RIGHTS IN DATA (Publication and
In general, grantees own the data generated by or resulting from
a grant-supported project. Special terms and conditions of the
award may specify alternative rights; e.g., under a cooperative
agreement or if there are shared rights to data. Except as otherwise
provided in the terms and conditions of the award, the grantee
is free to copyright without NIH approval when publications,
or other copyrightable works are developed under, or in the course
of, work under an NIH grant. Copyrighted or copyrightable works
also include materials developed by students, fellows, or trainees
under awards whose primary purpose is to further the education
or training of such individuals. Whenever any work subject to
this copyright policy is developed by a consortium participant
or a contractor (or subcontractor) under a grant, the written
agreement/contract must require the consortium participant/contractor
(subcontractor) to comply with these requirements and can in no
way diminish NIH's rights in that work. NIH must be provided a
royalty-free, nonexclusive, and irrevocable license for the Government
to reproduce, publish, or otherwise use the material and to authorize
others to do so for Federal purposes.
Grantees may arrange for publication of initial reports of original
research, supported in whole or in part by NIH grant funds, in
primary scientific journals and for copyright by the journal unless
the journal's copyright policy would preclude individuals from
making or having made, by any means available to them without
regard to the copyright of the journal and without royalty, a
single copy of any such article for their own use (see 45 CFR
74.36 and 92.34). The disposition of royalties and other income
earned from a copyrighted work is addressed in "Administrative
Management Systems and Procedures
Income". Grantees are encouraged to assert copyright in scientific
and technical articles based on data produced under the grant
where this is necessary to effect publication in academic, technical,
or professional journals, symposia, proceedings, or similar works.
Grantees are required to place an acknowledgment of NIH grant
support and a disclaimer, as appropriate, on any publication written
or published with such support and, if feasible, on any publication
reporting the results of, or describing, a grant-supported activity.
An acknowledgment shall be to the effect that:
"This publication was made possible by Grant Number ________
from _________" or "The project described was
supported by Grant Number ________ from ________" and
"Its contents are solely the responsibility of the authors
and do not necessarily represent the official views of the (name
of awarding office) or NIH."
In the event that the recipient wishes to join with NIH in a simultaneous
news release announcing the results of a project, the action should
be coordinated with the awarding office.
One copy of each publication resulting from work performed under
an NIH grant-supported project must accompany the annual progress
report submitted to the NIH awarding office (see "Administrative
UNIQUE RESEARCH RESOURCES
Investigators conducting biomedical research frequently develop
unique research resources. Categories of these resources include
synthetic compounds, organisms, cell lines, viruses, cell products,
and cloned DNA, as well as DNA sequences, mapping information,
crystallographic coordinates, and spectroscopic data. Specific
examples include specialized and/or genetically defined cells,
including normal and diseased human cells; monoclonal antibodies;
hybridoma cell lines; microbial cells and products; viruses and
viral products; recombinant nucleic acid molecules; DNA probes;
nucleic acid and protein sequences; certain types of animals,
such as transgenic mice; and intellectual property, such as computer
Restricted availability of unique resources upon which further
studies are dependent can impede the advancement of research and
the delivery of medical care. Therefore, when these resources
developed with NIH funds and the associated research findings
have been published or after they have been provided to NIH, it
is important that they be made readily available for research
purposes to qualified individuals within the scientific community.
This policy applies to grants, cooperative agreements, and contracts.
Investigators who believe they will be unable to implement this
policy should promptly contact the appropriate Program Official
to discuss the circumstances, obtain information that might facilitate
compliance with this policy, and reach an understanding in advance
of the subsequent award. In order to facilitate the availability
of unique or novel biological materials and resources developed
with NIH funds, investigators may distribute the materials through
their own laboratory or organization or submit them, if appropriate,
to entities such as the American Type Culture Collection or other
repositories. In the case of unique biological information, such
as DNA sequences or crystallographic coordinates, investigators
are expected to submit them to the appropriate data banks, because,
otherwise, they are not truly accessible to the scientific community.
When distributing unique resources, investigators are to include
pertinent information on the nature, quality, or characterization
of the materials.
Investigators must exercise great care to ensure that resources
involving human cells or tissues do not identify original donors
or subjects, directly or through identifiers such as codes linked
to the donors or subjects.
INVENTIONS AND PATENTS
Pursuant to the Bayh-Dole Act and Executive Order 12591 (April
10, 1987), all recipients of NIH research funding (i.e., all NIH
grantees and contractors and consortium participants and other
organizations receiving funds under NIH grants and contracts,
whether small businesses, large businesses, or non-profit organizations)
are subject to the same invention reporting requirements and regulations.
