Americans are living through a scientific golden age. Over the past few decades, U.S. researchers have developed hundreds of lifesaving medicines, including HIV/AIDS therapies, Alzheimer's diagnostics, and CAR T-cell technologies that allow doctors to create customized cancer treatments.
These breakthroughs likely wouldn't have happened without a little-known law called the Bayh-Dole Act. That 1980 legislation allows universities and other research institutions to patent discoveries made with federal funding, and then license those insights to companies that can develop them into usable products.
Over my three decades working at the National Institutes of Health, including a decade as director of its Technology Transfer Office, I've seen firsthand just how much the Bayh-Dole system has spurred medical innovation. Yet now, some influential government officials want to scrap this system, instead of seizing the opportunity to strengthen it even further.
American taxpayers help finance tens of billions of dollars of basic research each year, at the NIH's own labs and through NIH grants to university researchers. And those scientists frequently make breakthrough discoveries.
But a discovery that remains in a lab, or only appears in an academic journal, does little good for patients. Americans need companies to turn those discoveries into tangible medicines, diagnostics, devices, and other products that improve people's lives.
The Bayh-Dole Act creates a clear pathway for that commercialization by empowering research institutions to license promising discoveries that benefited from federal funding to private industry partners with the time, money, and expertise to turn the research into real-world products.
Without those companies -- the majority of which are small biotechs and spinouts -- most of these discoveries would never become usable products. These companies shoulder the costs and financial risks associated with bringing a drug to market. In fact, my research has shown that the private sector spends about $100 bringing a drug to market for every $1 that the government spends on the underlying research.
Before lawmakers passed Bayh-Dole, the government almost exclusively owned the patents on federally funded discoveries -- and rarely licensed them for further development. In fact, it only licensed about 1,400 of the 28,000 patents it held.
Compare that to the present system under Bayh-Dole. Since 2021, universities and nonprofit research institutions have inked over 19,000 licensing agreements each year, on average -- with many of them involving federally funded discoveries.
Consider research at the University of Pittsburgh that paved the way for modern Alzheimer's detection methods that have helped patients and their families catch the disease earlier. Or consider a therapy for multiple sclerosis from Baylor College of Medicine in Houston, which is custom-designed for each patient's immune system and condition.
The list goes on and on: epilepsy therapies, blood tests for brain injuries, cervical cancer tests, MRI advancements, and nasal spray vaccines have all saved and improved countless lives across the country.
Our technology-transfer system has also generated enormous economic benefits. A new report shows that since 1996, Bayh-Dole-enabled technology transfer has contributed up to $3.3 trillion to U.S. gross economic output and as much as $1.7 trillion to the U.S. GDP. In the last 25 years, it has helped launch over 17,000 new products and more than 19,000 startups -- helping to create millions of new jobs nationwide.
But future benefits aren't guaranteed. Cuts to federal research funding threaten the pipeline of discoveries that feed into the Bayh-Dole commercialization system. Meanwhile, the NIH has adopted guidelines that require industry licensees to submit burdensome, ongoing product-access plans before and throughout commercialization -- information NIH can use to revoke licenses even after products have been developed, in violation of Bayh-Dole.
Rather than disrupting a system with a decades-long record of success, policymakers should build on it. One of the best ways to do so would be for the NIH to make technology transfer and commercialization key measures of success when it assesses the impact of federally funded research.
Every time a scientist makes a major lab breakthrough, it's a reason to celebrate. But those discoveries alone don't make any real-world difference for patients -- until they're transformed into new products and therapies.
Mark L. Rohrbaugh Ph.D, JD served as Special Advisor for Technology Transfer and the Director of Division of Technology Transfer and Innovation Policy at the National Institutes of Health from 2014-2023.
