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Intellectual Property and Human Development
Trends and scenarios in the legal protection
of traditional knowledge
Charles McManis and Yolanda Terán1

Introduction

This chapter discusses the currently much debated issue of traditional knowledge (TK)
protection. Opinions differ widely, not only as to how TK should be protected, but even as to
whether TK should be protected at all. It is commonly accepted that intellectual property rights
(IPRs) in their current form are ill-suited for this category of knowledge. But does it follow that
TK should be placed or left in the public domain for anybody to use as they wish? For many
indigenous peoples, traditional communities and developing country governments, this seems
neither fair nor reasonable. In response, they have insisted that this issue be discussed at the
highest level in such forums as the World Intellectual Property Organization (WIPO), the World
Trade Organization (WTO) and the Convention on Biological Diversity (CBD) Conference of
the Parties (COP), and also be addressed at the national and regional levels. Proposals have
included reforms to current IP regimes in order to prevent misappropriation of TK and the
development of sui generis systems that vest rights in TK holders and TK-producing
communities. However, considerable conceptual and political difficulties remain, and these
remaining difficulties make it hard to predict the future of TK, as a legal and diplomatic issue.
The trends discussed in this chapter suggest at least three potentially overlapping scenarios for the future legal protection of TK: (1) continuing and/or increased reliance on existing means of legal protection for TK; (2) development of non-uniform, country- or region-specific means for protecting TK; and (3) development of internationally harmonized approaches to the protection of TK. While significant efforts are taking place towards the development of internationally harmonized approaches, it is not impossible to envisage a break-down of negotiations on the subject due to developed country manoeuvring, widening differences among the developing countries, or a realization among the developing countries that the economic stakes are not as high as they had been led to believe. However, a break-down at the international level would not preclude breakthroughs at the national and regional levels. Scenario planning by indigenous and local communities might be one way of teasing out the issues and challenges, as well as options, in the protection of their TK. Section 1 of this chapter introduces some basic concepts in relation to TK and its legal protection. Section 2 emphasizes that the preservation and transmission of TK depends not only on legal reforms in this area, but also on many socio-economic and environmental factors. Thus, legal protection for TK needs to be approached within integrated solutions to protect the bio-cultural heritage of indigenous peoples and local communities. Section 3 discusses international legal instruments of relevance to TK protection, while Section 4 highlights trends in using IP regimes or sui generis systems to protect TK at the national, regional and international levels. Some ideas and considerations for scenario planning in this area are explored in the conclusion. "IP resources the right size, at the right time, in the right place" www.piipa.org Public Interest Intellectual Property Advisors 2011 – shared under a Creative Commons Attribution-NonCommercial-NoDerivs licence Intellectual Property and Human Development
1. Fundamental concepts and distinctions in the legal protection of traditional
knowledge

Traditional knowledge has been defined as ‘a body of knowledge built by a group of people
through generations living in close contact with nature' (Johnson 1992, pp. 3–4).2 It typically
includes ‘a system of classification, a set of empirical observations about the local environment,
and a system of self-management that governs resources use' (ibid., p. 4). Contrary to popular
belief, TK is not static and unchanging, but rather develops and changes over time, albeit by
means of traditional or customary practices (Balick 2007, p. 280).3
Whether TK is understood in the strict sense as encompassing only knowledge and ideas as such or in a broader sense as extending to expressions of knowledge and ideas as well (i.e. traditional cultural expressions, or TCEs), TK serves as a means of physical survival and of cultural identity, and thus must be understood holistically. Its practical, cultural and spiritual elements serve to integrate a community with its environment (Pires de Carvalho 2007). Likewise, while the WIPO Intergovernmental Committee on Genetic Resources, Traditional Knowledge and Traditional Cultural Expressions (‘IGC') has developed two sets of draft provisions, one for TK as such and one for TCEs, the IGC nevertheless recognizes that ‘for many communities these are closely related, even integral, aspects of respect for and protection of their cultural and intellectual heritage'.4 Meanwhile, national legislation in this area tends, albeit with a few exceptions, to keep to a separation of TK in a strict sense and TCEs. Accordingly, this chapter focuses on the protection of the former, while Chapter 5 addresses the protection of TCEs. In a 2001 report, the WIPO IGC Secretariat highlights two main IP-related concerns articulated by WIPO member states in the field of TK, namely, the availability of IP protection for TK holders (i.e. the need for affirmative legal protection) and the acquisition by parties other than TK holders of intellectual property rights over TK-based creations and innovations (i.e. the need for defensive legal protection) (see WIPO 2001, para. 63). Both these aspects of protection for TK are discussed in this chapter. In exploring legal protection for TK, the WIPO IGC Secretariat recognizes that it may not be possible to develop a singular and exclusive definition of the term ‘traditional knowledge', given the highly diverse and dynamic nature of TK (ibid., para. 65). Such a singular definition may not be necessary to delimit the scope of subject matter for which IP protection is sought (ibid.). National IP systems are said to function satisfactorily without iron-clad definitions, and neither of the two basic IP conventions administered by the WIPO – namely, the Paris Convention for the Protection of Industrial Property5 and the Berne Convention for the Protection of Literary and Artistic Works6 – contain exclusive definitions of what constitute ‘inventions', ‘industrial designs', or ‘literary and artistic works', respectively.7 Indigenous peoples, the custodians of much of the TK over which these legal reforms are taking place, emphasize a holistic approach towards protecting their TK. While legal and economic discussions tend to compartmentalize resources as land, minerals or genetic resources, indigenous peoples view their TK as inseparable from all these elements. TK has ancestral and historical value for these peoples and cannot be ‘isolated' from larger questions of their cultural identity and survival. TK is seen as for the collective benefit and well-being of communities, not to be ‘cut in pieces' and treated merely as merchandise. As Degawan (2008) notes: ‘Traditional "IP resources the right size, at the right time, in the right place" www.piipa.org Public Interest Intellectual Property Advisors 2011 – shared under a Creative Commons Attribution-NonCommercial-NoDerivs licence Intellectual Property and Human Development
knowledge is an inseparable part of indigenous culture, social structures, economy, livelihoods, beliefs, traditions, customs, customary law, health and their relationship to the local environment'. Integrated solutions are thus important in preserving the ‘bio-cultural' heritage of these peoples and other local communities. An important consideration for legal protection of TK is the interaction between IP laws and the customary laws of indigenous and local communities. The IGC Secretariat notes in its
2001 report that ‘many traditional societies have developed highly sophisticated and effective
customary intellectual property systems…[that] have, until now, remained invisible from the
point of view of the formal intellectual property system…' and that there is ‘a need to further
study the relationship between customary protection of traditional knowledge and the intellectual
property system' (WIPO 2001, para. 68). A World Bank publication furthermore states that: ‘The
creation of…a legal regime adequate for the protection of collective traditional knowledge has to
be based on the concept of legal pluralism and the recognition of the legal diversity existing in
traditional societies. To understand the essential elements of such a regime, it is necessary to
accept a plurality of legal systems, recognizing that our society is pluralistic and has parallel
legal systems manifest in the customary laws of local communities' (see World Bank 2006, p.
2).8
2. Transmission and loss of traditional knowledge

As recognized in the 2005 United Nations Development Programme (UNDP) Practice Note on
‘Traditional Knowledge, Access to Genetic Resources, and Benefit-Sharing', there are inherent
linkages between TK protection, the maintenance of indigenous cultural identity, language,
customary laws and rights over traditionally occupied lands (UNDP 2005, p. 7; Thomas 2001).
In relation to the latter, a study for the Ad-Hoc Working Group on Article 8(j) of the Convention
on Biological Diversity adds that the political will to address land claims is essential to the
retention and use of TK (see United Nations Environment Programme [UNEP] & Secretariat of
the CBD 2003, p. 52). Importantly, this Composite Report on the Status and Trends Regarding
the Knowledge, Innovations and Practices of Indigenous and Local Communities (Regional
Report for North America) recognizes that:
[I]t is the loss of opportunity to pursue the traditional practices that will result in the loss of the knowledge. Without opportunities to constantly review the traditional knowledge, innovation and practice, the indigenous way of knowing the earth will cease, except as a collection of data in reports such as this. Traditional indigenous knowledge is knowledge of a land. A pillar of the efforts to redress the decline in traditional knowledge, innovation and practice is to acknowledge the critical link between the land, the people, and the knowledge. (Ibid.) Intellectual property protection is thus but one component in the complex social and environmental rubric influencing the future preservation of TK. As emphasized in the Composite Report, the state of TK ‘remains under threat' and efforts to protect TK are ‘as yet insufficient' (ibid.). Along with persistent challenges facing indigenous peoples in retaining or recovering their land rights, the loss of TK is closely connected to other socio-economic factors including poverty, unemployment, rural-urban migration and the homogenizing effects of globalization on culture (UNDP 2004, p. 11; see generally Wood, Stedman-Edwards & Mang 2000). Along with "IP resources the right size, at the right time, in the right place" www.piipa.org Public Interest Intellectual Property Advisors 2011 – shared under a Creative Commons Attribution-NonCommercial-NoDerivs licence Intellectual Property and Human Development
these factors, the transmission of TK is affected by declines or interruptions in the transmission of indigenous languages, which encode TK.9 Particular groups within indigenous societies, for example, women and elders, play important roles in the transmission of language and TK. The threat to TK can furthermore be seen within the larger phenomenon of biodiversity loss which includes bio-cultural loss – that is, the ‘extinction of experience' (Maffi 2001; see
also Maffi 1998) – as well as genetic resource loss.10 Climate change has greatly exacerbated
these concerns and poses one of the most pressing challenges to the physical and cultural
survival of many peoples (see Box 4.1). In terms of integrated approaches towards rescuing bio-
cultural diversity, there are projects such as those stemming from the agreement between the
Association for Nature and Sustainable Development (ANDES) and the International Potato
Center (CIP), under which traditional potato varieties are being repatriated to the Quechua
Communities. This is an interesting trend towards the recuperation of agrobiodiversity and
associated TK, going beyond current debates centring on IP by focusing on transmission of TK
and dynamic experimentation in relation to factors such as food security and climate change.