These are included in the regulations issued by the Department
of Commerce, found at 37 CFR Part 401.
Grantees (and, in some cases, employee inventors) have rights
to inventions ("subject inventions") conceived or first
actually reduced to practice in the performance of work under
an NIH award. Grantee organizations must fulfill the following
- Establish and implement an employee invention reporting policy
(37 CFR 401.14(f)(2));
- Report all subject inventions within 2 months to OPERA (37
CFR 401.14(c) and (l));
- Elect title (or waive title) within 2 years of reporting to
OPERA (37 CFR 401.14(c)(2) and (l));
- File for patent within 1 year of electing title or public
disclosure, whichever comes first (37 CFR 401.14(c)(3));
- Upon election of title, provide a confirmatory license to
the Government (37 CFR 401.14(b));
- Acknowledge NIH support in any patent application or patent
(37 CFR 401.14(f)(4));
- Notify OPERA of any decision not to pursue patent rights (or
licensing) (37 CFR 401.14(f)(3) and (l));
- Submit an annual utilization report for all inventions where
election of title is made and for unpatented, yet licensed, inventions
(37 CFR 401.14(h));
- Exercise preference for U.S. industry and, if the grantee
is a non-profit organization, preference for small businesses
(37 CFR 401.14(i));
- Provide one copy of each publication resulting from work performed
under an NIH grant-supported project to the NIH awarding office
with the annual progress report; and
- Submit a final invention statement and certification to the
NIH awarding office within 90 days of the end of the project period.
(37 CFR 401.14(f)(5)).
Failure of the grantee to comply with these provisions may result
in the loss of patent rights. If the grantee waives its rights
to the employee-inventor, these requirements apply to the employee-inventor.
As specified in 45 CFR Part 74 and 37 CFR 401.1(b), fellowships,
scholarships, and training grants, which are funded by NIH primarily
for educational purposes, are not subject to invention reporting
requirements. The Federal Government (NIH) has no rights to any
inventions, or any income resulting from inventions conceived
or first actually reduced to practice during the course of such
Invention reporting requirements and the use of the Extramural
Invention Information Management System (Edison) are discussed
under "Administrative Requirements
To provide a more complete description of the invention and patent
reporting requirements, the complete text of the standard patent
rights clauses (37 CFR 401.14) is included below and may also
be found on the NIH link to the Interagency
Edison Web site.
Sec. 401.14, Standard Patent Rights
Clauses (Small Business Firms and Non-profit Organizations)
(July 1997) (NOTE: While the title of these clauses refers to
small businesses and non-profit organizations, the provisions
also apply to large for-profit businesses. The term "contractor"
in the text applies equally to grantees.)
(1) Invention means any invention or discovery which is
or may be patentable or otherwise protectable under Title 35 of
the United States Code, or any novel variety of plant which is
or may be protected under the Plant Variety Protection Act (7
U.S.C. 2321 et seq.).
(2) Subject invention means any invention of the contractor
conceived or first actually reduced to practice in the performance
of work under this contract, provided that in the case of a variety
of plant, the date of determination (as defined in section 41(d)
of the Plant Variety Protection Act, 7 U.S.C. 2401(d)) may also
occur during the period of contract performance.
(3) Practical Application means to manufacture in the case
of a composition or product, to practice in the case of a process
or method, or to operate in the case of a machine or system; and,
in each case, under such conditions as to establish that the invention
is being utilized and that its benefits are, to the extent permitted
by law or Government regulations, available to the public on reasonable
(4) Made when used in relation to any invention means the
conception or first actual reduction to practice of such invention.
(5) Small Business Firm means a small business concern
as defined at section 2 of Pub. L. 85-536 (16 U.S.C. 632) and
implementing regulations of the Administrator of the Small Business
Administration. For the purpose of this clause, the size standards
for small business concerns involved in Government procurement
and subcontracting at 13 CFR 121.3-8 and 13 CFR 121.3-12, respectively,
will be used.
(6) Non-profit Organization means a university or other
institution of higher education or an organization of the type
described in section 501(c)(3) of the Internal Revenue Code of
1954 (26 U.S.C. 501(c)) and exempt from taxation under section
501(a) of the Internal Revenue Code (25 U.S.C. 501(a)) or any
non-profit scientific or educational organization qualified under
a state non-profit organization statute.
