Federal proposal to seize patents via ‘march-in’ rights will harm innovation: Op-Ed by Lito Ramirez

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DUBLIN, Ohio — Approximately one in every 700 babies in the United States is born with Down syndrome. Funding research is crucial to investigating conditions that affect individuals with Down syndrome and developing interventions that significantly improve their quality of life.
As a father to a son living with Down syndrome, and leader of the Ohio nonprofit DownSyndrome Achieves (DSA), my work has a dual focus. We support families with loved ones living with Down syndrome, and we facilitate research efforts. DSA supplies researchers with biosamples from our DSA Biobank at Cincinnati Children’s Hospital Medical Center. Our research-supported initiatives are contributing to the development of breakthrough treatments and therapies for individuals living with Down syndrome, ultimately preventing life-threatening medical conditions such as Alzheimer’s disease, childhood leukemia, and damaging heart defects.
Together with the nation’s leading research universities, business groups, and patient advocacy organizations, DSA is concerned with a federal proposal that threatens a key component of our nation’s innovation ecosystem. This proposal from the Biden administration intends to use the Bayh-Dole Act’s “march-in” provision to forcibly relicense patents on products that benefited from federal research funding, imperiling public-private sector collaboration. The draft framework was published in the Federal Register at the end of last year and comments closed Feb. 6, meaning a final framework could be issued at any time.
The administration says it will use this legally dubious authority to bring down drug prices, but the proposal applies to all technologies across all industries. So it poses a serious and unnecessary blow to everyone who is hoping for advances in medicines and so much else, from digital technology and clean energy to defense and agricultural technologies.
Enacted in 1980, the Bayh-Dole Act enabled universities and other research institutions to keep the patent rights on inventions developed in whole or part with federal funding. This allowed these institutions to license their intellectual property to private firms for further research and development and commercialization. In medicine alone, the system of public-private partnerships enabled by Bayh-Dole has led to the creation of more than 200 new medications approved by the U.S. Food and Drug Administration. Bayh-Dole is also credited with the creation of a host of other critical technologies and companies, including Google.
DSA recently shared our concerns with the Biden administration. In assessing the proposal, our primary concern centers around the potential impact on the R&D ecosystem, particularly in the realm of Down syndrome research. DSA relies on private-sector investment, collaboration between public and private entities, and the protection of intellectual property rights to advance our mission.
We support making medicines more affordable and accessible. However, we are concerned that the proposed framework for the government’s exercise of the Bayh-Dole Act’s “march-in” authority will disrupt the system of public-private partnerships that has enabled the development of countless life-enhancing treatments.
Our worry is that if the federal government exercises march-in authority on patents, it would become unfeasible for private-sector partners to license them and invest the sums necessary to develop federally funded basic research into new treatments. This, in turn, would diminish the return our society currently reaps from the research the government funds.
Advances in medical care have significantly increased the life expectancy of individuals with Down syndrome. While it was around 25 years in 1983, life expectancy has now increased to an average of 60 years or more. Breakthroughs in Down syndrome research have contributed to improved educational strategies, early interventions, and medical treatments, enhancing the quality of life for individuals with Down syndrome.
Any measures that undermine the incentives for private-sector investment in innovative research pose a significant threat to our ability to make progress in understanding and addressing the unique healthcare needs of individuals with Down syndrome.
To protect our nation’s innovation and discovery capabilities, we hope the Biden administration shelves this proposal. 
Lito Ramirez, with over 20 years of senior-level experience in business-to-business health care, serves as CEO of DownSyndrome Achieves, an organization he founded to help advance basic science research related to Down syndrome.
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