Oluwatobiloba Moody Address

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Citation:
Oluwatobiloba Moody, Addressing Biopiracy through an
Access and Benefit Sharing Regime-Complex: In Search of
Effective Protection for Traditional Knowledge
Associated with Genetic Resources, 16 Asper Rev. Int'l
Bus. & Trade L. 231 (2016)
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ADDRESSING BIOPIRACY THROUGH AN
ACCESS AND BENEFIT SHARING REGIME-
COMPLEX: IN SEARCH OF EFFECTIVE
PROTECTION FOR TRADITIONAL
KNOWLEDGE ASSOCIATED WITH
GENETIC RESOURCES
OLUWATOBILOBA MOODY
TABLE OF CONTENTS
Synopsis 232
1. Introduction 233
II. A Regime Context 238

A. Biopiracy 246
1. Traditional Knowledge associated with Genetic Resources246
i. Genetic Resources 250
2. Biopiracy: Defining a Contemporary Pattern 254
III. The Nagoya Protocol as an ABS Regime Complex 262
LLB (Ibadan), LLM (Western Cape) PhD (Queen's), Post-doctoral Fellow, Centre for
International Governance Innovation (CIGI). Former coordinator, WIPO
Intergovernmental Committee on Intellectual Property and Genetic Resources,
Traditional Knowledge and Folklore. The writing and research for this paper was
concluded during the period of my doctoral studies. I am grateful for the generous
financial support by the Canadian Social Sciences and Humanities Research Council
(SSHRC) through the award of the Vanier Scholarship which made this paper possible.
I am also grateful for the very helpful comments received on the working draft of this
paper from participants at the Asper IntLaw Conference, 2016, as well as from the
anonymous reviewers of this paper. All views, errors and omissions remain mine. PTL.
232 Asper Review [Vol. XVI
A. A Legal Regime or a Regime's Law 264

B. Complementarity and an 'Open-Ended' Regime 265
IV. WIPO as an elemental constituent of the ABS regime-complex. 270
V. Conclusion 276
SYNOPSIS
The protection of traditional knowledge (TK) is a problem of central

significance to developing countries. Several possible reasons, including
economic reasons, environmental reasons, cultural reasons, and political
reasons such as the protection of indigenous rights may offer explanations
for this. A central reason though can be described as the seeming injustice
arising from the allocation of rights and resources over inventions based on
TK and genetic resources (GRs) through the mechanism of the intellectual
property (IP) system. In this sense, addressing the incidence of 'biopiracy' as
it is rhetorically termed, provides a central justification for the huge
investments and attention being paid to the design of solutions for
protecting TK in developing countries. Given the international nature of
the problem of biopiracy, it has also emerged as a major issue area for which
solutions are being pursued in international law. Two significant
developments in international law which will guide the discussion in this
paper are the successful emergence of the Nagoya Protocol on Access to Genetic
Resources and the Fair and Equitable Sharing of Benefits Arising from their
Utilization to the Convention on Biological Diversity (the Nagoya Protocol), and
the ongoing efforts to design a complementary system of protection within
the frame of the World Intellectual Property Organization (WIPO). This
paper suggests that the successful conclusion of the related WIPO
negotiations is an important aspect of current efforts to implement the
Nagoya Protocol to successfully address the incidence of biopiracy. It supports
its claims through a reflection on the nature ofbiopiracy articulated through
a regime analysis.
2016] Addressing Biopiracy 233
1. INTRODUCTION
The protection of traditional knowledge (TK) is an important issue

which has divided policy makers, academics and a wide range of
stakeholders. Beyond the question of whether or not TK should be
protected, questions rather relating to the what, how, where, and why of TK
protection have dominated the discussions on the protection of TK.' TK is
considered a part of the cultural assets of indigenous peoples, and provides
enormous possibilities for their daily lives. In this context, attention is
consistently drawn to the economic and social value of TK. Indeed, it plays
a central role in the sustenance and livelihood of indigenous peoples.
Furthermore, the importance of TK to modern society has been accentuated
with an increased recognition of its role, inter alia, in the conservation and
sustainable use of biodiversity, including as an input to both processes and
products of innovation. 3
Developing countries are particularly interested in the protection of TK
for a number of reasons including, but not limited to: economic reasons
associated with the loss of revenue; environmental reasons associated with
the depletion of biodiversity and, as such, associated TK practices; cultural
reasons associated with the preservation and respect for cultural practices of
its indigenous peoples; and even political reasons associated with leverage
and domestic populist views, amongst others. A central reason worth
mentioning though, and which forms the core of this paper's discussion, is
1 Manuel Ruiz Muller, "Protecting Shared Traditional Knowledge: Issues, Challenges

and Options", (2013) ICTSD Programme on Innovation, Technology and Intellectual
Property, Issue Paper No 39 at 2.
2 See Rebecca Crookshanks & Peter WB Phillips, "A Comparative Analysis of Access
and Benefits-sharing Systems" in Tania Bubela & E Richard Gold, eds, Genetic Resources
and Traditional Knowledge: Case Studies and Conflicting Interests (UK: Edward Elgar
Publishing Limited, 2012) 69-70, who in noting the value of TK refer to estimates
suggesting that if the US was forced to pay fair royalties on TK currently being used, it
would owe developing countries $302 million USD annually for agricultural products
and $5.1 billion USD annually for pharmaceuticals.
See Tania Bubela & E Richard Gold, "Introduction: Indigenous Rights and Traditional
Knowledge" in Tania Bubela & E Richard Gold, eds, Genetic Resources and Traditional
Knowledge: Case Studies and Conflicting Interests (UK: Edward Elgar Publishing Limited,
2012) at 1, noting the importance of TK in areas such as conservation and agricultural
practices, classification systems, land use practices, sustainable management of natural
resources, healthcare practices and medicinal properties of local species.
the seeming unfair distribution of rights and resources arising from the use
of TK - a justification popularly discussed as biopiracy. Biopiracy may be
construed as the result of the commercial/non-commercial drive to utilize
the intellectual property (IP) system to acquire rights over inventions based
on genetic resources (GRs) and/or its associated TK, without complying
with existing national or international legal obligations governing the
acquisition and use of such resources.
Arising from the importance of TK to indigenous groups and States and
the real threat of biopiracy, several countries, especially developing
countries, have taken on the difficult challenge of implementing regulations
governing the use and protection of TK within their borders. Beyond such
domestic measures, efforts to secure protection for TK have also been
pursued at the international level. Two significant normative developments
in international law - one concluded and the other ongoing - form the
basis of this paper's reflection on the effective protection of TK from
biopiracy.
First, the Nagoya Protocol.) The Nagoya Protocolwas adopted in 2010 and
entered into force in 2014.' A subsidiary instrument to the Convention on
Biological Diversity (CBD), the Nagoya Protocol was negotiated in response to
calls for an international regime which would implement the third objective
of the CBD that relates to the fair and equitable sharing of benefits arising
from the utilization of genetic resources (GRs). 6 The Nagoya Protocol
establishes this international access and benefit sharing (ABS) regime, made
up of the CBD, the Nagoya Protocol, and other complementary instruments
including the Bonn Guidelines and the InternationalTreaty for Plant Genetic
Resources for Food and Agriculture (ITPGRFA). "While the Nagoya Protocol does
not specifically call for the protection of TK, its general provisions offer in
4 Nagoya Protocol on Access to Genetic Resources and the Fair and Equitable Sharing of Benefits
arisingfrom their Utilization to the Convention on Biological Diversity, 29 October 2010, [no
UNTS Volume Number has yet been determined for this record] (entered into force 12
October 2014) [Nagoya Protocol].
The Nagoya Protocol entered into force exactly 90 days after the fiftieth country ratified
the Nagoya Protocol in accordance with Article 33 of the Nagoya Protocol.See Convention
on Biological Diversity [CBD], "Parties to the Nagoya Protocol", online: CBD
<https://www.cbd.int/abs/nagoya-protocol/signatories/>.
6 See Nagoya Protocol, supra note 4, para 2 (Preamble to the Nagoya Protocol). Convention
on Biological Diversity, 5 June 1992, [no UNTS Volume Number has yet been determined
for this record] (entered into force 29 December 1993) [CBD].
practice,[sic] tools and mechanisms that are driven by this underlying

objective." 7 In fact, an entire parallel set of provisions are contained within
the Nagoya Protocol addressing access and benefit sharing arising from the
use of an important subset of TK - TK associated with GRs (TKaGRs).
Through its provisions, the Nagoya Protocol seeks an actualization of the
CBD's other two objectives: the conservation of biodiversity and the
sustainable use of its components. 8 The Nagoya Protocol thus exists within
the broad framework of a biodiversity conservation regime. As of May 1",
2017, a total of 95 ratifications had been received for the Nagoya
Protocol.9The majority of countries that have ratified the Nagoya Protocol are
developing countries. This demonstrates the importance of the Nagoya
Protocol, and indeed the international ABS regime, to the developing world.
The second development I draw attention to is the ongoing process
within the WIPO Intergovernmental Committee on Intellectual Property
and Genetic Resources, Traditional Knowledge and Folklore (IGC). Set
against the backdrop of the IP regime, the IGC was established by the World
Intellectual Property Organization (WIPO) in 2000 as a policy forum for
the discussion of IP issues arising within the context of the protection of
TK and traditional cultural expressions (TCEs), as well as the sharing of
benefits arising from the use of GRs. The IGC has been fraught with major
difficulties through its 16 years of work; a central tension which is generated
by the difficulty in reconciling an IP-based protection of TK with the formal
IP system.
The global IP system is a system of governance which, amongst others,
seeks to incentivize innovation. IP is a term which broadly encapsulates
proprietary rights arising from creations of the mind."o It includes
See Muller, supra note 1 at 4.

8 See Convention on Biological Diversity, "Text of the Convention", at art 1, online:
CBD -< https://www.cbd.int/convention/text/default.shtml>. See also, Nagoya Protocol,
supra note 4 at art 1.
9 For a full listing, see Convetion on Biological Diversity, "Parties to the Nagoya
Protocol", online: CBD <https://www.cbd.int/abs/nagoya-protocol/signatories/>.
10 The Convention Establishingthe World Intellectual Property Organization, 14 July 1967, 828
UNTS 3 (entered into force 26 April 1970) [CEWIPO], notes that IP includes all rights
resulting from intellectual activity in the industrial, scientific, literary or artistic fields,
including the rights relating to; literary, artistic and scientific works; performances of
performing artists, phonograms, and broadcasts; inventions in all fields of human
endeavour; scientific discoveries; industrial designs; trademarks, service marks, and
commercial names and designations; and protection against unfair competition.
inventions, literary and artistic works, designs, symbols, names and images
which are used in the fields of commerce." Underlying its prescriptions are
two broad categories of justifications: the ethical/moral justifications and
the instrumental justifications.'"The former category is premised on the
natural rights that creators have in their creation, while the latter is
premised on the rationale that the lack of IP protection would mean an
insufficient production of intellectual products.1 3 It is in this latter context
that the IP system is recognized as a simulant for innovation and creativity.' 4
This underlying rationale, which draws its origins from the early
European experience, has served to exclude TK (and its holders) from its
protection framework. The exclusion of TK from the IP system presents a
difficulty for the continued justification of the IP system as we know it
today. This is on the basis that the IP system is not sufficiently representative
of knowledge holders and creators all around the world. The innovative
tendencies of indigenous and local communities, which are a significant
driver of 'modern' innovation, are thus largely undermined. Arising from
suggestions of incompatibility, '5 this exclusion is due to the peculiarities of
this knowledge which do not necessarily align with the general concept of
knowledge recognized and catered for within the classical IP system.'" Sanjay
Bavikatte notes the following anti-TK assumptions which underlie the IP
system: the assumption that the progenitors of knowledge are clearly
identifiable; the assumption that new knowledge is clearly distinguishable
CEWIPO Article 2 (viii).

" See World Intellectual Property Organization [WIPO], "What is Intellectual Property?",
online: WIPO -<www.wipo.int/about-ip/en/>. See also, WIPO, What is Intellectual
Property? (Geneva: WIPO, undated) 2, online:
<www.wipo.int/edocs/pubdocs/en/intproperty/450/wipo-pub-450.pdf>.
12 Lionel Bently & Brad Sherman Intellectual Property Law 4 ed (UK: Oxford University
Press, 2014) at 5.
13 Ibid.
14 Merges, Menell & Lemley, Intellectual Property in the New Technological Age, 2 ed
(Gaithersburg: Aspen Law & Business, 2000) at 10-24.
15 See Susy Frankel, "Ka Mate Ka Mate and the Protection of Traditional Knowledge" in
Rochelle Cooper Deyfuss & Jane C Ginsburg, eds, Intellectual Property at the Edge: The
Contested Contours of IP (UK: Cambridge University Press, 2014) 193-194.
16 See Kabir Sanjay Bavikatte, "A Critical Analysis of South African Legislation Relating
to Indigenous Knowledge: Towards a Rights Based Approach to Protection of
Indigenous Knowledge" 765 J World Intellectual Property.
from old knowledge; the assumption that knowledge creation and

development is primarily motivated by the 'potential of future rewards and
[that creators] would be willing to share their knowledge with society in
exchange for such rewards'; and the assumption that IP rights 'adequately
reward developers of 'new' knowledge by guaranteeing them exclusive and
time-bound use of such knowledge in exchange for sharing the knowledge
with society'. 7
Addressing the exclusion of TK from the IP system formed one of the
core rationales underlying the formation of the IGC. 18Since the late 2000s,
the IGC has continued to advance its work through text-based negotiations
aimed at agreeing on the text(s) of an international legal instrument(s)
which will address this exclusion by ensuring the effective protection of TK.
However, though progress has been made, delegates remain divided on a
number of core issues which are central to the conclusion of its normative
efforts. My intention is not to examine these issues here, but rather is to
emphasize the central role which the negotiators of the Nagoya Protocol
projected for the IGC in the very implementation of the Nagoya Protocol
as an effective solution to biopiracy. The relevance of the IGC to the efforts
to implement the Nagoya Protocol is an area which has not received
sufficient scholarly attention.
On the basis of the above, this article discusses the protection of
TKaGRs from biopiracy as a central concern of the developing world. It
highlights biopiracy as a trans-regime concern which requires solutions
drawn from both the Nagoya Protocol and the IP regime. Drawing from
aspects of regime theory, this article suggests a viewing of the Nagoya Protocol
within the context of an evolving regime-complex for a meaningful solution
to the problem of biopiracy. In support of this, it discusses the WIPO IGC
as an elemental part of the evolving regime complex being advanced by
developing countries to address the protection of TKaGRs. I justify a
viewing of this regime complex as an ABS regime complex - one which seeks
to address in an effective way the protection of TKaGRs from the rampant
17 Ibid.
1s See WIPO Background Brief No 2, "The WIPO Intergovernmental Committee on
Intellectual Property and Genetic Resources, Traditional Knowledge and Folklore
(IGC) (2016) at 2, noting that the IGC was 'conceived as part of a larger and structured
endeavour by WIPO to move towards a modern, responsive IP system that could
embrace non-Western forms of creativity and innovation, be comprehensive in terms
of beneficiaries, and be fully consistent with developmental and environmental goals'.
incidence of biopiracy - on the basis of a third world approach to