401.14(b) Allocation of Principal Rights.
The contractor may retain the entire right, title, and interest
throughout the world to each subject invention subject to the
provisions of this clause and 35 U.S.C. 203. With respect to any
subject invention in which the contractor retains title, the Federal
Government shall have a nonexclusive, nontransferable, irrevocable,
paid-up license to practice or have practiced for or on behalf
of the United States the subject invention throughout the world.
401.14(c) Invention Disclosure, Election of Title
and Filing of
Patent Application by Contractor.
(1) The contractor will disclose each subject invention to the
Federal agency within two months after the inventor discloses
it in writing to contractor personnel responsible for patent matters.
The disclosure to the agency shall be in the form of a written
report and shall identify the contract under which the invention
was made and the inventor(s). It shall be sufficiently complete
in technical detail to convey a clear understanding to the extent
known at the time of the disclosure, of the nature, purpose, operation,
and the physical, chemical, biological or electrical characteristics
of the invention. The disclosure shall also identify any publication,
on sale or public use of the invention and whether a manuscript
describing the invention has been submitted for publication and,
if so, whether it has been accepted for publication at the time
of disclosure. In addition, after disclosure to the agency, the
contractor will promptly notify the agency of the acceptance of
any manuscript describing the invention for publication or of
any on sale or public use planned by the contractor.
(2) The contractor will elect in writing whether or not to retain
title to any such invention by notifying the Federal agency within
two years of disclosure to the Federal agency. However,
in any case where publication, on sale or public use has initiated
the one year statutory period wherein valid patent protection
can still be obtained in the United States, the period for election
of title may be shortened by the agency to a date that is no more
than 60 days prior to the end of the statutory period.
(3) The contractor will file its initial patent application on
a subject invention to which it elects to retain title within
one year after election of title or, if earlier, prior to the
end of any statutory period wherein valid patent protection can
be obtained in the United States after a publication, on sale,
or public use. The contractor will file patent applications in
additional countries or international patent offices within either
ten months of the corresponding initial patent application or
six months from the date permission is granted by the Commissioner
of Patents and Trademarks to file foreign patent applications
where such filing has been prohibited by a Secrecy Order.
(4) Requests for extension of the time for disclosure, election,
and filing under subparagraphs (1), (2), and (3) may, at the discretion
of the agency, be granted.
401.14(d) Conditions When the Government May Obtain Title.
The contractor will convey to the Federal agency, upon written
request, title to any subject invention-
(1) If the contractor fails to disclose or elect title to the
subject invention within the times specified in (c), above, or
elects not to retain title; provided that the agency may only
request title within 60 days after learning of the failure of
the contractor to disclose or elect within the specified times.
(2) In those countries in which the contractor fails to file patent
applications within the times specified in (c) above; provided,
however, that if the contractor has filed a patent application
in a country after the times specified in (c) above, but prior
to its receipt of the written request of the Federal agency, the
contractor shall continue to retain title in that country.
(3) In any country in which the contractor decides not to continue
the prosecution of any application for, to pay the maintenance
fees on, or defend in reexamination or opposition proceeding on,
a patent on a subject invention.
401.14(e) Minimum Rights to Contractor and Protection of the Contractor
Right to File.
(1) The contractor will retain a nonexclusive royalty-free license
throughout the world in each subject invention to which the Government
obtains title, except if the contractor fails to disclose the
invention within the times specified in (c), above. The contractor's
license extends to its domestic subsidiary and affiliates, if
any, within the corporate structure of which the contractor is
a party and includes the right to grant sublicenses of the same
scope to the extent the contractor was legally obligated to do
so at the time the contract was awarded. The license is transferable
only with the approval of the Federal agency except when transferred
to the successor of that party of the contractor's business to
which the invention pertains.
(2) The contractor's domestic license may be revoked or modified
by the funding Federal agency to the extent necessary to achieve
expeditious practical application of the subject invention pursuant
to an application for an exclusive license submitted in accordance
with applicable provisions at 37 CFR part 404 and agency licensing
regulations, if any. This license will not be revoked in that
field of use or the geographical areas in which the contractor
has achieved practical application and continues to make the benefits
of the invention reasonably accessible to the public. The license
in any foreign country may be revoked or modified at the discretion
of the funding Federal agency to the extent the contractor, its
licensees, or the domestic subsidiaries or affiliates have failed
to achieve practical application in that foreign country.
