NIH GUIDE, Volume
25, Number 16, May 17, 1996
P.T. 36; K.W. 0780010, 1014006
National Institutes of Health
A. Purpose
This notice 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 notice are intended to simplify:
- the reporting by Contractors of their intention
to not file a patent application on the invention
but to license the tangible biological material;
and
- 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. A notice
in the NIH Guide for Grants and Contracts (Vol.
23, No. 26, July 15, 1994) 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 notice referenced above and the
PHS Grants Policy Statement also set forth PHS
policy encouraging the commercialization of the
products of research developed with PHS funding,
and allow 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
notice (referenced above) and the 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.
D. Procedures
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 or electronic
request to the Division of Extramural Inventions
and Technology Resources, National Institutes
of Health, 6701 Rockledge Drive, MSC 7750, Bethesda,
MD 20814-7750
- 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 nonprofit research community. Generally,
this can be accomplished through nonexclusive
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 nonprofit
research community. Any exclusive license must
provide for conversion to nonexclusive 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 Contractor 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 Contractor to comply
with the Unique Research Resource requirements
of its grant.
F. Effective Date
The policies and procedures set forth in this
notice are effective immediately.
INQUIRIES
For additional information on this notice, contact:
Division of Extramural Inventions & Technology Resources (DEITR), OPERA, OER
National Institutes of Health (NIH)
6705 Rockledge Drive, Suite 310, MSC 7980
Bethesda, MD 20892-7980
Telephone: (301) 435-1986
FAX: (301) 480-0272
Email: Edison@nih.gov