Appendix D.2.

United States Public Health Service
Technology Transfer Manual
Chapter No. 300

PHS Licensing Policy


The purpose of this Public Health Service (PHS) Technology Transfer Manual Chapter is to set forth policy for licensing technologies developed in PHS laboratories.


The primary mission of PHS research laboratories is to acquire new knowledge through the conduct and support of biomedical research to improve the health of the American people. In 1986, Federal laboratories, including PHS research laboratories at the National Institutes of Health (NIH), Food and Drug Administration (FDA), and Centers for Disease Control and Prevention (CDC) were given a statutory mandate to ensure that new technologies developed in those laboratories are transferred to the private sector and commercialized in an expeditious and efficient manner. PHS is cognizant of its role in protecting the public interest as NIH, FDA, and CDC technologies are transferred.

Realization of the considerable anticipated health benefits inherent in PHS-conducted and supported biomedical research will depend in large part on the ability and willingness of private sector technology transfer partners to commercialize new technologies. For potential preventive, diagnostic, and therapeutic products, that willingness almost invariably hinges on the existence of patent protection in the United States and foreign countries for the technology in question.


PHS generally seeks to patent and license biomedical technologies when a patent will facilitate and attract investment by commercial partners for further research and commercial development of the technology. This is critical where the utility of the patentable subject matter is as a potential preventive, diagnostic, or therapeutic product. However, it also could occur when a patent is necessary to encourage a commercial partner to keep important materials or products available for research use. Patent protection is generally not sought by PHS where further research and development is not necessary to realize the technology's primary use and future therapeutic, diagnostic, or preventive uses are not reasonably anticipated. For example, PHS will generally not seek patent protection for research tools, such as transgenic mice, receptors, or cell lines. Such materials can be licensed effectively in the absence of patent protection, under royalty-bearing biological materials licenses, or distributed to the research community through non royalty-bearing material transfer agreements. For research tools, the public interest is served primarily by ensuring that the tool is widely available to both academic and commercial scientists to advance further scientific discovery. Secondarily, a financial return to the public is obtained through royalties on the rare research tool that has significant commercial value.

In addition, 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 most expeditiously through publication. For such technologies, patenting and licensing are unnecessary and could inhibit broad dissemination and application of the technology. Methods of performing surgical procedures, for example, could fall within this category.

In contrast, for technologies with potential preventive, diagnostic, or therapeutic uses, where some type of exclusivity (and therefore patent protection) is necessary for product development, licensing of the patent rights is the primary vehicle for transferring the technology to commercial partners. Due to the importance of effective patent licensing to the development and availability of new products arising from PHS technology, the PHS licensing program is governed by the following principles in marketing, negotiating, executing, and monitoring licenses to PHS patents:


The policies and procedures set forth in this Manual Chapter are effective immediately.


Questions about this Manual Chapter may be directed to the Deputy Director, Office of Technology Transfer, Ms. Barbara McGarey, on (301) 496-7057.

PHS Technology Transfer Policy Board
PHS Licensing Policy