Symposium Process for IP Management_ Cultivar Release_ and Licensing by malj

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									Symposium: Process for IP
Management, Cultivar Release, and
Licensing
Gulf Coast Research and Education Center, Balm, Florida
August 6, 2012

 John C. Beuttenmuller
 Executive Director
 Florida Foundation Seed Producers, Inc.
Discussion Topics
   How the Process Works:
    ◦   Cultivar Development
    ◦   Cultivar Release
    ◦   Intellectual Property Protection
    ◦   Licensing
    ◦   Royalty Distribution
   Results of 2012 Peer Survey
Bayh-Dole Act (35 U.S.C. § 200-
212)
   Act sponsored by:
    ◦ Senators Birch Bayh (Indiana), Bob Dole
      (Kansas)
 Enacted by U.S. Congress in 1980
 Allowed U.S. universities and other
  recipients of federal research funds to
  own, license, and manage intellectual
  property created through federally
  funded research
Bayh-Dole Act (35 U.S.C. § 200-212)
    "Unless private industry has the
 protection of some exclusive use under
 patent or license agreements, they cannot
 afford the risk of commercialization
 expenditures. As a result, many new
 developments resulting from government
 research are left idle."
   - Senator Birch Bayh
    Introductory Statement, September 13, 1978
Bayh-Dole Act (35 U.S.C. § 200-212)
   Prior to 1980, only 250 patents had been
    issued to U.S. universities
    “Bill designed to promote signed to promote the utilization and
    commercialization of inventions made with government support ...
    Ultimately, it is believed that these improvements in government
    patent policy will lead to greater productivity in the United States,
    provide new jobs for our citizens, create new economic growth,
    foster increased competition, make government research and
    development contracting more competitive, and stimulate a
    greater return on the billions of dollars spent each year by the
    Government on its research and development programs.”
         - Senate Judiciary Committee Report on S. 414, unanimously
         approved and reported to the Senate, December 12, 1979
University of Florida:
Intellectual Property Policy
   Research conducted        by   University
    personnel
    ◦ Patentable inventions and other marketable
      forms of intellectual property result
   Obligation to serve the public interest by
    insuring that intellectual property is
    appropriately developed
University of Florida:
Intellectual Property Policy
 Encourage and enable technology
  development and transfer for benefit of
  the public
 Encourage the creation of technology by
  providing incentive to inventors
 Fund further research at the University
University of Florida:
Intellectual Property Policy
   Inventions of germplasm and cultivars in
    which the University asserts its interests
    (other than those protected by utility
    patents) are assigned to Florida
    Foundation Seed Producers, Inc. (“FFSP”)
    ◦ FFSP is a Florida non-profit corporation and
      direct support organization (DSO) of the
      University of Florida
University of Florida:
Intellectual Property Policy
   All other inventions (mainly protected
    under U.S. utility patents) in which the
    University asserts its interests are assigned
    to the University of Florida Research
    Foundation, Inc. (“UFRF”) and managed by
    the Office of Technology Transfer
    ◦ Similar to FFSP, UFRF is a Florida non-profit
      corporation and direct support organization
      of the University of Florida
     University of Florida:
     Intellectual Property Policy
                               University of Florida


Plant Germplasm
  and Cultivars                                              All Other University
 (Plant patents,                                              Inventions (Utility
  plant variety                                                    patents,
   protection                                                  copyrights, etc.)
certificates PVP)




                                                       University of Florida
         Florida Foundation
                                                       Research Foundation,
        Seed Producers, Inc.
