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Laura
Karanja
PRESENTED AT KALRO-NJORO 28.9.2015
 Objectives
 Introduction – True case histories
 An overview of International Regulatory
Framework
 Genetic resources and IP protections relevant
to KALRO
 What can KALRO borrow to improve their IPR
Protection
 To give an overview of the International
Regulatory Framework and implementation on
the Genetic Resources
 To understand the IPR associated with genetic
resources and their management
 Reflect over regulatory options from which
KALRO could borrow for future
 To help each other to recognize the importance
of managing intellectual properties
Case history 1: Starch “Gene”
(US)
 Researcher isolates genetic material
that increases production of starch in
potatoes
 Colleague from industry visits
 Researcher “loans” “gene”
 Company patents and restricts
access
 Researcher not able to work with
“gene” as anticipated
Case history 2: Malaria treatment
 Researcher discovers unique treatment
(India)
 University administrators tell researcher
to do whatever he wants with the idea
 Administrators urged to take steps to
help
 Researcher asks for assistance from
others, none received
 Publishes the study and the unique
treatment is not being used
 Intellectual Properties Are:
 IDEAS
 Ideas! IDEAS!
 Word or phrase
 Books/Protocols/Recipes
 Symbol
 Invention
 Biotechnology innovation
 New plant variety
 CBD /ABS= Convention on Biological diversity
1992/93/Access and Benefit sharing
 TRIPS = Trade Related Intellectual Property
Rights/WTO,1994/95
 FAO-IT-PGRFA = FAO International Treaty for Plant Genetic
Resources for Food and Agriculture, 2001/2004
 UPOV = International Union for the Protection of Plant Varieties,
1991/97
 WIPO –IGCGRTKF/Nagoya = World Intellectual Property
Organization; Inter-Governmental Committee on Genetic
Resources, Traditional Knowledge and Folklore, 2000
 Biosafety protocol = Cartagena, 2002
 IPPC = International Plant Protection Convention, 1997
 GDCT = Global Diversity Conservation Trust)
 PCT – Patent Cooperation Treaty
Minimum common denominators?
 Access
 Knowledge
 Innovation
The FAO-IT-PGRFA, CBD, TRIPS, UPOV, WIPO-
IGC etc
• They provide: New legal boundaries =
freedom to operate/innovate -under
different regimes- for a range of biological
material
 Genetic Resource and their importance
 CBD/ABS
 FAO –ITPGRFA
 UPOV
 Institutional IP policies/management practices
• Genetic resources have historically been
considered to be freely available.
• In 1983, the UN Food and Agriculture
Organization (FAO) proposed that ‘plant genetic
resources are a heritage of mankind and
should be available without restriction.
• Developing countries with abundant genetic
resources voiced their opposition to the way
resources were treated, including monopolization
by patent rights.
• Since then, how to address concerns about the
misappropriation of genetic resources and
traditional knowledge have been high on the
agenda of a variety of multilateral forums.
Genetic resources are needed because new
traits are desired:
By consumers (taste, convenience etc.)
By the processing industry (shelf life,
commodity market, new processing
techniques etc.)
By the grower (new growing techniques,
new pest resistances, demands for lower
input etc.)
 CBD applies to all genetic resources, including plant
genetic resources.
 The CBD provides for the conservation and
sustainable utilization of genetic resources and a
regime for access and benefit-sharing.
 The CBD has almost universal application (193
parties).
 Means any genetic material of plant origin
of actual or potential value for food and
agriculture
 The objective of this Treaty is the
conservation and sustainable use
of plant genetic resources for food
and agriculture and the fair and
equitable sharing of the benefits
arising out of their use
 The value in agricultural genetic resources lies
in diversity within a crop, not at a species
level.
 Intra-specific diversity is important for
resistance to diseases and environmental
challenges, as well as for maintaining yields.
 Plant genetic resources are essential for future
food security.
