2016 Xtandi Petition

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.

KEI and UACT asked that the NIH use either its royalty-free, non-exclusive license or march-in rights.

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.