Realization of the considerable anticipated health benefits inherent in Public Health Service (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.
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.
PHS generally seeks to patent biomedical technologies when a patent will facilitate and attract investment by commercial partners for further research and commercial development of the technology. Patent protection generally will 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 generally will 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 generally will 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), NIH 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.
NIH 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.