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Plan for Bayh-Dole Act threatens patients, innovators

By Kent Kaiser - InsideSources.com | Jan 17, 2024

Doesn’t it seem as if there’s an extraordinary innovation announced every day? Thanks to some of the world’s greatest incentives and smartest scientists, Americans have become accustomed to incredible inventions, many of which have been at least partly funded by federal government research grants.

The bipartisan Bayh-Dole Act, which President Jimmy Carter signed into law in 1980, was created to empower universities, small businesses and nonprofit institutions to license to the private sector for further development and potential commercialization of the technologies and discoveries resulting from federal research grants. By encouraging investment to secure intellectual property rights to these inventions, the act has been a catalyst for incredible innovation.

As a safeguard for taxpayers, the act, under a narrow set of circumstances, grants authority for the federal government to “march in” on federally funded inventions and force patent holders to relinquish their intellectual property rights and grant a license to a “responsible applicant.” The two most common circumstances: (1) where “effective steps have not been taken, or are not expected to be taken, within a reasonable period” to commercialize the invention, or (2) the action is necessary to alleviate “health or safety needs not reasonably satisfied by the patent holder or licensee.”

Notably, none of the grounds includes pricing as a reason to invoke march-in authority. Indeed, the law’s co-authors, former senators Birch Bayh, D-Ind., and Robert Dole, R-Kan., explicitly said they did not intend that the government set prices on products resulting from the law. They noted that the omission of any reference to price controls in the law was intentional.

Since then, the price has never been a trigger for march-in. It never should be. Democratic and Republican administrations for over 40 years have declined to march-in under Bayh-Dole to control prices.

Yet, President Biden, even after voting for Bayh-Dole as a senator 44 years ago, is moving to undermine the catalytic power of the act by asserting march-in authority on prescription drug patents to lower drug prices.

In his December 2023 statement on why his administration is preparing to assert march-in authority, Biden talked only about price and made no claim that pharmaceutical companies have failed to commercialize their medicines adequately or that drug patent holders are failing to satisfy health or safety needs. Moreover, the administration is making this move despite the National Institutes of Health expressly confirming that the “extraordinary remedy of march-in is not an appropriate means of controlling prices.”

The president’s intent might sound good at first. Still, his actions could be devastating to patients and to America’s global preeminence in medical innovation. His administration’s misapplication of the Bayh-Dole Act’s provisions would have a serious chilling effect on public-private partnerships. It could create a disincentive for scientists and drug companies to make the large and long-term investments required to explore cures and therapies for diseases or to respond quickly to global health emergencies.

The shortsightedness implicit in asserting march-in authority on the pharmaceutical market is astounding — on multiple fronts.

–We need scientists to continue researching and developing breakthrough medicines. Sacrificing future innovation to achieve some short-term financial savings will ultimately hurt the very people that the president purports to want to help — patients.

–Marching-in on patent rights would harm the U.S. economy, as drug research and innovation would sputter because of a lack of funding.

–The United States would fall behind in international medical competitiveness, and we could be surpassed by hostile foreign adversaries.

Our nation should favor policies that boost incentives for scientists and researchers to continue providing the cutting-edge therapies and miracle cures that Americans have come to expect.

Moreover, undermining the Bayh-Dole Act would disrupt greater innovative ecosystems. It could create a slippery slope for wide-ranging intellectual property rights infringement. Any industry could become a political target.

From now through February 6, the administration is seeking public comments that could be considered in deciding whether to exercise march-in rights. Americans should call on the president to reverse course.

Kent Kaiser is the executive director of the Trade Alliance to Promote Prosperity. He wrote this for InsideSources.com.

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