1. 1 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 Enhancing & Documenting the Impact of Research Outcomes 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. 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. 4 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 Stevenson-Wydler Act, 1980 Federal Technology Transfer Act, 1986 (FTTA) National Technology Transfer and Advancement Act, 1995 Technology Transfer Commercialization Act, 2000 U.S. Technology Transfer Legislation -- public sector, federal researchers --

5. 5 “Technology transfer, consistent with mission responsibilities, is a responsibility of each laboratory science and engineering professional.” 15USC§3710(a)(2) Federal Law “Each laboratory director shall 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. 6 U.S. Technology Transfer Legislation -- public sector, non-federal researchers -- Bayh-Dole Act, 1980  Extramural research 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. 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. 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 … 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. 9 Technology Transfer: the adoption of research outcomes for public benefit

10. 10 and Technology Transfer and Technology Transfer The Changing Landscape of Technology …

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

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

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

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

16. 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. 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. 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. 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. 23 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) Service to ARS Scientists, Customers, Stakeholders …

24. 24 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 Service to ARS Scientists, Customers, Stakeholders …

25. 25 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) Service to ARS Scientists, Customers, Stakeholders …

26. 26 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) Service to ARS Scientists, Customers, Stakeholders …

27. 27 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) Service to ARS Scientists, Customers, Stakeholders …

28. 28 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.) Service to ARS Scientists, Customers, Stakeholders …

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

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

31. 31 Avoiding “Nightmare” CRADAs Corporate Research Need ARS Scientist Technology Transfer Coordinator DRAFT Cooperative Research & Development Agreement (CRADA) Review by Deputy Asst. Admin. 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. CRADA Development and Approval Process at ARS Scientist, Cooperator, & TTC* discuss potential CRADA & draft Statement of Work and budget Scientist immediately processes 425, 416/417 for Area / ONP approval Approved (see next slide) Disapproved Negotiation and CRADA development ends *Technology Transfer Coordinator

33. 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 Approved (from previous slide) If Cooperator is a non-US institution, TTC* submits a CRADA Opportunity announcement to Marketing and sends a U.S. Trade Rep. notice to HQ; also review process for compliance with Export Administration Regulations. Scientist files ADODR Certification (ethics) DisapprovedApproved Identify suitable alternate ADODR or PI (NPS, Area Office) *Technology Transfer Coordinator ** Deputy Assistant Administrator3

34. 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 OTT (DAA**) creates final CRADA document; sends Statement of Work and budget to NPL for approval OTT-DAA (ADO) signs & forwards to Cooperator *Technology Transfer Coordinator ** Deputy Assistant Administrator

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

36. 36 Our Newest Tool for Partnerships

37. 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. Model of a Public/Private Partnership for Commercialization of Research Outcomes Structural Assets and Financial Resources T2T2 Intellectual Capital Intellectual Assets Intellectual Property Human Capital Complementary Assets Distribution Capabilities Product Registration Manufacturing Facilities Technical Expertise— Product Dev, Scale-up, QC Marketing and Distribution Capabilities Product Registration Expertise Investment Capital These can be facilitated by Partnership Intermediaries of ARS OTT (Technology-Based Economic Development entities) CRADA Adapted from Sullivan, P.H., Profiting From Intellectual Capital, John Wiley & Sons, New York, 2000.

39. 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. 40 Richard J. Brenner, Ph.D. Assistant Administrator Office of Technology Transfer 5601 Sunnyside Ave Beltsville, MD 20705 (301) 504-6905 Photo: Quiet Waters Park, Annapolis, MD (Joann Perkins) The Office of Technology Transfer is at your service…. http://www.ars.usda.gov/Business/Business.htm

41. 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. 42

43. 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. 44 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 Guidance to scientists on use of agreements

45. 45 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 Guidance to scientists on use of agreements

46. 46 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 Guidance to scientists on use of agreements

47. 47 Cooperative Research and Development Agreement (CRADA)  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  Benefits to ARS:  Results-Oriented Research/Impact  Market information  Identification of Licensee  Resources (For the Project) Guidance to scientists on use of agreements

48. 48 CRADA Negotiations CRADA Negotiations USDA May Provide Any of the Above Except Money Firms May Provide: çExpertise çMaterials çEquipment çEmployees çMoney çFacilities Guidance to scientists on use of agreements