3. Principal international agreements relevant to the legal protection of
traditional knowledge

The international agreements relevant to the legal protection of TK range from those that are
essentially aspirational in character to those that impose on parties concrete legal obligations
backed by international enforcement mechanisms. In the former category are such agreements as
the International Covenant on Economic, Social and Cultural Rights,11 the International Labour
Organization's Convention (No. 169) Concerning Indigenous and Tribal Peoples in Independent
Countries12 and the Convention on Biological Diversity (CBD).13 Some aspects of the CBD, the
Box 4.1. Traditional ecological knowledge and climate change
Climate change is affecting both urban and rural societies, with potentially irreversible
consequences for our common future (UNDP 2007). Communities whose cultural ways and
sustainable livelihoods are closely bound up with the environment already experience the effects of
climate change in an immediate and far-reaching manner. The unprecedented impacts of climate
change may jeopardize the very survival of some peoples, whether located in the Arctic, on small
islands or in other highly vulnerable areas (International Union for Conservation of Nature [IUCN]
2008, p. 35). As Degawan (2008, p. 53) observes:
[C]limate-induced changes are happening faster than anything previously observed…While climate change is indeed impacting on everyone, indigenous peoples are affected more adversely due to factors such as direct dependence on natural resources, poverty, marginalization, access to services, abilities to cope, and their geographical, social, cultural and political position. As with other communities, indigenous peoples are affected by food shortages, extended drought, floods and other physical, easily measured impacts.14 Some emphasize that TK systems can help indigenous and other local communities adapt to climate change, for example, through maintenance of agrobiodiversity that support local food systems (IIED 2008, p. 16). Traditional ecological knowledge in one region may also provide ideas and strategies to cope with new challenges in other regions of the world caused by sea-level rise, shifts of vegetation zones, changes in animal species diversity, range and distribution (IUCN 2008). "IP resources the right size, at the right time, in the right place" www.piipa.org Public Interest Intellectual Property Advisors 2011 – shared under a Creative Commons Attribution-NonCommercial-NoDerivs licence Intellectual Property and Human Development
At the same time, the ‘speed with which the climate is changing is putting the abilities of indigenous communities to adapt to the test' (Degawan 2008, p. 53). Since indigenous peoples' TK and cultural practices are closely linked to their use of and dependency on natural resources and biological diversity, Degawan notes that ‘the loss in terms of traditional knowledge and cultural practices' has yet to be thoroughly reviewed (ibid.). Particular sectors within indigenous communities may be harder hit. As noted in a report on Climate Change & Indigenous Women by the Indigenous Peoples' International Centre for Policy Research and Education (TEBTEBBA): ‘Indigenous women may lose their traditional ecological knowledge, practices and sustainable livelihoods with the destruction of their resources to climate change. The loss of traditional plants or medicinal plants due to droughts or floods means the reduced opportunities for the coming generations to learn and practice traditional health, biodiversity conservation and protection and food security knowledge among others' (TEBTEBBA n.d., p. 3). Legal solutions to protect TK must thus be coordinated with strategies to protect the environment in which indigenous peoples and local communities live. An IUCN report emphasizes that ‘it is essential to further explore culturally appropriate ways to enhance the resilience of traditional and Indigenous Peoples' (2008, p. 59). Along with traditional ecological knowledge, customary principles of indigenous peoples also hold lessons and hope for the earth's future – the understanding of ‘rights and responsibilities' of many indigenous communities extend not only between persons, but also to other species and the earth. Source: Degawan 2008; International Institute for Environment and Development (IIED) 2008; TEBTEBBA (n.d.); IUCN 2008. first international agreement to make explicit reference to the protection of TK, are discussed in Box 4.2. Significantly, the UN General Assembly adopted on 17 September 2007 the UN Declaration on the Rights of Indigenous Peoples, which includes provisions relating to TK.15 At the other end of the spectrum is the World Trade Organization (WTO) Agreement on Trade-Related Aspects of Intellectual Property Rights (‘TRIPS Agreement').16 This Agreement requires its members to adhere to specific minimum standards for the protection and enforcement of IPRs, and establishes an international dispute settlement process to resolve disputes among members and to authorize the imposition of sanctions on members who fail to carry out their obligations under the Agreement.17 Falling between these two extremes is the Food and Agriculture Organization (FAO) International Treaty for Plant Genetic Resources for Food and Agriculture (ITPGRFA),18 which creates a formal ‘Multilateral System' – that is, a system of ‘common-pool goods' – in thirty-six genera of crops and twenty-nine genera of forages, guaranteeing both ‘facilitated' (i.e. free or low-cost) access to these genetic resources and a system for equitable sharing of the benefits derived from any commercialized products that incorporate materials from the Multilateral System.19 An important TRIPS-related development with respect to the protection of TK was the 2001 Doha Ministerial Declaration of the WTO, which instructed the WTO's Council for TRIPS ‘to examine, inter alia, the relationship between the TRIPS Agreement and the Convention on Biological Diversity, [and] the protection of traditional knowledge and folklore' (para. 19; see discussion in Section 4.3).20 Of particular significance to the implementation of the CBD was the 2003 promulgation of the Bonn Guidelines on Access to Genetic Resources and Fair and Equitable Sharing of the Benefits Arising out of their Utilization (‘Bonn Guidelines').21 These Guidelines are designed to assist parties, governments and other stakeholders in developing an "IP resources the right size, at the right time, in the right place" www.piipa.org Public Interest Intellectual Property Advisors 2011 – shared under a Creative Commons Attribution-NonCommercial-NoDerivs licence Intellectual Property and Human Development
overall access and benefit-sharing (ABS) strategy and in identifying the steps relevant to ABS. Some guidance on the elements and basic principles of a prior informed consent (PIC) system, in accordance with Article 15 of the CBD, are provided in the Guidelines (see Box 4.2). An International Regime on Access and Benefit-Sharing is also being negotiated at the CBD and is discussed later in Section 4.3. Box 4.2. Prior informed consent, genetic resources and traditional knowledge22
According to Article 15 of the CBD, access to genetic resources is subject to the ‘prior informed
consent' (PIC) of the provider country, and the fair and equitable sharing of benefits. This Article
affirms the sovereign rights of states over their natural resources, including genetic resources which
until the CBD had been treated as part of an international commons. TK may be inextricably linked
to the genetic resources accessed. The CBD recognizes the relevance of the ‘knowledge,
innovations and practices of indigenous and local communities' in conserving biological diversity.
Article 8(j) of the CBD states that:
Each party shall, as far as possible and as appropriate:… (j) Subject to its national legislation, respect, preserve and maintain knowledge, innovations and practices of indigenous and local communities embodying traditional lifestyles relevant for the conservation and sustainable use of biological diversity and promote their wider application with the approval and involvement of the holders of such knowledge, innovations and practices and encourage the equitable sharing of the benefits arising from the utilization of such knowledge, innovations and practices… The text of the CBD essentially leaves it to sovereign states to pursue legal reforms and measures towards ensuring the ‘approval and involvement' of TK holders in such cases. Article 8(j) does not indicate ‘prior' approval of TK holders. In response to lobbying from indigenous peoples' organizations and their supporters, at the Fifth Meeting of the Conference of the Parties to the Convention on Biological Diversity in Nairobi in 2000, Decision V/1623 was adopted. This Decision stated as a general principle that: Access to traditional knowledge, innovations and practices of indigenous and local communities should be subject to prior informed consent or prior informed approval from the holders of such knowledge, innovations and practices. Detailed guidance to put PIC into practice is offered in the Bonn Guidelines on Access to Genetic Resources and the Fair and Equitable Sharing of the Benefits Arising out of their Utilization. These were adopted by the Conference of the Parties to the Convention on Biological Diversity at its sixth meeting in 2002. Among other initiatives to develop voluntary codes of conduct to ensure that researchers rigorously apply the principle of PIC and establish equitable research relationships with indigenous peoples and local communities is the ‘Code of Ethics' adopted in 2006 by the International Society of Ethnobiology (ISE) (Laird & Noejovich 2002).24 Also, draft elements of a code of ethical conduct for respecting the cultural and intellectual heritage of indigenous and local communities relevant to the conservation and sustainable use of biological diversity are being elaborated as part of the programme of work relating to Article 8(j) of the CBD (COP9 Decision IX/13). "IP resources the right size, at the right time, in the right place" www.piipa.org Public Interest Intellectual Property Advisors 2011 – shared under a Creative Commons Attribution-NonCommercial-NoDerivs licence Intellectual Property and Human Development
Normative work relating to a principle of ‘free, prior and informed consent' (FPIC) beyond the CBD context is evolving in international law, particularly in relation to indigenous peoples' rights (Tamang 2005). Mackay (2004) suggests that: In contemporary international law, Indigenous Peoples' have the right to participate in decision making and to give or withhold their consent to activities affecting their lands, territories and resources or rights in general. Consent must be freely given, obtained prior to implementation of activities and founded upon an understanding of the full range of issues implicated by the activity or decision in question, hence the formulation, free, prior and informed consent. The term ‘free' in addition to ‘prior' perhaps makes explicit what is implicit in the term ‘consent'. Noting that the bargaining positions of stakeholders can be very different, the UNDP Practice Note on Traditional Knowledge, Access to Genetic Resources and Benefit-Sharing emphasizes that consent should be given without duress and that stakeholders including indigenous peoples and local communities should be educated as to their relevant rights and the circumstances of access to their TK and/or genetic resources embodying such TK (2005, p. 8). Thus, awareness and capacity-building measures are required to inform TK holders of such elements as legal frameworks (including those governing IPRs), intended uses of the TK, and mechanisms for benefit-sharing (ibid.). In September 2007, the UN General Assembly adopted the UN Declaration on the Rights of Indigenous Peoples, following twenty years of negotiations involving indigenous peoples and national governments.25 The Declaration was adopted with an overwhelming majority of 143 votes in favour, only 4 negative votes cast (Canada, Australia, New Zealand and US) and 11 abstentions.26 While the UN Human Rights Council had endorsed the Declaration on the Rights of Indigenous Peoples in 2006, the process for its formal adoption by the UN General Assembly had come to a halt in November 2006, when the UN General Assembly's Third Committee adopted a non-action resolution, apparently at the behest of a number of African states.27 But this turned out to be a temporary hitch. As further considered in Chapter 5 of this book, the future of indigenous rights, including the protection of their TK, depends a great deal on the political will of governments to recognize these important rights, connected ultimately to historically rooted questions of indigenous peoples' self-determination. A provision of particular significance to the IP protection of TK from the UN Declaration on the Rights of Indigenous Peoples is Article 31(1) which states that: Indigenous peoples have the right to maintain, control, protect and develop their cultural heritage, traditional knowledge and traditional cultural expressions, as well as the manifestations of their sciences, technologies and cultures, including human and genetic resources, seeds, medicines, knowledge of the properties of fauna and flora, oral traditions, literatures, designs, sports and traditional games and visual and performing arts. They also have the right to maintain, control, protect and develop their intellectual property over such cultural heritage, traditional knowledge, and traditional cultural expressions. Article 31(2) provides that ‘States shall take effective measures to recognize and protect the exercise of these rights', in conjunction with indigenous peoples. These rights are rather broad "IP resources the right size, at the right time, in the right place" www.piipa.org Public Interest Intellectual Property Advisors 2011 – shared under a Creative Commons Attribution-NonCommercial-NoDerivs licence Intellectual Property and Human Development
and could be better defined. Consequently, there are many possible ways to interpret and uphold them in national laws and policies. With respect to IP and the TRIPS Agreement, one can anticipate considerable debate on the question of whether certain provisions of TRIPS, or ways that these provisions tend to be implemented, would impinge on the full enjoyment of these indigenous peoples' rights. The TRIPS Agreement takes legal precedence over the non-binding Declaration. Nonetheless, some countries may still choose to give priority to the Declaration irrespective of what the international law of treaties indicates. Significantly, Bolivia has adopted provisions reflecting the UN Declaration on the Rights of Indigenous Peoples in its national law.28 The UN Declaration on the Rights of Indigenous Peoples makes explicit reference, furthermore, to the right of indigenous peoples to their ‘traditional medicines' and to maintain
their health practices, including ‘the conservation of their vital medicinal plants, animals and
minerals' (Article 24). The value of traditional medicinal knowledge (TMK) in meeting the
primary health needs of populations around the world is highlighted in Chapter 2 of this book on
medicine. Appendix C discusses relevant strategies and resolutions of the World Health
Organization (WHO) to facilitate integration of traditional medicine into national health care
systems, promote the IPRs of traditional practitioners and encourage the development of national
sui generis protection for TMK. An example of a national sui generis law designed and enacted
for the protection of traditional medicine is the Act on Protection and Promotion of Traditional
Thai Medicinal Intelligence (1999 [BE 2542]) (see Appendix C).
4. Trends in the legal protection of traditional knowledge

This section looks at current options and trends in the legal protection of TK. It first evaluates the
relevance of existing forms of IP for the protection of TK, including both affirmative and
defensive means for protecting TK. It then explores special ABS legislation relating to TK and
associated genetic resources under national and regional laws. This is followed by a discussion
of internationally harmonized approaches which are being developed for the protection of TK.
4.1. Existing means for extending IP protection to traditional knowledge

The TRIPS Agreement establishes minimum standards of affirmative legal protection for seven
categories of intellectual property,29 of which six are at least theoretically relevant to the
protection of TK and TCEs (McManis 2004, pp. 434–447). Two of these categories (i.e.
copyright and related rights; industrial design protection) have some relevance for the protection
of TCEs; two categories (i.e. patents and undisclosed information) are primarily relevant to the
protection of TK; and two categories (i.e. trademarks and geographical indications) are relevant
to the protection of both TK and TCEs. The TRIPS Agreement also recognizes (but does not
specify explicit minimum standards for) an additional form of IP protection for plant varieties
(Article 27.3(b)), which is relevant to the protection of traditional agricultural knowledge (TAK).
This chapter focuses on the categories of IPRs relevant to the protection of TK, while Chapter 5
focuses on the categories relevant to protection of TCEs.
An important supplementary (and independent) means of protecting both TK and TCEs is through the mechanism of contracts, although there are limitations to this mechanism. As noted in a UNDP Practice Note: ‘A major drawback to private contracts between holders and users of "IP resources the right size, at the right time, in the right place" www.piipa.org Public Interest Intellectual Property Advisors 2011 – shared under a Creative Commons Attribution-NonCommercial-NoDerivs licence Intellectual Property and Human Development
TK could be the significant disparities in the bargaining power, resources, access to legal advice
and negotiating skills between the indigenous community and its counterpart. Capacity building
of TK holders is particularly important to level those differences' (UNDP 2005, p. 33).