Levels of Dependency on genetic
resources
Country
Dependenc
y (%)
Main source of energy supply
Primary region of
diversity of crops
China
Japan
Republic of
Korea
46 - 55
43 - 61
30 - 54
Non-native - wheat, sugar, maize,
potato
Native - rice and soybean
East Asia - rice, soybean,
orange, Brassica, millet, tea,
onion
Bangladesh
India
Nepal
14 - 21
35 - 47
47 - 57
Non-native - wheat, maize
Native - rice, sugarcane, millet
South Asia - rice, banana,
sugarcane, sesame, millet,
Brassica rapa, B juncea
Kenya
South Africa
Ethiopia
89 - 98
90 - 98
28 - 56
Non-native - Phaseolus, maize,
sweet potato, potato, cassava,
banana, plantain, wheat, rice
Native (for Ethiopia) - tef, Avena
Abyssinian, Brassica carinata
East and Southern Africa
- sorghum, millet, yam
Brazil
Andean Region
Argentina
Colombia
81 - 94
89 - 95
84 - 94
Non-native - wheat, sugar, rice,
maize, soybean, plantain, banana
Native - potato, Phaseolus (for
Andean Region); cassava (Brazil)
Andean region – pineapple
groundnut, sweet potato,
tomato, cocoa, Phaseolus,
potato, cassava,
US
Canada
77 - 100
84 - 99
Non-local - wheat, sugar, soybean,
potato, maize, barley, rice, North America - sunflower
Source: Palacios (1998)
 Access and Benefit Sharing
(ABS) rules
 Convention on Biological Diversity
(CBD)
 International Treaty on Plant Genetic
Resources for Food and Agriculture
 Intellectual Property (IP) rules
 Plant variety protection (PVP)
 Patents
 Unprotected
varieties
 Free for further
breeding
 PVP Protected
varieties
 Breeders’
exemption
 Patented varieties
 License
Additional national ABS requirements may be relevant
 Conditions research institute
 Public
 Private
 ABS rules in country where institute is
based
 Public
 Private
 Conditions of owners
 Biodiversity legislation, in particular
ABS rules
 Convention on Biological Diversity (CBD)
 Nagoya Protocol
 International Treaty on Plant genetic
Resources for Food and Agriculture (IT
PGRFA)
 Standard Material Transfer Agreement (SMTA)
 General provisions including definitions
 Rights and obligations of provider
 Allowed uses
 Benefit sharing
 Rights and obligations of recipient
 Clear cut-off point until where
 Any enclosure of genetic material
 Contract in perpetuity
 Dispute settlement
 "Any access to a biological resource,
innovation, practice, knowledge or
technology, shall be subject to the prior
informed consent (pic) of the concerned
community or communities ensuring that
women fully and equally participate in decision
making."
Common heritage
 International Undertaking; IU (1983)
Sovereign rights
 Convention on Biological diversity; CBD (1993)
 Bonn Guidelines on Access and benefit Sharing
(2002)
 International Treaty on Plant genetic resources for
Food and Agriculture; IT PGRFA (2004)
 Standard Material Transfer Agreement: SMTA (2006)
 Nagoya Protocol on Access and benefit Sharing
(2010) Fair and equitable benefit sharing
 Facilitated access, which is, itself, a major
benefit
 Exchange of information
 Access to and transfer of technology
 Capacity building
 The sharing of monetary and other benefits of
commercialization
Monetary benefit sharing
 Obligatory payment of 1.1 % of Sales minus 30%, if
material is not free for research and breeding
 Voluntary contribution when material is free for
research and breeding; recognition of the breeders’
exemption
 Alternative payment system.
 Non-monetary benefit sharing
 Information sharing
 Recognition of the enormous contribution that
farmers and their communities have made and
continue to make to the conservation and
development of plant genetic resources.
 Farmers’ rights include the protection of
traditional knowledge and the right to
participate equitably in benefit-sharing and
in national decision making about plant genetic
resources.
 Governments are responsible for realizing these
rights.