(3) Before revocation or modification of the license, the funding
Federal agency will furnish the contractor a written notice of
its intention to revoke or modify the license, and the contractor
will be allowed thirty days (or such other time as may be authorized
by the funding Federal agency for good cause shown by the contractor)
after the notice to show cause why the license should not be revoked
or modified. The contractor has the right to appeal, in accordance
with applicable regulations in 37 CFR part 404 and agency regulations,
if any, concerning the licensing of Government-owned inventions,
any decision concerning the revocation or modification of the
401.14(f) Contractor Action to Protect the Government's Interest.
(1) The contractor agrees to execute or to have executed and promptly
deliver to the Federal agency all instruments necessary to:
(i) establish or confirm the rights the Government has throughout
the world in those subject inventions to which the contractor
elects to retain title, and
(ii) convey title to the Federal agency when requested under para-graph
(d) above and to enable the Government to obtain patent protection
throughout the world in that subject invention.
(2) The contractor agrees to require, by written agreement, its
employees, other than clerical and non-technical employees, to
disclose promptly in writing to personnel identified as responsible
for the administration of patent matters and in a format suggested
by the contractor each subject invention made under contract in
order that the contractor can comply with the disclosure provisions
of paragraph (c), above, and to execute all papers necessary to
file patent applications on subject inventions and to establish
the Government's rights in the subject inventions. This disclosure
format should require, as a minimum, the information required
by (c)(1), above. The contractor shall instruct such employees
through employee agreements or other suitable educational programs
on the importance of reporting inventions in sufficient time to
permit the filing of patent applications prior to U.S. or foreign
(3) The contractor will notify the Federal agency of any decisions
not to continue the prosecution of a patent application, pay maintenance
fees, or defend in a reexamination or opposition proceeding on
a patent, in any country, not less than thirty days before the
expiration of the response period required by the relevant patent
(4) The contractor agrees to include, within the specification
of any United States patent applications and any patent issuing
thereon covering a subject invention, the following statement,
"This invention was made with Government support under (identify
the contract) awarded by (identify the Federal agency). The Government
has certain rights in the invention."
(5) The contractor agrees to provide a final invention statement
and certification prior to close-out listing all subject inventions
or stating that there were none.
(6) The contractor will provide the patent application filing
date, serial number and title; copy of the page of the patent
application with the statement identified in (4) above (and, upon
request, a copy of the patent application); and patent number
and is due date for any subject invention in any country in which
the contractor has applied for patent.
(1) The contractor will include this clause, suitably modified
to identify the parties, in all subcontracts, regardless of tier,
for experimental, developmental or research work to be performed
by a small business firm or domestic non-profit organization.
The subcontractor will retain all rights provided for the contractor
in this clause, and the contractor will not, as part of the consideration
for awarding the subcontract, obtain rights in the subcontractor's
(2) The contractor will include in all other subcontracts, regardless
of tier, for experimental developmental or research work the patent
rights clause required by (cite section of agency implementing
regulations or FAR).
(3) In the case of subcontracts, at any tier, when the prime award
with the Federal agency was a contract (but not a grant or cooperative
agreement), the agency, subcontractor, and the contractor agree
that the mutual obligations of the parties created by this clause
constitute a contract between the subcontractor and the Federal
agency with respect to the matters covered by the clause; provided,
however, that nothing in this paragraph is intended to confer
any jurisdiction under the Contract Disputes Act in connection
with any proceedings under paragraph (j) of this clause.
401.14(h) Reporting on Utilization of Subject Inventions.
The contractor agrees to submit on request periodic reports no
more frequently than annually on the utilization of a subject
invention or on efforts at obtaining such utilization that are
being made by the contractor or its licensees or assignees. Such
reports shall include information regarding the status of development,
date of first commercial sale or use, gross royalties received
by the contractor, and such other data and information as the
agency may reasonably specify. The contractor also agrees to provide
additional reports as may be requested by the agency in connection
with any march-in proceeding undertaken by the agency in accordance
with paragraph (j) of this clause. As required by 35 U.S.C. 202(c)(5),
the agency agrees it will not disclose such information to persons
outside the Government without permission of the contractor.
401.14(i) Preference for United States Industry.
Notwithstanding any other provision of this clause, the contractor
agrees that neither it nor any assignee will grant to any person
the exclusive right to use or sell any subject inventions in the
United States unless such person agrees that any products embodying
the subject invention or produced through the use of the subject
invention will be manufactured substantially in the United States.
