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Bio-cultural Rights, Genetic
Resources and Intellectual
Property:
Interacting Regimes and
Epicentres of Power
Södertörn University College | Institution for Life Sciences
Master thesis 30 hp | Environmental science | Spring term 2008
Author: Magnus Ulaner
Supervisor: Björn Hassler
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ABSTRACT
This thesis analyses the struggle over rights to benefits and ownership of plant genetic resources
and the global regime complex on the management of plant genetic resources, and how different
regimes concerning these resources cooperate or stand in opposition to each other. Because of
changes in US patent law and the establishment of TRIPS, patent claims over plant genetic
resources has increased dramatically globally. This, amongst other things, in turn has lead to the
acrimonious negotiations of access and benefit sharing arrangements within the framework CBD.
The objective of this thesis is to examine the interaction between the international regimes
regulating genetic resources and intellectual property and to analyse how these regime
interactions, affect the protection of traditional knowledge held by local communities, indigenous
peoples and small farmers in developing countries. The thesis concludes that it exists several
regime interactions that are disruptive and undermine the possibility of protecting traditional
knowledge from misappropriation. It is further concluded that modifications of the existing IPR
regimes, on the disclosure of inventions, with a certificate of legal provenance, securing FPIC,
MAT and benefit sharing, may serve as one brick in the wall that protect traditional knowledge
from misappropriation through wrongly granted patents. But a certificate of legal provenance will
not do the work alone. To protect traditional knowledge associated with genetic resources in the
long term bio-cultural solutions which sustains the entire community where traditional
knowledge is embedded is needed.
Keywords: traditional knowledge, plant genetic resources, intellectual property rights, access and
benefit sharing, regime interaction
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INTRODUCTION .............................................................................................................................. 8
RESEARCH PROBLEM ........................................................................................................................... 12
OBJECTIVE ........................................................................................................................................... 12
RESEARCH QUESTIONS ........................................................................................................................ 12
PREVIOUS RESEARCH………………………………………………………………………………………..12
THEORETICAL FRAMEWORK ................................................................................................... 15
WORLD ORDER STRUCTURES ............................................................................................................. 15
STRUCTURAL POWER .......................................................................................................................... 17
THE POWER BROKERS IN THE GAME................................................................................................... 19
REGIME ANALYSIS ............................................................................................................................... 22
THE REGIME CONCEPT 22
REGIME INTERACTION 24
REGIME SHIFTING 27
SUMMARIZING THE THEORETICAL FRAMEWORK .............................................................................. 29
METHOD ............................................................................................................................................ 32
CASE-STUDY APPROACH ..................................................................................................................... 32
MATERIAL, COLLECTION AND CREDIBILITY ............................................................................... 32
THE USE OF THEORY IN THE ANALYSIS ....................................................................................... 34
THE NATURE OF INTELLECTUAL PROPERTY RIGHTS, THE COMMON HERITAGE
AND THE PUBLIC DOMAIN ........................................................................................................ 35
THE CONCEPT OF INTELLECTUAL PROPERTY RIGHTS ..................................................................... 35
BIOGENETIC RESOURCES AND INTELLECTUAL PROPERTY RIGHTS ................................................ 37
THE COMMON HERITAGE AND THE PUBLIC DOMAIN ....................................................................... 39
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SUMMARY ............................................................................................................................................. 40
THE NATURE OF TRADITIONAL KNOWLEDGE ................................................................. 42
SUMMARIZING THE NATURE OF TRADITIONAL KNOWLEDGE.......................................................... 46
BIOPROSPECTING - LEGALIZED BIOPIRACY OR A FAIR DEAL? ............................... 48
THE CONCEPT OF BIOPROSPECTING ................................................................................................... 48
THE CONCEPT OF BIOPIRACY ............................................................................................................. 49
CASES OF BIOPIRACY........................................................................................................................... 51
SUMMARY ............................................................................................................................................. 58
THE INTERNATIONAL REGIMES ON BIOGENETIC RESOURCES, TRADITIONAL
KNOWLEDGE AND INTELLECTUAL PROPERTY RIGHTS .............................................. 59
THE CONVENTION ON BIOLOGICAL DIVERSITY ................................................................................ 59
THE BONN GUIDELINES 64
THE NEGOTIATIONS ON AN INTERNATIONAL REGIME ON ACCESS AND BENEFIT SHARING 65
SUMMARY ............................................................................................................................................. 68
INTERNATIONAL TREATY ON PLANT GENETIC RESOURCES FOR FOOD AND AGRICULTURE ........ 70
THE AGREEMENT ON TRADE-RELATED ASPECTS OF INTELLECTUAL PROPERTY RIGHTS ........... 74
THE REVIEW PROCESS OF ARTICLE 27.3(B) 78
IN THE MEAN TIME: ‘TRIPS-PLUS’ AGREEMENTS 82
INTERNATIONAL UNION FOR THE PROTECTION OF NEW VARIETIES OF PLANTS ........................... 83
THE WORLD INTELLECTUAL PROPERTY ORGANISATION ................................................................ 85
THE PATENT LAW TREATY 86
THE INTERGOVERNMENTAL COMMITTEE ON INTELLECTUAL PROPERTY AND GENETIC RESOURCES,
TRADITIONAL KNOWLEDGE AND FOLKLORE 87
DRAFT SUBSTANTIVE PATENT LAW TREATY 89
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DECLARATIONS AND OTHER CONVENTIONS....................................................................................... 92
SUMMARY ............................................................................................................................................. 93
RATIONALES FOR THE PROTECTION OF TRADITIONAL KNOWLEDGE ON PLANT
GENETIC RESOURCES AND THE PREVENTION OF BIOPIRACY ................................ 95
APPROACHES TO PROTECT TRADITIONAL KNOWLEDGE ON GENETIC
RESOURCES ..................................................................................................................................... 97
TRADITIONAL KNOWLEDGE AS INTELLECTUAL PROPERTY 97
DEFENSIVE PROTECTION APPROACHES .............................................................................................. 99
DISCLOSURE OF ORIGIN/CERTIFICATE OF LEGAL PROVENANCE 100
TK PRIOR ART DATABASES 101
PATENTS AS PROTECTION OF TRADITIONAL KNOWLEDGE 103
GEOGRAPHICAL INDICATIONS AS PROTECTION OF TRADITIONAL KNOWLEDGE 104
PLANT VARIETY PROTECTION AS PROTECTION OF TRADITIONAL KNOWLEDGE 104
POSITIVE PROTECTION APPROACHES .............................................................................................. 105
SUI GENERIS SYSTEM FOR THE PROTECTION OF TRADITIONAL KNOWLEDGE AND ABS 105
HOLISTIC APPROACHES FOR THE PROTECTION OF TRADITIONAL KNOWLEDGE 106
SUMMARY ........................................................................................................................................... 109
ANALYSIS ........................................................................................................................................ 110
REGIME INTERACTION: TRIPS/UPOV - CBD/ITPGRFA ............................................................ 110
REGIME INTERACTION: WIPO (SPLT) – CBD/ITPGRFA............................................................. 115
BLOCKING DISCLOSURE OF ORIGIN – THE BIOTECH INDUSTRY IN THE ABS NEGOTIATIONS ...... 118
REGIME INTERACTION: CBD AND UNDRIP - THE ABS REGIME AND INDIGENOUS RIGHTS ...... 120
CONCLUDING REMARKS ....................................................................................................... 125
REFERENCES....................................................................................................................128
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List of abbreviations
ABS Access and Benefit Sharing
ABSA Access and Benefit Sharing Alliance
BCP Bio-cultural Community Protocol
CBD the Convention on Biological Diversity
CGIAR the Consultative Group on International Agricultural Research
COP Conference of Parties
CSO Civil-Society Organisation
Draft SPLT Draft Substantive Patent Law Treaty
FAO the United Nations Food and Agriculture Organization
FPIC Free, Prior and Informed Consent
GR Genetic Resources
ICG the Intergovernmental Committee on Intellectual Property and Genetic
Resources, Traditional Knowledge and Folklore
IIFB International Indigenous Forum on Biodiversity
ILC Indigenous Peoples and Local Communities
ILO the International Labour Organization
ILO Convention 169 International Labour Organization Convention Concerning Indigenous
and Tribal Peoples in Independent Countries
ITPGRFA the International Treaty on Plant Genetic Resource for Food and
Agriculture
JUSCANZ Informal coalition of Japan, USA, Canada, Australia and New Zealand
LMMC Like-Minded Megadiverse Countries
MAT Mutually Agreed Terms
MLS the Multilateral System
NGO Non-Governmental Organization
PIC Prior and Informed Consent
PLT the Patent Law Treaty
SCP the Standing Committee on the Law of Patents
SMTA Standard Material Transfer Agreement
TK Traditional Knowledge
TKDL Traditional Knowledge Digital Library
TRIPS the Agreement on Trade-Related Aspects on Intellectual Property
Rights
UNDRIP the United Nations Declaration on the Rights of Indigenous Peoples
UPOV Union internationale por la Protection des Obtentions Végétales.
(International Union for the Protection of New Varieties of Plants)
WGABS the ad-hoc Working Group on Access and Benefit Sharing
WG(8j) the Ad Hoc Open-ended Working Group on Article 8(j) and Related
Provisions
WIPO World Intellectual Property Organisation
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Introduction
In the international struggle on the power over bio-genetic resources indigenous peoples and
rural/local communities, who are the real custodians of the world’s bio-diverse forests, fields and
waters, are small players amongst the strong state and corporate players in this game. These
communities and peoples struggle to have a say in the international rule making on access to bio-
genetic resources in bioprospecting undertakings and the sharing of benefits steaming from their
subsequent commercial use. Indigenous peoples and rural communities’ livelihoods are
dependent on traditional knowledge, which has been used for several centuries under local laws,
customs and traditions. It has been passed down and evolved from a generation to the next.
Therefore traditional knowledge still plays a vital role in food security, agricultural development
and medical treatment. Traditional medicines fulfil the health needs of the majority of people in
developing countries, where access to ‘modern’ medicine is limited by economic and cultural
reasons.1 It is often the only affordable treatment available to poor people and in remote
communities. But the knowledge on medical plants is also important for the pharmaceutical
industry. Of the 199 drugs developed from higher plants which were available on the world
market in 1994, it was estimated that 74 per cent were discovered from a pool of traditional
herbal medicine.2 Natural products continue to play a dominant role in the discovery of leads for
the development of drug and contribute significantly to the research of the pharmaceutical
industry.3
The benefits of biological diversity may not only be understood as the benefits arising from the
commercial use of genetic resources, but also as those benefits steaming from the daily use of
biological diversity amongst local communities and indigenous peoples. Today these direct
benefits are in increasing pace dissociated from the hard work of conservation and sustainable
1 As an example the per capita use of traditional medicine in Malaysia is more than double than the consumption of
modern pharmaceuticals. See Correa, C. (2001) Traditional Knowledge and Intellectual Property - Issues and options
surrounding the protection of traditional knowledge. p.3 2 Pretorius, W. ’TRIPS and Developing Countries: How Level is the Playing Field?’ in Drahos, P. and Mayne, R.
(Eds.) (2002) Global Intellectual Property Rights: Knowledge, Access and Development. p. 185 3 As an example of this, between ‘January 1981- June 2006, 47% of cancer drugs, and 34% of all small molecule
new chemical entities (NCE) for all disease categories, were either natural products or directly derived there from.
Laird, S. and Wynberg, R. (2008). ‘Access and Benefit Sharing: Arrangements Existing in Specific Sectors.’ p.6
9
use, and indigenous peoples and rural communities are rapidly being marginalised by economic
globalisation processes and political forces which undermine traditional rural livelihoods based
on natural resource management. The proprietarization of biogenetic resources, and the
associated traditional knowledge, through intellectual property rights such as patents and plant
breeders rights, without proper recognition and fair compensation is seen to undermine traditional
systems of common sharing of these bio-genetic resources amongst societies and in the end
erodes biodiversity. As of today international and national policies have so far proved inadequate
to protect the traditional knowledge associated with biogenetic resources, from these forces.
In the struggle over biogenetic resources the idiom of ‘rights’ has been widely used. It is used by
the now dominant intellectual property rights regimes. But if ‘Breeders Rights’ and the rights of
investors ‘was the pivot upon which agribusiness’ and pharmaceutical industries ‘lobbied for
change in commercial law, Farmers Right, indigenous rights and more recently, human rights
provide the ground upon which resistance to plant variety IPRs and patents on biogenetic
resources is being waged.’4 These rights to traditional knowledge related to medical plants and
agricultural crops are increasingly put forward when this knowledge is gradually ‘recognized as
having a rigorous empirical basis and scientific and technological value.’5
Traditional knowledge, the access to biogenetic resources and the sharing of benefits from the
commercial use of these resources are issues climbing on the political agenda. The attention on
traditional knowledge and benefit sharing has come up on the international agenda due to the
expanding web of Intellectual Property Rights (IPR)6 - ‘the primary means of control in a
globalized economy’7 - in the field of biology and biotechnology and the following struggles and
4 Borowaik, C. (2004). ‘Farmers’ Rights: Intellectual Property Regimes and the Struggle over Seeds’ p. 512
5 Taubman, A. (2005). ’Saving the village: Conserving jurisprudential diversity in the international protection of
traditional knowledge’. in Maskus, K.E. and Reichman, J.H. (Eds.) International public goods and transfer of
technology under a globalized intellectual property regime p. 522-523 6 The following components of property has been identified: ‘(1) the right to exclusive possession; (2) the right
to personal use and enjoyment; (3) the right to manage use by others; (4) the right to the income from use by others;
(5) the right to the capital value, including alienation, consumption, waste, or destruction; (6) the right to security
(that is, immunity from expropriation); (7) the power of transmissibility by gift, devise, or descent; (8) the lack of
any term on these rights; (9) the duty to refrain from using the object in ways that harm others; (10) the liability to
execution for repayment of debts; and (11) residual rights on the reversion of lapsed ownership rights held by
others.’ In intellectual property rights the exclusion of others may be considered to be the most important.
Safrin, S. (2007). ‘Chain Reaction: How Property Begets Property. p. 28 7 GRAIN. (2003). ‘One global patent system? WIPO's Substantive Patent Law Treaty’. p. 1
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debates on the misappropriation of biological resources and traditional knowledge – biopiracy. In
today’s global economy where the production of tangible goods is increasingly moved to
developing countries, strong IPR protection becomes absolutely crucial for multinational
corporations, since they ‘no longer sell the goods as such, only their IPR component.’8
The case of plant genetic resources and traditional knowledge lies at the nexus of several areas in
global politics: intellectual property, biodiversity protection, agriculture and trade. Because of the
nature of this complex issue area, in the intersection between protection of traditional knowledge,
intellectual property rights and biodiversity, it has lead to an intense international lawmaking
activity, it is negotiated and discussed in a number of fora and regulated by several international
regimes:
The international concern for the loss of biological diversity and the accompanied loss of
biogenetic diversity, led up to the adoption of the Convention on Biological Diversity (CBD), at
the United Nations Conference on Environment and Development held in Rio de Janeiro in 1992.
CBD provides national sovereignty over genetic resources and has thereby lead to the
development of access conditions for other sovereign parties. The convention also demands a
prior informed consent on mutual agreed terms and benefit sharing of the commercial utilization
of genetic resources, and the recognition of the traditional knowledge, held by local communities
and indigenous peoples, associated to the genetic resources.
Under the flag of the World Trade Organisation (WTO) the agreement on Trade Related
Intellectual Property Rights (TRIPS) was adopted in Marrakech in 1994 and provides a minimum
IP protection standard for biological matter such as plant varieties, micro-organisms, and
microbiological processes, to be implemented in national IPR laws of the member parties. If
member parties do not want to provide for patent protection in patent varieties TRIPS gives a
possibility to form a sui generis system or adopt UPOV 91. Since the TRIPS Agreement
strengthened intellectual property rights on a global scale a increasing number of states, NGOs,
and officials of intergovernmental organizations have raised concerns about expanding IPRs, in
several international venues.
8 GRAIN. (2003). p. 1
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Within the World Intellectual Property Organization (WIPO) in Geneva the Intergovernmental
Committee on Intellectual Property and Genetic Resources, Traditional Knowledge and Folklore
(ICGTK) was set up in 2001, in order to discuss IPR issues relating to access to genetic resources
and the protection of traditional knowledge, including disclosure requirements in patent
applications. At the same time negotiations on as Substantial Patent Law Treaty (SPLT) are
taking place, a process which is aiming at harmonising IP laws globally.
Under the UN Food and Agricultural Organisation the International Treaty on Plant genetic
Resources for Food and Agriculture where negotiated in 2001 and adopted in 2004. The Treaty’s
aim is to facilitate the international flow of plant genetic resources for agriculture within a
Multilateral System, the CGIAR system, and strengthen the rights of farmers as custodians of the
crop genetic diversity worldwide.
In September 2007 the United Nations Declaration on the Rights of Indigenous Peoples,
(UNDRIPS) was adopted by the General Assembly.9 This declaration contains provisions on
traditional knowledge on biogenetic resources.
This complex international environment for the management of genetic resource, the protection
of traditional knowledge and intellectual property is increasingly creating interactions between
these different regimes. These interactions are both disruptive and supportive in nature and when
disruptive highly controversial.
9 Article 31 is central for protection of traditional knowledge associated with genetic resources:
‘Indigenous peoples have the right to maintain, control, protect and develop their cultural heritage, traditional
knowledge and traditional cultural expressions, as well as the manifestations of their sciences, technologies and
cultures, including human and genetic resources, seeds, medicines, knowledge of the properties of fauna and flora,
oral traditions, literatures, designs, sports and traditional games and visual and performing arts. They also have the
right to maintain, control, protect and develop their intellectual property over such cultural heritage, traditional
knowledge, and traditional cultural expressions.’
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Research problem
The regimes pertaining the international management of genetic resources and associated
traditional knowledge make up a complex web and have lead to acrimonious battles. Those
regimes dealing with patent applications on genetic resources have potentially negative affects on
the rights of indigenous peoples, rural communities and small farmers, by decreasing their control
over their genetic resources and the traditional knowledge associated to these resources. The IPR
regimes are normatively strong and since international regimes increasingly interact with one
another this thesis examines how the interaction between the IPR regimes and the regimes
regulating access to genetic resources and the benefit sharing of the commercial use of biological
genetic resources, affects the protection of traditional knowledge and its holders. The thesis also
examines why there is such a dead-lock in the negotiations concerning these issues.
Objective
The objective of this thesis is to examine the interaction between the international regimes
regulating genetic resources and intellectual property and to analyse how these regime
interactions, affect the protection of traditional knowledge held by local communities, indigenous
peoples and small farmers in developing countries.
Research questions
Which are the main regime interactions that can be uncovered in the regime complex on
intellectual property rights, plant genetic resources, and traditional knowledge?
How do provisions in the international regimes on intellectual property rights, plant genetic
resources and traditional knowledge affect the possibilities of protecting traditional knowledge,
under international law, from misappropriation?
How do the different rationales within the regimes in the international lawmaking on IPR,
genetic resources, affect the possibility of protecting traditional knowledge?
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Previous research
Research in the field of traditional knowledge on plant genetic resources and the regimes that
regulate the handling and ownership of these recourses are extensive. Early research in the field
was done by Brush, Stephen B. and Stabinsky, Doreen (Eds.) (1996). Valuing Local Knowledge:
Indigenous People and Intellectual Property Rights, and Posey, Darrell A. and Dutfield, Graham.
(1996). Beyond intellectual property: towards traditional resource rights for indigenous peoples
and local communities. These studies conclude that traditional knowledge is valuable and that
extensive intellectual property rights threatens the integrity of local communities. The knowledge
base on lawmaking on traditional knowledge, plant genetic resource and intellectual property
rights was deepened by the Crucible II Group. (2000) Seedling Solutions. Vol.1: Policy Options
for Genetic Resources: People, Plants, and Patents Revisited and Seeding solutions. Vol.2:
Options for national laws governing control over genetic resources and biological innovations.
Also Correa, Carlos M. (2001) ‘Traditional Knowledge and Intellectual Property - Issues and
options surrounding the protection of traditional knowledge’ and Dutfield, Graham (2000)
Intellectual Property Rights, Trade and Biodiversity deepened the problematics of the issues. The
NGOs GRAIN and ETC Group have made important contributions to the field of knowledge
concerning issues of power and ownership on plant genetics, during almost 20 years. These
books and material from mentioned NGOs have served as a knowledge base for this thesis.
The analysis on how regimes interact in general have been made by Young, Oran R. see for
example (1996) ‘Institutional Linkages in International Society: Polar Perspectives’ and more
recently by Oberthuer, Sebastian and Gehring, Thomas (Eds.) (2006) Institutional Interaction:
Enhancing Cooperation and Preventing Conflicts Between International and European
Environmental Institutions, reflecting on different modes of interactions between international
regimes. Helfer, Laurence R. (2004) ’Regime Shifting: The TRIPs Agreement and New Dynamics
of International Intellectual Property Lawmaking’ have analysed how lawmaking in international
regimes shift due to power dynamics. Helfer´s theoretical assumptions serve as an analytical tool
of this thesis.
Important contributions to the regime analysis in this field of plant genetics, IPR and traditional
knowledge have been made by Raustiala, Kal and Victor, David G. (2004) ’The Regime Complex
14
for Plant Genetic Resources’ and Safrin, Sabrina (2004) ‘Hyperownership in Times of
Biotechnological Promise: The International Conflict to Control the Building Blocks of Life.’
The Fritjof Nansen Institute have made important contributions to the area of regime interaction
and plant genetics, see especially Rosendal G. Kristin (2006) ‘Regulating the Use of Genetic
Resources – Between International Authorities’ and Andersen, Regine (2007) Governing
Agrobiodiversity: International Regimes, Plant Genetic Resources and Developing Countries.
15
Theoretical Framework
In this section the theoretical framework and concepts used to analyse the international struggle
over plant genetic resources, intellectual property rights and traditional knowledge, is defined
and discussed. The section starts of with an overview of realism, critical theory and structural
power, and proceeds to sections on regimes, regime interaction and regime shifting.
World Order Structures
An insecure world with endemic violence and conflict is portrayed by realist theorists. To realists
the stat is a central actor, and the conflictual behaviour of nation-states can only be explained by
a focus on the most powerful states.10
Early realists such as Carr focused on the unequal
distribution of power in the international system, and believed that the contemporary liberals had
a utopian view on the harmony of interests amongst states. The liberals believed that ‘every
nation had an identical interest in peace and that any state which behaved aggressively or failed
to respect the peace was acting irrational.’11
Carr, though, argued that this simply is the
expression of the ‘satisfied powers’, with interest in preserving the stability and status quo of the
international system.12
Another classic realist, Morgenthau, viewed the imperfections in the
international system as the result of forces inherent in human nature. Therefore we must work
with these forces not against them, and create a balance of interests.13
He believes that politics is
governed by objective laws steaming from human nature and that the ‘idea of interest defined in
terms of power reveals the true behaviour’ of states.14
The classical realist writings of Carr and
Morgenthau, and descending realists, is concerned with ‘a number of empirical and normative
preoccupations; (a) sovereign states are both the primary actors and basic unit of analysis; (b)
inter-state behaviour taking place in an environment of ungoverned anarchy; (c) the behaviour of
states can by understood ‘rationally’ as the pursuit of power defined as interest.’15
This is called
the unitary rational actor model (URA model). Further it is assumed in the realist school that
10
Burchill, S. (2001). Theories of International Relations. p. 70 11
Ibid. p. 73 12
Ibid. p. 73 13
Ibid. p. 78 14
Ibid. p. 79 15
Ibid. p. 85
16
international law and institutions rarely play more than an epiphenomenal role in the ordering of
international relations.16
Realism has come under criticism from Marxists for being an intended expression of dominant
classes, because of its concern with the reinforcement and reproduction of capitalist relations of
production. Therefore it is argued that realism is a theory with an inherent ideology, which has
the unintended consequence of preserving structures which favours dominant classes and social
groups.17
Waltz and Krasner are amongst the writers termed neo-realists. Waltz argues that the
international system has a ‘precisely defined structure with three important characteristics: (1) the
ordering principle of the system; (2) the character of the units in the system; and (3) the
distribution of the capabilities of the units in the system.’18
The ordering principle of the
international system is anarchic19, with an absence of a supranational authority regulating the
behaviour of nation-states. This is in stark contrast to the domestic political system which is
hierarchic. The anarchic environment forces nation states to seek security and military power, in
their search for survival. This socializes them into behaviour of mutual distrust and self reliance.20
However, although states are functionally similar, they have vastly different capabilities and there
is an unequal and shifting distribution of power in the international system.
Ruggie criticises Waltz for putting to great emphasis on the anarchic nature of the international
system and thereby overlooking the institutionalization that actually exists. He suggests that
institutionalization has the capacity to move states beyond self-interest into the realm of
cooperation.21 A similar critique has been put forward by Linklater, who argues that Waltz
anarchic system leaves little or no room for systemic change induced by the states (units)
themselves. Waltz theory of anarchy in the international system also dismisses the rationalist
16
Rosendal, K. (2006a). p.8 17
Burchill, S. (2001). p. 85 18
Ibid. p. 91 19
Here anarchy is used in a negative sense as no authority and thereby no responsibility, as opposed to the positive
anarchy concept, were it is seen as freedom of oppression from authorities and individual responsibility, used by
individuals and groups calling themselves anarchists. 20
Burchill, S. (2001). p. 91 21
Ruggie, J.G. (1998). Constructing the World Polity: Essays on International Institutionalism. p. 3
17
view that even if the system is anarchic it is also normatively regulated.22 Also Helfer points out
that the assumption of states as rational unitary actors pursuing their interest in an environment of
anarchy is over simplified. He argues that ‘states are not unitary but are composed of a diverse
array of governmental institutions populated by officials who pursue their own agendas and draw
legitimacy from their relationship to domestic constituencies.’ Further there is ‘private interest
groups and members of civil society’ who also plays critical roles in ‘aggregating individual
preferences and lobbying the various branches of government to adopt the policies they favor.’
When viewing states in this way one can make an analysis of international lawmaking by
‘disaggregating states into transparent entities composed of distinct governmental and
nongovernmental actors.’ These concentrated interest groups will devote ‘significant resources to
lobbying government officials if doing so allows those groups to acquire advantages through
regulation that would be unavailable in the market.’23
Structural Power
Here a comment on the concept of power is in its place. Power may be defined as the ability of an
actor to get others to do what they otherwise would not do, but what the actor wants them to do.
Morgenthau is a representative of this view since he defines power as ‘a relation between those
who exercise it and those over whom it is exercised, which gives the former control over certain
actions.’24
Here power is seen as power in the structures, referring to the immanent power in the
political-economic structures, and its effect on societal development. Another approach to power
is that of Keohane and Nye who view power by distinguishing between control over outcomes
and the potential to achieve such control. They focus on the initial power resources providing an
actor with the potential ability for action, rather than the actual influence that the actor exerts on
the patterns of outcome. Here power is the power to shape the structures, referring to the ability
to shape the political-economic structures within which other actors operate. This view of power
is based on the assumption that the global system is characterized by growing interdependence
22
Burchill, S. (2001). p. 92 23
Helfer, L (2004). ’Regime Shifting: The TRIPs Agreement and New Dynamics of International Intellectual
Property Lawmaking’ p.18-19 24
Andersen, R. (2007). Governing Agrobiodiversity: International Regimes, Plant Genetics and Developing
Countries. p. 52
18
amongst states and economies. Power in such an international environment can only be identified
by uncovering the patterns of asymmetries.25
Susan Strange argues for that there are ‘two kinds of power exercised in a political economy –
structural power and relational power.’26
The relational power is the sort of power described by
classical realists such as Morgenthau while structural power is the sort of power described by
Keohane and Nye. Strange defines this structural power as the power ‘to shape and determine the
structures of the global political economy within other states, their political institutions, their
economic enterprises and scientists and other professional people have to have to operate.’27
Strange identifies four fundamental structures were structural power is exercised: control over
security; control over production; control over credit and control over knowledge, beliefs and
ideas.28
1) The control over security lies with those, people or institutions, whom exercise this
control. 2) The production structure is defined as ‘the sum of all the arrangements determining
what is produced, by whom and for whom, by what method and on what terms. It is people at
work, and the wealth they produce by working.’29
3) Control over the credit, or financial system,
is defined ‘as the sum of all the arrangements governing the availability of credit plus all the
factors determining the terms on which currencies are exchanged for on another.’30
4) The fourth
structural power is knowledge and ‘whoever is able to develop or acquire and to deny the access
of others to a kind of knowledge respected and sought by others; and whoever can control the
channels by which it is communicated to those given access to it, will exercise a very special kind
of structural power’31
Knowledge provides a competitive advantage to its holders, and it may be
argued that a ‘trader would invest in acquiring knowledge and skills to increase his wealth.’32
This private sector control of knowledge often results in the alteration of the ‘basic institutional
framework.’33
Strange´s classification of knowledge as one of the four ’structural powers’ in
international political economy provides a basis for analyzing the full importance of knowledge
25
Andersen, R. (2007). p. 53 26
Strange (1988) States and Markets. p. 24 27
Ibid. p. 24-25 28
Ibid. p. 26 29
Ibid. p. 61 30
Ibid. p. 88 31
Ibid. p. 30 32
North (1991) cited in Phillips, P.W.B. and Onwuekwe, C.B (2007). Accessing and Sharing the Benefits of the
Genomics Revolution. p. 11 33
Phillips, P.W.B. and Onwuekwe, C.B (2007). p. 11
19
and the interests at play within the TRIPS and CBD regimes. It is apparent that power amongst
states are uneven distributed along North-South lines, even though countries such as India, China
and Brazil are gaining global power and influence.
The power brokers in the game
In the international struggle on plant genetic resources and traditional knowledge states are the
primary actors. States act both on their own and in coalitions. In the negotiations on an
international regime on access and benefit sharing the power brokers are: the Like Minded Mega-
Diverse countries (most Latin America, South Asian & Asian countries) and the African Group,
these two negotiation groups want a legally binding treaty. These countries are often described as
countries of origin or provider countries; the industrialized/developed countries (EU, JUSCANZ,
including Japan, Canada, Australia, New Zealand, and indirect the USA) are the countries where
the users of genetic resources and the IPR holders are located. These countries are not keen in
renegotiation international IPR law with an obligatory disclosure of origin obligation and they
prefer a non-binding ABS regime and are proposing sector-vise model clauses for ABS contracts.
These countries are often referred to as user countries, but can also be countries of origin and/or
providers. Outside these coalitions Norway stands out as a state making compromises.
Apart from states, the actors influencing the regimes regulating plant genetic resources,
traditional knowledge and IPR are mainly multinational corporations from the life science
industry and CSOs representing farmers and indigenous peoples. Here it must be pointed out that
the industrialized countries governments are not the users, but the corporations operating from
these countries. JUSCANZ, in the interest of industry, assert the primacy of the WTO TRIPS
Agreement and WIPO´s patent treaties over the CBD as far as regulating patents; the
biotechnology industry are the primary beneficiaries of intellectual property rights over genetic
resources and commercialization. The corporations, making up the industry, wants predictable
guidelines for bilateral contracts and view burdensome regulation as a bar to access and also a
limit to the amount of benefits that can be generated.34
The Access and Benefit Sharing Alliance
34
Indigenous Peoples Council on Biocolonialism. (2006). ‘The Convention on Biological Diversity’s International
Regime on Access & Benefit Sharing: background & considerations for Indigenous Peoples’. p. 7
20
(ABSA)35
is the life science industry’s lobbying organisation. It works with ‘focused advocacy in
support of the full patentability of genetic resource and traditional knowledge-related inventions
needed to encourage research and development of innovative products by entrepreneurs in both
developing and developed states.’36
Further it tries to ‘counter the unprecedented global threat to
biotechnology patents in the WTO.’37
Referring to the review on TRIPS article 27.3(b) in the
TRIPS Council and the negotiations on an international regime on access and benefit sharing,
with the possibility of resulting in an mandatory disclosure of origin obligation in patent
applications. Civil society organisations also play a role to pressure government in adapting
policies that favour farmers rights, protection of traditional knowledge and hinder the
misappropriation of plant genetic resources. They give developing countries delegations support
for their claims in negotiations. CSO active in the field include; GRAIN (a small international
non-profit organisation that works to support small farmers and social movements in their
struggles for community-controlled and biodiversity-based food systems);38
Via Campensina (the
international movement of peasants, small- and medium-sized producers, landless, rural women,
indigenous people, rural youth and agricultural workers. They defend the values and the basic
interests of its members, whom are from 56 countries from Asia, Africa, Europe, and the
Americas);39
the Southeast Asia Regional Initiatives for Community Empowerment (SEARICE)
(a regional non-government development organization that promotes and implements
community-based conservation, development and sustainable use of plant genetic resources in
partnership with civil society organizations, government agencies, academic research institutions
and local government units in Bhutan, Lao PDR, the Philippines, Thailand and Vietnam);40
the
International Indigenous Forum on Biodiversity (IIFB) (a collection of representatives from
indigenous governments, indigenous non-governmental organizations and indigenous scholars
and activists that organize around the CBD and other important international environmental
meetings to help coordinate indigenous strategies at these meetings, provide advice to the
government parties, and influence the interpretations of government obligations to recognize and
35
This name was recently changed from the previous name - the American BioIndustry Alliance (ABIA) which was
formed in September 2005 by the US biotechnology industry. 36
www.abs-alliance.org (Accessed 12 April 2008) 37
New, W. (2006). ‘Biotech Industry Fights Disclosure In Patents On Three IP Policy Fronts’ 38
http://www.grain.org/front/ (Accessed 12 April 2008) 39
www.viacampensina.org (Accessed 12 April 2008) 40
www.searice.org.ph (Accessed 12 April 2008)
21
respect indigenous rights to the knowledge and resources);41
The Action Group on Erosion
Technology and Concentration (ETC Group) address the socioeconomic and ecological issues
surrounding new technologies that could have an impact on the world’s poorest and most
vulnerable. They investigate ecological erosion (including the erosion of cultures and human
rights); the development of new technologies (especially agricultural but also new technologies
that work with genomics and matter); and monitor global governance issues including corporate
concentration and trade in technologies. ETC operates at the global political level).42
Industry
NGOs and civil society organisations mentioned above are secondary actors in this game.