 To provide and promote an effective
system of plant variety protection, with the
aim of encouraging the development of new
varieties of plants, for the benefit of
society
Plant breeding is long and expensive
 BUT
 Plant varieties can be easily and
quickly reproduced
 Breeders need protection
 To recover Investment
 To provide and promote an
effective system of plant variety
protection (PVP)
A right to exclude others from commercial use of
what is patented
 A temporary right: usually 20 years
 Requires fee payments for maintenance
 Can be granted upon application, if the
patentability criteria are fulfilled:
 Novelty and New
:
 Plant and animal varieties not be patentable
. BUT
 Inventions which concern plants or animals shall be
patentable if the technical feasibility of the invention is not
confined to a particular plant or animal variety.”
 Not meant to cover discoveries or natural phenomena
but to foster new inventive technical processes and
products
 Nowadays: Patents are granted on gene sequences, plants
and animals ...
 Ethical reasons: living nature is not a technical invention
 Scientific arguments: a gene sequence is not a normal
chemical substance but a code of information with a lot of
different functions. A holder of a patent which describes
one commercial use should not get a monopoly on all possible
functions.
 Social and economic reasons: Patents can block access
to genetic resources. This is a problem in agriculture, plant
breeding and health care.
 NEW! NOVEL! IDEAS!
 Word or phrase
 Symbol
 Invention
 Biotechnology innovation
 New plant variety
 Food and food processing
 Forestry
 Herbal medicines
 Direct the use of the intellectual property
 Reserve the right for future state protection
 Ensure proper distribution of the intellectual
property
 Potential financial gain
 Recognition of innovators’ efforts
 Gain prestige for the institution
 Benefiting society – the most important
reason
 How can KALRO use this info (Kakamega case)
 Capture all ideas even those without
immediate benefit and document these within a
database
 Collect all experimental data manuals and
carefully archive these
 Be vigilant in MTA enforcement
 Maximise scientists knowledge bind them after
leaving KALRO from sharing information for
some years
 Benefits to the scientist (Breeders rights)
 Support scientists on innovative but crazy
ideas
 Packaging IPR TRAINING DIFFERENTLY to
include all:
 IP policy for the organization will benefit
everyone from the highest level administrator
to lowest level worker, and especially society.
“Information is not
Knowledge”
Albert Einstein

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Genetic resources and ipr

  • 2.  Objectives  Introduction – True case histories  An overview of International Regulatory Framework  Genetic resources and IP protections relevant to KALRO  What can KALRO borrow to improve their IPR Protection
  • 3.  To give an overview of the International Regulatory Framework and implementation on the Genetic Resources  To understand the IPR associated with genetic resources and their management  Reflect over regulatory options from which KALRO could borrow for future  To help each other to recognize the importance of managing intellectual properties
  • 4. Case history 1: Starch “Gene” (US)  Researcher isolates genetic material that increases production of starch in potatoes  Colleague from industry visits  Researcher “loans” “gene”  Company patents and restricts access  Researcher not able to work with “gene” as anticipated
  • 5. Case history 2: Malaria treatment  Researcher discovers unique treatment (India)  University administrators tell researcher to do whatever he wants with the idea  Administrators urged to take steps to help  Researcher asks for assistance from others, none received  Publishes the study and the unique treatment is not being used
  • 6.  Intellectual Properties Are:  IDEAS  Ideas! IDEAS!  Word or phrase  Books/Protocols/Recipes  Symbol  Invention  Biotechnology innovation  New plant variety
  • 7.  CBD /ABS= Convention on Biological diversity 1992/93/Access and Benefit sharing  TRIPS = Trade Related Intellectual Property Rights/WTO,1994/95  FAO-IT-PGRFA = FAO International Treaty for Plant Genetic Resources for Food and Agriculture, 2001/2004  UPOV = International Union for the Protection of Plant Varieties, 1991/97  WIPO –IGCGRTKF/Nagoya = World Intellectual Property Organization; Inter-Governmental Committee on Genetic Resources, Traditional Knowledge and Folklore, 2000  Biosafety protocol = Cartagena, 2002  IPPC = International Plant Protection Convention, 1997  GDCT = Global Diversity Conservation Trust)  PCT – Patent Cooperation Treaty
  • 8. Minimum common denominators?  Access  Knowledge  Innovation The FAO-IT-PGRFA, CBD, TRIPS, UPOV, WIPO- IGC etc • They provide: New legal boundaries = freedom to operate/innovate -under different regimes- for a range of biological material
  • 9.  Genetic Resource and their importance  CBD/ABS  FAO –ITPGRFA  UPOV  Institutional IP policies/management practices
  • 10. • Genetic resources have historically been considered to be freely available. • In 1983, the UN Food and Agriculture Organization (FAO) proposed that ‘plant genetic resources are a heritage of mankind and should be available without restriction. • Developing countries with abundant genetic resources voiced their opposition to the way resources were treated, including monopolization by patent rights. • Since then, how to address concerns about the misappropriation of genetic resources and traditional knowledge have been high on the agenda of a variety of multilateral forums.
