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

opportunitiesRichard J. Brenner, Ph.D.

Assistant Administrator of ARSOffice of Technology Transfer

Panelists: June Blalock, Gail Poulos, Rob Griesbach, Tom Moreland

Enhancing & Documenting the Impact of Research Outcomes

APHIS Annual Agreements ConferenceApril 7, 2009

Riverdale, MD

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

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.

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, 1980Federal Technology Transfer Act, 1986 (FTTA)National Technology Transfer and Advancement Act, 1995Technology Transfer Commercialization Act, 2000

U.S. Technology Transfer Legislation-- public sector, federal researchers --

“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)

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

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

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

Technology Transfer: the adoption of research outcomes for public benefit

and Technology TransferThe Changing Landscape of Technology …

Office of Technology TransferCoordinates Tech Transfer activities in ARSHas 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

Office of Technology TransferOffice 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

David Nicholson – PWA510-559-5641David.Nicholson@ars.usda.gov

Rob Griesbach -BA301-504-6421Rob.Griesbach@ars.usda.gov

Don Nordlund – SAA/ MSA706-546-3496Don.Nordlund@ars.usda.gov

Renee Wagner – MWA309-681-6565Renee.Wagner@ars.usda.gov

Thomas ValcoCotton Tech Tran & Education Coordinator662-686-5255CTTEC@ars.usda.gov

Bryan Kaphammer – NPA / SPA970-229-5528Bryan.Kaphammer@.ars.usda.gov

Vic Chavez215-233-6610Vic.Chavez@ars.usda.gov

Joe Lipovsky – SRRC Assoc. TTC504-286-4355Joe.Lipovsky@ars.usda.gov

Technology Transfer Coordinators

Office of Technology TransferOffice of Technology Transfer

Office of Technology TransferOffice of Technology TransferPatent Advisors

Beth Sampson / Howard Owens – PWA510-559-6067 / 5731Esampson@ars.usda.govHowens@ars.usda.gov

Byron Stover - BA301-504-4783Byron.Stover@ars.usda.gov

Gail Poulos – SAA Robert Jones301-504-5302Gail.Poulos@ars.usda.gov

Albert Tsui – MWA & NPA309-681-6512Albert.Tsui@ars.usda.gov

Evelyn Rabin - MSA301 504-4781Evelyn.Rabin@ars.usda.gov

Albert Tsui – NPA309-681-6512Albert.Tsui@ars.usda.gov

Byron Stover –ERRC301-504-4783Byron.Stover@ars.usda.govEvelyn Rabin -- NAA301 504-4781Evelyn.Rabin@ars.usda.gov

Randy Deck – MWA & SPA309-681-6515Randy.Deck@ars.usda.gov

Richard BrennerAssistant Administrator (AA)

Martha SteinbockDeputy Assistant Administrator (DAA)

June Blalock AA

Tech Licensing CoordinatorJune Blalock AA

Tech Licensing Coordinator

Licensing StaffLicensing Staff

Brian NakanishiLicensing Specialist Brian NakanishiLicensing Specialist

Diana TuckerLicensing Specialist Diana TuckerLicensing Specialist

Kalpana ReddyLicensing Specialist Kalpana ReddyLicensing Specialist

Carla Boettinger Program AnalystCarla Boettinger Program Analyst

Deborah Penot Foreign Patent SpecialistDeborah Penot Foreign Patent Specialist

Dianne HoffmannLegal Instruments Examiner

Kim MeltonLicensing AssistantKim MeltonLicensing Assistant

Beltsville, MDBeltsville, MD

Byron StoverPatent Advisor (BA, ERRC & Chemical)

Vacant AA

Marketing Specialist Vacant AA

Marketing Specialist

Natasha SnuggsMarketing AssistantNatasha SnuggsMarketing Assistant

Marketing Marketing

Chulee “Pin” HarrisMarketing TechnicianChulee “Pin” HarrisMarketing Technician

CRADACRADAThomas Moreland DAA

Program AnalystThomas Moreland DAA

Program Analyst

Paula ReedExecutive AsstPaula ReedExecutive Asst

Executive Support StaffExecutive Support Staff

Kim GarnerProgram Support Asst.

