TY - JOUR
T1 - The Bayh-Dole Act at 40
T2 - Accomplishments, Challenges, and Possible Reforms
AU - Sarpatwari, Ameet
AU - Kesselheim, Aaron S.
AU - Cook-Deegan, Robert
N1 - Publisher Copyright:
© 2022 by Duke University Press.
PY - 2022/12/1
Y1 - 2022/12/1
N2 - More than 40 years have passed since the enactment of the Patent and Trademark Amendment (Bayh-Dole) Act, which authorized institutions to patent inventions arising from federally funded research. Although some experts have heralded the Bayh-Dole Act as ushering in a new era of technological advances, others have been less sanguine about its impact. In recent years, the high price of prescription drugs and the patenting of COVID-19 therapeutics and vaccines developed with substantial federal government support have rekindled the debate over whether companies should receive more restricted rights to products originating with government funding. This article traces the history leading to the enactment of the Bayh-Dole Act and critically assesses its strengths and weaknesses as well as unresolved questions concerning its scope. Based on this analysis, the authors propose reforms to better align the Bayh-Dole Act with public values and health outcomes, including clarifying government-use rights, making it easier to invoke march-in rights for failure to meet health and safety needs, increasing transparency in how patents are licensed, and testing different approaches to foster the development and application of inventions.
AB - More than 40 years have passed since the enactment of the Patent and Trademark Amendment (Bayh-Dole) Act, which authorized institutions to patent inventions arising from federally funded research. Although some experts have heralded the Bayh-Dole Act as ushering in a new era of technological advances, others have been less sanguine about its impact. In recent years, the high price of prescription drugs and the patenting of COVID-19 therapeutics and vaccines developed with substantial federal government support have rekindled the debate over whether companies should receive more restricted rights to products originating with government funding. This article traces the history leading to the enactment of the Bayh-Dole Act and critically assesses its strengths and weaknesses as well as unresolved questions concerning its scope. Based on this analysis, the authors propose reforms to better align the Bayh-Dole Act with public values and health outcomes, including clarifying government-use rights, making it easier to invoke march-in rights for failure to meet health and safety needs, increasing transparency in how patents are licensed, and testing different approaches to foster the development and application of inventions.
KW - biotechnology
KW - drug development
KW - innovation
KW - patents
KW - technology transfer
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U2 - 10.1215/03616878-10041247
DO - 10.1215/03616878-10041247
M3 - Article
C2 - 35877952
AN - SCOPUS:85144593865
SN - 0361-6878
VL - 47
SP - 879
EP - 895
JO - Journal of health politics, policy and law
JF - Journal of health politics, policy and law
IS - 6
ER -