                                                           Inc. (UFRF)
    UF/IFAS Plant Breeding Programs
26 Plant Breeding Scientists       DIVERSITY        Wide Array of Different Crops
         Aglaonema               Forestry         Soybean
         Alfalfa                 Gerbera          St. Augustinegrass
         Anthurium               Gladiolus
                                                    Strawberry
         Apple                   Grape
         Bahiagrass              Lisianthus       Tomato
         Beans                   Nectarine        Triticale
         Bermudagrass            Oats             Tropical Fruit
         Blueberry               Paspalum         Wheat
         Caladium                Peach
                                                    White Clover
         Centipedegrass          Peanut
         Citrus                  Plum             Zoysiagrass
         Coleus                  Pumpkin
         Corn                    Red Clover
         Cucurbits               Rye
         Dieffenbachia           Ryegrass
         Floral                  Sorghum
Plant Breeding Process
   Various methods uses to develop new
    plant germplasm
    ◦   Mass selection (e.g. annual ryegrass)
    ◦   Hybridization (e.g. tomato)
    ◦   Backcrossing (e.g. peanut)
    ◦   Mutagenesis (e.g. aglaonema)
    ◦   Somaclonal variation (e.g. sweet orange)
Plant Breeding Process
   Through several generations of selection,
    the breeder identifies genotypes within
    populations that have improved
    characteristics such as:
    ◦   Disease resistance
    ◦   Yield
    ◦   Flavor, color, habit
    ◦   Time of maturity
UF/IFAS Cultivar Release Process
   General Guidelines
     New cultivar shall have potential to make a
      significant contribution to Florida agriculture
      and/or the general public.
      i.e. - increased yield potential, disease resistance,
       extend market window
     Do advantages over existing cultivars
      outweigh disadvantages?
     Are growers likely to use the new cultivar?
UF/IFAS Cultivar Release Process
1.        Novel plant variety developed by UF/IFAS
          plant breeder
2.        Plant breeder notifies Department Chair
3.        Department Chair convenes Cultivar
          Release Advisory Committee (CRAC)
     a.    Evaluate proposed release in regards to its intended
           purpose(s)
     b.    Provide scientific scrutiny of data, etc.
     c.    Recommend form of IP protection (plant patent,
           utility patent, PVP, public release)
4.        CRAC makes recommendation to the
          UF/IFAS Cultivar Release Committee (CRC)
UF/IFAS Cultivar Release Process
5.    IFAS Cultivar Release Committee (CRC)
      reviews CRAC recommendation and
      considers the cultivar for release
6.    CRC votes in favor of release
7.    Director of FAES approves release
8.    Intellectual property protection filed
9.    Licensed through Florida Foundation Seed
      Producers, Inc.
     ◦ Exclusively – ITN Process – or –
     ◦ Non-exclusively
Florida Foundation Seed
Producers, Inc. (FFSP)
 1943 – Florida Crop Improvement
  Association (FCIA) formed as an
  agricultural cooperative (501(c) 5)
 1957 – FCIA became FFSP
Florida Foundation Seed
Producers, Inc. (FFSP)
   Purpose:
    ◦ To annually provide to Florida producers of
      crop seed and nursery stock, foundation seed
      stocks of the best known varieties adaptable
      to Florida climate and soils in adequate
      quantities at reasonable prices
    ◦ To cooperate with the Agricultural
      Experiment Stations, University of Florida, in
      making available new varieties
Florida Foundation Seed
Producers, Inc. (FFSP)
   1979
    ◦ FFSP becomes direct support organization
      (DSO) of the University of Florida
      Non-profit corporation to utilize resources of the
       University of Florida to conduct its business in
       support of the University.
Intellectual Property
Protection for Plant Varieties
   USA
    ◦ Plant patent
      Administered by United States Patent and
       Trademark Office (USPTO)
      Granted to novel, distinct, and non-obvious plant
       varieties which are asexually reproduced
        E.g. blueberry, strawberry, gerbera, vegetatively propagated
         turfgrass
Intellectual Property
Protection for Plant Varieties
   USA
    ◦ Plant Variety Protection Certificate (PVP)
      Administered by United States Department of
       Agriculture (USDA)
      Granted to novel, distinct, uniform, and stable
       varieties which are sexually reproduced
        E.g. peanut, oats, bahiagrass, wheat, tomato
Intellectual Property
Protection for Plant Varieties
   USA
    ◦ Trademarks
      Administered by USPTO
      Don’t protect varieties – only marks used in
       combination with certain goods or services to
       identify such goods and services as unique and
       distinguishable.
