Employee-inventors may request to retain title
to their inventions which have not been elected by
the grantee/contractor subject to certain conditions
set forth by the regulations appearing in 35 U.S.C.
Section 202(d) and 37 CFR 401.9.
Once a nonprofit grantee/contractor organization
has waived rights to a particular Subject Invention,
the Government must approve the requested assignment.
As an alternative to approving the assignment, the
Government may choose to retain rights if it is
the opinion of the awarding agency that this is
in the public's best interest.
In order to make this determination, a thorough
review of the history of the invention, including
patent and commercialization efforts, must be undertaken
by the awarding agency.
The review by NIH that can lead to the approval
of an assignment of rights to the inventor will
not commence until all of the following actions
have been taken by the grantee/contractor organization
and inventor(s) and respective documents received
by the NIH.
- A copy of the original invention disclosure
must have been received by the NIH. There
is no specific format for this document.
It must be a written description of the invention
indicating the title of the invention, the names
of all inventors, the source of federal funding,
and the date of disclosure as indicated through
the signature and date of the inventors.
If the disclosure has been previously sent to
the NIH, but can not be located, the NIH will
contact the grantee/contractor organization to
receive an additional copy.
- An inventor
certification form must be completed. The signed, completed
form serves two purposes in the assignment request.
The signatures of all inventors (either on the
form or in counterpart) certify that the inventors
recognize and understand their legal obligation
to comply with the Bayh-Dole Act regulations.
For instances in which not all inventors wish
to assume the rights and Bayh-Dole-related obligations,
signed statements indicating relinquishment of
all rights and interest in the invention must
accompany the executed inventor certification
The second requirement met by the form
is a statement of the willingness of the grantee/contractor
organization to release the rights. The signature
of an authorized representative of the grantee/contractor
organization attests this decision. It is
important to understand that this signatory must
be an organizational official with complete legal
authority to waive all right and title to inventions
made by the institution.
- A complete copy of all patent applications and issued
patents pertaining to the invention must be provided to the NIH.
Patent-related information must include documentation
to account for all PTO office actions. This
information is necessary for the NIH to review
the extent of effort that was put forth to commercialize
- A completed set of invention commercialization
questions must be submitted to the NIH. The answers to these
questions will allow the NIH to further resolve
the extent of commercialization efforts undertaken
by the grantee/contractor organization prior to
the decision to waive invention rights.
Once the questions have been completed on-line,
the answers can be submitted to NIH automatically
via an e-mail link at the bottom of the interactive
Please note that the review
for approval of assignment of rights to the inventor(s)
will not commence until all four sets of information
listed above have been received by the NIH.
You must direct all information either by fax or
U.S. mail to:
Division of Extramural Inventions & Technology Resources (DEITR), OPERA, OER
National Institutes of Health (NIH)
Attn: Inventor Waiver Review
6705 Rockledge Drive, Suite 310, MSC 7980
Bethesda, MD 20892-7980
Information may be faxed to NIH at (301) 480-0272.