All these actors can change an existing situation by, interests, priorities or value systems. Even
though different actors can shape outcomes in regime rule making ‘power dynamics are often at
the heart of disputes over changes to international regimes. According to a realist understanding
of regimes, the rules of a regime are tailored to the national interests of hegemons. When those
interests change, rule changes necessarily follow.’ But power, although important, is not the sole
determinant of how a regime evolves over time. International institutions often limit the scope for
hegemonic action and allow weaker states and non-state actors some leeway to influence the
development of principles, norms, and rules. Voting and other procedural devices, for example,
create opportunities for alliances or networks among less powerful states, with the support of
CSOs.43
41
http://www.iifb.net/ (Accessed 12 April 2008) 42
http://www.etcgroup.org/en/about 43
Helfer, L (2004). p. 13
22
Regime analysis
To make it possible to answer the research questions dealing with: how the international regimes
on intellectual property rights, plant genetic resources and traditional knowledge affect the
possibilities of protecting traditional knowledge; and which the main regime interaction are; this
section outline the concepts of regimes and regime interactions.
The Regime Concept
The concept of international regimes has been put forward by scholars to ‘capture the diversity
and complexity of the cooperative arrangements that states use to address transborder issues of
mutual concern.’44
Regimes may be seen as a form of international institutionalization and central
elements for engendering cooperation in the international system. This form of defining the
regime concept makes it interchangeably with particular intergovernmental organizations or
international agreements. But it is important to note that regimes may be seen as being ‘broader
than specific organizations or treaties, reflecting the fact that states (and, increasingly, non-state
actors) can cooperate without creating formal institutions or legally binding commitments’45
Regimes are by definition issue specific, Rosendal points out, and they are generally established
to deal with specific problems within this specific issue-areas.46
International regimes have also been defined as composite of four analytical component parts: ‘ a
sets of implicit or explicit principles, norms, rules and decision making procedures around which
actors’ expectations converge in a given issue area of international relations.’ 47
In this definition
principles are seen as ‘beliefs of fact, causation, and rectitude’, norms are viewed as ‘standards of
behaviour defined in terms of rights and obligations’, while rules are ‘specific prescriptions or
proscriptions for action.’ Finally the decision-making procedures are the ‘prevailing practices for
making and implementing collective choice.’48
Kratochwill and Ruggie broadly define regimes
‘as governing arrangements constructed by states to coordinate their expectations and organize
44
Helfer, L. (2004). p.10 45
Helfer, L. (2004). p.10 46
Rosendal, K.G. (2001). ‘Overlapping International Regimes: The Case of the Intergovernmental Forum on Forest
(IFF) between Climate Change and Biodiversity’.p. 458 47
Krasner, S.D. (1983). ‘Structural Causes and Regime Consequences: Regimes as Intervening Variables’ in
Krasner, S.D. (1983). International Regimes. p. 2 48
Ibid. p. 2
23
aspects of international behaviour in various issue-areas’49
In Young’s version international
regimes are defined as ’social institutions that define practices, assign roles and guide the
interactions of the occupants of these roles within an issue area’50 and international institutions.51
Keohane defines the components of the regime concept in a similar way as other scholars, regime
principles are ‘the purposes that their members are expected to pursue; regime norms are
standards of behavior articulated ‘in terms of rights and obligations’ and regime rules indicate in
greater detail members’ specific rights and obligations.52
A regime’s principles, norms and rules
may be seen as its substantive components.
Using the intellectual property system as an example, the principles of the IPR regime include the
‘recognition of state-created private property in intangible objects that embody human innovation
and creativity and the need to protect that property from unauthorized exploitation across national
borders.’ In the case of norms the regime include ‘an obligation for states to create legal
monopolies (in the form of exclusive rights controlled by private parties) that generate incentives
for human innovation and creativity and to allow foreign creators and inventors to market their
products in different national jurisdictions on an equal footing with local creators and inventors.’
In the IPR regime the rules are made up of ‘the specific prescriptions by which these principles
and norms are given effect, such as the national treatment rule, specific exclusive rights and
minimum standards of protection, and coordinated procedural mechanisms or priority rules.’53
Another element of international regimes is their institutional components, which are the
cooperative arrangements that state actors use to decide on principles, norms and rules.
Arrangements may vary from structured intergovernmental organisations hosting staff, secretariat
and budget, to more ‘informal networks of government officials who exchange information and
coordinate national policies at the other.’54
There is also a third component of international
regimes, their relational aspect, which ‘focuses on the substantive issue areas that are included
within a particular regime and the ways in which they intersect with the issue areas of other
49
Kratochwill, F. and Ruggie, J.G. (1994). ‘International Organization: A State of the Art on an Art of the State’ in
Kratochwill, F. International Organization: A Reader. p. 7 50
Young, O.R. (1994). ‘International Governance – Protecting the Environment in a Stateless Society’. p. 3 51
The concept international institutions are often used interchangeably with the concept international regimes. 52
Keohane, R. (1984). Hegemony: Cooperation and Discord in the World Political Economy. p.107 53
Helfer, L. (2004). p.10 54
Ibid. p.10
24
regimes.’ This relational question of linkage is often controversial, creating conflict among states
and thereby serves as an engine driving regime change.55
The relational component is the main
focus of the coming analysis.
Regime Interaction
A weakness in regime theory has been its tendency to analyse a regime as a ’stand-alone
phenomenon’ that can be analysed without taking into consideration its interaction with broader
or functionally bordering regimes.56 In reality international institutions, like environmental
regimes and trade regimes, increasingly interact, both in synergy and disruption. Interaction is
taking place ‘if one institution affects the institutional development or the effectiveness of
another institution.’57 Interaction between international regimes is often a result of ’externalities
(unintended consequences) of institutional developments within separately defined issue areas.’58
But disruptive interaction may also be an effect of ‘covert activity, as a strategic move by some
of the negotiating parties.’59
These sorts of strategic moves might be occurring when new regimes
with new norms are ‘created to combat and undermine the first’, a counter-regime with ‘counter-
regime norms’60
are negotiated as a way to circumventing the regulatory means and objectives of
the first regime.61
In the literature a number of terms to represent the phenomenon of inter-
institutional influence have arisen, these include: interplay, linkage, interlinkage, overlap and
inter-connection.62
In this thesis the term regime interaction will be used.
Young has been influential in the analysis of interacting regimes. He points to four different types
of interactions between international regimes: Embeddedness – meaning the relationship of a
regime to overarching principles and practices such as sovereignty; Nestedness – represent the
55
Helfer, L. (2004). p. 12-13 56
Stokke, O.S. (2000). ‘Managing straddling stocks: the interplay of global and regional regimes’. p. 221, and
Raustiala, K. och Victor, D.G. (2004). p. 278 57
Oberthuer, S. and Gehring, T. (2006). Institutional Interaction: Enhancing Cooperation and Preventing Conflicts Between
International and European Environmental Institutions. p. 6 58
Rosendal, K.G. (2006). ‘Regulating the Use of Genetic Resources – Between International Authorities’. p. 269 59
Rosendal, K.G. (2001). ‘Overlapping International Regimes: The Case of the Intergovernmental Forum on Forests
(IFF) between Climate Change and Biodiversity’. p. 458 60
Helfer, L. (2004). p.15 61
Rosendal, K.G. (2001). p. 458, and Rosendal, K.G. (2006) p. 269 62
Oberthuer, S. and Gehring, T. (2006). p. 4
25
‘relationship of a smaller institution to a functionally or geographically broader institution’63
;
Clustering - describes the intentional linking of several institutions, such as in the issue are
concerning the law of the sea; Overlap – represent ‘a separate category of linkages in which
individual regimes that were formed for different purposes and largely without reference to one
another intersect on a de facto basis, producing substantial impacts on each other in the process’64
Young further defines this overlap as implying that ‘the functional scope of one regime protrudes
into the functional scope of others.’65
Stokke identifies four different pathways in which regimes interact/interplay: (1) diffusion - is a
situation when one regime influence the material contents of another regime in, for example
assisting in the process of defining ’basic principles or other normative or operational regime
elements’ that have been found to be effective in the first regime; (2) political spillover – ‘is
triggered when interests or capabilities defined under one regime influence the operation of
another’ for example can the possibilities given a state under one regime be mobilised to
influence the operationalization of another regime; (3) normative interplay – this pathway occurs
when ‘the rules upheld in one regime conflict or reinforce those established under another’
regime; (4) operational interplay – points to the ‘deliberate coordination of activities under
separate regimes in order to avoid normative conflict or wasteful duplication.’66
This sort of
coordination is sometimes initiated in the negotiation phase, but may also grow over time when
the ruling body’s of two regimes discovers that their programmes and regulatory work interacts.
The purpose of coordination can be to ‘maximize coherence between norms promulgated in
different regime processes which may become relevant to the same activity and states.’
Arguments have been put forward, that the normative interplay between environmental regimes,
such as the CBD and trade regimes, such as TRIPS, would benefit from more extensive contacts.
A second purpose of operational interplay can be to ‘avoid duplication, or otherwise pool
resources available for problem-solving activities such as scientific research.’67
63
Young, O.R. (1996). ‘Institutional Linkages in International Society: Polar Perspectives’ Global
Governance 2. p. 3 64
Ibid. . p. 6 65
See Rosendal, K.G. (2001). ‘Overlapping International Regimes: The Case of the Intergovernmental Forum on
Forests (IFF) between Climate Change and Biodiversity’. p. 458, referencing Young (1996). 66
Stokke,O.S. (2000). p. 222 67
Ibid. p. 230
26
Raustiala and Victor have a different way to speak about how regimes or judicial arrangements
interact with one another – they view them as a regime complex. A regime complex is seen as ‘an
array of partially overlapping and non-hierarchical institutions governing a particular issue-area.’
Such a complex is marked by the ‘existence of several legal agreements that are created and
maintained in distinct fora with participation of different sets of actors.’68
In the issue area of
traditional knowledge and genetic resources these distinct forums are for example the TRIPS
Council or CBDs Conference of the Parties. The legal arrangements are the rules, principles and
norms of an elemental regime, which is defined as ‘an international institution, based on an
explicit agreement, that reflects agreed principles and norms and codifies specific rules and
decision-making procedures’69
In the international legal system the decision-making processes is
highly disaggregated which have the consequence that ‘agreements reached in one forum do not
automatically extend to.…agreements developed in other forums.’70
The relevant rules pertaining
traditional knowledge and genetic resources are found in at least four international elemental
regimes: the CBD, TRIPS, the ITPGRFA, the UPOV, as well as in ongoing negotiations in
WIPO and several soft law initiatives.
The writings of Oberthuer and Gehring portray a casual relationship between two institutions,
where the source institution influences the target institution.71
What is of interest here are how
the collectively agreed-on norms and decisions of an institution, which prescribe an permit
behavior (output), results at least potentially, in changes of behavior of states and/or substate
actors, such as industry (outcome), changes that have real or potential effects on another
institutions target of governance (impact), ex trade or biodiversity.72
The authors have identified four casual mechanisms in regime interaction. In the two first
mechanisms interaction works in a way that affect the decision-making process in the target
institution. (1) Interaction may be based on the transfer of knowledge from one institution to the
other. In this case the institutions don’t have to overlap or deal with the same issue-area
68
Raustiala, K. and Victor, D.G. (2004). p. 279 69
Ibid. p. 283 70
Ibid. p. 279 71
Oberthur, S. and Gehring, T. (2006). p. 6 72
Ibid. p. 7, 34
27
(Cognitive Interaction)73; (2) A case of interaction may also occur when commitments are made
in one institution (the source) affect the constellation of interests and the decision-making
processes within another institution (the target) so that the end result of the options are effected
(Interaction through Commitment). In this case the issue and membership of the interacting
institutions must overlap so that member states are affected by the commitments.74
In the other two casual mechanisms interaction affects the effectiveness of the target institution
within its own issue-area; (3) Here the source institution may trigger behavioural changes of
actors within its own issue area that affect the effectiveness of the target institution within its
issue area (Behavioural Interaction). This form of interaction occurs outside the decision-making
processes of the two involved institutions and is the effect of non-state actors such as
corporations, NGOs and citizens that are active within the issue area. Here the target institution
are influenced by the source institution at the outcome level (observable influence of behaviour)
when the source institution triggers behavioural effects within its own domain that becomes
relevant for the target institution; (4) Impact-level Interaction occurs when effects on an
institutions target of governance are induced by the source institution at the impact level and
thereby affect the performance and effectiveness of the target institution.75
Regime Shifting
In the international lawmaking of complex issue-areas actors are pursuing their interests in
forums where they most efficiently can favour their interests and has the strongest bargaining
power, and ability to shift ‘negotiation foci according to the dynamics of regime formation.’76
This negotiation strategy has been termed forum shopping: ‘the act of undermining the
regulations emanating from one regime by moving the issue to another forum.’77 The
interchangeable concept of regime shifting has been elaborated by Helfer, who define it as ‘an
attempt to alter the status quo ante by moving treaty negotiations, lawmaking initiatives, or
73
Oberthur, S. and Gehring, T. (2006). p.8 74
Ibid. p.8 75
Ibid. p.8 76
Andersen, R. (2005). p.3 77
Rosendal, G.K. (2006).‘Regulating the Use of Genetic Resources – Between International Authorities’. p. 271
28
standard setting activities from one international venue to another.’78
A powerful state which is
unable to realize its goals and objectives through international treaty negotiations may ‘shift to
domestic lawmaking and enact rules with extraterritorial effects that have much of the same
effect.’ States may as well simultaneously work in multiple domestic and international fora with
parallel lawmaking agendas.79
Forum shifting, according to Braithwaite and Drahos,
‘encompasses three kinds of strategies: moving an agenda from one organization to another,
abandoning an organization, and pursuing the same agenda in more than one organization.’ It is
argued that ’forum-shifting is a strategy that only the powerful and well-resourced can use.’80
Smaller and less powerful states are forced to use reactive strategies, attempting to block forum
shifting activities by powerful nations which doesn’t favour the smaller states interests, or, where
the blocking strategy is impossible, advancing their interests as successful as possible in the new
forum.81
But Helfer holds that also ‘weaker states and networks of states and NGOs can engage
in regime shifting, although the specific rationales and the strategies they employ may differ from
those of well-resourced nations.’82
States and NGOs whom seek to generate counter-regime
norms can shift to ‘another lawmaking venue situated within the same regime (an intra-regime
shift), or they can move to a venue located in an entirely different regime (an inter-regime shift).’
When states move the issue of IPR from multilateral negotiations to regional trade pacts or
bilateral negotiations there is an example of intra-regime shifting, as the case with the so called
TRIPS-Plus agreements. Here Helfer is defining regimes as a cluster of treaties or agreements in
a specific issue area. When rules on ABS are shifted from a multilateral environmental agreement
to forums and intergovernmental organizations which as its main objective is IPR protection, this
is an example of inter-regime shift.83
78
Helfer, L. (2004). p. 14 79
Ibid. p. 14 80
Braithwaite, J. and Drahos. P. (2000) . Global business regulation. p. 564-565. 81
Ibid. p.564-564 82
Helfer, L. (2004) p. 17 83
Ibid. p. 16
29
Table 1 Rationales for regime shifting84
Biodiversity (generally) Plant Genetic Resources
Predominant rationale for post-
TRIPS regime shifting by
developing countries and CSOs
Laboratories to maximize desired
policy outcomes (e.g., controlling
access to national biodiversity and
protecting traditional knowledge)
Laboratories to maximize desired
policy outcomes (e.g., facilitating
access to PGRs in international
seed banks in exchange for benefit
sharing)
Subsidiary rationale for post-
TRIPS regime shifting by
developing countries and CSOs
Integrating new principles, norms,
and rules into TRIPS and WIPO
(e.g., new disclosure rules for
biodiversity patents and protecting TK)
Creating safety valves (e.g.,
protecting farmers’ rights and
traditional knowledge)
Source: Helfer, L. (2004). p. 62
Summarizing the theoretical framework
To realists the state is a central actor: sovereign states are both the primary actors and basic unit
of analysis; inter-state behaviour taking place in an environment of ungoverned anarchy; the
behaviour of states can by understood ‘rationally’ as the pursuit of power defined as interest.’85
Further the realist school assumes that international law and institutions rarely play more than an
epiphenomenal role in the ordering of international relations.86
In critique of the realist position it
is suggested that institutionalization has the capacity to move states beyond self-interest into the
realm of cooperation.87 So even if the system is anarchic it is also normatively regulated, which
makes the assumption of the international system as anarchic over simplified. With
institutionalisation ‘private interest groups and members of civil society’ also plays critical roles
in international rule making. Institutions reflect the power relations prevailing when the
institution where formed, but ‘eventually institutions take on their own life; they become a
battleground of opposing tendencies, ore rivalry institutions may reflect different tendencies.’88
The basis for the analysis in this thesis is that state actors are the primary actors, although other
actors, especially biotechnology corporations, but also civil society organisations, can change
outcomes in international lawmaking.
84
Helfer, L. (2004). p. 62 85
Burchill, S. (2001). p. 85 86
Rosendal, K.G. (2006). p. 270 87
Ruggie, J.G. (1998). Constructing the World Polity: Essays on International Institutionalism. p. 3 88
Cox. R.W (1986). ‘Social Forces, States and World Orders: Beyond International Relations Theory’. in Keohane
R., Neorealism and Its Critics. p. 219
30
Structural power has been defined by Strange as the power ‘to shape and determine the structures
of the global political economy within other states, their political institutions, their economic
enterprises and scientists and other professional people have to have to operate.’89
Of special
interest to this thesis is the structural power in the form of knowledge. Strange argue that
‘whoever is able to develop or acquire and to deny the access of others to a kind of knowledge
respected and sought by others; and whoever can control the channels by which it is
communicated to those given access to it, will exercise a very special kind of structural power’90
In this sense power is uneven distributed amongst state actors – mainly along North-South lines.
This provides a basis for analysing the full importance of knowledge, IPR and the power interests
at play within the IPR and biodiversity regimes.
International regimes are defined as ’social institutions that define practices, assign roles and
guide the interactions of the occupants of these roles within an issue area.’91 International regimes
have further been defined as composite of four analytical component parts: ‘ a sets of implicit or
explicit principles, norms, rules and decision making procedures around which actors’
expectations converge in a given issue area of international relations.’ 92
Consequently regimes
may be seen as being broader than specific organizations or treaties. Although this is the basic
definition of regimes used in this thesis, regimes is also considered as clusters of international
agreements in an specific issue area, for example the IPR regime consisting of TRIPS, UPOV and
the WIPO agreements.
International institutions, like the CBD regime and the TRIPS regime, increasingly interact, both
in synergy and disruption. This interaction is taking place ‘if one institution affects the
institutional development or the effectiveness of another institution.’ A case of interaction is at
hand when the collectively agreed-on norms and decisions of an institution, which prescribe an
permit behavior (output) results, at least potentially, in changes of behavior of states and/or
substate actors (outcome), such as industry, changes that have real or potential effects on another
89
Strange, S. (1988) States and Markets. p. 24-25 90
Ibid. p. 30 91
Young, O.R. (1994). ‘International Governance – Protecting the Environment in a Stateless Society’. p. 3 92 Krasner, S.D. (Ed.) (1983). ‘Structural Causes and Regime Consequences: Regimes as Intervening Variables’ in
Krasner, S.D. (1983). International Regimes International Regimes. p. 2
31
institutions target of governance (impact).93
This definition of regime interaction is used in this
thesis.
In the international lawmaking of complex issue-areas actors are pursuing their interests in
forums where they most efficiently can favour their interests and has the strongest bargaining
power. This negotiation strategy has been termed forum shopping: ‘the act of undermining the
regulations emanating from one regime by moving the issue to another forum.’94 The
interchangeable concept of regime shifting is define as ‘an attempt to alter the status quo ante by
moving treaty negotiations, lawmaking initiatives, or standard setting activities from one
international venue to another.’95
Regime shifting is a concept used to analyse state actors
behaviour in the international game on plant genetic resources and associated traditional
knowledge.
93
Oberthur and Gehring (2006). p. 7, 34 94
Rosendal, G.K.. (2006). p. 271 95
Helfer, L.R. (2004). p. 14
32
Method
Case-study Approach
Yin defines the use of a case study approach as appropriate for the study of ‘a contemporary
phenomenon within its real-life context, especially when the boundaries between phenomenon
and context are not clearly evident’.96
Gustavsson has a similar approach: ‘case-studies are used
predominantly to understand phenomenon which is partly or totally unknown and which contains
large amounts of variables and where connections thereby become complex.’97
The struggle and
management of plant genetic resources and the protection of traditional knowledge fall into this
category of political phenomenon’s, it is a complex web which stretches over several parts of
international politics and law, as well as over several fields of research. To grasp this complex
reality one has to touch upon: law, political science, biology and anthropology. Because of this,
inquiry in this field of research will be wide in scope to give a fair picture of a complex web of
interconnectedness. A case does in principle deal with the interaction between different factors in
a certain situation.98
A case-study can furthermore be seen as a qualitative method, which regards
every phenomenon as a unique combination of qualities and characteristics.99
This thesis is an
interpretative case study as the case is chosen due to an interest in the case per se, rather than for
the purpose of theory building. Furthermore, the subject of this thesis is a case of a field in
international lawmaking with an increasingly number of regime interactions. Here cases of
several different regime interactions and regime shifting behaviour can also be found.
Material, collection and credibility
The material is textual and both primary and secondary in nature. It includes official documents;
convention text, international regimes secretariat documents, statements from different actors and
96
Yin, R.K. (1994). Case Study Research. Design and Methods. p. 13 97
Gustavsson, B. (2004). Kunskapande metoder inom samhällsvetenskapen. p. 115 98
Bell, J. (1995). Introduktion till forskningsmetodik. p. 15 99
Ibid. p. 61
33
decisions (primary). Academic books, and scientific-journal articles serves as secondary material.
The secondary material, on which this thesis is predominantly based, has foremost been collected
via Google Scholar. Search words that have been used are: traditional knowledge, farmers rights,
plant genetic resources for food and agriculture, common heritage, biopiracy, intellectual
property rights, access and benefit sharing, ITPGRFA, CBD, TRIPS and UPOV. These search
words result in an enormous amount of material, which generates selection problem. Also the
document production within regimes and on-going negotiations is extensive and might be seen as
is a salient feature regimes and negotiations, especially for the framework convention approach
of the Convention on Biological Diversity. The next step has been to collect the articles which
most accurately reflected the research case, i.e how international regimes interact and how
traditional knowledge may be protected under international law, through Södertörn University
College e-journal archive. Scholars whom have been extensively cited and seem to have a central
role in the field have been prioritized in the selection. Further, literature lists has been used to
collect relevant material, as a kind of snow-balling. The majority of the literature dates between
2001 and 2008, with some exemptions dating further back and some dating in 2009 and 2010.
Sources have been collected both before and during the writing.
A substantial part of the literature in the field has been read. The strengths with the use of a great
number of written material is that it gives a wide view of the complex debate on traditional
knowledge, genetic resources and intellectual property rights and the development in
international lawmaking. A challenge using this method is also connected to the amount of
material used since the navigation between wearying accounts becomes difficult. The work with
the material has been conducted in following way. Books and articles have been read both briefly
and more deeply. While reading the articles and books notes on how to analyse the texts from the
theoretical framework have been made. Analytical reasoning by scholars has been pushed to, and
reflected upon in, the analysis section of the thesis. Articles that use theory to explain the case of
this thesis have been studied more deeply, to gain insight for the analytical work of this thesis. It
has not been possible to reflect all the positions taken by authors, so the thesis is a patch work of
positions taken by several scholars. Citations are used when scholars have formulated their view
in a precise and painting way.
34
When interpreting the material or within the material itself, potential and actual biases occur, due
to ideology and interest of the reader or the author. It may be argued that ‘credibility in
quantitative research depends on instrument construction, in qualitative research, “the researcher
is the instrument". Thus, it seems when quantitative researchers speak of research validity and
reliability, they are usually referring to a research that is credible while the credibility of a
qualitative research depends on the ability and effort of the researcher.’100
To ensure reliability in
qualitative research, examination of trustworthiness is crucial, ‘trustworthiness of a research
report lies at the heart of issues conventionally discussed as validity and reliability’.101
While the
terms reliability and validity ‘are essential criterion for quality in quantitative paradigms, in
qualitative paradigms the terms credibility, neutrality or confirmability, consistency or
dependability and applicability or transferability are to be the essential criteria for quality.’102
In several contested issues concerning plant genetic resources, traditional knowledge and IPR
scholars are making similar conclusions, but distinct camps of assumptions exist. This thesis
navigate between these camps but mainly stay close to the equity argument for the protection of
traditional knowledge on plant genetic resources and the potential threat intellectual property-
laws pose on protection of biodiversity and traditional knowledge. The analysis and result has
high credibility because of that it draws similar conclusions as several influential scholars. A
selection work from scholars central in the field of regime interaction study and the study of
traditional knowledge, IPR and plant genetic resources are read and thereby give credibility to the
thesis analysis. Also multiple sources are used to strengthen and make the analysis and
conclusions credible.
The use of theory in the analysis
In the analysis the theoretical concepts are used in a way that has been useful to analyse the
noticed phenomenon of regime interactions which affects the protection of traditional knowledge.
This has the effect that not all parts of the theory section are reflected in the analysis. In this sense
100
Golafshani, N. (2003). ‘Understanding Reliability and Validity in Qualitative Research’. p. 597-607. 101
Golafshani, N. (2003). p. 601 102
Ibid. p. 601
35
the theory section also serves as a backdrop to understand why state actors and other actors
behave the way they do. The analysis is structured around interactions between pairs of
international regimes and soft law declarations, but several regimes are analysed under each
section in the analysis. The different regimes are analysed both separately and as clusters: the
conventional IPR regime cluster and the biodiversity and equity regime cluster.
The Nature of Intellectual Property Rights, the Common Heritage and
the Public Domain
The following section discusses the nature of intellectual property rights, such as patents, and
their relation to the concepts of common heritage of mankind, the commons and the public
domain. Harold Demsetz theory of how a change in value of a good gives incentives for
intellectual property rights is reviewed. A brief history of patents on biological material is also
given to give a context to the struggles on IPR, genetic resources and traditional knowledge.
The concept of Intellectual Property Rights
Abstract concepts such as ideas, knowledge or information are today protected in the same
manner as tangible property. An intellectual property right entitles the owner the right to use, to
exclude others from using the intangible resource, and the right to transfer the right to use the
resource to someone else. Intellectual property rights differ from property rights over tangible
resources on the basic that they don’t have any physical boundaries.103
In market-economies intellectual property rights is a part of the institutional framework, despite
the fact that patents means a clear exception from the principle of free competition.104
This
exception is due to the problem of free-riding. The dominant agenda is generally based on the
assumption that when costly research and development activities are undertaken to gain results,
103
Byström, M. and Einarsson, P. (2002). ‘TRIPS: vad betyder WTOs patentavtal för de fattiga ländernas människor
och miljö?’ p. 9 104
Tansey, G. (1999). ‘Trade, Intellectual Property, Food and Biodiversity: Key issues and options for the 1999
review of Article 27.3(b) of the TRIPS Agreement’. p. 3
36
competitors may gain advantages by using these results for commercial purposes without bearing
the costs of initial research. This is viewed by many to have the consequence that companies and
institutions in the long run doesn’t regain their investments and therefore abstain from research
and development. Patents and other forms of intellectual property rights are seen as essential to
solve this problem. In theory the IP system should be balanced in a way where the total
economical societal benefits from innovations are out weighting the societal cost of the
monopoly.105
Accordingly, to prevent that some patents may harm public interest, such as public
health, governments retain the right to over-ride them in certain circumstances, using a
‘compulsory licence’.
To gain insight on the driving forces behind corporate interests for intellectual property rights the
theory of Harold Demsetz is helpful. Demsetz portray the expansion of IPRs in new fields of
technology and societal spheres as a function of changes in value, ‘changes to which old property
rights are poorly attuned.’ He argues that ‘property rights develop to internalize externalities
when the gains of internalization become larger that the costs of internalization.’ These new
property rights therefore are developed ‘in response to the desires of the interacting persons for
adjustment to new benefit-cost possibilities.’106
These ‘persons’ are in the field of life-sciences,
today mainly large corporations.107
So, when the value of a good, technology or a new
application rises, potential owners will pressure governments to change property laws to allow
them to capture the added value.108
In line with this argumentation the value of plant genetic
resources, for both pharmaceutical and breeding purposes, have increased because of
biotechnology, and thereof the expanding interest of IPR protection of these resources. The
revolutionary development in genomics and biotechnology ‘offered economic reward to those
who could isolate genetic sequences and create bioengineered innovations.’109
Because of this,
most developed countries extended patent protection to bio-innovations as a means to encourage
their emerging biotechnology industries. However it may be argued that the change in the
landscape of property rights associated to genetic resources, from an ‘open access or global
commons good to a private or government owned good’ does not entirely relate to the increased
105
Byström, M. and Einarsson, P. (2002). p. 11 106
Demsetz, H. (1967). ‘Toward a Theory of Property Rights’, p. 350 107
On the market concentration within the life-sciences industry see: ETC Group. (2008). ‘Who Owns Nature?
Corporate Power and the Final Frontier in the Commodification of Life’. 108
Raustiala, K. and Victor, D.G. (2004). p. 282 109
Safrin, S. (2007). ’Chain Reaction: How Property Begets Property’, p. 9.
37
actual or potential value of these resources. ‘Indeed, the extent of these rights and the costs of
establishing and maintaining them often exceed the material’s economic value.’110
Here political
struggles for justice and post-colonial distrust in North-South relations play a major role.
There are a number of intellectual property rights but of most relevance to this thesis are patents,
plant breeders’ rights and geographical indications. Here the nature of patents is described, while
the others are described in other parts of the thesis.
Patent is the strongest form of intellectual property protection, a monopoly privilege granted to
innovations after investigation at patent offices. To be granted patent protection an invention
must be; a) new; b) involve an inventive step/non-obvious; c) capable of industrial
application/useful.111
Further the innovation must be sufficiently disclosed to fulfill the
publication criteria.112
All use of the patented innovation, except for some private use, must be
approved or licensed by the owner, during the minimum 20 years the patent is valid for. This
provides the rights holder with an effective monopoly on a particular product or production
process, valid in the country in which it has been issued, this makes patents territorial.
However, there is heated debate on whether the patent system, as it stands today, is the most
effective way to achieve the incentives for research and innovation and if it should include
biological material. Many patent-based industries start out from the research and innovation
previously done by public sector; they fail to address research needs in areas where there is no
market; and even use patents to block new research and competition.113
Biogenetic Resources and Intellectual Property Rights
Two hundred years of legal doctrine that conceptualized life forms as ‘product of nature’ and
therefore not an human invention which may be assigned patent protection, ended with the 1980
110
Ibid. p. 2-3 111
TRIPS Article 27.1 112
Byström, M. and Einarsson, P. (2002). p. 9 113
On the ineffectiveness of to rigorous patent laws see Heller, M.A. and Eisenberg, R. S. (1998).’Can patents deter
innovation? The anticommons in biomedical research’. and Heller, M.A. (1998) ‘The tragedy of the anticommons:
property in the transition from Marx to markets’.