  • 11. Genetic resources are needed because new traits are desired: By consumers (taste, convenience etc.) By the processing industry (shelf life, commodity market, new processing techniques etc.) By the grower (new growing techniques, new pest resistances, demands for lower input etc.)
  • 12.  CBD applies to all genetic resources, including plant genetic resources.  The CBD provides for the conservation and sustainable utilization of genetic resources and a regime for access and benefit-sharing.  The CBD has almost universal application (193 parties).
  • 13.  Means any genetic material of plant origin of actual or potential value for food and agriculture  The objective of this Treaty is the conservation and sustainable use of plant genetic resources for food and agriculture and the fair and equitable sharing of the benefits arising out of their use
  • 14.  The value in agricultural genetic resources lies in diversity within a crop, not at a species level.  Intra-specific diversity is important for resistance to diseases and environmental challenges, as well as for maintaining yields.  Plant genetic resources are essential for future food security.
  • 15. Levels of Dependency on genetic resources Country Dependenc y (%) Main source of energy supply Primary region of diversity of crops China Japan Republic of Korea 46 - 55 43 - 61 30 - 54 Non-native - wheat, sugar, maize, potato Native - rice and soybean East Asia - rice, soybean, orange, Brassica, millet, tea, onion Bangladesh India Nepal 14 - 21 35 - 47 47 - 57 Non-native - wheat, maize Native - rice, sugarcane, millet South Asia - rice, banana, sugarcane, sesame, millet, Brassica rapa, B juncea Kenya South Africa Ethiopia 89 - 98 90 - 98 28 - 56 Non-native - Phaseolus, maize, sweet potato, potato, cassava, banana, plantain, wheat, rice Native (for Ethiopia) - tef, Avena Abyssinian, Brassica carinata East and Southern Africa - sorghum, millet, yam Brazil Andean Region Argentina Colombia 81 - 94 89 - 95 84 - 94 Non-native - wheat, sugar, rice, maize, soybean, plantain, banana Native - potato, Phaseolus (for Andean Region); cassava (Brazil) Andean region – pineapple groundnut, sweet potato, tomato, cocoa, Phaseolus, potato, cassava, US Canada 77 - 100 84 - 99 Non-local - wheat, sugar, soybean, potato, maize, barley, rice, North America - sunflower Source: Palacios (1998)
  • 16.  Access and Benefit Sharing (ABS) rules  Convention on Biological Diversity (CBD)  International Treaty on Plant Genetic Resources for Food and Agriculture  Intellectual Property (IP) rules  Plant variety protection (PVP)  Patents
  • 17.  Unprotected varieties  Free for further breeding  PVP Protected varieties  Breeders’ exemption  Patented varieties  License Additional national ABS requirements may be relevant
  • 18.  Conditions research institute  Public  Private  ABS rules in country where institute is based  Public  Private
  • 19.  Conditions of owners  Biodiversity legislation, in particular ABS rules  Convention on Biological Diversity (CBD)  Nagoya Protocol  International Treaty on Plant genetic Resources for Food and Agriculture (IT PGRFA)  Standard Material Transfer Agreement (SMTA)
  • 20.  General provisions including definitions  Rights and obligations of provider  Allowed uses  Benefit sharing  Rights and obligations of recipient  Clear cut-off point until where  Any enclosure of genetic material  Contract in perpetuity  Dispute settlement
  • 21.  "Any access to a biological resource, innovation, practice, knowledge or technology, shall be subject to the prior informed consent (pic) of the concerned community or communities ensuring that women fully and equally participate in decision making."