4.1.1. Affirmative means for the protection of traditional knowledge

Traditional knowledge that is not widely known or readily accessible to humanity generally may
be protected as undisclosed information (see McManis 2004, pp. 436–438). This protection is not
limited to those who are engaged in a trade or business, but extends to any natural person or legal
entity possessed of information that is valuable because it is not generally known (ibid.). Due to
the widespread publicity given to national and regional efforts to ensure an equitable sharing of
benefits arising out of the use of genetic resources (see Section 4.2) over the past fifteen years,
both academic researchers and representatives from the private sector are becoming increasingly
sensitive to the need to recognize the contributions of TK holders, to obtain their PIC to utilize
their TK, and to engage in some form of equitable benefit-sharing.
In theory, at least, TK may also be protected under patent law. One of the grounds on which critics tend to dismiss the relevance of patent law for TK protection is that patent protection is limited to protection of individual inventors whose inventions meet the exacting standards of novelty, utility (or ‘industrial application') and non-obviousness (or ‘inventive step'). It should be noted that novelty in patent law means little more than that the claimed invention is not disclosed in the ‘prior art' (ibid., p. 443). What counts as prior art and how novelty and non-obviousness are defined in various patent systems around the world is highly variable. In some regimes, patent protection has been granted for elements of TK, or innovations based on TK. In cases where the patents have been sought by third parties without the prior consent and involvement of TK holders, there has been considerable controversy over alleged ‘misappropriation' of TK. Some examples, including the case of the hoodia plant, are discussed in Box 4.3. Traditional knowledge that does not meet existing patent standards may in some cases be protected through the mechanism of contracts, including contracts assigning patent ownership (or a portion thereof) to the TK holder, if the TK in question provides the starting point for the development of a patentable invention. Some limitations of contracts have been discussed earlier. Plant variety protection (PVP) is an alternative means for protecting TAK as embodied in plant varieties. It dispenses with any non-obviousness requirement, and generally requires only that new plant varieties be distinct, uniform and stable (DUS) (see McManis 2002, p. 64). It is important to note that the novelty and DUS standards may discriminate against some traditional landraces, although PVP may offer significant protection for innovative TAK holders. At the same time, PVP systems generally contain some sort of farmers' privilege as well as breeders' exemptions which explicitly permit protected varieties to be used to develop other new varieties, as long as the latter are not ‘essentially derived' from the protected variety.30 According to the International Seed Federation (ISF), this breeders' exemption ‘is essential for continued progress from plant breeding'.31 Some PVP systems also permit farmers to save and replant seeds of a protected variety, either at no cost or at a discount (see McManis 1998). "IP resources the right size, at the right time, in the right place" www.piipa.org Public Interest Intellectual Property Advisors 2011 – shared under a Creative Commons Attribution-NonCommercial-NoDerivs licence Intellectual Property and Human Development
As discussed in Chapter 3, some countries are bound by the International Convention for the Protection of New Varieties of Plants as administered by UPOV (International Union for the Protection of New Varieties of Plants) for protection of plant varieties. The obligations of countries under the Convention vary significantly depending on whether they are signatory to the original 1961 Convention, the revised 1972 Act, the 1978 Act or the 1991 Act (see Chapter 3). Under the 1991 Act, countries have the option to restrict the breeders' right in relation to any variety to permit farmers to use for propagating purposes, on their own holdings, the product of Box 4.3. Third-party patenting of innovations based on traditional knowledge: Hoodia and
other case studies
There has been significant public scrutiny and controversy over the patenting of TK-based
innovation by third parties without prior consent and involvement of TK custodians. Oft-cited case
studies include the neem, turmeric, quinoa, ayahuasca, maca and hoodia patents.32 In some cases,
the TK involved is treated within national laws as part of the public domain, though this may not
reflect the views of the TK custodians. In relation to patent law, questions are frequently raised as
to whether there is sufficient novelty and ‘inventive step' for patents on TK-related innovation to
be granted and validly sustained (see Section 4.1). While a patent that has been granted can be
invalidated through subsequent third party challenge, this will often involve substantial litigation
costs.
In Thailand, several patents relating to the medicinal herb kwao krua (Pueraria mirifica)33 have been challenged in the Thai courts on the ground that the grant of patents did not comply with the patentability requirements of novelty and inventive step (Robinson & Kuanpoth 2009, pp. 383–384). An earlier patent issued in May 1999 (Thai Patent No. 8912) claiming a chemical derivative of a plant product as part of a composition has not been challenged, though there are questions as to whether the so-called invention could be considered already to be in the public domain ‘through documentation and public use' (ibid., p. 386). There are claims by some healers that the TK on kwao krua has origins in the Isan (Northeast) region of Thailand where the plant is most prevalent (ibid.). At the same time, the herb is endemic to the Southeast Asian region, and has been used by traditional healers in various indigenous communities in the region. The herb can be found, for example, in Thailand, Burma and Laos (ibid.). Kuanpoth and Robinson suggest that ‘the debatable origin of kwao krua and of its therapeutic applications raises important questions about whose consent should be sought from in such a case and how fair and equitable benefits could be provided to custodians of the plant and associated traditional knowledge' (ibid.). Observing that not all the communities may be geographically locatable in the case of kwao krua, they suggest that a possible solution could be to provide benefits to traditional healers' networks which conserve the herb, if profits were created from the commercialization of patented kwao krua derivatives (ibid.). Cases such as kwao krua spurred legal reforms relating to TK in Thailand, including the enactment of the Act on Protection and Promotion of Traditional Thai Medicinal Intelligence (1999 [BE 2542]; see discussion in Appendix C). The number of patents related to the neem tree (Azadirachta indica) has drawn significant attention (see Dutfield 2000, p. 66). Many of these appear to use public domain TK as a starting point, and a few have been the subject of particular controversy, especially in India, where many of the TK holders are found (ibid., p. 66). There have been patent challenges, for example, to a European Patent Office (EPO) patent for fungicidal effects of neem oil (Patent No. 43627 B1), and a US patent for a storage stable azadirachtin formulation (Patent No. 5124349) (ibid.). Following the challenge to the former patent, the EPO invalidated it on the basis of lack of novelty. "IP resources the right size, at the right time, in the right place" www.piipa.org Public Interest Intellectual Property Advisors 2011 – shared under a Creative Commons Attribution-NonCommercial-NoDerivs licence Intellectual Property and Human Development
In the case of hoodia (hoodia gordonii), the active ingredient was patented by the South African government's Council for Scientific and Industrial Research (CSIR) and licensed for further development to the British company Phytopharm (which in turn sold additional licences to Pfizer, a US drug company, and later to the food multinational Unilever). The San peoples of Southern Africa have known and used the appetite and thirst suppressant qualities of the succulent plant hoodia for hundreds of years (Laird & Wynberg 2008, p. 83). While the CSIR patent was obtained without prior consultation with the San people, following considerable media outcry the patent owner (CSIR) entered into a benefit-sharing agreement with the San community in South Africa in 2003, which gave the San a share (6%) of royalties from successful exploitation of products. The San would also receive 8% of the milestone income received by CSIR from Phytopharm when certain performance targets were reached during the product development phase (ibid., p. 89). One approach to commercializing the hoodia is based on a patented hoodia extract under development as a functional ‘weight loss' food for the mass market (ibid., p. 84). Here the situation has become uncertain since Unilever recently withdrew from the arrangement. The other approach is the commercialization of hoodia as a raw, ground up material through incorporation into herbal supplements (ibid., pp. 83–84). For the latter, a second benefit-sharing agreement was signed separately between the San and the South African Hoodia Growers in early February 2006 to ensure the San receive some benefits from products being commercialized outside of the CSIR agreement. The income derived from these contracts is to be paid into a fund to support the San communities.34 Separately from these deals, hoodia products are on sale in health food shops and on the Internet. The San do not benefit at all from this, and these products tend in any case to be highly adulterated with insufficient content to produce much if any of the desired effect. Laird and Wynberg suggest that the hoodia case demonstrates the value of having an integrated system to protect and promote TK (ibid., p. 98). While perhaps atypical in potentially bringing some financial benefits to TK holders under the agreements described earlier, the hoodia case also demonstrates many of the complexities on the ground for ABS laws and arrangements. These include: putting PIC into practice; identifying and valuating TK inputs into the patented innovations; the cross-border distribution of certain TK, which raises questions of uneven protection for TK holders inhabiting different countries; intra-community equity in terms of how benefits from arrangements involving third parties are shared within a community, as well as concepts of benefit-sharing with future generations. As Laird and Wynberg observe: ‘If significant monies are eventually received by the San there will be extremely difficult issues to deal with in terms of determining who benefits and how benefits are spread across geographical boundaries and within communities…The due compensation of other communities such as the Nama, Damara and Topnaar will also require careful consideration. Overwhelmingly, there will be a need for continued legal, administrative and technical support to enable beneficiaries to claim what is rightfully theirs, and to do so in a manner that consciously and cautiously brings tangible and effective benefits to the original holders of Hoodia knowledge' (ibid., p. 98). While Laird and Wynberg emphasize the need to minimize any ‘negative social and economic impacts and conflicts that could arise with the introduction of large sums of money into impoverished communities' (ibid.), financial benefits in most cases of ABS would hardly reach the potential magnitude of the hoodia case.35 Expectations or concerns in other communities in relation to other TK have to be realistic. There are concerns, moreover, that local communities and rural producers may suffer when opportunities for commercialization of local products are cut off (ibid., p. 128) or alternatively when unauthorized commercial activity is allowed to take place. Without further international frameworks governing ABS, stark differences may meanwhile develop in relation to benefits that different custodian communities might derive from the same TK.36 Sound "IP resources the right size, at the right time, in the right place" www.piipa.org Public Interest Intellectual Property Advisors 2011 – shared under a Creative Commons Attribution-NonCommercial-NoDerivs licence Intellectual Property and Human Development
and sustainable development policies which take into account human development needs are meanwhile required to ensure fair intracommunity benefit-sharing. Non-monetary benefits to the community need to be explored alongside monetary ones (Gupta 2004). Source: Dutfield 2000; Laird & Wynberg 2008; Robinson & Kuanpoth 2009. harvest from protected varieties planted on those holdings. This privilege must, however, be exercised ‘within reasonable limits and subject to the safeguarding of the legitimate interests of the breeders'.37 Unlike the 1978 Act, the 1991 version of the farmers' privilege does not authorize farmers to sell or exchange seeds with other farmers for propagating purposes. As noted in a 2004 FAO report, commentators have criticized this limitation as inconsistent with the practices of farmers in many developing nations, where seeds are freely and unconditionally exchanged for purposes of crop and variety rotation (Helfer 2004, p. 25). Finally, trademarks, certification marks and geographical indications can be used to protect the identity of TK holders against the likelihood of confusion in the marketplace or the
dilution of famous identifying symbols (McManis 2004, pp. 441–442). These marks and
indications also offer interesting means for protecting TCEs against certain forms of
unauthorized commercial use, and are discussed in detail in Chapter 5.