Kate Baker DAA

Management AnalystKate Baker DAA

Management Analyst

Howard OwensPatent Advisor (PWA)Howard OwensPatent Advisor (PWA)

Sonya DomingoLegal Instruments ExaminerSonya DomingoLegal Instruments Examiner

Elizabeth SampsonPatent Advisor (PWA)Elizabeth SampsonPatent Advisor (PWA)

Albany, CAAlbany, CA Robin McCormick Legal Instruments ExaminerRobin McCormick Legal Instruments Examiner

Gernard LittlePatent AssistantGernard LittlePatent Assistant

Evelyn RabinPatent Advisor(NAA, MSA, & Biotech)

Gail Poulos AA

Supervisory Patent Advisor (SAA)Gail Poulos AA

Supervisory Patent Advisor (SAA)

Kelli GanttPatent AssistantKelli GanttPatent Assistant

vacantPatent AssistantvacantPatent Assistant

Patent StaffPatent Staff

Peoria, ILPeoria, IL

Albert TsuiPatent Advisor (MWA & NPA)Albert TsuiPatent Advisor (MWA & NPA)

Randy Deck Patent Advisor (SPA & MWA) Randy Deck Patent Advisor (SPA & MWA)

Sheri WhitehurstLegal Instruments ExaminerSheri WhitehurstLegal Instruments Examiner

Robert JonesPatent Advisor(SAA)

TTC StaffTTC Staff

Marcie Currie-GrossExtramural Agrmnts. Asst.Marcie Currie-GrossExtramural Agrmnts. Asst.

Annetta EbelharSecretaryAnnetta EbelharSecretary

Rob Griesbach DAA

BA, Tech Tran CoordinatorRob Griesbach DAA

BA, Tech Tran Coordinator

Dolores ShilkitusTech Tran Assistant Dolores ShilkitusTech Tran Assistant

Bryan Kaphammer DAA

NPA/SPA, Tech Tran CoordinatorBryan Kaphammer DAA

NPA/SPA, Tech Tran Coordinator

Don Nordlund DAA

SAA/MSA, Tech Tran CoordinatorDon Nordlund DAA

SAA/MSA, Tech Tran Coordinator

David Nicholson DAA

PWA, Tech Tran CoordinatorDavid Nicholson DAA

PWA, Tech Tran Coordinator

Jason BrayTech Tran AssistantJason BrayTech Tran Assistant

Vic Chavez DAA

NAA, Tech Tran CoordinatorVic Chavez DAA

NAA, Tech Tran Coordinator

Kristin KimballTech Tran Assistant Kristin KimballTech Tran Assistant

Thomas Valco DAA

Cotton Tech Tran & Education CoordThomas Valco DAA

Cotton Tech Tran & Education Coord

Renee Wagner DAA

MWA, Tech Tran CoordinatorRenee Wagner DAA

MWA, Tech Tran Coordinator

vacant Tech Tran Assistantvacant Tech Tran Assistant

Babette DavisSecretaryBabette DavisSecretary

Joe LipovskySRRC, Assoc. Tech Tran Coord.Joe LipovskySRRC, Assoc. Tech Tran Coord.

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.

ARS Policies and ProceduresDocumented in P & P 141.2 (revision in draft)

Policy / Procedural Issues for APHIS

Need to develop generic documentsCRADAs, MTAs, CAs

Properly delegate signature authorityCRADAs, MTAs, CA

Establish review & approval processesEthics clearanceProgram alignmentLine management issues

Develop and deliver training -- a critically important process

Policy / Procedural Issues for APHIS

Invention Disclosure Review Committee (?)Define agency policy on partnershipsRegulatory 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)

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

Mechanisms of Technology Transfer

Publication Trade Publication Seminars / Workshops Field Days Release of Public Plant Varieties

Management of Intellectual Property Rights (IPR)

Research Partnerships

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

Professional Services of ARS OTT – Tech Transfer CoordinatorsTraining 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 …

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

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)

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)

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)

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.)

