PLB143 - Lecture 20

In the end, how does all of this matter? (2) The origin of crops and what it tells us about ownership of biological resources


Presentation slides

Sources of information
a) Increased emphasis on Intellectual Property

  • Gepts, P. 2004. Who owns biodiversity and how should the owners be compensated? Plant Physiology 134:1295-1307  Pdf version   (© 2004 American Society of Plant Biologists)
  • Gepts P.  2002. A comparison between crop domestication, classical plant breeding, and genetic engineering. Crop Sci. 42: 1780-1790.  Pdf version  ( © 2002 Crop Science Society of America)
  • Pachico, D. 2001. Implementing farmers' rights in genetic resources: approaches to benefit sharing. Biopolicy journal 2001:Paper 1 (online). http://www.bioline.org.br/request?py01001
  • Dawkins K, Thom M, Carr C. Information about intellectual property rights No. 1.
    http://www.netlink.de:80/gen/biopiracy.html
  • Jondle RJ (1992) Legal aspects of varietal protection using molecular markers.
    Proc. Joint Plant Breeding Symposia Series, Nov. 1, 1992, Minneapolis, Minnesota.
    Crop Science Society of America: pp. 50-52
  • Kloppenburg J, Kleinman DL (1987) Seeds of struggle: the geopolitics of genetic
    resources. Technology review Febr./March 1987: 46-53
  • Kloppenburg J, Kleinman DL (1987) The plant germplasm controversy.
    BioScience 37: 190-198
  • Kloppenburg JR (1988) First the seed: the political economy of plant biotechnology.
    Cambridge Univ. Press, Cambridge, UK
  • Mooney PR (1983) The law of the seed: another development and plant genetic
    resources. Development Dialogue 1983 (1-2): 1-172
  • OECD (1996) Intellectual property, technology transfer and genetic resources. OECD, Paris
  • ETC group - Action Group on Erosion, Technology, and Concentration
  • U.S.D.A. Plant Variety Protection Office. http://www.ams.usda.gov/science/PVPO/PVPindex.htm
  • U.S. Patent and Trademark Office. http://www.uspto.gov/
  • IPWatchDog
  • Union for the Protection of New Plant Varieties. http://www.upov.int/index.html
  • Nagoya Protocol on Access and Benefit Sharing: http://www.cbd.int/abs/text/

b) The yellow bean patent and Plant Variety Protection (PVP) certificate

  • US Patent Office: Patent 5,894,079: Field bean cultivar named enola
  • USDA Plant Variety Protection Office: Enola Bean:
  • Pallottini, L., E. Garcia, J. Kami, G. Barcaccia, and P. Gepts. 2004. The genetic anatomy of a patented yellow bean. Crop Sci 44:968-977  Pdf version  ( © 2004 Crop Science Society of America)

c) "Terminator" technology



What are Intellectual Property rights? Miranda Santos

  • Property rights for intellectual endeavors, such as:
    • authorship of literature, music, etc
    • invention of new products or new processes
    • development of new cultivars, etc
    • Major differences between physical and intellectual property

Physical Intellectual
Perpetual Temporary: patent: 20 yrs.; PVP: 20-25 yrs
Tangible Intangible contents: e.g., distinction between grain and seed
Holds everywhere Only in those countries where title of property was awarded

Goal of an Intellectual Property legislation

  • create incentives and stimulate development of new technologies by providing financial returns for the investment made
  • what does the inventor get? exclusive rights for a period of time --> reward for investment
  • what does society get? new technology made public ("disclosure"); stimulus for further technological development by competition

Why increased emphasis on Intellectual Property rights for genetic resources?