4.1.2. Defensive protection of traditional knowledge

Defensive protection refers to the safeguarding against illegitimate third-party assertion of IPRs
over TK. A principal means by which TK holders can prevent the assertion of IPRs by others is
by making relevant disqualifying information available to patent and trademark examiners, either
directly or through the development of publicly available and searchable databases (Pires de
Carvalho 2007, pp. 247–248). A 2004 report by the United National University Institute of
Advanced Studies (UNU-IAS) on the ‘Role of Registers and Databases in the Protection of
Traditional Knowledge: A Comparative Analysis' notes, however, that ‘one of the principle
contradictions in the notion of defensive protection is that in order to prevent others from
misappropriating TK, Indigenous Peoples may be required to place their TK in the public
domain, where it can be more freely used by all' (see UNU-IAS 2004, p. 38). The paper
recommends that:
As a basic guiding principle there is a need to ensure that all reasonable efforts are made to obtain prior informed consent from the relevant Indigenous Peoples as a condition for placing information on a database, whether that TK is in the public domain or not. Explicit institutional policies need to be developed by museums, botanical gardens, universities, companies and all entities working with biological materials and related to TK. (Ibid., p. 39) Unfair competition laws may, in some cases, provide protection from misappropriation of TK. Defensive measures also include requirements in national legislation for the disclosure of origin of genetic resources and associated TK used in research and development (R&D) of inventions for which patents are sought. Some national laws have already been adapted to include a requirement for disclosure of origin. Some countries that have made the requirement a formal condition of patentability include Brazil, Colombia, Peru, Costa Rica, Egypt, Switzerland and "IP resources the right size, at the right time, in the right place" www.piipa.org Public Interest Intellectual Property Advisors 2011 – shared under a Creative Commons Attribution-NonCommercial-NoDerivs licence Intellectual Property and Human Development
India (see Pires de Carvalho 2007, pp. 249–251; Hoare and Tarasofsky 2007). As of 1 October 2009, China's patent law required disclosure of the origin of any genetic resources used in an invention for which patent protection is sought in China (see Gollin & Barry 2009). Some other countries in the process of developing laws on ‘disclosure of origin' are New Zealand and Turkey (ibid.). Disclosure requirements do not always extend to the TK associated with genetic resources. While some members of the European Union (e.g. Belgium, Denmark and Sweden) have incorporated disclosure requirements in their national laws, Hoare and Tarasofsky (2007, p. 154) observe that existing EU member state legislation applies only to genetic resources and does not refer to ‘the use of TK in an invention'. In contrast, Switzerland's recently revised patent law obliges the patent applicant to give information regarding the source of a genetic resource and TK in the patent application.38 Hoare and Tarasofsky point out that the disclosure requirements introduced in South and Central American countries also tend to cover both genetic resources and TK (ibid., p. 155). Pires de Carvalho (2007, pp. 249–251) suggests, furthermore, that the member states of the Andean Community, Brazil and Costa Rica have extended the requirement to other areas of industrial property law beyond patents, such as plant breeders' rights and, where it applies, utility model protection (see also Ruiz 2004; Correa 2005). Comparing approaches in different countries, Gollin and Barry (2009) observe the wide variance in ‘the disclosure requirements in national laws, and penalties for failure to comply': At the lenient end of the spectrum is Sweden, whose law states that patent applicants should, but are not required to, provide information on the geographical origin of the material, but that failure to comply will not affect the examination of applications or the validity of an issued patent. At the strict end of the spectrum, India requires disclosure of the source and geographical origin of biological material used in the invention, and provides that it is a criminal act, punishable by imprisonment, to apply for IP rights in any country for an invention based on a biological resource originating in India without prior approval from India's National Biodiversity Authority. More commonly, however, national laws require disclosure of the source or origin of the materials, and failure to comply may result in invalidity or unenforceability of the patent at issue (see e.g. South Africa). The ongoing debates on the TRIPS compatibility of national requirements that make ‘disclosure
of origin' mandatory, and over the potential inclusion of disclosure requirements in an
international regime on access to genetic resources and benefit-sharing, are addressed in Section
4.3. Meanwhile, Hoare and Tarasofsky (2007, p. 156) suggest that national disclosure
requirements have had limited impact thus far, ‘in part because they have not been in place very
long'. Another reason for the limited observed impact is that these requirements usually refer to
national patent applications only and thus do not affect patents filed, for example, through the
European Patent Office (EPO) or under the Patent Cooperation Treaty (PCT) (ibid., pp. 153,
156).39
4.1.3. Limitations in existing forms of IP for protecting traditional knowledge

The principal limitations on the foregoing approaches to providing affirmative and/or defensive
protection for TK are: (1) fragmentation of protection and a failure to address the protection of
TK holistically (Pires de Carvalho 2007, pp. 259–261); (2) the high transaction costs that are
often entailed in securing these forms of protection (Van Overwalle 2007, pp. 355, 360–361);40
"IP resources the right size, at the right time, in the right place" www.piipa.org Public Interest Intellectual Property Advisors 2011 – shared under a Creative Commons Attribution-NonCommercial-NoDerivs licence Intellectual Property and Human Development
(3) the unavailability of competent and affordable legal counsel to represent the interests of TK
holders in securing such protection (ibid.);41 and (4) the complications generated by the fact that
TK is often shared widely among communities, making it difficult, if not impossible, to identify
(or even define) true or legitimate owners or to obtain PIC from the same.42 While various types
of capacity building can to some extent overcome the first three limitations, the fourth constitutes
an inherent limitation in the use of IP tools such as patents and copyright as the primary or sole
means of protecting TK. On the latter point, the UNDP Human Development Report 2004 on
‘Cultural Liberty in Today's Diverse World' emphasizes that: ‘If current intellectual property
standards cannot accommodate commonly known traditional knowledge or its attributes of group
ownership, the rules will need to be revised' (UNDP 2004, p. 11).
4.2. National and regional traditional knowledge protection models

The CBD's affirmation of the ‘sovereign right' of states to exploit their own genetic resources
pursuant to their own environmental policies has stimulated a variety of national and regional
measures for regulating access to genetic resources and promoting benefit-sharing (see generally
Barber et al. 2002). These measures may promote, tolerate or discourage the practice of
‘bioprospecting' (ibid.).43 If a country (or region) wishes to encourage bioprospecting, it would
do well to follow the example of Costa Rica, and put in place a system that is: (1) relatively
simple and attractive to the private sector and research institutions; and (2) adds value to its stock
of genetic resources, which involves investing in building scientific capacity (ibid.).44 One of the
important objectives of the Costa Rican Biodiversity Law is to ‘provide compensation for the
knowledge, practices and innovations of Indigenous Peoples and local communities in the
conservation and sustainable ecological use of the components of biodiversity'.45 Other examples
of how this approach can be used to provide affirmative legal protection for TK are to be found
among the International Cooperative Biodiversity Group (ICBG) projects sponsored by the US
National Institutes of Health (see Rosenthal 1999, p. 5; Soejarto et al. 2007; McManis 2003, pp.
547, 553–554, 565–576), although some difficulties have been experienced in their practical
application (Heineke & Wolff 2004, p. 28).46
More and more national and regional legislative frameworks are being established to guard against misappropriation of genetic resources and associated TK, and to implement the principle of PIC. A WIPO document notes that almost all national sui generis laws for TK protection apply the principle of PIC to TK (see WIPO 2006b, p. 18 of Annex). For example, the African Model Law,47 the Brazilian Provisional Measure,48 the sui generis TK provisions under the Costa Rican Biodiversity Law,49 the Indian Biodiversity Act,50 the Peruvian sui generis law,51 the Indigenous Peoples' Rights Act of the Philippines,52 and the sui generis law of Portugal53 make access and acquisition to TK subject to PIC.54 Some elements of the Peruvian sui generis law are described in Box 4.4 alongside the Andean Community regional framework for the protection of TK. As national and regional systems give increasing weight to protecting against ‘biopiracy' and safeguarding interests and values such as PIC,55 there may be a ‘race to the bottom', with bioprospecting activities shifting to those countries with the least restrictive legislation.56 Regional agreements may ameliorate the latter problem, but only if coherent regional benefit-sharing arrangements are included, and if such agreements are widely adopted throughout the various regions of the world. It is the need for protection of TK beyond national and regional "IP resources the right size, at the right time, in the right place" www.piipa.org Public Interest Intellectual Property Advisors 2011 – shared under a Creative Commons Attribution-NonCommercial-NoDerivs licence Intellectual Property and Human Development
jurisdictions which has led increasingly to discussions of international frameworks for the protection of TK. This is discussed in Section 4.3. A joint paper published by the Southern Africa Development Community (SADC), International Union for the Conservation of Nature (IUCN) and United Nations Development Programme (UNDP) has called for the development of a SADC sub-regional legislative and policy framework on ABS in line with the socio-economic realities of the region.57 In this paper, Chishakwe and Young (2003, p. 15) highlight the need to develop standards promoting the interests of source countries especially, and to explore a regional or multi-regional ‘collective' approach under which source countries could band together to increase their bargaining power ‘in the face of the lack of credible information from genetic resource users on the value, markets, and mechanisms relevant to ABS'. Some have, indeed, argued that nothing short of a ‘biodiversity cartel' will effectively combat biodiversity loss and promote equitable benefit-sharing (see e.g. Vogel 2007, p. 115). Box 4.4. Regional and national sui generis systems for the protection of traditional
knowledge: A look at the Andean Community and Peru

Brendan Tobin and Emily Taylor58 The Andean Community (CAN) is empowered to enact regionally binding legislation.59 In 1996, CAN adopted Decision 391,60 which requires proof of prior informed consent, benefit-sharing and disclosure of origin for grant of patents (Cervantes-Rodriguez, 2006). Decision 391 was shaped by the belief that the sharing of genetic resources would become a source of considerable wealth for the countries involved; that states should have strict control over the flow of genes in order to combat biopiracy; and that parties entering into ABS agreements should consider not only national but also regional interests in decision making. The result was legislation requiring strict and complex state-led processes to regulate the use and transfer of genetic resources (Ruiz 2003a). Decision 391 also provided common regional standards to protect the rights of traditional communities. In 2000, CAN adopted Decision 486,61 establishing a regional regime for IPRs which sets out clear obligations regarding ABS and TK. Decision 486 was the first regional instrument to include binding legal obligations to disclose the origin and demonstrate a legal right to use genetic resources and TK in patent applications. These obligations apply to any application for a patent if the product or process for which the application is filed was obtained or developed from genetic resources, derived products or TK originating in any one of the CAN member countries. Decision 486 establishes an important precedent by subordinating the right to a grant of a patent to compliance with relevant Andean, international and national laws relating to acquisition of genetic resources and TK. This creates a link between the grant of IPRs and the manner of access to genetic resources and TK. Although the decision does not specifically mention customary law, its requirement that PIC be obtained from indigenous, Afro-American and local communities may in effect make the grant of patents conditional upon compliance with relevant customary laws relating to access and use of TK. The Decision provides that competent national authorities may, ex officio or upon request of a party at any time, declare a patent null and void when the applicant failed to show valid PIC for use of TK (Ruiz 2006).62 In August 2002, Peru adopted a legal protection regime for the collective knowledge of indigenous peoples derived from biological resources.63 This sui generis law recognizes the rights "IP resources the right size, at the right time, in the right place" www.piipa.org Public Interest Intellectual Property Advisors 2011 – shared under a Creative Commons Attribution-NonCommercial-NoDerivs licence Intellectual Property and Human Development
of indigenous peoples and communities to their collective knowledge (Article 1). The PIC of the relevant community is required for access to collective knowledge for the purposes of scientific, commercial and industrial application (Article 6). This PIC is to be obtained through the representative organizations of the indigenous peoples possessing the knowledge (Article 6). A written licensing agreement must be signed with the representative organization in question for commercial or industrial use of the collective knowledge, on terms that ensure due reward and guarantee an equitable distribution of the benefits derived from such use (Article 7; see also Articles 26 and 27). Article 13 provides that collective knowledge is deemed to be in the public domain when it has been made accessible to persons other than the indigenous peoples by mass communication media such as publication or, when the properties, uses or characteristics of a biological resource are concerned, where it has become extensively known outside the confines of the indigenous peoples and communities. In cases where the collective knowledge has passed into the public domain within the previous twenty years, a percentage (not less than 10%) of the value, before tax, of the gross sales resulting from the marketing of the goods developed on the basis of that knowledge shall be set aside for the Fund for the Development of Indigenous Peoples provided for in the Act (Articles 37 et seq.). In 2009, Peru entered into a Free Trade Agreement (FTA) with the US, and adopted Law 29316 to implement this FTA.64 Some aspects of the FTA and Law 29316 are on their face inconsistent with Decision 486 of the Andean Community and the national sui generis TK law, and have raised concerns about their implementation. Several concerns have been raised: first, that isolated genes and germplasm are not in the list of subject-matter exclusions from patentability; second, that there is not provision for the annulment of patents granted using TK for which evidence of a licence or authorization has not been provided; and third, that indigenous peoples' and local communities' rights to control access to and use of TK in the public domain are not secured. Law 29316 specifically states that access to TK in the public domain does not require PIC. As Decision 486 is directly binding upon Peru, implementation of both the FTA and Law 29316 will need to be carried out in a manner which conforms with its provisions. Source: Tobin & Taylor 2009, pp. 28–32; UNDP 2005, pp. 11–12. It is important, at the same time, to ensure that ABS legislation is transparent and not excessively burdensome towards access for academic or scientific research in good faith.65 There are areas of research involving genetic resources and associated TK which could yield significant breakthroughs for human development in areas including health and agriculture. What is important is that research on TK and associated genetic resources involve the consent and decision-making of custodians. The research communities are not always familiar, however, with national laws and mechanisms to obtain PIC, and in many cases these regulatory frameworks are yet to be put in place (see Laird & Wynberg 2008, pp. 126–128).66 As discussed earlier, some guidance on the principle of PIC is provided in the Bonn Guidelines. Beyond these guidelines, voluntary codes of conduct have been put together to help researchers apply the principle of PIC and establish equitable research relationships with indigenous peoples and local communities (see Box 4.2). As Laird and Wynberg observe: ‘Obtaining the prior informed consent of communities holding knowledge about biodiversity from the very outset of a project – and engaging them as active partners – is an absolutely fundamental principle of benefit sharing' (ibid., p. 97). There should also be mechanisms for the results of the research to be shared with the local communities. Box 4.5 provides an example of research into medical cures involving the active collaboration of TK holders. "IP resources the right size, at the right time, in the right place" www.piipa.org Public Interest Intellectual Property Advisors 2011 – shared under a Creative Commons Attribution-NonCommercial-NoDerivs licence Intellectual Property and Human Development
Box 4.5. Collaborative research between traditional knowledge holders and research
institutions: AIDS and cancer research based on the mamala tree
Some collaborative arrangements between indigenous peoples and external research institutions for
R&D based on TK have emerged over recent years. One development is an agreement entered into
in 2004 between the University of California, Berkeley, and the government of Samoa, for
development of prostratin, a new AIDS and cancer drug derived from indigenous uses of the
mamala tree. Scientists on the project are attempting to clone genes from the tree that naturally
produces prostratin for insertion into bacteria to make microbial factories for the drug. This project
involves collaborative research with indigenous peoples and reportedly provides for benefit-sharing
with various villages in Samoa (International Expert Group on Biotechnology, Innovation and
Intellectual Property [IEGBIIP] 2008, p. 31). It is said that PIC from the elders in the collaborating
villages was obtained for the project (Sanders 2004). Under the agreement, the state of Samoa and
UC Berkeley will hold equal shares in any commercial proceeds from the project (ibid.). It is said
that Samoa's 50% share will be allocated to the government, to villages, and to the families of
healers who first taught the ethnobotanist Dr. Paul Alan Cox how to use the plant (ibid.). The
agreement also states that UC Berkeley and Samoa will negotiate the distribution of the drug in
developing nations at a minimal profit if the scientists involved are successful in this process
(ibid.). A similar technology is currently being explored to produce the anti-malarial drug
artemisinin (ibid.). UC Berkeley is said to have committed itself to ‘exert reasonable efforts in
licensing such patents or copyrights for public benefit, keeping in mind UC Berkeley's and
Samoa's mutual goals of providing low cost therapies for free, at cost, or with minimal profit in the
developing world' (IEGBIIP 2008, p. 31). As with other projects involving the collaboration of TK
holders, it also remains to be seen what benefits are eventually shared with the local community,
and what mechanisms are in place to divide these benefits equitably within the community.
