Request for CMS to provide a Bayh-Dole Section 202 license and a 28 USC 1498 authorization and consent to use three patents listed in the FDA Orange Book for the cancer drug enzalutamide

Posted on by James Love

Letter from KEI, UACT and UAEM to Chiquita White Brooks-Lasure, Administrator of the Office of the Administrator, Centers for Medicare and Medicaid Services, at HHS, asking that CMS to provide a Bayh-Dole Section 202 license and a 28 USC 1498 authorization and consent to use three patents listed in the FDA Orange Book for the cancer drug enzalutamide.

CMS.authorization.genericXtandi.9april2024

This is the text of the email that was sent with the PDF of the letter.

April 9, 2024

Chiquita White Brooks-Lasure
Administrator
Office of the Administrator, Centers for Medicare and Medicaid Services
United States Department of Health and Human Services [HHS]
Via: chiquita.brooks-lasure@cms.hhs.gov

Dear Administrator Chiquita White Brooks-Lasure,

Attached is a letter from three US organizations requesting CMS to provide a Bayh-Dole Section 202 license and a 28 USC 1498 authorization and consent to use three patents listed in the FDA Orange Book for the cancer drug enzalutamide.

This drug, currently sold by the Japanese company Astellas, is extremely expensive in the United States relative to all other high income countries, including Japan, where the price is about 1/6th of the 2022 Dashboard Medicare Part D or Medicaid prices.

This is not a march-in case, it is a request that the federal government use its 35 USC 202(c)(4) royalty free right to three patented inventions, as well as the federal government authorization and consent authority under 28 USC 1498. Specifically, we ask that CMS use its rights in the three enzalutamide patents to permit generic suppliers. Two companies already have tentative FDA approval, and several other well known generic companies have inexpensive versions on sale in other countries.

From 2021 to 2022, the most recent years for which we have data, the Medicaid and Medicare programs spent more than $5 billion on this U.S. government funded cancer drug, roughly as much as the company charged for every other country combined.

Unlike a federal march-in request, the Section 202 license, when used with a 1498 government use authorization and consent, can ensure that generic products enter the market soon, without Astellas protecting their abused monopoly privileges through meritless, foot dragging, administrative and judicial appeals.

As noted in the letter, we would like to discuss this with you and/or your staff.

James Love, Director Knowledge Ecology International
Cell phone +1.202.361.3040; james.love@keionline.org

Justin Justin Mendoza, MPH, Executive Director, North America, Universities Allied for Essential Medicines (UAEM)

Manon Ress, Founder and Acting Director, Union for Affordable Cancer Treatment (UACT)

Attachment:
https://www.keionline.org/wp-content/uploads/CMS.authorization.genericXtandi.9april2024.pdf

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