A. PURPOSE

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.

B. BACKGROUND

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.

C. POLICY

• The PHS will seek patent protection on biomedical technologies only when a patent facilitates availability of the technology to the public for preventive, diagnostic, therapeutic, or research use, or other commercial use. Generally a patent is necessary to facilitate and attract investment by commercial partners for further research and commercial development of the technology, such as where the utility of the patentable subject matter is as a potential preventive, diagnostic, or therapeutic product. However, a patent might also be necessary to encourage a commercial partner to make available for research use important materials or products.

• Patent protection will generally not be sought by the 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 commercially valuable research tools (knock-out mice, receptors, cell lines) for the sole purpose of excluding others from using the patentable subject matter without a license. Such materials can be licensed under biological materials licenses or distributed to the research community without further compensation.

• PHS will generally not seek patent protection on a technology unless the commercial or public health value of the technology warrants the expenditure of funds for patenting. If PHS determines that a technology is patentable, but declines to seek patent protection due to low public health or commercial priority, waiver of patent rights to the employee-inventor of the technology may be appropriate and may be considered in accordance with applicable policies and procedures.

• When commercialization and technology transfer can best be accomplished without patent protection, such protection will not be sought. For example, some technologies may be commercialized through non-patent licensing, and some technologies are transferred to the private sector most expeditiously through publication. For those best transferred through publication, 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.

• With regard to the patenting of research results arising under a Cooperative Research and Development Agreement (CRADA), PHS will evaluate whether to file for patent protection in accordance with these principles, to the extent consistent with the terms of the CRADA and the collaborative relationship.

• In accordance with a longstanding tradition of scientific freedom, PHS research results are published freely. Publication of research is not to be significantly delayed for the purpose of either filing patent applications on patentable subject matter, or conducting further research to develop patentable subject matter.

• With regard to the patenting of research results which are in early stages of development, PHS will file for patent protection only on research that has a practical utility or a reasonable expectation of future practical utility. Practical utility for this purpose is based on the reasonable expectation of at least one commercial or public health use that is directly and specifically related to the research results in question. For example, the practical utility of a cDNA sequence is determined according to whether a potential use is directly a consequence of the particular sequence, not a use common to all DNA.

• Once initiated, prosecution of patent applications and maintenance of issued patents will continue only as long as there exists a reasonable expectation of transferring the patent rights to a commercial partner through licensing.

• PHS will enforce and defend its patents, where appropriate, either through its own resources, by granting its licensees the right of enforcement and defense as provided by 35 U.S.C. 207 (a)(2), or by referring the matter directly to the Department of Justice. In any case, no litigation may be undertaken in the Federal Court system without approval of the Department of Justice.

D. EFFECTIVE DATE

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

E. ADDITIONAL INFORMATION

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