Source: Sanders 2004; IEGBIIP 2008, p. 31.
It is beyond the scope of this chapter to survey all regional and national efforts at sui generis TK and ABS systems. An important precedent in devising regional legislative frameworks for the protection of TK is the case of the Andean Community (see Box 4.4). Regional frameworks are also being considered or established in other regions and sub-regions.67 Examples include the Draft Framework for an African Instrument on the Protection of Traditional Knowledge (‘Draft ARIPO/OAPI Framework')68 and the Draft Legal Instrument for SAARC (South Asian Association for Regional Cooperation) Countries on Protection of Traditional Knowledge (‘Draft SAARC Instrument')69 which seek to balance access to TK with protection for the custodians of TK. The Draft SAARC Instrument states that TK protection ‘should be for the principal benefit of the holders of that knowledge', and specifies as particular beneficiaries ‘the traditional and tribal communities and peoples that develop, maintain and identify culturally with TK and seek to pass it on between generations, as well as recognized individuals within these communities and peoples'.70 At the same time, in identifying exceptions and limitations, the Draft Instrument provides, for example, that TK protection ‘should not adversely affect (i) the continued availability of traditional knowledge for the customary practice, exchange, use and transmission of traditional knowledge by traditional knowledge holders; and (ii) the use of traditional medicine for household purposes, use in government hospitals, or for other non-commercial public health purposes'.71 "IP resources the right size, at the right time, in the right place" www.piipa.org Public Interest Intellectual Property Advisors 2011 – shared under a Creative Commons Attribution-NonCommercial-NoDerivs licence Intellectual Property and Human Development
In relation to TAK, there are national and regional legislative attempts to recognize the important role of farmers as custodians of genetic resources and sustainers of crop evolution (i.e.
‘farmers' rights'), for example, by accomplishing benefit-sharing through a centralized funding
mechanism imposing a licensing fee on commercialization of protected plant varieties that will
be paid into a fund to promote traditional farming techniques (see Brush 2007, pp. 297, 309–
311).72
4.3. Development of harmonized international approaches to the legal protection of
traditional knowledge
Looking towards the future, suggestions for developing a harmonized international approach to
the legal protection of TK have taken three main forms. First, there are a variety of suggestions
for modifying international patent and/or plant variety standards to require, as a condition of
acquiring or enforcing patents or PVP rights, that the applicant or rights holder disclose the
origin of any genetic resources and/or TK relied upon in developing the relevant invention or
plant variety and provide evidence of PIC of the relevant source countries, communities and/or
individuals (Sarnoff & Correa 2006; see also McManis 2004, pp. 37, 469–474; Pires de Carvalho
2007, pp. 249–257). Second, there are a variety of more ambitious suggestions for creating an
entirely new, sui generis regime of IP protection for TK. Third, there is the recent emergence of
a hybrid form of facilitated access to plant genetic resources for food and agriculture, proprietary
protection for improved plant varieties (including at least some landraces embodying TAK), and
mandatory benefit-sharing, as adopted in the FAO International Treaty for Plant Genetic
Resources for Food and Agriculture (ITPGRFA).
At the Seventh Session of the Conference of the Parties (COP7) to the CBD, the COP mandated the Working Group on Access and Benefit-Sharing (ABS Working Group), with the collaboration of the Working Group on Article 8(j), ‘to elaborate and negotiate an international regime on access to genetic resources and benefit-sharing with the aim of adopting an instrument [or] instruments to effectively implement the provisions in Article 15 and Article 8(j) of the Convention and the three objectives of the Convention' (COP 7 Decision VII/19, Part D, para. 1).73 In doing so, the ABS Working Group seeks to ensure ‘the participation of indigenous and local communities, non-Governmental organizations, industry and scientific and academic institutions, as well as interGovernmental organizations' (ibid.). This mandate was renewed at the Eighth Session of the Conference of the Parties (COP 8), where a deadline was set to finalize the work of the ABS working group before the Tenth Session (COP 10) in 2010.74 At the Ninth Session (COP 9) in May 2008, the COP consolidated its work on a range of issues including those of relevance to IP, especially TK protection and the interplay between regulation of genetic resources and the patent system (see COP 9 Decision IX/12).75 A comprehensive work program was set for the following two years, with the goals of adopting an ABS regime (referring both to genetic resources and TK) by 2010 and carrying out further work on TK questions concerning Article 8(j) and other related articles of the CBD. Along with many elements of the regime discussed through successive meetings of the COP, some components further highlighted at COP 9 in relation to access to genetic resources/associated TK include non-discrimination of access rules; international access standards (that do not require harmonization of domestic access legislation) to support compliance across jurisdictions; "IP resources the right size, at the right time, in the right place" www.piipa.org Public Interest Intellectual Property Advisors 2011 – shared under a Creative Commons Attribution-NonCommercial-NoDerivs licence Intellectual Property and Human Development
internationally developed model domestic legislation; minimization of administration and transaction costs; and simplified access rules for non-commercial research (COP 9 Decision IX/12). Discussions in relation to the proposed international ABS regime have focused largely on potential requirements that inventions claiming or using genetic resources and associated TK disclose the source of such resources and knowledge in their patent applications and provide evidence of PIC (see also Section 4.1.2). It has been argued by some that requiring disclosure of origin and evidence of PIC as a condition for acquiring patent protection is inconsistent with the TRIPS Agreement and would thus require a revision of TRIPS (see Pires de Carvalho 2000; 2007, pp. 251–255). A study commissioned by PIIPA suggests, on the other hand, that most forms of the disclosure of origin requirement, as conditions on patent acquisition, are not inconsistent with the TRIPS Agreement.76 Notwithstanding the recent success in revising the TRIPS compulsory licensing requirements, however, it seems highly unlikely that the industrialized world will agree to such a condition for acquiring patent rights, for two reasons. First, such a requirement could be perceived as imposing on patent offices a crushing burden to evaluate the sufficiency of disclosures on potentially large numbers of patent applications with respect to matters about which patent offices have no particular expertise, as the expertise of patent examiners extends only to the assessment of technology, not to assessment of the sufficiency of disclosure of origin and evidence of PIC (McManis 2004, p. 471). Second, the cost of such a requirement might outweigh any economic benefits generated as a majority of issued patents ultimately turn out to be worthless (ibid.). In a study prepared for UNCTAD, Sarnoff and Correa (2006) identify, on the other hand, ways of implementing a disclosure obligation without imposing a ‘crushing burden' on patent offices. A more nuanced version of the disclosure of origin and PIC requirement may be to make it a condition for the enforcement of an otherwise valid patent or PVP certificate, by analogy to the well-established (in jurisdictions such as the US) equitable patent defence of unclean hands. While the appropriate disclosures could be required as a part of the application process, the sufficiency of those disclosures would be evaluated by courts, not patent offices. The rights holder of an otherwise valid patent or certificate would seek to enforce it through infringement proceedings only if the patent or certificate has sufficient value. The de facto penalty for inadequate initial disclosure of origin and/or PIC would be that, as a condition for enforcing an otherwise valid and clearly valuable IP right, the right holder would first be required to retroactively negotiate a benefit-sharing agreement with any relevant source country, communities and/or individuals from whom PIC originally should have been obtained (McManis 2004, pp. 471–472). The primary limitation on this form of TK protection is that it assumes the ability to define and identify those TK or genetic-resource holders from whom PIC must be obtained. As pointed out earlier, a resort to customary rules has been necessary in many practical cases to resolve complex issues over the identification of legitimate owners of TK and their representatives. This is one of the most problematic issues to overcome in any future scenario on protecting TK. Furthermore, challenging an issued patent usually requires significant mobilization and expenses in litigation, an option that is beyond the means of most TK custodians.77 "IP resources the right size, at the right time, in the right place" www.piipa.org Public Interest Intellectual Property Advisors 2011 – shared under a Creative Commons Attribution-NonCommercial-NoDerivs licence Intellectual Property and Human Development
Beyond the discussions on an ABS regime, one of the issues that has been increasingly raised is whether there should furthermore be an international treaty addressing the sui generis protection of TK. Pires de Carvalho (2007, pp. 264–268) suggests, for instance, that such a treaty could contain minimum, mandatory standards relating to the acquisition and enforcement of rights while leaving countries free to define, at the national level, the scope of protection and the identification of the owners (i.e. the attribution of rights). He adds that such a treaty could draw from the flexible notion of ‘same treatment' adopted in the Paris Convention for the Protection of Industrial Property, to ensure reciprocity (ibid., pp. 264–265).78 In a paper prepared for the Commonwealth Secretariat, Drahos emphasizes that any treaty on TK would have to accommodate the diversity of TK and different national standards of protection, and that the key to any successful treaty at the international level is ‘harmonious and cooperative relationships between indigenous groups and national governments'.79 He suggests that, at this stage of the evolution of protection for TK, a treaty should not attempt to set substantive international norms of protection which might discourage the development of national approaches and norm-creation on TK. He argues, rather, that an international treaty should offer the treaty members a means of cooperating and coordinating with respect to the enforcement of TK. The history of efforts to develop sui generis forms of IP protection, including the recent regional experience of the EU with respect to database protection, suggests some obstacles ahead. First, intense political lobbying on the part of a narrow class of interested stakeholders may result in a product reflecting the relative political clout of the various stakeholders rather than what is actually in the public interest, and is also more likely to generate conflict than consensus among competing stakeholders (McManis 2004, pp. 474–475). Second, in cobbling together hybrid IP systems, it may be difficult to calibrate the cost of acquiring protection with the resulting value of the rights bestowed (ibid., pp. 475–476).80 Third, sui generis IP protection, like other forms of IP protection, assumes the ability to define and identify TK owners. The lack of consensus so far on whether there should be a TK treaty, and on the potential nature and coverage of such a treaty, has led the IGC at WIPO to focus meanwhile on drafting policy objectives and core principles, as encapsulated in the WIPO Revised Draft Provisions for the Protection of Traditional Knowledge.81 These draft provisions may be developed further, and it remains to be seen whether they are eventually adopted as part of a treaty. A third international approach to TK protection is embodied in the ITPGRFA, which envisions a hybrid system, ensuring ‘facilitated access' to (i.e. no IP protection on) plant genetic resources in the precise form received into the Multilateral System, but also ensuring the development of both public and proprietary improved plant varieties based on plant genetic resources from the Multilateral System, and mandatory benefit-sharing with respect to commercially developed plant varieties (Brush 2003). These benefits are to be deposited into an appropriate mechanism, such as a Trust Account, which the Governing Body can utilize to implement the ITPGRFA.82 Such funds could be used not only to compensate identifiable TAK holders but also to subsidize traditional farming practices that contribute genetic resources to the Multilateral System, thus ameliorating the problem of defining and identifying specific TAK holders (Guerin-McManus, Nnadozie & Laird 2002, pp. 333–359). According to Article 13.3 of "IP resources the right size, at the right time, in the right place" www.piipa.org Public Interest Intellectual Property Advisors 2011 – shared under a Creative Commons Attribution-NonCommercial-NoDerivs licence Intellectual Property and Human Development
the ITPGRFA, the benefits arising from the use of plant genetic resources for food and
agriculture shared under the Multilateral System should flow, primarily, to farmers in all
countries (especially developing countries and countries with economies in transition) who
conserve and sustainably utilize plant genetic resources for food and agriculture. Importantly,
Article 9 of the ITPGRFA recognizes the responsibilities of national governments to promote
and protect farmers' rights. These include rights to the protection of TK relevant to plant genetic
resources for food and agriculture; to equitably participate in sharing benefits arising from the
utilization of such resources; as well as to participate in decision-making at the national level on
matters related to their conservation and sustainable use (Article 9).