38
U.S. Supreme Court decision in the Diamond v. Chakrabarty case.114
This decision permitted the
practice of patenting living organisms, their parts or components and thereby granting private
monopoly control rights over them and their offspring.’115
What was being decided on was
whether ‘a genetically modified strain of bacteria capable of degrading components of crude oil
and thus useful in cleaning up oil spills was patentable as a new and useful manufacture or
composition of matter.’116
The Court decision however affirmed that components and
phenomena’s of nature are not patentable in theirs natural state. Seen from a Demsetzian point of
view this decision was taken to capture the economic value of the genomics and biotechnology
revolution. During the following ten years after Chakrabarty the propertization of biological
material exploded, with patents on isolated and purified genetic sequences, to ‘man-made plants’
and to animals. 117
New plant varieties were protected by utility patents, some of them so
‘broadly conceived that they covered all seeds and plants of a particular species that were
genetically engineered in any manner’118
Now days a ‘product may be considered patentable
when only slightly modified, discovered or extracted from nature, and, in some jurisdictions,
simply because it is described in chemical terms for the first time.’119
The scientific plant
breeders and pharmaceutical researchers takes the seeds or plant material from the public domain
of knowledge, work and experiment on them, adds the originality of spirit, and manage to breed a
new variety of plant or isolate a chemical active substance and produces a finished work. ‘The
ideas return to the public domain, thus enriching it for future use.’120
But because the researchers
‘originality has marked the form of the work as “unique,” the form or expression becomes his
alone.’ It is the scientists who had the ‘original and innovative insight, who contributed the added
value, and who brought about something new.’ Therefore they are perceived to be the once who
should have the ownership to the end result.121
This idea of the scientific uniqueness began to
represent seeds, breeding and plant material as property. A discursive framework characterized
114
Chapman, A.R. (1998).‘A Human Rights Perspective on Intellectual Property, Scientific Progress and Access to
the Benefits of Science. p. 16 and Diamond v. Chakrabarty, 447 U.S. 303 (1980) 115 Ekpere, J.A. (2000). ‘The OAU's Model Law: The Protection of the Rights of Local Communities, Farmers and
Breeders, and for the Regulation of Access to Biological Resources. An Explanatory Booklet’. p. 5 116
Chapman, A.R. (1998). p. 16 117
Safrin 2007 p. 8 (See Safrin footnotes p. 8 for detailed references to patents on isolated and purified genetic
sequences, ‘man-made plants’ and animals.) 118
Chapman, A.R. (1998). p. 16 119
Swiderska, K. (2006).‘Banishing the Biopirates: A New Approach to Protecting Traditional Knowledge’. p. 6 120
Borowiak, C. (2004). p. 515 121
Ibid. p. 515. Citing James Boyle on ‘the myth of the author’.
39
more by commerce, science, technology and property than by agronomy, community and nature,
gained strength and this changed suited capitalist interests.122
This idea and process effectively
excluded the collective plant breeding practices and plant conservation practises, found in
communities around the world and the traditional knowledge orally transmitted between
generations, from the notion of innovation.
The Common Heritage and the Public Domain
Until the 1980s, nations and individuals considered plant genetic resources as the ’common
heritage of mankind’123
and these resources were managed internationally by a number of loosely
defined practices in an open access regime. These practices imply that plant genetic resources
were a collective resource and that farmer’s seeds and indigenous community’s traditional
knowledge in principle where open for all to access. Further it implied that ‘no one held an
exclusive ownership in this material, and individuals and countries freely shared samples of
seeds, soil and even animal specimens containing it.’124
This concept has a deeply Westerncentric
bias, since it mainly were researchers and corporations from the North that accessed plant genetic
resources from peoples and communities in the South, through the CGIAR system (Consultative
Group on International Agricultural Research) and botanical gardens. However, this was before
the time of expanding intellectual property rights on plant genetic resources, which ended this
open access system. The 1992 Convention on Biological Diversity also changed this practice in
international law of plant collection by strengthening the national sovereignty over
‘undomesticated’ plant genetic resources.
The patent system terms all knowledge which is not protected by IPRs as located in the ‘public
domain’ and thus freely available to all for use in innovative processes. Accordingly, all
knowledge that cannot be protected by IPRs because it does not live up to the subject matter
criteria’s of being new, involve an inventive step and usefulness, are seen by the dominant IPR
agenda as being in the public domain. This may give the ‘impression that the work of local
122
Ibid. p. 515 123
‘The phrase "common heritage of mankind" was derived from Hugo Grotius and brought into contemporary usage
by the Ambassador of Malta, Arvid Pardo, in an address on Nov. 1, 1967 where he spoke of the deep seabed.’ Aoki,
K. (2003). ‘Weeds, Seeds & Deeds: Recent Skirmishes in the Seed Wars’ p. 32-33 (footnote 15) 124
Safrin, S. (2007) p. 1
40
farmers and communities is valueless.’125
Traditional knowledge on medical plants and the
properties of seeds for agricultural purposes thereby is seen as being located in the public
domain126
, also referred to as the commons.127
By treating plant genetic resources and the
associated traditional knowledge as ‘effectively un-owned, the intellectual property law made
that knowledge available for unrestricted exploitation by outsiders. Many of these outsiders used
this knowledge as an upstream input for later downstream innovations that were themselves
privatized through patents, copyrights, and plant breeders rights’128
The fact that traditional
knowledge is treated as to be located in the public domain ‘is likely to encourage the presumption
that nobody is harmed and no rules are broken when research institutions and corporations use it
freely.’129
The notion of the public domain is accordingly at the core of the heated struggles over
traditional knowledge, genetic resources and IPR.
Summary
Abstract concepts such as ideas, knowledge or information are today protected in the same
manner as tangible property. An intellectual property right entitles the owner the right to use, to
exclude others from using the intangible resource, and the right to transfer the right to use the
resource to someone else. Intellectual property rights are developed in response to the desires of
corporations to capture new commercial possibilities and avoid free-riding. Most developed
countries extended laws an patent protection to bio-innovations as a means to encourage their
emerging biotechnology industries. To be granted patent protection an invention must be; a) new;
b) involve an inventive step/non-obvious; c) capable of industrial application/useful. The
outcome of the 1980 Diamond v. Chakrabarty case permitted the practice of patenting living
125
Kameri-Mbote, P. (2003). ‘Community, Farmers´ and Breeders Rights in Africa: Towards a Legal Framework for
Sui Generis Legislation’ p. 11 126
The NGO GRAIN asks difficult questions in relation to the 500,000 designated accessions held as “public
domain” by the CGIAR. ‘What if the farmers or indigenous groups consider the seeds part of their heritage and want
to have a certain kind of control over who accesses them, how they are used and what happens to them? What if they
have their own proactive understanding of sovereignty – not necessarily vested in national governments, the FAO or
the CGIAR for that matter – which applies? Are the sovereign rights of indigenous peoples, which are increasingly
getting crystallised in national and international law, properly accounted for through this “public domain” tag? What
if they see these seeds, these plant varieties taken from their lands and farms, as subject to collective rights –
historically, today and for the future? Are these collective rights compatible with “public domain”?
GRAIN. (2002). ‘Biopiracy by Another Name? A critique of the FAO-CGIAR trusteeship system.’ 127
Phillips, P.W.B. and Onwuekwe, C.B (2007). p. 8 128
Helfer, L. (2003). ‘Human Rights and Intellectual Property: Conflict or Coexistence?’ 129
Dutfield, G. (2001). ‘TRIPS-Related Aspects of Traditional Knowledge’. p.233, 238, 247
41
organisms, their parts or components and thereby granting private monopoly control rights over
them and their offspring.’130
Nowdays a ‘product may be considered patentable when only
slightly modified, discovered or extracted from nature, and, in some jurisdictions, simply because
it is described in chemical terms for the first time.’131
Until the 1980s, nations and individuals
considered plant genetic resources as the ’common heritage of mankind’ and these resources
were managed internationally by a number of loosely defined practices in an open access regime.
These practices imply that plant genetic resources were a collective resource and that farmer’s
seeds and indigenous community’s traditional knowledge in principle where open for all to
access, though mostly researchers from developed countries. The expanding web of IPR in
national and international law and the sovereignty principle of CBD put a strain on the open
access principle. The patent system terms all knowledge which is not protected by IPRs as
located in the ‘public domain’ and thus freely available to all for use in innovative processes.
Traditional knowledge on medical plants and the properties of seeds for agricultural purposes
thereby is seen as being located in the public domain and thereby as unowned.
130 Ekpere, J.A. (2000. p. 5 131
Swiderska, K. (2006).‘Banishing the Biopirates: A New Approach to Protecting Traditional Knowledge’. p. 6
42
The Nature of Traditional Knowledge
To answer the question ‘how do provisions in the international regimes on IPR, plant genetic
resources and traditional knowledge affect the possibilities of protecting traditional knowledge,
under international law’ the following section outlines the nature and characteristics of the
concept Traditional Knowledge. The concept is defined from its roots in the local sphere and also
by its linkage to indigenous peoples. The risk of reproducing the image of “the noble savage” is
briefly touched upon.
The knowledge held by indigenous132 and local communities has been transmitted and evolved
from generation to generation under local laws, customs and traditions. This traditional or
indigenous knowledge has been and still is vital for food sovereignty133, agricultural development
and medical treatment and therefore central in the daily life of many communities in the global
south but also exists in highly industrialized and secular societies, as Sweden. This traditional
knowledge has been defined as:
‘...the content or substance of knowledge that is the result of intellectual activity and
insight in a traditional context, and includes the know-how, skills, innovations,
practices and learning that form part of traditional knowledge systems, and knowledge
that is embodied in the traditional lifestyles of a community or people, or is contained
in codified knowledge systems passed between generations. It is not limited to any
specific technical field, and may include agricultural, environmental and medicinal
knowledge, and knowledge associated with genetic resources.’134
132
Indigenous people refers to those people ‘who are regarded as indigenous on account of their descent from the
populations which inhabit the country, or a geographical region to which the country belongs, at the time of conquest
or colonization or the establishment of present state boundaries and who, irrespective of their legal status, retain
some or all of their own social, economic, cultural and political institutions.’
Article 1, International Labor Organization Convention Concerning Indigenous and Tribal Peoples in Independent
Countries, June 1989 (referred to as ILO Convention 169). 133
FAOs definition of food security: ‘Physical and economic access, at all times, to sufficient, safe and nutritious
food to meet dietary needs and food preferences for an active and healthy life’. Today many indigenous peoples,
small-farmer organizations and NGOs talks about, not just food security but also of community sovereignty over its
resources; land, water and genetic resources. The over-arching concept is today Food Sovereignty. ’Food
Sovereignty is the right of peoples, communities, and countries to define their own agricultural, labour, fishing, food
and land policies which are ecologically, socially, economically and culturally appropriate to their unique
circumstances. It includes the true right to food and to produce food, which means that all people have the right to
safe, nutritious and culturally appropriate food and to food-producing resources and the ability to sustain themselves
and their societies.’
Food Sovereignty: A Right For All, Political Statement of the NGO/CSO Forum for Food Sovereignty, June 14 2002. 134
, WIPO (2004). ‘The Protection of Traditional Knowledge: Outline of Policy Options and Legal Elements.’ Annex
1, para. 54 or B.3(2)
43
Under the concept of traditional knowledge very different types of knowledge is meant. These
may be distinguished by ‘the elements involved, the knowledge’s potential or actual application,
the level of codification, the individual or collective form of possession, and its legal status’.135
The holders of TK can be one individual (eg healing practices and rituals), several individuals or
everyone belonging to a local community or an indigenous people (common knowledge).136
The
majority of indigenous and traditional communities have a ‘strong sharing ethos, but this does not
mean that everything is shared with everybody.’137
Concepts similar to terms like ‘ownership’
and ‘property’ exists in most if not all traditional societies. Custom-based ‘intellectual property’
systems, with rules governing access to knowledge, are diverse and complex and exist in many
traditional communities. Despite this, it is often assumed that traditional knowledge is shared
freely and where some sort of property rights exist, these are assumed to be collective rather than
individual as in formalised Western property rights systems.138
The commonly held knowledge
might be the knowledge on herbal-home medicines held by the majority of rural women and
elders. TK may be codified, i.e. formalised in for example textile design or ayurvedic traditional
medicine, but a great part is non-codified.139
‘Traditional knowledge’ and ‘indigenous knowledge’ might not be seen as synonymous, even
though they share many attributes, such as being unwritten, customary, pragmatic, experiential
and holistic. Having this said the primary distinction between these two pertains to the holders of
the knowledge rather than the knowledge per se. Traditional knowledge is a broader concept
which applies to the knowledge held by a vast set of local communities, while indigenous
knowledge is the knowledge held by relatively clearly defined indigenous communities and
peoples. The characteristics of traditional and indigenous knowledge include (1) localness,
(2) oral transmission, (3) origin in practical experience, (4) emphasis on the empirical rather than
theoretical, (5) repetitiveness, (6) changeability, (7) being widely shared, (8) fragmentary
distribution, (9) orientation to practical performance, and (10) holism.140
Here the word ‘tradition’
135
Correa, C.M. (2001). ‘Traditional Knowledge and Intellectual Property: Issues and options surrounding the
protection of traditional knowledge’. p. 4 136
Haugen, H.M. (2005) ’Traditional Knowledge and Human Rights’p. 665 137
Dutfield G. (2005). ‘Legal and Economic Aspects of Traditional Knowledge’ in Maskus, K.E. and Reichman, J.H.
(Eds.) International public goods and transfer of technology under a globalized intellectual property regime. p. 501 138
Dutfield G. (2004). p. 95 139
Corrrea, C.M. (2001). p. 4 140
Bruch, S.B. (2005). ‘Farmers´ Rights and Protection of Traditional Agricultural Knowledge’ p. 8-9
44
is defined in a positive sense to mean customs, laws, practices and beliefs that are passed down
within a community. But ‘tradition’ was also the crime of handling over sacred text and
information about a community to foreign persecutors, and the word thereby share its roots with
‘traitor’ and ‘betrayal’. Today the same relationship concerning traditional and sacred knowledge
may apply, when this knowledge is transmitted and made available to the public or foreign
interests and thereby is seen as a betrayal or a violation of customary laws, which causes offence
or damage the community.141
Communities that are in the view of knowledge as a good which
can not be shared without it’s diminish or loss of its original flame, does not view knowledge as a
non-rivalrous public good.142
It may be argued that ‘knowledge is not ‘traditional’ because of its specific subject matter or
content, nor its age or antiquity, nor for that matter its aesthetic qualities. What makes it
traditional is the way it has been preserved and transmitted between generations within a
community.’143
This definition gives TK a local character, where it is embedded in social
structures that ‘create, use, preserve and pass down TK between generations, and the customary
laws...that govern these processes, are deeply rooted in their traditional location and community
setting’144
and integral to the land and environment. Further, traditional knowledge may not be
viewed simply as information since it has an inherent normative and social component. Though,
as information it can easily be communicated to outside interests, while the norms, social
practices and values that makes up the ‘traditional’ aspect is not as easily transmitted.145
Here it
may be pointed out that ‘indigenous knowledge is, in the main, something more than matter of-
fact information. Rather, it is usually invested with a sacred quality and systemic unity, supplying
the foundation on which members of a traditional culture sense their communitas, personal
identity, and ancestral anchorage.’146
141
Taubman, A. (2005). ’Saving the village: Conserving jurisprudential diversity in the international protection of
traditional knowledge’. in Maskus, Keith E. and Reichman, Jerome H. (Eds.) International public goods and
transfer of technology under a globalized intellectual property regime. p. 522 142
Ibid. p. 522 143
Ibid. p. 523 144
Ibid. P 523 145
Ibid. p. 523 146
Greaves, T. (1996). ‘Tribal Right’ in Brush, S.B. and Stabinsky, D. (Eds.) Valuing Local Knowledge: Indigenous
Peoples and Intellectual Property Rights. p. 26
45
It is important to point out that traditional knowledge is knowledge, like mathematics, biology or
sociology and one should not conclude that TK is inherently unscientific, because ‘a great deal of
traditional knowledge is empirical and systematic.’147
What makes TK distinct is that it has been
‘carefully and patiently created, built, nourished, circulated and promoted by common, non-
powerful people: small farmers, fisher folk, hunter-gatherers, traditional healers, midwives,
artisans, traditional poets, and many others.’ Since a large number of these people make out rural
cultures, such knowledge is intimately linked to the understanding of natural processes.148
This
traditional environmental knowledge is characterized as:
‘....a body of knowledge built by a group of people through generations living in close
contact with nature. It includes a system of classification, a set of empirical observations
about the local environment, and a system of self-management that governs resource use.’149
Further the traditional environmental knowledge and customary laws are often shaped by
spiritual beliefs in relation to natural resources and landscapes. For example, Andean Quechua
farmers believe that knowledge and customary laws come from sacred mountains that are their
‘teachers’. In India members of the Yanadi tribe holds in belief that their knowledge comes from
the gods and goddesses that reside in sacred forests. Many indigenous conservation norms are
based on fear of upsetting the gods that provide seeds, knowledge and natural resources.150
Traditional knowledge is not static, it is ‘continuously evolving, integrating new knowledge into
a rich pool that has been tested and enriched over centuries.’151
This new knowledge or
information is a result ‘of improvements or adaptations to changing circumstances.’152
This
means that the TK handed down from one generation to another, is not necessary the same
knowledge which it is passing on.153
This suggests that innovation is taking place amongst
holders of traditional knowledge. It is therefore a misconception that developments in plant
147
Dutfield G. (2004). p. 94 148
GRAIN. Jargon Buster: Knowledge. 149
Johnson, M. (1992). Lore: Capturing Traditional Environmental Knowledge. p. 3-4 cited in Dutfield, G. (2004).
Intellectual Property, Biogenetic Resources and Traditional Knowledge. p. 91 150
Swiderska, K. (2006).‘Banishing the Biopirates: A New Approach to Protecting Traditional Knowledge’. p. 14 151
GRAIN. Jargon Buster: Knowledge. 152
Correa, C.M. (2001). p. 4 153
Dutfield G. (2004). p. 95
46
resources-related knowledge ‘are mere discoveries of “natural phenomena” waiting for the
fortunate discoverer.’154
This plant resource-related knowledge (PRRK) is the knowledge ´related
to plants, whether modified or not and….knowledge of the use(s) of the plant itself, parts or
derivates thereof’155
It also has to be pointed out that the protection of traditional knowledge held
by rural communities and indigenous peoples is not about the reinvention of the ‘Noble Savage
all over again’ as suggested by some.156
The defence of traditional knowledge is not about a
romanticism of a ‘primitive’ past, but about concrete struggles for liberation from oppression and
recognition of a space in the world system. Expressed by a traditional healer in Nigeria: ‘If you
feel exploited or dispossessed of your goods or knowledge, and believe that someone else is
profiting without any consideration for you, then you feel a sense of indignation.’157
Summarizing the Nature of Traditional Knowledge
Traditional knowledge may be defined as: ‘...the content or substance of knowledge that is the
result of intellectual activity and insight in a traditional context, and includes the know-how,
skills, innovations, practices and learning that form part of traditional knowledge systems, and
knowledge that is embodied in the traditional lifestyles of a community or people, or is contained
in codified knowledge systems passed between generations. It is not limited to any specific
technical field, and may include agricultural, environmental and medicinal knowledge, and
knowledge associated with genetic resources.’158
The characteristics of traditional and indigenous
knowledge include (1) localness, (2) oral transmission, (3) origin in practical experience, (4)
emphasis on the empirical rather than theoretical, (5) repetitiveness, (6) changeability, (7) being
widely shared, (8) fragmentary distribution, (9) orientation to practical performance, and (10)
154
Mobeoji, I. (2001). ‘Patents and Plant Resources-Related Knowledge: Towards a Regime of Communal Patents
for Plant Resources-Related Knowledge’ p. 81. 155
Ibid. p. 92 156
Lange, D.L. (2005). ‘Comment: Traditional Knowledge, folklore and the case for benign neglect’ in Maskus, K.E.
and Reichmann, J.H. (Eds.) International public goods and transfer of technology under a globalized intellectual
property regime. p. 596 157
Tovioujdi, Louis M. a traditional healer from the district of Avrankou in south-east Benin, near the Nigerian
border. In Seedling October 2007 p. 9 158
WIPO (2004). Annex 1, para. 54 or B.3(2)
47
holism.159
Traditional knowledge may not be viewed simply as information since it has an
inherent normative and social component. Though, as information it can easily be communicated
to outside interests, while the norms, social practices and values that makes up the ‘traditional’
aspect is not as easy transmitted.160
159
Bruch, S.B. (2005). ‘Farmers´ Rights and Protection of Traditional Agricultural Knowledge’ p. 8-9 160
Taubman, A. (2005). p. 523
48
Bioprospecting - Legalized Biopiracy or a Fair Deal?
In following section the contested concepts and phenomenon’s of bioprospecting and biopiracy
are outlined to form the basis for understanding the heated negotiations on genetic resources and
associated traditional knowledge, taking place in TRIPS Council, the COP of the CBD and
WIPOs Committee on traditional knowledge and genetic resources. A large number of patents
have been granted on plant genetic resources, and the associated traditional knowledge,
obtained from developing countries, without the consent of the original possessors. In the
following section some of the most well-known cases are described.
The concept of Bioprospecting
The concept bioprospecting has recently been coined to describe ‘the centuries-old practice of
collecting and screening plant and other biological material for commercial purposes’161
, such as
the development of new drugs, seeds and cosmetics. Institutions and corporations, especially
from the pharmaceutical and food industries, that undertake bioprospecting activities wish to
uncover information from the collected genetic resource that will eventually lead to a new
commercial product. This information or ‘good’ may be in the form of genes useful to
biotechnology, chemical useful for enzymes, and biological structures and constructs useful for
industrial purposes. To give an example of the potentials, less than one percent of flowering
plants have been thoroughly investigated for their chemical composition.162
Further wild relatives
of domestic crops provide a variable genetic pool-resource which may be crucial in example
overcoming disease outbreaks or for adjusting crops to climatic change.163
The biogenetic
information is sometimes acquired from local communities and indigenous peoples, including
shamans and native healers. Conservationists have argued that bioprospecting plays a part in
conserving tropical forests, coral reefs and other ecosystems with high biodiversity. The
argument builds on the assumption that when highlighting the economic potential of biogenetic
resources this will also help the conservation of biologically diverse and threatened ecosystems.
When acquiring knowledge from genetic resources, bioprospectors seek intellectual property
rights (e.g. patents or plant variety protection) on ‘the resulting product to gain competitive
161
Graham, D. (2003) ’Bioprospecting: legitimate research or 'biopiracy'?’ 162
Rosendal, K.G. (2007). ‘Regulating conservation and use of biodiversity: Science and Politics’. p. 1-2 163
Ibid. p. 1-2
49
advantage through exclusive market rights.’164
The IPRs protecting the results are often so close
to the original genetic resource and the associated traditional knowledge so that they actually may
constitute a form of biological and intellectual piracy - biopiracy.165
The concept of Biopiracy
Biopiracy is a contested phenomenon and concept for which there is no consensus definition. It
has been defined by the Action Group on Erosion, Technology and Concentration (ETC Group)
as ‘the appropriation of the knowledge and genetic resources of farming and indigenous
communities by individuals or institutions seeking exclusive monopoly control (usually patents
or plant breeders' rights) over these resources and knowledge.’166
Individuals, institutions and
corporations from developing countries hereby free-ride on the biogenetic resources and
traditional knowledge of peoples and communities in developing countries. The UK Government
Commission on Intellectual Property Rights has described biopiracy in a two folded ways:
a) The granting of ‘wrong’ patents. Patents granted for inventions that are either not novel or are
not inventive in relation to traditional knowledge already in the public domain. ‘Such patents may
be granted due either to oversights during the examination of the patent or simply because the
patent examiner did not have access to the knowledge.’ This might be the case because the
knowledge it is written down but not accessible using the tools available to the examiner, or
because it is unwritten oral knowledge.167
b) The granting of ‘right’ patents. ‘Patents may be correctly granted according to national law on
inventions derived from a community’s traditional knowledge or genetic resources. It could be
argued this constitutes “biopiracy” on the following grounds:
• Patenting standards are too low. Patents are allowed, for instance, for inventions which amount
to little more than discoveries. Alternatively, the national patent regime (for example, as in the
US) may not recognise some forms of public disclosure of traditional knowledge as prior art.
164
Swiderska, K. (2006). p. 4 165
Graham, D. (2003) ’Bioprospecting: legitimate research or 'biopiracy'?’ 166
ETC Group. Issues. www.etcgroup.org/en/issues 167
Commission on Intellectual Property Rights. (2002). p. 74
50
• Even if the patent represents a genuine invention, however defined, no arrangements may have
been made to obtain the prior informed consent (PIC) of the communities providing the
knowledge or resource, and for sharing the benefits of commercialisation to reward them
appropriately in accordance with the principles of the CBD.’168
Further a wide range of acts related to collection and use, listed below, have been considered as
acts of biopiracy: the unauthorized use of common TK on genetic resources; the unauthorized use
of TK on biogenetic resources only found among one indigenous group; the unauthorized use of
TK and biogenetic resources acquired by deception or failure to fully disclosure the commercial
motive behind the acquisition; the unauthorized use of TK and biogenetic resources acquired on
the basis of a transaction deemed to be exploitative; the unauthorized use of TK acquired on the
basis of a conviction that all such transactions are inherently exploitative ('all bioprospecting is
biopiracy'); and the commercial use of TK on the basis of a literature search.169
Biopiracy, or in other words the misappropriation of biogenetic resources and traditional
knowledge, both in the past as well as today takes place because of ‘insufficient understanding of
the community rules, rituals and expertise that preserved and improved varieties of plants, which
may look wild compared to a pruned French garden, but are equally cultivated.’170
The acts of
biopiracy ‘undervalue the bioresource economically, culturally, nutritionally and spiritually.’171
Further, in exercising their IPRs corporations force the original cultivators to pay royalties to
them when using their changed seeds or plant material. While not denying the technological
contribution, the fact is that corporations first deny recognizing the contribution of the original
custodians. Since biopiracy is ‘not just a matter of law, but also one of morality and of fairness, it
is not always easy to draw the line between an act of biopiracy and a legitimate practice.’172
Today it is hard to evaluate how much biopiracy actually takes place, there is a large information
gap, although some work has been done, for example identifying thirty-six cases from African
168
Commission on Intellectual Property Rights. (2002). p. 74 169
Tansey, G. and Rajotte, T. (2008). p. 148 170
Mushita, A.T. and Thompson, C.B. (2007). Biopiracy of Biodiversity: Global Exchange as Enclosure. p. 15 171
Ibid. p. 21 172
Tansey, G. and Rajotte, T. (2008). p. 147
51
countries.173
But the answer of how much biopiracy actually taking place, also depends on how
one ‘differentiates between legitimate and unfair exploitation’ and whether resources are
considered to be wild and unowned or domesticated and owned. Often genetic resources
‘considered 'gifts of nature' in fact result from many generations of selective crop breeding and
landscape management.’174
Cases of Biopiracy
Neem
The Neem tree (Azadirachta indica)175
is a versatile evergreen growing in India and other parts of
South and Southeast Asia and is planted across the tropics because of its properties as a natural
medicine, pesticide and fertilizer.176
The residue of neem seeds, after oil has been extracted, has
been used for generations against hundreds of pests and fungal diseases that attack food crops and
the oil extracted from its seeds is used to treat colds and flu and, mixed in soap and toothpaste, it
is believed to offer low-cost relief from malaria, skin diseases and even meningitis.177
Additionally, small branches of the neem tree have been used as an antiseptic toothbrush.178
The neem tree has been the subject to a large number of patents, with 40 in the US alone and at
least 150 globally.179
These patents are held by companies such as W.R. Grace & Co., the Native
Plant Institute, and the Japanese Terumo Corporation. In 1971 a US scientist, Robert Larson,
whom was aware of the multiple uses of the neem tree in India, imported and started research on
neem seeds in the US. This resulted in the production and patenting of the pesticide named
173
See McGown, Jay (2006) ‘Out of Africa: Mysteries of Access and Benefit Sharing’. Discovering 36 cases of
probable biopiracy in Africa, during just one month’s investigation. Further the cost of biopiracy has been estimated
to cost the developing countries $US 50 billion. This is as much as the global aid budget. See also Shiva, V. (2004)
‘TRIPS, Human Rights and the Public Domain´ p. 667 174
Tansey, G. and Rajotte, T. (2008). p. 148; see also Young, T. (2005). ‘Analysis of Claims of Unauthorised Access
and Misappropriation of Genetic Resources and Associated Traditional Knowledge’. 175
Hindi for ’the free tree’. 176
Aoki, K. (1998). ‘Neocolonialism, Anticommons Property, and Biopiracy in the (Not-so brave) New World Order
of International Intellectual Property Protection’. p. 14; Commission on Intellectual Property Rights. (2002). p. 77 177
O´Connor, B. (2003). ‘Protecting Traditional Knowledge: An Overview of a Developing Area of Intellectual
Property Law’. p.682 178
Aoki, K. (1998). p. 14 179
Dutfield, G. (2004). p. 52
52
Margosan-O, made from neem extract. In 1988 Larson sold his patent to W.R. Grace & Co. and
in 1994 W.R. Grace and the US Department of Agriculture were granted a European patent for a
‘method for controlling fungi on plants by the aid of a hydrophobic extracted neem oil.’180
In
June 1995, a legal opposition against the grant of this patent was filed181
and succeeded in 2000
when the EPO revoked the patent on the grounds of lack of novelty and inventive step.182
This
was because of that Indian holders of traditional knowledge (in the public domain) for centuries
had known and used hydrophobic extract both in Ayurvedic medicine183
to cure dermatological
diseases and in traditional agricultural practice to protect crops from being destroyed by fungal
infections.
An effect of the W.R. Grace patent on neem was that the corporation set up a plant and network
to process twenty tons of neem seed per day. This made neem seed prices go up from 300 rupees
per ton to 3000 to 4000 rupees per ton, turning: ‘an often free resource into an exorbitantly priced
one, with the local user now competing for seed with an industry that is supplying wealthy
consumers in the North.’184
As the local farmer cannot afford the market price, the diversion of
the seed as raw material from the community to industry will ultimately establish a regime in
which a handful of companies holding patents will control all access and all production related to
neem as raw material.185
Turmeric
Turmeric (Curcuma longa) is a plant of the ginger family yielding saffron-coloured rhizomes
used as a spice for flavouring Indian cooking. It has been used as a dye, medicine and flavouring
since 600 B.C. In 1280, Marco Polo described Turmeric as ‘a vegetable with the properties of
180
European Patent No. 436 257 B1 was granted by the European Patent Office on 14 September 1994. For a more
recent patent filed in the US see e.g., US Patent 6,623,766, of September 2003, assigned to the Council of Scientific
and Industrial Research (CSIR) an autonomous institution under the Department of Science and Technology,
Government of India, concerning the insecticidal formulation of neem controlling malaria vector. 181
By Magda Aelvoet, Member of the European Parliament, on behalf of the Green Group in the European
Parliament, Brussels, Dr Vandana Shiva, on behalf of the Research Foundation for Science, Technology, and Natural
Resource Policy, New Delhi, and the International Federation of Organic Agriculture Movements, based in
Germany. 182
Dutfield, G. (2004). p. 52 183
Ayurveda is an Indian system of traditional medicine and healing that originated thousands of years ago. The
word is a combination of two Sanskrit words: Ayu which means life and Veda which means the knowledge. 184
Aoki, K. (1998). p. 14 185
Ibid. p. 14
53
saffron, yet it is not really saffron.’186
Turmeric has been used medicinally throughout Asia to
treat stomach and liver ailments. It also has properties that make it effective to used externally to
heal wounds and rashes.187
In 1995, two Indian nationals at the University of Mississippi Medical
Centre were granted US patent on ‘use of turmeric in wound healing’.188
The Indian Council of
Scientific and Industrial Research (CSIR) filed a request to the US USPTO to re-examine the
patent. The CSIR based its argumentation on the fact that turmeric has been used for thousands of
years for healing wounds and rashes and therefore its medicinal use was not novel. The challenge
for the CSIR was to find published information on the use of turmeric.189
This was found in
thirty-two references, amongst them a ancient Sanskrit text and a paper published in 1953 in the
Journal of the Indian Medical Association. Despite arguments by the patentees, the USPTO
upheld the CSIR objections and revoked the patent in August 2002.190
In spite of the fact that the
decision on the Turmeric case appeared later than the revocation of the neem patent, this case
attracted even more attention from the public. This case put focus on the problem areas in
challenging the laws of a foreign jurisdiction with common and traditional knowledge. The
lessons learnt and problem areas as identified by the CSIR after the Turmeric experience can be
summarized thus:
- there is a wide gap in the availability of information for patent examination purposes pertaining
to TK bases from biodiversity-rich third-world countries. Traditional knowledge therefore needs
to be documented and put into the public domain to discourage the grant of patents based on the
centuries-old use of natural products. Although re-examination proceedings are available in US
and European patent laws the costs for bringing a case for re-examination are high, which makes
this sort of procedure not feasible at all time and certainly not for indigenous and local peoples.
