DHHS Secretary Donna Shalala to Rep Jan Schakowsky in 2000, on WHO access to fed funded patent rights

In 2000, President Clinton asked Donna Shalala, then the Secretary of the Department of Health and Human Services (DHHS), to write to Representative Jan Schakowsky. Schakowky had asked President Clinton to provide the World Health Organization with royalty free rights to health care products, for which the United States holds rights.

Schakowsky was pressing President Clinton to share its rights, under 35 USC 202(c)(4) -- a federal statute that reserves certain rights in patents where the federal government provided funding for the invention.

35 U.S.C. 202 Disposition of rights.

(c) (4) With respect to any invention in which the contractor elects rights, the Federal agency shall have a nonexclusive, nontransferable, irrevocable, paid-up license to practice or have practiced for or on behalf of the United States any subject invention throughout the world: Provided, That the funding agreement may provide for such additional rights, including the right to assign or have assigned foreign patent rights in the subject invention, as are determined by the agency as necessary for meeting the obligations of the United States under any treaty, international agreement, arrangement of cooperation, memorandum of understanding, or similar arrangement, including military agreements relating to weapons development and production.

In the March 17, 2000, letter, attached here, Shalala is trying to persuade Schakowsky that the federal government does not control any patent rights worth sharing. But she also concedes that the request could be granted under U.S. law, and refers to an ongoing WHO feasibility study to review what is appropriate:

"In principle, the U.S. government can license patent rights to the WHO. . . . I am committed to a multilateral approach to improve access to treatment, including continuing the discussions with WHO that we have recently initiated. In addition, we understand that WHO is undertaking a feasibility study to review what they have done in this area and what their appropriate role should be vis a vis government scientific institutions worldwide. We are assisting WHO in this effort."

President Clinton never entered into an agreement with the WHO. Later Secretary Tommy Thompson was asked to share U.S. rights in federally funded patents, and he also declined to do so.

donnashalala2janschakowsky.pdf2.1 MB