New developments in last twenty years:
  • new technologies: biotechnology, emphasis on private sector: food, pharmaceutical, and seed companies
  • new markets: globalization of the world economy: e.g., free-trade agreements
  • new international treaties:
    • CBD: Convention on Biological Diversity: June 5, 1992 in Rio de Janeiro:
      • Article 1: Triple goal
        • conservation of biological diversity
        • sustainable use of its components
        • fair and equitable sharing of benefits from genetic resources, including appropriate access and transfer of relevant technology
      • Article 15: Confirmed principle of sovereign rights of states over their natural resources, including potential legislation
      • Articles 16 and 17: Technology transfer
        • licensing of proprietary technology
        • sharing of research and development results
        • training
        • protection
    • TRIPS: Trade-related Intellectual Property rights: April 15, 1994 in Marrakech
      • Obligation of members of WTO to provide patents for both products and process inventions in all fields of technology, provided they are:
        • new
        • involve an inventive step
        • capable of industrial application
      • Patents (or some other form of protection: sui generis) should be available and patent rights may be exercised without discrimination as to place of invention, field of technology, and whether products are imported or produced locally.
        • Term: 20 yrs.
        • Possibility to exclude plant and animal patents, essential biological processes
        • Review after 4 yrs (1999)
        • Burden of proof in patent infringement trials on manufacturer (and not owner of patent)
    • Revisions to UPOV convention: 1991
      • Plant variety protection (PVP): national legislations and international treaty (UPOV convention): first 1961; current version: 1978; most recent modifications: 1991
      • limit farmers' exemption: right to save seed to plant future crops and sell seeds; now: only saving seeds is allowed
      • maintains breeders' exemption but extends protection to "essentially derived" varieties: "although clearly distinguishable from the initial variety, conforms to the initial variety in the expression that result from the genotype."; can be obtained by selection of natural or induced mutants, somaclonal variants, backcrossing, genetic engineering, etc.
      • for self-pollinated varieties, F1 hybrid varieties, and tuber-propagated varieties
      • requires deposit of seed sample
  • New concept or principle: IP for living organisms or biological processes:
    • not novel nor non-obvious
    • decline in agricultural diversity: only patented varieties; focus on crops with major commercial value
    • limits national economic and social development strategies: e.g, many countries currently only allow patents on processes but not products (the latter being made available through "compulsory licensing"): induces national industries, through reverse engineering to develop own products
    • provides means for biotechnology companies to compete in world market place with substitutes for natural products: sugar, cocoa, plant oils
    • bioprospecting = biopiracy?: issue: how to reward not only inventors (recipients of biodiversity) but native farmers and indigenous people (donors of biodiversity)?

Example of the neem tree

  • Several extracts of the neem tree have recently been patented by U.S. (Grace, NPI) and Japanese (Terumo) companies. This action has been met with widespread protest in India from 
  • Uses of the neem tree
    • Medicine: bark, leaves, flowers, seeds; leprosy, diabetes, ulcers, etc.
    • Toiletry: oil for toothpaste and soap; twigs as antiseptic toothbrushes
    • Contraception: oil = spermicide; also by ascetics to abate their sexual desire
    • Timber: chemical resistance to termites
    • Fuel: lamp oil
    • Agriculture: insecticide; soil improvement; conservation tree on degraded soils







(from http://fisher.genfys.slu.se:80/pgen/
pichtm/azadf1.htm
and http://www.biochem.
gla.ac.uk:80/JHWeb/3H/SH96/Proj/Strang.html)

  • Role in the economy:
    • Since millennia (documents in sanskrit)
    • Villages: extraction of seed oil and insecticidal emulsion with inexpensive equipment
    • Small companies: pesticides, medicines, cosmetics
      • (under Indian law, agricultural and medicinal products are not patentable)
  • Patent controversy:
    • Neither azadirachtin nor any other active principles have been synthesized in the lab
    • Grace: claims it has developed a modernized extraction method: "Although traditional knowledge inspired the research and development that led to these patented compositions and processes, they were considered sufficiently novel and different from the original product of nature and the traditional method to be patentable "
      • Water solubility vs. traditional emulsion
      • More stable
    • Indians:
      • Indian Central Insecticide Board (1968): refused to register neem products: neem materials have been in use in India for various purposes since time immemorial, without any known deleterious effects
      • Indian Agricultural Research Institute: 1960s-1970s: research on extraction methods and pesticidal properties of neem
    • European Patent Organization:
      • Rescinded patent

The Enola yellow bean patent: "Field bean cultivar named enola," Patent No. 5,894,079

