CHANGES IN GRANTEE/CONTRACTOR REPORTING OF INTELLECTUAL PROPERTY UTILIZATION

Release Date:  December 13, 2001

NOTICE:  NOT-OD-02-019

National Institutes of Health

Effective January 1, 2002 requirements for reporting of invention 
utilization will be changed to include the commercial name of any FDA-
approved products, utilizing any subject invention, which have reached 
the market during the annual reporting period.  

The Bayh-Dole Act of 1980 (P.L. 96-517) mandates grantees to report any 
inventions that are derived or first actually reduced to practice 
through any federal funding agreement (grant, cooperative agreement, or 
contract).  Part of the requirements for NIH grantees includes annual 
reporting on the utilization of each federally funded invention.  
Invention utilization reporting requirements are based on regulations 
at 37 CFR Section 401.14(h).  Based on statute, the content of all 
Bayh-Dole-related reports are maintained by NIH as confidential, 
releasable only through the Freedom of Information Act.

Since October 1995 there have been two ways by which invention 
utilization can be reported to the NIH: via paper correspondence, or as 
a feature of the Interagency Edison Internet-based invention reporting 
system (http://iedison.gov).  Using either approach, utilization 
reporting involves response to 8 questions relating to the status of 
commercialization, extent of licensing, and an indication as to whether 
of not any invention-related products have reached the market.

Starting in July of this year, the information items required for 
invention utilization were examined for currency in light of changing 
trends in administration of intellectual property that have taken place 
since 1995, and as part of the redesign of the iEdison system.  A 
formal analysis was undertaken by a working group of intellectual 
property professionals from various NIH extramural grantee 
organizations.  This group, the Interagency Edison Working Group 
(IEWG), provided the NIH with formal recommendations for changes in 
utilization reporting requirements.  Additional recommendations were 
described in a report,  "A Plan to Ensure Taxpayers" Interests are 
Protected" (http://www.nih.gov/news/070101wyden.htm), prepared by NIH 
as an outcome of interactions with congressional representatives.  

In light of these recommendations, effective January 1, 2002, invention 
utilization reporting requirements will change.  The most substantive 
change involves the addition of a question that requires the commercial 
name of any FDA-approved products, utilizing any invention, that have 
reached the market during the annual reporting period.  The reporting 
procedure and new list of utilization questions are summarized below.

o Utilization reporting will be required according to a 
grantee/contractor-defined 12-month cycle. 
o Grantee/contractor organizations may report via paper or through 
the iEdison electronic reporting system, though the use of iEdison 
is strongly recommended by the NIH.  
o For each invention whose principal rights have been retained 
(elected) by the grantee organization, the following questions must 
be answered as part of the utilization report. 

o Indicate the latest stage of development of any product 
arising from the invention, according to the following 
categories: Not Licensed/Licensed/Commercialized.
o Report the total income received during the reporting period 
as a result of license or option agreements for the invention.  
Specific patent costs reimbursement is not to be included.
o Identify the calendar year of the first commercial sale of any 
product arising from the invention that has reached the 
market.
o Indicate whether during the designated reporting period the 
grantee/contractor organization or any of the exclusive 
licensees requested a waiver of the U.S. manufacturing 
requirements for the invention.  Also indicate how many such 
waivers were obtained.
o Report the number of exclusive licenses and/or options that 
have been awarded for the invention during the designated 
reporting period.
o Report the number of non-exclusive licenses and/or options 
that have been awarded for the invention during the designated 
reporting period.
o Indicate for the invention the number of licenses and/or 
options of any types that were awarded to small businesses 
(<500 employees) during the designated reporting period.
o Provide the commercial name of any FDA-approved products, 
utilizing the invention, that have reached the market.

For further  information on intellectual property policy or
reporting requirements, please contact J.P. Kim, NIH Office 
of Extramural Research, 301-435-0679, [email protected].

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