Context: The high cost of new prescription drugs and other medical products is a growing health policy issue. Many of the most transformative drugs and vaccines had their origins in public-sector funding to nonprofit research institutions. Although the Bayh-Dole Act of 1980 provides for "march-in rights" through which the government can invoke some degree of control over the patents protecting products developed from public funding to ensure public access to these medications, the applicability of this provision to current policy options is not clear.
Methods: We conducted a primary-source document review of the Bayh-Dole Act's legislative history as well as of hearings of past march-in rights petitions to the National Institutes of Health (NIH). We then conducted semistructured interviews of 12 key experts in the march-in rights of the Bayh-Dole Act to identify the sources of the disputes and the main themes in the statute's implementation. We analyzed the interview transcripts using standard qualitative techniques.
Findings: Since 1980, the NIH has fully reviewed only 5 petitions to invoke governmental march-in rights for 4 health-related technologies or medical products developed from federally funded research. Three of these requests related to reducing the high prices of brand-name drugs, one related to relieving a drug shortage, and one related to a potentially patent-infringing medical device. In each of these cases, the NIH rejected the requests. Interviewees were split on the implications of these experiences, finding the NIH's reluctance to implement its march-in rights to be evidence of either a system working as intended or of a flawed system needing reform.
Conclusions: The Bayh-Dole Act's march-in rights continue to be invoked by policymakers and health advocates, most recently in the context of new,high-cost products originally discovered with federally funded research. We found that the existence of march-in rights may select for government research licensees more likely to commercialize the results and that they can be used to extract minor concessions from licensees. But as currently specified in the statute, such march-in rights are unlikely to serve as a counterweight to lower the prices of medical products arising from federally funded research.
Keywords: Bayh-Dole Act; National Institutes of Health; government-funded research; march-in rights.