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Licensing of Inventions
Policy and Points to Consider

  1. FDA generally seeks to patent and license technology when commercial development of the technology is anticipated.
  2. Federal laboratories' research leading to substantial benefits to the public health depend in large part on the ability and willingness of technology transfer partners to commercialize new technologies.
  3. FDA, as well as other PHS agencies, generally will not seek patent protection for research tools, such as transgenic mice, receptors, or cell lines. Such materials can be licensed without patent protection, under royalty-bearing Biological Materials Licenses, or distributed to the research community through nonroyalty-bearing Material Transfer Agreements.
  4. When commercialization and technology transfer can best be accomplished without patent protection, such protection will not be sought. For example, some technologies may be transferred to the private sector through publication.
  5. Where some type of exclusivity (and, therefore, patent protection) is necessary, licensing of the patent rights is the primary vehicle for transferring the technology.
  6. The following principles and objectives apply to marketing, negotiating, executing and monitoring patent licensing agreements:

Model licensing agreements have been developed for PHS-wide use and are available for review. Please contact one of the Technology Development Office Contacts listed on this Web site.

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