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, firstname.lastname@example.org.
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