Technology Transfer Transactions: Implications to supporting policy, statutes, and enhanced partnership opportunities

1. 1953-2003 Enhancing & Documenting the Impact of Research Outcomes Technology Transfer Transactions: Implications to supporting policy, statutes, and enhanced partnership opportunities Richard J. Brenner, Ph.D. Assistant Administrator of ARS Office of Technology Transfer Panelists: June Blalock, Gail Poulos, Rob Griesbach, Tom Moreland APHIS Annual Agreements Conference April 7, 2009 Riverdale, MD

2. Why Do We Do Technology Transfer at ARS? • Required by law (15 USC 3710a) • Helps fulfill our mission to serve the public good • Documents impact of scientists’ research outcomes • Enhances the public’s perception of ARS

3. Goals of Technology Transfer • Transfer of technology is primary objective, not income. • Facilitate research partnerships & adoption of federal research outcomes for broad U.S. public benefit. • Protect intellectual property primarily if it enhances technology transfer, using the patent system that provides incentives for scientists and protection for U.S. industry. • Enhance U.S. economic development, global competition, and sustainable economic security.

4. U.S. Technology Transfer Legislation-- public sector, federal researchers -- Stevenson-Wydler Act, 1980 Federal Technology Transfer Act, 1986 (FTTA) National Technology Transfer and Advancement Act, 1995 Technology Transfer Commercialization Act, 2000 Intramural research by federal employees, federally funded • Special Cooperative Research And Development Agreement (CRADA) authority with private sector companies • right to negotiate exclusive license without Federal Register notice; confidentiality of data up to 5 years • Technology transfer becomes an obligation “…of each laboratory science & engineering professional;” royalties capped at $150K / inventor / year • Extends licensing to “protectable” invention

5. Federal Law “Technology transfer, consistent with mission responsibilities, is a responsibility of each laboratory science and engineering professional.” 15USC§3710(a)(2) “Eachlaboratory directorshall 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.” 15USC§3710(a)(3)

6. U.S. Technology Transfer Legislation-- public sector, non-federal researchers -- Bayh-Dole Act, 1980 • Extramuralresearch with federal funds (university, private research firms, etc.) • Right to take title to invention and license according to institution policies & practices • Rights “flow with the funds” • If elect not to take title, or if patent prosecution / patent maintenance is abandoned, rights must be returned to federal government

7. U.S. Technology Transfer Legislation Why has Congress spent so much time on this issue over the past 25 years? • To help translate research results into practical products • To give taxpayers a return on their investment in research • To promote economic competitiveness and job creation

8. Our Current Environment… Economic crisis ( National, states, local), energy crisis, global warming, food shortages, water issues, land management, unemployment rising, global competition, emerging plant, animal and human diseases, natural disasters … There is an urgent need for innovation and creative partnering to develop technology to meet these multiple challenges

9. Technology Transfer: the adoption of research outcomes for public benefit

10. The Changing Landscape of Technology … and Technology Transfer

11. Office of Technology Transfer Coordinates Tech Transfer activities in ARS • Has authority to develop and sign Cooperative Research And Development Agreements (CRADAs) for ARS and to review those of other USDA agencies • Has sole authority, delegated by the Secretary of Agriculture for licensing any inventions developed from intramural research within any of the USDA agencies (including Forest Service (FS), Food Safety Inspection Service (FSIS), Animal & Plant Health Inspection Service (APHIS)) Facilitating partnerships to adopt research outcomes for broad public availability

12. Patenting Marketing Licensing Tech Transfer Coordinators • 8 registered patent agents (1 Ph.D, 4 w/ law degrees; 1 MBA) • Located in Beltsville, MD; Peoria, IL; Albany, CA • Targeted marketing (staff of 3) • Web subscribe Tech Alerts • Partnering opportunities • 4 senior licensing specialists (2 w / law degrees; 2 MBA) • HQ based • 8 specialists with life science / ag background (4 Ph.D, 1 law degree) • Distributed across geographic Areas of ARS Office of Technology Transfer Centralized in policy and approvals, licensing, marketing; decentralized in negotiation and implementation of CRADAs

