Program agenda:
- The history of the Bayh-Dole Act and its record of success in stimulating university innovations and economic growth
- An overview of the government’s march-in rights on patents under Bayh-Dole, and how march-in rights were designed to further Bayh-Dole’s purpose of promoting private investment in innovative technologies developed by non-profits
- A review of past march-in petitions, including NIH’s consistent refusal to march-in based on licensee drug pricing practices
- The Biden Administration’s Draft Framework for Considering the Exercise of March-In Rights and other ongoing attempts to use the government’s march-in rights as leverage to regulate drug pricing
- What can we expect going forward? The future of the Bayh-Dole Act and its impact on technology transfer, including:
- Licensee risk
- Investment in university-owned IP
- Industry and other partnerships
- License agreement terms
- Drug development
- U.S. competitiveness
The U.S. government’s proposed framework for exercising march-in rights under Bayh-Dole – including pricing considerations — has been met with a flurry of reactions. On one hand, supporters are praising the framework as a means to long-promised drug cost controls. On the other are cautionary skeptics and vocal critics – including tech transfer professionals, AUTM, BIO, The Bayh-Dole Coalition and many others — who envision these rights as going far beyond drug pricing and sending a dagger straight to the heart of government-funded innovation, university tech transfer, and U.S. competitiveness in critical technology fields.
Even though the NIH declined the March 2023 petition to exercise march-in rights on Xtandi, prominent members of Congress have been vocal with their disappointment on the issue, further fueling support for the measure. With the majority of university-based research and innovation being supported in some measure through government funding, it begs the question: How could this framework affect the future of our ability to develop and commercialize government-funded IP?
Will start-ups be able to attract VC funding without assurance that their patents won’t be co-opted by the government? Will licensees perceive new levels of risk that make deals harder to come by and reduce the royalty rates and other fees they’re willing to pay? Do license and funding agreements now need to address the potential for march-in rights based on drug pricing considerations, and how? Also at stake are precious partnerships between research institutions and corporations that could be jeopardized out of fears that any project supported by government funding risks the loss of rights to critical IP.
The future is uncertain around march-in rights and their potential impact, and that’s why we’ve teamed up with Donald Ware and Andrew London from Foley Hoag to lead this critical and timely one-hour session.
