- Find the specific technology to license. Technologies available for licensing can be found in TTC’s online database of Available Technologies or by discussions with a TTC Invention Development and Marketing Specialist. Preliminary discussions may then lead to detailed discussions with the researcher/inventor and a Licensing and Patent Manager, and these discussions can be covered by a Confidential Disclosure Agreement (CDA) executed by the TTC. A CDA also may be obtained through the LPM if a party wants to obtain a copy of an unpublished patent application that covers the technology of interest.
- Submit a License Application: A company that wants to license an NIH invention must complete an Application For License and submit it to a Licensing and Patent Manager at the NCI TTC. This application serves as the primary basis for licensing decisions. It provides the TTC with information about the potential licensee, the type of license desired, some of the terms desired and the potential licensee's plans for development and/or commercialization of the invention. Also, if the applicant desires a license with some form of exclusivity, the completed application provides TTC with the applicant's justification for an exclusive license. Note: Confidential commercial or financial information provided in a license application is exempt from disclosure under the Freedom of Information Act (FOIA) (5 USC 552(b)).
- Review of the License Application: After reviewing the license application, TTC determines if the applicant's proposal is consistent with the licensing strategy developed for the invention and whether the grant of the license would benefit the public and be consistent with the interests of the Federal government.
If the applicant has requested a nonexclusive license and a favorable determination has been made upon the application by NCI Licensing and Patenting Managers, then negotiations will begin as appropriate.
If the applicant has requested an exclusive or partially exclusive license, TTC will publish a notice in the Federal Register, as required by law, and after a 15 day period to receive comments on the proposed grant of an exclusive or partially-exclusive license, the TTC will re-evaluate the application and all comments to make a final determination regarding the license. The criteria to be considered in evaluating exclusive license applications (37 CFR §404.7) include whether:
- Exclusive licensing serves the best interests of the public.
- Practical application of the invention is not likely to be achieved under a nonexclusive license.
- An exclusive or partially exclusive license is a reasonable and necessary incentive to promote the investment of risk capital to bring the invention to practical application.
- Exclusive or partially exclusive license terms and conditions are not broader than necessary.
- Exclusive licensing will not lessen competition.
- Preference for "equally as likely" small business.
- Evaluate Exclusive License Applications:
- Proposed field of use and its availability
- Proposed research, development and commercialization plan and market analysis (37 CFR 404.5)
- Infrastructure (FTEs, financial position, core competency and commitment to bring product and/or service to market)
- Statutory criteria
- Publish Intent to Grant Exclusive Notice in Federal Register for period of 15 days
- Opportunity for others to comment and/or object
- Valid objection in the form of a license application
- Possible outcomes:
- Co-exclusive or partial (territory, FOU) exclusive license
- Collaborate or partner with one another
- Grant or deny a license to one party
- Non-exclusive license for all
- Final determination. If no objections are received or objection is resolved, review activities during Notice Period, NCI consults with relevant parties and makes a Final Determination to negotiate and finalize a license (~6 months). About 15% of NIH’s executed license agreements are exclusive.
Denied applicants can file objections/appeals to the NCI TTC Associate Director, and then if still disastified, to the NCI Director. Judicial review may occur as the law permits.
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Thursday, August 18, 2016