However people could continue to sell or use turmeric in whatever form, despite the patent. What
was offensive was the very idea an exclusive right to sell and use turmeric for the purpose of
wound healing as claimed in the patent. The ‘affected interest’ may not be easily tracked unless
there is a substantial market potential for the patented product.
186
O´Connor, B. (2003). p. 682 187
Commission on Intellectual Property Rights. (2002). p. 76 188
US Patent no. 5,401,504 granted on March 28 1995. available at http://patft.uspto.gov 189
Dahr, B. and Anuradha, R.V. (2004). ‘Access, Benefit-Sharing and Intellectual Property Rights’ p. 604 190
Commission on Intellectual Property Rights. (2002). p. 76
54
Ayahuasca
The use of the bark from the plant Banisteriopsis caapi, by shamans of indigenous peoples in the
Amazonian Peru, Ecuador, Bolivia, Columbia, and Western Brazil, to prepare the ceremonial
drink Ayahuasca for medicinal and ritual purposes has existed for generations and was observed
as early as the 1850s by British and German ethno-botanists.191
Ayahuasca means ‘vine of the
spirits’ on the language of the Amazon Quichua people and it has hallucinogenic properties used
in sacred rituals.192
The USPTO granted in 1986 a patent on ayahuasca to an US scientist, after
research in the Ecuadorian Amazonia.193
The patentee claimed that an alleged variety of
Banisteriopsis caapi, given the name ‘Da Vine’, represented a new and distinct variety, primarily
because of the flower colour.194
This patent was revoked in 1999 because of evidence of earlier
publications on the properties of Ayahuasca, presented by Coordinating Body for the Indigenous
Organizations of the Amazon Basin (COICA)195
, the Coalition for Amazonian Peoples and Their
Environment, and lawyers at the Center for International Environmental Law (CIEL).196
However, the USPTO reversed its rejection in January 2001 and issued a certificate allowing the
patent to stand for the remaining two years of its term.197
This case could be seen as an example
of biopiracy through a ‘wrong’ patent, a patent granted for an invention that are either not novel
or are not inventive in relation to traditional knowledge already in the public domain.
Hoodia Cactus198
Certain groups of the San people, Khomani, who live around the Kalahari Desert in southern
Africa, have traditionally eaten the Hoodia cactus as an appetite depressor to stave off hunger and
thirst on long hunting trips on the run. In 1937, a Dutch anthropologist studying the San noted
this use of Hoodia.199
Also South African soldiers, who used the help of the Khomani people in
191
Cottier, T. and Panizzon, M. (2004). ‘Legal Perspectives on Traditional Knowledge: The Case for Intellectual
Property Protection’ in footnote no. 8 on p. 374 192
O´Connor, B. (2003). p.682 193
US Plant patent No 5,751, held by Loren Miller. 194
O´Connor, B. (2003). p.683 195
An umbrella organization representing over 400 indigenous groups; see http://www.coica.org.ec/ 196
Correa, C. (2001). p. 18; see also http://www.ciel.org/Biodiversity/ayahuascapatentcase.html and also
http://www.amazonlink.org/biopiracy/ayahuasca.htm on indigenous protests against the Ayahuasca patent. 197
O´Connor, B. (2003). p.683 198
The Hoodia cactus is a succulent plant. http://en.wikipedia.org/wiki/Hoodia 199
Commission on Intellectual Property Rights. (2002). p. 77
55
tracking during the 1980s when Namibia gained national independence, noticed this practice.200
Scientists at the South African Council for Scientific and Industrial Research (CSIR), a
government institution only recently began research on the plant. As a result of this CSIR
patented Hoodia’s appetite-suppressing element (P57) in 1995. The Khomani people is not
mentioned at all in the patent specification.201
Two years later CSIR licensed P57 to Phytopharm,
a UK biotech company. In 1998, the pharmaceutical giant Pfizer acquired the rights to develop
and market P57 as a potential slimming drug and cure for obesity (a market worth more than £6
billion), from Phytopharm for up to $32 million in royalty and milestone payments. This was
done without even notifying the San people, let alone getting their prior informed consent to
comply with the CBD, to such a transaction. Some observers argue that initial reluctance to engage
the San as partners was due to concern that expectations would be raised, that the genuine holders
of traditional knowledge about Hoodia could not be identified, and that this would be challenged
by other groups holding this knowledge. But surprisingly Phytopharm representatives claimed
they believed the San peoples who used Hoodia were extinct. In actuality, the San number
100,000 across South Africa, Botswana, Namibia, and Angola.202
Most of the remaining San
were at the time living in a tented camp 1500 miles from their tribal lands.203 The head of
Phytopharm even stated that ‘the evidence seems to show that they (the Khomani) used the plant
as a food supplement and didn’t even think about obesity.’(!!)204
On hearing of possible
exploitation of their traditional knowledge, the San People threatened legal action against the
CSIR on grounds of biopiracy and demanded benefit sharing. Only after public pressure and wide
criticism of CSIR and Phytopharm for failing to get the consent of the San or to recognize the
role that San knowledge had played in identifying the ethnobotanical properties of Hoodia, were
the San offered a benefit sharing arrangement in March 2002. The San’s share in the arrangement
amounted to less than 0.003% of net sales and was only to come out of CSIR’s share in the deal;
Phytopharm's and Pfizer’s incomes are to go untouched205
, but it may amount to a substantial size
in considering the potential market for an obesity drug.206
It has been agreed among the San
200
Dutfield, G. (2004) p. 51 201
Dutfield, G. (2004). p. 52 202
Harry, D. and Kanehe, Le`a M. (2005).’The BS in Access and Benefit Sharing (ABS): Critical Questions for
Indigenous Peoples’. p. 98 203
Commission on Intellectual Property Rights. (2002). p.77 204
Dutfield, G. (2004). p. 52 205
Harry, D. and Kanehe, Le`a M. (2005). p. 98 206
Commission on Intellectual Property Rights. (2002). p.77
56
exercise to link benefit-sharing to specific communities was divisive and that benefits must be
shared equally amongst all San groups.207
This will be done through the San Hoodia Benefit-
Sharing Trust, which will receive milestone payments and royalties from CSIR. Not long after
the benefit sharing arrangements was set up, Pfizer terminated its Hoodia research, returning its
P57 rights to Phytopharm. In December 2004, Phytopharm licensed Hoodia to Unilever which
claims it will not make pharmaceuticals from Hoodia. Instead, the company says that, in less than
three years, it will sell “functional food” products made from Hoodia. The company says these
new products will be covered by new patents, but it is unclear how the new claims and new
patents will impact benefits to the San, since their benefit-sharing arrangement was negotiated
while Pfizer was still interested in P57. Phytopharm has received US $12.5 million from Unilever
and is waiting to receive more $27.5 million more, plus an undisclosed royalty once the Unilever
products are commercialized.
There are several opinions on the benefit sharing agreement between the San people and CSIR.
Laird, and Wynberg conclude that ‘the initiative has demonstrated the importance of moving
forward, even in the absence of full certainty, and ‘learning from doing’ rather than waiting for
complete resolution of often intractable issues.’208
The CIPR is optimistic in its opinion that: ‘this
case would appear to demonstrate that with goodwill on all sides, mutually acceptable
arrangements for access and benefit sharing can be agreed. The importance of intellectual
property in securing future benefits appears to have been recognised by all parties including the
San.’209
The indigenous people’s activists Harry and Kanehe make a critical analysis shown in
this extensive quote:
‘In the benefit sharing contract, the San are rewarded on a one-time-only basis for their
knowledge of Hoodia and further, they are explicitly prevented from using that knowledge in
any other commercial application. Effectively, Phytopharm and Pfizer have bought a
perpetual monopoly on the San’s traditional knowledge of the Hoodia. It is important to note
that the San were compensated for their traditional knowledge and not for any right they
might have in the genetic resource itself. It was the CSIR, and not the San who consented to
access to the genetic resource itself.’…. ‘The monies derived from the agreement, we are
told, are held in the San Hoodia Benefit Trust to be used for health care, infrastructure, and
social security.’….’What such an analysis neglects to notice is that quality health care,
207
Laird, S. A. and Wynberg, R. (2005). ‘The Commercial Use of Biodiversity: An Update on Current Trends in
Demand for Access to Genetic Resources and Benefit-Sharing, and Industry Perspectives on ABS Policy and
Implementation’. p. 28 208
Ibid. p. 28 209
Commission on Intellectual Property Rights. (2002). p. 78
57
education, and other essential services are among the basic human rights for all peoples.
Access to these fundamental needs should not be tied to a requirement for an exchange of
traditional knowledge or biological resources. Furthermore, it is outrageous to promote
selling a monopoly on traditional knowledge to a Western corporation so that marginalized
communities can earn recognition as Indigenous peoples.’…’had CSIR and Phytopharm not
been "caught red-handed", appropriating San knowledge, the San may have simply remained
unknown victims of theft. We see the case as a recent, very instructive example of the power
dynamics typical when Indigenous peoples are forced to contend with the actions of colonial
states and multinational corporations.’210
210
Harry, D. and Kanehe, L. M. (2005).’The BS in Access and Benefit Sharing (ABS): Critical Questions for
Indigenous Peoples’ p. 99-102
58
Summary
The concept bioprospecting has recently been coined to describe ‘the centuries-old practice of
collecting and screening plant and other biological material for commercial purposes’211
, such as
the development of new drugs, seeds and cosmetics. Institutions and corporations, especially
from the pharmaceutical and food industries, that undertake bioprospecting often with the help of
local communities and indigenous peoples traditional knowledge. Conservationists have argued
that bioprospecting plays a part in conserving tropical forests, coral reefs and other ecosystems
with high biodiversity. The argument builds on the assumption that when highlighting the
economic potential of biogenetic resources this will also help the conservation of biologically
diverse and threatened ecosystems. When acquiring knowledge from genetic resources,
bioprospectors seek intellectual property rights for the resulting product. Bioprospecting is
criticized as being biopiracy: the granting of ‘wrong’ patents for inventions that are either not
novel or are not inventive in relation to traditional knowledge already in the public domain;
‘patents may be correctly granted according to national law, i.e. granting of ‘right’ patents, on
inventions derived from a community’s traditional knowledge or genetic resources. Some argue
that this constitutes “biopiracy” because patenting standards are too low, i.e. allowed for
inventions which amount to little more than discoveries. Even if the patent represents a genuine
invention no arrangements may have been made to obtain the prior informed consent from the
communities providing the knowledge or resource.212
The collection and use may thereby be
unauthorized in different ways. A number of cases of biopiracy have gained attention. These
include patents on the Neem tree, Tumeric, Ayahuasca, the Hoodia catctus.
211
Graham, D. (2003) 212
Commission on Intellectual Property Rights. (2002). p. 74
59
The International Regimes on Biogenetic Resources, Traditional
Knowledge and Intellectual Property Rights
This section gives a overview of the international regimes of relevance for the international
handling of genetic resources and protection of the associated traditional knowledge. It describes
principles, norms and rules of these regimes and other initiatives taken by state actors.
The Convention on Biological Diversity
Due to the insight and knowledge about the rate in which the loss of biodiversity is taking place
globally, the international community negotiated the Convention on Biological Diversity (CBD).
The convention was opened for signature at the United Nations Conference on Environment and
Development in Rio de Janeiro 1992 and came into force in 1993 and now has 193 parties.213
CBD is an international legally binding framework for the conservation of biological diversity
and sustainable and economic use of its components, thus reconciling the diverging interests of
Southern countries with their wealth of biological diversity, and the technologically advanced
countries of the North. It thereby provide criteria for the development of bilateral cooperation and
the concerted settlement of key aspects of access to genetic resources and the technology based
on them and the sharing of benefits arising from the use of biodiversity. The CBD provisions are
aimed at all types of biodiversity and the three main objectives are stated in article 1:
- ‘the conservation of biological diversity;
- the sustainable use of its components;
- fair and equitable sharing of the benefits arising out of the utilization of genetic resources,
including by appropriate access to genetic resources and by appropriate transfer of relevant
technologies, taking into account all rights over those resources and to technologies, and by
appropriate funding.’214
213
http://www.cbd.int/convention/parties/list/ (Accessed 2010-07-08) 214
CBD, Article 1, Objectives
60
The conservation of biological diversity and the sustainable use of its components and fair and
equitable sharing of the benefits may be seen as core norms215 of the CBD, while access to genetic
resources, together with respect for and maintenance of traditional knowledge, may be seen as
secondary norms.216 The logic behind the objectives stated in article 1, is that biodiversity can
only be conserved if resources are used in a sustainable manner, particularly by the life-science
industry, and that benefits (monetary and non monetary) of such use must flow back to
conservation activities in developing countries.217
Equitable benefit sharing is regarded as a
prerequisite for achieving the two first objectives.218
CBD reaffirms in article 3 states ‘the
sovereign right to exploit their own resources pursuant to their own environmental policies’, but
states shall also ‘create conditions to facilitate access to genetic resources for environmentally
sound uses by other Contracting Parties and not to impose restrictions that run counter to the
objectives of this Convention.’ according to article 15.2. The national sovereignty principle
concerning genetic resources is a turn in international law. Before the adoption of CBD, genetic
resources had been treated as a ‘common heritage of mankind’. The key provisions especially
relating to traditional knowledge, access to genetic resources and the benefit sharing and
intellectual property are articles 8(j), 15 and 16 and related articles and thematic work
programmes.
Article 8 deals with in situ conservation219
, which in effect calls for protection the traditional
knowledge of indigenous and local communities. In article 8(j) the secondary norm of
maintenance of traditional knowledge are stated and the Contracting Parties makes the following
obligations:
215
Core norms are defined as ’expectations concerning what the Contracting Parties ‘must’ or ‘ought to’ do.
Andersen, R. (2007). Governing Agrobiodiversity: International Regimes, Plant Genetic Resources and Developing
Countries. p. 47 216
Secondary norms refers to ‘what the Contracting Parties ‘should’ or ‘could’ do pertaining to an overall objective
of an international agreement.’ Andersen, R. (2007). p. 47 217
Posey, D.A. and Dutfield, G. (1996). Beyond Intellectual Property: towards traditional resource rights for
indigenous peoples and local communities. p. 103 218
Rosendal, K.G. (2006). ‘Regulating the Use of Genetic Resources – Between International Authorities’. p. 267 219
‘In-situ conservation means the conservation of ecosystems and natural habitats and the maintenance and
recovery of viable populations of species in their natural surroundings and, in the case of domesticated or cultivated
species, in the surroundings. In-situ conditions means conditions where genetic resources exist within ecosystems
and natural habitats, and, in the case of domesticated or cultivated species, in the surroundings where they have
developed their distinctive properties.’ CBD, Article 2, Use of Terms
61
- ‘…respect, preserve and maintain knowledge, innovations and practices of indigenous and local
communities embodying traditional lifestyles relevant for the conservation and sustainable use of
biological diversity;
- promote their wider application with the approval and involvement of the holders of such
knowledge, innovations and practices and;
- encourage the equitable sharing of the benefits arising from the utilization of such knowledge,
innovations and practices;’
(Emphasis added)
The article 8 though states that these provisions are subject to national legislation, something that
makes it vague. The third Conference of the Parties (COP) started the process of implementation
of Article 8(j).220
This led to that the parties to the CBD decided to establish an Ad Hoc Open
Ended Working Group on Article 8(j) and Related Provisions at COP 4 in 1998.221
Article 8(j) is
closely linked to a number of other provisions of the Convention, in particular Articles 10(c) and
15 to 19 (see below) and also to the thematic work programmes on marine and coastal,
agricultural, inland water and forest biological diversity, and biodiversity of dry and sub-humid
lands. Article 10 on the Sustainable use of components of biological diversity, where 10(c) states
that Parties shall ‘protect and encourage customary use of biological resources in accordance with
traditional cultural practices that are compatible with conservation or sustainable use
requirements.’ Article 15 create conditions to facilitate access to genetic resources on mutually
agreed terms222
and subject to prior informed consent223
and developing legislative or other
220
Decision III/14 221
Decision IV/9 222
‘Mutually agreed terms take into account the different capacities and needs of those involved, including
governments, indigenous and local communities, holders of ex situ collections, and the intended user organizations.
This approach will contribute to fair negotiations and equitable shared benefits.’ Thornström C.G. and Björk, L.
(2007). ‘Access and Benefit Sharing: Illustrated Procedures for the Collection and Importation of Biological
Materials’ p. 1473 223
The prior informed consent includes: conditions for export of biological material and related information;
conditions for use of the material and related knowledge; conditions for how and what to make public; patents and
country of origin; how and where to solve disputes. Thornström C.G. and Björk, L. (2007). p. 1472
Free, Prior and Informed Consent (FPIC) is a term used by a number of UN agencies and NGOs. ‘Free - implying
no coercion, intimidation or manipulation; Prior - should imply consent has been sought sufficiently in advance of
any authorization or commencement of activities and respect time requirements of indigenous
consultation/consensus processes; Informed – should imply that information is provided that covers (at least) the
following aspects: the nature, size, pace, reversibility and scope of any proposed project or activity; the reason/s or
purpose of the project and/or activity; the duration of the above; the locality of areas that will be affected; a
preliminary assessment of the likely economic, social, cultural and environmental impact, including potential risks
and fair and equitable benefit sharing in a context that respects the precautionary principle; personnel likely to be
62
policy measures on fair and equitable benefit sharing. This article thereby states the core norm of
benefit sharing as well as the secondary norm of access to genetic resources. The provisions are
as follows:
1. Recognizing the sovereign rights of States over their natural resources and that the authority to
determine access to genetic resources rests with the national governments and its subject to
national legislation.
2. Each Contracting Party shall endeavour to create conditions to facilitate access to genetic
resources for environmentally sound uses by other Contracting Parties and not to impose
restrictions that run counter to the objectives of this Convention.
3. The genetic resources being provided by a Contracting Party are only those that are provided by
Contracting Parties that are countries of origin of such resources or by the Parties that have
acquired the genetic resources in accordance with this Convention.
4. Access, where granted, shall be on mutually agreed terms and subject to the provisions of this
Article.
5. Access to genetic resources shall be subject to prior informed consent of the Contracting Party
providing such resources, unless otherwise determined by that Party.
6. Each Contracting Party shall endeavour to develop and carry out scientific research based on
genetic resources provided by other Contracting Parties with the full participation of, and where
possible in, such Contracting Parties.
7. Each Contracting Party shall take legislative, administrative or policy measures, as appropriate,
and in accordance with Articles 16 and 19 and, where necessary, through the financial
mechanism, with the aim of sharing in a fair and equitable way the results of research and
development and the benefits arising from the commercial and other utilization of genetic
involved in the execution of the proposed project (including indigenous peoples, private sector staff, research
institutions, government employees and others); procedures that the project may entail. Consent - Consultation and
participation are crucial components of a consent process. Consultation should be undertaken in good faith. The
parties should establish a dialogue allowing them to find appropriate solutions in an atmosphere of mutual respect in
good faith, and full and equitable participation. Consultation requires time and an effective system for
communicating among interest holders. Indigenous peoples should be able to participate through their own freely
chosen representatives and customary or other institutions. The inclusion of a gender perspective and the
participation of indigenous women is essential, as well as participation of children and youth as appropriate. This
process may include the option of withholding consent. Consent to any agreement should be interpreted as
indigenous peoples have reasonably understood it.’
United Nations Permanent Forum on Indigenous Issues. (2005). Report of the International Workshop on
Methodologies Regarding Free Prior and Informed Consent and Indigenous Peoples p. 23-24
63
resources with the Contracting Party providing such resources. Such sharing shall be upon
mutually agreed terms. (Emphasis added)
The implementation of Article 15 is closely linked to that of other Articles, such as 8(j), 11, 16.2,
16.5, 17.2, and 19. In 2000 the Ad Hoc Working Group on Access and Benefit Sharing (WG-
ABS) was established to develop guidelines on the implementation of article 15, and have so far
meet nine times and working towards the 2010 dead-line to have a international regime on ABS
in place.
Article 16 on Access to and Transfer of technology require that access to and transfer of
technologies subject to patents or other intellectual property rights shall be provided on terms
consistent with the adequate and effective protection of these rights, but at the same time
recognizing that patents and other intellectual property rights may have an influence on the
implementation of the CBD. Technology may here be interpreted as meaning indigenous and
traditional technology and the associated knowledge.224
Article 17 on Exchange of information,
17.2 states that: ‘exchange of information shall include exchange of results of technical, scientific
and socioeconomic research, as well as information on training and surveying programmes,
specialized knowledge, indigenous and traditional knowledge as such and in combination with
the technologies referred to in Article 16.1’ Article 18 on Technical and scientific cooperation,
18.4 requires that: ‘The Contracting Parties shall, in accordance with national legislation and
policies, encourage and develop methods of cooperation for the development and use of
technologies, including indigenous and traditional technologies, in pursuance of the objectives of
this Convention.’ Article 19 on Handling of biotechnology and distribution of its benefits, 19.1
states that ‘Each Contracting Party shall take legislative, administrative or policy measures, as
appropriate, to provide for the effective participation in biotechnological research activities by
those Contracting Parties, especially developing countries, which provide the genetic resources
for such research, and where feasible in such Contracting Parties.’ According to 19.2 Parties
’shall take all practicable measures to promote and advance priority access on a fair and equitable
basis by Contracting Parties, especially developing countries, to the results and benefits arising
from biotechnologies based upon genetic resources provided by those Contracting Parties. Such
224
Posey, D.A. and Dutfield, G. (1996). p.105
64
access shall be on mutually agreed terms.’ The Settlement of disputes is regulated in article 27.
If a dispute arises between Contracting Parties concerning the interpretation or application of
CBD, the parties concerned shall seek solution by negotiation. If the parties cannot reach
agreement by negotiation, they may jointly seek the good offices of, or request mediation by, a
third party. Dispute settlement may be resolved by arbitration or by submission of the dispute to
the International Court of Justice. It is important to note that this dispute settlement is to be made
between contracting parties, so for example a strong state like the US, which has not ratified the
CBD, is not affected by this procedure. It may also be noted that the Dispute Settlement
Mechanism of the WTO is a much stronger supra-national mechanism than what the CBDs
article 27 provides for, because of it may impose retaliatory trade sanctions against the violator in
order to force it to behave in accordance with international trade law and thereby change its
national law.
The Bonn Guidelines
The Bonn Guidelines were drafted in October 2001 and adopted, with some changes, by COP 6
in The Hague in April 2002.225
The Bonn Guidelines are not legally binding, but identify steps in
the access and benefit sharing process. The Guidelines especially emphasize the obligation for
users of components of biological diversity and genetic resources to get a prior informed consent
from providers, in many cases local communities and indigenous peoples. The Guidelines also
identify the basic requirements for mutually agreed terms and define the main roles and
responsibilities of users and providers and stress the importance of the involvement of all
stakeholders. Further they cover other elements such as incentives, accountability, means for
verification and dispute settlement. Finally, they specify suggested elements for inclusion in
material transfer agreements and provide an indicative list of both monetary and non-monetary
benefits.226
Monetary benefits may include access fees, up-front payments for bioprospecting,
milestone payments during the process of bioprospecting and payments of royalties as well as
licence fees in cases of commercialisation. Non-monetary benefits may include the sharing of
research, research collaboration, admittance to ex situ facilities and databases, participation in
225
Secretariat of the Convention on Biological Diversity. (2002). Bonn Guidelines on Access to Genetic Resources
and Fair and Equitable Sharing of the Benefits Arising out of their Utilization. p. III 226
Ibid. p. IV
65
product development, technology transfer, capacity building, access to scientific information, and
contributions to local economies.227
Of special interest for this thesis is the out spelled relationship to relevant international regimes
(D) General provision 10. Here it is stated that: ‘The guidelines should be applied in a manner
that is coherent and mutually supportive of the work of relevant international agreements and
institutions. The guidelines are without prejudice to the access and benefit-sharing provisions of
the FAO International Treaty for Plant Genetic Resources for Food and Agriculture. Furthermore,
the work of the World Intellectual Property Organization (WIPO) on issues of relevance to access
and benefit-sharing should be taken into account. The application of the guidelines should also
take into account existing regional legislation and agreements on access and benefit-sharing.’228
The Negotiations on an International Regime on Access and Benefit Sharing
The World Summit on Sustainable Development in Johannesburg, South Africa in 2002
recommended governments to ‘negotiate within the framework of the Convention on Biological
Diversity, bearing in mind the Bonn Guidelines, an international regime to promote and
safeguard the fair and equitable sharing of benefits arising out of the utilization of genetic
resources…’229 The COP-7 meeting in 2004 mandated the Ad Hoc Working Group on Access and
Benefit Sharing to negotiate such a regime.230
The Terms of Reference for the WG-ABS adopted
at this meeting, list as one element to be considered by this working group for inclusion in the
international regime, the ‘disclosure of origin/source/legal provenance of genetic resources and
associated traditional knowledge in applications for intellectual property rights.’ Besides the
CBD, other international forums are currently considering such disclosure requirements, namely
the ICG at WIPO and the TRIPS Council at WTO231
227
CBD (2002). p. 18-19 228
Ibid. p. 2 229
Plan of Implementation, paragraph 42(o) 230
Final Document UNEP/CBD/COP/7/21, Decision VII/19 D. 231
Girsberger, M.A. (2005) ‘Disclosure of the Source of Genetic Resources and Traditional Knowledge in Patent
Applications’
66
At its fourth meeting in Granada, Spain in jan/feb 2006 the WG ABS agreed on a draft text to
serve as the basis for future negotiations. At its sixth meeting (January 2008, Geneva,
Switzerland), the ABS Working Group focused on the main components of the international
regime, including fair and equitable sharing of benefits, access to genetic resources, compliance,
traditional knowledge and genetic resources, and capacity building. Considerable progress were
made in producing a short and concise working document on the international regime, consisting
of sections on the main components and lists of items ‘to be further elaborated with the aim of
incorporating them in the international regime’ in the case of agreement in principle, or ‘for
further consideration’ in the case of disagreement or need for further clarification.232
At its CBD COP 9 in Bonn, in May 2008, the mandate of the Working Group on Access and
Benefit-sharing was extended, “Bonn Roadmap” (decision IX/12). The COP 9 instructed the WG
ABS to finalize an international regime and to submit for consideration and adoption by COP 10
an instrument/instruments to effectively implement the provisions in Article 15 and 8(j). COP 10
will he held in Nagoya, Japan in October 2010. In this decision five components for the
international ABS regime was identified. These include: access; fair and equitable benefit
sharing; compliance measures; traditional knowledge and capacity building. Under the
compliance component one of the measures for “further consideration” is the disclosure of origin
requirements.
At the seventh WG ABS meeting, in Paris in early April 2009, the heavily bracketed draft text
was continuously negotiated.233
Delegates undertook the first round of “real” negotiations on
operational text regarding a number of the core components of the future regime – objective,
scope, access, benefit-sharing and compliance – and adopted negotiating documents on these
elements. The meeting saw repeated clashes between the major negotiating groups and the
negotiation strategy of WG ABS meeting 6 were abandoned. Some progress was achieved with
regard to substance, but parties lost faith in each others’ goodwill.234
232
Earth Negotiation Bulletin. (2009). Summary of the Seventh Meeting of the Working Group on Access and
Benefit-Sharing of the Convention on Biological Diversity. p. 2 233
See the operational text in: Report of the Seventh Meeting of the Ad Hoc Open-Ended Working Group on Access
and Benefit-Sharing. 234
Earth Negotiation Bulletin. (2009). Summary of the Seventh Meeting of the Working Group on Access and
Benefit-Sharing of the Convention on Biological Diversity. p 12-14
67
At the 8th
meeting of the WG ABS parties addressed operative text on the components of the
regime, including traditional knowledge, capacity building, compliance, benefit-sharing and
access. A discussion on the legal nature of the regime was held. The meeting adopted the
Montreal Annex, consisting of a consolidated draft on the international regime, and a second
annex on proposals for operational texts left in abeyance for consideration at the next meeting of
the Working Group. On the issue of traditional knowledge the African Group and LMMC
stressed the inseparability of traditional knowledge and genetic resources. Norway and the
LMMC stressed that provisions related to traditional knowledge should be integrated into the
regime as a cross-cutting issue, including in the components on access and on benefit-sharing,
with the IIFB adding that traditional knowledge should be included in any definition of
misappropriation. The LMMC proposed that: parties ensure that respect for the rights of
indigenous and local communities form the basis for PIC; the internationally recognized
certificate of compliance requires evidence that PIC and MAT are fulfilled when traditional
knowledge is accessed; and that the regime cover traditional knowledge associated with genetic
resources accessed ex situ. Canada said the international regime should be limited to traditional
knowledge associated with genetic resources and not in the public domain. The EU stressed that
those seeking access to traditional knowledge would benefit from a system where indigenous and
local communities identify the authority to decide the terms for ABS. The Central and Eastern
European countries stated that national legislation should incorporate customary laws, and the
international regime should protect indigenous and local community rights. 235
The 9th
meeting of the WG ABS in Santiago de Cali, Colombia, in March 2010 for the first time
in the process, negotiations were conducted on the basis of a draft protocol, tabled as a Co-
Chairs’ text. Progress was made achieved on a number of issues, including benefit-sharing from
derivatives and an internationally recognized certificate of compliance. Due to procedural
wrangling, the meetings participants never managed to enter into text-based negotiations and
talks temporarily broke down. The Working Group agreed to: suspend WG ABS 9 and convene a
resumed session in July 2010; and forward the draft protocol text, to the resumed session, with
235
Earth Negotiations Bulletin (2009). Summary of the Eighth Meeting of the Working Group on Access and
Benefit-Sharing of the Convention on Biological Diversity. p. 4
68
the understanding that the draft was not negotiated, is without prejudice to the rights of parties to
make further amendments and additions to the text.236
At the resumed 9th
WG ABS, in Montreal in July 2010, there were still fundamental differences,
primarily between developing and developed countries. Just three out of 32 articles of the draft
protocol were agreed to by the end of the Montreal meeting. These relate to the Objective of the
Protocol; Contribution to Conservation and Sustainable Use; and Transboundary Cooperation.
However, the substantive core of the draft protocol is still far from reaching consensus. The
significant progress made in Montreal was that there is now a text of a draft protocol that is
“owned” by the CBD Parties and for which they are responsible, after almost five years of the
Working Group’s work and before that another ten years of discussion culminating in a mandate
to develop an “international regime on ABS”. While further “understanding” was reached on the
core of the international regime dealing with the substantive issues of benefit sharing, access and
compliance, it was also clear that almost all developed country parties (except Norway) seek to
have an international regime with generally “soft” obligations. Further, a number of important
provisions in the draft text related to the rights of indigenous peoples that had undergone
extensive negotiations at WG ABS 9 in Cali were rapidly diluted at the WG ABS Montreal
meeting.237
Summary
CBD is an international legally binding framework for the conservation of biological diversity
and sustainable and economic use of its components, it was signed in Rio 1992 and came into
force in 1993. The three main objectives are: the conservation of biological diversity; the
sustainable use of its components; and the fair and equitable sharing of the benefits arising out of
the utilization of genetic resources. The CBD strengthens the national sovereignty principle
concerning genetic resources. Before the adoption of CBD, genetic resources had been treated as
a ‘common heritage of mankind’. Article 8(j) binds parties to respect, preserve and maintain
knowledge, innovations and practices of indigenous and local communities and encourage the
236
Earth Negotiations Bulletin. (2010). Summary of the Ninth Meeting of the Working Group on Access and
Benefit-Sharing of the Convention on Biological Diversity. p. 1 237
Chee Yoke Ling, TWN Info Service on Intellectual Property Issues (Aug10/01) 9 August 2010,Third World
Network
69
equitable sharing of the benefits arising from the utilization of such knowledge. Article 15 create
conditions to facilitate access to genetic resources on mutually agreed terms and subject to prior
informed consent and developing legislative or other policy measures on fair and equitable
benefit sharing. In 2000 the Ad Hoc Working Group on Access and Benefit Sharing (WG-ABS)
was established to develop guidelines on the implementation of article 15, and international
regime on ABS. The negotiations on an international regime on ABS have been highly
contentious along North/South lines.
