NIH Utilization Reporting 2016 Importance of Reporting Utilization

NIH Utilization Reporting 2016

Importance of Reporting • Utilization Reporting of Subject Inventions o Identifies potentially (at the time of reporting) promising discoveries using the definitions of Patenting: • • Novel Not Obvious (to a person of ordinary skill in the area) Has Utility (Useful) & also Plant Variety Protectable (different definitions than above; uncommon for NIH – very common for USDA/Agricultural Colleges) o These are indications of the productivity of Research Funding measured by items in the above area in addition to research publications 2

Importance of Reporting • Links the potentially patentable (or plant variety protectable) Subject Inventions o To the Scientific Programs that funded them via the Award number(s) cited. o Provides a conceptual basis of the discovery that may lead to a patent/PVP application in the future. o Ensures that different Agencies are aware of combined efforts that may result in a single invention through the funding of multiple Federal Agencies. o Is a required obligation of the Contractor – patenting, though desirable, is not required, however Invention and Patent reporting is a requirement. 3

Utilization Reporting o Identifies Commercialization activities and progress for Subject Inventions o A utilization report is a one-year snapshot of data – the status of the commercialization of the Subject Invention as of that year and includes: • Latest Stage of Development • Date of First Commercial Sale or Use • Number of licenses (exclusive, non-exclusive, small business, etc. ) in force during the year • Total Income (licenses and option agreements) • Commercial name(s) of any FDA-approved products 4

To Create a Utilization Report • General Steps to Create a Utilization Report: o Go to Edison. gov and log-in. o Main Edison page: select create a utilization report. o Answer all questions. 5

Utilization Reporting continued A few points: 1. A Utilization Reporting ‘fiscal’ year is defined by the month, which is set by the Contractor prior to submitting any utilization report. 1. 2. 3. Utilization Reporting begins for each subject invention on the day that title is elected for that subject invention. Utilization Reporting is cumulative for each fiscal year for all Patents/applications and child Inventions covered by a particular Subject Invention. 1. 4. Once contractor/grantee chooses its “fiscal year” it cannot be changed and applies to all Edison reporting. Utilization reporting is due for each year. Can use the government’s fiscal year 10/1 through 9/30. Only 1 utilization report is due for a subject invention’s “family” of patents. A license is “in force” or “active” if it is valid for any portion of the reporting year. 6

Utilization Reporting continued • NIH’s utilization report and questions have not changed since 2002. • See: https: //public. era. nih. gov/iedison/public/utilization_reporting. jsp o Can also access NIH utilization information by clicking on NIH on the right-hand side of the Edison home page. o Or, go to https: //public. era. nih. gov/iedison/public/nihprocs. jsp o Then go to the 2 nd entry from the bottom of the list: “Renewed importance of Invention Utilization Reporting” 7

Utilization Reporting continued • There are 9 questions that need to be answered each year for NIH Utilization Reporting. • Utilization Reporting is confidential and has a statutory FOIA exemption. • NIH and other federal agencies may reasonably specify other questions on a case -by-case basis to supplement its standard utilization questions at their discretion. 8

Thank You • NIH Contact Information: o Edison. gov 9