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NIH Patent Policy

The Public Health Service (PHS) may determine that it is necessary to seek patent protection on its inventions, when doing so would facilitate the commercial development of products or services that will benefit the public health, or when a patent will advance another PHS objective. 
 
The decision whether or not to file a patent application will also be informed by PHS policies, as appropriate, including, for example, the NIH Policies on Research Tools and Genomic Inventions.Therefore, multiple factors will be weighed, in consideration of making a strategic decision on whether or not to file. Such factors can include the patentability of an invention, the stage of invention development, the commercialization potential of a product generated from an invention, and the mission and programmatic goals the NIH institution, as well as the research interest toward further invention development by the lead inventive NIH laboratory.
 
Below are listed some common reasons why an invention might not get patented:
 
  • Past public disclosures by the inventor or other scientists in the field may limit or destroy the patentability of an invention. This situation can be avoided by submitting your EIR to the TTC well in advance of any contemplated public disclosures; 
  • The invention is in such an early stage, such that a patent application would not result in the issuance of a patent by the USPTO (e.g. proof-of-concept is not well supported). You will be encouraged to contact the TTC when additional information is available for re-evaluation of the technology. TTC staff will assist inventors in such situations and will advise as to when an EIR should be re-submitted; 
  • The claims of the patent are too narrow to attract licensing by a commercial entity. In this instance, it is generally not recommended to file a patent application; the inventor will be given feedback on further research goals that would allow them to further develop the inventive concept and is encouraged to submit an updated EIR at a later time.
  • The Institute's Division Director decides against filing a patent application or subsequently decides to abandon a patent application. If this is the case, an inventor may request a waiver to obtain the rights to the invention. If you are interested in requesting a waiver, or  in learning more about the implications of a securing a waiver, please contact TTC for more information;
  • NIH Policy requires that certain inventions remain in the public domain (e.g. methods of performing surgical procedures) in order to ensure that they are freely and widely available.  For instance, the NIH generally does not seek patent protection on the inventions which can be defined as “Research Tools”, although NCI has the authority to license non-patented biological materials and substances through a Biological Material License (BML), for which inventors can still receive royalties.

Research Tools, also called research resources or research materials, are biological or other materials that are:

  • Primarily useful for research purposes, such as to the elucidation of disease mechanisms or to drug discovery; 
  • By definition, are finished products that often do not require further development time and development costs in order to be utilized; and
  • Broadly enabling inventions, useful in developing multiple products in numerous disciplines, rather than a single project-specific or product-specific use.

Common examples of Research Tools include:

  • antibodies;
  • expression plasmids and proteins derived from them;
  • cell receptors;
  • cell lines;
  • animal models (e.g., knockout mice);
  • laboratory and drug-screening methods or protocols; and
  • certain software.