5. Conclusion

The trends discussed in this chapter suggest at least three potentially overlapping scenarios for
the future legal protection of TK: (1) continuing and/or increased reliance on existing means of
legal protection for TK (McManis 2004); (2) development of non-uniform, country-specific (or
region-specific) means for protecting TK (Barber, Glowka & La Vina 2002); and (3)
development of internationally harmonized approaches to the protection of TK (Pires de
Carvalho 2007). While there have been significant discussions and efforts towards harmonized
approaches at the international level, the progress has been slow and it is not impossible to
envisage a scenario where negotiations on the subject break down. The latter might be brought
about by a variety of factors, such as developed country manoeuvring or widening differences
among developing countries. There might also be a realization among developing countries that
the economic stakes are not so high as they had been led to believe. This would not preclude
breakthroughs at national and regional levels; it just suggests that multilateral solutions may
never be achieved. The development of new disciplines and technologies such as bioinformatics,
genomics, proteomics and synthetic biology may meanwhile dilute some of the attention on the
use of TK for pharmaceutical R&D, by facilitating the alternative use of information tools to
create and model new products. At the same time, the establishment of an international regime
on access to genetic resources and benefit-sharing within the CBD framework, if successful at
COP 10, might perhaps have a catalytic effect on negotiations towards multilateral frameworks
targeting the protection of TK.
Scenario planning by indigenous and local communities might be one way of teasing out the issues and challenges, as well as options, in the protection of their TK. Our literature review found that little scenario planning has been conducted so far in this area, whether at the local or international level. Box 4.6 summarizes some of the driving forces and uncertainties which may combine with other factors to shape the legal protection of TK in the future. Along with the trends identified in this chapter, such considerations might be helpful towards any scenario planning carried out on this theme. Among other issues discussed in the chapter, a major consideration for the future would be in clarifying the role of customary laws of indigenous peoples in informing and shaping the legal protection of TK. Few national sui generis systems currently make explicit reference to the customary laws of indigenous peoples. In this regard, a working group of indigenous experts on the TK of the Andean Community have notably elaborated a proposal for the sui generis protection of TK from the indigenous perspective, taking into account the customary laws and "IP resources the right size, at the right time, in the right place" www.piipa.org Public Interest Intellectual Property Advisors 2011 – shared under a Creative Commons Attribution-NonCommercial-NoDerivs licence Intellectual Property and Human Development
cultural practices of the indigenous peoples of the member countries of the Andean Community.83 This proposal could present an interesting reference for other reforms at the national, regional and international levels (Ruiz 2006, pp. 175–176). Box 4.6. Some uncertainties and driving forces for the future protection of traditional
knowledge84
The future protection of TK is shaped by a number of uncertainties including:
(1) The choice of forum for resolving issues relating to TK and genetic resources, and whether
there will be some concerted effort to coordinate the discussions and work at the different forums which have pursued quite separate agendas;85 (2) Potential strategic alliances amongst developing countries;86
(3) Indigenous peoples' access to decision-making processes whether at the national or
international levels, and related capacity-building; (4) Whether developing country governments will maintain a sustained interest in TK protection
once market access is gained in other areas under the multilateral framework or through FTAs;87 (5) The extent to which international instruments and individual governments will go in
recognizing the land rights, self-determination and customary law of indigenous peoples; (6) The effects of new technology on future research demands for genetic resources and TK;
(7) Whether IP is increasingly seen as a problem in TK protection or part of the solution; and
(8) Whether protection of TK is approached piecemeal, or seen as part of integrated approaches
towards the protection and transmission of indigenous bio-cultural heritage. Given these and other uncertainties, scenario planning offers a way to grapple with several alternatives, including an international sui generis regime for the protection of TK. Would such a regime harmonize national laws in this area, or might it provide a system where different instruments play different roles?88 As the protection of the TK of indigenous peoples is increasingly addressed within the framework of human rights, the interaction between IP and human rights regimes are likely to take on further importance. Indeed, while there are many initiatives and discussions on the protection of TK at various levels, a pivotal component that is often missing is the indigenous peoples' full participation as their own representatives, describing their own vision of the future protection of TK and the directions this should take. As recently pointed out in a paper by the Call of the Earth (2007): ‘While IP debates relevant to TK, cultural expressions and human genetic resources are all about Indigenous Peoples and directly affect their cultural integrity and livelihoods, Indigenous Peoples have only limited participatory rights in the international policy making fora where decisions are made'.89 Referring to the ‘Way Forward', this paper emphasizes that ‘full and effective participation of Indigenous Peoples in all policy making processes that affect them is a necessary pre-cursor to appropriate policy making' and that ‘in a number of different fora Indigenous Peoples have called for participatory arrangements that reflect their status as rights holders' (ibid.). The effective participation of indigenous peoples and local communities in policymaking regarding the protection of TK requires significant capacity building, including training on these legal issues, access to planning resources,90 the use of languages accessible to these peoples and "IP resources the right size, at the right time, in the right place" www.piipa.org Public Interest Intellectual Property Advisors 2011 – shared under a Creative Commons Attribution-NonCommercial-NoDerivs licence Intellectual Property and Human Development
communities in national and international forums addressing related reforms, access to decision-
making in such forums, and the direct involvement of these peoples and communities in research
on these issues. The results of relevant research have to be devolved to the indigenous and local
communities in a comprehensible way and format. Importantly, integrated solutions are needed
for the protection of TK, going beyond the legal measures discussed in this chapter. As Laird and
Wynberg (2008, p. 98) point out, there is ‘an urgent need to introduce new forms of protection
for traditional knowledge that not only give communities rights over their knowledge but also
enable the wider preservation and promotion of such knowledge systems'.
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1 Substantive inputs have been received from Graham Dutfield, Michael Gollin, Claudia Fernandini, Manuel Ruiz,
Joshua Sarnoff and Tzen Wong. 2 Quoted in United Nations Environment Programme/ Convention on Biological Diversity (UNEP/CBD) Ad Hoc Open-Ended Working Group on Access and Benefit Sharing 2001, para. 21 [hereinafter ‘UNEP/CBD Report 2001']. 3 See further UNEP/CBD Report 2001, p. 5, where it is clarified that: ‘In the context of knowledge, innovation is a feature of indigenous and local communities whereby tradition acts as a filter through which innovation occurs. In this context, it is traditional methods of research and application and not always particular pieces of knowledge that persist. Practices should therefore be seen as the manifestations of knowledge and innovation.' "IP resources the right size, at the right time, in the right place" www.piipa.org Public Interest Intellectual Property Advisors 2011 – shared under a Creative Commons Attribution-NonCommercial-NoDerivs licence Intellectual Property and Human Development
4 See WIPO 2006a, Introduction Section. 5 Paris Convention for the Protection of Industrial Property (Paris, 20 March 1883), as revised at Stockholm, 14 July 1967, and amended 28 September 1979, 828 U.N.T.S. 303 (entered into force 7 July 1884) [hereinafter ‘Paris Convention'], available at: http://www.wipo.int/export/sites/www/treaties/en/ip/paris/pdf/trtdocs_wo020.pdf (accessed 3 February 2010). 6 Berne Convention for the Protection of Literary and Artistic Works (Berne, 9 September 1886), as revised at Paris, 24 July 1971, and amended 28 September 1979, 1161 U.N.T.S. 30 (The Act of Paris entered into force 15 December 1972) [hereinafter ‘Berne Convention'], available at: http://www.wipo.int/treaties/en/ip/berne/trtdocs_wo001.html (accessed 3 February 2010). 7 WIPO 2001, para. 65. The Secretariat suggests that the more important definitional and conceptual issues have to do with the substantive and procedural standards affecting the availability, acquisition, scope, maintenance and enforcement of IPRs (ibid.). 8 See also Pant, R. 2006, ‘Globalization and Intellectual Property Legislation in India: Protection of TK and Plant Variety Protection', paper presented at the XVth Congress of the Commission on Folk Law and Legal Pluralism, 28 June – 2 July 2006, Depok, Indonesia, available at: http://www.solutionexchange-un.net.in/environment/cr/res02010702.doc (accessed 15 November 2010). She notes that: ‘[I]ncorporation of customary laws and principles in the sui generis systems will only provide protection to TK and the bio-genetic resources, when these get sufficient respect and recognition in the formal legal, judicial and administrative processes. Not only is the space provided to customary laws at the higher judicial levels wanting, these have to be comprehended by the society at large' (ibid., p. 20). 9 Pretty, J., Adams, B., Berkes, F., Ferreira de Athayde, S. et al. 2008, ‘How do Biodiversity and Culture Intersect?', paper presented at the conference ‘Sustaining Cultural and Biological Diversity In a Rapidly Changing World: Lessons for Global Policy', organized by American Museum of Natural History's Center for Biodiversity and Conservation, International Union for Conservation of Nature (IUCN) and Terralingua, 2–5 April 2008, pp. 3–6, available at: http://symposia.cbc.amnh.org/archives/biocultural/pdf-docs/intersect.doc (accessed 16 November 2008). They note that ‘languages encode knowledge bases in a way that is often non-translatable into other languages but nonetheless bridges its speakers to their landscape inextricably' (ibid., p. 6). 10 Pimm and Brooks (1997) discuss the impending ‘sixth great extinction' – due to the impact of human activity on the natural world. 11 International Covenant on Economic, Social and Cultural Rights (New York, 16 December 1966), 993 U.N.T.S. 3, 6 I.L.M. 360 (1967), G.A. Res. 2200A (XXI), UN Doc. A/6316 (1966) (entered into force 3 January 1976) [hereinafter ‘ICESCR'], available at http://www2.ohchr.org/english/law/cescr.pdf (accessed 3 February 2010); see Articles 15 and 27, discussed in Chapters 1 and 5. 12 International Labour Organization (ILO) Convention Concerning Indigenous and Tribal Peoples in Independent Countries (No. 169) (Geneva, 27 June 1989), 1650 U.N.T.S. 383, 28 I.L.M. 1382, 72 ILO Official Bull. 59 (1989) (entered into force 5 September 1991), available at: http://www.un-documents.net/c169.htm (accessed 22 February 2010). Article 2 of the Convention states that: ‘Governments shall have the responsibility for developing, with the participation of the peoples concerned, co-ordinated and systematic action to protect the rights of these peoples and to guarantee respect for their integrity.' Article 5 of the Convention states that: ‘In applying the provisions of this Convention: (a) The social, cultural, religious and spiritual values and practices of these peoples shall be recognised and protected, and due account shall be taken of the nature of the problems which face them both as groups and as individuals; (b) The integrity of the values, practices and institutions of these peoples shall be respected; (c) Policies aimed at mitigating the difficulties experienced by these peoples in facing new conditions of life and work shall be adopted, with the participation and co-operation of the peoples affected.' 13 Convention on Biological Diversity (Rio de Janeiro, 5 June 1992), 1760 U.N.T.S. 79, 31 I.L.M. 818 (1992) (entered into force 29 December 1993) [hereinafter ‘CBD'], available at http://www.cbd.int/doc/legal/cbd-un-en.pdf (accessed 3 February 2010). 14 As Degawan (2008, p. 53) notes, indigenous peoples ‘face the direct adverse consequences of climate change on a daily basis'. They experience the ‘drying-up of once fertile farmlands, the torrential floodwaters that inundate their soon-to-be harvested gardens, the dwindling water supply during summer, and the diminishing of the fruits of the land in general' (ibid.). 15 See International Workgroup for Indigenous Affairs 2007, ‘Declaration on the Rights of Indigenous Peoples', available at: http://www.iwgia.org/sw248.asp (accessed 21 November 2008). "IP resources the right size, at the right time, in the right place" www.piipa.org Public Interest Intellectual Property Advisors 2011 – shared under a Creative Commons Attribution-NonCommercial-NoDerivs licence Intellectual Property and Human Development
