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.
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.
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.