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Policies and Guidelines
NIH Procedures for Handling Non-Election of Title to Patentable Biological Materials
This 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.
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 referenced below 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.
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:
The Contractor must make a written request to the National Institutes
of Health, Office of Extramural Research, Office of Policy for Extramural
Research Administration (OPERA), Inventions and Extramural Reportintg Branch,
Rockledge II, Room 3190, MSC 7750, Bethesda, MD 20892-7750;
- Information describing the invention must be made publicly available
either through publication in the scientific literature or by other appropriate means;
- 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;
- 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;
- 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
- 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.
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