70
International Treaty on Plant Genetic Resources for Food and Agriculture
The International Treaty on Plant Genetic Resources for Food and Agriculture (ITPGRFA) is
a landmark international agreement designed to deal with the rapid loss of agricultural
biodiversity. In the past century, 95% of the varieties of food crops have been lost from
farmers’ fields, with losses running at 2% per year.238
The objective of ITPGRFA 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, in harmony with the CBD,
for sustainable agriculture and food security (Article 1). The ITPGRFA, also called the Seed
Treaty, was agreed upon at the 2001 FAO Conference and entered into force in June 2004,
when the 40th country had ratified the treaty. It builds on the 1983 International Undertaking
(IU) on plant genetic resources for food and agriculture but, unlike the IU, contains binding
obligations with respect to access to plant genetic resources and benefit-sharing in the area of
food and agriculture.
The treaty’s backbone is the ‘Multilateral System’ containing a list of crops, 64 food crops
and 29 forages crops (Annex 1), that is agreed upon to be freely accessible for commercial
plant breeders, farmers and research institutions. These crops are located in the so called
‘public domain’, i.e. in the Consultative Group on International Agricultural Research
(CGIAR) system of International Agricultural Research Center´s seed banks. Important food
crops such as rice, corn, potato and wheat, whom stands for more than half of the world’s
calorie intake, are listed in Annex 1.239
All together stand the food crops in the list for 80
percent of the world’s calorie intake.240
On the other hand are important crops such as soya
beans, oil palm, cotton, sugar cane, cacao, coffee, unions and most vegetables, ex tomato, and
most tropical forages crops, not included in Annex 1.241
Several countries intentionally
negotiated in a way that kept some varieties of food and forage crops outside the multilateral
system in the belief that they would be able to secure greater benefits by negotiating access
agreements to these genetic resources under the terms of the CBD.242
238
Practical Action. ‘International Seed Treaty on major food crops: The first ever legally-binding treaty on
biodiversity for food and agriculture’. 239
Ibid. 240
South Asia Watch on Trade, Economics & Environment (SAWTEE) (2004). p. 5 241
Andersen., R. (2005). p. 12 242
Garforth, K. and Frison, C. (2007).’Key Issues for the relationship between the Convention on
Biological Diversity & the International Treaty on Plant Genetic Resources for Food and Agriculture’. p. 6
71
The multilateral system is intended to maintain the idea and principle of ’the common
heritage of mankind’.243
This has in effect created ‘a hybrid system’ where common heritage
based on state sovereignty and contract arrangements form the parts.244
Article 12 regulates
facilitated access to PGRFA within the MLS. Access shall be provided: for the purpose of
utilization and conservation for research, breeding and training for food and agriculture,
without the need to track individual accessions and free of charge, or, when a fee is charged, it
shall not exceed the minimal cost involved; access to the PGRFA under development,
including material being developed by farmers, shall be at the discretion of its developer,
during the period of its development; access to PGRFA protected by intellectual and other
property rights shall be consistent with relevant international agreements, and with relevant
national laws; PGRFA accessed under the Multilateral System and conserved shall continue
to be made available to the Multilateral System by the recipients of those plant genetic
resources for food and agriculture, under the terms of this Treaty.
In order to ensure that access to the listed crops remains as open as possible, article 12.3(d)
states that ‘recipients of the crops cannot impose intellectual property or other rights that limit
access to the resources covered by the Treaty, or their genetic parts or components, in the
form received from the Multilateral System’. This is a highly contested article of the treaty. It
is not entirely clear what constitutes ‘in the form received’. What seems to be clear is that a
corporation or research institution cannot receive a patent over the material as it is received,
but when using the material to breed new plant varieties, these varieties may obtain patent
protection.245
However patent protection cannot be given if the effect of this patent is that
access to the original material in any way is limited.246
In opposition to this view stands the
view of several NGOs, that both the seed or material, in the form received from the
multilateral system, as well as the product that incorporate these genetic resources should not
be allowed patent protection247
243
Brush. S.B. (2005). p.22 244
Garforth, K. and Frison, C. (2007). p. 3 245
Bridges Trade BioRes. (2006). 246
Moore, G. och Tymowski, W. (2005). ‘Explanatory Guide to the International Treaty on Plant Genetic Resources for
Food and Agriculture’. P. 93 247
See for example: Practical Action. International Seed Treaty on major food crops: The first ever legally-
binding treaty on biodiversity for food and agriculture.
72
Access to plant genetic resources in the Multilateral System is provided under a standard
material transfer agreement (SMTA). The SMTA, adopted at the first meeting of the
Governing Body of the ITPGRFA in June 2006,248
sets out three possible benefit-sharing
arrangements from which the recipients of plant genetic resources can choose. One option
requires the recipient to pay 1.1 percent of the sale revenues (minus thirty percent to cover
cost of transport, marketing and other related costs) derived from the commercialisation of a
product that incorporates material from the Multilateral System, in cases where use of the
product is restricted, i.e. where patent or plant variety protection is given the product or
variety, Article 6.7. An alternative option requires the recipient to make a voluntary payment,
in a case where material is incorporated into a product, but this product is available without
restriction to others for further research and breeding, Article 6.8. The third option is where a
recipient transfers PGRFA under development, shall the recipient pay 0.5 percent of
commercial revenues for all products incorporating material from the crops in the Multilateral
System, regardless of whether the use of the product has been restricted or whether the
products contain material provided by the Multilateral System.
In ITPGRFA a system of benefit sharing for the crops listed in annex 1 is also set up. It is
described in Article 13 as including exchange of information; access to and transfer of
technology; capacity building; and sharing of the benefits arising from commercialisation.
Article 13.2(b) calls for countries to provide access to and transfer of technologies for the
conservation, characterisation, evaluation and use of the resources covered. Article 13.2(d)(ii)
obliges recipients who commercialise a PGRFA that incorporates material received from the
Multilateral System to equitably share the benefits arising from the commercialisation in
cases where availability of the product is restricted for further research and breeding. If
availability is not restricted, benefit-sharing is “encouraged”. Benefits will be paid to the
Account Fund set up in Article 19.3f. Article 18.5 specifies that priority use of these funds is
to go to farmers in developing countries who conserve and sustainable utilise plant genetic
resources for food and agriculture. In June 2009, 11 projects received around $500 000 from
the Account Fund. These funds came from a Norway, Spain, Italy and Switzerland and not
from percentage of revenues from patented material.249
The largest share of the funds was
given to national agriculture research centres and not to farmer’s organisations, something
248
International Treaty on OPlant Genetic Resources for Food and Agriculture. Governing Body Resolution
1/2006 of June 2006. 249
FAO Newsroom. Reward for conserving crops: 11 projects announced in Tunis to receive grants from treaty
on food plants genes
73
that has been criticized by NGOs. Via Campesina states that industry continues to profit
through research and seeds accessed through the MLS, while farmers are still waiting to see
any benefits.250
In comparison to the $500 000 handed out, the Governing Body appealed to
governments, private donors and foundations for $116 million to strengthen the Treaty’s work
in helping developing countries grow better crops.251
Farmers Rights have been a contested issue during the negotiations running up to the
ITPGRFA an now in the Treaty’s implementation phase. A working definition of Farmers
Rights has been developed by the Farmers Rights Project on basis of its research:
’Farmers' Rights consist of the customary rights of farmers to save, use, exchange and sell farm-
saved seed and propagating material, their rights to be recognized, rewarded and supported for
their contribution to the global pool of genetic resources as well as to the development of
commercial varieties of plants, and to participate in decision making on issues related to crop
genetic resources.’252
The Treaty’s Article 9 explicitly recognises Farmers’ Rights, for the first time in international
law.253 Article 9.1 recognizes ‘the enormous contribution that local and indigenous
communities and farmers have made and will continue to make for the conservation and
development of plant genetic resources which constitute the basis of food and agriculture
production throughout the world.’ In addition Article 9.2 states that ‘the responsibility for
realizing Farmers’ Rights…rests with national governments. In accordance with their needs
and priorities, each Contracting Party should, as appropriate, and subject to its national
legislation, take measures to protect and promote Farmers’ Rights, including:
a) protection of traditional knowledge relevant to plant genetic resources for food and
agriculture ;
b) the right to equitably participate in sharing benefits arising from the utilization of plant
genetic resources for food and agriculture; and
c) the right to participate in making decisions, at the national level, on matters related to the
conservation and sustainable use of plant genetic resources for food and agriculture.’
250
Earth Negotiations Bulletin. (2009) Summary of the Third Session of the Governing Body of the International
Treaty on Plant Genetic Resources for Food and Agriculture. p. 5. See also Via Campensina. A sizeable Step
Towards a Real Commitment to Farmers’ Rights at the FAO? 251
FAO Newsroom. First fruits of plant gene pact. 252
Farmers Rights project at the Fritjof Nansen Institute. 253
International Centre for Trade and Sustainable Development ‘International law relating to biotechnology’
p. 86-87
74
Further Article 9.3 states that ‘nothing in this Article should be interpreted to limit any right
that farmers have to save, use, exchange and sell farm-saved seed/propagating material,
subject to national law and as appropriate.’ The wording ‘subject to national law’ is debated,
since national laws, descending from UPOV 91 in a increasing number of countries are seen
to limit farmers from freely save, use, exchange and sell farm-saved seed.254
The Agreement on Trade-Related Aspects of Intellectual Property Rights
‘Intellectual property laws, with their epicentres in Washington, New York, Brussels and Geneva,
travel like invisible tsunamis to developing countries’…in these cities…’the tribe of intellectual
property meet and plan.’255
During the last decades a number of multilateral trade agreements have been established
within the framework of the General Agreement of Tariffs and Trade (GATT) whom in
January 1995 was transformed to the World Trade Organisation (WTO), seated in Geneva.
Today the world trade is mainly regulated by the norms and rules negotiated and established
within the WTO. The WTO have since the mid- nineties thereby become a global actor with
extensive power to enforce decisions taken within the organisation on a global scale. The
WTO have two bearing principles; the first principle ‘national-treatment’, which means that
imported goods should be treated the same as national goods; the second principle is – ‘most-
favoured-nation-treatment’, means that a country have to treat all other countries equally, in
example custom-rules.256
However there are a number of exceptions of these principles stated
within the WTO agreements. In addition, the negotiations at WTO operate on the principle of
consensus.
Within the package of the three agreements which formed WTO is the Agreement on Trade-
Related Aspects of Intellectual Property Rights (TRIPS), adopted 14 April 1994. The aim of
TRIPS is to stimulate technological innovation through a harmonisation and strengthening of
national intellectual property law in the Contracting Parties of the WTO. This purpose is
stated in Article 7: ‘The protection and enforcement of intellectual property rights should
contribute to the promotion of technological innovation and to the transfer and dissemination
254
See ex. Pistorius, R., Lim E.S., Ghijsen H., Visser B., (2009). Results of an Online conference on ‘Options for
Farmers´ Rights’. p.10-11 255
Drahos, P. ‘IPR Epicentres. A Geography of Intellectual Property’. p.2 256
WTO Agreement on Trade Related Aspects of Intellectual Property Rights, 15 April 1994. Article 3 and 4.
75
of technology, to the mutual advantage of producers and users of technological knowledge
and in a manner conducive to social and economic welfare, and to a balance of rights and
obligations.’ The agreement covers intellectual property rights such as copyrights,
trademarks, geographical indicators, industrial design and patents (article 9-27).257
TRIPS in
reality provide an international minimum standard for intellectual property rights
protection.258
Since TRIPS are one of three agreements under the general WTO framework it’s also covered
by the Dispute Settlement Mechanism. This mechanism was established under GATT, and
was strengthened in 1988. The General Council which oversees the operation of the WTO
agreements regularly also acts as the Dispute Settlement Body.259
If the basic principles are
violated by a Contracting Party the Party being discriminated can turn to the Dispute
Settlement Mechanism, which may impose retaliatory trade sanctions against the violator in
order to force it to behave in accordance with international trade law and thereby change its
national law. This dispute-settlement mechanism is the strongest tool in international law and
makes the WTO rules both regulatory and normatively strong.260
This means that countries
that fail to follow its rules face real consequences, which is not the case for most other
international bodies, except the UN Security Council.261
In TRIPS the national-treatment principle are stated as: ‘Each Member shall accord to the
nationals of other Members treatment no less favourable than that it accords to its own
nationals with regard to the protection’, Article 3.1262 The principle of most-favoured-nation-
treatment are referred to in TRIPS as ‘with regard to the protection of intellectual property,
any advantage, favour, privilege or immunity granted by a Member to the nationals of any
other country shall be accorded immediately and unconditionally to the nationals of all other
Members’, Article 4.
257
WTO Agreement on Trade Related Aspects of Intellectual Property Rights, 15 April 1994. 258
Andersen, R. (2007). p. 175 259
Ibid p. 193 260
Up until 2002 there had been 24 cases of dispute settlement concerning TRIPS in the WTO, the vast majority
having been brought by the US and the EU. Of these 23 were brought by developed country members, and one
by Brazil. Sixteen were disputes between developed countries, seven were cases brought by developed against
developing countries, and one by Brazil against the US. Of the 24, ten have been settled by mutual agreement,
seven were decided by panels set up under the procedure, and seven are still pending. CIPR (2002). p.157, 3 261
Tansey G. (2008). ‘Farming, Food and Global Rules’ p. 6 262
WTO Agreement on Trade Related Aspects of Intellectual Property Rights, Article 3.1
76
The provisions on patents stated in Article 27 are the most relevant to the handling of genetic
resources and traditional knowledge. This article holds ‘that patents shall be available for any
inventions, whether products or processes, in all fields of technology, provided that they are
new, involve an inventive step and are capable of industrial application.’263 In Article 27.2 it
is stated that ‘members may exclude from patentability inventions, the prevention within their
territory of the commercial exploitation of which is necessary to protect ordre public264 or
morality, including to protect human, animal or plant life or health or to avoid serious
prejudice to the environment, provided that such exclusion is not made merely because the
exploitation is prohibited by their law.’ Members may also exclude from patentability:
(a) Diagnostic, therapeutic and surgical methods for the treatment of humans or animals;
(b) Plants and animals other than micro-organisms, and essentially biological processes for
the production of plants or animals other than non-biological and microbiological processes.
However, Members shall provide for the protection of plant varieties either by patents or by
an effective sui generis system265
or by any combination thereof. The provisions of this
subparagraph shall be reviewed four years after the date of entry into force of the WTO
Agreement.
In relevance for plant genetic resources and traditional knowledge the exceptions in Article
27.3(b) are of great interest. The protection of plant varieties by patents or by an effective sui
generis system or by a combined system, is a core norm of the TRIPS regarding genetic
resources and therefore also of TK.266
The possibility to exclude plants and animals and
essentially biological processes for the production of plants or animals from patentability may
be seen as a secondary norm. Article 27.3(b) article are highly controversial since it opens up
for ’patents on life’ on a global scale, and also because several of the concepts used in it are
open to interpretations, for example micro-organisms, essentially biological processes and
non-biological and microbiological processes. Further are the meaning of an effective sui
generis system debated, though has many members, mostly developed nations as well as the
UPOV itself, put forward UPOV 91 as such a effective sui generis system for Plant Variety
263
WTO Agreement on Trade Related Aspects of Intellectual Property Rights, Article 27.1 (emphasis added) 264
The term ordre public, derived from French law, expresses concerns about matters threatening the social
structures which tie a society together, i.e., matters that threaten the structure of civil society as such. 265
Sui generis, is Latin for ’its own kind’, express a form of intellectual property rights law which has been
created for a specific area of use or a specific technology, and thereby a country’s special needs 266
Andersen. R. (2007). p.197
77
Protection (PVP) or Plant Breeders Rights (PBR).267 This has had the consequence that a
growing number of developing countries have joined the UPOV 91, as an option to patents on
seeds aimed for food and agriculture.
In accordance with Article 29, Conditions on Patent Applicants, ’members shall require that
an applicant for a patent shall disclose the invention in a manner sufficiently clear and
complete for the invention to be carried out by a person skilled in the art and may require the
applicant to indicate the best mode for carrying out the invention known to the inventor.’ This
disclosure does not include from whom or where the genetic resource is obtained.
Further Article 22 on the Protection of Geographical Indications (GI) has relevance for plant
genetic resources and associated traditional knowledge. This article treats geographical
indications which: ‘identify a good as originating in the territory of a Member, or a region or
locality in that territory, where a given quality, reputation or other characteristic of the good is
essentially attributable to its geographical origin. Members shall provide the legal means for
interested parties to prevent: (a) the use of any means in the designation or presentation of a
good that indicates or suggests that the good in question originates in a geographical area
other than the true place of origin in a manner which misleads the public as to the
geographical origin of the good;’268
Geographical Indications are economically significant monopoly rights that ‘aim to halt
cultural appropriation by outsiders – a concern that resonates strongly in an increasingly
globalized world.’ 269
In this sense, they share similarities with the protection of traditional
knowledge, since the core values are the concepts of heritage and authenticity. This far wine
and spirits270
has been given special protection of Geographical Indications, but it would
probably be possible to protect plant varieties, steaming from traditional use and knowledge,
such as the north Indian rice variety Basmati, under article 22.
267
Raustiala. K. och Victor, D. G. (2004). p..291; Crucible II Group. (2000). Seedling Solutions. Vol.1: ‘Policy
Options for Genetic Resources: People, Plants, and Patents Revisited’. p. 101 268 WTO Agreement on Trade Related Aspects of Intellectual Property Rights, Article 22, (selected parts) 269
Raustiala, K. and Munzer, S R. (2007) ‘The Global Struggle over Geographic Indications. p. 345 270
For example, the name champagne is reserved exclusively for sparkling wines made in the Champagne region
in northern France; sparkling wines made outside this region cannot be called champagne.
78
The Review process of Article 27.3(b)
A review of Article 27.3(b) was to be undertaken as stated in the article: ‘provisions of this
subparagraph shall be reviewed four years after the date of entry into force of the WTO
Agreement.’ This meant that the review was supposed to take place in 1999, a year before 69
developing countries were supposed to have implemented TRIPS in national law. The least
developed countries were granted a 10 year extension up to 1 January 2006, while the
developed countries were supposed to have implemented TRIPS in 1996.271
Of the 69
developing countries that were supposed to implement TRIPS on 1 January 2000 only 30 had
done so272
, implementation where ‘slow, costly and a source of domestic opposition’ in many
developing countries.273
Paragraph 19 of the 2001 Doha Ministerial Declaration274
instructs
the TRIPS Council, in its review of Article 27.3 (b) of the TRIPS Agreement, to consider the
relationship between the TRIPS Agreement and the CBD by the end of 2002.275
Since the
review process started, a number of proposals have been submitted to the TRIPS Council. The
following are the central proposals in this process:
In 2002 the EC made a Communication to the TRIPS Council, where the EU ‘see no reason to
amend Article 27.3(b)’ since it ‘allows Members sufficient flexibility to modulate patent
protection as a function of their needs, interests or ethical standards.’ Further the ‘EC agree to
examine and discuss the possible introduction of a system, such as for instance a self-standing
disclosure requirement, that would allow Members to keep track, at global level, of all patent
applications with regard to genetic resources for which they have granted access.’ Concerning
situations when, Traditional Knowledge ‘is used as a basis for further innovations, disclosure
of the original TK from which inventions are derived would be an important way of ensuring
that holders of traditional knowledge share in the benefits.’ 276
Though the EC finds it to be to
difficult for patent offices to be responsible for that PIC has been given and that national
271
Andersen (2007). p. 175; WTO Agreement on TRIPS, Article 65-66 272
GRAIN (2000). ’For a full review of TRIPS 27.3(b). An Update on where Developing Countries stand with
the push to Patent Life at WTO’. p. 5 273
Helfer, L. (2004). ‘Regime Shifting: The TRIPs Agreement and New Dynamics of International Intellectual
Property Lawmaking’. p. 24 274
Paragraf 19 of the Doha Ministerial Declaration also instructs the review of Article 71.1 of WTO Agreement
on TRIPS. 275
Perrault, A. and Olivia, M.J. (2005) ICTSD/CIEL/IDDRI/IUCN/QUNO. Dialogue on Disclosure
Requirements: Incorporating the CBD Principles in the TRIPS Agreement On the Road to Hong Kong WTO
Public Symposium, Geneva, April 21 2005, p.1
276 Review of Article 27.3(b) of the TRIPS Agreement, and the Relationship between the TRIPS Agreement
and the Convention on Biological Diversity, and the Protection of Traditional Knowledge and Folklore.
Communication from the European Communities and their Member States. p.1-2
79
access and benefit laws in the country of origin has been complied with by the patentee.277
These questions should not be dealt with in the TRIPS Council, but in the WIPO
Intergovernmental Committee on Intellectual Property, Genetic Resources, Traditional
Knowledge and Folklore.278
In June 2003 Bolivia, Brazil, Cuba Dominican Republic Ecuador, India, Peru, Thailand and
Venezuela proposed to make amendments to the TRIPS Agreement in order ‘to include an
obligation to disclose the origin of genetic resources and associated traditional knowledge and
to provide evidence of PIC and fair and equitable benefit sharing are imperative to implement
the TRIPS Agreement and the CBD in a mutually supportive and complementary way.’ These
countries also looked into the contract model and its weaknesses.279
This is a strengthening of
the June 2002 proposal to amend TRIPS with mandatory disclosure of origin requirements. 280
African group proposed in June 2003 that ‘members shall require an applicant for a patent to
disclose the country and area of origin of any biological resources and traditional knowledge
used or involved in the invention, and to provide confirmation of compliance with all access
regulations in the country of origin.’281
Switzerland proposed in June 2003 to ‘enable the national patent legislation to require the
declaration of the source of genetic resources and traditional knowledge in patent
applications.’ More specifically, Switzerland proposes to ‘amend the Regulations under the
Patent Cooperation Treaty (PCT) of the World Intellectual Property Organization (WIPO) to
explicitly enable the Contracting Parties of the PCT to require patent applicants’…’to declare
the source of genetic resources and/or traditional knowledge, if an invention is based on or
277
Haugen, M.H. (2005). ‘Traditional Knowledge and Human Rights’ 278
Review of Article 27.3(b) of the TRIPS Agreement, and the Relationship between the TRIPS Agreement and
the Convention on Biological Diversity, and the Protection of Traditional Knowledge and Folklore. WTO
Document IP/C/W/383 p.2 279
The Relationship between the TRIPS Agreement and the CBD and the Protection of Traditional knowledge.
WTO Document IP/C/W/403 and Elements of the Obligation to Disclose the Source and Country of Origin of
Biological Resources and/or Traditional Knowledge used in an Invention. WTO Document IP/C/W/429 280
The Relationship between the TRIPS Agreement and the CBD and the Protection of Traditional Knowledge.
WTO Document IP/C/W/356, para. 11 281
Taking Forward the Review of Article 27.3(B) of the TRIPS Agreement.WTO Document IP/C/W/404. p.6
80
uses such resource or knowledge.’282
The Swiss proposal put more force behind the demand
of disclosure of origin in patent applications.283
Norway proposed in June 2006 that to implement TRIPS and the CBD in a mutually
supportive manner ‘a mandatory obligation in the TRIPS Agreement to disclose the origin of
genetic resources and traditional knowledge in patent applications’ would ‘ensure
transparency as regards the origin of biological materials that are to be patented. This would
make it easier for parties to enforce their rights to their own genetic resources when these are
the subject of a patent application, which in turn would make the CBD provisions on prior
informed consent and benefit-sharing more effective.’284
The proposals from the EU and Switzerland does not require the re-opening of the text
negotiations of TRIPS, as the proposals from Brazil, Cuba, Ecuador, India, Peru, Thailand
and Venezuela; and the African Group, requires.285 The developing countries argues that there
is time to move to text-based negotiations and wants the disclosure amendment to require
information on prior informed consent and equitable benefit sharing, while the EU only
proposes disclosure of origin requirements. Further is the EU determined to keep sanctions for
non-compliance outside the patent regime, whereas the developing countries want a
possibility to revoke a patent if the patentee fails to comply with the disclosure of origin
rules.286
In the TRIPS Council the USA have opposed the disclosure of origin obligation on a number
of grounds. The USA argues that: (1) disclosure will not prevent misappropriation, but create
uncertainty about patent rights; (2) it is unclear how much disclosure will be required, who
determines if it is proper, and how derivative material is treated. The USA further holds that a
solution to the problem of ‘biopiracy’ raised by developing countries can be found under
national law, by means such as: collection permits; contractual arrangements; unfair
282
Article 27.3(b), the Relationship between the TRIPS Agreement and the Convention on Biological Diversity,
and the Protection of Traditional Knowledge. WTO Document IP/C/W/400/Rev.1 p. 1-2 283
Andersen, R. (2007) p.186 284
The Relationship between the TRIPS Agreement, the Convention on Biological Diversity and the protection
of traditional knowledge — Amending the TRIPS Agreement to Introduce an Obligation to Disclose the Origin
of Genetic Resources and Traditional Knowledge in Patent Applications. WTO Document IP/C/W/473 285
Andersen, R. (2007). p.186 286
Mara, K. and New, W. (Intellectual Property Watch) 14 March 2008. ‘TRIPS Council: Half Of WTO
Membership Backs Biodiversity Amendment’
81
competition rules; civil/criminal penalties; databases; post-grant examination; harmonization
of patent law.287
At the moment 80 of the WTOs 151 member states support a TRIPS amendment to include an
mandatory requirement for the disclosure of the country providing/source of genetic
resources, and/or associated traditional knowledge and the prior informed consent and benefit
sharing.288
The Doha Declarations recommended dead-line for 2002 have now long gone
passed and the TRIPS Council have not yet made any recommendations to the Trade
Negotiations Committee of the WTO, on the relationship between the TRIPS Agreement and
the Convention on Biological Diversity.289
Therefore, the newly invigorated WTO
negotiations is at risk if not parties come closer to each other in the negotiation on the
modalities (i.e. the basic parameters for the negotiations) concerning the proposed disclosure
of origin amendment and the GI register, i.e. the extension to other products of the higher
level of GI protection wines and spirits enjoy. Since a significant majority of WTO member
states support either the proposed disclosure of origin amendment, or the GI extension, and
proponents have during the consultations linked these two issues to each others. Though a
number of member states disagree to negotiate a disclosure of origin amendment of TRIPS, or
extension of the GI register, basically Argentina, Australia, Chile, Japan, New Zealand and
the United States, but do not exclude further discussion. The European Commission have
signalled that it may be willing to support the amendment in exchange for developing country
support on increased GI protection, though it seems willing so far only to discuss disclosure
of origin, and not the prior informed consent and access and benefit sharing clauses that the
countries proposing the amendment also wants to include.290
There are different positions on
GI protection amongst developing countries, but many favour GIs for their famous goods, for
example: Mexico for Tequila and Mezcal, and India for Basmati rice and Darjeeling tea. But
simultaneously many developing countries recognize that GI protection is linked with other
policies of developed countries, such as substantial farm subsidies, that they oppose.291
287 Article 27.3(b), relationship between the TRIPS Agreement and the CBD, and the protection of traditional
knowledge and folklore. WTO Document IP/C/W/434
288 Bridges Trade BioRes, (2008). ‘Developing Countries: Mounting Support For Trips Amendment To
Protect Biodiversity’. For the latest communication on this issue see WTO document TN/C/W/52, 19 July 2008
circulated at the request of the delegations of Brazil, the EU, India and Switzerland. 289
Dahr, B. and Anuradha, R.V. (2004). p. 608 290
Mara, K. (Intellectual Property Watch). (2008). ‘Further Resolution Needed To Keep IP Issues In WTO
Negotiations’ 291
Raustiala, K.and Munzer, S.R. (2007). p. 351-352
82
In the mean-time: ‘TRIPS-plus’ agreements
After the TRIPS have come into operation, and during the time of the acrimonious debates on
amending TRIPS article 27.3(b), a number of Bilateral Investment Treaties (BITs), Bilateral
Intellectual Property Agreements (BIPs) and Bilateral Free-Trade Agreements (FTAs) have
been negotiated.292
These bilateral and regional agreements have come to include provisions
on intellectual property stricter than those of TRIPS, thereof the nick-name ‘TRIPS Plus’. For
example in article 18 of the FTA between the US and Jordan there are fewer exclusions from
patentability than in article 27.3(b) of TRIPS and the European Union is including strict IPRs
in the Euro-Mediterranean negotiations on a free-trade area between the EU and twelve
Mediterranean countries by 2010.293
In recently concluded FTAs between the US and almost
half a dozen Latin American countries it is required of all parties to join UPOV and make ‘all
reasonable efforts’ to allow patents on plants. These agreements also state that this policy
shift must never be reversed.294
Further the Budapest Treaty295, administered by WIPO and
with the aim to facilitate the process of obtaining patents on micro-organisms, and which has
no references to the CBD and national legislation on biodiversity, is being incorporated in
regional FTAs, as the Central American Free Trade Agreement (CAFTA) 296
292
See GRAIN and South Asia Network for Food, Ecology and Culture (SANFEC) (2001). ‘TRIPS-plus through
the back door: How bilateral treaties impose much stronger rules for IPRs on life than the WTO’; GRAIN.
(2008). ‘Bilateral agreements imposing TRIPS-plus intellectual property rights on biodiversity in developing
countries’ 293
Drahos, P. and Mayne, R. (2002). Global Intellectual Property Rights: Knowledge, Access, and
Development. p. 173-174. On the FTA between US and Jordan see also El-Said, Mohammed (2005). ‘The Road
from TRIPS-Minus, to TRIPS, to TRIPS-Plus: Implications of IPRs for the Arab World’ 294
This is under the US–Central America FTA (CAFTA, concluded in 2004 with Costa Rica, El Salvador,
Nicaragua, Honduras, Guatemala and the Dominican Republic), the US–Peru FTA (concluded in 2005), the US–
Colombia FTA (concluded in 2006) and the US–Panama FTA (concluded in 2006). GRAIN Briefing. February
(2007).‘The End of Farm-saved Seed? Industry’s wish list for the next revision of UPOV’. p.10 295
Budapest Treaty on the International Recognition of the Deposit of Microorganisms for the Purpose of Patent
Procedure, signed in Budapest 1977 and came into force in 1980. 296
Rodríguez, S. (2008) ‘CAFTA and the Budapest Treaty: The Debate in Costa Rica’. p. 37
83
International Union for the Protection of New Varieties of Plants
As mentioned earlier, the sui generis option in TRIPS article 27.3(b) has had the consequence
that a growing number of developing countries joined the International Union for the
Protection of New Varieties of Plants (UPOV) 297 and its convention on plant variety
protection (PVP)298
, as an option to patents on seeds aimed for food and agriculture. Since
agriculture is practiced by a huge proportion of the world’s poor population and traditional
knowledge is deeply entwined with agricultural practices this section will briefly describe the
UPOV and its legal framework.
UPOV is an intergovernmental organisation which was established by the International
Convention for the Protection of New Varieties of Plants. The convention was adopted in
Paris 1961 and was reviewed 1972, -78 and -91. UPOV 1991 came into force in April 1998
and at the same time the possibility to become a signatory party to UPOV 78 where closed.
This means that all new countries in interest of applying to membership of UPOV have to
adopt UPOV 91.299
UPOV was originally an organisation for OECD countries, but has
become relevant for developing countries through the TRIPS article 27.3(b), which require
that ‘Members shall provide for the protection of plant varieties either by patents or by an
effective sui generis system or by any combination thereof.’ UPOV 91 has been put forward
as an effective sui generis system by developed countries and by UPOV itself. UPOV is
housed at WIPO in Geneva and is governed by the Council of UPOV, which consists of the
representatives of the members of the Union. Each member that is a State has one vote in the
Council. Under the 1991 Act, certain intergovernmental organizations300 may also become
members of the Union.301
Since 1994 the number of member countries has doubled and today
developing countries and transitional countries account for almost half of the member
states.302
The objective of UPOV is to provide and promote an effective system of plant
297
The abbreviation steam from the organizations French name: Union internationale por la Protection des
Obtentions Végétales. 298
“Variety” means a plant grouping within a single botanical taxon of the lowest known rank, which grouping,
irrespective of whether the conditions for the grant of a breeder’s right are fully met, can be: - defined by the expression of the characteristics resulting from a given genotype or combination of genotypes,
- distinguished from any other plant grouping by the expression of at least one of the said characteristics and
- considered as a unit with regard to its suitability for being propagated unchanged. UPOV art. 1(vi) 299
Andersen, R. (2005). ‘Norway say “no” to UPOV 1991’. 300
Today European Community is a member as a regional organisation, as well as the African Intellectual
Property Organization 301
UPOV (2007) ‘UPOV: What it is, what it does’. p. 1 302
GRAIN (2007) p.5; see also http://www.upov.int/en/about/members/
84
variety protection, with the aim of encouraging the development of new varieties of plants.