What is claimed is …
  • 1: A Phaseolus vulgaris field bean seed designated Enola as deposited with the American Type Culture Collection under accession number 209549.
  • 4: A field bean plant having all the physiological and morphological characteristics of the field bean plant of claim 2.
  • 5, 6, 7: Also claims progenies of crosses …
  • 8: A field bean variety of Phaseolus vulgaris that produces seed having a seed coat that is yellow in color, wherein the yellow color is from about 7.5 Y 8.5/4 to about 7.5 Y 8.5/6 in the Munsell Book of Color when viewed in natural light.
  • 10: The Phaseolus vulgaris of claim 9 wherein the hilar ring has a color of rom about 2.5 Y 9/4 to about 2.5 Y 9/6 in the Munsell Book of Color when viewed in natural light.
Munsell
Requirements for a patent:
  • Novel
  • Useful
  • Non-obvious
  • Enablement
Requirements for a Plant Variety Protection (PVP) Certificate:

  • Distinct
  • Uniform
  • Stable
  • Non-essentially derived
Does the "Enola" patent fit the requirements for patent?
  • Novelty?
    • Yellow beans are well known to bean researchers around the world
    • There are commercial bean classes with a yellow seed color in the centers of origin of beans: Voysest (2000)
    • Yellow beans have been documented in the U.S. since at least 1931:
      • Hedrick (1931): Sulfur bean
      • National Gardening (1992)
A collection of beans from the course instructor (Photo © Paul Gepts)

Bean seeds
Voysest (2000):  Voysest cover  , which includes the following photos  about commercial bean classes in Latin America  Yellow seeded commercial bean classes National Gardening Magazine (1992), with an article on heirloom beans, including yellow beans

National Gardening 1992

Gepts PhD thesis (U. of Wisconsin: 1984) with yellow beans
Gepts thesis yellow beans
  • Non-obviousness? = Inventiveness?
    • DNA fingerprinting (Pallottini et al. 2004)
      • Bean sample
      • DNA markers
Sample of beans, especially yellow beans: Enola (ATCC) is the pateneted yellow bean, Azufrado Pimono 78 and Azufrado Peruano 87 are yellow bean varieties developed by Mexican breeders, and Sulphur is an American heirloom variety (Fig. 1 from Pallotini et al. 2004)
Pallottini et al. 2004 Fig. 1
AFLP markers used for fingerprinting: their main advantage is their large number:
DNA markers
Results of the DNA fingerprinting: Enola is most closely related if not identical to Mexican yellow bean varieties, especially Azufrado Peruano 87  (Fig. 2 from Pallottini et al. 2004)
Result: Probability of an independent match in DNA fingerprint:
    • Range for breeding scenarios: 10^-5 to 10^-14
    • Range for selection within existing yellow seeded varieties: 10^-1 to 10^-2
Furthermore, other researchers have shown that the genes responsible for yellow color are the same as those in a variety described previously

Bassett et al. 2000
Inferences
  • The most likely origin of Enola is from an improved cultivar in Mexico, likely AP 87, based on probability calculations resulting from the data presented here
  • Enola does not satisfy the novelty and non-obviousness statutory requirements of the patent legislation.
  • It does not satisfy the distinctness and non-essential derivation requirements of the PVP legislation.

Current status of Enola patent
  • nRequest for Reexamination: 5,894,079, Reexam. S.N. 90/005,892, Dec. 20, 2000, Cl. 800/260, FIELD BEAN CULTIVAR NAMED ENOLA, Larry M. Proctor, Owner of Record: Pod-Ners, Inc., Delta, CO, Attorney or Agent: Dressler, Goldsmith, Milnamow & Katz. Ltd., Chicago, IL, Ex. Gp.: 1638, Requester: The International Center for Tropical Agriculture (CIAT),John Dodds, Dodds and Associates, Washington, DC
  • Reissue Applications Notice: 5,894,079, Re. S.N. 09/773,303, Jan. 31, 2001, Cl./Sub 800/313, FIELD BEAN CULTIVAR NAMED 'ENOLA' Larry M. Proctor, Owner of Record: Pod-ners, LLC, Delta, CO, Attorney or Agent: Emery L. Tracy, Ex. Gp: 1638

Issues

  • nForeign sources of materials
    • Convention on Biological Diversity
    • TRIPS (WTO)
    • International Treaty on Plant Genetic Resources for Food and Agriculture
  • Burden of proof
    • Scientific data?
  • What type of protection? 
    • Plant Variety Protection 
      • Breeders and farmers exemption 
    • Patent: 
      • Plant 
      • Utility: no breeders nor farmers exemption 
  • Gains from royalties or from increased productivity?