international law (TWAIL).' 9
This paper is broken down into five main parts. After this introduction,
part two offers a contextual introduction to international regimes for the
purpose of comprehending the purpose of an international regime on ABS.
Part three introduces the issue area of biopiracy. As part of this discussion,
considerable effort is made to introduce TKaGRs as a subject of
appropriation within the biopiracy debate. In part four, I provide a
discussion of the Nagoya Protocol as a regime complex aimed at addressing
the incidence of biopiracy. Significantly, I highlight its open-ended nature
and its evolutionary context which support a viewing of the WIPO IGC as
an intended component of the Nagoya Protocol's mechanism. In part five, I
conclude by discussing the relevance of the WIPO IGC to the Nagoya
Protocol'sregime, noting the importance of a complementary outcome as the
defining precondition for such an inclusion. The significance of this article
is contained in the viewing of fragmented international efforts as necessary
complementary pieces for achieving the objective of TK protection from
biopiracy.
II. A REGIME CONTEXT
International law is made up of normative and institutional fragments

which interact in diverse ways.20 There really has never been a central
19 The TWAIL scholarship is channelled towards a 'commitment to centre the rest rather
than merely the west, thereby taking the lives and experiences of those who have self-
identified as Third World much more seriously than has generally been the case'. See
Obiora Okafor, "Critical Third World Approaches to International Law (TWAIL):
Theory, Methodology, or Both?" (2008) 10 Intl Community L Rev 371 at 376. See also
Antony Anghie & BS Chimni, "Third World Approaches to International Law and
Individual Responsibility in Internal Conflicts" (2003) 2 Chinese J Intl L 77 at 78,
noting that TWAIL scholarship bears a contextual undertone which views international
law from the perspective of the lived history of third world peoples. Consequently,
TWAIL draws its distinctiveness on the basis of a historically aware methodology - one
which challenges the simplistic visions of an innocent third world and a colonizing and
dominating first world. See James Thuo Gathii, "TWAIL: A Brief History of its Origins,
its Decentralized Network, and a Tentative Bibliography" (2011) 3:1 Trade L & Dev 26
at 34.
20 Wilfred Jenks is attributed with providing the earliest background analysis on
fragmentation of international law. See ILC Study Group, 'Fragmentation of
International Law: Difficulties arising from the Diversification and Expansion of
international law - a homogenous instrument, negotiated centrally, which

governs international relations from a unified perspective. 2 ' Rather,
international law has developed in response to specific needs, as a body of
fragmented regulations governing various areas of state relations. Far from
existing as independent isolated fragments of regulation, these fragments
tend to overlap in several ways, creating a diverse range of new issue
relationships in international law.22 The existence of normative fragments
could serve, for instance, to provoke the emergence of counter-norms
seeking to balance the effects of existing norms, or could serve as
foundations for the emergence of strengthened norms aimed at the
consolidation of existing norms. Yet again, normative fragments could
emerge within an interpretive context, seeking to provide further
clarification or explanation to existing norms. The emergence of
international norms, as with international regimes, may therefore be said to
be path dependent, and are generally reactive to, or predicated on, existing
regimes. 23
International Law' Report of the Study Group of the International Law Commission
finalized by Martti Koskenneimi (A/CN.4/L.682 and Corr.1) (13 April 2006) paras 5-
6. He identified the international world's lack of a general legislative body which
resulted in multiple unrelated sources churning out international laws as well as the
development of laws governing the revision of multilateral instruments as well as
defining the effects of such revisions, as the two key reasons for the fragmentation of
international law. Ibid. See also C Wilfried Jenks, "The Conflict of Law-Making
Treaties", (1953) 30 Brit YB Intl L at 403.
21 See Margaret Young, "Introduction: The Productive Friction between Regimes", in
Margaret Young, ed, Regime Interactionin InternationalLaw: Facing Fragmentation, 1 at 2
noting that there has never been a single global legislature or appellate court to mould
a unified body of international law. Nor has there ever been a uniform will for such a
system by sovereign states. See also, Amir A Majid noting, with reference to formation
of international institutions; '...the international legal regime does not have a
pyramidical organization converging its ultimate authority in a universal legislature or
government which can set up regulatory procedures or criteria...'. See Amir A Majid,
Legal Status of International Institutions: SITA, INMARSAT and EUROCONTROL
Examined (England: Dartmouth Publishing Company Ltd., 1996) at 119.
22 See Margaret A Young, "Regime Interaction in Creating, Implementing and Enforcing
International Law" in Margaret A Young, ed, Regime Interaction in International Law:
Facing Fragmentation(Cambridge, UK: Cambridge University Press, 2012) at 91, noting
the interaction of regimes during the making, implementation and enforcement of
international law.
23 See, for instance, Raustiala, who makes this argument, albeit within the context of
international regime complexes. See Kal Raustiala & David G Victor, "The Regime
The concept of international regimes has been developed and

popularized by scholars of international relations seeking "to capture the
diversity and complexity of the cooperative arrangements that states use to
address transborder issues of mutual concern."" Stephen Krasner is
attributed with the canonical definition of the term, which he defines as
implicit or explicit principles, norms, rules, and decision-making procedures
around which actors' expectations converge in a given area of international
relations. "Across and within the fields of international relations and
international law, the understanding and use of the international regime
concept has differed." The resulting imprecision and wooliness of the term,
arising from such diverse usage of the concept, is a factor often cited as a
criticism against the study of international regimes. International law
Complex for Plant Genetic Resources" in Beth A Simmons & Richard H Steinberg,
eds, InternationalLaw & InternationalRelations (Cambridge University Press, 2006). See
also Andreas Hasenclever, Peter Mayer & Volker Rittberger, Theories of International
Regimes (Cambridge University Press: UK, 1997) at 37, noting that 'regimes do not
emerge in a cognitive and institutional vacuum', but are rather based on and influenced
by earlier experiences of actors.
24 Laurence R Helfer, "Regime Shifting: The TRIPs Agreement and New Dynamics of
International Intellectual Property Lawmaking" (2004) 29 Yale J Intl L 1 at 10. See also
Hasenclever, Mayer & Rittberger, supra note 23 at 1.
25 This 'consensus' definition, as elaborated by Stephen Krasner in his introductory essay
to international regimes, was one of the results of a conference convened to prepare the
1982 special issue of International Organization on international regimes. It has been
widely criticized for its imprecision and the difficulty of distinguishing among its various
components. According to Krasner, principles are beliefs of fact, causation, and
rectitude. Norms are standards of behaviour defined in terms of rights and obligations.
Rules are specific prescriptions or proscriptions for action. Decision-making procedures
are prevailing practices for making and implementing collective choice. See
Hasenclever, Mayer & Rittberger, InternationalRegimes, supra note 23 at 8.
26 See Young, "Productive Friction", supra note 21 at 2. This difference is also closely
linked to the difficult historical relationship between international relations and
international law scholarship. See, for instance, John H Currie, Craig Forcese & Valerie
Oosterveld, InternationalLaw: Doctrine, Practiceand Theory (Toronto, Canada: Irwin Law,
2007) 29-38, who describe a tense relationship stemming from the questioning by
international relations scholars (particularly those of the realist and non-realist school)
of the relevance of international law to international affairs.
27 See, for instance, Susan Strange, "Cave! Hic Dragones: A Critique of Regime
Analysis",
(1982) 36:2 Intl Organization, at 484-485, who argues that the problem with such
woolly words like regimes is that, where they do not actually mislead and misrepresent,
they only serve to disorient and confuse. See also Oran Young, InternationalCooperation:
Building Regimes for Natural Resources and the Environment (New York: Cornell University
scholars, however, have largely shown an interest in the concept of

international regimes within the context of its relevance, amongst others, to
the development, interpretation, implementation, enforcement and
application of international law.28 The international law scholarship is
focused mainly on understanding how different branches of norms and
institutions overlap on issues of global concern.2 9 As Margaret Young notes,
this overlap "is not simply a matter of international judicial tribunals who
seek to interpret conflicting norms, but is a constant feature in the setting
of agendas for new negotiations[and] the ongoing norm elaboration within
n, 30
regimes...
.
A central part of international regimes which is of central importance

to this paper's analysis relates to articulation of regime issue areas.
Hasenclever et al. have observed, that "issue-area specificity is an essential
attribute of regimes, [and as such] the concept of regime can only be as clear
as the concept of an issue-area has been made." 3 1 In other words, the clarity
of an actual regime rests on the clarity of the issue-area for which
cooperation is sought. The concept of 'issue area', though largely
overlooked, is thus another important aspect of regimes that is worth
mentioning. 32 An issue area consists of one or more, in the perception of
the actors, inseparably connected objects of contention and of the behavior
directed to them. The boundaries of such issue areas are determined by the
perceptions of the participating actors. 33 This definition, amongst others,
Press, 1989) at 9, who notes that critics have reasonably questioned whether the concept
of regimes is 'anything but a woolly notion likely to produce more confusion than
illumination'.
28 See generally Beth A Simmons & Richard H Steinberg, eds, International Law and
InternationalRelations (Cambridge University Press: 2006, UK), which covers a broad
range of topics, authored by law practitioners as well as political scientists, dealing with
international regimes, within the specific context of the interaction of international law
and international relations. See also, Margaret A Young, ed, Regime Interaction in
InternationalLaw: Facing Fragmentation(New York: Cambridge University Press, 2012).
29 See Young, "Productive Friction", supra note 21 at 1.
30 Ibid.
31 See Hasenclever, Mayer & Rittberger, supra note 23 at 60.
32 See Hasenclever, Mayer & Rittberger, ibid at 60, who note that little attention has
surprisingly been paid to the concept of issue area by students of international relations
despite its centrality to the regime concept.
3 See Manfred Efinger & Michael Zurn, "Explaining Conflict Management in East-West
Relations: A Quantitative Test of Problem-Structural Typologies", in Volker Rittberger,
highlights the political nature of the circumscription of issue areas given its
reliance on actors' perceptions, as well as emphasizes the conflictual nature
of issue areas. 34
The perception-dependency of issue-areas deserves to be stressed: it has the
important implication that issue-areas can change without any corresponding
change taking place in the objective facts to which policymakers are responding.
Moreover, analysis is complicated by the fact that perceptions of actors as to which
issues are indeed 'inseparably connected' can diverge: typically the formation of an
issue-area is itself a highly political process.
The Nagoya Protocol's international ABS regime thus offers an

interesting framework for which the determination of the issue-area may
prove a challenge for reasons alluded to above. Prima facie, the ABS regime
seeks to ensure cooperation among Parties on the effective implementation
of the CBD's third objective - equitable sharing of benefits arising from the
utilization of genetic resources (GRs) and traditional knowledge associated
with such genetic resources (TKaGRs). The flip side to this issue of benefit
sharing is the issue of access to the resources largely located in the Third
World. Highlighting the conflictual nature of the two sides, the user-actors,
mostly located within developed countries, are primarily concerned with
issues of legal certainty surrounding the access terrain to resources, while
the provider-actors are principally concerned with ensuring compliance
with the terms of access especially as regards the sharing of benefits arising
from use.
From the perspective of developing countries, the immediate issue area
draws from a broad historical ancillary context of unfair access to and use
of resources by user-actors, coupled with an inadequate or non-existent
sharing of benefits with provider-actors. Given that the construction of issue
areas is linked to the perception of actors and is largely a political issue, it
would be a mistake to fail to acknowledge the underlying political
sensitivities which benefit sharing has emerged to address within the third
world - the eradication of biopiracy.
International Regimes in East - West Politics (London: Pinter Publishers, 1990) 64 at

68.
3 See Hasenclever, Mayer & Rittberger, supra note 23 at 61. Conflict is not used to refer
to hostilities or violence, but is rather used to refer to incompatible preferences or
differences in issue positions. The actions of actors in relation to these, is discussed as
conflict management.
3 Ibid.
Indeed, for developing countries, the search for solutions to biopiracy

lies at the heart of the efforts to implement the Nagoya Protocol. The
Government of India, for instance, upon ratification of the Nagoya Protocol
noted in its press release:
India has been a victim of misappropriation or biopiracy of our genetic resources
and associated traditional knowledge, which have been patented in other
countries... it is expected that the ABS Protocol which is a key missing pillar of the
CBD, would address this concern. 36
The Government of Mexico also noted upon ratification of the Nagoya

Protocol that the Nagoya Protocol
[w]ould provide legal certainty regarding the use of genetic resources to indigenous
and local communities, industries, pharmaceutical companies and researchers, by
establishing measures to avoid misappropriation and misuse.
Again, in this context, the former Vice President of Indonesia, Prof.