Therefore the purpose of the UPOV Convention is to ensure that the members of the Union
acknowledge the achievements of breeders of new varieties of plants, by granting to them an
intellectual property right, on the basis of a set of clearly defined principles.303
This
acknowledgement of breeder’s achievements is also called plant breeder rights (PBR), which
is synonymous with plant variety protection. Commercial plant breeders promoted them as an
alternative, because of the political opposition to extending patent protection to plants and the
legal complexities of defining plant varieties.304
To be eligible for protection, varieties have to be (i) distinct from existing, commonly known
varieties, (ii) sufficiently uniform, (iii) stable, (iv) and new in the sense that they must not
have been commercialized prior to certain dates established by reference to the date of the
application for protection.305
Like all intellectual property rights, plant breeders’ rights are
granted for a limited period of time, at the end of which varieties protected by them pass into
the public domain. The rights are also subject to controls, in the public interest, against any
possible abuse.
In the first versions of the UPOV convention the PVP is clearly seen as a copyright.306 The
reach of the monopoly was limited, as well as the criteria for protection. The holder of the
PVP/PBR had the right to control the commercial breeding material and the sale of it, but
farmers could freely save protected seeds for own use and use the harvest without restriction,
called the farmers privilege. The rights holder had no rights over the varieties genetic content
and other commercial and public breeders could freely use a protected variety to develop a
subsequently derived variety307 as long as the protected variety where not repeatedly required
in the production of the new variety, called the research exemption.
303
UPOV (2007). p. 1 304
Ramanna, A. and Smale. M. (2004). ‘Rights and Access to Plant Genetic Resources under India’s New Law’
p. 425 305
the International Convention for the Protection of New Varieties of Plants, Act of 1991, Article 5, Conditions
of Protection 306
A copyright, protect the idea from repeated copy, but it doesn’t protect the idea in itself. 307
a variety is deemed to be essentially derived from another variety (“the initial variety”) when: (i) it is
predominantly derived from the initial variety, or from a variety that is itself predominantly derived from the
initial variety, while retaining the expression of the essential characteristics that result from the genotype or
combination of genotypes of the initial variety, (ii) it is clearly distinguishable from the initial variety and (iii)
except for the differences which result from the act of derivation, it conforms to the initial variety in the
expression of the essential characteristics that result from the genotype or combination of genotypes of the initial
variety. Article 14(5)(b) of the 1991 Act of the UPOV Convention
85
During the 1980s the pressure increased from the seed industry, which in many cases had
emerged with chemical- and pharmaceutical corporations, to strengthen the PVP.308
With the
review of the UPOV convention in 1991 the protection where strengthened, so that PVP now
looks more like patents. Today it is no longer automatically allowed for farmers to save
protected seeds for reproduction and multiplication, Article 14.1a;vii, member countries can
only as a optional exception legalise seed-saving and reproduction for own use, but this still
gives the seed company the right to collect royalties, Article 15.2. This article and its national
implementation ‘tend to turn farmers’ seed production and particularly the exchange and sale
of farm-saved seed into illegal activities and put severe restrictions on initiatives that support
farmers’ seed systems’.309
The monopoly now even stretches to the harvest, Article 14.2 and
14.3. If royalties on the used seeds hasn’t been paid for, the rights holder may demand the end
user of the harvest to pay the royalties. Other breeders are still allowed to use protected
varieties for breeding, but if a new variety is essentially derived from an existing variety it
cannot obtain PVP, Article 14.5. This provision where specifically introduced to hinder
biotechnology corporations to receive protection for varieties to which only a single gene has
been added. There are no demands to prove that the variety is a novelty and in UPOV 91 the
minimum time a variety has to be protected has increased from 15-18 years to 20-25 years.310
The World Intellectual Property Organisation
The World Intellectual Property Organisation (WIPO), a specialized United Nations agency,
is by far the most important international institution handling intellectual property rights, and
its importance is likely to increase as it builds closer links with WTO, FAO and, the CBD and
its Secretariat.311
Therefore this part portrays the comings of WIPO.
The World Intellectual Property Organisation, located in Geneva, administrates most of the
international agreements pertaining intellectual property rights312 and has 184 member
308
GRAIN. (2007).‘The End of Farm-saved Seed?’ p. 4 309
Louwaars, Niels (2007) Seeds of Confusion; The impact of policies on seed systems. p.6 310
Ibid. p. 4 311
Dutfield, G. (2004). p. 132 312
Madrid Agreement Concerning the International Registration of Trademarks (1891), the Lisbon Agreement
for the Protection of Appellations of Origin and their International Registration (1958), the Patent Cooperation
Treaty (1970) and the Budapest Treaty on the International Recognition of the Deposit of Micro-organisms for
the Purpose of Patent Procedure. see Dutfield, G. (2004). p. 128
86
countries.313
WIPO has its origins in the Paris Convention314 and the Bern Convention315, and
the Convention establishing WIPO was signed in Stockholm 1967 and entered into force
1980. The WIPO’s primary objectives are to administer the international IP laws; to provide
assistance to member states in the creation of national IP laws; and to seek harmonization of
national laws, aiming to promote the protection of IP throughout the world. Of its funding
about 90% comes not from member governments (as in WTO or other UN agencies) but from
the private sector by way of fees paid by patent applicants under the Patent Cooperation
Treaty (PCT).316
WIPO does not have a dispute settlement mechanism, to deal with
accusations of non-compliance, as the WTO has. This was one of the reasons why the TRIPS
with its minimum standards in IP were negotiated.317 Further WIPO are housing the
International Union for the Protection of New Varieties of Plants (UPOV).
The Patent Law Treaty
Within WIPO the Standing Committee on the Law of Patents (SCP), a specialized committee
on patent law, negotiated the Patent Law Treaty (PLT) in 2000, for the purpose of
harmonising various aspects of patent law. During the negotiations of the PLT Colombia
argued for that the PLT ‘should comprise provisions linking the filing of patent applications
with access and benefit sharing regulations’318
steaming from the CBD:
‘All industrial property protection shall guarantee the protection of the country’s biological
and genetic heritage. Consequently, the grant of patents or registrations that relate to the
elements of that heritage shall be subject to their having been acquired legally’; and
313
http://www.wipo.int/members/en/ 314
The Paris Convention, from 1883, regulates the protection of industrial property. 315
The Bern Convention, from 1886, pertains the protection of literary and artistic work. The Paris and Bern
Conventions were ratified by the four colonial powers: France, Germany, Spain and the UK. These countries
included their colonies and protectorates in the Conventions, this had the effect that when the struggle for
independence where won, new governments were confronted with IP Conventions which were controlled by the
former colonial powers. See Drahos, P. and Mayne, R (2002). Global intellectual property rights: knowledge,
access, and development. p. 164-165 316
CIPR (2002). p. 157-158. The PCT aims to simplify and reduce the cost of obtaining international patent
protection. By filing one international patent application under the PCT, an applicant can simultaneously seek
protection for an invention in over one hundred countries. Recent PCT applications are published in the PCT
Gazette to facilitate public access to technical information. 317
Dutfield, G. (2004). p. 128 318
Dahr, B. and Anuradha, R.V. (2004). ‘Access, Benefit-Sharing and Intellectual Property Rights’. p. 608
87
‘Every document shall specify the registration number of the contract affording access to
genetic resources and a copy thereof where the goods or services for which protection is
sought have been manufactured or developed from genetic resources or products thereof, of
which one of the Member countries is the country of origin.’319
United States, the EU and Japan opposed this proposal on the ground that this was elements
of substantive patent law. The proposal where supported by the bulk of developing countries,
but in the end the provisions building on this proposal was not included in the PLT.320
The Intergovernmental Committee on Intellectual Property and Genetic Resources,
Traditional Knowledge and Folklore
The establishment of the Intergovernmental Committee on Intellectual Property and Genetic
Resources, Traditional Knowledge and Folklore (ICG), was an unintended outcome from the
above mentioned proposal from the Colombian delegation at the third session of the SCP, in
September 1999. At the 25th
Session of the WIPO´s General Assembly in 2000, the ICG was
formally approved as a forum for members to discuss three themes: intellectual property
issues that arise out of the context of (i) access to genetic resources and benefit sharing; (ii)
protection of traditional knowledge, whether or not associated with those resources; and (iii)
the protection of expressions of folklore.321 In the ICG substantive discussions on how patent
law might more effectively support benefit sharing and prevent misappropriation of TK have
focused on two approaches. The first approach is the disclosure of origin of genetic resources
and/or associated traditional knowledge in patent applications. Many developing countries,
especially India and Brazil as we seen before, argues that such disclosure requirements would
provide evidence of prior informed consent and compliance with access and benefit sharing
laws in provider countries, in accordance with the CBD. On the opposite the US argued that
such requirements would conflict with TRIPS by creating another substantive criterion on
patentability, beyond those stated in TRIPS.322 The second approach was to improve the
accessibility of traditional knowledge in the public domain for patent examiners, in their
search for prior art, to prevent misappropriation of TK in granting of patents. This could be
done either to provide an inventory list of publications that regularly document traditional
319
WIPO (1999). ‘Protection of Biological and Genetic Resources: Proposal by the Delegation of Colombia’,
Standing Committee on Law of Patents, WIPO Document, SCP/33/10 p.1 320
Dahr, B. and Anuradha, R.V. (2004). p.609 321
Dutfield, G.(2004). p.135 322
Ibid. p. 135
88
knowledge, or to set up databases of public domain traditional knowledge, something done by
India.323
In the ICG several years of little movement in negotiations have eroded trust between
opposing sides and parties. At the WIPO General Assemblies on 1 October 2009 it was
agreed on a compromise text that gave the ICG its strongest mandate so far. The ICG were to
undertake text-based negotiations that will eventually become an “international legal
instrument or instruments”. The focus of the ICG work in 2010/2011 will build on the
existing work carried out by the ICG and use all WIPO working documents, including the
three documents on Traditional Cultural Expressions, Traditional Knowledge and Genetic
Resources324
, which are to constitute the basis on text-based negotiations. In its 15th
meeting,
in December 2009 the ICG was not able to pull positions close enough for agreement on how
to proceed on the committee’s vaguely-worded new mandate. Although the meeting held
discussions on substantive issues, such as what legal form of protection against
misappropriation of traditional knowledge should take, which is a step forward. At its 16th
meeting in May 2010, the ICG reached an agreement on how to conduct intersessional
working groups. These intersessionals are intended to help speed the committee’s work
towards an “international legal instrument” for the protection of traditional knowledge,
traditional cultural expressions and genetic resources, which the committee is mandated to
create. The text on these intersessionals is an important first step for the start of the
discussion. The substantive negotiation on an international instrument has started in
earnest.325
This represents ‘monumental progress’ for the WIPO Intergovernmental
Committee on Intellectual Property and Genetic Resources, Traditional Knowledge and
Folklore.326
323
Ibid. p. 135 324
WIPO Document GRTKF/IC/9/4, GRTKF/IC/9/5 and GRTKF/IC/11/8A 325
WIPO Document GRTKF/IC/16/5 ‘The Protection of Traditional Knowledge: Revised Objectives and
Principles’ 326
Mara, K.. (Intellectual Property Watch) (2010). ‘WIPO Traditional Knowledge Committee Moving Toward
Legal Agreement.
89
Draft Substantive Patent Law Treaty
Another process taking place at WIPO is the negotiations on a Draft Substantive Patent Law
Treaty (SPLT)327
, negotiated in the Standing Committee on the Law of Patents (SCP). The
objective of these negotiations are not openly spelled out, but can be assumed to be a
international harmonization on outstanding issues in the law of patent, such as a common
understanding of standards governing the patent criteria, patent applications and patent
claims, and their equal interpretation. The Draft SPLT first drafted already in 1991, before the
adoption of TRIPS, is essentially a hybrid of the laws prevailing in a number of developed
countries, in particular the US and the EU.328
There are three legal documents being negotiated: the Draft SPLT, the Draft Regulations
under the SPLT and the Draft Practical Guidelines. Only the Draft SPLT is likely to be legally
binding, but the other two documents will have a normative effect when the SPLT is about to
be implemented.329 A main issue in the negotiations of the Draft SPLT is to create a common
understanding of the term ‘invention’. International harmonisation of the term ‘invention’ will
affect the ‘public domain’, for example if plant generic resources that previously were open
for everybody to use in the public domain are given patent protection the public domain are
reduced. The public domain is the open space in which creative individuals and communities
‘can freely work without undue regulatory hindrance’330 (i.e. no individual exclusive rights).
The draft Treaty states that ‘mere discoveries’ shall not be considered eligible for patent
protection.331 The suggestions for the harmonisation of the term ‘invention’ are at the moment
similar to the present interpretations and practice in developed countries.332
In April 2006 the negotiations on the SPLT in SCP came to a stand since WIPOs members
were not even able to agree on the working plan of the SCP. The harmonisation process now
goes on in less formalised ways amongst developed countries (B-group), and in cooperation
327
Draft Substantive Patent Law Treaty, WIPO Document SCP/10/4 328
Commission on Intellectual Property Rights (CIPR). (2002). Integrating Intellectual Property Rights and
Development Policy. p. 132
329 Tvedt, M.W. (2005). ‘How Will a Substantive Patent Law Treaty Affect the Public Domain for Genetic
Resources and Biological Material?’ p. 311 330
Tvedt, M.W. (2005). p. 312.
‘Public Domain refers to the social and cultural space that is commonly shared by communities throughout the
world, and the ideas, principles, artefacts and applications that belong to this space.’ Definition from GRAIN
http://www.grain.org/jargon/?id=32 (Accessed 25 Mars 2008) 331
Article 12(1)(b)(i) Draft SPLT, SCP/10/4, p. 22 332
Tvedt, M.W. (2005). p. 312
90
between the Trilateral Patent Offices (the European, US and Japanese Patent Offices).333 This
collapse was due the disagreements between developed countries, emphasising cost-
effectiveness, and the developing countries doubting that further harmonisation would benefit
them. There is a total disagreement on if these issues are technical or political.334 A short-list
negotiation agenda was proposed by the developed countries, something that the developing
countries didn’t agree with. These countries wanted to negotiate a more comprehensive set of
issues, including development perspectives.335
Today all the necessary institutional
arrangements, with minor changes, are in place for a Worldwide Universal Patent System, but
as we seen, the political agreement is lacking.336 Even though the negotiations on a draft SPLT
in SCP have broken down, some of the Draft Articles with relevance to genetic resources and
traditional knowledge are reviewed here.
Of interest here is the possibility to make exemptions from, or refuse, patent on genetic
resources, and obligation to disclosure of origin and prior informed consent on mutually
agreed terms, with states or/and holders of traditional knowledge. The grounds for exemptions
are listed in Article 13(1), and here no references to genetic resources or traditional
knowledge are made. However, in Article 13(4) there are references to both access to genetic
resources and the protection of traditional knowledge, although bracketed:
[(4) [Compliance With Applicable Law on Other Matters] A Contracting Party may also
require with the applicable law on public health, nutrition, ethics in scientific research,
environment, access to genetic resources, protection of traditional knowledge and other areas
of public interest in sectors of vital importance for their social, economic and technological
development.]337
Since the wording ‘may’ is used in this paragraph it does not oblige the Member countries to
make laws to ensure compliance with CBD or ITPGRFA and that other ’applicable law’
cannot be imposed as a patent criterion, Tvedt argues. This means that compliance with these
regimes is to be dealt with outside patent law and cannot have any effects on the granting of a
patent. According to Tvedt this argumentation is similar to the one that has been put forward
333
Tvedt, M.W. (2007). ‘The Path to One Universial Patent’. p. 2. At these three patent offices more than 85 per
cent of all patent applications filed worldwide are processed, see Olivia, M.J. (2008) in Tansey, G. and Rajotte,
T. ‘The Future Control of Food’. p. 74 334
Tvedt. M.W. (2007). p. 5 335
Ibid. p. 9 336
Ibid. p. 3-8 337
Article 13(4) Draft SPLT, SCP/10/4. The SCP agreed at the eight session to include this paragraph in square
brackets, but to postpone substantive discussions on this provision. Square brackets means not yet agreed on in
the negotiations.
91
on the interpretation of TRIPS, namely that access and benefit sharing provisions and
provisions regarding traditional knowledge cannot be included in patent law as a patent
criterion.338
As we seen before there are possibilities to make exemptions from patent protection of plants
and animals in Article 27.3(b) of the TRIPS agreement, and the possibility of creating a sui
generis system for the protection of plant varieties. These exemptions are not possible in the
draft SPLT.339 Further there are no references in the draft SPLT to the extensive discussions
on disclosure of origin in relation to genetic resources and traditional knowledge, which has
taken place in the CBD, the ITPGRFA the TRIPS Council and as well as in WIPO’s own
Intergovernmental Committee on Intellectual Property and Genetic Resources, Traditional
Knowledge and Folklore.
In regard to inventive step the following provision are stated in the draft SPLT:
‘[General Knowledge of the Person Skilled in the Art] For the determination of inventive
step (non-obviousness), the general knowledge of the person skilled in the art on the
priority date of the claimed invention shall be taken into account’340
Tvedt argues that ‘the type of knowledge in which the person is assumed to be skilled will
likely be assumed by the patent system to be technical Western knowledge not, for example,
traditional or indigenous knowledge. Thus, using biological material in a manner ‘obvious for
a person possessing traditional knowledge probably will not be sufficient to keep that
resource in the public domain’341, i.e. not granting patent protection. Therefore this will have
significant impact on the negotiations and implementation of provisions of the CBD,
concerning fair and equitable benefit sharing and prior informed consent on mutually agreed
terms when traditional knowledge are incorporated in biological developments.
At WIPO also other processes of relevance to plant genetic resources and ABS are taking
place. Since 2004 member countries has been engaged in, often acrimonious deliberations
mainly on North-South lines, on how to proceed with the 111 proposals on the "Development
338
Tvedt, M.W. (2005). p.320, See the EU Patent Directive 98/44/EC for the argument of separate laws on
ABS/TK and Patents. 339
Tvedt, M.W. (2005). p. 323 340
Rule 15(3) Draft SPLT Regulations, SCP/10/5, 341
Tvedt, M.W. (2005). p.332
92
Agenda". This agenda is an ‘attempt to ensure WIPO activities and IP discussions are driven
towards development-oriented results.’342
This process will though not be reviewed in this
thesis.
Another process of interest to traditional knowledge, plant genetic resources and IPR is an
agreement between WIPO and FAO to establish a mutually supportive relationship. Critics’
fear that this will result in a situation where FAO, and other international organisations
dealing with biodiversity, will have to accept the advice given from WIPO, which is mostly
pro-industry. Instead FAO would need their own legal and technical expertise to approach
IPR issues from the point of view of its own core mandate.343
Further the above mentioned
Budapest Treaty344
, administered by WIPO and with the aim to facilitate the process of
obtaining patents on micro-organisms, with no references to the CBD and national legislation
on biodiversity, is being incorporated in bilateral free trade agreements, so called TRIPS-Plus
Agreements.345
Declarations and other conventions
The rights of indigenous peoples have during the last 50 years been more widely acknowledge
in international law. In September 2007 the United Nations Declaration on the Rights of
Indigenous Peoples, (UNDRIPS) was adopted by the General Assembly. Article 31 is central
for protection of traditional knowledge associated with genetic resources: ‘indigenous peoples
have the right to maintain, control, protect and develop their cultural heritage, traditional
knowledge and traditional cultural expressions, as well as the manifestations of their sciences,
technologies and cultures, including human and genetic resources, seeds, medicines,
knowledge of the properties of fauna and flora, oral traditions, literatures, designs, sports and
traditional games and visual and performing arts. They also have the right to maintain,
control, protect and develop their intellectual property over such cultural heritage, traditional
knowledge, and traditional cultural expressions.’346
At CBD COP 9 in Bonn May 2008 the
EU, Mexico, Bolivia and Ecuador urged using UNDRIPS as a framework for work on Article
342
Oliva, M. J. (2007) Promoting and Extending the Reach of Intellectual Property: The World Intellectual
Property Organization (WIPO), in Tansey, G. and Rajotte, T. ‘The Future Control of Food’ 343
Tansey, Geoff (2007). ‘Fear over growing WIPO-FAO links’. p. 56-57 344
Budapest Treaty on the International Recognition of the Deposit of Microorganisms for the Purpose of Patent
Procedure, signed in Budapest 1977 and came into force in 1980. 345
Rodríguez, S. ‘CAFTA and the Budapest Treaty: The Debate in Costa Rica’. Seedling. January 2008. p. 37 346
United Nations Declaration on the Rights of Indigenous Peoples (A/RES/61/295), Article 31
93
8(j) of the CBD.347 The recognition of indigenous peoples has also been expressed by the
adoption of the Convention 169 of the International Labour Organization in 1989. Further
some key international human rights treaties, namely the International Convention on Civil
and Political Rights (art. 27)348
and the International Convention on Economic, Social and
Cultural Rights (art. 15.1)349
, also protect the rights of indigenous peoples, including their
rights to their traditional knowledge and thereby also ‘provide for balancing private rights,
including IPRs, against the public interest, including the protection of all human rights.’350
Table 2. What the international regimes and processes regulate/negotiate
Conservation and ABS from utilization of
Traditional Knowledge and Genetic Resources
Intellectual Property Rights
CBD (binding law)
ABS (binding or non-binding regime
being negotiated under CBD)
TRIPS agreement
Article 27.3(b) concerning patent application
on genetic resources
(binding law, no references to ABS)
ITPGRFA
(binding law, references to ABS)
SPLT (no references to ABS)
(binding law being negotiated)
ICG (discussions, references to ABS) ICG (discussions, references to ABS)
Source: after Andersen, R. (2007).
Summary
The international concern for the loss of biological diversity and the accompanied loss of
biogenetic diversity, leaded up to the adoption of the Convention on Biological Diversity
(CBD) in 1992. CBD provides national sovereignty over genetic resources and has thereby
lead to the development of access conditions for other sovereign parties. The convention also
demands a prior informed consent on mutual agreed terms and benefit sharing of the
commercial utilization of genetic resources, and the recognition of the traditional knowledge,
held by local communities and indigenous peoples, associated to the genetic resources. The
agreement on Trade Related Intellectual Property Rights (TRIPS) adopted in 1994, provides a
minimum IP protection standard for biological matter such as plant varieties, micro-
organisms, and microbiological processes, to be implemented in national IPR laws of the
347
Earth Negotiation Bulletin. Thursday, 22 May 2008, Vol. 9 No. 445, p.2 348
The International Convent on Civil and Political Rights, New York, 16 December 1966. 349
The International Convention on Economic, Social and Cultural Rights, New York, 16 December 1966 350
Tarasofsky, R.G., (2002). ‘Towards a mutually supportive relationship between the Convention on Biological
Diversity and the World Trade Organization: An Action Guide’. p. 19
94
member parties. If member parties do not want to provide for patent protection in patent
varieties TRIPS gives a possibility to form a sui generis system or adopt UPOV 91. Within
the World Intellectual Property Organization (WIPO), the Intergovernmental Committee on
Intellectual Property and Genetic Resources, Traditional Knowledge and Folklore (ICG) was
set up in 2001, in order to discuss IP issues relating to access to genetic resources and the
protection of traditional knowledge, including disclosure requirements in patent applications.
At the same time negotiations on as Substantial Patent Law Treaty (SPLT) are taking place at
WIPO, a process which is aiming at harmonising IP laws globally. Under the UN Food and
Agricultural Organisation the International Treaty on Plant genetic Resources for Food and
Agriculture was adopted in 2004. The Treaty’s aim is to facilitate the international flow of
plant genetic resources for agriculture within a Multilateral System, the CGIAR system, and
strengthen the rights of farmers as custodians of the crop genetic diversity worldwide. In 2007
the United Nations Declaration on the Rights of Indigenous Peoples, (UNDRIPS) was
adopted by the General Assembly. This declaration contains provisions on the traditional
knowledge on biogenetic resources.
95
Rationales for the Protection of Traditional Knowledge on Plant
Genetic Resources and the Prevention of Biopiracy
This section stakes out the reasons and rationales for protecting traditional knowledge,
associated with plant genetic resources, at the international and national level. The main
reasons are: equity considerations, biodiversity conservations concerns, the preservation of
traditional practices and culture, and the prevention of misappropriation of traditional
knowledge and genetic resources by unauthorised parties.
The traditional knowledge steaming from the experience gained by generations of people and
adapted to the local cultural and natural context, has always played, and still plays, a vital role
for the food systems and medical systems of the majority of people in the world.351
Knowledge of the healing properties of certain plants has been the source of many modern
medicines. In addition, the use and continuous development by local farmers of plant
varieties, and the knowledge associated with them, play an important role in agricultural
systems in developing countries.352
Therefore there are a number of reasons for the
protection353 of traditional knowledge. The holders of traditional knowledge express concerns
about:
- the loss of traditional lifestyles and the attached knowledge, and the reluctance of the
community youths to carry forward traditional practices.
- the lack of respect for TK and holders of traditional knowledge and the lack of
recognition of the need to preserve and promote further use of traditional knowledge.
- the misappropriation of traditional knowledge, i.e. the use of TK without any free and
prior informed consent or sharing of benefits.354
351
According to the WHO, up to 80 per cent of the world’s population depends on traditional medicine for its
primary health needs, and for the poorest TK is indispensable for survival. See Dutfield, G. (2004). p. 97 352
O’Connor, B. (2003) ‘Protecting Traditional Knowledge: An Overview of a Developing Area of Intellectual
Property Law’. p. 676 353
Here the word ‘protection’ should not be equated directly with the use of ’protection’ in the IPR sense.
Protection, from an IP law perspective, means that the owner of a patent has a legal right to exclude others from
using or reproducing it. The IPR forms of protection for intellectual creations and innovations are time limited,
individualistic, monopolistic and exist for economic benefit. Instead protection is here seen as a measure to
preserve TK against the forces and uses which negatively affect the holders of TK and erode the cultures that
develop and apply traditional knowledge. 354
CIPR. (2002). p. 75. For the concept Free Prior and Informed Consent see UN Permanent Forum on
Indigenous Issues. Fourth session. ‘Report of the International Workshop on Methodologies Regarding Free
Prior and Informed Consent and Indigenous Peoples’. (New York, 17-19 January 2005)
96
The main arguments for granting protection to traditional knowledge therefore include:
equity considerations – the holders and custodians of TK should receive fair compensation
and share the benefits if the traditional knowledge leads to commercial incomes for the user
of the traditional knowledge and the genetic resource. An example of when this have not been
the case is where farmers varieties has been used in breeding of improved varieties and the
farmers haven’t been compensated for the germplasm the contributed with and the value they
helped to create.
conservations concerns – if traditional knowledge is protected the maintenance of the
biological diversity in for example farming systems will be sustained. The protection of TK
and its continued use will lead to in situ conservation of genetic resources. It may be argued
that a ‘conservation ethic is a prevalent feature of the subsistence and resource management
practices’ of indigenous and traditional communities, something supported by many field
studies. But on the other hand this may be ‘romanticism’, since communities may have low-
impact due to its small size. Nevertheless there is an increasingly awareness of the extent to
which traditional natural resource management can enhance biodiversity and for example that
anthropogenic landscapes with high biodiversity exists even within ‘pristine’ tropical
forests.355
the preservation of traditional practices and culture – traditional knowledge is a key
component of the rights to self-identification and a condition for the continuous existence of
indigenous and traditional peoples. Protection could also be used to raise the profile of the
knowledge and the holders of it both inside and outside of the communities. It has been
pointed out that the external legal recognition of traditional knowledge ‘will make the
learning and development of such knowledge a more attractive prospect for the younger
members of such communities, thus perpetuating its existence.’356
the prevention of appropriation by unauthorised parties: biopiracy – this relates to the
process where genetic resources and TK and the rights associated to these are
misappropriated, trough patent in another country, without prior informed consent and mutual
agreed terms (in the language of CBD). For many developing countries governments and
355
Dutfield, G. (2004) p. 99 356
Crucible II Group (2001) vol 2. p. 10
97
indigenous peoples organisations and other NGOs the protection of traditional knowledge is
mainly motivated to prevent biopiracy.
the promotion of its use and its importance in development – to protect TK against
misappropriation and loss, or ensure compensation to TK holder is necessary to stimulate the
use of such knowledge. Protection may create the trust which is needed for the
local/indigenous communities to part their knowledge and give access to the genetic resources
and TK, to obtain value from it. Legal protection may help to strengthen local innovation in
products and services derived from TK and thereby reinforcing or rebuilding local cultures.357
Approaches to protect Traditional Knowledge on Genetic Resources
To make it possible to answer the research question ’how do provisions in the international
regimes on intellectual property rights, plant genetic resources and traditional knowledge
affect the possibilities of protecting traditional knowledge, under international law?’ the
following section describes approaches to protect traditional knowledge on genetic resources
put forward in the international debate and negotiations. Both defensive and positive ways of
protection are presented, and broader approaches which go beyond the ways of protection
within the conventional system of IPR are also discussed. These approaches build on the
different rationales for the protection of traditional knowledge presented in previous section.
Traditional Knowledge as Intellectual Property
‘Community rights over biodiversity and indigenous knowledge are collective in
nature, and therefore cannot be privatized or individualized. Current systems of
intellectual property rights applied to biodiversity and traditional knowledge are
private and monopolistic in nature and therefore incompatible with community
rights.’358
In opposition to the above quote it is suggested that traditional knowledge and traditional
innovation may be protected as intellectual property. At first sight TK is not easily
protected under present-day IPR laws because it does not directly yield ‘innovation’ in
the common meaning. So recognition of innovation made in rural and traditional
communities is important for the continued use of TK in a fair and equitable way, it is
argued. There are three broad approaches put forward on the protection of traditional
knowledge; (a) the use of the existing IPRs system; (b) developing a sui generis system
357
Section based on Correa, C. (2001) p. 5-8 358 The Valley of 1000 Hills Declaration, March 7 2002, Kwa Zulu Natal, South Africa
98
to protect traditional knowledge; (c) the use of customary law and developing contracts
for benefit-sharing359 if the product or process builds on the traditional knowledge.360
The first approach that suggests the use of conventional Western forms of IPR like patents,
copyrights, trademarks and so on.361
It proposes the protection of the TK and the rights of the
holders so that they can ‘use the monopoly rights they would enjoy as a result for extracting
the rents arising from the use of the knowledge by third parties.’362
To protect traditional
knowledge associated in particular with genetic resources, patents, plant breeder rights (as
provided by UPOV) and geographical indications (under TRIPS) have been suggested as
possible ways of protection.
These approaches are underpinned by the mercantile rationale to promote both cultural
survival and genetic conservation. It is argued that ‘cultural or indigenous knowledge be
treated as a form of intellectual property in order to increase the economic return from
biological resources maintained by peasants and tribal people.’363
Here it is reasoned that
there is an ‘underinvestment in the conservation’ of traditional knowledge and genetic
resources, since they are public goods. Therefore it is proposed that turning these resources
‘into commodities that can be bought and sold could possibly enable tribal herbalists, peasant
farmers or governments to profit from their knowledge and from conserving plant
resources.’364
Though it must be noted that the interests of the two former groups could stand
in stark contrast to the interests of the state and government. Further it is argued that
’carefully designed IPRs in traditional knowledge could help developing countries become
full players in global agricultural markets’, the horticulture, pharmaceutical, and cosmetics
sectors, while simultaneously ‘equitably rewarding indigenous peoples for their contributions
to international well-being.’365
It is also argued that IP protection of TK would give the
holders incentives to undertake formal, stable and sustainable agricultural cultivation
359
Contractual arrangements for ABS of genetic resources and traditional knowledge includes among others: the
INBio-Merck agreement, Nigerian communities-International Co-operative Biodiversity Group programme, The
Kani tribes of Kerala-the Tropical Botanical Garden and Research Institute. 360
Dhar, B. and Anuradha, R.V. (2004). ‘Access, Benefit-Sharing and Intellectual Property Rights’. p.620 361
Copyrights, trademarks, trade-names and industrial design have been proposed in the protection of
‘traditional cultural expressions’ like literary works, tales legends and textile works; ceramics, leather, wood
work and so on. 362
Dhar, Biswajit and Anuradha, R.V. (2004). p. 620 363
Brush, S.B. (1996). ’Whose Knowledge, Whose Genes, Whose Rights?’ in Brush, S.B and Stabinsky, D.
