Exclusive Patent License Agreement
Federal government regulations reflect a preference for nonexclusive licenses; however, exclusive licenses are available when appropriate to promote successful commercial development of a licensed invention. An exclusive patent license agreement with the NIH will be based on the model Patent License Exclusive Agreement adopted by the U.S. Public Health Service (“PHS”) Technology Transfer Policy Board for use by components of the National Institutes of Health (“NIH”), the Centers for Disease Control and Prevention (“CDC”), and the Food and Drug Administration (“FDA”), which are agencies of the PHS within the Department of Health and Human Services (“HHS”). A copy of this agreement can be found here. A company that desires a license to develop an NIH invention must complete and submit to the NCI Technology Transfer Center ("TTC") an "Application For License To Public Health Service Inventions", which is available here.
This application 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. The completed application also provides the applicant's justification for an exclusive license. Therefore, it is important for the license applicant to completely and comprehensively fill out the license application before submission.
Upon receipt of an exclusive license application, the TTC will evaluate the license application using a number of criteria to determine if an exclusive license is warranted (see 37 CFR §404.7). If the TTC determines an exclusive license is warranted after review of the application, a notice of intent to grant the license will be published in the Federal Register for a period of time, generally fifteen (15) days. During the Federal Register notice period, any member of the public, including businesses and competitors of the applicant, may object to the grant of the license by filing comments or competing license applications. However, the Federal Register notice requirement will be waived for a CRADA Collaborator that files an exclusive license application for a CRADA Subject Invention if the CRADA Collaborator elects and files the license application within the time period laid out in the CRADA. After the notice and comment period closes, the TTC will make a final decision regarding the grant of the exclusive license.
Below is a Brief Outline of the Exclusive License Process:
- TTC evaluates the license application using a number of criteria to determine if an exclusive license is warranted (see, 37 CFR §404.7)
- Exclusive Licenses are subject to a comment period, generally 15 days, via publication of a public notice in the Federal Register
- Other organizations and individuals may object to the proposed grant of an exclusive license and/or apply for a competing license to the technology
- After the notice period, the TTC will review and consider any objections and comments, and notify the applicant of its decision regarding the proposed grant of an exclusive license.