49. 49 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 Guidance to scientists on use of agreements

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

51. 51 Rights to IP Depend On Source of Funding Intellectual Property (IP) issues  Mechanisms for ARS to offer IP to private sector  Background inventions (made by federal researchers under normal research authority)  If exclusive license is requested, ARS must publish notice of intention of licensing in Federal Register and address all objections.  CRADA subject inventions  Exclusivity allowed without publishing notice of intent.  Up to 5 years confidentiality from FOIA (we rarely grant more than 1).  NOTE: do not hire univ. personnel to work on a CRADA! This mixes Bayh-Dole IP rights with FTTA IP rights.

52. 52 Three “Subject Matter” Committees  Life Sciences  Chemical  Mechanical and Measurement New ARS National Patent Committees (Oct. 2007) Each cover all geographic Areas of ARS Each Area will have at least 2 members on each Committee, rotate at 5 years.

53. 53 Advantages of ARS National Committees to Agency  Uniform committee recommendations across the Agency  Committee recommendation within three months of filing an Invention Disclosure (meet quarterly)  Scientists and management notified of annual schedule at the beginning of each fiscal year

54. 54 Patent Committee Criteria Q1: Is there current commercial interest in the invention or a high probability of commercialization in the future? Q2: Is the magnitude of the market relative to the cost of commercialization sufficiently large to warrant a patent? Q3: Would the patent likely play a significant role in transferring the technology to the user? Q4: Would a patent be enforceable, i.e., is the invention drawn to, or does it employ a unique and readily identifiable material or device which could be bought or sold? Q5: Is the invention of sufficient scope to justify patenting?

55. 55 Invention Disclosure Submitted Approval 2 Weeks Committee 2-3 Months Application Preparation 1 Year Prosecution 2-3 Years Issue 2-3 Months Appeals 3-5 Years The Patenting Process Years 1234

56. 56 Precautions Know the technology you are using: If you use patented genes or patented tools to insert genes, royalties to patent holders may result. In other words, your new “cheap and better” technology just got expensive for a commercial producer! But may help identify licensee of your invention. ARS generally does not patent ‘research tools,’ but others do!

57. 57 Due Diligence in Protecting Intellectual Property: Inventorship & Laboratory Notebooks  Ownership of intellectual property is determined by inventorship  An inventor must be able to document their contribution to “conception & reduction to practice” for at least one claim in an allowed patent  Documentation has strict legal requirements  Signed & witnessed lab notebook pages  Consecutive numbered bound pages, single line through errors (deletions) in data

58. 58 Good Laboratory Notebook Practices ARS Laboratory Notebooks are bound notebooks Always Use Official ARS Laboratory Notebook (ARS FORM 1)

59. 59  CRADAs:  Active: 230  New: 69 (record!)  Amended: 76  Material Transfer Agreements: 884 (648 outgoing) (record!)  Invention Disclosures: 133  Patent Applications Filed: 114 (record!)  Patents Issued: 27 Annual Report to Congress on Technology Transfer --- FY 2008 Metrics

60. 60 Annual Report to Congress on Technology Transfer --- FY 2008 Metrics  Licenses:  Active: 315 ( ~130 with universities)  New: 27  Biological Materials: 24 (4 new)  Licenses with products on market: 112 (record!)  (28 from university co-owned)  ~30 are plant materials (plant patent or Plant Variety Protection Certificate)  Total Income: $3,953,415 (record!)  To Inventors: $756,458

61. 61 Goals of Agricultural Technology Innovation Partnership Program (through PIAs) To partner with selected economic development agencies to enhance the effectiveness of the ARS technology transfer program and to expand its impact To enhance the flow of ARS technologies to small and expanding businesses and to encourage technology-based economic development

62. 62 Goals of ARS Partnership Intermediaries Provide complementary assets to ARS Office of Technology Transfer  Guide local / regional business with research needs to the appropriate ARS scientist across ARS (CRADA opportunities)  Triage business plans of private sector to seek “winners” as candidates for licensing / research partnerships with ARS  Acquire marketing assessments on ARS technologies from 3 rd party sources (business schools, entrepreneur programs, angel investors, etc.) for targeted marketing  Coordinate “Technology Showcase” events to facilitate partnerships with private sector companies (TEDCO, October 30, 2008 – Four Points Sheraton at BWI)

