For more information on the 2021-2022 Xtandi request please visit: https://www.keionline.org/xtandi2021
(More on government funded inventions here.)
On January 14, 2016, Knowledge Ecology International (KEI) and the Union for Affordable Cancer Treatment (UACT) submitted a request to the National Institutes of Health (NIH) and Department of Defense (DoD) asking that they exercise their authority under the Bayh-Dole Act to authorize the generic production of an expensive prostate cancer drug. See: https://www.keionline.org/22987. KEI and UACT were asking the NIH use either its royalty-free, non-exclusive license or march-in rights.
On April 22, 2016, Biolyse Pharma offered to sell generic versions of enzalutamide to Medicare and other federal programs for $3 per pill, a discount of about 95 percent compared to the Astellas price of Xtandi to Medicare. See: https://www.keionline.org/node/2480
On June 20, 2016, NIH Director Francis Collins rejected the march-in/royalty free request. See: https://www.keionline.org/node/2603
On August 5, 2016, the US Army rejected the march-in/royalty free request. See: https://www.keionline.org/31053
On April 29, 2017, KEI and UACT appealed the Collins decision HHS Secretary Price. The appeal was rejected by Francis Collins on June 7, 2017. See: https://www.keionline.org/23322.
July 10, 2017. Senate Armed Services Committee Report 115-125 on the NDAA includes a directive on licensing of federally owned medical inventions. https://www.keionline.org/23404
On February 4, 2019, Clare Melvin Love and David Reed submitted a request to the Army asking them to use march-in or royalty free rights in enzalutamide patents. Their petition is available here.
On April 12, 2021. Robert Sachs filed a petition with the Department of Defense, asking to join the outstanding Love and Reed march-in petition on the patents for the prostate cancer drug enzalutamide, sold under the brand name Xtandi by Astellas.
On November 18, 2021, Robert Sachs and Clare Love petitioned the Secretary of Health and Human Services Xavier Becerra asking that HHS grant march-in rights for the patents on the prostate cancer drug enzalutamide. More information on the 2021-2022 Xtandi request is available here: https://www.keionline.org/xtandi2021
Background
Enzalutamide, marketed as Xtandi by the Japanese firm Astellas Pharma, was developed with the support of NIH and DoD grants at the University of California, Los Angeles. Astellas markets Xtandi for over $129,000 per year per patient in the United States, which is over two to four times higher than the price of other high-income, high-GDP countries. The KEI and UACT request asked the NIH to use its march-in or royalty-free rights on Xtandi, citing the comparatively high price of Xtandi in the United States and the failure of Astellas to make the drug available to the public on reasonable terms.
Links to relevant pages on KEI’s website on the request are available below, and this page will be updated with new developments.
- US Army Rejects Request to Exercize March-in Rights in Prostate Cancer Drug Xtandi
- Xtandi March-in Request, links to news stories, blogs
- Bayh-Dole Act and difference between March-In Rights and the world wide royalty free rights in patents
- 11 Groups Urge NIH to Lower Price of Xtandi, NIH/Army-Funded Prostate Cancer Drug With $129k/Year Price Tag
- 51 members of Congress have asked the NIH to use March-In rights to rein in high drug prices
- 56 NGOs ask US Government enable export of low cost generic versions Xtandi to developing countries
- Alfred Engelberg and Aaron Kesselheim in Nature on Bayh-Dole royalty free rights in patents, Xtandi case
- Bicameral letter from 6 Senators and 6 members of the House to NIH
- Biolyse Pharma offers to supply enzalutamide (Xtandi) for $3 per pill to Medicare and developing countries
- Bloomberg: CVS Will Exclude Xtandi From Formulary in 2017
- Congressman Doggett Voices Support for KEI/UACT Petition to NIH on Xtandi
- Harvoni & Sovaldi, Xtandi in Top 20 Costliest Medicare Drugs
- Letter to HHS and NIH regarding impact of high prices on cost effectiveness of Xtandi
- NIH acknowledges KEI/UACT request to use royalty-free or march-in rights on Xtandi
- NIH to taxpayers — we don’t care about high prices in US for Xtandi
- Rep. Lloyd Doggett keynote address at CAP drug pricing event highlights Xtandi, federal funding of pharmaceutical R&D
- S. Ward Casscells, Pentagon Medical Chief, Praised Army Role in Xtandi Development
- Washington Monthly Cover Story Highlights Petition to Lower Price of Xtandi in U.S.
- Xtandi patient on Medicare — with supplement — pays $441.97 per month