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  5. Types of Licenses
  1. Licensing and Collaboration Opportunities

Types of Licenses

FDA is looking for commercial partners who are interested in developing and marketing technologies created by FDA scientists.

FDA offers several types license agreements:

Internal Commercial Use Licenses -- grants a licensee the nonexclusive right to make and use the invention for internal use only. These licenses do not grant the right to sell or otherwise distribute the invention, but allow the licensee to use the invention in their commercial development activities.

Biological Materials License (BML) -- allows a Company to license biological materials FDA has developed 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 FDA laboratories. FDA has two kinds of BMLs:

  1. Biological Materials License used for field limited commercial purposes
  2. Biological Materials License--Internal research purposes only. The licensee may not distribute the invention, but may use the invention in their commercial development activities.

Commercial Evaluation Licenses - grants 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 technology. Companies are required to obtain a commercial license for further use and/or development of the invention.

Nonexclusive Patent Licenses - allows a company to commercialize a patented or patent pending technology. Non-exclusive licensing allows use by multiple licensees.

FDA has two kinds of non-exclusive patent licenses.

  1. Non-Exclusive-patent license
  2. Non-Exclusive-patent license for internal research purposes only. The licensee may not distribute the technology, but may use the technology in their commercial development activities.
     

Exclusive Patent Licenses- allows a company to commercialize a patented, or patent pending, invention. An exclusive license limits the use of the Invention to a single group or entity.
 

FDA uses certain criteria when evaluating an exclusive license application that are based on the requirements set forth in 37 CFR §404.7.

These criteria include whether:
1. Exclusive licensing serves the best interests of the public
2. Practical application of the invention is not likely to be achieved under a nonexclusive license
3. 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
4. Exclusive license terms and conditions are not broader than necessary and
5. Exclusive licensing will not lessen competition.