(Eds.) Valuing Local Knowledge. p. 2 364
Brush, S.B. (1996). p. 2 365
Cottier, T. and Panizzon M. (2004). ‘Legal Perspectives on Traditional Knowledge: the Case for Intellectual
Property Protection.’ p. 372
99
practices with the plants usually harvested in the wild and thereby minimising risks of over-
harvesting and loss of biodiversity.366
A distinction has been made between two modes of protection of traditional knowledge, one
positive and one defensive:
‘Positive protection entails the active assertion of IP rights in protected subject matter, with a
view to excluding others from making specific forms of use of the protected material.
Defensive protection does not entail the assertion of IP rights, but rather aims at preventing
third parties from claiming rights in misappropriated subject matter.’367
Positive protection in this meaning may lead to the adoption of IPRs for TK holders created
under a new sui generis system, but defensive protection can, in other words, be ensured by
making use of the existing legislation to protect TK from illegitimate assertion of patents.368
Positive protection will require committed work from governments, while defensive
protection may be more easily achieved since it is a modification of existing IPR laws.369
Defensive protection approaches
In international forums and regime negotiations two proposals for defensive protection of TK
through the conventional patent system have come up; (1) disclosure of origin where
applicants of a patent have to reveal the geographical location from were the genetic resource
have been collected and if TK is associated with this resource; (2) databases of published
traditional knowledge in where patent examiners can search for prior art which make the
novelty criteria of the patent application invalid. In addition to these two a proposal for a
misappropriation regime has emerged.
366
Cottier, T and Panizzon, M. (2004). p.372-373 367
WIPO Document . WIPO/GRTKF/IC/4/8, 30 September 2002.’Elements of a Sui Generis System for the
Protection of Traditional Knowledge’ para. 13. Cited in Haugen, H.M (2005) ’Traditional Knowledge and
Human Rights’. p. 665 368
Ibid. p. 665 and WIPO Secretariat (2008) Draft Gap Analysis on the Protection of Traditional Knowledge,
Annex, p. 10 369
Dutfield, G. (2004). Intellectual Property, Biogenetic Resources and Traditional Knowledge. p. 110
100
Disclosure of origin/certificate of legal provenance
The proposal to make a disclose the origin of a genetic resource a requirement in patent
applications is intended to help realize the CBD provisions on fair and equitable benefit
sharing. The proposals come in three forms: weak, medium and strong. (a) the weak form is
where a voluntary disclosure is encouraged. If a disclosure of the origin of genetic resources
and/or TK is not made this would not make the application invalid. This version hopes to
increase the transparency of the international commercial transfers of genetic resources and
associated traditional knowledge370 and is supported by the EC, whom also consider that ‘the
non-respect of the requirement should lie outside the ambit of patent law.’371
(b) In the
medium version disclosure of origin would be mandatory. If this disclosure is not fulfilled or
the disclosure is dishonest this would have consequences; ‘the patent application would not be
accepted or be rejected during the prosecution stage; if grated it would not be enforceable or
revoked with possible criminal sanctions for wrongdoers.’372
The applicants of the patent and
the patent examiners are the once whom the burden of compliance is placed on in this
proposal. (c) The strong version, is the proposal put forward by the Like-Minded Megadiverse
countries373
to create an international system of certificates, issued by a legally competent
body, to accompany genetic resources as a proof that the movement of the item has fulfilled
basic CBD requirements on PIC and MAT as well as any additional conditions imposed by
national legislation.374
The term they use is certificates of legal provenance, but has also been
called proof of legal acquisition. It would create ‘a legal obligation for all member states of
the CBD to monitor compliance with whatever conditions provider countries have set down,
and provide sanctions for non-compliance under their own legal systems.’375
Only with a
370
Dutfield, G. (2005). ‘Thinking Aloud on Disclosure of Origin’ p. 2 371
WTO Document IP/C/W/383. Communication from the European Communities and their Member States. 17
October 2002. ‘Review of Article 27.3(b) of the TRIPS Agreement, and the Relationship between the TRIPS
Agreement and the Convention on Biological Diversity,and the Protection of Traditional Knowledge and
Folklore’. p.2 372
Dutfield, G. (2005). p. 2 373
See Declaration of the Like-minded Megadiverse countries, (Cancun, 18 February 2002). The Megadiverse
Group includes Bolivia, Brazil, China, Colombia, Costa Rica, Democratic Republic of Congo, Ecuador, India,
Indonesia, Kenya, Madagascar, Malaysia, Mexico, Peru, Philippines, South Africa and Venezuela. The group is
basically a biodiversity cartel, aiming to strengthen the bargaining position of these countries, in the same way as
OPEC. 374
Countries such as Panama, Costa Rica, Brazil and the Andean Community of Nations (Venezuela, Colombia,
Ecuador, Peru and Bolivia) have laws in place which establish basic requirements to access and use traditional
knowledge. These laws however, generally refer to cases where knowledge is sought directly, in situ, from
indigenous communities. They do not address the issue of knowledge kept in publicly available databases or in
the public domain in general. 375
GRAIN (2005) ’Re-situating the benefits from biodiversity: a perspective on the CBD regime on access and
benefit-sharing’ p. 7
101
valid certificate of provenance would it be legitimate to submit a patent application for a
product based upon a genetic resource. This certificate would be a mechanism for developing
countries to achieve a ‘disclosure of origin’ requirement in patent applications. The difference
is that the certificate would be ‘an independent system, likely comprised of national
government agencies and coordinated by the CBD.’ The patent offices in the user countries
would only have to control whether there was a valid certificate, just as they check other
formal requirements in patent applications.376
This version of disclosure of origin differ from
the other two in that it is a independent document and thereby would not involve the patent
offices in the actual assessment of whether the conditions were fulfilled.377
Correa argues that
the proposals to oblige patent applicants to disclose the origin of biological materials should
not be viewed as an additional patentability requirement besides novelty, inventive step (non-
obviousness) and industrial application (utility). Instead it is a component of the general rule
that patent applicants should disclose to the patent authority all information known to be
material to patentability, i.e. the disclosure requirement, stipulated in TRIPS article 29.378
TK prior art databases
Compiling databases of traditional knowledge nationally is something being developed in
several countries, led by China and India and with India’s Traditional Knowledge Digital
Library (TKDL)379
as the prime example. In the TKDL it is possible to search for already
documented information on traditional Ayurvedic health knowledge and medical plants used
by Ayurvedic practitioners.380
These databases are set up to facilitate examiners at patent
offices to make prior art search and will do so taking into account WIPOs international
classification standards to make the information easily accessible.381
At the same time the vast
breath and depth, and inherent nature of traditional knowledge limits the databases
possibilities of coverage. Undocumented knowledge based on oral tradition in local language
makes is especially hard to cover in databases. 382
376
GRAIN (2005) p. 7-8 377
GRAIN (2005) p. 8 378
Correa, C. (2005). ‘The Politics and Practicalities of a Disclosure of Origin Obligation’. p. 5 379
The National Institute for Science and Communication (NISCOM) is the implementing institution. 380
Dutfield, G. (2004). Intellectual Property, Biogenetic Resources and Traditional Knowledge. p. 114 381
CIPR (2002). p. 82 382
Dahr, B. and Anuradha, R.V. (2004). p. 614-15
102
It has been argued that databases ‘can complement the purpose of expanded disclosure
norms’, but that they ‘cannot be a substitute for them.’383
They therefore could have made
wrongly granted biopiracy patents, like the turmeric patent, impossible, but at the same time
may not have prevented other controversial patents by providing novelty-destroying prior art
for patents on products derived from TK and genetic resources.384
Documentation may
provide for benefit sharing but at the same time will not ensure this to take place and since the
knowledge is view as prior art benefit sharing may even be impossible.385
As much traditional
knowledge will continue to be undocumented the concept of absolute novelty, ‘whereby any
disclosure including through use, anywhere in the world, is sufficient to destroy the novelty of
an invention’ is argued to be a necessary safeguard against biopiracy.386
Finally these
initiatives to safeguard TK, for instance through documenting and publishing it in databases,
may in fact ‘amount to a betrayal of sacred or social duties to protect their heritage, to the
detriment of customary means of preserving and passing on TK. It may amount to a passing
on to external interests who are not bound by the traditions embedded in the knowledge that
define its spiritual and ethical context.’387
Further it is argued that ‘knowledge within
communities is not equally distributed; rather it is distributed and exchanged according to
particular norms and criteria, all of which may be disrupted by the publication process’.
Furthermore, due to the complex ways in which knowledge is generated and flows within
indigenous communities ‘removal or transfer of information from the group through
publication can threaten internal and external stability.’388 The Indigenous Peoples Council on
Bio-colonialism argues that ‘traditional knowledge is dynamic, not static and cannot simply
be documented and “fixed in a tangible form” to suit intellectual property law standards’ and
that databases could be means to ‘facilitate access by external entities, making traditional
knowledge vulnerable to exploitation.’389 In summary some indigenous peoples and local
communities may see database documentation as a way to prevent biopiracy, by making their
TK ‘prior art’, even without patents, while others experience databases as a inappropriate way
383
Dahr, B. and Anuradha, R.V. (2004). p. 615 384
Dutfield, G. (2004). p. 114 385
Correa, C. (2001). ‘Traditional Knowledge and Intellectual Property: Issues and options surrounding the
protection of traditional knowledge’ p. 18 386
Commission on Intellectual Property Rights (2002). p. 83 387
Taubman, A. (2005). p. 522 388
Laird, S., Alexaides, M., Bannister, K., and Posey, D. (2002). ‘Publication of Biodiversity Research Results
and the Flow of Knowledge.’ In Laird, S. (ed). Biodiversity and Traditional Knowledge: Equitable Partnerships
in Practice. p. 82 389
Indigenous Peoples Council on Biocolonialism. (2006).‘The Convention on Biological Diversity’s
International Regime on Access and Benefit Sharing: background and considerations for indigenous peoples’
p. 10
103
to store indigenous ideas and knowledge. WIPO has made efforts to examine the extent of
traditional knowledge available on the internet, but at the same time both WIPO and
developing countries have expressed worries that information collected in databases on the
internet may have been recorded without the prior informed consent of the holders of this
knowledge.390
Patents as protection of Traditional Knowledge
Patents are seen to have some possibilities to protect traditional knowledge. Indigenous
peoples, rural communities or organizations representing these groups could apply for patents;
these groups could have shared ownership with companies whom would apply on their
behalf; or community members could be named as inventors possessing contractual rights of
compensation in a patent filed by a company.391
Thought in the case of patents one can find
four major objections on the possibility to protect traditional knowledge under patent law: (a)
TK is to a large extent collectively held and generated while in patent law the inventive step
have to be assigned to an individual or juridical person; (b) in patent applications there has to
be proof of a single act of discovery, something that would exclude most traditional
knowledge; (c) the application and patent specification have to be written in a technical way
so it is easily accessible for the patent examiner. This would be difficult and expensive for
rural and indigenous communities; (d) to apply for patent and enforcing them is very
expensive since administrative and juridical processes are costly and lengthily exercises. So
the reality is that ‘the lack of economic self-sufficiency of many traditional communities, the
unequal power relations between them and the corporate world, and the high cost of litigation,
would make it very difficult for them to protect and enforce their IPRs through the patent
system.’392
But maybe the most important objection against patent protection of TK is the
fundamental opposition against the Western patent system, and its view of knowledge, in the
majority of indigenous and rural communities. These communities have traditional norms and
customary practices that view the world and define relationships in other ways.393
390
Commission on Intellectual Property Rights (2002). p. 82 391
Dutfield, G. (2004). p. 105 392
Dutfield, G. (2004). p. 105 393
Swiderska, K. (2006).‘Banishing the Biopirates: A New Approach to Protecting Traditional Knowledge’.
p. 12
104
Geographical Indications as protection of Traditional Knowledge
Today geographical indications are confined mainly to wine/spirits and food items, but could
also protect certain traditional knowledge associated with locally produced goods, especially
food items and herbal formulations. An example of a food-crop that could be protected by GI
is the North Indian and Pakistani rice variety Basmati. This rice commands a high price in
industrialised countries markets because of its high quality as well as its authenticity. Both
European and US companies have actively appropriated the name and thereby its high
reputation. If the Basmati rice is to be protected as a GI under TRIPS it has to be proven that
Basmati is distinctive, both by its inherent qualities as well as its geographical origin and local
know-how/traditional knowledge.394 Within WTO several developing countries have indicated
that they are interested in an enhanced protection in GIs. Egypt has proposed to extend Article
23.1 of TRIPS395 to products of interest to developing countries.396 This has been supported by
Cuba, Dominican Republic, Honduras, Indonesia; Nicaragua and Pakistan, the African Group,
and Venezuela.397 GIs may prevent the misuse of the geographical indication, but not protect
the knowledge as such.398
Plant Variety Protection as protection of Traditional Knowledge
Traditional framers are innovators and breeders of landraces and should therefore be able to
acquire plant variety protection or hold plant breeder rights, for their landraces. This is
controversial because there is little agreement about what constitutes a variety. There is
increasing international recognition that ‘the innovative activities of farmers and their
communities must be recognized and encouraged to ensure food security and improve
agricultural productivity, to conserve and create agricultural biodiversity; less certain is
whether a sui generis system that provides protection for farmers' varieties will help realize
394
Dutfield, G (2004). p. 107-108 and CIPR. (2002). p. 98 395
TRIPS, Article 23: Additional Protection for Geographical Indications for Wines and Spirits “1. Each Member shall provide the legal means for interested parties to prevent use of a geographical indication identifying
wines for wines not originating in the place indicated by the geographical indication in question or identifying spirits for
spirits not originating in the place indicated by the geographical indication in question, even where the true origin of the
goods is indicated or the geographical indication is used in translation or accompanied by expressions such as "kind",
"type", "style", "imitation" or “the like.” 396
WTO Document WT/GC/W/136 397
WTO Document WT/GC/W/208, Cuba, Dominican Republic, Honduras, Indonesia, Nicaragua and Pakistan;
WTO Document WT/GC/W/302, the African Group; and WTO Document WT/GC/W/282, Venezuela 398
Correa, C. (2001). p. 13
105
these objectives.’399
To be protected by PVP a variety has to differ from existing varieties, be
uniform and stable.400
These requirements implies that only breeders of uniform varieties can
obtain plant breeder rights, and since landraces are usually diverse and thereby non-stable and
uniform they may not be classified as ‘varieties’ in the UPOV sense. This makes the use of
plant breeder rights as a means of protection of the traditional knowledge on plant genetic
resources of limited use.401
As it seems rural communities show little interest in this form of
protection402
and it may even be that plant breeders rights as stipulated in UPOV 91 is an
threat to traditional knowledge and the agro-genetic diversity, because of its strict rules on
seed-saving practices.403
Positive Protection approaches
Sui Generis system for the Protection of Traditional Knowledge and ABS
More than 35 countries, mainly developing countries, have introduced national legislation on
access and benefit sharing and appointed national authorities for ABS. If the countries which
are in the process of passing ABS laws are included the number counts to over 40 nations.404
Some of these national legislations recognise the rights of communities over their traditional
knowledge. These sui generis405
systems fall basically under the conventional IPR-model
because they protect only intellectual rights and focus mainly on commercial benefits.406
The
sui generis ABS legislation generally includes a number of obligations on the user having
access: (a) full information concerning new products and/or knowledge developed from
accessed materials; (b) priority access by the providing country to such new products and/or
knowledge; (c) a share in financial and other benefits derived from the commercial
exploitation of accessed materials and their derivatives; (d) obligatory deposit of a specimen
of each accession; (e) transfer to third parties only after authorization; (f) involvement of local
399
Crucible II Group. (2000). Seedling Solutions. Vol.1: ‘Policy Options for Genetic Resources: People, Plants,
and Patents Revisited’. p. 98 400
International Convention for the Protection of New Varieties of Plants, Act of 1991,
Article 5: Conditions of Protection 401
Dutfield, G (2004). p. 107 402
Borowaik, C. (2004). ‘Farmers’ Rights: Intellectual Property Regimes and the Struggle over Seeds’. p. 531 403
See GRAIN Briefing. February (2007).‘The End of Farm-saved Seed? Industry’s wish list for the next
revision of UPOV’. 404
Safrin, S.(2007) ’Chain Reaction: How Property Begets Property’ p. 11 405
A legal regime ‘of its own kind’ (latin). 406
Swiderska, K. (2006).‘Banishing the Biopirates p. 8-9
106
scientists in collection/research.407
(g) equitable benefit-sharing of immediate, medium- and
long-term benefits resulting from bioprospecting activities among the government and/or
communities concerned. Examples of countries and regional organizations that have
developed national legislation is the Philippines (Executive Order 247)408
, Costa Rica
(Biodiversity law)409
, India (The Protection of Plant Varieties and Farmers´ Rights Act and
The Biodiversity Bill)410 Andean Community (Common Regime on Access to Genetic
Resources, Decision 391),411
and the African Union (African Model Legislation for the
Protection of Rights of Local Communities, Farmers and Breeders, and for the Regulation of
Access to Biological Resources)412
.
Holistic approaches for the Protection of Traditional Knowledge
Several alternative ways to assign IPRs on traditional knowledge have been put forward.
These include ‘tribal/communal rights’, ‘community intellectual rights’, ‘traditional resource
rights’413
, ‘community patent’414
and ‘traditional intellectual property rights’ (TIP-Rights).
TIP-Rights would be adapted to the nature of traditional knowledge and would not rely on
novelty but would encompass pre-existing traditional knowledge and know-how relating to
plant and animal genetic resources.415
But as Correa notes may all these legal tools be
insufficient to prevent TK loss if communities are not able to keep their land and their
traditional cultures and lifestyles. In fact, too much emphasis on IPRs for TK may distract
attention from the real factors that put the preservation of TK at risk which include such
things as security of tenure, control of resources, respect for traditional culture and ownership
rights.416
A holistic approach to protect traditional knowledge, the Collective Bio-Cultural Heritage
Framework, is put forward by Swiderska and the International Institute for Environment and
407
Correa, C. (2001). p. 15 408
The Philippines Executive Order No 247 (May 1995) 409
Ley de Biodiversidad No 7788 (1998) 410
www.grain.org/brl/?docid=322&lawid=1378 411
Andean Community Common Regime on Access to Genetic Resources, Decision 391 412
African Union. (2000) ‘African Model Legislation for the Protection of Rights of Local Communities,
Farmers and Breeders, and for the Regulation of Access to Biological Resources’ 413
See Posey, D. A. and Dutfield, G. (1996). Beyond intellectual property: towards traditional resource rights
for indigenous peoples and local communities. 414
Mobeoji, I. (2001). ‘Patents and Plant Resources-Related Knowledge: Towards a Regime of Communal
Patents for Plant Resources-Related Knowledge’ p. 111 415
Dhar, B. and Anuradha, R.V. (2004). p. 621 416
Correa, C. (2001). p10
107
Development (IIED). This approach steam from the call by indigenous and farmers
organisations, for more holistic approaches to protecting their rights to traditional knowledge,
bio-genetic resources, territories, culture and customary laws. The framework of collective
bio-cultural heritage ‘addresses biodiversity and culture together, rather than separating them’
since these ‘components of indigenous knowledge systems and heritage cannot be separated.’
It recognises collective as opposed to individual rights and frame biodiversity and culture as
‘heritage’ as opposed to ‘property’.417
The Collective Bio-Cultural Heritage Framework
implies:
• That states acknowledge that their sovereign right over their genetic resources (as
recognised by the CBD article 3) is conditioned by indigenous peoples and local
communities’ customary rights over their traditional knowledge, resources and land. The
resource and land rights must thereby also be recognised by the states.
• The strengthening of community natural resource management, customary laws and
institutions, and collective land tenure as the basis for local control over traditional knowledge
and resources. For example, the establishment of Indigenous managed Bio-cultural Heritage
Areas can enhance rights over TK, traditional livelihoods and biodiversity conservation.
• Facilitating access for peoples and communities, not just researchers and companies, to
genetic resources held ex situ in gene banks. With genetic erosion caused by modern
agriculture, development etc, many peoples and communities need access to this material if
they are to restore diversity to cope with the climate change.418
The development of Bio-Cultural Community Protocols (BCPs) by indigenous peoples and
local communities is another way in which communities can increase their capacity and legal
empowerment to drive the local implementation of international and national laws on ABS.419
The process of developing a bio-cultural community protocol involves reflection about the
inter-connectedness of various aspects of the peoples and communities ways of life (such as
417
Swiderska, K. (2006).‘Banishing the Biopirates: A New Approach to Protecting Traditional Knowledge’. p. 1 418
Ibid. p. 1 419
These communities have developed BCPs: Raika Pastoralist (Rajastan, India); Samburu Pastoralists (Kenya);
Vaidyas of the Malayali Hills (Tamil Nadu, India); Gunis and Medicinal Plants Conservation Farmers of Mewar
(rajastan, India) and Bushbuckridge Traditional Healers (South Africa).
Bavikatte, K. and Jonas, H. (2009) Bio-Cultural Community Protocols – A community Approach to Ensure the
Integrity of Environmental Law and Policy. p. 21
108
between culture, customary laws, community-based natural resources management, and
traditional knowledge) and may involve resource mapping, evaluating governance systems
and reviewing community development plans. A community may want to evaluate on what
terms it would engage with potential commercial and non-commercial researchers wanting
access to their traditional knowledge concerning plants, what the community’s research
priorities are, what would constitute free and prior informed consent, and what types of
benefits the community would want to secure.420
The development of Bio-Cultural Community Protocols steam out of the critique of the way
in which the negotiations on an international regime on access and benefit sharing purporting
to implement Article 8(j)421
, heavily focus on the commodification of knowledge,
innovations, and practices. It is argued that ‘this poses a number of challenges for bio-cultural
communities who face serious and ever-escalating threats to their ways of life: desperate
exchanges422
of their TK, which is perceived as tradable cultural goods under this regime, for
benefits (usually limited income) without any corresponding respect for the inalienable
aspects of their TK. This can further weaken the very bio-cultural foundations upon which TK
is developed.’423
420
Bavikatte. K. And Jonas, H. (2009) Square Brackets, CBD newsletter for civil society. 421
the Ad Hoc Open-ended Working Group on Article 8(j) and Related Provisions have pointed on that BCP:s
may provide a useful approach to establishing well defined structures for competent authorities in indigenous
and local community, to handle international and national regulations on ABS.
Report of the Sixth Meeting of the Ad Hoc Open-Ended Inter-Sessional Working Group on Article 8(j) and
Related Provisions of the Convention on Biological Diversity. Annex II, 3(xi) and (xvi). 422
A situation of desperate exchange is when ILCs dispossessed of their lands and culturally marginalized are
left with little choice than to trade their TK at the best possible market price. Desperate exchanges are a moral
double bind in which on the one hand for many ILCs, the sale of TK is a much needed source of income, but on
the other hand it undercuts the spirit of the CBD article 8(j) that seeks to affirm and promote a value system
underlying the ways of life that have conserved and sustainably used biological diversity.
Bavikatte, K. and Jonas, H. (2009). p. 17 423
Bavikatte, K. and Jonas, H. (2009). p. 20
109
Summary
It is suggested that traditional knowledge and traditional innovation may be protected as
intellectual property. There are three broad approaches put forward on the protection of
traditional knowledge; (a) the use of the existing IPRs system - disclosure of origin in patent
applications, TK data-bases, PVP and geographical indications; (b) developing a sui generis
system to protect traditional knowledge; (c) the use of customary law and developing
contracts for benefit-sharing if the product or process builds on the traditional knowledge.424
All of these ways of protecting TK are treating biogenetic resources and traditional
knowledge as a commodity from interconnected lives-styles of communities and peoples. If
traditional knowledge are to be protected the communities which holds the knowledge have to
gain secure land tenure, control of natural resources and respect for language and customary
practises. And if traditional knowledge are to be used by interests outside the landscapes and
communities where it originated the peoples and communities must be able to develop their
own Bio-Cultural Community Protocols on the handling of these issues within a Collective
Bio-Cultural Heritage Framework.
424
Dhar, B. and Anuradha, R.V. (2004). ‘Access, Benefit-Sharing and Intellectual Property Rights’. p.620
110
Analysis
In the following section the regime interaction between the legal frameworks regulating
genetic resources, traditional knowledge and intellectual property rights is analysed. The
interaction between the exclusive IPR regimes and the biodiversity regimes is looked upon.
Further interactions between the CBD and developments in international soft law is analysed,
and also the strong actor influence from multinational biotechnology corporations is
discussed. The theoretical concept of regime shifting is used as a tool to analyse how state
actors try to enhance their power resources in international law making. Closely related to
regime shifting is the concept of norm diffusion. This concept is used as a tool to analyse how
norms travel between regimes, whom at first look seem to regulating very different issue
areas.
Regime Interaction: TRIPS/UPOV - CBD/ITPGRFA
State actors within the negotiations of TRIPS was most probably fully aware of the provisions
of CBD which were putting demands of benefit sharing, PIC and MAT in the application for
IPRs, but it seems that they disagreed with the rational of these equity norms and thereby
ignored them. CBD on the other hand, might be viewed as a counter-regime to the strict IPR
rules drafted during the TRIPS negotiations and the contemporary trends in national law on
patents in biological material in the late 1980s. CBD continued to be a counter-regime and
produce counter-norms, when TRIPS was negotiated and the implementation began. Helfer
argues that ‘the expansion of intellectual property protection standards and enforcement
mechanisms in TRIPS and in other international agreements has led developing countries and
NGOs to engage in regime shifting.’425 These shifts are shown in soft lawmaking, such as the
Bonn Guidelines, and in hard law ‘regimes that had previously devoted no attention to
intellectual property matters, and by an increased attention devoted to intellectual property
issues in other regimes’426
such as the negotiations on an instrument to protect TK, within the
WIPO. The provisions of the non-binding Bonn Guidelines, negotiated to realise, PIC and
MAT in ABS-contracts, may stand in conflict, normatively but not necessary legalistically,
with TRIPS provisions. These disruptive interactions might be the effect of strategic moves
by negotiating states, which has ‘created new legal inconsistencies as a strategy for revising
425
Helfer, L. (2004) ’Regime Shifting: The TRIPs Agreement and New Dynamics of International Intellectual
Property Lawmaking’. p. 51 426
Ibid. p. 51
111
principles, norms, and rules they disfavor’,427
but these interactions might as well be
unintended consequences of different rationales in relation to the question of innovation in
biological matter.
The norms of benefit sharing, prior informed consent on mutually agreed terms and the
protection of traditional knowledge, is now days found not only in CBD but in several other
forums; in WIPOs IGC, in discussions at the TRIPS Council and in an increasing number of
soft-law agreements, such as the newly adopted UNDRIP. It is considered by Rosendal that it
is a learning process through norm diffusion - a situation when one regime influence the
material contents of another regime in, for example assisting in the process of defining ’basic
principles or other normative or operational regime elements’ that have been found to be
effective in the first regime – that ‘account for the fact that the CBD objective of benefit
sharing is now taking centre stage in a number of international arenas.’ 428
This might be a
sign that a convergence in policy objectives is emerging, but at the same time looking beyond
negotiation agendas and examining the actual behaviour that results from negotiation outputs,
however, a neorealist view provides the best explanation for state behaviour.429
There is still
weak support by parties with strong life sciences industries for mandatory disclosure of origin
requirements (or certificate of legal provenance which the Like-minded Megadiverse
countries proposes) or real benefit sharing through both monetary and bio-culturally
acceptable methods. It is also a resistance to forcefully implement Farmers Rights through the
securing of legal space in national seed laws, stemming from UPOV membership, to save,
exchange and sell all seeds (proprietary or not). The development of TRIPS Plus agreements
clearly shows that developed countries still pursue their interests in strengthened IPRs without
taking account of the equity provisions in CBD (and its articles 15 and 8(j)) and the article on
farmers rights in the ITPGRFA.
In accordance with TRIPS Article 29 an applicant shall ‘disclose the invention in a manner
sufficiently clear and complete for the invention to be carried out by a person skilled in the
art.’ It seems clear that this does not require disclosure of origin of the genetic resource and
associated traditional knowledge, thereby threaten to undermine states as well as communities
and peoples sovereignty over their genetic resource through biopiracy. It also seems clear that
427
Helfer, L. (2004). p. 75 428
Rosendal, K.G. (2006) ‘Balancing Access and Benefit Sharing and Legal Protection of Innovations from
Bioprospecting: Impacts on Conservation of Biodiversity’ p. 435 429
Ibid. p. 436
112
the provision therefore does not consider traditional knowledge as prior art in the patent
examination. This stands in stark contrast to CBDs article 8(j) where state actors oblige
themselves to ‘respect, preserve and maintain knowledge, innovations and practices of
indigenous and local communities’ and the principles on prior informed consent, mutually
agreed terms and benefit sharing under article 15.
Correa argues for the importance to keep the TRIPS council as the main negotiation forum for
negotiating disclosure of origin. Further if article 29 is amended this would ‘ensure that an
almost universal, mandatory minimum standard become applicable’. Even though disclosure
of origin is not the ‘silver bullet’ for prevention of biopiracy and the protection of TK, the
developing countries should avoid trade-offs for a compromise in this field. Correa also
argues for that ‘an international disclosure of origin obligation is one component of a broader
misappropriation regime that need to be put in place in order to reconcile the TRIPS
Agreement with the CBD.’430
If a mandatory disclosure of origin is implemented, this would
mean that developing countries would have ‘won an important battle, but in no way
established mechanisms that will effectively prevent misappropriation and ensure benefit
sharing.’431
To have an effective misappropriation regime in place, documentation of TK and
proof of origin of materials and the consent form state authorities and/or indigenous peoples
would have to be disclosed, according to Correa. Though other commentators would argue
that this solution to the problem of biopiracy is framed within the IPR paradigm/rational and
therefore is alien to the way indigenous peoples and local communities interact with their
resources and the knowledge pertaining them. In line with this argumentation a much broader
respect for local communities and indigenous peoples, which includes land rights, rights to
language and so on, is needed. Here the rights to traditional knowledge and protection of
biodiversity is addressed together with cultural survival.
Furthermore could the process on an amendment of TRIPS art. 29 be undermined if the draft
Substantive Patent Law Treaty (SPLT) is negotiated and adopted. Here the draft SPLT have
the potential to causes disruptive interaction through commitment in relation to the possibility
of having an outcome of a mandatory disclosure of origin requirement in international IPR
law. If parties whom is members of both WTO/TRIPS makes commitments in an SPLT this
430
Correa, C. (2005) ’The Politics and Practicalities of a Disclosure of Origin Obligation. p. 10 431
Ibid. p. 10
113
affect the constellation of interests and the decision-making processes within the process of
amending TRIPS with disclosure of origin requirements.