13. Vic Chavez 215-233-6610 Vic.Chavez@ars.usda.gov Rob Griesbach -BA 301-504-6421 Rob.Griesbach@ars.usda.gov Renee Wagner – MWA 309-681-6565 Renee.Wagner@ars.usda.gov Don Nordlund – SAA/ MSA 706-546-3496 Don.Nordlund@ars.usda.gov Joe Lipovsky – SRRC Assoc. TTC 504-286-4355 Joe.Lipovsky@ars.usda.gov David Nicholson – PWA 510-559-5641 David.Nicholson @ars.usda.gov Bryan Kaphammer – NPA / SPA 970-229-5528 Bryan.Kaphammer@.ars.usda.gov Thomas Valco Cotton Tech Tran & Education Coordinator 662-686-5255 CTTEC@ars.usda.gov Office of Technology Transfer Technology Transfer Coordinators

14. Office of Technology Transfer Byron Stover –ERRC 301-504-4783 Byron.Stover@ars.usda.gov Evelyn Rabin -- NAA 301 504-4781 Evelyn.Rabin@ars.usda.gov Patent Advisors Byron Stover - BA 301-504-4783 Byron.Stover@ars.usda.gov Albert Tsui – MWA & NPA 309-681-6512 Albert.Tsui@ars.usda.gov Gail Poulos – SAA Robert Jones 301-504-5302 Gail.Poulos@ars.usda.gov Evelyn Rabin - MSA 301 504-4781 Evelyn.Rabin@ars.usda.gov Beth Sampson / Howard Owens – PWA 510-559-6067 / 5731 Esampson@ars.usda.gov Howens@ars.usda.gov Albert Tsui – NPA 309-681-6512Albert.Tsui@ars.usda.gov Randy Deck – MWA & SPA 309-681-6515 Randy.Deck@ars.usda.gov

15. ExecutiveSupport Staff Kate Baker DAA Management Analyst Kim Garner Program Support Asst. Paula Reed Executive Asst Richard Brenner Assistant Administrator (AA) Marketing TTC Staff VacantAA Marketing Specialist Vic Chavez DAA NAA, Tech Tran Coordinator Martha Steinbock Deputy Assistant Administrator (DAA) Chulee “Pin” Harris Marketing Technician Dolores Shilkitus Tech Tran Assistant Natasha Snuggs Marketing Assistant Rob Griesbach DAA BA, Tech Tran Coordinator CRADA vacant Tech Tran Assistant Thomas Moreland DAA Program Analyst Bryan Kaphammer DAA NPA/SPA, Tech Tran Coordinator Licensing Staff Patent Staff Marcie Currie-Gross Extramural Agrmnts. Asst. Gail Poulos AA Supervisory Patent Advisor (SAA) June Blalock AA Tech Licensing Coordinator Don Nordlund DAA SAA/MSA, Tech Tran Coordinator Brian Nakanishi Licensing Specialist Peoria, IL Beltsville, MD Byron Stover Patent Advisor (BA, ERRC & Chemical) Diana Tucker Licensing Specialist Albert Tsui Patent Advisor (MWA & NPA) Joe Lipovsky SRRC, Assoc. Tech Tran Coord. Kalpana Reddy Licensing Specialist Randy Deck Patent Advisor (SPA & MWA) Jason Bray Tech Tran Assistant Evelyn Rabin Patent Advisor (NAA, MSA, & Biotech) Deborah Penot Foreign Patent Specialist Sheri Whitehurst Legal Instruments Examiner David NicholsonDAA PWA, Tech Tran Coordinator Robert Jones Patent Advisor (SAA) Carla Boettinger Program Analyst Kristin Kimball Tech Tran Assistant vacant Patent Assistant Dianne Hoffmann Legal Instruments Examiner Thomas Valco DAA Cotton Tech Tran & Education Coord Robin McCormick Legal Instruments Examiner Albany, CA Annetta Ebelhar Secretary Howard Owens Patent Advisor (PWA) Kim Melton Licensing Assistant Kelli Gantt Patent Assistant Renee Wagner DAA MWA, Tech Tran Coordinator Elizabeth Sampson Patent Advisor (PWA) Gernard Little Patent Assistant Babette Davis Secretary Sonya Domingo Legal Instruments Examiner

