The NIH Office of Technology Transfer evaluates, protects, monitors, and manages the wide range of NIH and FDA discoveries, inventions, and other intellectual property as mandated by the Federal Technology Transfer Act and related legislation.

To accomplish its mission, OTT oversees patent prosecution and negotiates and monitors licensing agreements. OTT performs similar functions for patenting and licensing activities for the Food and Drug Administration (FDA), another component of the Department of Health and Human Services (HHS).

Other major functions within OTT include the development of technology transfer policies for NIH and with the other two major research components of HHS (FDA and the Centers for Disease Control and Prevention [CDC]) and the implementation of decisions by the Technology Transfer Policy Board. ¹⁾

The United States Federal Technology Transfer Act of 1986 (P.L. 99-502) Original FederalRegister Paper Document ²⁾

Federal Technology Transfer Act of 1986 - Amends the Stevenson-Wydler Technology Innovation Act of 1980 to authorize Federal agencies, subject to specified conditions, to permit the directors of their Government-operated Federal laboratories to: (1) enter into cooperative research and development agreements with other Federal agencies, State or local governments, industrial organizations, industrial development organizations, public and private foundations, nonprofit organizations including universities, licensees of Federal inventions, and other persons; and (2) negotiate patent licensing agreements.

Authorizes Government-operated Federal laboratories, under such agreements and subject to specified conditions, to: (1) accept funds, services, and property from collaborating parties and provide services and property to collaborating parties; (2) grant patent licenses or assignments, or options, in any subject invention made by a Federal employee, or made jointly by a Federal employee and an employee of the collaborating party, and to retain such rights as the laboratory deems appropriate; (3) waive any right of ownership which the Federal Government may have to any subject invention made by a collaborating party or such party's employee under the agreement; and (4) to the extent consistent with applicable agency requirements, permit employees or former employees of the laboratory to participate in efforts to commercialize inventions they made while in the service of the United States.

Sets forth contract considerations.

Requires Federal agencies to make separate determinations of the missions of each of their laboratories, for purposes of cooperative research and development agreements.

Establishes the Federal Laboratory Consortium for Technology Transfer. Sets forth Consortium duties relating to the commercial potential of new technologies generated by Federal laboratory research. Includes among such duties assisting colleges, universities, businesses, nonprofit organizations, State or local governments, or regional organizations to establish cooperative programs to stimulate research and encourage technology transfer in such areas as technology program development, curriculum design, long-term research planning, personnel needs projections, and productivity assessments.

Directs the Consortium to furnish information and provide technical assistance, but prohibits the Consortium from engaging in the direct transfer of technology. Provides that each Federal laboratory or agency shall transfer technology directly to users or representatives of users, but not to the Consortium.

Requires the Director of the National Bureau of Standards to provide the Consortium with administrative services on a reimbursable basis.

Requires the Chairman of the Consortium to report annually to the President and to the appropriate authorization and appropriation committees of the Congress on the Consortium and other specified activities.

Requires, for FY 1987 through 1991, Federal agencies to transfer a specified portion of the research and development budget of their laboratories to the National Bureau of Standards for use by the Consortium in carrying out its activities.

Directs the Consortium to use five percent of such funds to establish demonstration projects in technology transfer.

Makes technology transfer, consistent with mission responsibilities, the responsibility of each Federal laboratory science and engineering professional. Requires each Federal laboratory director to ensure that efforts to transfer technology are considered positively in laboratory job descriptions, employee promotion policies, and evaluation of the job performance of scientists and engineers in the laboratory.

Requires each Federal laboratory with 200 or more full-time scientific and engineering professionals to have at least one full-time equivalent technology transfer position as staff for its Office of Research and Technology Applications. Requires that individuals filling such positions be included in the overall laboratory/agency management program so as to ensure that highly competent technical managers are full participants in the technology transfer process.

Abolishes the Center for the Utilization of Federal Technology and transfers its functions to the National Technical Information Service (NTIS).

Requires Federal agencies to report annually on technology transfer efforts in their annual budget submission to the Congress.

Authorizes the Secretary of Commerce to: (1) make available to interested agencies the expertise of the Department of Commerce regarding the commercial potential of inventions and methods and options for commercialization which are available to the Federal laboratories, including research and development limited partnerships; (2) develop model provisions for use on a voluntary basis in cooperative research and development arrangements, and disseminate such provisions to appropriate agency and laboratory personnel; and (3) furnish advice and assistance to Federal agencies concerning their cooperative research and development efforts.