        E.g.:
Intellectual Property
Protection for Plant Varieties
   USA
    ◦ Utility Patents
      Administered by USPTO
      Granted for a new and useful process, machine,
       article of manufacture, or composition of matter,
       or any new and useful improvement thereof.
        E.g.: High oleic peanuts and peanut products
Intellectual Property
Protection for Plant Varieties
   International
    ◦ Plant Breeder’s Rights
      Each foreign country administers its own legislation
       which provides PVP-like protection to new
       varieties of plants
      International Union for the Protection of New
       Varieties of Plants (UPOV)
        Established in 1961 to encourage the development of new
         varieties of plants for the benefit of society
        70 signatory countries to the UPOV convention
Intellectual Property
Protection for Plant Varieties
   International
    ◦ If international protections are not sought,
      plant varieties become part of the public
      domain in foreign territories
    ◦ A variety can be protected under U.S. plant
      patent or PVP and licensed domestically, but
      this protection only governs the use and
      commercialization of such variety in the U.S.
Intellectual Property
Protection for Plant Varieties
   International
    ◦ It is not cost effective to file plant breeders
      rights in all territories – only file where there
      is potential for commercialization of such
      variety within the territory
    ◦ Through international protection and
      licensing, royalties can be returned to Florida
      to support the continued development of
      varieties in the State of Florida
FFSP’s Licensing Process
   Mission
    ◦ Advance the mission of UF/IFAS and the
      Florida Agricultural Experiment Station and
      the plant breeding programs for the benefit of
      the public
FFSP’s Licensing Process
   Non-exclusive licensing
    ◦ Multiple companies (nurseries, seed
      companies, producers, etc.) offered license
      agreements for production and sale
   Exclusive licensing
    ◦ IFAS implemented Invitation to Negotiate
      (ITN) process in 2006
    ◦ Scope of exclusivity – structure of industry
Invitation to Negotiate:
What is an ITN?
 A public call for interested parties to
  submit proposals for an exclusive license
  of a new cultivar developed by UF/IFAS
 An opportunity for parties who have an
  interest in a new cultivar developed by
  UF/IFAS to comment and provide input
  regarding the commercial licensing of a
  new cultivar
 Three Principles of the ITN
          Process
1. What is good for ….
          the State of Florida and its people?


2. What is good for…
           the University of Florida - IFAS?


3. What is good for …
      the breeder and the breeding program?
How are Proposals Evaluated?
   Consistent methodology is used to
    evaluate all proposals, in the following
    primary areas:
    ◦   Marketing plans and goals
    ◦   Production plans and goals
    ◦   Financial considerations
    ◦   Intellectual property protection
    ◦   Prior experience with UF/IFAS/FFSP
ITN Review Committee
   Members:
    ◦ FFSP Representatives:
      Executive Director
      Licensing Associate
    ◦ Lead Breeder
    ◦ Independent UF/IFAS Breeder
    ◦ Statewide Research Program Leader (when
      applicable)
   Committee makes recommendation to
    Director of FAES
Who Benefits?
   Industry
    ◦ All interested companies are considered fairly
      and objectively
    ◦ The process provides an opportunity for industry
      representatives such as trade groups/associations
      to comment on the licensing of new IFAS
      cultivars
   Breeding Program
    ◦ Maximizes exposure of new cultivars developed
      by IFAS breeding programs
    ◦ The process provides the breeder a means of
      objectively evaluating commercial license
      proposals
Who Benefits?
   UF/IFAS
    ◦ Proposals submitted help UF/IFAS and FFSP select a
      commercial partner whose vision is consistent with
      the goals of UF/IFAS for the new cultivar
    ◦ Comments submitted in response to the ITN help
      UF/IFAS and FFSP select the right partner and allow
      FFSP to negotiate the most appropriate license terms
   State of Florida
    ◦ Stakeholders are assured that an exclusive
      arrangement is granted to the commercial partner
      that has been identified as having a vision consistent
      with the best interests of the State of Florida and its
      people, UF/IFAS and FFSP, and the breeding program
Royalty Distributions for Cultivars
and Germplasm (FFSP)
 ◦ Costs deducted prior to distribution (patent
   and legal expenses, etc.)