  • 22. Common heritage  International Undertaking; IU (1983) Sovereign rights  Convention on Biological diversity; CBD (1993)  Bonn Guidelines on Access and benefit Sharing (2002)  International Treaty on Plant genetic resources for Food and Agriculture; IT PGRFA (2004)  Standard Material Transfer Agreement: SMTA (2006)  Nagoya Protocol on Access and benefit Sharing (2010) Fair and equitable benefit sharing
  • 23.  Facilitated access, which is, itself, a major benefit  Exchange of information  Access to and transfer of technology  Capacity building  The sharing of monetary and other benefits of commercialization
  • 24. Monetary benefit sharing  Obligatory payment of 1.1 % of Sales minus 30%, if material is not free for research and breeding  Voluntary contribution when material is free for research and breeding; recognition of the breeders’ exemption  Alternative payment system.  Non-monetary benefit sharing  Information sharing
  • 25.  Recognition of the enormous contribution that farmers and their communities have made and continue to make to the conservation and development of plant genetic resources.  Farmers’ rights include the protection of traditional knowledge and the right to participate equitably in benefit-sharing and in national decision making about plant genetic resources.  Governments are responsible for realizing these rights.
  • 26.  To provide and promote an effective system of plant variety protection, with the aim of encouraging the development of new varieties of plants, for the benefit of society
  • 27. Plant breeding is long and expensive  BUT  Plant varieties can be easily and quickly reproduced  Breeders need protection  To recover Investment  To provide and promote an effective system of plant variety protection (PVP)
  • 28. A right to exclude others from commercial use of what is patented  A temporary right: usually 20 years  Requires fee payments for maintenance  Can be granted upon application, if the patentability criteria are fulfilled:  Novelty and New
  • 29. :  Plant and animal varieties not be patentable . BUT  Inventions which concern plants or animals shall be patentable if the technical feasibility of the invention is not confined to a particular plant or animal variety.”  Not meant to cover discoveries or natural phenomena but to foster new inventive technical processes and products  Nowadays: Patents are granted on gene sequences, plants and animals ...
  • 30.  Ethical reasons: living nature is not a technical invention  Scientific arguments: a gene sequence is not a normal chemical substance but a code of information with a lot of different functions. A holder of a patent which describes one commercial use should not get a monopoly on all possible functions.  Social and economic reasons: Patents can block access to genetic resources. This is a problem in agriculture, plant breeding and health care.
  • 31.  NEW! NOVEL! IDEAS!  Word or phrase  Symbol  Invention  Biotechnology innovation  New plant variety  Food and food processing  Forestry  Herbal medicines
  • 32.  Direct the use of the intellectual property  Reserve the right for future state protection  Ensure proper distribution of the intellectual property  Potential financial gain  Recognition of innovators’ efforts  Gain prestige for the institution  Benefiting society – the most important reason
  • 33.  How can KALRO use this info (Kakamega case)  Capture all ideas even those without immediate benefit and document these within a database  Collect all experimental data manuals and carefully archive these  Be vigilant in MTA enforcement
  • 34.  Maximise scientists knowledge bind them after leaving KALRO from sharing information for some years  Benefits to the scientist (Breeders rights)  Support scientists on innovative but crazy ideas  Packaging IPR TRAINING DIFFERENTLY to include all:
  • 35.  IP policy for the organization will benefit everyone from the highest level administrator to lowest level worker, and especially society.

Editor's Notes

  1. Today no nation is completely independent in terms of genetic resources for food and agriculture and both, developed and developing countries have come to rely on non-indigenous crops for their food supply. A study assessing the degree of a country’s dependence on non-indigenous crops (measured in terms of calorific contribution to nutrition contributed by crops whose centre of diversity is outside the country in question) has shown that all countries grow or import crops that come from distant lands. Ghana is just as dependent on crops originating outside of Ghana (70-81%), as Italy is on crops originating outside of Italy (71-81%).