Boediono, in offering support for the ratification of the Nagoya Protocol,
noted that
with the [Nagoya Protocol], Indonesia will have a firm legal basis to protect and
preserve its genetic resources and traditional knowledge related to genetic
resources....[i]n addition, the law will also lay a legal basis for the country to prevent
theft and illegal utilization of biodiversity.3 8
36 Intellectual Property Watch, "Brief: India Ratifies Nagoya Protocol on Biodiversity

Access And Benefit-Sharing" (5 October 2012) IP Watch, online: Intellectual Property
Watch <https://www.ip-watch.org>. This can be contrasted with the press statement of
the European Union on the signature of the Nagoya Protocol which stated: "The Nagoya
Protocol should create the opportunities for biodiversity rich countries to conserve and
sustainably use their biodiversity opportunities for fair and equitable sharing of benefits
from their use. At the same time, the Nagoya Protocol should create a clear and
transparent framework for user countries to use the same opportunities as a resource to
increase scientific knowledge and understanding, or to develop commercial products."
EU Press Statement on the signature of the Nagoya Protocol (23 June 2011), online:
<http://eu-un.europa.eu>.
3 CBD, "Press Release: Megadiverse Mexico Ratifies the Nagoya Protocol on Genetic
Resources" (23 May 2012), online: CBD <https://www.cbd.int/doc/press/201 2 /pr-
2012-05-23-Mexico-en.pdf>.
38 Antara News, "Indonesia to Ratify Nagoya Protocol in May" Antara News
(5
February 2013), online:
<http://www.antaranews.com/en/news/87253/indonesia-to-ratify-nagoya-
protocol-in-may>.
39
What then these three megadiverse country views point to is an
expectation that the implementation of the Nagoya Protocolwill significantly
assist their respective governments in the quest to prevent the continued
theft, misappropriation or misuse of TKaGRs and GRs from within their
respective territories. These concerns, as expressed, are generally subsumed
within the biopiracy rhetoric. Therefore, from the perspective of several
developing countries, the Nagoya Protocol is a central instrument for
addressing biopiracy. In other words, the eradication of biopiracy represents
an underlying expectation of benefit sharing arrangements within the
concluded text of the Nagoya Protocol and, by extension, the ABS regime.
This implies that beyond explicit primary regime objectives, regime
signatories could yet approach the implementation of specific regimes for
the fulfilment of ancillary objectives. Indeed, the ability to address these
ancillary objectives could serve to determine - negatively or positively - the
potential effectiveness of the said regime. Understanding biopiracy as an
ancillary Third World objective of the ABS regime assists with an
understanding of the ABS regime and its implementation from the
perspective of the developing world.
Characterizing biopiracy as the central aim of the Nagoya Protocol
based on an ancillary interpretation may admittedly seem simplistic,
especially given that the express objective of the Nagoya Protocol, as noted
earlier, relates to the fair and equitable sharing of benefits, aimed at
ensuring the conservation and sustainable use of biodiversity. In making
this characterization, I however wish to focus on biopiracy as an implicit issue
area of global governance. In reality, as explained above, the definition of
regime issue areas is based primarily on the perceptions of actors within
regimes and thus constitutes a largely political issue. Andrew Lang, through
an analysis of the international trade regime, argues that each international
regime contains "principles of vision - the particular implicit frameworks
of visibility and invisibility.. .which reflect the politics of the regime above
and beyond the regime's expressed mandate."4 0 This suggests that beyond
39 The Like-Minded Megadiverse Countries (LMMC) was established by the Cancun

Declarationof Like-Minded Megadiverse Countries, 18 February 2002 [Cancun Declaration].
The LMMC today is a group of 17 countries "which hold more than 70% of all
biodiversity, and 45% of the earth population." See Group LMMC, "Like Minded
Megadiverse Countries" (2009), online:
-<http://pe.biosafetyclearinghouse.net/actividades/2009/ grouplmmc.pdf> at 2.
40 See Andrew T F Lang, "Legal Regimes and Professional Knowledges: The Internal
an express regime mandate, the politics of the regime could actually devolve
on ancillary objectives. As evidenced above, several developing countries
have consistently referenced the issue of biopiracy in expressing their hopes
and expectations for the implementation of the Nagoya Protocol. In other
words, in adopting Andrew Lang's analysis, Third World actors consider
the issue of biopiracy to be an implicit 'principle of vision' underlying the
express objective of the ABS regime." Consequently, while some countries
like the United States have struggled to even acknowledge the existence of
a phenomenon called biopiracy,1 2 Third World countries have placed the
eradication of biopiracy as a core justification underlying the very existence
of the Nagoya Protocol's international ABS regime.
Does this then suggest an 'issue' shift in the core rationale of the ABS
regime? Absolutely not. The ABS regime, founded on the principle of
benefit sharing and aimed at conserving and using biodiversity in a
sustainable way, remains an intact shared regime objective by all its
signatories. However, while developed countries have sought to clarify the
rules for access to GRs and TKaGRs, thus promoting legal certainty for
research and investment through such a regime, Third World countries
have sought to reclaim a terrain of exploitation, by which token their
sovereign rights over their resources have often been compromised. In
reasserting the rights over resources located within their territories, the
Politics of Regime Definition" in Margaret A Young, ed, Regime Interaction in

InternationalLaw: Facing Fragmentation (New York: Cambridge University Press, 2012)
116-117 [Lang, "Legal Regimes & Professional Knowledges"].
41 Through an analysis of the international trade regime, Andrew Lang argues that each
regime contains what he terms, 'inner principles of vision - particular implicit
frameworks of visibility and invisibility - which reflect the politics of the regime above
and beyond the regime's expressed mandate. Understanding how these principles of
vision are produced, contested and sustained is a necessary part of unearthing the
internal politics of a regime. See Lang, "Legal Regimes & Professional Knowledges",
ibid at 116-117.
42 As summarized by the WITO Secretariat, the US observed, in response to the
submission of India, contained in WT/CTE/W/156, "Protection of Biodiversity and
Traditional Knowledge - The Indian Experience", "whilst there were often disputed
about whether something was patent-worthy, the US noted that the examples in India's
paper had been successfully addressed. The US was not sure it accepted that there was
a phenomenon that could be termed biopiracy." For a full summary of the exchanges,
see Someshwar Singh, "US Not Sure What's Biopiracy" (July 20, 2000) South North
Development Monitor, online: GRAIN -<https://www.grain.org/article/entries/2103-
us-not-sure-what-s-biopiracy>.
biopiracy rhetoric has offered a useful framework through which the

implementation of the ABS regime is perceived within the Third World. In
the rest of this work, my analysis of the ABS regime will be pursued in the
context of benefit sharing as a tool addressing the protection of TKaGRs
from biopiracy.
A. Biopiracy
Biopiracy is the result of a commercial/non-commercial drive to utilize
the IP system to acquire rights over inventions based on GRs and/or its
associated TK, without complying with existing legal obligations, national
or international, governing the acquisition and use of such resources.
Principally, the regulations governing the acquisition and use of GRs and
TKaGRs are contained within the access and benefit sharing (ABS)
framework, which, at the international level, is comprised of the Nagoya
Protocol, the CBD, the ITPGRFA, the Bonn Guidelines, and other
complementary instruments. Not only do international regulations govern
the use of GRs, but importantly, the domestic regulations of States form a
core component of such regulations governing the acquisition and use of
resources. Evading such regulations, while yet securing legitimate IP rights
over inventions based on GRs and TKaGRs, lies at the heart of biopiracy's
conceptualization. As a first step in discussing biopiracy, I will turn first to
offer an introductory discussion on TKaGRs - the subject of appropriation
on which I primarily focus in this paper.
1. Traditional Knowledge Associated with Genetic Resources

The idea of 'traditional knowledge' (TK) as a terminology has been
invented only recently.43 Currently, though widely recognized, there yet
remains no authoritative and internationally agreed-upon definition for
TK." Teshager Dagne suggests that the very "definitional venture of [TK]
poses various theoretical and methodological dilemmas due to the
43 Madhavi Sunder, "The Invention of Traditional Knowledge" (2007) 70 L

&
Contemporary Problems, 97 at 110.

44 See Bubela & Gold, supra note 2 at 2-3, noting the varying approaches adopted at
international fora with its definitions, and thus identifying that the concept of TK is
used regularly to refer to different ideas, such as indigenous knowledge systems,
innovations, customary laws or practices. See also Deepa Varadarajan, "A Trade Secret
Approach to Protecting Traditional Knowledge" (2011) 36 Yale J Intl L 371 at 373
(identifying the lack of a definition as a problem for its protection).
complexity of issues surrounding the term."" WIPO, which is currently in

the process of negotiating an international definition for TK,16 has
attributed this complexity to the highly diverse and dynamic nature of TK.
It identifies this as a central factor which challenges efforts to develop a
single and exclusive definition of TK.17
A combined reading of 'traditional' and 'knowledge', supports a basic
understanding of TK as 'a body of tradition-based knowledge4 8 which is
handed down or transmitted (orally) from generation to generation"; 4 a
45 Teshager Dagne, "The Protection of Traditional Knowledge in the Knowledge

Economy: Cross-Cutting Challenges in International Intellectual Property Law" (2012)
14 Intl Community L Rev 137 at 139.
46 QIPO's emerging definition, identifies three key characteristics of TK as: its creation
and maintenance in a collective context by indigenous peoples; its direct link or
association with the cultural and/or social identity of indigenous peoples, and its
transmission from generation to generation. Other important characteristics are its
dynamic and evolving nature, as well as its existence in codified, oral or other forms.
See WIPO, "The Protection of Traditional Knowledge: Draft Articles", WIPO Doc
WIPO/GRTKF/IC/28/5, art 1 at 7. As a definition-in-progress, the text remains
heavily bracketed around contested areas of the draft definition.
47 See WIPO, Intellectual Property Needs and Expectations of Traditional Knowledge Holders:
WIPO Report on Fact-Finding Missions on Intellectual Property and Traditional
Knowledge(1998 - 1999)" (Geneva: World Intellectual Property Organization, 2001) at
25. [WIPO, Fact-FindingMission Report].
48 WIPO in its fact finding mission conceptualizes the term tradition-based in reference
to knowledge systems that have generally been transmitted from generation to
generation; are generally regarded as pertaining to a particular people or its territory;
and, are constantly evolving in response to a changing environment. WIPO, Fact Finding
Mission Report, supra note 47 at 25. See also Sumathi Subbiah, "Reaping what they Sow:
The Basmati Rice Controversy and Strategies for Protecting Traditional Knowledge"
(2004) 27 BC Intl & Comp L Rev at 532.
49 With regard to the generational transmission of TK, Martha Johnson observes that in
contradistinction to western scientific knowledge, TK: is recorded and transmitted
orally; is learned through observation and hands-on experience; is based on the
understanding that the elements of matter have a life force; does not view human life
as superior to other animate and inanimate elements but that all life-forms have kinship
and are interdependent; is holistic rather than reductionist; is intuitive rather than
analytical; is based on data collected by resource users themselves rather than specialised
group of researchers; is based on diachronic rather than synchronic data; is rooted in a
social context that sees the world in terms of social and spiritual relations between all
life forms and; derives its explanations of environmental phenomena from cumulative,
collective and often spiritual experiences. See Martha Johnson, "Research on
Traditional Environmental Knowledge: Its Development and Its Role" in Martha
Johnson, ed, Lore: CapturingTraditionalEnvironmentalKnowledge (Ottawa: Dene Cultural
product of age-long experience, generationally improved upon";o " a

collectively owned heritage as against an individually owned right";" "an
adaptive innovative lifestyle generated for survival";" and "a largely
unwritten body of instruction and belief".53
Institute & International Development Research Centre, 1992) 7-8.

50 See Graham Dutfield, "Legal and Economic Aspects of Traditional Knowledge" in
Keith E Maskus & Jerome H Reichman, eds, InternationalPublic Goods and Transfer of
Technology Under a Globalized Intellectual Property Regime (UK: Cambridge University
Press, 2005) at 500-50 1, discrediting the widely held view that TK is antique, void of
innovation and lacking in creativity. Rather TK is described as being progressive, highly
innovative and involving a continuous reformation of knowledge handed down to meet
up with the adaptive requirements of the present environmental realities by indigenous
communities. "In short, knowledge held and generated within 'traditional societies' can
be new as well as old ... TK has been adaptive because adaptation is the key to survival
in precarious environments ... while TK is handed down from one generation to
another, this does not mean that what each generation inherits is what it passes on ...
TK develops incrementally with each generation adding to the stock of knowledge". See
also Bubela & Gold, supra note 2 at 2-3 and see, Krishna Ravi Srinivas, "Traditional
Knowledge and Intellectual Property Rights: A Note on Issues, Some Solutions and
Some Suggestions" (2008) 3 Asian J WTO & Intl Health L & Policy at 84.
5 Despite general acknowledgement that a major limitation in the quest for increased
protection for TK in the IP sense, lies in its nature of collective ownership; See Javier
Garcia, "Fighting Biopiracy: The Legislative Protection of Traditional Knowledge"
(2007) 18 Berkeley La Raza LJ 7 [Garcia, "Fighting Biopiracy"]. See also Daniel Gervias,
"Traditional Knowledge and Intellectual Property: A TRIPS Compatible Approach"
(2005) Mich State L Rev at 140 [Daniel Gervias "Traditional Knowledge and
Intellectual Property"]; many authors are quick to point out that it amounts to a
generalization fallacy to conclude that all TK is communally owned. See, for instance,
Graham Dutfield & Uma Suthersanen, Global Intellectual Property Law (UK: Edward
Elgar, 2008) [Dutfield & Suthersanen, Global Intellectual Property Law] where the authors
state that "the idea that traditional property rights are always collective or communal in
nature while notions of western property are inherently individualist is an inaccurate
clich". Significantly, several communities have well defined and established customary
law practices which regulate intellectual property rights.
52 See WIPO IGCOR, WIP Doc WIPO/GRTKF/IC/5/7, 2003 (WIPO Secretariat
Consolidated Survey of Intellectual Property Protection of TK, TK and Folklore)
describing the concept of TK as: "ideas developed by traditional communities and
indigenous people, in a traditional and informal way, as a response to the needs
imposed by their physical and cultural environments"; a definition which emphasizes
in clearer terms the strong relationship between indigenous communities and their
environments; their TK and their quest for survival.
5 Srinivas, supra note 50 at 84. See Oluwatobiloba Moody, The Nagoya Protocol: A Possible
Solution to the Protection of Traditional Knowledge in Biodiverse Societies of Africa (Cape
Indigenous peoples view their TK as a holistic concept which is

inseparably connected to their indigenous culture, identity, spirituality,
livelihood, location, environment and the natural conditions in which they
live.54 This connectionism, from the perspective of indigenous peoples,
serves to connect the skills and understandings of indigenous peoples with
their medical remedies, plant and animal products, technologies and
cultural expressions.55 TK is thus the totality of all knowledge and practices,
whether implicit or explicit, used in the management of socio-economic and
ecological facets of life. 6 It constitutes a central component of the
biocultural heritage of indigenous groups.
Despite this holistic nature of TK, it is often broken down into various
categories to fit within western paradigms." Within WIPO's negotiations,
Town: University of the Western Cape, 2011).

