A. PURPOSE

This Manual Chapter sets forth the National Institutes of Health (NIH) policy for allowing contractors and grantees (hereafter "Contractor") to license biological materials on which the contractor elects not to file a patent application and which are submitted to the NIH for review and possible election of government title under the Bayh-Dole Act.

B. BACKGROUND

The NIH Office of Technology Transfer (OTT) has been delegated the authority to elect title to extramural inventions on behalf of the NIH. Under the Bayh-Dole Act, the NIH Contractor may elect title to inventions developed with NIH funding, but must file a patent application within one year of such election. Where the Contractor elects not to file a patent application, the Government may request title. Typically, the Contractor's election not to file a patent application on an invention is an indication that the Contractor is not interested in retaining domain over the invention.

However, this is not necessarily the case with regard to patentable biological materials, which may frequently be licensed for commercial use without patent protection. The policy and procedures established by this Manual Chapter are intended to simplify: 1) the reporting by Contractors of their intention to not file a patent application on the invention but to license the tangible biological material; and 2) the non-election of title to these inventions by the Federal Government where certain terms and conditions are met.

C. POLICY

It is the policy of the United States Public Health Service (PHS) to make available to the public the results and accomplishments of the activities it funds. Restricted availability of unique research resources, upon which further studies are dependent, can impede the advancement of research and delivery of medical care. The NIH Guide for Grants and Contracts (Vol. 21, No. 33) and the PHS Grants Policy Statement explain in full PHS policy with regard to the distribution of research resources developed with PHS funds.

The NIH Guide and PHS Grants Policy Statement also set forth PHS policy encouraging the commercialization of the products of research developed with PHS funding, and allows institutions to make materials available to others for commercial purposes with appropriate restrictions and licensing terms. To ensure consistency with its public availability goals, the NIH Guide and PHS Grants Policy Statement require that where the product of research developed with federal funding is a patentable, but unpatented, research product, the terms of a license must be no more restrictive than they would have been if the product had been patented.

Accordingly, where the Contractor agrees with the conditions set forth below, which ensure the availability of unique research resources, NIH will not request title to the subject invention and will grant a Contractor's request to distribute the unpatented, tangible material through licensing.

A contractor electing title to patentable biological materials and requesting to distribute them through licensing as unpatented tangible research materials must agree to the following conditions:

1. The Contractor must make a written request to the Office of Extramural Programs, National Institutes of Health, Building 31 Room 5B62, Bethesda, MD 20892-2190;

2. Information describing the invention must be made publicly available either through publication in the scientific literature or by other appropriate means;

3. The licensing strategy must ensure that the research resource will be made available to the non-profit research community. Generally, this can be accomplished through non-exclusive licensing, or exclusive licensing for distribution or sale of the materials. If an exclusive license is negotiated for internal use by a for-profit entity, the license must address continuing availability of the material to the non-profit research community. Any exclusive license must provide for conversion to non-exclusive status or termination of licensee's rights upon failure to comply with the terms addressing continuing availability;

4. If an exclusive license is executed, provision must be made for independent maintenance of the material, such as at a national repository, or the originating grantee laboratory;

5. The government shall have a worldwide, irrevocable, unlimited royalty free, paid-up license in the material to make, use or distribute, or to have it made, used, or distributed for the Government. Upon request, sufficient quantities of the biological material shall be provided to the Government with such documentation as the Government is needed to preserve, use, and replicate the material to meet PHS needs; and

6. If the grantee fails to fulfill the conditions of paragraphs 1-4 above, NIH shall automatically have the right to: 1) distribute the material, or 2) require the grantee to comply with the Unique Research Resource requirements of its grant.

E. EFFECTIVE DATE

The policies and procedures set forth in this Manual Chapter are effective immediately.

F. ADDITIONAL INFORMATION

For additional information on this Manual Chapter, contact Ms. Sue Ohata, Office of Extramural Programs, NIH, on (301) 435-1986 or Ms. Barbara McGarey, Deputy Director, Office of Technology Transfer, NIH, on (301) 496-7057.