Licensing
Overview
Each year, hundreds of new inventions are made at NIH and CDC laboratories. Nine NIH Institutes or Centers (ICs) transfer NIH and CDC inventions through licenses to the private sector for further research and development and eventual commercialization. Often, companies require patent protection to justify the expenditure of resources needed to fully develop a particular invention. Where necessary to ensure the rapid and effective development of a particular invention, the NIH seeks intellectual property protection (both domestic and foreign) on these inventions.
Technology Protection
Upon receiving an invention report, Technology Transfer Professionals evaluate the invention to assess patentability and probability of commercial success of the invention, as well as the need for patent protection to ensure rapid and effective development of the invention. If indicated, NIH will seek patent protection for commercially valuable inventions and initiate this process by filing an application for a patent in the U.S. Patent and Trademark Office (USPTO).
Typically, NIH will re-evaluate the patent strategy at PCT and National Stage conversion deadlines and will decide if patent protection for the invention continues to be the best intellectual property strategy for the invention.
Technology Licensing
If a company would like to acquire rights to use or commercialize either an unpatented material, or a patented or patent-pending invention, a license is required. A license is a legal agreement by which the owner of an invention promises not to take action to exclude the licensed party from making, using, and/or selling the invention. Where appropriate, licenses can be granted on a worldwide basis. 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 the invention and the distribution of its benefits to the public.
Types of Licenses Available
If the invention desired by the company for commercial purposes is claimed in a patent or patent application owned by the U.S. Government, the company must negotiate a Commercial Evaluation License, an Internal Commercial Use License, a Nonexclusive Patent License or an Exclusive Patent License through NIH.
Commercial Evaluation Licenses grant the nonexclusive right to make and use the technology for the purpose of evaluating its commercial potential. The license is for a limited number of months and does not grant the right to sell or otherwise distribute the invention. Companies are required to obtain a commercial patent license for further use and/or development of the invention.
Internal Commercial Use Licenses grant the nonexclusive right to make and use the invention for the purpose of internal use by the licensee. These licenses do not grant the right to sell or otherwise distribute the invention, but allow the licensee to use the invention as a tool in their commercial development activities.
Nonexclusive and Exclusive Patent Licenses allow a company to commercialize the invention, under appropriate circumstances pursuant to applicable statutes and regulations. An exclusive license limits the use of the invention to a single group or entity while a nonexclusive license allows for use by multiple parties.
If the invention desired by the company for commercial purposes is not claimed in a patent or patent application owned by the U.S. Government, the company must negotiate a Biological Materials License. Biological Materials Licenses allow a company to make, use and/or sell commercially useful biological materials which are not in the public domain and for which patent protection cannot or will not be obtained. This type of license typically is nonexclusive and facilitates the commercial development of biological materials developed in NIH or CDC laboratories without requiring that patent protection be obtained for every material.
How to Obtain a License
A company that desires a license to develop an NIH or CDC invention must complete and submit to NIH an Application for License [PDF | WORD]. This application forms the primary basis for licensing decisions. It provides NIH 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 the NIH with the applicant's justification for an exclusive license.
After reviewing the license application, the NIH 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 the Technology Transfer Professionals, then negotiations will begin as appropriate.
If the applicant has requested an exclusive or partially exclusive license the NIH will publish a notice in the Federal Register, as required by law, and after a 15 day period will reevaluate the application and all comments received from the public 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.
- 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.
Terms Included in the License
NIH has developed several model license agreements that serve as the basis for license negotiation. 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. The HHS Agencies work closely with licensees to monitor performance and to adjust benchmarks, when appropriate, to ensure the successful commercial development of its inventions.
Licensees are required to respond at least annually on their utilization of or efforts to utilize 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 (5 U.S.C. §552).
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. Licensees also must normally agree that any products embodying the invention or made using the invention, and which are sold in the United States will be manufactured in the United States.
Additional Information
Information on technologies currently available for licensing may be obtained by contacting one of our Technology Transfer Professionals. You can also view a searchable listing of licensing opportunities.