* See Susy Frankel & Peter Drahos, "Indigenous Peoples' Innovation and Intellectual
Property: The Issues (2012) 2 Victoria University of Wellington Legal Research Papers
at 13-23 who describe the concept of 'connectionism' to explain the holistic nature of
indigenous innovation. This view is supported by Anderson who notes in her analysis,
the holistic manner in which indigenous peoples experience their knowledge systems.
Jane Anderson, "Indigenous/Traditional Knowledge and Intellectual Property" (2010)
Center for the Study of the Public Domain, Duke University School of Law Issues Paper
at 5.
5 Stephen Munzer & Kal Raustiala, "The Uneasy Case for Intellectual Property Rights in
Traditional Knowledge" (2009) 27 Cardozo Arts & Entertainment LJ 48, defining TK
as an understanding or skill which is typically possessed by indigenous peoples and
whose existence typically predates colonial contact (typically with the West), that relates
to medical remedies, plant and animal products, technologies and cultural expressions.
56 See John Mugabe, "Intellectual Property Protection and Traditional Knowledge: An
Exploration in International Policy Discourse", online: WIPO <
http://www.wipo.int/portal/en/> at 3,
5 Biocultural heritage refers to the "Knowledge, innovations and practices of indigenous
and local communities that are collectively held and are inextricably linked to:
traditional resources and territories, local economies, the diversity of genes, species and
ecosystems, cultural and spiritual values, and customary laws shaped within the socio-
ecological context of communities". See Graham Dutfield, Alejandro Argumedo
&
Krystyna Swiderska, "Designing an Effective Biocultural Heritage Indication Labelling

System" (August 2015) at 4.
58 From an indigenous perspective, this is often deemed inappropriate. Muller in this
context observes, "applying western legal concepts to a very distinct reality has often
been deemed inappropriate, in as much as these concepts and approaches are very
utilitarian and anthropocentric - excluding variables and elements, which in the view
of indigenous peoples and communities have to be part of the whole and clearly
for instance, the broad concept of TK is broken down into three main
aspects: TK as such, traditional cultural expressions (TCEs) and genetic
resources (GRs). According to WIPO, these categorizations are important
for policy development and scholarship in the field of IP as the various
categories raise distinct issues which require distinct solutions.59 A
discussion of TCEs for this reason falls outside the scope of this paper. 60
Rather, drawing from the Nagoya Protocol, elements of TK and GRs are
merged to describe a subset of TK referred to as 'TK associated with GRs'
(TKaGRs).6
i. Genetic Resources
GRs are "biological resources". The importance of biological resources
cannot be overstated. "Forty percent of the world's economy depends
directly or indirectly on biological resources... The rural poor especially
depend on biological resources for up to 90 percent of their daily needs",
with natural goods and services provided by biodiversity being a key source
of food, water, shelter, incomes and livelihoods or billions of people
globally. 63 GRs are thus a valuable component of human livelihood and
reflected". See Ruiz, supra note 1 at 9.

59 See WIPO Background Brief 1, Traditional Knowledge and Intellectual Property
(2016), at 2-3, online:
<http://www.wipo.int/edocs/pubdocs/en/wipo-pub-tk-1.pdf>.
60 TCEs are often viewed as reflecting the literary and artistic manifestations of knowledge
of indigenous groups. Also called expressions of folklore, TCEs may include music,
dance, art, designs, names, signs and symbols, performances, ceremonies, architectural
forms, handicrafts and narratives, or many other artistic or cultural expressions. See
WIPO, "Traditional Cultural Expressions", online: WIPO
-<http://www.wipo.int/tk/en/folklore/>,.
61 Specifically, the Nagoya Protocol, supra note 4, art 3, defines the TK to which the Nagoya
Protocol applies as being that which is associated with GRs within the scope of the
Convention on Biological Diversity, "Text of the Convention", online: CBD -<
https://www.cbd.int/convention/text/default.shtml> at art 15 [CBD]. The scope
offered by CBD, ibid, art 15 may be conceptualised as referring to TK associated with
GRs held by Contracting Parties which are either countries of origin of such resources
or in valid acquisition of the GRs according to the Convention.
62 See CBD, supra note 6, art 2. It defines biological resources as including GRs, organisms
or parts thereof, populations or any other biotic component of ecosystems with actual
or potential use or value for humanity.
63 International Centre for Trade and Sustainable Development, "Navigating Nagoya:
Will CBD COP 10 Deliver an ABS Protocol" (2010) 4:3 ICTSD, online: ITCSD,
existence. Within the CBD, GRs are defined as genetic material of actual or
potential value.6 ' They are living components of plant, animal or
microorganism species that possess functional units of heredity (genes).
GRs are a potential source of income for biodiversity rich communities as
well as biotechnology industries which rely on GRs as a major source of
input for research into the development of a wide range of health,
agricultural and cosmetic products. The consistent interaction and
dependence of indigenous peoples on their environments offers them
unique insight into the special properties and characteristics of GRs which
occur within their domain. This knowledge provides useful pointers and
leads for industry R&D and, as such, is an important resource which has
been the subject of bioprospecting and biopiracy.
The association of TK with genetic resources (GRs) underscores the
close relationship, often described as inseparable, of indigenous peoples
with their environments. Furthermore, it points to the unique knowledge
that indigenous peoples have developed over time regarding the properties
and uses of GRs. This relationship is recognized as being important for the
conservation of biodiversity, the sustainable use of its components, and for
the sustainable livelihood of indigenous communities that depend on
them. 66 Highlighting the inseparability of TK and GRs in the articulation
of TKaGRs, several authors and policy makers have viewed GRs as
<http://www.ictsd.org/bridges-news/biores/news/navigating-nagoya-will-cbd-cop-10-
deliver-an-abs-protocol>.
64 See CBD, supra note 6, art 2. Furthermore, the preamble to the CBD recognises
biodiversity as possessing high intrinsic value and identifies the ecological, genetic,
social, economic, scientific, educational, cultural, recreational and aesthetic value of its
components (including GRs). See CBD, ibid, preamble at para 1. CBD, ibid, art 2 defines
genetic material to mean any material of plant, animal, microbial or other origin
containing functional units of heredity.
65 See Thomas Greiber, Sonia Pena Moreno, Mattias Ahren, Jimena Nieto Carrasco,
Evanson Chege Kamau, Jorge Cabrera Medaglia, Maria Julia Oliva & Frederic Perron-
Welch in cooperation with Natasha Ali & China Williams, An Explanatory Guide to the
Nagoya Protocol on Access and Benefit Sharing (Gland, Switzerland: IUCN, 2012) 71-72
[Greiber et al, An Explanatory Guide to the Nagoya Protocol], noting that functional units
of heredity refer to genes - a segment of deoxyribonucleic acid (DNA) that is responsible
for the physical and inheritable characteristics or phenotype of any living entity
66 See Nagoya Protocol, supra note 4, Preamble at para 22, noting, inter alia, the
interrelationship between GRs and TK and their inseparable nature for indigenous and
local communities. See also CBD, supra note 6, Preamble at para 12.
constituting a tangible aspect of the intangible TK. 7 In a tangible sense, it

reflects GRs as an innovative output of the knowledge systems of indigenous
peoples - a product - thus reflecting the role of indigenous peoples in
maintaining and conserving GRs over generations. In an intangible sense,
it draws attention to TKaGRs and its various 'know-how' subdivisions, such
as traditional agricultural knowledge (TAK), traditional ecological
knowledge (TEK) and traditional medical knowledge (TMK).6 ' TKaGRs
form a sub-category of TK, and may also be seen as a sub-category of GRs.
The admittedly simplified diagram below seeks to locate TKaGRs within
the broad discourse of TK.
67 See, for instance, Protection of Biodiversity and Traditional Knowledge - The Indian
Experience: Submission by India, WT/CTE/W/156; IP/C/W/198, WTOOR, 2000
[The Indian Experience] at para 2. Geertrui Overwalle "Holder and User Perspectives
in the Traditional Knowledge Debate: A European View" in Charles McManis, ed,
Biodiversity and the Law: Intellectual Property, Biotechnology and TraditionalKnowledge (UK:
Earthscan, 2007) 357, for instance, categorizes TK under two broad headings; tangible
and intangible components. The tangible components are the GRs, the intangible
aspects are subdivided into Traditional Medical knowledge (TMK), Traditional
Ecological Knowledge (TEK) and Traditional Agricultural Knowledge (TAK). See,
however, Zamudio et al, who contend that, contrary to the legal definitions of the CBD,
GRs are not tangible material. They are rather intangible, coded information - a fact
well understood by scientists but less so by politicians. Teodora Zamudio, Joseph Vogel
& Muller Ruiz, "Logic Should Prevail: A New Conceptual and Operational Framework
for an International Regime of Access to Genetic Resources" Research Document;
Initiative for the Prevention of Biopiracy (2010) cited in Ruiz, "Shared Traditional
Knowledge", supra note 1 at 20 (note 3).
68 See Overwalle, "Holder and User Perspectives", supra note 67, at 357. See also Charles
McManis, "Biodiversity, Biotechnology & Traditional Knowledge Protection: Law,
Science & Practice" in Charles McManis, ed., Biodiversity & th Law: Intellectual Property,
Biotechnology & Traditional Knowledge (UK: Earthscan, 2007) at 4, who, by contrast
identifies TAK and TMK as the two categories of TK related to GRs.
Traditional Knowledge
GRs 69 TK stricto sensu TCEs
TKaGRs TK (lato sensu)
TMK TEK TAK
Within the WIPO negotiations, a further distinction is attempted

between TKaGRs and 'associated TK'. Associated TK is conceptualized as
the entire body of knowledge of indigenous peoples that may be associated
with or connected to GRs, including innovations, skills, practices and
learning. TKaGRs, however, refer to the substantive knowledge of the
properties and uses of GRs held by indigenous peoples. 70 In practical terms,
therefore, while associated knowledge may include, inter alia, ceremonies,
songs, handicrafts and inventions that use or draw inspiration from GRs,
TKaGRs would be limited to the know-how of indigenous peoples about
the specific properties and uses of GRs - including medicinal, agricultural
and even environmental uses.
In sum, the inseparable relationship between TK and GRs is an
important one which draws into perspective the survival instincts of
indigenous groups within the context of their unique environments.
Furthermore, it highlights the cultural realities of indigenous life - one
which bears immense relevance for the conservation and sustainable use of
the earth's biodiversity. Again, TKaGRs is the subject of appropriation from
biotechnology industries and users of GRs mainly located in the
69 Further subcategories of GRs could be mentioned, such as, plant GRs, animal
GRs,
and even human GRs. In line with the scope of the Nagoya Protocol, however, its use is
aimed at capturing the scope of GRs as covered by the Nagoya Protocol - i.e. GRs within
the scope of Article 15 of the CBD. See Nagoya Protocol, supra note 4, art 3.
70 See, Document WIPO/GRTKF/IC/30/4, "Consolidated Document Relating to
Intellectual Property and Genetic Resources", annex at 2.
industrialized world, due to its valuable role in the identification of leads

for inventions associated with GRs.7 1 Such inventions typically enjoy
protection from the IP system, which advances a protection mechanism by
which inventors are able to reap profits through the grant of exclusive time-
bound commercial rights over the exploitation of their inventions. This has
led to concerns over unfair wealth distribution arising from the use of
TKaGRs, especially in those cases where TKaGRs are accessed and used
without permission, or beyond the terms of the agreements permitting their
use, or yet still, without adequate compensation being returned to the
communities or States from which such TKaGRs were sourced. Such acts
of misappropriation and/or misuse are broadly discussed as biopiracy. The
Nagoya Protocol was negotiated to establish an international ABS regime,
which would effectively address this concern.7 2
2. Biopiracy: Defining a Contemporary Pattern

"The stylized story of biopiracy follows a simple pattern of
misappropriation of resources located in developing countries by users
located in industrialized countries through the mechanism of the IP
system. 73 David Castle & Richard Gold present this typical "wrongful
exploitation scenario" of biopiracy as follows:
An indigenous group has traditional knowledge. Another group, typically but not
necessarily members of an industrialized country, recognizes the potential utility
of the knowledge and exploits it. When the latter does so, it gains access to and
control over the benefits arising from the knowledge to the exclusion of the
indigenous group. As a result, an objection is raised that this is an inequitable
outcome [...] The situation is made more egregious when the industrial party asks
71 Surinder Kaur Verma, "Protecting Traditional Knowledge: Is a Sui Generis System an

