The U.S. Chamber of Commerce’s Global Innovation Policy Center (GIPC) has been actively advocating for the expansion of the march-in rights provision under the Bayh-Dole Act as the intellectual property (IP) community eagerly anticipates the Biden Administration’s decision on the proposal. The GIPC has been pushing back against the administration’s argument that the mechanism would lower drug prices, emphasizing the potential negative impact on American innovation.
The comment period for the National Institute of Standards & Technology (NIST) and the Department of Commerce’s Request for Information (RFI) on the march-in proposal closed in early February. Despite rumors of the framework being finalized and published, no official decision has been made public yet.
Under the proposed framework, agencies would consider factors such as the pricing and availability of products utilizing federally-funded inventions. The aim is to ensure that these inventions are commercialized effectively. Historically, petitions for march-in rights based on pricing concerns have been consistently rejected by both Democratic and Republican Administrations over the last two decades.
For instance, the Department of Health and Human Services (HHS) denied an appeal to march in on the prostate cancer drug, Xtandi®, just a day before the comment period closed in February. Many argue that the proposed framework is misguided, as it only covers inventions made with federal support, not those created by the private sector where most drug patents originate.
The comments submitted in response to the RFI reflected broad bipartisan opposition to including pricing as a trigger for march-in rights. While some, like the Federal Trade Commission (FTC), view the proposed framework as utilizing previously unutilized provisions of the Bayh-Dole Act, others believe it could stifle innovation and investment in the private sector.
The GIPC raised concerns in a June blog post that the proposed framework could lead to a decline in American technological advancement and product creation if implemented. The lack of information on the status of the proposal has left many in the IP community wondering about the administration’s next steps.
As the IP community continues to wait for clarity on the march-in proposal, it remains to be seen whether the Biden Administration will align with the Democratic platform during the upcoming Democratic National Convention. The strong opposition from various sectors, including the generics industry, former leaders of the United States Patent and Trademark Office (USPTO), and university research institutions, may prompt the administration to reconsider or revise the framework before finalizing it.
In conclusion, the future of the march-in proposal under the Bayh-Dole Act remains uncertain, with stakeholders closely monitoring any developments from the Biden Administration. The debate over the balance between innovation incentives and access to affordable products continues to shape the ongoing discussion within the IP community.