16. ARS Decision-Making Principles • ARS conducts research to develop and transfer solutions to agricultural problems of high national priority.Licensing policies are mission driven. • Research programs are designed with stakeholder input, and outcomes are measured by positive impacts.ARS has a “market pull” orientation. • A variety of tools are available for partnering and technology transfer.Select the right tool for the job.

17. ARS Policies and Procedures • Documented in P & P 141.2 (revision in draft)

18. Policy / Procedural Issues for APHIS • Need to develop generic documents • CRADAs, MTAs, CAs • Properly delegate signature authority • CRADAs, MTAs, CA • Establish review & approval processes • Ethics clearance • Program alignment • Line management issues • Develop and deliver training -- a critically important process

19. Policy / Procedural Issues for APHIS • Invention Disclosure Review Committee (?) • Define agency policy on partnerships • Regulatory agency? • Cooperators can pay travel? • Cooperators in APHIS labs? • No money CRADAs? • Use of other cooperative research instruments? • (e.g., 7 U.S.C. 3318(b)

20. Policy / Procedures Developed by OTT for APHIS WS • Resulted from joint meetings with OTT staff, WS management, WS scientists • Provided some hard copies (administrative) • Provided to scientists on CDs with hyperlinked documents & forms • Provides basis for training • Could be modified to serve all APHIS

21. Mechanisms of Technology Transfer • Publication • Trade Publication • Seminars / Workshops • Field Days • Release of Public Plant Varieties • Management of Intellectual Property Rights (IPR) • Research Partnerships

22. Types of Tools Used in Technology Transfer Transactions • Confidentiality Agreement (CA) • Material Transfer Agreement (MTA) • Cooperative Research and Development Agreement (CRADA) • Patent, PVPC • License Agreement • Trust Fund Cooperative Agreement • Memorandum of Understanding (MOU) • Non Funded Cooperative Agreement • Partnership Intermediary Agreement

23. Service to ARS Scientists, Customers, Stakeholders … Professional Services of ARS OTT – Tech Transfer Coordinators • Training to all ARS scientists and Research Leaders (w/ patent, licensing, marketing staff) • Negotiation, review, approval, and management of CRADAs, Material Transfer Agreements, and Confidentiality Agreements • Review of other partnership instruments for implications to management of intellectual property • Assist in scheduling cooperator meetings; help develop Statements of Work (CRADA)

24. Service to ARS Scientists, Customers, Stakeholders … Professional Services of ARS OTT – Patent Section • Create, manage & convene Patent Review Committees (e.g., Invention Disclosure) • Advises scientists on strategy (often with TTC, licensing, marketing) • Prepare, file, and prosecute U.S. patent applications, & process Plant Variety Protection Certificate applications • Coordinate cooperator-filed PVP and U.S. patent applications • Facilitate and direct foreign filings with contractor

25. Service to ARS Scientists, Customers, Stakeholders … Professional Services of ARS OTT -- Licensing • Advises on intellectual asset management strategy • Negotiates licenses • Files appropriate Federal Register notices of intent to license • Monitors for license compliance • Distributes royalties for the duration of the license (up to 20 years)

26. Service to ARS Scientists, Customers, Stakeholders … Professional Services of ARS OTT-- Marketing • Conduct targeted marketing to private sector companies by technology category • “Tech Alerts”:over 3,000 subscribers (large and small businesses, university researchers, state extension and economic agencies)

27. Service to ARS Scientists, Customers, Stakeholders … Professional Services of ARS OTT-- HQ • Coordination and monitoring of iEdison database on invention disclosures made by ARS (and CSREES) cooperators (Bayh-Dole Act of 1980; provides additional metrics for GPRA, PART, BPI) • Annual Report to Congress through OMB and Appropriations committees (metrics, downstream outcomes & success stories) • Technology Transfer recognition through the Federal Laboratory Consortium (leadership; T2 award nominations)

28. Service to ARS Scientists, Customers, Stakeholders … Professional Services of ARS OTT-- HQ • Consultation with Office of National Programs on intellectual property issues related to research program management • Provide guidance and consultation to Secretary of Agriculture and Executive Branch on policies regarding intellectual property management in agriculture • Assist in negotiation with foreign governments and international NGO entities • Coordinate interactions & activities of Partnership Intermediaries (econom. develop.)