Answer?" (2004) 7:6 J World Intellectual Property, 765 at 768, notes that the valuable
leads provided by TK save time, money and investment of modern biotech firms into
any research and product development. It is estimated that a hit-rate of 80 percent or
more can be achieved in developing medical drugs where the screening of plants is
limited to species used by indigenous communities.
72 Reji K Joseph, "International Regime on Access and Benefit Sharing: Where Are We
Now?" (2010) 12:3 Asian Biotechnology & Development Rev at 78 [Reji, "International
Regime on ABS"].
n Philip Schuler, "Biopiracy and Commercialization of Ethnobotanical Knowledge" in J
Michael Finger & Philip Schuler, eds, Poor People's Knowledge: Promoting Intellectual
Property in Developing Countries (Washington, DC: 2004, The World Bank & Oxford
University Press) 160.
for compensation from developing country consumers for goods and services
74
incorporating the exploited knowledge.
In supporting this stylization of biopiracy, Paul Heald offers two

interesting hypothetical examples of biopiracy:
MegaPharmCorp [in collaboration with the University of the North], seek a new
treatment for diabetes and sends researchers to a remote rain forest where the
inhabitants suffer an unusually low incidence of the disease. After many interviews
with local residents, they identify an enzyme in a variety of squash cultivated by
them which seems responsible for the low rate of the condition. The researchers
return home, isolate the gene that codes for the enzyme and mass produce a
successful and valuable patented drug. The company never compensates any of the
local residents.
MegaAgriCorp is developing a smut-resistant strain of corn and sends researchers

around the world to identify varieties of plants worth studying. In the highlands
of Mexico, they interview farmers who for hundreds of years have maintained a
strain with significant smut-resistant characteristics. The researchers acquire
several of the plants and embark on a successful cross-breeding program when they
return home. The information acquired during the interviews saves them
thousands of research hours. They do not share any of the profits earned from
sales of their new patented hybrid seed with the Mexican farmers.7 5
These stylized cases suggest biopiracy as arising within the context of

unfair resource acquisitions as well as unjust distribution of economic
benefits arising from its use. It also highlights the failure to rightly
acknowledge the roles of indigenous peoples within the formal innovation
chain. A common denominator in the above depictions and examples of
biopiracy is the influence of multinationals and/or individuals based in the
North that utilize the existing legal terrain to secure rights over resources
and/or knowledge acquired from communities located in the poorer South.
This dynamic on the use of GRs and TKaGRs, coupled with the fact that
most of the earth's biodiversity is located within and/or is endemic to
developing countries of the South while the users are largely located in the
technologically advanced countries of the North, has often supported the
7 David Castle & Richard Gold, "Traditional Knowledge & Benefit Sharing: From
Compensation to Transaction" in Peter WB Phillips & Chika B Onwuekwe, eds.
Accessing & Sharing the Benefits of the Genomics Revolution (The Netherlands:
Springer, 2007) at 67.
7 These two examples were slightly modified and have simply been adapted for use here.
The originals are found in Paul Heald, 'The Rhetoric of Biopiracy' (2003) 11 Cardozo
J Intl & Comp L 519 at 520-521.
76 Kate and Laird note that the world's biodiversity is distributed largely in inverse
consideration of biopiracy as a North-South issue - i.e. one in which the

interests of the North are diametrically opposite to the interests of the
South. This is not entirely accurate. However, as natural product research
and development is driven principally by the innovation industry which is
concentrated mainly within the industrialized world and which plays a
major role in the shaping of government policies, there is analytical value in
viewing the struggle as one of indigenous peoples within biodiverse
developing countries' for the protection of their TKaGRs from powerful
corporations, states and systems which seek to exploit the actual/potential
value inherent in such TKaGRs. Though this stylization accounts for the
general outlook of most biopiracy cases as we understand them today, the
peculiarities of individual cases often differ.7 7
A plethora of definitions for biopiracy thus exist, often highlighting
various aspects of this injustice. However, for our purposes, a restrictive
approach to biopiracy - one which aligns with the above stylization of
biopiracy - is adopted. In its restrictive context, biopiracy is defined by
linking the misappropriation of resources with the IP system.7 1 In this
restrictive context, biopiracy has three major elements; the acquisition of
resources (legally and/or illegally); the misappropriation and/or misuse of
resources;7 9 and the acquisition/seeking the acquisition of IP rights over the
proportion to scientific and technological capacity. Kate Ten Kerry & Sarah Laird,
"Biodiversity and Business: Coming to Terms with the Grand Bargain" (2000) 76 Intl
Affairs 241 at 241, quoting C Macilwain, "When rhetoric hits reality in debate on
bioprospecting" (1998) Nature 392 at 535-41.
7 For a review of biopiracy cases, including an overview of their peculiar categorizations,
see generally, Daniel F Robinson, Confronting Biopiracy: Challenges, Cases and
InternationalDebates (UK: Earthscan, 2010).
78 Based on a review of existing definitions of biopiracy in the literature, a broad scope of
scenarios and activities could potentially qualify as biopiracy. Two main definitional
approaches are noticeable, which I categorize along 'restrictive' and 'inclusive' lines.
The inclusive approach tends to label practically all acts of unpermitted appropriation
of GRs and/or TK (with inequitable, or without any form of compensation being
returned to the providing country) as biopiracy. In this category, the parameters for an
alleged biopiratical act is generally linked to the perception of injustice arising from
appropriative acts. The restrictive approach however includes those definitions which
involve a strict linkage between the violation of ABS obligations and the IP system. The
acquisition of patents usually provides a symbol of the unjust appropriation.
79 Though there is no agreed definition of the terms "misappropriation" and "misuse" of
GRs, misappropriation is linked to the acquisition of GRs in violation of domestic ABS
legislation requiring prior informed consent (PIC) and mutually agreed terms (MATs)
resource-based inventions. This restrictive context provides insight into the

nature of an emphasized relationship between IP and the appropriation of
TKaGRs - a relationship which reflects a disproportionate power balance,
thrives on the vulnerability of holders of GRs and TK and their regulatory
institutions, and highlights, in several instances, the predatory tendencies
of 'individuals, global systems and institutions' involved in their commercial
use.80 The IP system, its institutions and its major users are, in this regard,
often portrayed as the main culprits, 8 ' while indigenous groups and Third
World countries are typically viewed as the victims of biopiracy. It is little
wonder that Philip Schuler, in summing up biopiracy, notes that the central
criticism in the biopiracy literature is that businesses in industrial countries
are getting rich off of poor people's knowledge at developing countries'
expense.8 2
A restrictive interpretation of biopiracy draws increasing significance
from the fact that despite the seemingly recent labelling of biopiracy, acts of
biopiracy have been in existence long before 1993. In fact, as Mgbeoji and
other scholars point out, biopiracy may be traced to the early colonial
expeditions and conquering of discovered lands by Christopher
Columbus. 83 The acquisition of exotic resources and the transferring of
and may be understood as the unlawful appropriation of GRs. Misuse, on the other
hand, arises out of contractual obligations and indicates the situations in which GRs
are used in violation of MAT that were set up between the provider and the user i.e.
the utilization of GRs in a non-agreed way, without sharing any benefits. See Greiber et
al, An Explanatory Guide to the Nagoya Protocol, supra note 65 at 12.
80 Highlighting this predatory nature of biopiracy, see, for instance, Mgbeoji, who
describes biopiracy as the asymmetrical and unrequited movement of plants from the
South to the North through the processes of international institutions and the patent
system. See Ikechi Mgbeoji, Global Biopiracy: Patents, Plants and Indigenous Knowledge
(Vancouver: UBC Press, 2006) at 13.
81 Ibid.
82 Philip Schuler, "Biopiracy and Commercialization of Ethnobotanical Knowledge",
supra note 73.
83 Often described as the discoverer of the New World, Christopher Columbus was an
Italian-born navigator and explorer, who sailed the world in the service of Spain. He
was granted by the Queen Isabel and Kind Ferdinand of Spain, the privileges of
'discovery and conquest'. Vandana Shiva, Biopiracy: The Plunder of Nature and Knowledge
(South End Press: 1997, Boston, Massachusetts) 1-5. See also, Mgbeoji, supra note 80
at 96, noting that "for historical convenience rather than exactitude, the origins of the
appropriation of plants may be traced to the 'Columbian Exchange' of 1492, when
Christopher Columbus's forays into the Americas with some plant germplasm marked
same to Europe were the first instances of biopiracy. In this early exchange,
the appropriation of resources was seen as a natural right of the colonizer,
and was fueled by a sense of entitlement by the European colonialists over
the earth, its peoples and resources." The idea that GRs were part of the
common heritage of mankind overtime served to justify this continued
exchange with GRs being viewed as global resources which were freely
available and to which no country could claim exclusive rights." This
historical element of biopiracy reflects biopiracy as an international
problem involving the expropriation of resources across jurisdictional
borders. In this context, the trans-border nature of biopiracy - as a problem
which transcends single state borders and which requires solutions that
effectively monitor the trans-border appropriation of resources - is
observable.
the introduction of 'exotic' plant species".

84 Shiva, in describing this state of affairs, remarks that the Pope as the vicar of God
commanded the world, as if it were a tool in his hands and thus considered the world
as his property to be disposed according to his will. He was thus able to 'legitimately'
grant discovered and yet to be discovered portions of the earth to whomsoever he
deemed fit. In effect, Christian monarchs of Europe were considered rulers of all
nations, 'wherever they may be found and whatever creed they may embrace'. See
Vandana Shiva, Biopiracy: The Plunder of Nature and Knowledge (South End Press: 1997,
Boston, Massachusetts) 1-2.
85 According to Doris Schroeder and Thomas Pogge argue the idea of the common
heritage of humankind entered into the canon of international law in the late twentieth
century with the conclusion of two UN treaties: The Agreement Governing the Activities of
States on the Moon and Other Celestial Bodies (1979) and The Convention on the Law of the
Sea (1982). See Doris Schroeder & Thomas Pogge, "Justice and the Convention on
Biological Diversity" (2009) 23:3 Ethics & Intl Affairs 268. In explaining the common
heritage principle within the context of GRs, Brush points out that 'common heritage
refers to the treatment of genetic resources as belonging to the public domain and not
owned or otherwise monopolised by a single group or interest'. Brush maintains that,
reference to crop genetic resources as a common heritage appeared in the 1 9 8 0's in
association with the establishment of the Commission of Plant Genetic Resources at
the Food and Agricultural Organisation of the United Nations (FAO Commission) and
the launching of the International Undertaking of Plant Genetic Resources. The 1983
conference establishing the FAO Commission and International Undertaking affirmed
a resolution stating that 'Plant genetic resources are a heritage of mankind and
consequently should be available without restriction'. See Brush S, "The Demise of
'Common Heritage' and Protection for Traditional Agricultural Knowledge" in Charles
McManis, ed, Biodiversity and the Law: Intellectual Property, Biotechnology and Traditional
Knowledge (UK: Earthscan, 2007) 298-299. See also Srinivas, supra note 50 at 89.
By focusing however on the restrictive explanation of biopiracy, the

historical phenomenon of biopiracy is placed within a contemporary frame.
In this context, beyond a mere trans-border problem, biopiracy sits at the
intersection of two major regimes: the ABS and IP regimes. I term these the
sore spots of emphasis within the biopiracy discourse - on the one hand a
failure to share benefits adequately and/or equitably, and on the other, an
effective IP system which could be used to assign ownership rights over TK-
based inventions/discoveries. Acts of biopiracy are thus facilitated by the
working of the IP regime in disregard for standards of resource use laid out
in the ABS regime. In other words, the ability of users to secure private IP
rights over inventions which make use of GRs and/or TKaGRs, while yet
failing to secure the prior informed consent of providers of TKaGRs, as well
as establish mutually agreed terms for benefit sharing with providers,
explains the challenge of biopiracy which most developing countries have
had to contend with.
Consequently, while the content of appropriation of resources has
continued through generations, the nature of biopiracy has changed over
time. Notably, the mechanisms facilitating the appropriation of resources,
as well as the motivations underlying such appropriations, have gradually
changed. The conquering of foreign territories underscored the early
appropriation of resources; however, in more recent times, the institutional
structures that have risen to reward and stimulate innovation have served
to continue this exchange. According to Daniel Robinson,
Although the colonial enterprise of plant and animal collecting has been ongoing
for centuries, the biopiracy discourse was generated to illustrate that more recent
technological and institutional changes have encouraged new inequities and
compounded old ones. In the context of the new global intellectual property rules,
biopiracy has essentially been wielded as a counter-discourse to intellectual
' 86
property 'piracy'.
In essence, moving away from a strict trans-border problem of resource
expropriation, the problem of biopiracy today is closely linked to a similar
trans-border problem, albeit in the context of international regimes. It is for
this reason that biopiracy can be viewed as a trans-regime issue area; one
which finds its articulation and manifestation within the overlap of
independent regimes. Consequently, this restrictive context also
importantly describes a contemporary expression of a historical problem by
drawing attention to the trans-regime nature of biopiracy.
86 Robinson, supra note 77 at 14.

By trans-regime, I refer to biopiracy as an issue area which is articulated

through the interaction of independent elemental regimes. As a
terminology, "biopiracy" was coined in 1993;" an important year in which
global attention was focused on two main novel introductions to the
international regulatory system: the CBD, and the Agreement on Trade-Related
Aspects of Intellectual Property Rights (TRIPS). The CBD's entry into force in
1993 ushered in the firm entrenchment of benefit sharing principles in
international law. Its emergence also played a central role in clarifying the
principles of state sovereignty over GRs." On the other hand, within the
sphere of international trade, the Uruguay Round of the multilateral trading
system had since 1986 continued to make progress on the largest and most
comprehensive trade negotiations. In late 1993, agreement was reached on
virtually all issues, including the text of the TRIPS agreement.8 9 The
adoption of the TRIPS agreement the following year signified that the efforts
of industrialized countries, driven by major industry representatives, to
incorporate IP rules within the multilateral trading system as a way of
addressing concerns of counterfeit (pirated) goods in international trade
had been successful. Through the TRIPS agreement, an era of globalization
for IP rights emerged, one in which obligatory minimum standards of
protection for intellectual property rights were exported to all Members of
the trading system and backed with real teeth.9 o
For activists like Pat Mooney, this strengthening of the intellectual
property system was in fact hypocritical as it failed to acknowledge that
piracy was also perpetuated by several corporations that had acquired the
87 This was by Mr. Pat Mooney of the Canadian NGO, Rural Advancement Foundation
International (RAFI), now known as the ETC Group. See Robinson, supra note 77 at
14.
88 CBD, supra note 6, art 15.1.
89 See World Trade Organization, Understanding the WTO: Basics - The Uruguay
Round,
online: WTO -<https://www.wto.org/english/thewto-e/whatis-e/tif e/fact5_e.htm>.
Essentially, therefore, as Watal notes, the TRIPS Agreement is the result of seven years
of negotiation; September 1986 to December 1993. See Jayashree Watal, Intellectual
Property Rights in the WTO & Developing Countries (The Netherlands: Kluwer Law
International, 2001) at 11.
90 Graeme B Dinwoodie, "The International Intellectual Property System:
Treaties,
Norms, National Courts, & Private Ordering" in Daniel Gervais, ed, Intellectual
Property, Trade & Development: Strategies to Optimize Economic Development in a TRIPS-Plus
Era (New York: Oxford University Press, 2007) at 77, online:
-<https://papers.ssrn.com/sol3/papers.cfm?abstractid=1306608>.
resources and/or knowledge of indigenous peoples without due permission,

recognition or even acknowledgment. The term biopiracy thus emerged
within this context. Explaining this point, Graham Dutfield observes that
the term biopiracy was developed as
part of a counter attack strategy on behalf of developing countries that had been
accused by developed countries of condoning or supporting 'intellectual piracy',
but who felt that they were hardly as piratical as corporations which acquire[d]
resources and traditional knowledge from their countries, use[d] them in their
research and development programs, and acquire[d] patents and other intellectual
property rights - all without compensating the provider countries and
communities. 91
The difficult relationship between the IP system and the conservation

of biodiversity thus underlies the biopiracy rhetoric. On the basis of the
above, three closing points are worth noting regarding the biopiracy
terminology:
First, it was principally designed for developing countries and their local
and indigenous communities. Though the victims of biopiracy cases are not
limited to this identified category, its use has grown to define a problem
which, until now, stereotypically portrays developing countries and their
indigenous groups as the significant biopiracy victims. Second, the term
biopiracy emerged as a counter-attack. In other words, it emerged as a
defensive strategy against the allegations of piracy which, at the time, were
principally being channeled towards the developing world. These
allegations were widely regarded as justifications for the need for a
globalized and strengthened regime of IP through TRIPS. In a wider sense,
therefore, the biopiracy terminology emerged as an attack on the core
rationale and expansionist basis of the global IP system; and third, it bore
within it an effort to expand the standard conceptualization of piracy - the
commercial violation of legally sanctioned IP 92 - to include acts which
centered on the uncompensated commercial exploitation of biodiversity
and related knowledge.
91 See Graham Dutfield, "TRIPS-Related Aspects of Traditional Knowledge" (2001) 33

