the authority to allow generic drug manufacturers to produce patents that were originally granted to universities.

The move came shortly after the DOJ joined a lawsuit filed by the nonprofit Access Unlimited against Harvard over its patents for a promising coronavirus therapy called remdesivir. The group claims that the university is blocking affordable access to the lifesaving drug during the pandemic and that the drug was developed with significant federal funding.

It's the latest clash between President Donald Trump and Harvard, one of several elite universities that have been criticized for their large endowments and reliance on federal research dollars.

"Unfortunately, the original inventor of remdesivir, the federal government, allowed the patent to be owned by Gilead and exclusively licensed to BioExpress, Pfizer, and Genentech," Derek Bateman, a lawyer with the group, said in a statement. "Thus, the DOJ is now taking action to ensure that these patent rights are used in a way that is fair and reasonable to the American public."

The inquiry is likely to add further scrutiny to the Bayh-Dole Act itself and whether it is helping or hindering innovations that could save lives.

"...Bayh-Dole has failed in its primary objective and purpose of accelerating the commercialization of inventions arising from federally funded research," said Andrew Sherman, who advises innovation-based companies on legal issues. "A threshold problem is that a patent is only as strong as the ability to enforce it, and with the high cost of litigation, it is often cheaper to wait until the patent expires than to invest in enforcement action."

For its part, Harvard has argued that the lawsuit is merely a "costly and unnecessary distraction" and that the drug companies have been making remdesivir accessible to patients in the U.S. and around the world.

"The complaint filed by Access Unlimited asks for discounts for a private charity for its own patients at the expense of other American patients and healthcare providers as well as patients and providers around the world," Harvard University spokesperson Jonathan Swain said in a statement to NPR. "It is a classic example of the law of unintended consequences well-intentioned but misguided and counterproductive to the goals of increasing access to lifesaving treatments."

Still, the Trump administration's move injects a new dynamic into the lawsuit and could set a precedent for how the government tackles intellectual property issues involving university research in future public health crises.

"This is going to be huge," said Brian Skoloff, a veteran patent attorney and a partner at the firm Oblon. "The outcome of this case is going to have significant implications for administrative and executive authority under the Bayh-Dole Act and what can be done in a time of national emergency, and I think that's why this is such a landmark case."

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