NIH acknowledges KEI/UACT request to use royalty-free or march-in rights on Xtandi

On February 8, 2016, the National Institutes of Health (NIH) responded to Knowledge Ecology International (KEI) and the Union for Affordable Cancer Treatment’s (UACT) letter requesting that the federal government exercise its authority under the Bayh-Dole Act to break patents on an expensive prostate cancer drug.

Ann M. Hammersla, the Director of the NIH Division of Extramural Inventions and Technology Resources and of the Office of Policy for Extramural Research Administration (OPERA), acknowledged the January 14, 2016 KEI and UACT request that the NIH or Department of Defense use its non-exclusive, royalty-free rights or march-in rights on patents on enzalutamide, which was developed with the support of federal funds.

Enzalutamide, marketed as Xtandi by the Japanese firm Astellas Pharma, was developed at the University of California, Los Angeles, by two scientists working under NIH and U.S. Army grants. The 2015 average wholesale price for Xtandi was $88.48 per capsule in the United States, or over $129,000 per patient per year. The U.S. price of Xtandi was over two to four times higher than other high-income, high-GDP countries.

The text of the letter is below and available as a pdf attachment to this page.

More information is available on this page on KEI’s website: http://keionline.org/xtandi.


February 8, 2016

Andrew S. Goldman, Esquire
Knowledge Ecology International
Policy and Legal Affairs
1621 Connecticut Avenue, Suite 500
Washington, DC 20009

Dear Mr. Goldman:

This is to acknowledge receipt of the recent letter from you to Honorable Mary Mathews Burwell, Honorable Aston Carter, and Dr. Francis Collins dated January 14, 2016 requesting the Federal Government exercise its march-in rights pursuant to 35 U.S.C. § 203 to patented inventions made by the University of California with funding from the National Institutes of Health (NIH) and the Department of Defense.

The authority to exercise march-in rights in connection with grants and contracts from the NIH has been delegated to NIH’s Office of Extramural Research. Accordingly, your request is being handled by the Office of Policy for Extramural Research Administration (OPERA). The NIH has begun its investigation of the important public health matters you have brought to our attention. You may contact me at the address below if you have further questions.

Sincerely,

Ann M. Hammersla

Sent by Email February 8, 2016: andrew.goldman@keionline.org

Ann M. Hammersla, J.D.
Director, Division of Extramural Inventions and Technology Resources
Office of Policy for Extramural Research Administration
hammerslaa@mail.nih.gov

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