BD associated TK IP Protection in India with special ...shodhganga.inflibnet.ac.in/bitstream/10603/27083/12/12_chapter6.pdf · BD associated TK IP Protection in India with special

Chapter VI

BD associated TK IP Protection in India with special

reference to ABS Experience of the Kani Tribe in Kerala

6. Introduction

Biodiversity is the biological capital of our planet as well as the

foundation upon which the human civilisation is built. Traditional societies

all over the world have rich ethnobiological knowledge that is particularly

linked to the biological resources around them. Identifying themselves as a

part of the ecosystem and understanding the interdependence among its

components, the tribals have developed a symbiotic association with nature

and natural resources around, both in space and time. Understanding this

knowledge and integrating the same into the modern scientific paradigm

could profitably be utilised in bioprospecting for drugs and other forest-

based products, with concern for management and conservation of forest-

based genetic resources.

The biodiversity and associated indigenous knowledge systems are

the two invaluable capital assets of countries like India. The Indian

subcontinent that is blessed with unique geographic position, distinct

physiographic, edaphic and climatic zones and gradients, abodes a very rich

and diverse flora and fauna with high percentage of endemism. According

to the latest assessment, it is placed as 10th among the plant rich nations of

the world and 4th among the Asian countries. Out of the 25 global 'hot

spots' of Biodiversity two are located in India - The Eastern Himalaya and

the Western Ghats. Based on the uniqueness of the phytogeographical

zones and pattern of endemism, 25 micro hot spots centres of endemic flora

have also been identified in India.

India's species richness is complemented by enormous genetic

diversity found within individual species. This indeed makes India one

among the 12 mega gene centers of the world. India's biodiversity is thus

marked by the occurrence of diverse types of ecosystems, high species

diversity with high incidence of endemism, and enormous genetic diversity

244 Chapter VI

in crop plants, domesticated animals and their wild relatives. The rich

biodiversity of India is matched with an equally rich cultural diversity, and

there exists a unique wealth of Traditional Knowledge System (TKS)

associated with the conservation and sustainable use of biological

resources. Thus, an important aspect of protecting biodiversity is the

protection of indigenous knowledge of local communities.

TKS embody a plethora of unique time-tested knowledge, wisdom,

beliefs, traditions and practices associated with conservation and

sustainable use of biogenetic resources. The traditional knowledge base of

Indian ethnic and local communities is perhaps the richest in the Third

World. India's tribal and folklore traditions, particularly the traditional

medicine systems are rich and unique. And, India's herbal or traditional

medicine systems have the potentials to capture the world drug and

pharmaceutical markets, provided the country strives to bring in substantial

improvement and value addition to the existing traditional knowledge base

through appropriate scientific and technological intervention and policy

support. The biological wealth and associated traditional knowledge

systems of India offer excellent opportunities ahead for harnessing the

biocultural diversity for generation, protection and maintenance of

intellectual property rights (IPR) in the domains of herbals and other

national product development technologies and related knowledge-based

commercial and industrial ventures.

An important aspect of protecting biodiversity is the protection of

indigenous knowledge of local communities. Indian ethnic and local

communities are perhaps the richest in the Third World and has the

potentials to capture the world drug and pharmaceutical markets, provided

the country strives to bring in substantial improvement and value addition

to the existing traditional knowledge base through appropriate scientific

and technological intervention and policy support. A benefit sharing

approach based on legally binding contracts would allow for flexible

solutions to biopiracy. Action at the national level would be inadequate for

achieving the stated objectives of CBD unless an international recognition

is given to these national systems, through an enforceable instrument.

BD associated TK IP Protection in India… 245

Hence, an internationally accepted solution to such bio-piracy was considered

necessary. Developing countries seek to amend the TRIPS framework as a

vehicle to enforce the benefit-sharing requirements of CBD. In general, the

discussions within the CBD are taking place against the backdrop of those IPR

debates. There are many open and complex issues that would need to be

addressed in any IPR disclosure scheme, whether within TRIPS or within the

CBD. There is an implicit recognition that outsiders misappropriate resources

and associated traditional knowledge, and therefore a benefit sharing

mechanism would reverse the wrong. The primary focus of this chapter is to

analyse the challenges and opportunities associated with Access and Benefit

Sharing which have been examined in the specific context of the experience of

the Kani Tribe in Kerala.

6.1 Bio-Piracy: The Indian Experience

As discussed in the previous chapter, there have been several cases of

bio-piracy of traditional knowledge from India. First, it was the patent in the

US PTO on wound healing properties of haldi (turmeric), then there was the

patent granted on the neem derivatives in the European Patent Office (both of

which were got revoked through considerable time, effort and expenditure by

the public/NGO sector of India) and now patents have been obtained in other

countries on hypoglycemic properties of karela (bitter gourd), brinjal etc.

