March-in rights are rights granted to the federal government, allowing the government the ability to grant patent licenses to other parties or take licenses for themselves if they helped to fund the patent owner’s research and development. March-in rights can also be granted to a company’s competitor if the government believes it to be necessary. However, march-in rights are typically not used unless there are public safety threats that the patent owner is unable to handle themselves and can also be granted if the patent owner hasn’t taken any practical steps toward executing the patent.
March-In Rights for Enzalutamide – The History
Astellas Pharma, a company with headquarters in Japan, charges United States patients $156,000 annually for its prostate cancer drug Xtandi (enzalutamide), which is three to five times what it charges residents of other countries. Xtandi was discovered by scientists at UCLA with grants from the National Institutes of Health (NIH) and the United States Army.
In January 2016, Knowledge Ecology International (KEI) and the Union for Affordable Cancer Treatment (UACT) requested that the NIH and Department of Defense (DOD) exercise their under the Bayh-Dole Act (including march-in rights) and authorize the generic production of a prostate cancer drug.
In June 2016, NIH rejected the request and in August 2016, the United States Army did the same. In April 2017, KEI and UACT appealed the NIH decision to HHS Secretary Tom Price and NIH again rejected the appeal on June 7, 2017.
On February 4, 2019, prostate cancer patients Clare Melvin Love and David Reed submitted a new request to the Army, asking them to use either march-in rights or royalty-free rights in enzalutamide patents. On April 12, 2021, Robert Sachs filed a petition with the DOD, asking to join the outstanding Love-Reed march-in petition.
On November 18, 2021, Sachs and Love petitioned HHS Secretary Xavier Becerra, asking that HHS grant march-in rights for the patents on enzalutamide. About a month later, in December 2021, cancer patient Eric Sawyer petitions HHS to join the Love Sachs petitions.
On December 23, 2021, Sachs and Dr. Tara A. Schwetz, Acting Principal Deputy Director of the NIH, communicated back and forth, with Sachs restating the request for hearing on the issue, asking who at NIH would review the petition, and what the expected timeline was. In January 2022, Dr. Schwetz responded that the petition will be reviewed by the NIH Office of the Director, that the review would likely take about a month, and whether a hearing would be held would follow a decision by NIH to move forward with the march-in request.
Support for the March-In Request Grows
In January 2022, the momentum supporting the march-in request continued, with Universities Allied for Essential Medicines, Public Citizen, and Robert Mermell (a prostate cancer patient) requesting to join the march-in petition.
In February 2022, academics and politicians got involved with the march-in request. On February 2, 2022, a group of Harvard academics submitted a letter of support to both HHS Secretary Becerra and Acting NIH Director Lawrence Tabak. On February 8, 2022, a dozen United States Representatives sent a letter to HHS Secretary Becerra, urging him to follow through with the Xtandi request. On February 17, 2022, a group of United States Senators gets involved by sending a letter to HHS Secretary Becerra, supporting the Xtandi march-in petition.
What’s Next?
As of the writing of this article, no further action has been taken by HHS or NIH on the march-in petitions. While Astellas and three of the patients who have written in support of the march-in petitions have gone back and forth on statements, no official action has taken place.
Much has been said about whether the Biden Administration will be the one to hold the first march-in petition hearing since the 2004 hearings on ritonavir, an HIV drug that Abbott Laboratories increased prices 400% before agreeing to roll back the price for patients on federal programs and “permanently freeze the price.” Supporters point to HHS’ Comprehensive Plan for Addressing High Drug Prices and President Biden’s Executive Order on Promoting Competition in the American Economy as to why they believe now might be the time for a march-in petition to be approved, but only time will tell.
If the Biden Administration does exercise march-in rights for Xtandi, it would set a precedent for drugs, vaccines, and other therapies that were developed as a result of federal funding.