16 Agreement on Trade-Related Aspects of Intellectual Property Rights (Marrakesh, 15 April 1994), Marrakesh Agreement Establishing the World Trade Organization, Annex 1C, 1869 U.N.T.S. 299, 33 I.L.M. 1197 (1994) (entered into force 1 January 1995) [hereinafter ‘TRIPS Agreement'], available at: http://www.wto.org/english/tratop_e/trips_e/t_agm0_e.htm (accessed 3 February 2010). 17 See generally United Nations Conference on Trade and Development & International Centre for Trade and Sustainable Development (UNCTAD-ICTSD) 2005. 18 Food and Agriculture Organization (FAO) International Treaty on Plant Genetic Resources for Food and Agriculture (Rome, 3 November 2001), FAO Conference Res. 3/2001, S. Treaty Doc. No. 110–19 (entered into force 29 June 2004) [hereinafter ‘'ITPGRFA'], available at: http://www.planttreaty.org/texts_en.htm (accessed 16 March 2010). 19 Article 13.3 of the FAO ITPGRFA specifies that the benefits arising from the use of plant genetic resources for food and agriculture that are shared under the Multilateral System should flow primarily, directly and indirectly, to farmers in all countries, especially in developing countries, and countries with economies in transition, who conserve and sustainably use plant genetic resources for food and agriculture. 20 See World Trade Organization (WTO), Ministerial Declaration (Doha, 14 November 2001), 41 I.L.M. 746 (2002), Doc. WT/MIN(01)/DEC/W/1 [hereinafter ‘Doha Ministerial Declaration'], available at: http://www.wto.org/English/thewto_e/minist_e/min01_e/mindecl_e.htm (accessed 1 March 2010). 21 See Conference of the Parties (COP) to the Convention on Biological Diversity (CBD), Decision VI/24/A: Bonn Guidelines on Access to Genetic Resources and Fair and Equitable Sharing of the Benefits Arising out of their Utilization (The Hague, 19 April 2002), UN Doc. UNEP/CBD/COP/6/20 (2002), pp. 262–278 [hereinafter ‘Bonn Guidelines'], available at: http://www.cbd.int/decision/cop/?id=7198 (accessed 16 March 2010). 22 Contributed by Graham Dutfield and Tzen Wong. 23 Conference of the Parties (COP) to the CBD, Decision V/16: Article 8(j) and related provisions (Nairobi, 26 May 2000), UN Doc. UNEP/CBD/COP/5/23 (2000), pp. 139–146, available at: http://www.cbd.int/doc/decisions/COP-05-dec-en.pdf (accessed 26 March 2010). 24 The ISE is also developing an internet-based ‘ethics' toolkit with supporting material for implementation of the Code of Ethics. See the ISE website, available at: http://www.ethnobiology.net/ (accessed 23 April 2010). 25 United Nations Declaration on the Rights of Indigenous Peoples (13 September 2007), 46 I.L.M. 1013 (2007), G.A. Res. 61/295, UN Doc. A/RES/61/295 (2007), available at: http://www.un.org/esa/socdev/unpfii/documents/DRIPS_en.pdf (accessed 24 March 2010). 26 See the International Work Group for Indigenous Affairs (IWGIA) website, available at: http://www.iwgia.org/sw18043.asp (accessed 26 March 2010). Australia has recently changed its position and endorsed the Declaration. See Statement on the United Nations Declaration on the Rights of Indigenous Peoples, Parliament House, Canberra, 3 April 2009, available at: http://www.jennymacklin.fahcsia.gov.au/internet/jennymacklin.nsf/content/un_declaration_03apr09.htm (accessed 8 March 2010). 27 Ibid. See International Workgroup for Indigenous Affairs 2006, ‘Africa Proposes No Action on Adoption of the
Declaration', available at: http://iwgia.synkron.com/graphics/SynkronLibrary/Documents/Noticeboard/News/International/AfricaproposesnoactionDD.htm (accessed 21 November 2008). 28 National Law 3760, passed in November 2007. 29 See generally UNCTAD-ICTSD 2005. 30 The restriction in relation to ‘essentially derived varieties' was introduced in the 1991 Act of the International Convention for the Protection of New Varieties of Plants as administered by UPOV for protection of plant varieties, and applies to countries bound by the said Act of the Convention. See International Convention for the Protection of New Varieties of Plants (Paris, 2 December 1961), 815 U.N.T.S. 89 (entered into force 10 August 1968), as revised at Geneva, 10 November 1972, 23 October 1978 and 19 March 1991 [hereinafter ‘UPOV Convention'], available at: http://www.upov.int/en/publications/conventions/index.html (accessed 24 February 2010). See Jördens 2002, p. 19. 31 International Seed Trade Federation/International Association of Plant Breeders (FIS/ASSINSEL) 1999. 32 See CIPR 2002, pp. 76–78, for some case studies. See also Dutfield 2000, pp. 65–67. Patent litigation has also been initiated through PIIPA's pro bono network on behalf of the Peruvian Working Group on Maca, to challenge the validity of a number of US patents involving maca root, a traditional medicine of the Inca. See Upano, A. "IP resources the right size, at the right time, in the right place" www.piipa.org Public Interest Intellectual Property Advisors 2011 – shared under a Creative Commons Attribution-NonCommercial-NoDerivs licence Intellectual Property and Human Development
2004, ‘D.C. Team Gets to the Root of the Problem', Legal Times, 12 January 2004, vol. XXVII, no. 2, available at: http://www.piipa.org/Upano1–12-04.pdf (accessed 26 March 2010). 33 This includes Thai Patents Numbers 046779, 048605 and 052443 claiming extracts of Pueraria mirifica (white kwao krua), Butea superba (red kwao krua) and/or Mucuna collettii (black kwao krua). In addition, the claimed invention under Thai Patent No. 052443 was also the subject of a patent invention in the US filed under US Patent No. 6,673,377. See discussion in Kuanpoth and Robinson 2009. 34 See Berne Declaration website, ‘The Hoodia Case – A Side Event at the COP in Curitiba', 29 March 2006, available at: http://www.bernedeclaration.ch/en/p25011028.html (accessed 26 March 2010). 35 While Laird and Wynberg (2008, p. 93) cite sources to give an idea of the high stakes potentially involved in the ‘functional food' sector, earlier expectations of windfall benefits from hoodia might have been optimistic: turning hoodia into a functional food product is not a straightforward process, whether technically or commercially. 36 For the most detailed coverage of the hoodia case and its wider implications, see Wynberg, Schroeder and 37 Art. 15(2) of the 1991 Act of the UPOV Convention, available at: http://www.upov.int/en/publications/conventions/1991/act1991.htm (accessed 30 November 2008). 38 See the Swiss Federal Institute of Intellectual Property website, ‘Patent Law Reform – Biotechnological Inventions', available at: https://www.ige.ch/en/legal-info/legal-areas/patents/biotechnological-inventions.html (accessed 20 April 2010). 39 Patent Cooperation Treaty (Washington,19 June 1970), 1160 U.N.T.S. 231, 9 I.L.M. 978 (1970), 28 U.S.T. 7645 (entered into force 24 January 1978), as amended 3 October 2001 (entered into force as amended 1 April 2002), available at: http://www.wipo.int/pct/en/texts/articles/atoc.htm (accessed 3 February 2010). 40 One means of lowering the cost of IP protection would be to adopt a lower fee structure for indigenous communities and other TK holders, somewhat analogous to the discounted fees that the United States Patent and Trademark Office (USPTO) charges individual inventors, small businesses, and non-profit educational institutions. United States patent law also allows for provisional patent applications, which effectively extends the period in which claims must be filed, and allows patent applications to remain confidential if the applicant waives the right to file in jurisdictions other than the US. 41 This limitation, and to a certain extent the previous two limitations as well, can be ameliorated by appropriate legal capacity building, as represented by the activities of PIIPA. See Gollin 2007 and McManis 2007, who, respectively, discuss an existing network of pro bono IP lawyers and an existing IP legal clinic that have the capacity to provide IP legal services to TK holders. 42 A partial response to this problem would be to relax any existing requirements that IP applicants be individuals or legal entities, and permit contractual associations of individuals to file for protection. 43 An outright prohibition against access to genetic resources, however, would appear to violate the CBD requirement that members facilitate access to genetic resources. 44 As a practical matter, such a system will largely rely on private contracting, with minimal state regulation and 45 Article 10.6, Costa Rican Law No. 7788 of 1998 on Biodiversity (‘Costa Rican Biodiversity Law'), available at: http://www.wipo.int/clea/en/text_pdf.jsp?lang=ES&id=896 (accessed 30 November 2008). 46 Referring to the contractual solutions for ABS under the ICBG program, Heineke and Wolff (2004, p. 28) observe that: ‘The actual outcome of negotiations in the form of a contractual agreement always depends on the bargaining power of the different actors involved. Indigenous and local communities often lack the knowledge of possible benefits or the legal capacity to negotiate a fair contract'. 47 African Model Legislation for the Protection of the Rights of Local Communities, Farmers and Breeders, and for the Regulation of Access to Biological Resources of 2000 (‘African Model Law'), available at: http://www.grain.org/brl_files/oau-model-law-en.pdf (accessed 30 November 2008). 48 Brazilian Provisional Measure No. 2186–16 of 2001 Regulating Access to the Genetic Heritage, Protection of and Access to Associated Traditional Knowledge (‘Brazilian Provisional Measure'). See Articles 16(9) and 16(4) on PIC generally, as well as Articles 21 and 24 on mutually agreed terms, available at: http://www.grain.org/brl/?docid=850&lawid=1768 (accessed 30 November 2008). 49 See Article 63 (1)–(3). 50 Indian Biological Diversity Act of 2002 (‘Indian Biodiversity Act'), available at: http://www.grain.org/brl_files/india-biodiversityact-2002.pdf (accessed 30 November 2008). See section 3.1 of the Act; see also section 21 on mutually agreed terms and benefit-sharing. "IP resources the right size, at the right time, in the right place" www.piipa.org Public Interest Intellectual Property Advisors 2011 – shared under a Creative Commons Attribution-NonCommercial-NoDerivs licence Intellectual Property and Human Development