Case Western Reserve J Intl L 233 at 23 7-38.
92 See Adrian Johns, Piracy: The Intellectual Property Wars from Gutenberg to Gates (University
of Chicago Press: 2009, USA) at 6. Though he identifies this definition of piracy as "the
standard definition", he notes that it falls short of what piracy is in that it fails to
recognize cases of piracy which occur without IP being in issue pointing out that cases
of piracy had existed before the IP system as we know it emerged.
In sum, embodied within the context in which biopiracy emerged and

continues to thrive is an emotive response on behalf of the developing world
to the unilateral attack on developing countries by the developed world for
failing to hallow the western-styled IP system viz-a-viz the protection of GRs
and their associated TK. From its humble beginnings as a privately
developed rhetoric in 1993, biopiracy has today grown into a widely
accepted public and diplomatic tool, occupying a sensitive place in modern
discourse, particularly within the ABS and IP regimes. It today stands as a
recurring theme within these multilateral discussions - one which generally
pitches the developing world against the industrialized world. In practice,
its use has also been aimed at securing political leverage within related and
unrelated negotiations. 93 Through its use, several developing countries as
well as indigenous groups continue to advocate for reform in a global state
of affairs within which they feel disadvantaged.9
III. THE NAGOYA PROTOCOL AS AN ABS REGIME COMPLEX '
The Nagoya Protocol was adopted in 2010 and entered into force in
2014. Its adoption brought to a close a sustained and intensive six years of
negotiation by the Parties to the CBD for an international regime on access
and benefit sharing. The Nagoya Protocol was negotiated in direct response
to the call by the World Summit on Sustainable Development (WSSD) to
negotiate within the framework of the CBD, bearing in mind the Bonn
Guidelines, an international regime which would promote and safeguard the
"fair and equitable sharing of benefits arising from use of [GRs]".9' As a
direct consequence of this call, the CBD mandated the Ad Hoc Open-ended
Working Group on Access and Benefit Sharing to negotiate and elaborate
93 Robinson describes biopiracy as a "discursive tool that both describes an injustice and
is used for political leverage". Daniel Robinson, "Biopiracy and the Innovations of
Indigenous Peoples and Local Communities" in Peter Drahos & Susy Frankel, eds,
Indigenous People's Innovation: Intellectual Property Pathways to Development (Canberra:
ANU E Press, 2012) at 78.
94 Ibid. Robinson contends that the biopiracy discourse has emerged as a powerful counter
to the perception of new hegemonies imposed by IP rules with global reach such as the
TRIPS Agreement.
95 This call was contained in the Johannesburg Plan of Implementation; see Report of the
World Summit on Sustainable Development, Johannesburg, South Africa, 26 August
- 4 September 2002, ch I, Resolution 1, Annex, para 44, online:
-<www.unmillenniumproject.org/documents/131302_wssdreport-reissued.pdf>.
an international regime on access to GRs and benefit sharing in

collaboration with the Ad Hoc Open-ended Intersessional Working Group
on Article 8(j) and Related Provisions. This was to be aimed at adopting an
instrument/instruments to effectively implement the provisions of Article
15 and Article 8(j) of the Convention, as well as the Convention's three
objectives.16Consequently, the Nagoya Protocol's central objective is the fair
and equitable sharing of benefits arising from the utilization of GRs, as well
as TKaGRs.9 7
A subsidiary instrument to the CBD, the Nagoya Protocol contains a 27-
paragraph preamble, 36 substantive articles, and an Annex.9'The preamble
offers a context for interpretation of its Articles and Annex,9 9 and references
key provisions of the CBD which must be understood for a deeper and
contextual understanding of the Nagoya Protocol. 00 It also refers to other
international agreements and treaties that relate directly to the issues dealt
within the Nagoya Protocol.'0 Though a single instrument was therefore
adopted, it yet sat at the center of what was to be known as the international
regime on ABS made up of the CBD, the Nagoya Protocol, and
complementary instruments including the International Treaty on Plant
96 See Decision VII/19 D 1.
97 See Nagoya Protocol, supra note 4, arts 1 & 3.

98 The singular annex of the Nagoya Protocol relates to the monetary and non-monetary
benefits which could form the basis of negotiations in benefit sharing agreements.
99 The Vienna Convention on the Law of Treaties provides that the preamble to a treaty must
be construed as forming a part of the treaty. See Article 31(2) United Nations "Vienna
Convention on the Law of Treaties 1969" (2005) UN Treaty Series, Vol 1155 at 331
[Vienna Convention]. The Nagoya Protocol, by the general rules of interpretation of the
Vienna Convention forms an appendage to the CBD. See Vienna Convention, ibid, art 31
(2 )(a). It must therefore be read as a part of the CBD. Though it therefore constitutes a
separate instrument in its own self, in a wider perspective, it forms a part of the CBD
and should therefore be interpreted within the context of the CBD. See Vienna
Covention, ibid, art 31 (3 )(a).
100 See direct references for instance made in Par 2 (which refers to Article 3 of the CBD),
Par 4 (which refers to Article 15 of the CBD), Par 5 (which refers to Articles 16 and 19
of the CBD), and Par 21 (which refers to Article 8(j) of the CBD).
101 Examples of these include the International Health Regulations (2005) of the WHO,
the International Treaty on Plant Genetic Resources for Food and Agriculture, the UN
Declaration on the Rights of Indigenous Peoples, and a section which, in a blanket
fashion, acknowledges "ongoing work in other international forums relating to access
and benefit sharing". Nagoya Protocol, supra note 4.
Genetic Resources for Food and Agriculture (ITPGRFA) and the Bonn
Guidelines. 0 2The international regime was opened for signature between
February 2, 2011, and February 1, 2012,103 a period within which it amassed
a total of 92 signatures.1 04 It entered into force on October 12, 2014, which
was the ninetieth day after the deposit of the fiftieth instrument of
ratification/accession.1 05 As of May 1, 2017, , a total of 95 ratifications have
been received for the Nagoya Protocol.'
A. A Legal Regime or a Regime's Law

Consequently, while the outcome of the negotiations of the
international ABS regime is correctly cited as the Nagoya Protocol, in
accordance with the WSSD call the Nagoya Protocol exists within the
framework of the CBD and draws extensively from the Bonn Guidelines. A
preliminary question worth asking, however centers on the status of the
Nagoya Protocol: is the Nagoya Protocol the international ABS regime? In a
sense it is; in another it is not. Given that it reflects the outcome of the
direct negotiation for an international ABS regime, it could be viewed as
the international regime. This is to the extent that it contains the principles,
norms, rules and decision making procedures which the ABS regime
ascribes to. The decision adopting the Nagoya Protocol, however clarifies that
this international ABS regime is made up of several instruments. According
to the decision, "the international regime is constituted of the CBD, the
Nagoya Protocol, as well as complementary instruments, including the
International Treaty on Plant Genetic Resources for Food and Agriculture
(ITPGRFA) and the Bonn Guidelines."o' 0 Therefore, the implication is that
the above-mentioned instruments align with a series of principles, norms,

rules and decision making procedures embodied within the Nagoya
Protocol's ABS mechanism. The alignment with the central ABS objective is
a golden thread running through all the instruments. For this reason also,
102 See COP 10 Decision X/1, Preamble, at para 6.

103 See COP 10 Decision X/1 1.2. See also, Nagoya Protocol, supra note 4, art 32.
104 For a full listing, see CBD, "Parties to the Nagoya Protocl", online: CBD
<https://www.cbd.int/abs/nagoya-protocol/signatories/>.
105 See Nagoya Protocol, supra note 4, art 33.
106 For a full listing, see CBD, supra note 104.
107 See para 6, preamble to Decision X/1, UNEP/CBD/COP/DEC/X/1 at 1.
the Nagoya Protocol could be viewed as the core international ABS law
upon which the ABS regime is anchored.
It is particularly significant that, as part of the terms of reference for the
negotiation of the international ABS regime, it was stipulated that this
international regime could consist of one or more instruments within a set
of principles, norms, rules and decision making procedures. 08 Bearing in
mind that regimes are social institutions which unite actors and/or
participants towards common objective(s) with respect to specific
international issue-area(s),1 09 the significance of the open-ended terms of
reference draws from the diversity of the instruments which are mentioned
as forming part of the regime. It also offers a basis for determining further
instruments which could possibly be a part of the regime.
B. Complementarity and an 'Open-Ended' Regime

As a regime, the mentioned instruments exist in harmony or
complementarity towards the attainment of a set ABS objective. The CBD
as one of the component regime instruments, for instance, adopted the
benefit sharing principle as a market-based strategy to achieving objectives
linked to the conservation and sustainable use of biodiversity. It remains
the foundation for the ABS regime. The Bonn Guidelines, adopted in
2002,110 served as the first step of the evolution of measures to implement
these benefit sharing objectives of the CBD." Interestingly, the idea of a
binding ABS regime had been considered at the time of the negotiation of
1os See Decision VII/19 D, Annex (b). This decision's base requirement (principles,
norm,
rules and decision making procedures) draws directly from Krasner's regime definition
earlier stated. See Bavikatte, supra note 16.
109 See Friedrich V Kratochwil & John Gerard Ruggie, "International Organization: A
State of the Art on an Art of the State" (1986) 40 Intl Organization 753 at 764.
110 The Bonn Guidelines on Access to Genetic Resources and Fair and Equitable Sharing of the
Benefits arising out of their Utilization, 19 April 2002 [Bonn Guidelines], were adopted
pursuant to Decision VI/24 (2002) at the Sixth Session of the Conference of the Parties
to the CBD (COP-6) held in The Hague. Its designation as 'Bonn Guidelines',was derived
from the location of the intergovernmental meeting which held in Bonn, Germany in
October 2001 and which prepared the first draft of the eventual agreement.
... See para 6, Decision VI/24 A, and para 7, preamble to Decision VII/19 D,
UNEP/CBD/COP/DEC/VII/19, at 4. This evolutionary approach to the Guidelines
which forms one of its central features, envisaged a review, revision and improvement
of the Guidelines based on experience from ABS. See I.A.7(f) of the Bonn Guidelines.
the Bonn Guidelines."2 However, this idea had been jettisoned at the time in
favour of a set of guidelines which set forth broad principles within which
varying national approaches to the ABS challenge could be pursued." 3 The
Bonn Guidelines were therefore negotiated as an alternative to a binding
regime as the majority consensus within the negotiations had been that ABS
was an issue more contingent on national regulation than on international
regulation."' The Bonn Guidelines were thus designed to serve as voluntary
non-binding inputs to national efforts to develop and draft legislative,
administrative or policy measures relating to ABS."' Importantly, the
Parties were of the view that the Bonn Guidelines merely represented a useful
first step of an evolutionary process in implementing the ABS provisions of
the CBD."' Further developments to the Bonn Guidelines, arising from
experience gained in the implementation of ABS provisions, were
consequently envisaged."' If anything, the Bonn Guidelines were therefore
an international experiment in operationalizing the ABS principles of the
CBD, given the limited experience available to negotiators and the
international community in developing and implementing ABS provisions.
112 It had, for instance been discussed at the COP 4, where it was decided to set up an
expert group on ABS which could discuss all the options for ABS arrangements (see
CBD Decision IV/8). Further, it was discussed at two meetings of the CBD's Panel of
Experts on ABS in San Jose, Costa Rica (October 1999) and Montreal, Canada (March
2001). The discussion also took place within the CBD's Scientific Body on Technology
and Technological Advice (SBTTA) as well as in the final deliberations at COP-6 where
the Bonn Guidelines were formally adopted. W Bradnee Chambers, "WSSD and an
International Regime on Access and Benefit Sharing: Is a Protocol the Appropriate
Legal Instrument?" (2003) 12:3 Rev European Community & Intl Environmental L
310.
113 Ibid.
114 Ibid.
115 See COP 6 Decision VI/24 at para 4; see also Bonn Guidelines, I.A.1. See also Evanson
Chege Kamau, Bevis Fedder & Gerd Winter, "The Nagoya Protocol on Access to
Genetic Resources and Benefit Sharing: What is New and what are the Implications for
Provider and User Countries and the Scientific Community?" (2010) 6:3 L
Environment & Development J 246 at 249.
116 See COP 6 Decision VI/24 at para 6. See also, para 8, preamble Cusco Declarationon
Access to Genetic Resources, Traditional Knowledge and Intellectual Property Rights of Like-
Minded Megadiverse Countries, 29 November 2002 [Cusco Declaration].
117 This evolutionary approach to the Guidelines forms one of its central features. This
approach envisaged a review, revision and improvement of the Guidelines based on
experience from ABS. See Bonn Guidelines, supra note 110, art I.A.7(f.
Both of these instruments (CBD and the Bonn Guidelines) have not,
however, enjoyed a successful implementation for differing reasons. While
the CBD has often been cited as hard law characterized by a soft nature,
evidenced by its lack of an effective enforcement mechanism," 8 the weak
implementation of the Bonn Guidelines has generally been attributed to the
voluntary nature of its undertakings."' Addressing the weaknesses of these
prior instruments, the Nagoya Protocol is drafted in conformity with the Bonn
Guidelines, albeit with binding obligations, and is expected to further aid the
implementation of the CBD, with a specific emphasis on its benefit sharing
objective. While the complementary relationship between the CBD, the
Nagoya Protocol and the Bonn Guidelines within the context of the
international regime on ABS is clear, the ITPGRFA offers an interesting
dynamic, especially because, as an instrument, it was negotiated on another
platform and its benefit sharing structure slightly differs from that
obtainable under the CBD.
The ITPGRFA was negotiated within the framework of the Food and
Agriculture Organization of the United Nations. Similarly to the above
mentioned instruments, it pursues the objective of fair and equitable
sharing of benefits arising out of the use of GRs, albeit with a focus on a
specialized category of GRs - plant GRs relevant for food and agriculture
(PGRFA).1 20 It seeks to ensure the conservation and sustainable use' 2 ' of
PGRFAs, and pursues its objectives through a harmonization and close
linkage with the CBD. 22 Despite the ITPGRFA being mentioned as
constituting a part of the ABS regime, it is worth noting that it adopts a
substantially different approach to benefit sharing from that obtainable
"1 This has been attributed to its strict natured provisions which use mandatory language
to describe obligations of Parties, yet fail to accompany such mandatory obligations with
requisite enforcement measures in case of breaches. See Stuart Harrop R, "Living in
Harmony with Nature? Outcomes of the 2010 Nagoya Conference of the Convention
on Biological Diversity" (2011) 23 J Environmental L 117-128.
119 Hamdallah Zedan, "Patents and Biopiracy: The Search for Appropriate Policy and Legal
Responses" (2005) 12 Brown J World Affairs 195-196.
120 See International Treaty on Plant Genetic Resources for Food and Agriculture, 2001, [no
UNTS Volume Number has yet been determined for this record] {entered into force 29
June 2004), art 1.1, online: FAO
<ftp://ftp.fao.org/docrep/fao/0 11/i05 10e/i05 10e.pdf> [ITPGRFA].
121 Ibid.
122 See ibid, art 1.2.
under the above mentioned CBD-based instruments. Under the ITPGRFA's

