“This will have a dire impact on the commercialization of potentially life saving inventions made at NIH.”- Joseph Allen
The Bayh-Dole Coalition yesterday released an issue brief warning that there will be dire consequences if the Trump Administration doesn’t “immediately” roll back a Biden-imposed National Institutes of Health (NIH) policy published on January 10, titled “NIH Intramural Research Program Access Planning Policy.”
The draft proposal was first published in May 2024 as a Request for Information and was subtitled, “Promoting Equity in Access Planning.” But opponents argued it represented another attempt to misuse the Bayh-Dole Act that would hinder innovation.
The Bayh-Dole Coalition’s issue brief drew specific attention to “the requirement that prospective licensees explain to NIH how they’ll make any future products ‘available, affordable, acceptable, and sustainable,’” with the organization’s Executive Director Joseph Allen commenting that the guidelines “reimpose the bureaucratic micro-management that Congress ended when passing the Bayh-Dole Act.”
While potential licensees of government-owned patents are required to submit “a plan for development and/or marketing of the invention” under the Bayh-Dole Act, the issue brief said the recent guidelines “expand that simple instruction far beyond Congress’ original intent.”
In particular, according to the issue brief, the directive to ensure that products will be “available, affordable, acceptable, and sustainable” places a heavy burden on licensees. Plus, the Food and Drug Administration (FDA) can revoke a licensee’s license for a new therapy if it does not approve of the licensee’s access plan, which must be made publicly available within three months after approval.
“This will have a dire impact on the commercialization of potentially life saving inventions made at NIH,” wrote Allen.
The Coalition’s press release added: “If companies rightly fear that NIH officials can revoke their licenses for failing to meet these arbitrary and ill-defined conditions so rival companies can copy their products, entrepreneurs will not license NIH inventions in the first place.”
The brief also notes that NIH has tried this once before. NIH tried to implement a “reasonable pricing” clause in the 1990s, but “[r]ather than lowering drug prices, NIH partnerships collapsed.” Industry shied away from collaborations with NIH scientists due to the pricing clause and then-NIH Director Harold Varmus repealed it in order to “promote research that can enhance the health of the American people.”
The final policy published this week said that NIH received 48 responses to the RFI and that “more than half of the RFI respondents were supportive of the Policy proposal.”
The Trump Administration has come out hard against equity provisions more broadly across the federal government and also froze federal grants this week, which is worrying some research scientists.
Trump has nominated Dr. Jay Bhattacharya to be the new head of NIH. Matthew Memoli is serving as Acting Director.
