Office of Technology Transfer - Licensing Information - Overview
TECHNOLOGY LICENSING At NIMH
Background and Policy Information
Each year, scientists at the National Institute of Mental Health (NIMH), National Institutes of Health (NIH), generate new inventions based on rigorous basic scientific and biomedical research. The NIH Office of Technology Transfer (OTT), in turn, uses a variety of licensing mechanisms to transfer these inventions for development commercially that will benefit the public health. Where necessary, OTT seeks intellectual property protection (that is, "patents") on particular inventions to ensure their rapid and effective development.
What Technology Licensing Means
Where a company wishes to acquire rights to use or commercialize either an unpatented material, or a patented or patent-pending invention developed in NIMH laboratories, a license is required. Where appropriate, licenses to NIMH inventions, as with all inventions originating in Public Health Service (PHS) laboratories, are granted on a worldwide basis.
As a rule, most biomedical companies, whether large or small, desire worldwide patent protection to secure foreign markets or to use their assets in establishing strategic alliances which can add to the further development of an invention and the distribution of its benefits to the public.
Types Of Licenses Available
Where a company seeks to use an invention for commercial purposes that is claimed in a NIMH patent or patent application, the company must negotiate through the NIH Office of Technology Transfer for either a Commercial Evaluation License, an Internal Commercial Use License, a Nonexclusive Patent License, or an Exclusive Patent License.
How To Apply For And Obtain A License
A company that desires a license to develop a NIMH invention may contact the NIH Office of Technology Transfer (OTT). The primary basis for licensing decisions is made by the OTT upon submission of a completed Application For License To Public Health Service Inventions. This application provides the OTT with information about the potential licensee, the type of license sought, desired terms, and the party's plans for development and/or commercialization of the invention.
Applications seeking licensure with some form of exclusivity must include a justification. Upon review, OTT,in consultation with NIMH, will determines if the applicant's proposal is consistent with the licensing strategy developed for the invention, as well as its benefit, if granted, to the public. If the applicant has requested a nonexclusive license and OTT has rendered a favorable determination upon the application, then negotiations may begin. By contrast, where the applicant has requested an exclusive or partially exclusive license, OTT will place a notice in the Federal Register, as required by law, for a 60-day comment period.
Terms Included In The License
Several model license agreements are available through OTT that serve as the basis for license negotiations. In turn, the business development plan submitted as part of the license application process serves as the basis for establishing performance benchmarks that are included in the license agreement. In all cases, OTT works closely with licensees to monitor performance and to adjust benchmarks, when appropriate, to ensure the successful commercial development of NIMH and other PHS inventions.
When Licenses May Be Revoked
Lastly, licenses are revocable for specific reasons, such as:
- non-use of or failure to develop the invention;
- failure to comply with governing regulations;
- or failure to satisfy public health needs.
Reporting Requirements For Licensees
Accordingly, licensees are required to respond at least annually to OTT on their use of (or efforts to use) license patent rights. These responses are kept confidential and, to the extent permitted by law, are exempt from disclosure under the Freedom of Information Act. Licensees also must normally agree that any products embodying the invention or made through its use, and which are sold in the United States, will be manufactured in the United States, unless a waiver is obtained.
Additional information regarding technology development and licensing opportunities in general at PHS agencies may be obtained by contacting the Office of Technology Transfer (OTT), National Institutes of Health (NIH), 6011 Executive Boulevard, Suite 325, Rockville, MD 20852-3804 (Fax: 301.402.0220; telephone: 301.496.7057).