Multilateral System of Access and Benefit Sharing, the ITPGRFA pools a
total of 64 crops which account for 80 percent of plant-derived food into an
easily accessible global pool of GRs. It facilitates access to these resources
for purposes of research, breeding and training pursuant to a standard
Material Transfer Agreement,' 23 and ensures that benefits arising from their
use are shared through four benefit-sharing mechanisms, under the
guidance of the treaty's governing body.' With respect to TK, it requires
Contracting Parties to take measures to promote and protect farmers' rights,
including the protection of TK relevant to PGRFA as well as the right to
equitably participate in sharing benefits arising from the use of
PGRFAs.'It is important to note here that the benefit sharing mechanism
of the ITPGRFA differs considerably from the benefit sharing mechanism
of the Nagoya Protocol.
Despite this difference in approach, the ITPGRFA yet exists as part of
the international regime. This is also despite the fact that the ITPGRFA was
not negotiated on the platform of the CBD, and despite the clear differences
which exist between the Food and Agricultural Organisation's driving
objectives and those of the CBD. On what basis is it then included as a part
of the international regime? Its inclusion is on the basis of complementarity.
Noted in the decision, "the international regime is constituted of [...]
complementary instruments, including the ITPGRFA[sic]...".
Complementarity then does not necessarily indicate similitude, exactness of
approach, or overriding objectives, but rather implies coherence and
harmony among relevant international instruments in the operation of the
regime's principles, norms, rules and decision making procedures. It is again
important to note that the decision adopting the Nagoya Protocol suggests
that the above mentioned list of international instruments which comprise
the ABS regime does not constitute an exhaustive or closed list. Rather,
other relevant instruments are eligible for inclusion within this regime, also
123 See ibid, art 12.4.

124 See ibid, art 13.2. The four benefit sharing mechanisms proposed relate to the exchange
of information, access to and transfer of technology, capacity building, and the sharing
of the benefits arising from commercialization. For the detailed framework of the
IPGRFA's Multilateral System of Access and Benefit Sharing, see generally, ITPGRFA,
ibid, arts 10-13.
125 See generally ITPGRFA, ibid, art 9.
on the basis of complementarity. This potential of the ABS regime to

further incorporate other instruments is important in what may be
considered as the continuing evolutionary context of the ABS regime. In
this vein, the inclusion of the ITPGRFA suggests that further possible
constituents of this ABS regime are not limited to instruments negotiated
on the CBD platform, nor are they limited to instruments which are similar
or exact, or even share common objectives with the Nagoya Protocol.
Rather, the ABS regime is evolving, from the perspective of developing
countries, to incorporate a complementary set of ABS-related instruments
in the fight against biopiracy.
It is this evolving nature of the ABS regime on the basis of
complementarity that offers a basis for a consideration of its present and
future construct as a regime complex. Raustiala and Victor identify the
existence of multiple, overlapping elemental regimes as the defining
characteristic of a regime complex.' 2 6 These elemental regimes overlap in
scope, subject, and time, with events in one affecting those in others. 27
Consequently, regime complexes are marked by the existence of several legal
agreements that are created and maintained in distinct fora with
participation of different sets of actors.128 Indeed, one of the central features
of regime complexes is regime shifting.' 2 9 Regime shifting is an interest-
based shifting of negotiations by States and NGOs from one venue to
another within a single regime (intra-regime shift) or across regimes (inter-
regime shift).' 30 Reiterating the link between regime shifting and regime
complexes, Helfer suggests that ongoing interactions between separate
regimes
promot[es] the formation of networks among formerly disparate state,
intergovernmental, and non-state actors and linkages among formerly discrete
issue areas. The result is a "conglomerate type of regime" or a "regime complex"
-
a multi-issue, multi-venue mega-regime in which states and NGOs shift

negotiations from one venue to another within the conglomerate...131
126 See Raustiala & Victor, supra note 23 684 at 703.

127 Ibid at 686.
128 Ibid.
129 Ibid at 686-687, noting that the distinct negotiating fora within the regime complex
spurs forum shopping.
130 Laurence Helfer, supra note 24 at 16-17.
131 Ibid.
What we are then witnessing through the Nagoya Protocol is an

important initiative by the CBD to channel a "multi-venue mega-regime"
(regime complex) anchored on the Nagoya Protocol; one that from the
perspective of developing countries advances a protection mechanism for
TKaGRs from biopiracy. This important clarification lends strength to the
concluding segment of this paper, which involves a consideration of
WIPO's Intergovernmental Committee on Intellectual Property and
Genetic Resources, Traditional Knowledge and Folklore (IGC) as an
elemental constituent in this evolving ABS regime complex.
IV. WIPO AS AN ELEMENTAL CONSTITUENT OF THE ABS

REGIME-COMPLEX.
The decision adopting the Nagoya Protocol hints at an evolutionary

context for the international ABS regime. For this reason, a strong review
mechanism is built into the Nagoya Protocol. The Conference of the Parties
serving as the meeting of the Parties to the Nagoya
3 2
Protocol (COP/MOP),' for instance, which meets biennially, is expected
to keep the Nagoya Protocol's implementation under regular review.133
Furthermore, an inbuilt review of the Nagoya Protocol's mechanism to ensure
effective compliance with domestic regulatory requirements regarding
TKaGRs will be undertaken in 2018.134 The decision notes that this review
of Article 16 will be carried out "in light of developments in other relevant
international organizations, including... [WIPO], provided that [such
developments] do not run counter to the objectives of the Convention
[CBD] and the [Nagoya] Protocol."135 It is particularly telling that though an
insinuation is made to the related developments in several other relevant
international organizations, for which it is possible the negotiators of the
ABS regime could not predict, WIPO is the only intergovernmental
organization specifically mentioned. It is worth mentioning here that the
132 The Conference of the Parties Serving as the Meeting of the Parties to the Nagoya
Protocol (COP/MOP), serves as the meeting of the Parties to the Nagoya Protocol. It is
the institutional arm which makes decisions and keeps under review the
implementation of the Nagoya Protocol. See Nagoya Protocol, supra note 4, art 26.
133 Nagoya Protocol, supra note 4, art 26.4.
134 See ibid, art 31.
135 COP 10 Decision X/1 1.6
specific reference to WIPO and indeed the IP regime is an indication of the

central relevance of WIPO in the design and the projected evolution of the
international regime on ABS. This relevance is specifically with regard to
the implementation of the ABS regime and the attainment of the regime's
effectiveness in addressing the incidence of biopiracy.1360f course, this is
not to suggest that WIPO's developments will actually end up complying
with the expectations of the ABS negotiators, but it does provide a basis for
explaining the emerging related developments within WIPO.
It is important to note that despite the above, the relevance of WIPO is
made subject to a proviso. This proviso in the decision of the Committee 37
seems to align with the complementarity test that is expected to guide the
addition of further instruments to the ABS regime. In essence, therefore,
the expectation is that the review of the Nagoya Protocol will be conducted
in the light of developments within WIPO, as long as these developments
are complementary with the objectives of the Nagoya Protocol. I should
restate here that the express objective of the Nagoya Protocol is the fair and
equitable sharing of benefits arising from the use of GRs and TKaGRs with
an implicit objective of addressing biopiracy. In the next few paragraphs, my
intention is to outline broadly a few aspects of the WIPO developments
which point to a push, particularly by developing countries, to secure a
complementary outcome - an outcome which supports the Nagoya Protocol's
mechanism to address the incidence of biopiracy.
In the year 2010, when the Nagoya Protocolwas adopted and the decision
of the COP adopting the Nagoya Protocol was crafted, the relevant ongoing
work within WIPO which bore central relevance to the Nagoya Protocol was
the work of the WIPO Intergovernmental Committee on Intellectual
Property and Genetic Resources, Traditional Knowledge and Folklore
(IGC). This continues to be the case. Established in 2000, the IGC is a
policy forum within WIPO established for the discussion of IP issues arising
within the context of access to GRs and benefit sharing, as well as the
136 According to Simon West, a textured interpretation of the Nagoya Protocol requires its
interpretation within the context of the broader political economy of IP. This, he
argues, is because the Nagoya Protocol is imbued with obligations which are subservient
to the IP system, thus leaving its beneficiaries in a state of dependence on the IP system
for the actuation of their rights. Simon West, "Institutionalized Exclusion: The Political
Economy of Benefit Sharing and Intellectual Property" (2012) 8 Law Envt & Dev J 21
at 21.
137 Ibid.
protection of TK and TCEs.' 38 WIPO justifies the creation of the IGC on

three main grounds: to address the IP protection of GRs, TK and TCEs; to
accord recognition to GRs, TK and TCEs as forms of innovation located
within indigenous communities and developing countries - new players
within the IP policy space; and to respond as an organization to the need to
make the IP system more representative of all global forms of innovation..139
Interestingly, at the time of the adoption of the Nagoya Protocol, the IGC
had just entered a new phase within its evolution. This is significant as 2010
marked the commencement of a new era within the IGC in which attention
was focused on text-based negotiations directed at the development of an
international legal instrument which would ensure the effective protection
of TK and GRs. Two main phases which had preceded this phase were the
proposal/fact finding phase (1998 - 2003)140 and the international
dimension phase (2004 - 2009). At the inception of the international
dimension phase, the delegation of Philippines speaking on behalf of the
Asian group remarked, "the Asian group is pushing for a move beyond
academic work to a discussion on the international dimension of the issues
with a view to establishing norms and a legally binding instrument""' This
neatly summarizes the drive of developing countries within the 2004 - 2009
period. It involved an expansion of the discussion from mere concepts and
academic understandings to a reflection on the possibility of international
normative work and possible outcomes from the Committee. With the
adoption of the mandate of the Committee in 2009 for the 2010-2011
biennium, however, a text-based negotiation phase was ushered in 2010
138 See WIPO Background Brief No 2, WIPO Intergovernmental Committee on

