The NIH Office of Technology Transfer ~ OTT

1)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. 2)

History ~ Federal Technology Transfer Act of 1986

The United States Federal Technology Transfer Act of 1986 (P.L. 99-502) Original FederalRegister Paper Document 3)

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. 4)

Office of Technology Transfer and Development

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

Partnering with NHLBI and OTTAD’s Client Institutes

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. 5)

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

Follow The Money - TRANSFER ACTIVITIES

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 === 6)

Senate Investigation of OTT Benefits - Ovarian Cancer Drug Taxol

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:

Taxol is currently used to treat several types of cancer, including advanced ovarian and breast cancer, certain lung cancers (non-small cell) in patients who cannot have surgery or radiation therapy, and AIDS-related Kaposi's sarcoma. The bioactive compound in Taxol was first extracted from the bark of the slow-growing Pacific yew tree Taxus brevifolia in the 1960s. Following this discovery, the drug was developed primarily through research funded by NIH, and then transferred to the private sector and successfully commercialized by BMS. 7)

Cooperative Research And Development Agreements (CRADAs) and Material Transfer Agreements (MTAs)

CRADA Overview

CRADAs provide an exciting opportunity for NIH investigators to join with their colleagues from industry and academia in the joint pursuit of common research goals. Government scientists can leverage their own research resources, as well as serve the larger mission of NIH, to facilitate the development and commercialization of health-care pharmaceuticals and products. Companies also can leverage their own R&D efforts while collaborating in state-of-the-art NIH research.

The purpose of a CRADA is to make Government facilities, intellectual property, and expertise available for collaborative interactions to further the development of scientific and technological knowledge into useful, marketable products.

Each NIH institute has a Technology Development Coordinator (TDC) who should be consulted at an early stage of collaboration by the company and the NIH investigator to assist in identifying and developing the proper documents and obtaining the required approvals.

General

The intent of Congress in establishing CRADAs was to promote national technological competitiveness and the rapid transfer of the fruits of innovation to the marketplace. CRADA research and development at the NIH should be directed to the development of biological and behavioral technology, products, and processes by transferring relevant knowledge acquired from NIH research efforts to state and local governments, universities, and the private sector.

Advances in biomedical and behavioral research depend on a continuum of research efforts, from those aimed at discovering new knowledge, to those aimed at expanding existing knowledge, to those aimed at developing new procedures and products. There is not always a clear distinction among these research activities to allow a concise definition of which activities are appropriate for a CRADA. All CRADAs must be consonant with the primary biomedical research mission of the PHS and the specific laboratory involved, ensuring that no aspect of that mission is compromised. For example, a proposed CRADA would not be appropriate if the fundamental mission of the NIH is compromised by creating, either explicitly or indirectly, more than minimal constraints on research freedom and communication.

Although there is no restriction on the topic of research appropriate for a CRADA, all CRADA research projects must be highly focussed and delineated and each proposed CRADA must be carefully assessed for its overall research objectives. In considering a proposed CRADA, PHS operating components will determine if the objectives of a proposed collaboration warrant the establishment of a CRADA or if its goals are more appropriately met through a procurement contract, material transfer agreement, cooperative agreement or other contractual mechanism. Also, the proposed collaborator's scientific and business capabilities will be assessed.

Prohibition on General Funding

A CRADA is not intended to be a general funding mechanism to support directed research in a NIH laboratory. The majority of a laboratory's resources should not derive from CRADAs. CRADA-derived funds may not supplant appropriated funds in supporting NIH research. They are to be used only to defray the cost of the project specified in the CRADA.

Laboratories must be prepared to address the impact on the ongoing research if a CRADA and related financial support is terminated unexpectedly. The sole purpose of a CRADA cannot be to support post-doctoral fellows and/or technicians, to obtain funds, or to purchase equipment and/or supplies. Conversely, the sole justification of a CRADA cannot be for a NIH laboratory to conduct research or tests for the collaborator.