(Kaushik 2002: 4)

A review of literature in this regard reveals that the bio-piracy of

traditional knowledge associated with biodiversity is on increase. A survey

conducted by the Indian Drug Manufactures’ Association (IDMA) found 668

pharmaceutical patents filed during 1997. Most of the patents are based on the

traditional medicinal system of India i.e. Ayurveda. Many of these claims with

minor modifications in methods of extraction and processing- could amount to

bio-piracy of the centuries old traditional knowledge. Since 70 percent of

Indian health care depends on herbal medicine, the patents based on bio-piracy

could potentially deprive the rights of poor to health care.1

1 Cecilia Oh, “Intellectual Property Rights and Biological Resources: Implications for

Developing Countries,” at http://www.twnside.org.sg/index.htm

246 Chapter VI

There is a strong view that the TRIPS Agreement is aiding the

exploitation of biodiversity by privatising biodiversity expressed in life

forms and knowledge. As the TRIPS permits patenting of life forms and

organisms and it encourages 'bio-piracy'. A rational definition of 'bio-

piracy' would focus on activities relating to access or use of genetic

resources in contravention to national regimes based on the CBD.

Accordingly, a case of 'bio-piracy' will involve unauthorised access to a

controlled genetic resource and using that resource in a manner that

contravenes the national regime. It is hard to see how the filing of a patent

application can, in itself, amount to 'bio-piracy'. The filing of a patent

application presumes that something beyond the information relating to the

genetic resource has been developed namely an invention.

One can not accept the application of this term to cases where

indigenous knowledge is used to make a further invention: for example, by

isolating the active principle from a medicinal herb. Of course, the CBD may

require equitable sharing of the benefits from such an invention; if this does

not take place, this could then reasonably be termed 'bio-piracy'. However, the

wrong does not lie in filing the patent application, but in failing to deal fairly

with the parties that helped create the opportunity for innovation.2

Number of Patent Applications Filed During Last Five Years

From 2003-04 to 2007-2008 Under Various Fields of Inventions

Yea

r

Ch

em

ical

Dru

g

Foo

d

Ele

ctr

ica

l

Mech

an

ica

l

Co

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Ele

ctr

on

ics

Bio

tech

no

log

y

Oth

er f

ield

s

(See A

pp

- E

1

To

tal

2003-2004 2952 2525 123 2125 2717 23 2148 12613

2004-2005 391 6 2316 190 1079 3304 2787 1214 2659 17466

2005-2006 5810 2211 101 1274 4734 5700 1525 3150 24505

2006-2007 6354 3239 1223 2371 5536 5822 2774 1621 23940

2007-2008 6375 4267 233 2210 6424 4842 1950 711 0 35218

Source: http://ipindia.gov.in/cgpdtm/AnnualReport_English_2007-2008.pdf

2 TRIPS and the Biodiversity Convention (1999): “what conflict?,” Commission on

Intellectual and Industrial Property, June 28, at http://www.iccwbo.org/index.asp


There is growing worldwide opposition to the granting of patents on

biological materials such as genes, plants, animals and humans. Farmers

and indigenous peoples are outraged that plants that they developed are

being 'hijacked' by companies. Worldwide opposition to biological piracy'

is rapidly building up as more and more groups and people become aware

that big corporations are reaping massive profits from using the knowledge

and biological resources of Third World communities. Whilst the

corporations stand to make huge revenues from this process, the local

communities are unrewarded and in fact face the threat in future of having

to buy the products of these companies at high prices.

The transnational corporations are racing one after another to

manufacture pharmaceutical and agricultural products, the main ingredients

of which are the genetic materials of the medicinal plants and food crops of

these local communities. The firms are also collecting other living things,

ranging from soil microorganisms to animals and the genes of indigenous

people, which they use for research and making new products. These

companies are rushing to patent the new products containing the collected

genetic materials, so as to prevent competitors from using them. They may

then reap larger profits from being able to hike up prices for the products,

or by charging royalties to other firms wishing to use the technology.

The knowledge and use of 'biodiversity' resides with these farmers

and indigenous people which have shared their knowledge and plants

freely. Yet through patent applications, the companies are now claiming the

exclusive right to produce and sell many 'modified' plants and animals,

which have been manipulated to contain selected foreign genes. The

knowledge, innovation and efforts of these communities are not

acknowledged (and indeed are discarded) when the legal 'intellectual

property rights' systems grant patents on genetic and biological materials

and on living organisms to corporations. For the past few years, NGOs such

as RAFI, GRAIN and the Third World Network have been networking to

raise general awareness of the phenomenon of 'bio-piracy'. In a parallel

move, new campaigns have been launched by religious leaders and NGOs

against the patenting of life.

248 Chapter VI

If indigenous knowledge is the foundation of a new product,

compensation for the invention could be achieved on a contractual basis

amongst interested parties outside the Intellectual Property system. Such a

benefit sharing approach based on legally binding contracts would allow

for flexible solutions on a case-by-case basis. But there is a problem to the

contractual approach. If someone is the owner of a patent for a new product

that is based on traditional knowledge, he must be obliged to state the

source of origin in order for the indigenous communities to be aware of

how their traditional knowledge was used. Today, Article 27 of TRIPS

agreement provides for patentability irrespective of the source of origin.

