Diagnostic Kits/NIH Principles and Guidelines for Sharing of Biomedical Resources

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National Institutes of Health (NIH), Public Health Service, DHHS, NIH Principles and Guidelines for Sharing of Biomedical Resources -- Final (December 1999) Available at: http://www.ott.nih.gov/policy/research_tool.aspx

  • "This policy is designed to provide recipients of NIH funding with guidance concerning appropriate terms for disseminating and acquiring unique research resources developed with federal funds and is intended to assist recipients in complying with their obligations under the Bayh-Dole Act and NIH funding policy." http://www.ott.nih.gov/policy/rt_guide_final.aspx

NIH Principles

  1. Ensure Academic Freedom and Publication
  2. Ensure Appropriate Implementation of the Bayh-Dole Act
  3. Minimize Administrative Impediments to Academic Research
  4. Ensure Dissemination of Research Resources Developed with NIH Funds

Key Patent Policy

  • "The policy has been clarified to ensure that where patent protection is necessary for development of a research tool as a potential product for sale and distribution to the research community, Recipients are not discouraged from seeking such protection, but should license the intellectual property in a manner that maximizes the potential for broad distribution of the research tool." http://www.ott.nih.gov/policy/rt_guide_final.aspx
  • This balancing approach is a response to comments from innovators concerned that the NIH policy would discourage patenting. In an attempt to balance concern about patents as a barrier and patents as an important incentive the focus has been shifted to the goal of broad distribution of the research tool. Whether this is adequate to address the concerns of those concerned with patents as a barrier is debatable.

Application to Diagnostic Tests "One commenter requested that the definition of research tools be expanded to include diagnostic genetic tests performed with "home-brew" reagents. The commenter suggested that the patenting and exclusive licensing of such tests is having a deleterious effect on clinical education, clinical research, and patient care. NIH declines to expand the definition of research tools to include diagnostic genetic tests." http://www.ott.nih.gov/policy/rt_guide_final.aspx

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