   10% retained by FFSP
   20% personal incentive to inventors/cooperating
    scientists
   70% to Cultivar Development Research Support
    Program
Royalty Distributions for Cultivars
and Germplasm (FFSP)
   Cultivar Development Research Support
    (70%), calculated annually on a per cultivar
    basis
      100% of first $50,000 goes to the breeding program
      Next $100,000 goes 50% to the breeding program, 25%
       to the Unit, and 25% to the FAES
      All revenues above $150,000, 33% to the breeding
       program, 33% to the Unit, and 33% to the FAES
   Unit and FAES funds used for long-term
    support and sustainability of UF/IFAS plant
    breeding efforts
Royalty Distribution:
Sustainable Plant Breeding
Why License and Collect
Royalties?
   Royalties have the potential to:
    ◦ Cover the costs of development, IP protection
    ◦ Continue plant breeding programs to ensure that
      local industries remain competitive in an increasingly
      global marketplace through the development of new
      plant cultivars
       Success is dependent upon % of royalties which are
        returned to the developing plant breeding program vs.
        general university research, etc.
Why License and Collect
Royalties?
   Licensing allows for           extremely      efficient
    technology transfer
    ◦ Maximize availability of new plant varieties which often
      have superior characteristics which lead to direct
      benefit to the grower
    ◦ Creates incentive to remain competitive
    ◦ UF/IFAS succeeds when the grower succeeds
    Royalty Distribution:
    Sustainable Plant Breeding
   UF policy encourages and enables the
    development of commercially successful plant
    varieties and the transfer of these varieties to
    industry for the benefit of the agricultural sector
    and the general public in Florida, the U.S., and
    abroad
   As funding for plant breeding programs at land
    grant universities has decreased, many of these
    programs have become reliant on royalty
    returns for their survival
    2012 Peer Review Survey
   U.S. land grant universities and research
    programs (USDA/ARS) with active plant
    breeding programs surveyed
   17 questions
    ◦ Focuses:
        Cultivar release processes
        Breadth of plant breeders and programs
        Licensing processes
        Royalty distribution
    2012 Peer Review Survey
   Respondents:
    ◦ Rutgers University, University of Wisconsin, Auburn
      University, Iowa State University, Washington State
      University, North Carolina State University, University
      of Arkansas, USDA/ARS, Oregon State University,
      University of California Davis, University of Georgia,
      and Louisiana State University
    2012 Peer Review Survey
   Does your institution license released plant
    varieties and germplasm exclusively, non-
    exclusively, or both?

    ◦ 100% of institutions license both exclusively and non-
      exclusively.
    2012 Peer Review Survey
   How does your institution decide whether
    released plant varieties and germplasm are
    licensed exclusively or non-exclusively?
    ◦ UF: Decisions relative to plant variety licensing are
      made by FFSP based on guidance and
      recommendations of UF/IFAS plant breeders,
      academic department chairmen, and other
      representatives who serve on the UF/IFAS Cultivar
      Release Committee and the UF/IFAS Cultivar Release
      Advisory Committees.
    2012 Peer Review Survey
   How does your institution decide whether
    released plant varieties and germplasm are
    licensed exclusively or non-exclusively?
    ◦ Survey: most all respondents indicated that these
      decisions are made at the institution’s cultivar/variety
      release committee level with input sought from the
      office of technology transfer/licensing agent
    ◦ Exclusive arrangements are often sought when
      specialized marketing effort is required
    2012 Peer Review Survey
   How are royalty rates, license fees, and annual
    minimum royalty rates for plant varieties and
    germplasm established?