Directs the Secretary to report biennially to the President and the Congress on the use by the agencies and the Secretary of the authorities specified in the Act.

Directs the Secretary, within one year after the enactment of this Act, to report to the President and the Congress on: (1) any copyright provisions or legal or other barriers which restrict or limit the transfer of federally funded computer software to the private sector and to State and local governments and their agencies; and (2) the feasibility and cost of compiling and maintaining a current and comprehensive inventory of all federally funded training software.

Requires Federal agencies which expend certain amounts for research and development to establish cash awards programs to reward their scientific, engineering, and technical personnel for inventions or other exemplary activities relating to domestic technology transfer.

Sets forth rules and formulas for the distribution of royalties or other income received by Federal agencies from the licensing or assignment of inventions under such agreements under this Act, and from inventions of Government-operated Federal laboratories licensed under provisions of Federal law relating to domestic and foreign protection of federally owned inventions, or owned inventions, or under any other provision law. Requires Federal agencies to submit annually to the appropriate authorization and appropriation committees of the Congress summaries of the amount of royalties or other income received and expenditures made (including inventor awards) under such rules and formulas.

Authorizes Federal agencies to transfer rights of ownership to an invention under the Act to the employee inventor, subject to specified conditions.

Abolishes the National Industrial Technology Board.

Changes references to the Director of the Office of Industrial Technology to the Assistant Secretary for Productivity, Technology, and Innovation.

Renames the Centers for Industrial Technology as Cooperative Research Centers. ³⁾

Office of Technology Transfer and Development Bruce D. Goldstein, Esq. Director goldsteb@mail.nih.gov

The Office of Technology Transfer and Development (OTTAD) plays a key role in the development of cutting-edge research that will benefit national and global public health. It does this by helping to connect external partners to the cadre of world-class researchers, facilities, and knowledge within NHLBI and OTTAD’s client Institutes. OTTAD also assists external partners with navigating the technology development pathway of NHLBI and OTTAD’s client Institutes, from the point of discovery and invention development, to patenting and licensing.

What We Do

OTTAD is the primary point of contact for technology development activities for the NHLBI, and six other NIH Institutes: National Institute on Alcohol Abuse and Alcoholism (NIAAA), National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS), National Institute of Biomedical Imaging and Bioengineering (NIBIB), National Institute on Deafness and Other Communication Disorders (NIDCD), National Institute of Environmental Health Sciences (NIEHS), National Institute of Nursing Research (NINR). A variety of mechanisms exists that allow NHLBI and OTTAD’s client Institutes to collaborate with external partners for research and development purposes.

Licensing Agreements

OTTAD recognizes the importance of converting basic science discoveries into public health benefits, by licensing research discoveries derived from the intramural and extramural laboratories of NHLBI and OTTAD’s client Institutes. If an entity is licensing either an unpatented material or a patented or patent-pending technology for commercial purposes, a Commercial Evaluation License, a Biological Materials License, or an Exclusive/Nonexclusive License is required. OTTAD recommends using TechFinder, a live search engine for locating technologies developed in the labs NHLBI and OTTAD’s client Institutes by keyword or taxonomy classification. ⁴⁾

Please contact our Licensing and Patent Managers with questions about licensing opportunities.

Contacts: Uri Reichman, Ph.D., M.B.A., uri.reichman@nih.gov, Michael Shmilovich, Esq., CLP, michael.shmilovich@nih.gov

Fiscal Year 2003 to Fiscal Year 2005 1 Data reflect invention disclosures that include a government inventor. 2 Patent applications include only the first U.S. patent application for a new disclosure filed in the reporting period (data include CIP filings but not Divisional applications). 3 Total patent applications filed during the reporting period regardless of type. 4 Data reflect licenses that were fully executed during the reporting period. 5 Royalty income reflects monies received during the reporting period. 6 Royalty income for FY 2003 reflects figures reported by the NIH Office of Financial Management. 7 Royalty income for FY 2004 reflects information taken from TechTracs. 8 Royalty income for FY 2005 reflects information taken from TechTracs

Additional technology transfer statistics are available from the U.S. Department of Commerce. These government-wide statistics use various methods of calculation. The reader is referred to the FY 2004 OMB Circular A-11 (http://www.whitehouse.gov/omb/circulars/a11/current_year/a_11_2004.pdf). The statistics provided by the NIH Office of Technology Transfer to the U.S. Department of Commerce were based on category definitions that may be found embedded in the footnotes of the tables located at http://www.whitehouse.gov/omb/circulars/a11/current_year/ttechspreadsheet.xls.