(2016) at 1.
139 See WIPO Background Brief No 2, WIPO Intergovernmental Committee on
(2016) at 2.
140 Aimed principally at setting the agenda of the Committee's work, this phase involved
the identification and prioritization of issues for discussion within the Committee. It
was characterized by a flurry of proposals seeking to define the scope and work of the
Committee, including studies, sharing of Member experiences. The main success of this
phase was the formalization and concretization of discussions on GRs and TK within
WIPO.
141 See Document WO/GA/30/8 at para 59.
with the specific direction of arriving at an international legal instrument(s)

for the protection of TK.14 2
What the foregoing suggests is that right from the outset, the very
conception of the IGC was linked to the ABS regime, albeit from an IP
perspective. Consequently, while GRs are not being focused on as subjects
of IP protection, IP issues which arise within the context of the protection
of GRs (through the ABS regime) are. In this connection, the central
questions which the Committee has sought to address within the text of the
GRs instrument are issues of complementarity between the IP system and
the ABS system. One of its core objectives is stated as the promotion of
complementarity/mutual supportiveness with other international
agreements relating to the protection of GRs.1 43 The Nagoya Protocol, as an
instrument primarily negotiated to address the protection of GRs and
TKaGRs, clearly fits into this bracket.
This consideration of ways in which the IP system could be made to
support the implementation of ABS obligations significantly harbors the
central normative tussle within the IGC negotiations - a central question
on the insertion of a mandatory disclosure requirement within the patent
system, by which patent applications must be accompanied with a disclosure
of the source of origin of GRs, as well as evidence of compliance with ABS
principles before the grant of a patent. This is a sensitive issue which has
continued to divide the negotiators. Developing countries on the one hand
have generally placed the development of this disclosure requirement as a
central priority within the negotiations, while the majority of developed
countries have generally opposed this idea, on the basis of lack of evidence
and concerns over the implications of such a requirement on the IP system's
principal objective of innovation, amongst others. The centrality of this
issue to the completion of the work of the Committee, coupled with the
wide gap which still yet exists within the divergent policy views of
negotiators on this issue, has continued to raise doubts over a soon-to-be
conclusion to the normative work of the Committee. Developed countries
have continued to request studies and examples which offer empirical
clarity to the negotiations. 4 4 Balancing the requests and importance of
142 Seeking to clarify the import of this phase, the then WIPO Director General, Dr. Idris,
confirmed, in response to the Delegation of Pakistan, that the phase is principally aimed
at arriving at an international legal instrument. See WO/GA/38/20, paras 233-34.
143 See Document WIPO/GRTKF/IC/29/4, Policy Objectives, at 6.
144 A proposal for the Terms of Reference for the Study by the WIPO Secretariat on
factual studies (including the time required to undertake such studies) with
the progress of the Committee is addressed by mandating that studies and
examples should not serve to delay or establish preconditions for the
negotiations. 145
Another important aspect of the Committee's work relates to its efforts
with respect to defensive protection strategies for GRs. Defensive protection
of GRs involves the development of measures which prevent the grant of
patents over GRs which do not fulfill the requirements of novelty and non-
obviousness. This defensive consideration is a shared objective by both
developed and developing countries. Developed countries have an interest
in ensuring that patents are only issued to innovators in line with the
patentability criteria, thus preserving the integrity of the system. On the
other hand, developing countries seek a defensive solution to biopiracy as a
lot of biopiracy cases have actually arisen due to the grant of patents over
inventions based on TKaGRs and GRs which form part of the ancient
traditions and cultures of such developing countries. India, for instance, has
had to contend with a number of biopiracy cases, prominent ones of which
include the controversies surrounding the erroneous patents granted on the
neem tree,' 4 6 the basmati rice plant, 4 7 as well as the turmeric plant, 4 1 to
name but a few. Thailand has had to contend with erroneous patents
Measures Related to the Avoidance of the Erroneous Grant of Patents and Compliance
with Existing Access and Benefit Sharing Systems submitted by the Delegations of
Canada, Japan, Norway, the Republic of Korea, the Russian Federation and the United
States of America remains on the floor of the Committee. See Document
WIPO/GRTKF/IC/30/8/.
145 See World Intellectual Property Organanzation, "Matters Concerning the
Intergovernmental Committee on Intellectual Property and Genetic Resources,
Traditional Knowledge and Folklore", (2015), at para (d), online: WIPO
<www.wipo.int/export/sites/www/tk/en/igc/pdf/igc mandate 1617.pdf>.
146 For a discussion and analysis of the neem tree controversy, see generally,
Emily Marden,
"The Neem Tree Patent: International Conflict over the Commodification of Life"
(1999) 22 B C Intl & Comp L Rev 279-295. See also Shubha Ghosh, "Globalization,
Patents, and Traditional Knowledge" (2003-2004) 17 Colum J Asian L 73 at 106-108.
147 See Sumathi Subbiah, "Reaping What They Sow: The Basmati Rice Controversy and
Strategies For Protecting Traditional Knowledge" (2004) 27 BC Intl & Comp L Rev
529. See also Ghosh, "Globalization, Patents, and Traditional Knowledge", supra note
146 at 97-102. Again, see Robinson, Confronting Biopiracy, supra note 77 at 47-49.
148 Philip Schuler, "Biopiracy and Commercialization of Ethnobotanical Knowledge",
supra note 73 at 166-169.
granted on the Kwao Krua (Puerariamirifica) plant,"' as well as the Plao Noi
plant, another medicinal herb with early local documentation records.150
One of the key suggestions being explored in this regard is the
development of databases which will support patent examiners in their
search of prior art. Of course, this is not a straightforward discussion as it
remains fraught with concerns over accessibility to the database;
implications of system hacks as well as court orders; infrastructure and
capacity to develop and document such databases within developing
countries; and concerns from indigenous groups over the documentation
of aspects of their knowledge, particularly the secret and sacred aspects of
their TK practices. India has taken the lead, and has developed a digital
library for its TK which is accessible to registered patent offices to assist with
their search functions.'' A recent proposal by a group of developed
countries within the WIPO IGC for the development of a TK database
managed centrally by WIPO also continues to be deliberated on.'5 2 It is
worth mentioning here that these two aspects of the work (the normative
and the administrative) are increasingly being considered as being mutually
149 A local herb whose medicinal use was first document in Thai scriptures as far back as
1931. See Robinson, Confronting Biopiracy, supra note 77 at 55-59.
150 See ibid at 63-66.
151 According to the Indian Council for Science and Industrial Research (ICSIR), the
TKDL is a "pioneer initiative of India to prevent misappropriation" inspired by
significant incidents of biopiracy between 1990 and 2000. See Saikat Sen & Raja
Chakraborty, "Traditional Knowledge Digital Library: A Distinctive Approach to
Protect and Promote Indian Indigenous Medicinal Treasure" (2014) 106:10 Current
Science at 1341, who also note that the instances of biopiracy witnessed between 1990
and 2000, particularly patents on the turmeric (No. 5,401504 in 1995), basmatic rice
(No. 5663484 in 1997) by the USPTO, and the neem (No. 436257) by the EPO, led to
the formulation of a collaborative and multi-agency task force to prevent
misappropriation of Indian TK at international patent offices. The TKDL was the
outcome.
152 See the Joint Recommendation on the Use of Databases for the Defensive Protection
of Genetic Resources and Traditional Knowledge associated with Genetic Resources,
submitted by the Delegations of Canada, Japan, the Republic of Korea and the United
States of America in document WIPO/GRTKF/IC/30/7 (first submitted as document
WIPO/GRTKF/IC/23/7 to the Twenty-Third Session of the Committee in February
2013) at para 14. This proposed recommendation acknowledges the complementarity
between the IP system and the CBD, and proposes the use of a one-click database system
for the defensive protection of TKaGRs and GRs. It however notes that the patent
office has no business in ensuring or determining whether inventions which make use
of TKaGRs or GRs are made in compliance with the CBD or not. See para 14.
supportive solutions. In other words, they can both be developed in support

of the ABS regime.
V. CONCLUSION
Without a clear end yet in sight for the WIPO negotiations, questions
consequently still remain on the ability the Nagoya Protocol to effectively
address the incidence of biopiracy. The realization of this objective is hinged
on a complementary outcome within the WIPO IGC. In conclusion, four
key reasons drawn from the analysis in this paper are advanced below.
First, there exists an antecedent of weak implementation for
instruments agreed on the platform of the CBD, especially those within the
issue area of the Nagoya Protocol. Prior to the Nagoya Protocol, the CBD and
the Bonn Guidelines were negotiated to address, inter alia, the fair and
equitable sharing of benefits arising from the utilization of TK and GRs.
Neither of these instruments have, however, enjoyed a successful
implementation for differing reasons as noted above. A further instrument,
and indeed an international regime built on these instruments, will likely
arrive at the same fate if the key questions related to the IP system are not
made a part of its elaboration and implementation.
Second is the nature of the issue area to which the Nagoya Protocol is
addressed. As mentioned above, while the stated objective of the Nagoya
Protocol is the fair and equitable sharing of benefits arising from the
utilization of GRs, the underlying subtext to the Nagoya Protocol relates to
the protection of GRs and TK from the increasingly rampant incidence of
biopiracy. It is to this end that the sharing of benefits is aimed and thus
constitutes, from a Third World perspective, the raison d'etre for the Nagoya
Protocol. Indeed, this was the key issue that prompted the call by denandeurs,
most of which were megadiverse developing countries, for an international
regime on ABS. Given that biopiracy has thrived due to the incentives and
overall normative dominance of the global IP system specifically in relation
to the acquisition of rights over the use of TK and GRs, the issues, problems
and solutions relating to biopiracy, cannot be fully understood without an
understanding of the IP system.' 53 This brings into focus the contrasting
norms inherent within the IP system and the ABS system, and the effect of
153 Amanda J Landon, "Bioprospecting and Biopiracy in Latin America: The Case of Maca
in Peru" (2007) Nebraska Anthropologist 64.
these on efforts to develop solutions to biopiracy. Within the context of the

Nagoya Protocol's implementation, the effect that counter-regime IP norms
have on the implementation of the Nagoya Protocol forms an important
consideration while assessing the potential efficacy of the instrument.
Third is the diversity of the stakeholders and power relations that have
prompted the emergence of the Nagoya Protocol, and upon/through which
the implementation drive of the Nagoya Protocol will be sustained. Scholars
of international relations have extensively debated the formulation and
efficacy of international regimes from the perspectives of power, interest
and knowledge.' The proliferation of international regimes addressing
specific issue areas, amongst others, has led to questions relating to the role
of non-state actors in the global governance of specific issue areas. Given
that the central non-state beneficiaries of the protection of TK and GRs are
indigenous peoples as against the major non-state beneficiaries of IP
protection - multinational corporations - the respective roles and/or
influence that these respective non-state actors have had and continue to
exert on the formulation of public policy and/or state choices has a direct
bearing on the implementation of the Nagoya Protocol.
Finally, an underlying uncertainty regarding the potential
implementation of the Nagoya Protocol is decodable through an analysis of
the ongoing related work in the IP regime. Within the World Trade
Organization (WTO) and WIPO, negotiations which address elements that
directly impact or inform the implementation of the Nagoya Protocol's main
provisions are progressing. In contrast to the WTO's characteristic state-
centric negotiations,"' WIPO offers an accessible forum, similar to the
CBD, which draws participation from all major stakeholders.' 6 WIPOs
negotiations are aimed at developing a sui generis IP system which will ensure
the effective protection of TK (including traditional cultural expressions)
and GRs. Despite the fact that most of the same actors within the IP
154 Hasenclever, Mayer & Rittberger, supra note 23 at 9.

155 Negotiations within the WTO are undertaken strictly by Members and observer states
that intend to, or are in the process of negotiating membership to the W(TO. Decisions
on outcomes are, however, only taken by Member States. See World Trade
Organization, "How the Negotiations are Organized", online: 'QWTO
<https://www.wto.org/english/tratope/dda-e/workorgani e.htm>.
156 WIPO's negotiations are open to participation from states, indigenous peoples, relevant
intergovernmental organizations (IGOs), non-governmental organizations (NGOs),
corporate actors (including multinationals and research institutes) etc.
negotiations, and WIPO's in particular, are those that agreed to the

adoption of the Nagoya Protocol on the platform of the CBD (excluding the
United States), the WIPO negotiations have been remained difficult. The
differing postures from the actors within the sphere of the IP discussions
vis-a-vis the development of the Nagoya Protocol's provisions raises a genuine
concern about the political will backing the Nagoya Protocol's core
provisions, its implementation, and its ultimate potential to achieve its
desired objective.
Should the efforts of developing countries prevail within the WIPO
negotiations, we will definitely be ushering in an international legal
instrument(s) which complements the Nagoya Protocol through a disclosure
mechanism. It is probably only in this context that the IGC outcomes can
be said to offer a complementary system of protection and as such could be
viewed as one of the instruments within the ABS regime-complex. For now,
however, it is clear that ongoing IGC process represents a part of the regime-
complex, based on its representations and stated objectives. It remains to be
seen if this will translate into substantive outcomes which reinforce the
Nagoya Protocol.

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II. A Regime Context 238

III. The Nagoya Protocol as an ABS Regime Complex 262

A. A Legal Regime or a Regime's Law 264

IV. WIPO as an elemental constituent of the ABS regime-complex. 270

The protection of traditional knowledge (TK) is a problem of central

The protection of traditional knowledge (TK) is an important issue

1 Manuel Ruiz Muller, "Protecting Shared Traditional Knowledge: Issues, Challenges

practice,[sic] tools and mechanisms that are driven by this underlying

See Muller, supra note 1 at 4.

CEWIPO Article 2 (viii).

from old knowledge; the assumption that knowledge creation and

incidence of biopiracy - on the basis of a third world approach to

II. A REGIME CONTEXT

International law is made up of normative and institutional fragments

international law - a homogenous instrument, negotiated centrally, which

The concept of international regimes has been developed and

scholars, however, have largely shown an interest in the concept of

A central part of international regimes which is of central importance

The Nagoya Protocol's international ABS regime thus offers an

International Regimes in East - West Politics (London: Pinter Publishers, 1990) 64 at

Indeed, for developing countries, the search for solutions to biopiracy

The Government of Mexico also noted upon ratification of the Nagoya

Again, in this context, the former Vice President of Indonesia, Prof.

36 Intellectual Property Watch, "Brief: India Ratifies Nagoya Protocol on Biodiversity

39 The Like-Minded Megadiverse Countries (LMMC) was established by the Cancun

Politics of Regime Definition" in Margaret A Young, ed, Regime Interaction in

biopiracy rhetoric has offered a useful framework through which the

1. Traditional Knowledge Associated with Genetic Resources

43 Madhavi Sunder, "The Invention of Traditional Knowledge" (2007) 70 L

Contemporary Problems, 97 at 110.

complexity of issues surrounding the term."" WIPO, which is currently in

45 Teshager Dagne, "The Protection of Traditional Knowledge in the Knowledge

product of age-long experience, generationally improved upon";o " a

Institute & International Development Research Centre, 1992) 7-8.

Indigenous peoples view their TK as a holistic concept which is

Town: University of the Western Cape, 2011).

Krystyna Swiderska, "Designing an Effective Biocultural Heritage Indication Labelling

reflected". See Ruiz, supra note 1 at 9.

constituting a tangible aspect of the intangible TK. 7 In a tangible sense, it

GRs 69 TK stricto sensu TCEs

TKaGRs TK (lato sensu)

TMK TEK TAK

Within the WIPO negotiations, a further distinction is attempted

industrialized world, due to its valuable role in the identification of leads

2. Biopiracy: Defining a Contemporary Pattern

71 Surinder Kaur Verma, "Protecting Traditional Knowledge: Is a Sui Generis System an

In supporting this stylization of biopiracy, Paul Heald offers two

MegaAgriCorp is developing a smut-resistant strain of corn and sends researchers

These stylized cases suggest biopiracy as arising within the context of

consideration of biopiracy as a North-South issue - i.e. one in which the

resource-based inventions. This restrictive context provides insight into the

the introduction of 'exotic' plant species".

By focusing however on the restrictive explanation of biopiracy, the

86 Robinson, supra note 77 at 14.

By trans-regime, I refer to biopiracy as an issue area which is articulated

resources and/or knowledge of indigenous peoples without due permission,