    ◦ UF: Financial terms of license agreements are based
      on reasonable royalty rates which are generally
      accepted within a particular industry. FFSP analyzes
      the royalty rates of other proprietary plant varieties
      which have been developed, released, and licensed by
      other U.S. land grant institutions so that its royalty
      rates are comparable to those of others.
    2012 Peer Review Survey
   How are royalty rates, license fees, and annual
    minimum royalty rates for plant varieties and
    germplasm established?
    ◦ Survey:
      Historical precedent, industry standards, rates of other
       varieties
      Margins,
      Market approach - what market will bear?
      Advice of inventor, internal release and licensing committees
    2012 Peer Review Survey
   What process (e.g. ITN, bid solicitation, etc.) does
    your institution use to announce exclusive license
    opportunities? How are respondents evaluated?
    ◦ UF: ITN
    ◦ Survey:
       Bid solicitation – bids evaluated by committee (evaluate on
        multiple criteria)
       No announcement – seek out industry leaders
       Classified Ad and Federal Register posting
       Mostly for international
       Variety release/licensing committee evaluates
    2012 Peer Review Survey
   Are licenses granted internationally as well as
    domestically? If so, are both non-exclusive and
    exclusive licenses pursued for both?
   UF:
    ◦ Yes. Typically, international territories are licensed
      exclusively - exclusive licensee has increased
      capabilities and incentives to protect, market, trial,
      develop, and enforce the intellectual property
      protection of the licensed plant varieties. Both
      exclusive and non-exclusive licensing models are
      pursued domestically.
    2012 Peer Review Survey
   Are licenses granted internationally as well as
    domestically? If so, are both non-exclusive and
    exclusive licenses pursued for both?
   Survey:
    ◦ All respondents that have international demand and
      interest license internationally
    ◦ Most all license exclusively overseas
    ◦ A few predominately license only non-exclusively
      domestically, but the majority license both exclusively
      and nonexclusively, domestically and internationally
    2012 Peer Review Survey
   For international licensing, how does your
    institution reflect the equity position of in-state
    stakeholders versus out-of-state and foreign
    companies?
   UF:
    ◦ 1) Given the first opportunity to evaluate, license, grow, market,
      and commercialize plant varieties developed and released by
      UF/IFAS
    ◦ 2) In-state stakeholders benefit directly and indirectly from the
      extensive research and extension efforts carried out by UF/IFAS
      research and extension faculty
    2012 Peer Review Survey
   For international licensing, how does your
    institution reflect the equity position of in-state
    stakeholders versus out-of-state and foreign
    companies?
   UF (cont.):
    ◦ 3) In-state stakeholders are granted license agreement
      terms which are no less favorable than the terms extended
      to out-of-state and foreign companies
    ◦ 4) During times of short supply of plant material,
      preference is given to in-state producers
    2012 Peer Review Survey
   For international licensing, how does your
    institution reflect the equity position of in-state
    stakeholders versus out-of-state and foreign
    companies?
   Survey:
    ◦ Some have preferential/reduced royalty
    ◦ In-state research and extension efforts
    ◦ Reinvestment of international royalties into in-state
      programs
    2012 Peer Review Survey
   For international licensing, how does your
    institution reflect the equity position of in-state
    stakeholders versus out-of-state and foreign
    companies?
   Survey (cont.):
    ◦ Protection sought to ensure that royalties can be collected
    ◦ Delayed international licensing (timing of access, 2-5 years,
      crop dependent)
    ◦ Allocation of limited stocks to in-state producers first
    2012 Peer Review Survey
   For international licensing, what does your
    institution do (if anything) to manage
    competition between foreign producers and in-
    state growers/producers?
   UF:
    ◦ Provided first access to commercialize new varieties
    ◦ Generally granted preferential financial terms (e.g. a lower
      per plant based royalty, no production based royalty, etc.),
      thus giving these in-state growers/producers a competitive
      advantage over foreign producers.
    2012 Peer Review Survey
   For international licensing, what does your
    institution do (if anything) to manage
    competition between foreign producers and in-
    state growers/producers?
