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.

=== Historical data prior to introduction of automated tracking and analysis systems 1995 - 2002 === ⁵⁾

This is the accessible text file for GAO report number GAO-03-829 entitled 'Technology Transfer: NIH-Private Sector Partnership in the Development of Taxol' which was released on June 06, 2003.

Report to the Honorable Ron Wyden, U.S. Senate:

United States General Accounting Office:

GAO:

June 2003:

TECHNOLOGY TRANSFER:

NIH-Private Sector Partnership in the Development of Taxol:

GAO-03-829:

GAO Highlights:

Highlights of GAO-03-829, a report to the Honorable Ron Wyden, U.S. Senate

Why GAO Did This Study:

The transfer of technology from government-funded medical research laboratories to the private sector aims to have new pharmaceuticals brought to market more efficiently than would be possible for a federal agency acting alone. Much of the pharmaceutical-related technology transfer originates with research funded by the National Institutes of Health (NIH).

GAO was asked to examine the legal and financial issues involved in technology transfer as illustrated by the research, development, and commercialization of Taxol. Taxol was developed through a cooperative research and development agreement (CRADA) between NIH and the Bristol-Myers Squibb Company (BMS) and by 2001 had become the best-selling cancer drug in history.

Specifically, GAO examined (1) how the technology transfer partnership affected the research and development of Taxol, (2) what NIH’s financial investment was in Taxol-related research, and what the financial outcomes were of the technology transfer process related to Taxol, and (3) what factors influenced how NIH exercised its authority in Taxol-related technology transfer activities. GAO reviewed relevant materials and statutes governing technology transfer, reviewed the patent history of Taxol, interviewed NIH and BMS officials, and reviewed data on NIH’s financial investment and drug pricing policies.

What GAO Found:

The 1991 NIH-BMS CRADA was one of the first CRADAs to result in a major breakthrough drug. NIH’s partnership with BMS provided the company with the research results that enabled Taxol to be commercialized quickly and made available as a treatment for cancer patients. Prior to the CRADA and during the first 2 years of the agreement, NIH conducted most of the clinical trials associated with the drug. The results of these trials were critical for BMS to secure FDA’s approval in 1992 to market Taxol for the treatment of advanced ovarian cancer.

As agreed in the CRADA, BMS supplied the drug to NIH researchers to overcome previous shortages. The additional supplies from BMS allowed NIH to increase the number of patients enrolled in NIH clinical trials for this drug from 500 patients by 1989 to nearly 29,000 patients over the course of the CRADA.

NIH made substantial investments in research related to Taxol, but its financial benefits from the collaboration with BMS have not been great in comparison to BMS’s revenue from the drug. NIH estimates that it spent $183 million on all Taxol-related research from 1977 through the end of the CRADA’s term in 1997. For one portion of its spending, NIH estimates that it spent $96 million to conduct clinical trials supporting the CRADA; this was offset by a $16 million payment from BMS.

In addition, BMS supplied Taxol to NIH, the value of which GAO estimates to be $92 million. NIH spent an additional $301 million on Taxol-related research from 1998 through 2002, some of which was for cancer research, making NIH’s total Taxol-related spending $484 million through 2002. BMS’s sales of Taxol totaled over $9 billion from 1993 through 2002. BMS agreed to pay NIH royalties at a rate equal to 0.5 percent of worldwide sales of Taxol as part of a 1996 agreement to license three NIH Taxol-related inventions developed during the CRADA. Royalty payments to NIH have totaled $35 million.

The federal government has been a major payer for Taxol, primarily through Medicare. For example, Medicare payments for Taxol totaled $687 million from 1994 through 1999.

Several factors affected NIH’s exercise of its broad authority in negotiating its Taxol-related technology transfer activities. First, NIH did not have a patent on Taxol and thus could not grant an exclusive patent license to a CRADA partner. Second, in NIH’s evaluation, it was limited by a shortage of available, qualified alternative CRADA partners. Finally, the negotiation of royalties for NIH’s Taxol-related inventions was affected by multiple considerations, including the priorities that both NIH and BMS assigned to different factors in the setting of royalties. These factors include the stage of development, the potential market value of the license, and the contribution to public health of making the product available.

In commenting on a draft of this report, NIH provided additional information about its expenditures and the contributions of BMS, which GAO incorporated, and also discussed its evaluation of whether BMS’s pricing of Taxol was reasonable. www.gao.gov/cgi-bin/getrpt?GAO-03-829.

To view the full product, including the scope and methodology, click on the link above. For more information, contact Marcia Crosse at (202) 512-7119.

[End of section]

Results in Brief-

Background-

NIH-BMS Partnership Provided Research Results Critical to Developing Taxol's Commercial Uses:

NIH Invested Heavily in Taxol-Related Research, but Federal Financial Benefits Have Been Limited:

Several Factors Affected NIH's Exercise of Its Broad Authority in Technology Transfer Activities Related to the Development of Taxol:

• Concluding Observations:
• Agency and Bristol-Myers Squibb Company Comments and Our Evaluation:
• Appendix I: Selection of “Clinical Development of Taxol”
• CRADA Partner:
• Appendix II: Catalog of CRADAs and License Agreements
• Related to Taxol:
• Appendix III: Chronology of the Research and Development of
• Taxol (Paclitaxel):
• Appendix IV: Comments from the National Institutes of Health:
• Appendix V: GAO Contact and Staff Acknowledgments:
• GAO Contact:
• Acknowledgments:
• Tables:
• Table 1: BMS's Worldwide Taxol Sales, 1993-2002:
• Table 2: CRADAs Related to Taxol:
• Table 3: Patents Related to Taxol:
• Figure:
• Figure 1: NIH's Funding for Paclitaxel-Related Research: ⁶⁾