29. Seek Private Sector Interest For Commercialization • Marketing Section • Creates summary • Places on OTT website Licensing Section Models for Developing and Transferring Technologies to the Private Sector Background Invention (developed in USDA) Federal Register Notice Corporate response

30. Manufacture & Market ARS Scientist Technology Transfer Coordinator Corporation negotiates license (no FR notice) Cooperative Research & Development Agreement (CRADA) Patent Subject Invention (developed under CRADA) The CRADA Model for Developing and Transferring Technologies to the Private Sector Corporate Research Need

31. Corporate Research Need Review by Deputy Asst. Admin. ARS Scientist Technology Transfer Coordinator DRAFT Cooperative Research & Development Agreement (CRADA) Avoiding “Nightmare” CRADAs • Careful review of Statement of Work (SOW) to ensure precise scope • Check with Extramural Agreements Division to ensure that scientist does not have similar SOW in other Agreements, or other Bayh-Dole rights • Consult with Office of National Programs • Obtain Ethics clearance

32. Scientist immediately processes 425, 416/417 for Area / ONP approval Negotiation and CRADA development ends CRADA Development and Approval Process at ARS Scientist, Cooperator, & TTC* discuss potential CRADA & draft Statement of Work and budget Approved (see next slide) Disapproved *Technology Transfer Coordinator

33. TTC finishes negotiation with partner, prepares and submits final draft CRADA to Deputy**, OTT through Area line management CRADA Development and Approval Process at ARS Approved (from previous slide) If Cooperator is a non-US institution, TTC* submits a CRADA Opportunity announcement to Marketing and sends aU.S. Trade Rep. notice to HQ; also review process for compliance withExport Administration Regulations. Scientist files ADODR Certification (ethics) Approved Disapproved Identify suitable alternate ADODR or PI (NPS, Area Office) *Technology Transfer Coordinator ** Deputy Assistant Administrator3

34. OTT (DAA**) creates final CRADA document; sends Statement of Work and budget to NPL for approval OTT-DAA (ADO) signs & forwards to Cooperator CRADA Development and Approval Process at ARS TTC* finishes negotiation with partner, prepares and submits final draft CRADA to Deputy, OTT through Area line management *Technology Transfer Coordinator ** Deputy Assistant Administrator

35. Annual Report to Congress on Technology Transfer --- “Downstream Outcomes”

36. Our Newest Tool for Partnerships

37. 15 USC 3715 Partnership Intermediaries • Partnership Intermediary: • An agency of a State or local government, or a nonprofit entity that assists, counsels, advises, evaluates, or otherwise cooperates with small business firms or institutions of higher education, that need or can make demonstrably productive use of technology-related assistance from a Federal laboratory. • To provide services for the Federal laboratory that increase the likelihood of success in the conduct of cooperative or joint activities of such Federal laboratory.

38. Complementary Assets CRADA Human Capital Intellectual Assets T2 Marketing and Distribution Capabilities Technical Expertise— Product Dev, Scale-up, QC Manufacturing Facilities Product Registration Expertise Distribution Capabilities Product Registration Investment Capital Intellectual Property Model of a Public/Private Partnership for Commercialization of Research Outcomes Intellectual Capital Structural Assets and Financial Resources These can be facilitated by Partnership Intermediaries of ARS OTT (Technology-Based Economic Development entities) Adapted from Sullivan, P.H., Profiting From Intellectual Capital, John Wiley & Sons, New York, 2000.