However, in individual cases, the requirement for such an agreement
may be waived by the Federal agency upon a showing by the contractor
or its assignee that reasonable but unsuccessful efforts have
been made to grant licenses on similar terms to potential licensees
that would be likely to manufacture substantially in the United
States or that under the circumstances domestic manufacture is
not commercially feasible.
401.14(j) March-in Rights.
The contractor agrees that with respect to any subject invention
in which it has acquired title, the Federal agency has the right
in accordance with the procedures in 37 CFR 401.6 and any supplemental
regulations of the agency to require the contractor, an assignee
or exclusive licensee of a subject invention to grant a nonexclusive,
partially exclusive, or exclusive license in any field of use
to a responsible applicant or applicants, upon terms that are
reasonable under the circumstances, and if the contractor, assignee,
or exclusive licensee refuses such a request the Federal agency
has the right to grant such a license itself if the Federal agency
(1) Such action is necessary because the contractor or assignee
has not taken, or is not expected to take within a reasonable
time, effective steps to achieve practical application of the
subject invention in such field of use.
(2) Such action is necessary to alleviate health or safety needs
which are not reasonably satisfied by the contractor, assignee
or their licensees;
(3) Such action is necessary to meet requirements for public use
specified by Federal regulations and such requirements are not
reasonably satisfied by the contractor, assignee or licensees;
(4) Such action is necessary because the agreement required by
paragraph (i) of this clause has not been obtained or waived or
because a licensee of the exclusive right to use or sell any subject
invention in the United States is in breach of such agreement.
401.14(k) Special Provisions for Contracts with Non-profit Organizations.
If the contractor is a non-profit organization, it agrees that:
(1) Rights to a subject invention in the United States may not
be assigned without the approval of the Federal agency, except
where such assignment is made to an organization which has as
one of its primary functions the management of inventions, provided
that such assignee will be subject to the same provisions as the
(2) The contractor will share royalties collected on a subject
invention with the inventor, including Federal employee co-inventors
(when the agency deems it appropriate) when the subject invention
is assigned in accordance with 35 U.S.C. 202(e) and 37 CFR 401.10;
(3) The balance of any royalties or income earned by the contractor
with respect to subject inventions, after payment of expenses
(including payments to inventors) incidental to the administration
of subject inventions, will be utilized for the support of scientific
research or education; and
(4) It will make efforts that are reasonable under the circumstances
to attract licensees of subject invention that are small business
firms and that it will give a preference to a small business firm
when licensing a subject invention if the contractor determines
that the small business firm has a plan or proposal for marketing
the invention which, if executed, is equally as likely to bring
the invention to practical application as any plans or proposals
from applicants that are not small business firms; provided, that
the contractor is also satisfied that the small business firm
has the capability and resources to carry out its plan or proposal.
The decision whether to give a preference in any specific case
will be at the discretion of the contractor. However, the contractor
agrees that the Secretary may review the contractor's licensing
program and decisions regarding small business applicants, and
the contractor will negotiate changes to its licensing policies,
procedures, or practices with the Secretary when the Secretary's
review discloses that the contractor could take reasonable steps
to implement more effectively the requirements of this paragraph
All NIH-related disclosures, elections, confirmatory licenses
to the Government, face page of a patent application, waivers
and other routine communications should be sent to the following
Inventions and Extramural Reporting Branch
Division of Grants Policy, OPERA/OER/NIH
Rockledge II, Room 3190, MSC 7750
Bethesda, MD 20892-7750
FAX: (301) 480-0272
For other awarding agencies, please follow their instructions.
In most cases, invention information and communications should
be sent to the cognizant GMO.
The NIH link to the electronic Interagency Edison extramural invention
reporting system can be accessed through the Web at
This electronic reporting system was designed to facilitate reporting
compliance and timeliness, and to reduce paperwork. Edison also
has an e-mail address (Edison@od.nih.gov).
(End of clause)
In the most recent revision of 37 CFR 401, grantees are provided
the option of meeting reporting requirements through electronic
filing. Section 401.16, as stated below, describes changes in
provisions to accommodate electronic filing.
401.16 Electronic Filing.
Unless otherwise requested or directed by the agency:
- The written report required in (c)(1) of the standard clause
in sec. 401.14 may be electronically filed;
- The written election required in (c)(2) of the standard clause
in sec. 401.14 may be electronically filed; and
- The closeout report in (f)(5) of the standard clause in sec.
401.14 and the information identified in (f)(2) and (f)(3) of
sec. 401.5 may be electronically filed.