Strong, reliable, and clearly defined intellectual property (IP) protections are the foundation of America’s robust innovation ecosystem that patients across the globe rely on for the research and development of new cures and treatments. Those protections were reinforced with the passage of the Bayh-Dole Act in 1980, a bipartisan piece of legislation that established a clearer framework for public-private partnerships. Recently, the National Institute of Standards and Technology (NIST) accepted comments on the proposed rulemaking as it pertains to implementing parts of the Bayh-Dole Act.
Numerous organizations and experts highlighted the critical role IP protections play in continued innovation and the need for NIST to reaffirm those rights. Below are some of their thoughts:
- “Even a vague threat of potential for march-in based on price will likely have a chilling effect on the development of federally funded inventions. If potential licensees and their investors determine that the risks involved in further developing and commercializing federally funded inventions is too great, then price of the end-user product becomes a moot point because there will be no product to price. As a result, the public and the U.S. economy will suffer.”– Association of University Technology Managers
- “Bayh-Dole deliberately democratized secure IP protection and commercialization decisions. The certainty, exclusivity, and secure IP rights Bayh-Dole has provided launched many thousands of inventions. patents, startups, and new products, millions of new jobs, and trillions in economic benefit.” – Eagle Forum Education and Legal Defense Fund
- “The Chamber is also concerned that if the Bayh-Dole Act march-in provision is used to control drug prices, it may also lead to proposals to control prices of other products developed through federal government research. Such policies would potentially impact not only the pharmaceutical sector, but also life sciences, environmental sciences, computer sciences, engineering, automotive, and an almost endless array of inventions that could significantly benefit those, and other, industry sectors. Clearly, this could have a chilling impact on American innovation, the exact opposite of the Bayh-Dole Act’s intended purpose.” – U.S. Chamber of Commerce Global Innovation Policy Center
- “The government's march-in authority is not intended to set prices on resulting products …SBE Council believes the changes and clarifications made by NIST’s proposed rule continue to support the entrepreneur’s participation in federal funding projects and work - through streamlining, improved accountability, and through re-affirmation around the issue of march-in rights.” – Small Business & Entrepreneurship Council
- “Expansion of the march-in provision would have deleterious consequences for the virtuous cycle of public-private partnerships through which industry collaborates with, and sponsors, research at America’s universities. Those public-private relationships bring foundational research from the shadows of concept, through development to a useful product, and then out into the market for the benefit of all. This funds research, supports the work of faculty and graduate students, and adds to academic infrastructure.” – Licensing Executive Society USA & Canada
- “Accordingly, the real-world R&D data reveal that Bayh-Dole has fueled pharmaceutical R&D investment, not provided it some sort of free ride. There is simply no textual or logical basis for advocating march-in actions under Bayh-Dole on the basis of market prices. Pharmaceutical innovation demands billions of dollars in sunk costs of investment, not to mention potential product liability lawsuits for any errors. Strong patent protections, which Bayh-Dole codifies, help ensure that those costs and risks will be fairly and sufficiently rewarded. They provide innovators and investors the incentives to create pharmaceuticals that save millions and even billions of lives worldwide.” – Center for Individual Freedom
- “Section 401.6(e) is necessary because an academic price-control theory was superimposed on the Bayh-Dole Act statutory regime in 2001—many years after its enactment in 1980. Policy activists picked up this theoretical argument—without any basis in the statutory language or other legitimate sources of statutory meaning and intent—and have pushed it in the public policy debates and in petitions to NIH, sowing confusion about the meaning of the march-in power…” – Adam Mossoff, Professor of Law, George Mason University, Antonin Scalia Law School
America’s biopharmaceutical companies remain committed to protecting the work of our researchers and scientists. Continued innovation is critical to public health and ensuring that our best and brightest minds can continue to fight the world’s most complex diseases. For more information on the importance of IP rights, visit our IP page.
Megan Van Etten Megan Van Etten is senior director of public affairs at PhRMA. She is responsible for leading the association’s public affairs efforts on international issues, including trade, intellectual property and access to medicines. Prior to joining PhRMA, Megan was director of media and external communications at the U.S. Chamber of Commerce and communications director at the Beer Institute. She has also worked as a communications consultant for global public relations firms. When not at the office, Megan enjoys exploring new Washington, D.C. restaurants and traveling with her husband and friends.