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President Joe Biden has touted a plan that would allow federal agencies to seize patents on products developed in federally funded research if the government deems them too expensive. ing.
The White House outlined the proposal to revise the guidelines of the 1980 Bayh-Dole Act as part of the administration's broader push to lower prescription drug prices. But advocates for research universities, which rely heavily on federal funding, disagree.
They argue that the proposed framework may not be an effective tool to lower drug prices and that strong research between universities and the private sector has resulted in inventions such as mRNA vaccine platforms and electronic ink displays coming to market. They argue that it would weaken the partnership. For e-reader and internet browser algorithms.
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At a time when America's academic research enterprise is more important than ever to the future of America's national and economic security, public policy should support and enable, without undermining, public-private cooperation. said Barbara Snyder, president of the Association of Universities. America's top research universities proposed the change in a letter to National Institute of Standards and Technology Director Laurie LoCascio on February 6.
If not repealed, the existence of this framework as a potential agency policy will continue to create uncertainty and confusion for member institutions and their private sector partners, and will continue to create uncertainty and confusion for member institutions and their private sector partners, making public-private collaboration, a powerful force in innovation and research in the United States. This will weaken the driving force.
Data shows that from 1996 to 2020, academic technology transfer in the United States (universities often transfer inventions to industry partners for commercialization) contributed $1.9 trillion to gross industry product and 650 It has supported millions of jobs and resulted in more than 126,000 patents being granted to research institutions. Awarded by the Association of University Technology Managers (AUTM).
However, the public-private partnerships that emerged from university-led research were not always strong.
Until the 1980s, the federal government owned the intellectual property of discoveries made using federal research funds. The policy provides little incentive for universities to commercialize inventions, and according to the U.S. Government Accountability Office, only 5% of the 28,000 patents held by federal agencies have been approved for use. It was less than Things changed when Congress passed the Bayh-Dole Act in 1980. The law allows universities, nonprofit corporations, and small businesses to patent and commercialize federally funded inventions.
The bill also includes march-in provisions that would give the government control over federally funded inventions to alleviate health and safety concerns. However, no government agency has ever exercised the right of entry. NIST's proposed framework changes could consider price as a factor in determining whether a drug or taxpayer-funded invention is unavailable to the public, according to a December White House news release. was specified for the first time.
The public comment period for the revised framework ended last week. He received over 51,000 comments on NIST. The agency is considering comments and may finalize changes to include price as a valid reason for embarking on federally funded inventions.
Heather Pearce, acting chief scientific officer for the Association of American Medical Colleges, said our opposition to this mechanism is not an opposition to considering access and affordability to medicines, and said that our opposition to this mechanism is not an opposition to considering drug access and affordability. They questioned the effectiveness of changing guidelines to lower drug prices. drug prices.
The reason is that while a university may have used federal funds to fund the discovery of one component of a marketable product, other patentable components may not have been manufactured using federal funds. This is because it may not be eligible for march-in, as it may not be eligible for march-in.
Licensing one product to another company in hopes of developing the same drug at a lower price is potentially speculative, Pearce said. The march-in right itself does not affect the second company's final price.
Additionally, it said the proposed framework could have unintended consequences for academic research institutions.
Because this framework can be price-based, it is riskier for companies to decide to partner with academic institutions, especially when federally funded research is involved, Pierce said. Ta. This creates new incentives for companies to ensure that they do not license results that are not based on federally funded research or interact with academia.
AAMC also joined the AAU, American Council on Education, Association of Public and Land-Grant Universities, AUTM, and Council on Governmental Relations in sending a letter to NIST on February 1 stating that the proposal could have negative consequences. He also emphasized that there is. Even academic research.
This framework does not solve the identified problems, the letter states. Rather, it would cause unjustifiable collateral damage.
AAU lobbyist Kate Hudson said if the proposed guidelines would have the worrying effect of reducing federally funded research conducted by universities, they would also create disparities in publicly accessible knowledge. He said it would occur.
Hudson said that when federally funded research is conducted on college campuses, the results will be published, with very few exceptions, and that the model is a valuable knowledge base. It was pointed out that it produces That doesn't happen when the private sector funds research. It is accumulated by the company and is its own knowledge. They don't want it published or shared.
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