On Tuesday April 9, 2024, the Union for Affordable Cancer Treatment (UACT), Knowledge Ecology International (KEI), and Universities Allied for Essential Medicines (UAEM) requested that the Centers for Medicare and Medicaid Services (CMS) use the rights afforded to the government in 35 U.S.C. § 202 and 28 U.S.C. § 1498 on patents on the prostate cancer drug Xtandi (enzalutamide).

As noted in the request letter,

“The U.S. government has a “world wide nonexclusive, nontransferrable, irrevocable, paid-up license to practice or have practiced for or on behalf of the United States any subject invention throughout the world” (35 USC § 202(c)(4)). This worldwide paid-up license can be used at any time by the U.S. government, including to acquire generic versions of enzalutamide for federal programs such as Medicare, Medicaid or health care provided to federal employees or veterans.”

The Section 202 right is set out in the Bayh-Dole Act and applies to inventions that have been developed with US government funding, as is the case for three of the patents on Xtandi.

In addition to the rights afforded by the Bayh-Dole Act, 28 U.S.C. § 1498 conveys the right of the federal government to use or give third parties the right to use any U.S. granted patent on an invention.

This statute is often implemented by incorporating a reference in a contract to a standard contract clause in the Federal Acquisition Regulation (FAR) 52.227-1, Authorization and Consent. This clause, which reads “The Government authorizes and consents to all use and manufacture, in performing this contract or any subcontract at any tier, of any invention described in and covered by a United States patent,” can be incorporated in a contract as is, or the contract can be written more narrowly to only refer to specific patents.

The inclusion of an Authorization and Consent clause has been used extensively by the federal government, including in the contracts for the Moderna mRNA vaccines as well as in more quotidian agreements.

UACT, KEI, and UAEM has requested that CMS provide any qualified drug company with contracts (inclusive of the Authorization and Consent clause) to supply generic enzalutamide to patients in any federal program, including but not limited to Medicare, Medicaid and other drug purchase or reimbursement programs for federal employees and veterans.

The full letter to CMS is available here: UACT-KEI-UAEM-CMS-Letter-Authorization-Generic-Xtandi-9April2024