Models for Developing and Transferring Technologies to the Private Sector

Background Invention(developed in USDA)

Seek PrivateSector Interest

For Commercialization

Marketing Section•Creates summary•Places on OTT website

LicensingSectionCorporate

response

Federal Register Notice

The CRADA Model for Developing and Transferring Technologies to the Private

Sector

Subject Invention(developed under CRADA)

CorporateResearch Need

ARS Scientist

Technology Transfer

Coordinator

Patent

Corporation negotiates license (no FR notice)

Cooperative Research & Development

Agreement (CRADA)

Manufacture &Market

Avoiding “Nightmare” CRADAs

CorporateResearch 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

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

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

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

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

Our Newest Tool for Partnerships

15 USC 3715Partnership 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.

Model of a Public/Private Partnership for Commercialization of Research Outcomes

Structural Assets and Financial Resources

Intellectual Capital

IntellectualAssets

IntellectualProperty

HumanCapital

Complementary Assets

ilitie

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.

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.

Richard J. Brenner, Ph.D.Assistant Administrator

Office of Technology Transfer5601 Sunnyside AveBeltsville, 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

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

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

of answering questions.

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

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

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

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

Cooperative Research and Development Agreement (CRADA)

Benefits to Firms:Access to ARS research capacityFirst right to negotiate Exclusive License for Subject

Inventions without FR noticeConfidentiality (competitive advantage)Opportunity to compete in global markets

Benefits to ARS:Results-Oriented Research/Impact

Market information

Identification of Licensee

Resources (For the Project)

CRADA Negotiations

USDA May Provide Any of the Above Except Money

Firms May Provide:ExpertiseMaterialsEquipment

EmployeesMoneyFacilities

CRADA PartnersMay 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

Rights to IP Depend On Source of Funding

Intellectual Property (IP) issues

Ownership results from inventorshipEmployment of inventors and/or source of

salary determine rights of ownershipCongressionally appropriated $$ disbursed

outside USDA through extramural agreements(Bayh-Dole Act)

Congressionally appropriated $$ for intramural federal research (Fed. Tech. Trans. Act)

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 ofintention 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.

Three “Subject Matter” Committees

Life Sciences

Chemical

Mechanical and Measurement

New ARS National Patent Committees (Oct. 2007)

Each cover all geographic Areas of ARSEach Area will have at least 2 members on each Committee, rotate at 5 years.

Advantages of ARS National Committees to Agency

Uniform committee recommendations across the AgencyCommittee 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

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?

InventionDisclosureSubmitted

Approval

2 Weeks

Committee

2-3 Months

Application Preparation

1 Year

Prosecution

2-3 Years

2-3 Months

Appeals

3-5 Years

The Patenting Process

Years 1 2 3 4

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!

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 patentDocumentation has strict legal

requirementsSigned & witnessed lab notebook pagesConsecutive numbered bound pages, single

line through errors (deletions) in data

Good Laboratory Notebook Practices

ARS Laboratory Notebooks are bound notebooks

AlwaysUse Official ARS

Laboratory Notebook(ARS FORM 1)

CRADAs: Active: 230New: 69 (record!)Amended: 76

Material Transfer Agreements: 884 (648 outgoing) (record!)Invention Disclosures: 133Patent Applications Filed: 114 (record!)Patents Issued: 27

Annual Report to Congress on Technology Transfer --- FY 2008 Metrics

Licenses: Active: 315 ( ~130 with universities)New: 27Biological 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

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

Goals of ARS Partnership Intermediaries

Provide complementary assets to ARS Office of Technology TransferGuide 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 3rd

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)

Goals of ARS Partnership Intermediaries

Provide complementary assets needed by private sector to succeed in commercializing federal inventionsAssist 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

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 ARSWork with ARS to host events to assist the business

community Provide services to ARS partners such as help with

business plans, licensing, etc.

Our Newest Tool for PartnershipsARS 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)

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 …

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

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 …

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 …

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)

100% natural fruit bars from fruit puree (Tara McHugh, PWA; HR Mountain Sun; “Gorge Delights”) (license, CRADA)

Helping people with peanut allergies: “Sunbutter”® (Harmeet Guraya / Isabel Lima, MSA; Red River Commodities) (CRADA)

Table grape varieties --(David Ramming, PWA; California Table Grape Commission)

(license & infringement)

Human nutrition /

food allergies /

obesity

Humane mouse bleeding lancet: “Goldenrod”® (W. Golde / P. Gollibin / L. Rodriquez, NAA; MEDipoint, Inc.)

(CRADA)

George Inglett, MWA(Oatrim, Z-trim, Nutrim,

Calorie-trim)

Tom Casey, Mark Rasmussen

Jacob Petrich (Iowa State U.), MWA

(CRADA)

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.

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