   Survey:
    ◦ First access, terms structured to provide in-state industry
      with a competitive advantage
    ◦ Delayed international licensing
2012 Peer Review Survey
2012 Peer Review Survey
2012 Peer Review Survey
2012 Peer Review Survey
2012 Peer Review Survey
    2012 Peer Review Survey
   Does your institution have an intellectual
    property rights office or other affiliated
    organization (e.g. crop improvement association,
    foundation seed program) that deals with plant
    patents/PVPs, plant variety and germplasm
    licensing or other revenue-generating
    mechanisms?
   UF:
    ◦ Office is within foundation seed organization (FFSP)
    2012 Peer Review Survey
   Does your institution have an intellectual
    property rights office or other affiliated
    organization that deals with plant patents/PVPs,
    plant variety and germplasm licensing or other
    revenue-generating mechanisms?
   Survey:
    ◦ 10 are within central university/research administration office
      (e.g. research foundation)
    ◦ USDA/ARS – ARS Headquarters; University of Arkansas – in
      Experiment Station; Iowa State – Research Foundation and Crop
      Improvement/Foundation Seed
    2012 Peer Review Survey
   Number of full-time equivalent (FTE) staff
    handling intellectual property rights for plant
    varieties in calendar year 2011.
   UF:
    ◦ 2.25
   Survey:
    ◦ Average: 2.45 FTE(s) per institution
    2012 Peer Review Survey
   How are unreleased experimental lines and
    germplasm exchanged or transferred to other
    organizations?
   Transfer to other U.S. public research
    institutions:
    ◦ UF: MOU or MTA used and UBMTA used
    ◦ Survey:
      100% use MOUs or MTAs
      31% use license agreements
      54% use the Uniform Biological Materials Transfer Agreement
       (UBMTA)
    2012 Peer Review Survey
   How are unreleased experimental lines and
    germplasm exchanged or transferred to other
    organizations?
   Transfer to U.S. private companies:
    ◦ UF: MOU or MTA used
    ◦ Survey:
      92% use MOUs or MTAs
      54% use license agreements
      23% use the Uniform Biological Materials Transfer Agreement
       (UBMTA)
    2012 Peer Review Survey
   How are unreleased experimental lines and
    germplasm exchanged or transferred to other
    organizations?
   Transfer to international research institutions:
    ◦ UF: MOU or MTA used
    ◦ Survey:
       100% use MOUs or MTAs
       31% use license agreements
       23% use the Uniform Biological Materials Transfer Agreement
        (UBMTA)
    2012 Peer Review Survey
   How are unreleased experimental lines and
    germplasm exchanged or transferred to other
    organizations?
   Transfer to international private company:
    ◦ UF: MOU or MTA used
    ◦ Survey:
      92% use MOUs or MTAs
      54% use license agreements
      23% use the Uniform Biological Materials Transfer Agreement
       (UBMTA)
2012 Peer Review Survey
2012 Peer Review Survey
    2012 Peer Review Survey
   Takeaways from survey:
    ◦ UF and FFSP are very similar to other institutions in
      the use of exclusive and non-exclusive license
      agreements and the method for establishing royalty
      rates
    ◦ The UF and FFSP process of seeking and evaluating
      potential exclusive licensees is formal but not
      drastically different from the processes (bid
      solicitations, etc.) used by others
    2012 Peer Review Survey
   Takeaways from survey (cont.):
    ◦ UF/FFSP has the most aggressive royalty reinvestment
      policy for plant breeding research program support
      (70%)
      WSU is equivalent for seed crops
    ◦ FFSP has the lowest overhead rate (10%) of all
      institutions surveyed – allows for maximization of
      research program support
    ◦ UF/FFSP is unique in that plant variety licensing is
      managed by the foundation seed organization
Symposium: Process for IP
Management, Cultivar Release, and
Licensing
Gulf Coast Research and Education Center, Balm, Florida
August 6, 2012

 John C. Beuttenmuller
 Executive Director
 Florida Foundation Seed Producers, Inc.

								
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