Office of Technology Transfer - Basic PHS Patent Information
Working for a Healthier America
Background and Policy Information
The primary mission of Public Health Service (PHS) research laboratories is to acquire new knowledge through the conduct and support of basic scientific and 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 charged by Congress to ensure that new technologies developed in these laboratories are transferred to the private sector and commercialized in an expeditious and efficient manner
As the lead PHS agency to further this goal, the NIH Office of Technology Transfer (OTT) is cognizant of its role in protecting the public interest by seeking patent protection in the United States and foreign countries for new preventive, diagnostic, and therapeutic products developed by and through PHS scientists, including scientists at the National Institute of Mental Health (NIMH).
Who Determines Patentability
The US Patent and Trademark Office (USPTO), in conjunction with courts with jurisdiction over patent matters, is the premiere institution in the United States to render definitive decisions on the patentability of biomedical research discoveries, including human genetic material. Elsewhere, foreign countries similarly determine the scope and subject matter of patent protection within their own boundaries. These determinations require a careful analysis of the particular facts and circumstances of each patent application.
PHS Patent Policy Guidelines
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, PHS has established clear policy guidelines to assist agencies in the pursuit and maintenance of US and foreign patent protection for PHS-owned biomedical technology. These guidelines are summarized immediately below.
When PHS Will Pursue A Patent
PHS will seek patent protection only when a patent facilitates the availability of a biomedical technology to the public for preventive, diagnostic, therapeutic, research, or other commercial use. Generally, a patent is necessary to attract investment by commercial partners in further research and bringing a product to market. This is particularly true for preventive, diagnostic, and therapeutic products. Patent protection may also be sought, however, to encourage a commercial partner to make available important materials or products for continued health-related research.
With regard to the patenting of research results which are in the 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 for only so long as there exists a reasonable expectation of transferring the patent rights to a commercial partner through licensing.
Patents Arising Under CRADAs
With regard to the patenting of research results arising under a Cooperative Research and Development Agreement (CRADA), PHS will evaluate whether or not to file for patent protection in accordance with the foregoing principles, consistent as well with the terms of the CRADA and the collaborative relationship.
When PHS Will Not Pursue A Patent
As a general rule, PHS will not pursue patent protection where further research and development is unnecessary to realize a technology's primary use and where future therapeutic, diagnostic, or preventive uses are not reasonably anticipated. For example, PHS ordinarily will not seek patent protection for commercially valuable research tools for the sole purpose of excluding others from using the patentable subject matter without a license. Examples include, but are not limited to, knock-out mice, receptors, and cell lines. Rather, such materials can be licensed under biological materials licenses or distributed as a benefit to the research community without further compensation.
Nor will PHS generally seek patent protection on a technology unless its commercial or public health value warrants the expenditure of funds for patenting. Where PHS determines that a technology is patentable, but otherwise declines to seek patent protection due to low public health or commercial priority, then 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.
PHS vigorously enforces and defends its patents, where appropriate, either through its own resources, by granting licensees enforcement rights under 35 USC §207(a)(2), or by referring the matter directly to the US Department of Justice (DOJ). In no case, however, may litigation be undertaken in the Federal courts without first obtaining DOJ approval.
Other Transfer Mechanisms: Publication and Non-Patent Licensing
PHS will also not pursue a patent where commercialization can best be accomplished by other means. For example, some technologies may be commercialized through non-patent licensing. Still others may be transferred to the private sector most expeditiously through publication. In the second case, patenting and licensing are not only unnecessary, but may even inhibit the broad dissemination and application of a technology. Methods of performing surgical procedures, for example, could fall within this category.
To be sure, in accordance with a longstanding tradition of scientific freedom, PHS research results are published freely. Publication of research is not to be delayed significantly either for the purpose of filing patent applications on patentable subject matter or for conducting further research to develop patentable subject matter.