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Current Issues
NIH Commitment to Public Health Goals in Licensing Technologies
NIH endorses the approach of leading universities who have this week come together to publicly pledge their commitment to technology licensing principles that put public health goals above financial considerations. Click here to read the AUTM Principles.
The U.S. Public Health Service (PHS) is committed to the effective licensing of technologies to develop and make available new products arising from PHS funds. NIH’s mission as an agency within PHS is to lead the country to important medical discoveries that improve health and save lives. NIH seeks the development of technologies created from NIH-funded research for the broadest possible applications to the widest number of people. One of the agency’s goals is to foster fundamental creative discoveries, innovative research strategies, and their applications as a basis to advance the Nation's capacity to protect and improve human health.
PHS’ licensing and patenting policies (http://ott.od.nih.gov/policy/phslic_policy.aspx) provide a framework for achieving this goal when health-related inventions are made. It promotes the pursuit of patent protection and licensing activity to facilitate and attract investment by commercial partners for further research and development.
NIH seeks to maximize the number of products and therapies resulting from technologies developed at the NIH by providing appropriate incentives to commercial parties. NIH’s policy on Sharing Biomedical Research Resources (http://www.ott.nih.gov/policy/rt_guide_final.html) and the NIH’s Best Practices for the Licensing of Genomic Inventions (http://www.ott.nih.gov/policy/lic_gen.aspx) reinforce the agency’s perspective that intellectual property should be used to provide incentives for technology development to benefit public health worldwide.
Financial considerations in licenses should not be a barrier to the transfer of technologies developed through NIH research. For licenses on inventions coming from the NIH intramural program, NIH promotes commercial development of technologies in a way that provides broad accessibility for developing countries. Although NIH typically does not file patents in developing countries, the agency licenses unique biological materials to institutions that are willing to introduce new technologies to meet specific needs. For example, NIH has licensed vaccine technologies directed to rotavirus, haemophilus influenza b, and dengue fever – diseases that can disproportionately burden the populations of developing countries and emerging markets. NIH also promotes the licensing of technologies for neglected diseases by maintaining a database on its Web site compiling technologies that are available for licensing from NIH, FDA and non-profit institutions for neglected diseases as recognized by the World Health Organization (http://www.ott.nih.gov/Technologies/NegDis_ovrvw.aspx).
Licensing Executive Society's "Deal of Distinction Award™" for 2009
"Intellectual property (IP) development and the licensing of IP is an essential component of innovation in our knowledge-based economy. Each year, major IP deals between companies help drive innovation and ensure that new products continue to reach businesses and consumers"1. The National Institutes of Health (NIH) is pleased to announce that it has received the "Deal of Distinction Award™" along with Hope Pharmaceuticals and Aires Pharmaceuticals from the Licensing Executive Society (LES). This award was announced at the 2009 annual LES Meeting in San Francisco on October 21st and was awarded in the Industry-University-Government Interface Sector. The award for this category is a group of licensing agreements for the development of sodium nitrite as a repurposed pharmaceutical agent potentially effective against a number of serious medical conditions. The NIH, supported by four university collaborators, was able complete exclusive license agreements with Hope Pharmaceuticals (for infused delivery) and Aires Pharmaceuticals (for inhaled delivery) to develop new treatments for conditions not well-managed by existing therapies.
The license agreements were based upon the discovery by four NIH institutes (National Institute of Neurological Disorders and Stroke, National Heart Lung & Blood Institute, Clinical Center, and National Institute of Diabetes and Digestive and Kidney Diseases) and four universities (Loma Linda University, Louisiana State University, University of Alabama, and Wake Forest University) that low, physiological and non-toxic concentrations of sodium nitrite could be used in disease indications such as pulmonary hypertension, ischemia-reperfusion injury, hemolytic disease, hemoglobinopathies (including sickle cell disease) and cerebral vasospasm. Sodium nitrite is currently only available to patients by intravenous delivery for the treatment of cyanide poisoning.
The final license agreements are a testament to the willingness of all sides to work together with the hope that their efforts will culminate in new safe and effective treatments for significant diseases.
1 Link to related LES press release
HHS is Global Leader in Patenting
As reported in Intellectual Property Today, the US Department of Health and Human Services (HHS) has been named a leading governmental agency worldwide for patenting. HHS, which includes the National Institutes of Health (NIH), Food & Drug Administration (FDA), and Centers for Disease Control and Prevention (CDC), advanced to the top seven governmental agencies internationally for its overall patenting efforts on behalf of its intramural research programs, according to a report by The Patent Board™. Significantly, the HHS patent portfolio was rated the highest agency worldwide for "science strength," a rating measure indicating how much the agency uses science in building its patent portfolio. Additionally, HHS's portfolio ranked highly for overall technology strength, current impact on patenting efforts by others, and the number of patents granted.
The strength of NIH's intramural technology portfolio is further reflected by its translation to FDA-approved drugs, therapies, and vaccines. In fact, NIH's intramural research program portfolio leads US public sector research in the number of FDA-approved drugs, vaccines, and diagnostics to which it has contributed. More specifically, NIH's intramural research program has contributed to about 15% of all FDA-approved drugs, vaccines and diagnostics arising from public sector research since 1980. See Jensen, J.J. et al., "The Contribution of Public Sector Research to the Discovery of New Drugs," Association of University Technology Managers (AUTM) Annual Meeting, March 2007. Examples of such FDA-approved products to which NIH contributed include: Gardasil®, a vaccine for human papilloma virus (HPV) to protect from certain cancers; TAXOL®, a drug to treat advanced carcinoma of the ovary and also used as adjuvant treatment of node-positive breast cancer; Synagis®, a monoclonal antibody for treatment and prevention of respiratory syncytial virus (RSV); and didanosine, a drug for treatment of advanced HIV infection.
The NIH Office of Technology Transfer (NIH OTT) advances the HHS patent portfolio through evaluating, protecting, marketing, licensing, monitoring, and managing the wide range of NIH and FDA intramural research program inventions.
The report on HHS's patent portfolio strength is available at: http://www.iptoday.com/articles/2009-10-damato.asp. A showcase of products arising from NIH licensed technologies is available at: http://www.ott.nih.gov/productshowcase/.
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