NIH Office of Technology Transfer
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NIH Office of Technology Transfer manages all intramural inventions from the United States National Institutes of Health (NIH) and Food and Drug Administration (FDA) as mandated by the Federal Technology Transfer Act and related legislation.
Function and mission
The Office of Technology Transfer (OTT), manages the wide range of NIH and FDA intramural inventions as mandated by the Federal Technology Transfer Act and related legislation. The mission of the NIH OTT is to improve public health through the management of inventions made by NIH and FDA scientists and the development of intellectual property policies for NIH’s intramural and extramural research programs. In doing so, OTT serves a leading role in public sector biomedical technology transfer policy and practice.
To accomplish its mission, OTT oversees patent prosecution, executes and monitors licensing agreements, administers royalties, and leads the development of technology transfer policies. OTT performs similar functions for the FDA, another component of the Department of Health and Human Services (HHS). HHS has designated NIH as the lead agency for technology transfer policy matters. OTT, through its Division of Policy, has the lead responsibility for NIH intramural and extramural technology transfer policy and supports the Public Health Service (PHS) Technology Transfer Policy Board. This includes NIH CRADA Subcommittee the review of Cooperative Research and Development Agreements (CRADAs) negotiated by technology transfer staff at the NIH Institutes and Centers (ICs).
OTT carries out its technology transfer mandate by managing the inventions made in NIH's and FDA’s intramural laboratories and licensing these inventions to private entities to ensure use, commercialization, and public availability. Over the last 20 years, NIH has executed thousands of license agreements. These licenses transfer NIH and FDA inventions to the private sector for further research and development and for commercialization leading to significant public health benefits. The license types include biological materials licenses, commercial evaluation licenses, nonexclusive patent licenses for internal use, and nonexclusive and exclusive patent commercialization licenses. OTT also negotiates inter-institutional agreements and interagency agreements in order to consolidate rights in inventions jointly owned with other institutions. Finally, OTT has the authority to settle disputes associated with rights in inventions, such as those that are subject to US Patent and Trademark Office (USPTO) interference proceedings.
Structure and organization
Structurally, technology transfer at the NIH is at once centralized and decentralized. It is decentralized in that each NIH Institute or Center (IC) and the FDA are served by an internal office that negotiates agreements associated with research, including Cooperative Research and Development Agreements (CRADAs), Material Transfer Agreements (MTAs) and Clinical Trial Agreements (CTAs). On the other hand, it is centralized in that OTT is charged with overseeing patent prosecution and licensing of all inventions that result from research at each IC and the FDA, administering royalties, and developing technology transfer policies.
Organizationally, OTT is part of the NIH Intramural Research Program, which in turn is part of the NIH Office of the Director (OD). OTT comprises the Office of the Director, the Division of Technology Development and Transfer (DTDT), and the Division of Policy. DTDT is made up of five branches: General Medicine, Infectious Disease and Medical Engineering, Cancer, the Technology Transfer Service Center, and Monitoring and Enforcement. The staff holds many different degrees, including Ph.D., J.D, M.S., M.B.A., B.A., and B.S. as well as combinations of science and law or business degrees.
OTT has been instrumental in the commercialization of hundreds of products, 24 of which are FDA approved vaccines and therapeutics. The sale of these products by NIH licensees has surpassed $50 billion over the last 20 years, with nearly $6 billion in 2008 alone. More importantly, these products have served to prevent, treat or diagnose diseases ranging from different types of cancer to Human Papilloma Virus and HIV to macular degeneration.
OTT executes typically 250 to 315 license agreements per year. It is through these agreements that OTT facilitates research and commercialization of technologies that improve public health by bringing these technologies from bench to bedside.
The NIH Office of Technology Transfer was established in 1989 within the NIH Office of the Director as the Office of Invention Development to provide for a centralized technology transfer management and policy function for NIH. Gradually other NIH and FDA technology transfer transactional functions were consolidated within this office (renamed as the NIH Office of Technology Transfer), including U.S patent prosecution from the Patent Branch of the NIH Office of General Counsel as well as licensing, foreign patent prosecution and royalty administration from the National Technical Information Service (NTIS) of the U.S. Department of Commerce. To date acting or permanent Directors of the NIH Office of Technology Transfer have been: Philip Chen, Reid Adler, Don Christoferson, Maria Freire, and Mark Rohrbaugh.
Today with the NIH as the primary focal point for the government support of medical research and clinical development, the work of the Office of Technology Transfer serves as one of the leading examples of how research discoveries can be successfully partnered with commercial organizations as a means to bring innovative products to the marketplace to improve public health, create jobs, and maintain US competitiveness.