39. Summary of Issues • Management of intellectual assets is increasingly important to USDA customers and stakeholders, especially small U.S. businesses. • For most of the transactions,T2 requires a long view and a team approach with seasoned professionals. • Signing a CRADA is an obligation to a future licensing negotiation by USDA, and the relationship will last long beyond the CRADA. • Licenses and CRADAs (and the rights to IP) will make or break a public / private partnership; thus, forming such relationship must be deliberate, strategic, well planned, and nurtured. • Attention to detail, processes, and training are prerequisites for success.

40. Photo: Quiet Waters Park, Annapolis, MD (Joann Perkins) The Office of Technology Transfer is at your service…. Richard J. Brenner, Ph.D. Assistant Administrator Office of Technology Transfer 5601 Sunnyside Ave Beltsville, MD 20705 (301) 504-6905 http://www.ars.usda.gov/Business/Business.htm

41. Supplemental Information… • Agreement types: Confidentiality, Material Transfer Agreement, CRADAs • CRADA requirements & negotiations • Precautions against mixing IP rights and federal obligations • The Patenting Process, inventorship, and role of laboratory notebooks • Public / Private Partnerships: The Agricultural Technology Innovation Partnership program (with Partnership Intermediary Agreements (PIA)) • ARS Technology Transfer: ERS Analysis of ARS P&P. • Examples of success stories

42. The following slides are provided as background information that may stimulate questions, or may be referenced in support of answering questions.

43. Confidentiality Agreement • Used only when contemplating entering into a partnership. Otherwise we do not disclose or receive confidential information. Material Transfer Agreement • Used when transferring ARS materials to outside parties which may be, will be, or are patented • Used when transferring materials from outside parties into ARS when required by provider TTC must be consulted for such services

44. Guidance to scientists on use of agreements Confidentiality Agreement • Used only when contemplating entering into a partnership. Otherwise we do not disclose or receive confidential information. • Can be one way or two way • Protects patent rights • ARS standard format may be downloaded from the OTT website • Handled at scientist level • Reported monthly by OTT to Area, ONP

45. Guidance to scientists on use of agreements Material Transfer Agreement • Used when transferring materials which may be, or will be, or are patented, or when required by provider • ARS standard format may be downloaded from the OTT website • Reviewed to prevent “reach through” and other clauses that are contrary to ARS policy; MUST adhere to Export / Deemed Export regulations • Handled by TTC • Reported monthly by OTT to Area, ONP

46. Guidance to scientists on use of agreements Cooperative Research and Development Agreement (CRADA) • A joint research and development effort with at least one non-Federal, U.S. partner that has the possibility of developing to a commercial product • A cooperative partnership that may lead to the development of intellectual property

47. Benefits to Firms: Access to ARS research capacity First right to negotiate Exclusive License for Subject Inventions without FR notice Confidentiality (competitive advantage) Opportunity to compete in global markets Guidance to scientists on use of agreements Cooperative Research and Development Agreement (CRADA) • Benefits to ARS: • Results-Oriented Research/Impact • Market information • Identification of Licensee • Resources (For the Project)

48. Guidance to scientists on use of agreements CRADA Negotiations Firms May Provide: • Expertise • Materials • Equipment • Employees • Money • Facilities USDA May Provide Any of the Above Except Money

49. Guidance to scientists on use of agreements CRADA Partners • May be an individual company, group of firms, association, university or combination of above • May include, but not be limited to, cooperation with another Federal agency • ARS actively seeks CRADAs with small and/or minority-owned businesses • No need to “compete” for CRADAs, we are free to choose the best partner • Developed by TTCs • Cleared through line management and ONP • Reported monthly by OTT to Area, NPS

50. Intellectual Property (IP) issues Rights to IP Depend On Source of Funding • Ownership results from inventorship • Employment of inventors and/or source of salary determine rights ofownership • Congressionally appropriated $$ disbursed outside USDA through extramural agreements(Bayh-Dole Act) • Congressionally appropriated $$ for intramural federal research (Fed. Tech. Trans. Act)