NIH GUIDE, Volume 24, Number 33, September 22, 1995

P.T. 34


  Grants Administration/Policy+ 

National Institutes of Health

The National Institutes of Health (NIH) is providing guidance to

increase awareness of and compliance with the requirements for

extramural invention reporting to the NIH.  The Bayh-Dole Act [35

U.S.C. 200-212 (1994)] was enacted in part to promote the

utilization of inventions arising from Federally supported research

and to promote collaboration between commercial concerns and

nonprofit organizations, including universities.  See 35 U.S.C. 200


Toward this goal, the party to a contract, grant, or cooperative

agreement with a Federal Agency (awardee organization) for the

performance of Federally supported experimental, developmental, or

research work may elect to retain title in a subject invention

provided certain conditions are met.

37 CFR 401.14(a) requires awardee organizations to:

1) disclose each subject invention to the funding Agency within two

months after the inventor discloses the invention in writing to the

awardee organization.

2) elect in writing whether or not to retain title to any such

invention within two years from the date of disclosure to the funding


3) file an initial patent application on a subject invention to which

title has been elected within one year after election of title or

prior to the end of any statutory period that may bar obtaining valid

patent protection in the United States after a publication, sale, or

public use.

With respect to any invention in which the awardee organization

elects rights, the funding agency shall have a nonexclusive,

nontransferable, irrevocable, paid-up license to practice or have

practiced for or on behalf of the United States any subject invention

throughout the world.  If the awardee organization fails to disclose

or elect title within the times specified above or elects not to

retain title, the awardee organization may be required to convey

title to the subject invention to the Government.

If the awardee organization does not elect title, the Government may

elect title in the subject invention if obtaining patent protection

is in the public interest.  If an awardee organization does not elect

to retain title to a subject invention, the funding agency may

consider and, after consultation with the awardee organization, grant

requests for retention of rights by the inventor subject to the

provisions of the Bayh-Dole Act and regulations promulgated under the

Act. See 37 CFR Part 401 (1993).

All awardee organizations are to use Form HHS-568 ("Final Invention

Statement and Certification") to closeout a grant or contract.  The

notice with twenty frequently asked questions and a glossary of 20

terms entitled, "A 20-20 View of NIH Extramural Invention Reporting,"

is available in the electronic edition of this issue of the NIH Guide

for Grants and Contracts.


For additional information about the reporting requirements of

inventions developed with funding from the NIH, visit the EDISON

system at and contracts/edison or contact:

Ms. Sue Ohata

Office of Policy for Extramural Research Administration

National Institutes of Health

Building 31, Room 5B62

Bethesda, MD  20892

Telephone:  (301) 402-0850

FAX:  (301) 402-6012



Return to 1995 Index

Return to NIH Guide Main Index

Office of Extramural Research (OER) - Home Page Office of Extramural
Research (OER)
  National Institutes of Health (NIH) - Home Page National Institutes of Health (NIH)
9000 Rockville Pike
Bethesda, Maryland 20892
  Department of Health and Human Services (HHS) - Home Page Department of Health
and Human Services (HHS) - Government Made Easy

Note: For help accessing PDF, RTF, MS Word, Excel, PowerPoint, Audio or Video files, see Help Downloading Files.