In the negotiations on amendment of TRIPS art. 29 the developing countries proposal on a
strong version of disclosure of origin, certificate of legal provenance, differ from the other
two in that it is a independent document and thereby would not involve the patent offices in
the actual assessment of whether the conditions were fulfilled.432
Because of this, this version
seems to be the one that most surely will obtain the disclosure of origin of genetic resources,
both by geographical location as well as from whom it was obtained. Correa argues that
developing countries should ‘continue to simultaneously pursue the recognition of an
international disclosure of origin obligation in different fora.’ In the case of WIPO, the issue
should be ‘consistently raised in all relevant discussions and negotiations, such as at the IGC,
the Standing Committee on Patents and in the context of the PCT reform.’ A task to take on is
the preparation of a proposal for the PCT, which reflects the interests and objectives of
developing countries.433
The development of TRIPS Plus agreements clearly shows that developed countries still
pursue their interests in strengthened IPRs without taking account of the equity provisions on
and in CBD (art. 15 and 8(j) - PIC, MAT, TK) and the ITPGRFA (art 9 – farmers rights). In
these bilateral agreements ‘the US in particular has been using its superior bargaining power
to ratchet up standards of intellectual property protection in developing countries.’434
Even
though these treaties are negotiated by state actors they will probably ‘most benefit the
dominating transnational corporations in the life sciences.’435
The stronger IPR provisions
explicitly refer to UPOV 1991 as a sui generis system for the protection of plant varieties and
at the same time makes it obligatory to allow for patents in plants and animals. These
provisions thereby goes beyond those of TRIPS article 27.3(b) where countries is allowed to
exclude plants and animals from patent protection and where there is a possibility to develop
a national or regional sui generis system for plant variety protection, even though this in many
countries has meant a explosion of developing countries joining UPOV 1991.436
This
consequence of TRIPS is a normative interplay as defined by Stokke as occurring when ‘the
432
GRAIN (2005). p. 8 433
Correa, C. (2005) p. 9-10 434
Drahos, P. (2005). ‘Death of a Patent System – Introduction’ in Drahos, P. (Ed.) Death of Patents. p. 6 435
Rosendal . K.G. (2006) p. 436 436
http://www.upov.org/export/sites/upov/en/about/members/pdf/pub423.pdf ( Accessed 2009-11-11)
114
rules upheld in one regime conflict or reinforce those established under another’ regime,437 in
this case TRIPS reinforce the UPOV 1991 provisions. Since agriculture is practiced by a vast
proportion of the world’s poor population and traditional knowledge is deeply entwined with
agricultural practices the provisions in UPOV 1991, and its implementation in national seed
laws, which limits the possibilities of saving and sharing protected varieties are a treat to poor
farmers autonomy and food sovereignty. This is true because seed companies are marketing
themselves aggressively towards farmers, which by into the, sometimes true promises, and
sometimes false promises of increased harvests, made by the seed companies. When farmers
shift their use from traditional varieties to protected varieties and by law is prohibited to save
and reuse seeds, the traditional system of saving and sharing genetically diverse seeds and
knowledge associated to the sowing of these seeds, are diminished.438
Since UPOV 1991
came into force in April 1998 the possibility to become a signatory party to UPOV 78 where
closed. Since 1994 the number of member countries has doubled and today developing
countries and transitional countries account for almost half of the member states.439
This
development is strongly opposed by farmers’ organisations and is a hinder for the
implementation of article 9 on Farmers Rights of the ITPGRFA. This have resulted in a
resolution from the Governing body of the ITPGRFA inviting ‘each contracting Party to
consider reviewing, and if necessary, adjusting its national measures affecting the realization
of Farmers´ Rights as set out in Article 9.’440
This means that national governments should
consider reviewing its seed laws, particularly if these are affecting farmers' rights to save, use,
exchange and sell farm-saved seed important to enabling farmers to continue to conserve and
sustainably use plant genetic resources for food and agriculture.
437
Stokke,O. S. (2000). ‘Managing straddling stocks: the interplay of global and regional regimes’. p. 222 438
See Report of the Special Rapporteur on the right to food. (2009). ‘The right to food - Seed policies and the
right to food: enhancing agrobiodiversity and encouraging innovation’ 439
http://www.upov.org/export/sites/upov/en/about/members/pdf/pub423.pdf (Accessed 11 November 2009)
Most States are parties to the most recent version, UPOV 1991. However, for example Brazil, Canada, China,
Chile, France, Norway and South Africa are parties to the UPOV 1978. 440
Report of the Governing Body of the International Treaty on Plant Genetic Resources for Food and
Agriculture, Third Session, Tunis, Tunisia, 1–5 June 2009. Appendix A.6 Resolution 6/2009 Implementation of
Article 9, Farmers Rights.
115
Regime Interaction: WIPO (SPLT) – CBD/ITPGRFA
Activities within WIPO in the few years after the adoption of TRIPs have not always clearly
favored developed countries, although it might be argued that since the Uruguay Round,
WIPO may be seen as ‘the cowed and altogether accommodating servant of dominant special
interests in the United States and the European Union.’441
According to ETC Group (former
RAFI) up till at least 1998, WIPO and its subsidiary conventions, such as UPOV, maintained
a ‘stoic silence as the world around them raged over the indecency of biopiracy.’ While
parallel debates in the CBD, FAO and UNESCO lead to institutional action and coordination,
WIPO and UPOV have ‘adopted a passive aggressive pro-monopoly posture and confined
themselves to bean counting.’442
One of the developments at WIPO that may have the most disruptive effects on principles of
benefit sharing and protection of traditional knowledge is the negotiations of the Draft
Substantive Patent Law Treaty. Tvedt points to that in the Draft SPLT it is suggested that the
only legal formal requirements in national patent applications is supposed to steam from the
Draft SPLT and two other WIPO treaties.443
As drafted the SPLT will further harmonise
international patent law in terms of uniform substantive standards on prior art, novelty, utility
and inventiveness requirements, not taking account of the debates within WIPOs own ICG on
genetic resources, disclosure of origin, traditional knowledge and folklore, or the lengthily
negotiations within the CBD and TRIPS Council on traditional knowledge and ABS. If this
draft will be the outcome from, the at the moment closed, negotiations on the draft SPLT, the
possibility for a binding disclosure of origin requirement, as debated in the TRIPS Council to
reconcile TRIPS with the provisions of the CBD, will be closed. This interaction through
commitment will thereby tilt the initiative in proprietary knowledge towards developed
countries and its industry’s interests, an industry whom work hard to escape a disclosure of
origin requirement. The developed countries want to have a fast-track negotiation of the pre-
grant issue and leave development issues for later. This is a procedure that seems to give the
441
Helfer, L. (2004). p. 26. Citing Reichman J.H. (1997). ’Enforcing the Enforcement Procedures of the TRIPS
Agreement’. p. 354 442
RAFI (1998) ‘Pinning the Tail on the Ostrich: The Austrian PBR Scandal’. Cited in Adi, B. (2006).
‘Intellectual Property Rights in Biotechnology and the Fate of Poor Farmers´ Agriculture’, p. 104 443
The draft SPLT suggests that: “[(1) [Requirements Concerning Parts of Application] (a) Except where
otherwise provided for by this Treaty and the Regulations or the Patent Law Treaty, no Contracting Party shall
require compliance with any requirement relating to the request, description, claims, drawings or abstract of an
application different from or additional to the requirements relating to the request, description, claims, drawings
or abstract which are provided for under the Patent Cooperation Treaty in respect of international applications.”,
Article 5 (1) (a). WIPO Document SCP/10/4. p.10
116
opportunity to developed countries, and their life-science industry, to avoid the disclosure of
origin requirements. Tvedt thus argues that if a Universal Patent System, becomes the reality
through the draft SPLT, without a disclosure of origin requirement, the ‘chance for this to be
included at a later stage is minimal.’444
This interaction between the draft SPLT and CBDs
article 15 an 8(j) may be disruptive since the output of norms and rules in the draft SPLT may
restrict the implementation of the provisions of CBD on fair and equitable benefit sharing,
PIC and MAT, which might partly be realised through mandatory disclosure of origin
obligations in patent applications. Andersen points to that the draft SPLT ‘may lead to new
constellations and possibly a considerably stricter regime on intellectual property rights over
PGRFA than the TRIPS.’445
This is apparent in the draft SPLT since it closes the possibilities
to make exemptions from patent protection of plants and animals, and the possibility of
creating a sui generis system for the protection of plant varieties, as in article 27.3(b) of the
TRIPS agreement. Here it is important to note that developed countries tend to view TRIPS as
a floor in IPRs while developing countries tend to view TRIPS as a ceiling. Even in face of
this the harmonisation process now goes on in ‘less formalised ways amongst developed
countries (B-group), and in cooperation between the Trilateral Patent Offices (the European,
US and Japanese Patent Offices).’446
The substantive discussions between these three patent
bureaus, is very important for the future development of harmonisation of patent law. Tvedt
points to the fact that ‘all the three participants to these discussions are patent bureaus exposes
their talks of being less concerned about patent law in a social context and mostly influenced
by the internal patent law perspective.’447
This certainly will not benefit the normative
inclusion of recognizing traditional knowledge associated with genetic resources, as prior art
in patent applications. It seems likely that strong forces in the negotiations on the draft SPLT
will try to make the definition of prior art as narrow as possible. Tvedt argues that the
challenge for developing countries is to prevent a patent system where it is ‘not sufficient that
similar knowledge already exists, but there are requirements as to in what form this
knowledge is published and made available. This may easily exclude for instance traditional
knowledge that is handed down in oral or other informal ways.’448
444
Tvedt, M. (2007). p. 6. See also May, Christopher. (2008). ‘Technical assistance and WIPO’ Box 4.3, p.80 in
Tansey, G. and Rajotte. T. (2008) 445
Andersen, R. (2007) Governing Agrobiodiversity: International Regimes, Plant Genetic Resources and
Developing Countries. p. 209 446
Tvedt, M. (2007) p.69 447
Ibid. p.69 448
FNI News. 2010-05-10. ‘Most Developing Countries Stand to Lose from a Worldwide Patent System’
117
Some commentators argue for that ‘the dangers of a world system is that it would slow the
uptake of knowledge around the globe without an incentive effect of sufficient size to take
such a system into a positive welfare balance.’449
Whether a universal patent system will
bring with it ‘an overall increase in global welfare, only time will tell. Universialist systems,
as those who have lived on the periphery of empires have discovered, rarely deliver what they
promise.’ 450
The UK Governmental Commission on Intellectual Property Rights argues along
as similar line when stating that ‘developing countries should identify a strategy for dealing
with the risk that WIPO harmonisation will lead to standards that do not take account of their
interests.’ Further the Commission states that this could be done by seeking ‘continued
flexibility in the WIPO standards…by rejection of the WIPO process if it appears that the
outcome will not be in the interests of developing countries.’ 451
At the moment this seems to
be what developing countries have done in the negotiations on the Draft Substantive Patent
Law Treaty, since ‘a harmonized system would leave less flexibility’ than the TRIPS
Agreement. 452
There are indications that developed countries wants to shift negotiations on genetic resources
from the TRIPS Council to WIPO. At the TRIPS Council 80 developed countries now
support an amendment of TRIPS on mandatory disclosure of origin of genetic resources and
associated traditional knowledge, a certificate of legal provenance, as a mean to ‘combat
piracy of these items’.453
This might be so because of this issue has been tied to negotiations
on the expansion of the list of geographical indications, something promoted strongly by the
EU. Here it seems that the EU is acting with double agendas, at the one hand it supports
disclosure of origin in patent applications if this is linked to negotiations on an expanding list
of GIs, but on the other it proposes to shift all discussions on IPRs issues related to genetic
resources to WIPO, where developing countries are less organised in coalitions and where
developed countries are not seeking an international regime on traditional knowledge and
genetic resources at the moment. This regime shift might also be viewed as a response from
the US hegemon, as well as from other developed countries, to the counter-regime norms
inherent in the proposals on disclosure of origin/legal certificate of provenance and prior
informed consent on mutually agreed terms. Further as ‘hegemons have become more attuned
449
Drahos, P. (2005). p. 8 450
Ibid. p. 8 451
Commission on Intellectual Property Rights (2002) p. 132 452
Correa, C. (2004).’ The WIPO Draft Substantive Patent Law Treaty: A Review of Selected Provisions’ p. 8 453
New, W. (Intellectual Property Watch). ‘Positive Outcome for WIPO Committee on TK, Folklore and
Genetic Resources’ 29 February 2008.
118
to developing countries use of this strategy, they are responding with fresh rounds of
intellectual property regime shifting, this time to regional and bilateral arrangements (TRIPS
Plus) and to fora within existing multilateral institutions.’454
Blocking disclosure of origin – the biotech industry in the ABS negotiations
In the CBD negotiations on an international regime on Access and Benefit Sharing, the
industry has not been as active as in the TRIPS negotiations where it were a main driving
force. At the moment biotech industry and its lobbying organizations are focusing their
energy on ‘blocking the addition of disclosure of origin requirements in international patent
applications on three fronts’ where disclosure requirements is debated: TRIPS, WIPO and
CBD.455
The biotech industry organization Access and Benefit Sharing Alliance (ABSA) is
working to ‘counter the unprecedented global threat to biotechnology patents in the WTO.’456
The biotech industry are gathering its resources to convince government officials in each of
these forums, ‘to ensure that developments in the resumed WTO Doha Development Round
negotiations do not open the door to the negotiation of an amendment to the TRIPS
Agreement that would establish new, mandatory disclosure obligations.’ The ABSA also
supports U.S. opposition to amending WIPO patent treaties, with disclosure requirements.457
Industry views on certificates appear to be less hard-line, the biotech-industry ‘have a great
many questions about how a certificates system may function but may be willing to support
some sort of certificates mechanism if it results in legal certainty and does not create undue
administrative burdens.’458
The ABSA also support the development of comprehensive
traditional knowledge digital libraries or registries to help identify holders of genetic
resources; capacity building to promote best practices for IP management including trade
marks, trade secrets and patents, and the use of model Material Transfer Agreements (MTAs)
to ensure effective compliance with PIC and MAT and to provide front-loaded benefits and
clarity and fairness in the disposition or sharing of intellectual property rights.459
454
Helfer, L. (2004). p. 82-83 455
New, W. ‘Biotech Industry Fights Disclosure In Patents On Three IP Policy Fronts’, 2 March 2006 456
Ibid. 457
Access and Benefit Sharing Alliance (ABSA). (2008). ‘Who We Are’
http://www.abs-alliance.org/html/whoweare.html (Accessed 8 July 2008) 458
Bragdon, S., Garforth, K. and Haapala, J. E. Jr (2008) ‘Safeguarding Biodiversity: The Convention on
Biological Diversity (CBD)’ p.104 459
ABSA. (2008). ’ABS Negotiating Principles’ http://www.abs-alliance.org/files/ABS%20WG
6/ABIA%20ABS%20Negotiating%20Principles.pdf (Accessed 8 July 2008)
119
The president of ABSA is Jacques Gorlin, the same man whom where highly influential in the
negotiations and ‘one of a handful of key architects’, of the TRIPS Agreement.460
Member
companies of the ABSA include, the giants Bristol Myers-Squibb, General Electric, Merck,
Pfizer, Procter & Gamble, as well as less known companies; Avanti Therapeutics, Eli Lilly,
Excel Life Sciences, Hana Biosciences, Millennium Pharmaceuticals, Tethys Research and
ToxEM LLC.461
Theses companies, through ABSA, are strong actors in the negotiations on an
international regime on ABS, they lobby governments not to negotiate amendments and
thereby actively disturb the process towards a solution to the question of benefit sharing and
the fulfilment of the rights of the holders of traditional knowledge associated with genetic
resources. As it seems the biotech industry are defending its privileges with full power since
its unwillingness to accept any mandatory disclosure of origin. The industry defends the
prevailing order, in which corporations can access plant genetic material and other genetic
resources and patent these resources with minor changes, without disclosing its origin. But at
the same time there is an ambition to take part in the discussions due to the importance of
legal certainty for biotech corporations.
In the negotiations on the ITPGRFA and the sMTA the involvement of the industry informed
the negotiators of the business norms and realities, some argue. This facilitated the outcome
based on the practices already exiting amongst companies, and the fact that the seed industry,
represented by International Seed Federation (ISF), played a part both in the process and the
outcome, may mean a higher degree of willingness to implement the ITPGRFA.462
The
industry involvement might be viewed as either a positive thing, giving balance to the
outcome, or a thing which made the ITPGRFA weak and kept the CGIAR system open for the
biotech-seed industry, while at the same time not rewarding farmers for their contributions
and thereby still facilitating biopiracy. In the words of Andrew Mushita: ‘in effect,
governments are now enabling multinational seed companies to impose a legally-binding
regime that forces the exchange of farmers’ seeds without reciprocal benefits.’463
Garforth and
Frison argues that the high level of industry involvement of the ITPGRFA stands in contrast
to the ABS process of the CBD where industry involvement up till recently been fairly weak.
460
Bragdon, S., Garforth, K. and Haapala, J. E. Jr. (2008). p.104 461
ABSA. (2008). ‘Who We Are’ 462
Garforth, K. and Frison, C. (2007). Key Issues for the relationship between the Convention on Biological
Diversity & the International Treaty on Plant Genetic Resources for Food and Agriculture. p. 10 463
ETC Group, Via Campensina etc. (2007). ‘Farmers Call for Suspension of Seed Treaty Governments fail to
meet minimal Treaty obligations UN conference told’ Press release by the civil society and farmers’
organizations present at ITPGRFA Governing Body meeting no.2, Rom, 1 November 2007. p. 1
120
This may mean that whatever the outcome in the ABS negotiations, this outcome ‘will serve
to chill the use of genetic resources as industry will find it too onerous to implement and
comply with the requirements.’464 But even in the ITPGRFA the industry pressured
governments to decrease the percentage of monetary benefit sharing under the MLS and
thereby lowered the percentage of obligatory monetary benefit-sharing agreed upon in the
sMTA. If developing countries had demanded a higher percentage, there ‘likely would have
been no agreement on the sMTA at all…and industry likely would have refused to participate
in the MLS and there would have been little or no monetary benefit sharing.’ 465
These
accounts indicate that there is a reluctant attitude amongst both the seed industry and the
pharmaceutical industry to share its profits with countries, communities and peoples whom
have contributed with genetic resources, the development of these resources and traditional
knowledge.
Regime Interaction: CBD and UNDRIP - the ABS Regime and Indigenous
Rights
The recently adopted UN Declaration on the Rights of Indigenous Peoples may strengthen the
possibilities of including the rights of TK holders in the negotiations on an international
regime ABS. The UNDRIP has substantive provisions which are highly relevant to the ABS
regime under negotiation. Indeed, UNDRIP is recommended to be ‘viewed as integral part’ of
the international regime on ABS.466
This might as well result in a synergic interaction where
the UNDRIP supports the work of 8(j) WG of the CBD. Though this synergy with the work of
8(j) WG and ABS WG, seems to be weak since the COP 9 decision on access and benefit
sharing only are ‘taking note’ of UNDRIP.467
This is much weaker than the pre-COP 9 urging
by the EU, Mexico, Bolivia and Ecuador to use UNDRIP as ‘a framework for work on Article
8(j).’468
The draft decision to COP 9 stated: ‘considering that some of the rights identified in
464
Garforth, K. and Frison, C. (2007). p. 10 465
Ibid. p. 11 466
Report of the International Indigenous and Local Communities Consultation on Access and Benefit Sharing
and the Development of an International Regime. p. 3. 467
Decision IX/12 Access and Benefit Sharing. Available at: http://www.cbd.int/doc/decisions/COP-09-dec-
en.pdf (Accessed 8 July 2008) 468
Earth Negotiations Bulletin. Summary of the Ninth Conference of the Parties to the Convention on Biological
Diversity. p.10-11
121
the Declaration, particularly its Article 31469
that relates to traditional knowledge and genetic
resources will facilitate and guide Parties in their understanding of their commitments under
the Convention on Biological Diversity’ was also removed.470
But even though there are
weaknesses in the supportiveness of these two forums the linking of these two and their
provisions ‘seems to be a strengthening of the opposition against intellectual property
protection on traditional knowledge and genetic resources associated with TK, by companies
in industrialized countries. Although the UNDRIP does not specify how these rights are to be
given effect, nor does it address these provisions relationship to TRIPS.’471
At the same time
the UN Permanent Forum on Indigenous Issues did review the activities concerning
indigenous peoples within the UN system in 2002, including the issues relating to traditional
knowledge at WTO and WIPO, this point to that the UNPFII, backed by UNDRIP, will ‘keep
a track of intellectual property issues in these fora as part of its broader mandate to protect the
cultural rights of indigenous peoples.’472
The fairly weak acknowledgement of UNDRIP may further fuel the worries of indigenous
peoples organisations and local communities that an international regime on access and
benefit sharing will not sufficiently recognize and protect the rights of holders of traditional
knowledge and genetic resources. These worries were expressed in the opening statement at
COP 9 by the International Indigenous Forum on Biodiversity, declaring that ‘any proposed
International Regime on Access and Benefit Sharing must accord with the minimum
standards set out in the UNDRIP. This means that any regime must recognize, inter alia, that
Indigenous Peoples have rights over our genetic resources, and not just our traditional
knowledge associated to genetic resources. Indigenous peoples’ free and informed consent
must be obtained before access to our genetic resources and associated traditional knowledge
can occur.’ Further the tendency to use the word ‘communities’ instead of ‘peoples’ is
considered to be a way to diminish the rights of indigenous peoples – which is the appropriate
terminology that should be acknowledged and used in the international regime. If indigenous
469
UNDRIP article 31: Indigenous peoples have the right to maintain, control, protect and develop their cultural
heritage, traditional knowledge and traditional cultural expressions, as well as the manifestations of their
sciences, technologies and cultures, including human and genetic resources, seeds, medicines, knowledge of the
properties of fauna and flora, oral traditions, literatures, designs, sports and traditional games and visual and
performing arts. They also have the right to maintain, control, protect and develop their intellectual property over
such cultural heritage, traditional knowledge, and traditional cultural expressions. 470
Draft Decisions for the Ninth Meeting of the Conference of the Parties to the Convention on Biological
Diversity. UNEP/CBD/COP/9/1/Add.2 p. 53 see also Earth Negotiations Bulletin Vol. 9 No. 448, p.2 471
Helfer, L.(2004). p. 47 472
Ibid. p. 48
122
peoples are not called by their appropriate name they are not given the full recognition as
peoples under international human rights law.473
Indigenous peoples and farmer’s communities feel discomfort with CBD article 15.1 stating
that: ‘the sovereign rights of States over their natural resources and that the authority to
determine access to genetic resources rests with the national Governments and is subject to
national legislation.’ This article may be interpreted as giving nation-states the sole authority
to give or deny access to genetic resources within its territories, thereby threatening the
sovereignty of indigenous peoples and farmers communities to control access to their own
territories. But on the other hand national sovereignty over biological resources does not
automatically give national authorities full control. This sovereignty implies that authorities
have ‘the rights to set the rules of the game within their jurisdiction’, which may mean that
state authorities can assigning the right to give prior informed consent and negotiate mutually
agreed terms with holders of genetic resources and associated traditional knowledge,
including ‘the right to refuse consent and block access.’474
These ‘robust’ sovereign rights
over genetic material does, according to Safrin, ‘threaten the autonomy and interests of
individuals and indigenous communities in two ways.’ In the first case where access is
exclusively owned and given by state authorities, this might be a threat to the sovereignty of
indigenous peoples or farmers communities if these refuse to grant the authorities access, and
pressure the holders or simply access it by force. In the second case, where a centralized
control over genetic resources is applied to share benefits to the nation-state, as in Brazil and
India, this might be a threat to the sovereignty of peoples and communities, since it
diminishes their control, and indigenous peoples ‘tend to stress control over resources and
related knowledge above compensation’475
(There is today an over-tendency on monetary
benefit-sharing, while benefit sharing mechanisms should ‘predominantly be used to support
traditional lifestyles, land security, food security, cultural revitalization, restoration of lands
and waters, etc., because that will safe-guard the preservation of traditional knowledge and in
turn biodiversity’)476
As noted before access regimes does not automatically gather control
with central authorities , but ‘the track record of many governments – including a number of
473
Including Charter of the United Nations (1945); International Covenant on Economic, Social and Cultural
Rights & International Covenant on Civil and Political Rights (Adopted 1966, into force 1976). 474
GRAIN. (2005). p. 9-10 475
Safrin, S. (2004). ‘Hyperownership in Times of Biotechnological Promise: The International Conflict to
Control the Building Blocks of Life’ p. 658-659 476
Report of the International Indigenous and Local Community Consultation on Access and Benefit Sharing
and the Development of an International Regime. (2007). p. 3-4. UNEP/CBD/WG-ABS/5/INF/9
123
the leading Megadiverse countries – is not good.’ So fears that a strengthened legal position
for provider states under a new international regime on access and benefit sharing ‘would not
translate into a strengthened position for the biodiversity holders in these countries, but
possible the direct opposite’, is well grounded.477
Since indigenous peoples are nations in themselves and therefore have the right to sovereignty
over genetic resources under the same international law that states does. In the CBD process
the International Indigenous Forum on Biodiversity (IIFB) is clear on that ‘indigenous
peoples do not ask for delegated rights from states, but claim their own rights, just as they do
with territorial rights and other natural resources.’478
This is obviously a threat to the nation-
state order and viewed as threatening from governments. Further the IIFB has consistently
stated that it does not participate in the CBD work on ABS to facilitate access to indigenous
peoples TK nor the genetic resources in indigenous territories. The IIFB goes on stating that:
‘State sovereignty does not amount to absolute political or legal freedom. Sovereignty of
states is limited by the Charter of the United Nations and by other principles of international
law, such as human rights treaties…The CBD should remain mindful of, and act consistently
with, existing and evolving human rights standards regarding Indigenous peoples.’479
Indigenous people’s organisations look for systems that protect their traditional knowledge
‘as a whole: including the biological resources, landscapes and cultural values that form an
integral and vital part thereof.’ 480
Therefore they are worried that the ABS process and the
ICG process does address traditional knowledge systems separately from natural resources,
territories and customary laws, and deal with TK protection within ‘the paradigm of
property.’ More holistic policies based on principles of human rights and self-determination is
demanded. One indigenous peoples organisation argues that the peoples that makes an
agreement to share its knowledge ‘will be accepting western legal frameworks and concepts
that do not respect Indigenous laws and customs, and which, in essence, may compromise
their right of self-determination by permanently alienating resources and knowledge.’481
There are further weaknesses of the ABS framework seen from an perspective of indigenous
peoples; it deals with the transaction of genetic resources for commercial or scientific use, and
477
GRAIN (2005) p. 9-10 478
Ibid. p. 9-10. 479
Indigenous Peoples Council on Biocolonialism (2006) p. 9. See also Earth Negotiations Bulletin (2005) Vol.
9 No. 307, p.2 480
Swiderska, K. (2006).‘Banishing the Biopirates: A New Approach to Protecting Traditional Knowledge’. p. 8 481
Indigenous Peoples Council on Biocolonialism. (2006). p. 11-12
124
the IPRs protection of these, rather than genetic resource exchange for subsistence use by
communities and peoples. By this follows that it addresses TK and genetic resources in ‘a
paradigm of property, as opposed to one of community commons.’482
When access is
facilitated to ex situ collections, e.g. gene banks and botanical gardens, this may mean that
resources steaming from traditional community lands are accessed without the consent of the
original holders. But the other way around, communities are usually denied access to the same
ex situ collections, something highly needed because of the genetic erosion caused by modern
agriculture and development projects. This access is also vital to adapt to changing conditions
due to climate change.483
To address these weaknesses in the ABS framework and take
account of customary laws and traditional resource rights would imply: a requirement to
attain a free prior and informed consent from indigenous peoples for ‘the use of TK and bio-
genetic resources collected from their territories; a reciprocal or two-way access framework
which also facilitates access to resources by communities; and an emphasis on safeguarding
access to TK and resources for customary use.’484 At the International Indigenous and Local
Community Consultation on ABS and the Development of an International Regime, held in
autumn 2007, it is pointed out that ‘unless values such as sustainable customary use of
resources are secured, no access and benefit-sharing regime can be of relevance to indigenous
peoples.’ The international regime on ABS can therefore only be ‘additional to, and cannot
and should not substitute other obligations that governments have towards indigenous peoples
within their state. Benefit-sharing arrangements are always merely complementary to general
services to and protection of indigenous peoples’ cultures, societies and particular life-
styles.’485
The Consultation agreed that the concept of free, prior and informed consent is not
merely a procedural right, but a right linked to indigenous peoples’ material rights to
territories and resources, culture and self-determination. As a consequence of this an
international regime on ABS must recognize indigenous peoples’ right to FPIC pertaining to
their genetic resources and traditional knowledge, in accordance with the UNDRIPS and other
sources of international law.486
482
Swiderska, K. (2006).‘Banishing the Biopirates. p. 9-10 483
Ibid. p. 9-10 484
Ibid. p. 10 485
Report of the International Indigenous and Local Community Consultation on Access and Benefit Sharing
and the Development of an International Regime. (2007). p. 3-4 486
Ibid. p. 5.
125
Concluding remarks
To answer the three questions that have guided this thesis the main conclusions from the
analysis are gathered in this section. The answers to questions are not straight forward. They
are linked together as seen in the concluding remarks in section below.
Which are the main regime interactions that can be uncovered in the regime complex
on intellectual property rights, plant genetic resources, and traditional knowledge?
How do provisions in the international regimes on intellectual property rights, plant
genetic resources and traditional knowledge affect the possibilities of protecting
traditional knowledge, under international law, from misappropriation?
The provisions in TRIPS article 29, with substantive standards and conditions on patent
applications, demands no obligation to examine the traditional knowledge in the public
domain and demands no disclosure of origin of the genetic resource or TK. This causes a
threat to the protection against misappropriation of traditional knowledge. Modifications of
the existing IPR regimes, on the disclosure of inventions, with a certificate of legal
provenance, securing FPIC, MAT and benefit sharing, may serve as one brick in the wall that
protect traditional knowledge from misappropriation through wrongly granted patents. But a
certificate of legal provenance will not do the work alone. To protect traditional knowledge
associated with genetic resources in the long term bio-cultural solutions which sustains the
entire community where traditional knowledge is embedded is needed. Furthermore, if the
draft SPLT, negotiated at WIPO, is adopted, this have the potential to causes a disruptive
interaction through commitment, in relation to the possibility of having an outcome of a
mandatory disclosure of origin requirement in international IPR law. There are also
indications that developed countries want to shift negotiations on genetic resources from the
TRIPS council, where 80 developed countries now support an amendment of TRIPS on
mandatory disclosure of origin, to WIPO where developing countries are less organised and
where developed countries are not seeking an international regime on traditional knowledge
and genetic resources.
126
TRIPS article 27.3(b) where countries are allowed to exclude plants and animals from patent
protection and where there is a possibility to develop a national or regional sui generis system
for plant variety protection has resulted in an explosion of developing countries joining
UPOV 1991. This consequence of TRIPS is a normative interaction, where the rules upheld in
TRIPS reinforce the rules established under UPOV 1991. When more developing countries
join UPOV 1991 and legislate on national seed laws this has the consequence that the legal
space for farmers to save and exchange seeds is decreased, with the consequence that
practices related to the traditional knowledge on agro-genetic diversity is eroded. This causes
disruptive interaction with the implementation of the norm in article 9 on farmers rights under
the ITPGRFA, where farmers are allowed to save, use, exchange and sell farm-saved
seed/propagating material (although subject to national law). By adding the phrase on ‘subject
to national law’ the ITPGRFA makes it possible to side step the norm on farm saved seed and
thereby is reconciled with UPOV 1991. This further strengthens the rights of plant breeders
and patentees over the rights of farming communities and indigenous peoples traditional
knowledge practises.
How do the different rationales within the regimes in the international lawmaking on
IPR, genetic resources, affect the possibility of protecting traditional knowledge?
The rational of benefit sharing, prior informed consent on mutually agreed terms and the
protection of traditional knowledge, is nowdays found not only in CBD but in several other
forums; in WIPOs IGC, in discussions at the TRIPS Council and in an increasing number of
soft-law agreements, such as the newly adopted UNDRIP. This may be considered as learning
process through norm diffusion, although this norm diffusion mainly rest on the rational of
commercialization of GR and TK. If the international regime on access and benefit sharing
purporting to implement Article 8(j), by heavily focusing on the commoditization of
knowledge, innovations, and practices this poses a challenge for bio-cultural communities
whom face severe and ever-increasing threats to their ways of life. The rational who assumes
that commoditization through access to genetic resources and the associated traditional
knowledge is the main mean to protect and sustain traditional knowledge and bio-genetic
resources is not enough to protect traditional knowledge – in fact it may be flawed. This
rational is found in the CBD and have been central in the negotiations on the international
regime on ABS.
127
One of the the basic rationales in the regimes on IPR and genetic resources has to be the
empowerment of indigenous peoples and local communities to exercise their rights. This is a
key aspect to the protection of traditional knowledge and bio-genetic diversity. There is an
opportunity of synergic interaction between the UNDRIP and WG ABS if the rationale of bio-
cultural rights serves as cornerstone of the international ABS regime. But the disruptive
interaction between the provisions in TRIPS article 27, demanding that patents shall be
available for any inventions provided that they are new, involve an inventive step and are
capable of industrial application, without any disclosure of origin, FPIC and MAT, and the
provisions in article 15 and 8(j) of the CBD is still apparent. Further the rational that stronger
IPRs is a way forward which is expressed through the TRIPS-Plus agreements makes it
apparent that the EU and JUSCANZ countries even more pushes the agenda away from the
protection of traditional knowledge and genetic resources. Here they act as rational states and
using their strong bargaining power to strengthen their biotech-industries interests over the
interest of indigenous peoples and local communities in developing countries. The strong
actors influence by the biotech industry organisations effectively delays the benefit sharing
mechanisms within the ABS negotiations and mandatory disclosure of origin requirements in
patent applications. At the same time the proposed mechanisms for benefit sharing steaming
from bioprospecting deals is viewed with scepticism from the defenders and holders of
traditional knowledge – they want bio-cultural rights, not just trickle-down benefits.
128
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