Other controversial patents
Ehlers & Sterner 2000: Bean-nut popping beans, Patent No. 6,040,503

What is claimed is:
….
9. A bean seed produced by a cross of a nuna accession and a Phaseolus vulgaris cultivar exhibiting the characteristics of early maturity, bush type growth habit, synchronous fruiting, and photoperiod insensitivity, wherein said bean pops at a moisture of about 5 to 12 percent.
10. A bean seed of claim 9, wherein said nuna accession is selected from the group consisting of accession numbers W6 4296, W6 4297, W6 4298, PI 298820, PI 298822, PI 298824, PI 316013, PI 316014, PI 316016, PI 316017, PI 316018, PI 316019, PI 316020, PI 316021, PI 316022, PI 316023, PI 316024, PI 316025, PI 316029, PI 316030, PI 316031, PI 316032, PI 390771, PI 390775, PI 511763, PI 511767, PI 531862, PI 577677, PI 577678, PI 577679, PI 577680, PI 577682, and PI 608402.
11. A bean seed of claim 9, wherein said Phaseolus vulgaris cultivar is selected from the group consisting of small white, small red, navy, dark red kidney, light red kidney, black or black turtle, pink, pinto, cranberry, and canario.
………………
A Bolivian family who grew an extraordinary mixture of popping bean seeds

Bolivian family 

Popping bean seed   

How to reward farmers and indigenous people?

  • 1970s, 80s: Less developed countries expressed concern: asymmetric flow of germplasm:
    • South to North: free
    • North to South: cost: patented varieties
  • Forum: FAO:
    • 1983: - Commission on Plant Genetic Resources (now Commission on Genetic Resources for Food and Agriculture); one country = one vote
    • International Undertaking on Plant Genetic Resources: non-binding, international agreement:
      • "ensure that genetic resources of economic or social interest, particularly for agriculture, will be explored, preserved, evaluated and made available for plant breeding and for scientific purposes."
      • important principle: " genetic resources are a heritage of humanity and should therefore be available without restrictions."
      • reservations from industrialized nations (with large seed or biotechnology industry)
    • 1989: Annexes to the Undertaking:
      • 4/89: Farmers' Rights: recognizes the right of farmers to be compensated for developing and conserving plant genetic resources (now also acknowledged by CBD)
      • 5/89: Plant Breeders' Rights
    • 1991: 3/91: Sovereign rights of nations to determine how to preserve, protect and be compensated for innovations utilizing their native plant genetic resources (also acknowledged by CBD)
    • 1993: Initiate revision of the Undertaking:
      • incorporate annexes & harmonize with CBD
      • assure farmers' rights
      • legally binding agreement
    • 2004: Entry into force of International Treaty on Plant Genetic Resources for Food and Agriculture
  • Difficulties with assigning farmers' rights:
    • Who should be rewarded?:
      • Region of domestication: interdependency
      • Who domesticated in center of domestication?
        • "There are at least 30 million indigenous peoples in the Southeast Asian Centre of crop diversity, including the Montagnard, Meo, Javai, Asmat, Amungme, Penan, Arakenese, Chin, Kachin, Karen, Pelaung, Shan, Bangsa Moro, Bontoc, Hanunoo Ibaloy, Ifugao, Isneg, Kalinga, Kankai, Akha, Hmong, Lahu and Lisu. Collectively, they have domesticated 15 global crops including sugar cane, banana, and coconut."
        • In the Mesoamerican centre of crop biodiversity the Borocua, Bribri, Guatuso, Lenca, Pipile, Chol, Chuj, Kekchi, Quiche, Chorti, Miskito, Mixe, Tarahumara, Yaqui, Lacandon, Yucatec, Huichol, Nahual, Zapotec, Rama, Sumu, Wuanana, Embera, Guaymi and Kuna peoples, among others, collectively domesticated maize (corn), beans, cassava, sweet potatoes and 12 other food and industrial crops. At least 13 million indigenous peoples continue to harvest and protect Mother Earth's diversity and richness in the Mesoamerican centre." (Cultural Survival Canada)
        • Reward of country, group, village?
      • Amount of reward?