63. 63 Goals of ARS Partnership Intermediaries Provide complementary assets needed by private sector to succeed in commercializing federal inventions  Assist in accessing public / private funds  SBIR proposals  Angel investors / state funds  Manufacturing capacity  Manage their own seed/venture funds to support CRADA and license partners of ARS  Assist private sector in preparing license applications

64. 64 Role of PIA Partner  Learn about ARS technologies available for partnering  Introduce businesses to ARS  Point companies interesting in partnering with ARS to complementary assets: VC, grant opportunities, etc.)  Provide services such as market analyses to ARS  Work with ARS to host events to assist the business community  Provide services to ARS partners such as help with business plans, licensing, etc.

65. 65 Our Newest Tool for Partnerships ARS signed its first formal Partnership Intermediary Agreement (PIA) with the Maryland Technology Development Corporation (TEDCO) to promote joint public/private research & technology-based economic development with businesses in Maryland (September 28, 2007)  SRRC technology licensed to Maryland Co.  3 CRADAs funded by TEDCO  “Green Technologies” showcase (Oct. 30, 2008) ARS has now established a second PIA with the Mississippi Technology Alliance (Dec. 15, 2008)

66. 66 Culture of USDA: “The People’s Department”  Integration of T2 with research mission and priorities  ARS protects intellectual property principally when necessary to transfer technology (e.g., necessary for further research investments)  Prefer public release of plant varieties for broad availability – examined on case-by-case basis (meets needs of a changing industry)  Do not patent animals, nor research tools (could change)  Goal of licensing is to facilitate technology transfer  Permit license-free research with any ARS technology to promote further research ARS Policy …

67. 67 Does ARS IP Management Promote or Inhibit Technology Transfer?  Intellectual property rights, such as patents, protect new inventions from imitation and competition. A patent’s major objective is to provide incentives for invention, sacrificing short-term market efficiency for long-term economic gains. Conclusions … The Question Posed by USDA’s Economic Research Service

68. 68  More widespread use of patenting and licensing by ARS has not reduced the use of traditional instruments of technology transfer such as scientific publication Conclusions … Does ARS IP Management Promote or Inhibit Technology Transfer? The Question Posed by USDA’s Economic Research Service

69. 69  As commercial partners gain experience with the technology and learn more about the market, mutually advantageous revisions to license terms can maintain the incentives through which private companies distribute the benefits of public research. Conclusions … Does ARS IP Management Promote or Inhibit Technology Transfer? The Question Posed by USDA’s Economic Research Service

70. 70 Current Technologies In Successful Commercialization … Preserving color, crispness, and flavor of fresh cut apples --- “Apple Dippers”® (Attila Pavlath / Dominic Wong, PWA; Mantrose- Hauser) (license, CRADA, infringement)

71. 71 100% natural fruit bars from fruit puree (Tara McHugh, PWA; HR Mountain Sun; “Gorge Delights”) (license, CRADA) Current Technologies In Successful Commercialization …

72. 72 Helping people with peanut allergies: “Sunbutter”® (Harmeet Guraya / Isabel Lima, MSA; Red River Commodities) (CRADA) Current Technologies In Successful Commercialization …

73. 73 Table grape varieties -- (David Ramming, PWA; California Table Grape Commission) (license & infringement) Current Technologies In Successful Commercialization …

74. 74 Human nutrition / food allergies / obesity Humane mouse bleeding lancet: “Goldenrod”® (W. Golde / P. Gollibin / L. Rodriquez, NAA; MEDipoint, Inc.) (CRADA) Current Technologies In Successful Commercialization …

75. 75 George Inglett, MWA (Oatrim, Z-trim, Nutrim, Calorie- trim) Current Technologies In Successful Commercialization …

76. 76 Tom Casey, Mark Rasmussen Jacob Petrich (Iowa State U.), MWA (CRADA) Current Technologies In Successful Commercialization …

77. 77 Biodegradable soy-based hydraulic fluid (Sevim Erhan, MWA; test with National Park Service) Licensed exclusively to Agrilube / Bunge (Feb 2006) First sale in March, 2006. Current Technologies In Successful Commercialization …