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Research!America Files Comments in Opposition to Proposed Change to Bayh-Dole

Research!America today filed comments with the National Institute of Standards and Technology in strong opposition to a proposed change to federal government implementation of the Bayh-Dole Act that could stifle science and technology innovation in America and threaten U.S. global competitiveness. 

Bayh-Dole, landmark legislation enacted in 1980, created a uniform “technology transfer” process that enabled research institutions to maintain the intellectual property rights to inventions developed partly with federal funding. The new technology transfer rubric ensured that federally funded research could move along the R&D pipeline to produce remarkable advances in health, energy, agriculture, and many other areas of societal significance.   

The Science &technology infrastructure that Bayh-Dole established has also been a major driver of U.S. jobs, businesses, and economic growth. Since its passage, Bayh-Dole has led to $1.3 trillion in economic growth and the creation of 4.2 million jobs. More than 126,000 U.S. patents have been issued and more than 200 drugs and vaccines have been developed from partnerships created by the Bayh-Dole Act. Future contributions like these are threatened by a proposed policy change. 

The proposed policy framework would place the NIH and every other federal research & development agency in the position of monitoring and evaluating product prices and rescinding technology transfer agreements if the agency deems a product “unreasonably” priced. Beyond the dilution of R&D agencies’ missions and the administrative quagmire created by the monitoring of prices and executing march-in procedures, the proposed change would introduce significant uncertainty into technology transfer agreements. This uncertainty would dissuade private partners from entering into these agreements and divert investment from translating federally funded research into tangible solutions for patients and other consumers. 

“This proposed shift in Bayh-Dole would set America back to a time when federally funded research sat on the shelf rather than being used to develop life-saving treatments and benefits for society,” said Research!America President and CEO Mary Woolley. “As the law’s authors repeatedly asserted, Bayh-Dole was never intended to be used to regulate pricing. In fact, federal agencies have never used “march-in” rights for this purpose since the legislation was passed more than 40 years ago.” 

“There is a compelling need to address health care and prescription drug affordability; however, we do not believe the proposed policy implementation serves national interests or the public good. Our nation can, and must, find a better solution,” Woolley said. 

Research!America is calling on the Administration to reverse this proposed change and allow Bayh-Dole to continue spurring research and innovation in this country.

Contact Glenn O’Neal, Senior Director of Communications, at 571-482-2737 or goneal@researchamerica.org with press inquiries.