How to reward private companies? The "terminator" technology?

Also called "Technology protection system" or "Inducible, delayed-gene expression technology "

Patent 5,723,765

  • Co-owners: USDA, Delta and Pine Land Co.
    • D & P LC purchased by Monsanto (85% of US cotton seed market)
  • Three-gene system, either in single line or hybrid
  • Conditional, tissue-specific, delayed gene expression
  • Research expenses:
    • USDA: $ 190,000
    • D & P Land Co.: $ 530,000
  • UK patent to Zeneca: "Verminator"

Example: Lethal seed production






Terminator cartoon

Standpoint of Seed Companies

  • Make farmers return each growing season for new seed
  • Reproductive system: heterosis decay; control over inbred parent
  • Legal way: lawsuits for farmers saving and planting 2nd generation seed
  • Gene expression: lethal seeds ("Terminator")
  • Potential further developments:
    • Activate positive features or deactivate negative features with proprietary chemicals ("Terminator II or "Traitor")


1996 Monsanto Roundup-Ready Gene Agreement

  • Purchase of Roundup-ready soybeans
  • $ 5/bag "technology fee"
  • Right of Monsanto to inspect and test fields for 3 years
  • Use only Monsanto's brand of Roundup
  • May not save/replant seed
  • May not sell or supply seed to others
  • Similar for cotton and potentially other crops

Standpoint of Critics : Who are they?

  • Rural farmer advocates: e.g., ETC, PAN
  • Developing countries: e.g., India
  • CGIAR
  • Corporate watchdogs: e.g., Corporate Watch

Criticisms

  • Increasing corporate control over food production
  • USDA in patent business
  • Escape into surrounding plant vegetation
    • Incompletely efficient inducer treatment
    • Large scale
    • Gene flow even with autogamous plants
  • Effect of toxins on secondary organisms
    • Insects, etc.
  • Effect of tetracycline on beneficial microbes
    • External and internal symbionts
  • Seed composition and physiology


For a gene-rich country, is it better to promote free exchange of biodiversity or to insist on royalties?
Pachico 2001
  • System of royalties:
    • Net positive income:
      • Mexico, Central America, Andean South America
      • Europe
    • Net payments:
      • Brazil, USA/Canada, Sub-Saharan Africa
  • Gains from productivity increases through germplasm utilization
    • 7x to 66x higher than those from royalty payments
    • Even countries with positive income from royalties have generally larger incomes from improved germplasm obtained by exchange
The emphasis on intellectual property rights for biodiversity generally has a chilling effect on exchange with probable negative effect on biodiversity study and utilization, for example in plant breeding.

Breeding steps

(Gepts 2002)

General issues  (Gepts 2004)

  • Should living organisms and any of their constituting parts (including genes) be subject matter of IPRs?
  • Will reliance on IPRs (including the current Western-style IPRs and any alternative system that may be developed for collective, multi-generation inventions associated with local and indigenous groups) assure efficient conservation and utilization of biodiversity?
  • Will states and local indigenous groups have to intervene to assure that their cultural and ethical values are maintained? Will a different set of rights have to be developed to assure control over biodiversity resources and cultural knowledge?
  • Are the non-utilitarian functions of biodiversity, such as ecosystem health and function as well as its esthetic role, well served by a IPR regime?
  • Because biological and cultural diversity are inextricably linked, can legal and economic frameworks be instituted that address the conservation of both types of diversity?
  • Will the current IPR-driven regime for biodiversity primarily benefit the most powerful actors in the debate, i.e., transnational pharmaceutical and biotechnology companies and their respective governments, or will both sides benefit?