Appendix D.1.

United States Public Health Service
Technology Transfer Manual
Chapter No. 200

PHS Patent Policy


The purpose of this Public Health Service (PHS) Technology Transfer Manual Chapter is to set forth policy for the initiation and prosecution of patents on technologies developed in PHS laboratories.


The primary mission of U.S. Public Health Service (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.

The United States Patent and Trademark Office (PTO) and courts with jurisdiction over patent matters are the only entities that can make a definitive determination in the United States of the patentability of biomedical research discoveries, including human genetic material. Foreign countries similarly determine the scope and subject matter of patent protection within their boundaries. These determinations require a careful analysis of the particular facts and circumstances of each patent application.

Whether or not to file for patent protection on a given technology is a policy decision made at the discretion of the agency in which a Federal employee inventor works. Accordingly, the PHS has established the following policy to guide its agencies in the pursuit and maintenance of U.S. and foreign patent protection for PHS-owned biomedical technology.



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 Patent Policy