51 Law No. 27,811 of 2002 Introducing a Protection Regime for the Collective Knowledge of Indigenous Peoples Derived from Biological Resources (‘Peruvian Sui Generis Law'). See Article 6. 52 Indigenous Peoples Rights Act of 1997 (‘Philippines Act'), available at: http://www.grain.org/brl/?docid=801&lawid=1508 (accessed 10 December 2008). See section 35. 53 Portuguese Decree Law No.118 of 2002 Establishing a Legal Regime of Registration, Conservation, Legal Custody and Transfer of Plant Endogenous Material (‘Portuguese Sui Generis Law'). See Article 7(1). 54 These laws are discussed in WIPO 2006b, p. 18 of Annex. 55 Two examples are the Philippines Executive Order 247 on Access to Genetic Resources and Benefit Sharing and Decision 391 of the Andean Community. 56 Although Philippines Executive Order 247 (EO 247) represents the first comprehensive ABS regime, for the first four years of EO 247's operation, only fifteen applications were received – most of them were from local universities seeking academic research agreements and only one commercial research agreement was approved. Moreover, Bristol-Myers Squibb announced that it would not pursue natural products research in countries that impose requirements similar to those contained in EO 247. See Barber et al. 2002, pp. 408–409. While regional agreements, such as Decision 391 of the Andean Community, may deter competition among countries and promote regional benefit-sharing, Decision 391 itself does not establish specific mechanisms through which benefits may be shared among member states (ibid., p. 381). 57 For recent developments in the SADC, see Wynberg, Taylor and Laird 2007; Wynberg and Taylor 2009. 58 Extract from Tobin and Taylor 2009, pp. 28–32. 59 The Andean Community of Nations includes Bolivia, Colombia, Ecuador and Peru. The Bolivarian Republic of Venezuela, a member of CAN and its predecessor the Andean Pact, retired from the regional group in 2004. 60 CAN Decision 391, Régimen Común sobre Acceso a los Recursos Genéticos (Common Regime on Access to Genetic Resources), available at: http://www.comunidadandina.org/normativa/dec/d391.HTM (accessed 17 November 2009). 61 CAN Decision 486, Régimen Común sobre Propiedad Industrial (Common Regime on Industrial Property), available at: http://www.comunidadandina.org/normativa/dec/d486.HTM (accessed 17 November 2009). 62 On some potentials and limitations of CAN Decision 486, see Ruiz 2003b. 63 Peruvian Law 27811, Protection of Indigenous Peoples' Collective Knowledge Associated with Biological Resources 2002, available at: http://www.grain.org/brl/?docid=81&lawid=2041 (accessed 10 November 2009). 64 Peruvian Law 29316, Ley Que Modifica, Incorpora y Regula Diversas Disposiciones a fin de Implementar el Acuerdo de Promoción Comercial Suscrito Entre El Perú Y Los Estados Unidos De América (El Peruano, Lima, 14 January 2009). 65 The line may not always be clear between research for academic and commercial purposes, for example, in cases where primary or applied research at academic institutions is funded in part by commercial entities. The effects of some ABS policies on scientific research are considered by Laird and Wynberg (2008). They note that: ‘Researchers in both academia and industry express significant concern about the negative impact ABS is having upon basic science and upon traditions of trust and collaboration among scientists. Just as scientific and technological developments have dramatically improved our ability to study and use genetic and biochemical resources, the availability of organisms to research has diminished, including in countries with extremely threatened ecosystems where the future of these organisms is uncertain. Many felt that countries were shutting themselves behind an "iron curtain" and setting back their own capacity and development. Craig Venter, Director of the Venter Institute, remarked at a recent public lecture, "If Darwin were alive today, he would not have been able to have done his research"' (ibid., p. 128). 66 Laird and Wynberg (2008, p. 126) note that although more than 75 Contracting Parties have been involved in ABS law and policy development, only 26 of the 188 Contracting Parties to the CBD have adopted ABS laws and procedures. 67 For developments in the Asia-Pacific region, see Antons 2009. 68 African Regional Industrial Property Organization (ARIPO) and Organisation Africaine de la Propriété Intellectuelle (OAPI), Draft Framework for an African Instrument on the Protection of Traditional Knowledge (1998) [hereinafter ‘Draft ARIPO/OAPI Framework']; incorporated in ARIPO Regional Legal Instrument on the Protection of Traditional Knowledge and Expressions of Folklore (Maputo, 24 November 2006); OAPI Legal Instrument on ‘The Protection of Traditional Knowledge and Folklore' (Niamey, 27 July 2007). 69 South Asian Association for Regional Cooperation (SAARC), Draft Legal Instrument for SAARC Countries on Protection of Traditional Knowledge (approved by the SAARC Summit in 2006) [hereinafter ‘Draft SAARC "IP resources the right size, at the right time, in the right place" www.piipa.org Public Interest Intellectual Property Advisors 2011 – shared under a Creative Commons Attribution-NonCommercial-NoDerivs licence Intellectual Property and Human Development
Instrument'], available at: http://www.sdc.gov.in/Downloads/TKDL/Reportmain.htm#point24 (accessed 21 April 2010). 70 Article 8 of the Draft SAARC Instrument. 71 Article 7ter of the Draft SAARC Instrument. 72 Taxing certified crop varieties in this manner is likely to offer meagre financial resources, for two reasons. First, even in industrialized countries, PVP certificates have relatively low or negligible economic value, depending on the scope of the statutory privilege of farmers to save and replant seeds of protected varieties. Second, modern breeding programmes are increasingly dependent on the use of ‘elite' breeding lines that are several generations removed from farmers' varieties, thus making it difficult to estimate the contribution that a single landrace or collection makes to the value of a modern variety. One possible solution to this problem is the system of benefit-sharing envisioned in the ITPGRFA. 73 Conference of the Parties (COP) to the CBD, Decision VII/19: Access and benefit-sharing as related to genetic resources (Article 15) (Kuala Lumpur, 20 February 2004), UN Doc. UNEP/CBD/COP/DEC/VII/19, available at: http://www.cbd.int/decision/cop/?id=7756 (accessed 21 April 2010). 74 See Conference of the Parties (COP) to the CBD, Decision VIII/4: Access and benefit-sharing (Curitiba, 31 March 2006), UN Doc. UNEP/CBD/COP/DEC/VIII/4, available at: http://www.cbd.int/decision/cop/?id=11016 (accessed 21 April 2010). 75 See Conference of the Parties (COP) to the CBD, Decision IX/12: Access and benefit-sharing (Bonn, 30 May 2008), UN Doc. UNEP/CBD/COP/DEC/IX/12, available at: http://www.cbd.int/decision/cop/?id=11655 (accessed 21 April 2010). 76 See Sarnoff, J. 2004, Memorandum on ‘Compatibility With Existing International Intellectual Property Agreements of Requirements for Patent Applicants to Disclose Origins of Genetic Resources and Traditional Knowledge and Evidence of Legal Access and Benefit Sharing', Washington College of Law, available at: http://www.piipa.org/DOO_Memo.doc (accessed 10 December 2008). PIIPA commissioned this legal report from the IP clinic at American University's Washington College of Law, based on an issue framed with the Peruvian Working Group. The report concludes that it is consistent with international treaties if a national patent law requires patent applicants to file proof that biological materials were obtained with a suitable ABS agreement. The report is available to the public to assist other developing countries in bilateral and multilateral trade negotiations. 77 Pro bono assistance may be available in some cases (see Upano 2004), but is not available in all cases. 78 Article 2 of the Paris Convention for the Protection of Industrial Property provides that: ‘Nationals of any country of the Union shall, as regards the protection of industrial property, enjoy in all the other countries of the Union the advantages that their respective laws now grant, or may hereafter grant, to nationals; all without prejudice to the rights specially provided for by this Convention. Consequently, they shall have the same protection as the latter, and the same legal remedy against any infringement of their rights…' (emphasis added). 79 Drahos, P. 2004, ‘Towards an International Framework for the Protection of Traditional Group Knowledge and Practice', paper prepared for the Commonwealth Secretariat and presented at the UNCTAD-Commonwealth Secretariat Workshop on ‘Elements of National Sui Generis Systems for the Preservation, Protection and Promotion of Traditional Knowledge, Innovations and Practices and Options for an International Framework', Geneva, 4–6 February 2004, available at http://r0.unctad.org/trade_env/test1/meetings/tk2/drahos.draft.doc (accessed 11 December 2008). 80 Either the cost is too high and the rights turn out to be worthless, as is the case with the US plant variety protection, or the cost is too low in light of the private benefits bestowed, and the public winds up paying a subsidy to rights holders without any corresponding increase in innovation. The latter is arguably the case with respect to the EU's new sui generis form of protection for databases. See generally, Commission of the European Communities 2005, DG Internal Market and Services Working Paper: First evaluation of Directive 96/9/EC on the legal protection of databases (12 December 2005), available at: http://ec.europa.eu/dgs/internal_market/evaluation/evaluationdatabasesdirective.pdf (accessed 11 December 2008). See McManis 2002, pp. 71–72. 81 These revised draft provisions are under discussion at the WIPO Intergovernmental Committee on Genetic Resources, Traditional Knowledge and Traditional Cultural Expressions (IGC). See WIPO 2006a (document contains both the Revised Provisions for the Protection of TCEs/ Expressions of Folklore and the Revised Provisions for Protection of TK, along with commentary on the provisions), available at: http://www.wipo.int/export/sites/www/tk/en/consultations/draft_provisions/pdf/draft-provisions-booklet.pdf "IP resources the right size, at the right time, in the right place" www.piipa.org Public Interest Intellectual Property Advisors 2011 – shared under a Creative Commons Attribution-NonCommercial-NoDerivs licence Intellectual Property and Human Development
(accessed 15 February 2010). The drafts have not been adopted or endorsed by the IGC and may be developed further. For the latest status of this aspect of WIPO's work, see http://www.wipo.int/tk/en (accessed 10 March 2010). 82 See Articles 13.2(d)(ii) and 19.3(f) of the ITPGRFA. 83 Grupo de Trabajo de Expertos Indígenas sobre Conocimientos Tradicionales de la Comunidad Andina de Naciones 2004, Elementos para la Protección Sui Generis de los Conocimientos Tradicionales Colectivos e Integrales desde la Perspectiva Indígena, Documentos Informativos, Comunidad Andina, SG/di 724, available at: http: www.comunidadandina.org (accessed 26 March 2010). 84 These considerations have been suggested by Graham Dutfield, Michael Gollin, Manuel Ruiz and Tzen Wong. 85 In a paper for the South Centre, Correa (2004) suggests that a cooperative initiative involving several international organizations may be needed to develop international rules for the protection and promotion of TK. 86 Dutfield (2006, p. 33) explores the possibility of strategic groups of developing countries agreeing on harmonized standards and then applying the reciprocity principle under WTO to extend this to nationals of other members. 87 See Rodríguez Cervantes and GRAIN 2006. 88 In a policy brief for the Science and Development Network, Ruiz (2004) emphasizes that it is the way in which tools, instruments and laws (including modified IPRs) are ‘interrelated' in a ‘synergistic manner' that will ensure that indigenous peoples' interests are safeguarded in the legal protection of their TK. Some opening for this might perhaps be provided by the WIPO Development Agenda (see Chapter 9). 89 See also the United Nations Economic and Social Council 2007, Report on the ‘International Expert Group Meeting on the Convention on Biological Diversity's International Regime on Access and Benefit-Sharing and Indigenous Peoples' Human Rights', available at: http://www.un.org/esa/socdev/unpfii/documents/workshop_CBDABS_finalreport_en.doc (accessed 11 December 2008). The report emphasizes the need to further enhance indigenous peoples' rights to participate in CBD meetings. The Economic and Social Council endorsed this expert group at the recommendation of the Permanent Forum on Indigenous Issues. 90 One practical option would be to establish a database with the contact information of indigenous peoples' representatives who are dealing with critical issues relating to TK and ABS. "IP resources the right size, at the right time, in the right place" www.piipa.org Public Interest Intellectual Property Advisors 2011 – shared under a Creative Commons Attribution-NonCommercial-NoDerivs licence

Source: http://www.piipa.org/images/IP_Book/Chapter_4_-_IP_and_Human_Development.pdf