March-in rights are a rarely used federal measure within the Bayh-Dole Act[1] that widens access to high-cost prescription medications. The prices charged to U.S. patients for certain medications are often multiple times what patients in other wealthy countries are charged for the same drugs. In response, there have been several recent petitions for the Biden administration to exercise March-in rights, especially for COVID-19 treatments. A current petition pertains to a prostate cancer medication which costs upwards of $150,000 yearly.[2] The “March-in” process authorizes third-party licenses to federally funded patents if the original patent holder fails to make the invention “available to the public on reasonable terms.” The process requires the patent owner to grant a “nonexclusive, partially exclusive, or exclusive license” to a “responsible applicant or applicants.” If the patent owner refuses to do so, the government may grant the license itself which means that generic manufacturers would be permitted to manufacturer generic versions. While so far, the petitions have not received any government action, the Biden administration has issued statements in support of March-in rights.[3] This has widespread implications as many pharmaceutical products were invented with federal funds. However, a delicate balance must be maintained between private-sector development incentives and ensuring public access to medications through federal funding. Some individuals have suggested that Congress develop a database of all pharmaceuticals subject to the Bayh-Dole Act. As Congressional and public sentiment for March-in rights increases, Frier Levitt will keep you posted of any new developments in this area.
Frier Levitt’s Intellectual Property Group is dedicated to protecting and leveraging our pharma clients’ intellectual property interests including patents, trademarks, copyrights, trade secrets. Our attorneys provide patent strategy counseling, portfolio development and prosecution to a wide variety of industry stakeholders. Our group includes registered patent attorneys eligible to practice before the United States Patent & Trademark Office (USPTO), FDA attorneys with vast labeling expertise, and litigators with direct experience in disputes involving patents, trademarks, trade secrets, copyrights and related rights. Contact us to speak with an attorney in Frier Levitt’s Intellectual Property Group.
[1] P.L. 96-517. Also known as the Patent and Trademark Amendments Act of 1980
[2] Since 1997, NIH has received at least 6 petitions and has denied each one.
[3] Executive Order on Promoting Competition in the American Economy. White House Presidential Action. Executive Order 14036. July 9, 2021 and Comprehensive Plan for Addressing High Drug Prices. ASHE. HHS. Sept 9, 2021.