Ensuring Research Freedom

NIH investigators generally are free to choose the subject matter of their research, consistent with the mission of their Institute and the research programs of their Laboratories. No CRADA may contravene this freedom.

CRADAs that explicitly attempt to direct NIH research are not appropriate. Additionally, in considering any proposed CRADA, attention must be given to whether directed research implicitly will be the net effect. For example, the greater the extent to which a laboratory's resources derive from a CRADA, the less likely it will be that the laboratory will pursue other research opportunities outside of the CRADA; the broader the scope of a CRADA research plan, the less able a laboratory will be to provide fair access and interact with others. The achievement of this balance will be considered in the decision-making process. Thus, consideration should be given to:

a. the fraction of a laboratory's appropriated resources devoted to CRADA research;

b. the fraction of a laboratory's total resources that derive from CRADA support, and the time and scope of work devoted to a given CRADA;

c. the amount of time that any one investigator would give to one or more CRADAs;

d. the number of CRADAs an investigator or Laboratory/Branch has with one company; and

e. the number of CRADAs that any given company might have with the PHS and its operating components.

Scientific Communication and Dissemination of Research Results

It is fundamental to the mission of NIH that research results be published and discussed at public fora. Further, NIH scientists must operate within an atmosphere of scientific collegiality. Reasonable confidentiality requirements and brief delays in dissemination of research results are permitted under a CRADA, as necessary, in order to protect proprietary materials and intellectual property rights. CRADAs which in any way attempt to unreasonably restrict or constrain scientific interaction or the dissemination of research information will not be approved. In considering any proposed CRADA, consideration must be given to the possibility that the level of confidentiality associated with that CRADA project might, on balance, inappropriately impair the degree of openness necessary to maintain effective scientific communication and to serve the public interest.

Requirement of Intellectual Contribution by Collaborator

CRADAs are authorized only with collaborators who will make significant intellectual contributions to the research project undertaken or will contribute essential research materials or technical resources not otherwise reasonably available to NIH. CRADAs cannot attempt to direct or restrict research in a NIH laboratory. Sponsored research, such as routine, conventional testing, with no collaborative, intellectual contribution, is not appropriate for a CRADA.

Avoidance of Conflict of Interest

Pursuant to the CRADA-authorizing statute, every federal laboratory must ensure that there are no conflicts of interest in any CRADA. Extramural NIH staff scientists who administer grants and contracts may have an inherent conflict of interest that would preclude their participation in CRADAs. Intramural NIH scientists also may have conflicts of interest, in that they serve as a project officer on a contract or have authority over funding decisions in the course of their research. In both cases, the employee may have financial interests that would be affected by their proposed CRADA. Therefore, any conflict of interest–actual or apparent–must be addressed in the review and approval of CRADAs.

Fair Access to CRADA Opportunities

In compliance with the intent of the Federal Technology Transfer Act (FTTA) and the PHS Policy for Promoting Fair Access to CRADA Opportunities, the NIH shall ensure that outside organizations have fair access to collaborative opportunities, the licensing of federal technologies, and NIH scientific expertise, giving special consideration to small business and preference to those that are located in the U.S. and agree to manufacture in the U.S. products developed under the CRADA. Fair access to CRADAs is not to be considered as synonymous with the term “open competition,” as defined for contracts and small purchases. Evidence of fair access or discussion of unique resource requirements should be maintained as part of the official NIH Institutes and Centers (IC) CRADA file.

MTA Overview

A MTA generally is utilized when any proprietary material is exchanged, and when the receiving party intends to use it for his/her own research purposes. Neither rights in intellectual property nor rights for commercial purposes may be granted under this type of agreement. MTAs define the terms and conditions under which the recipients of materials, provided by either the NIH scientist or the other party, may use the materials. Included in the MTA are the requirements that the materials be used for research purposes only and that the materials cannot be used in human subjects. The NIH also requires that all materials received by their scientists originating from humans be collected under 45 CFR 46, Protection of Human Subjects. 8)

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