Thus benefits will not be shared equally amongst the innovator and the

indigenous community.3

The most crucial issue regarding conservation and sustainable use of

biodiversity and associated traditional knowledge are prevention of bio-

piracy and protection of TK and means of fair and equitable sharing of

benefits arising out of utilisation of biological resources and associated TK.

It is already discussed in the previous chapter that efforts are being made in

various countries with regard to the above issues. These include: using some

form of IPRs to provide legal protection to the holders of TK, sui generis

systems for protection of TK and prior informed consent and benefit sharing

and certain supplementary efforts for benefit sharing like contractual

arrangement for the prevention of bio-piracy. A number of countries like

Brazil, Costa Rica, India, Peru, Philippines, Andean Community, some

African initiatives are either providing or proposed to provide protection to

TK through a combination of various systems.

These regimes contain provision for prior informed consent in

access, and benefit sharing. Some other steps taken include restriction on

applying for IPRs based on biological resources and associated TK without

PIC and protection through various other means like registration of TK,

systems of contract, recognition of customary laws, etc. However, the

actual measures provided or proposed are different in each country. There

is no uniformity in the provisions and each country’s legislation is

3 “TRIPS and BIODIVERSITY,” at http://www.twnside.org.sg/index.htm


developed based on the specific requirements of individual country, its

communities, their lifestyles and types of traditional knowledge and the

way it is being protected or held by the traditional communities and the

way it is being accessed for modern scientific purposes. It is very clear that

a uniform international system for protection of biological resources and

associated TK would not be able to cater to the requirements of individual

country. Rather, the need is for a system, which recognises such diversity.

In an international seminar organised by UNCTAD and the

Government of India with the participation of 14 countries during 3-5 April

2002, the participants agreed that benefit-sharing mechanisms installed

through national legislation would need to be recognised in user countries.

Some of the essential components of a framework for international

recognition of various sui generis systems, customary law and others for

protection of TK identified include: (Kaushik 2002)

(i) local protection to the rights of TK holders through national level sui

generis regimes;

(ii) protection through registers of TK databases to avoid misappropriation;

(iii) a procedure whereby the use of TK from one country is allowed,

particularly for seeking IPR protection or commercialisation, only

after the competent national authority of the country of origin gives a

certificate that the source of origin is disclosed and prior informed

consent, including acceptance of benefit sharing conditions, obtained;

(iv) an internationally agreed instrument that recognises such national

level protection.

The participants recommended that their countries would work

together in various intergovernmental forums particularly CBD, FAO,

WIPO and UNCTAD to develop an international framework for the

recognition of national systems of protection, including diverse sui generis

systems.

The development at New Delhi only gives further focus to what has

been experienced by India. The task ahead is twofold. (Kaushik 2002) First,

250 Chapter VI

the diversity of approaches for protection of biological diversity and

associated traditional knowledge needs to be preserved through national

level systems. Second, action at the national level would be inadequate for

achieving the stated objectives of CBD unless an international recognition

is given to these national systems, through an enforceable instrument. The

international community now needs to focus on the forging of such an

instrument and deciding the forum where it can be lodged. (Kaushik 2002)

Hence, an internationally accepted solution to such bio-piracy was

considered necessary. Various suggestions have been advanced to extend

protection to knowledge, innovations and practices. Besides some

initiatives, documentation of traditional knowledge and Access and Benefit

Sharing (ABS) models with public/private sector partnership are most

widely discussed at the national level.

6.2 The Evolution of ABS in the Area of Biological Diversity

Like other global commons, biological diversity was treated as a

free good until the early 1990s. The UN Convention on Biological

Diversity changed this, and genetic resources and associated traditional

knowledge can no longer be treated as a free good and that there is scope

for the framing of regulations for controlling access to such resources in

the interest of the national and local communities. Genetic resources have

tremendous economic potential and much is being done to harness this

potential. Rather, the predominant use of genetic resources in the area of

medicine, and the emergence of the biotechnology era, make some believe

that the CBD was just an attempt to legitimise access to and control of the

genetic resources of the gene-rich countries.

Before putting in place any access regime, the problem of the

concept of ‘rights’ has to be grappled with. The problem is compounded

by the fact that the discourse on the subject limits itself often to the

modern and industrial definitions of rights, which do not necessarily

encompass the more traditional forms of right acquisition and

exploitation. For example, traditional knowledge in India has been

preserved through smriti and shruti, that is, through the word of the

teacher, which is heard and remembered, not documented, nor converted


into a statutory right in favour of the teacher or his disciple. Although this

form of right is enshrined in the common law principles and recognised

through jurisprudence in India and at times even converted into a statute

for a more predictable rights regime, it is not necessarily recognised

outside the jurisdiction of India.

The CBD has given some guiding principles to go by. Article 15

thereof confers on States sovereign rights over their genetic resources. It

obliges Parties to provide access to others, but only on mutually agreed

terms and subject to prior informed access. It also authorises Parties to

ensure fair and equitable sharing of benefits arising out of research as well

commercialisation of the resources.

But CBD does not clarify who has the rights on the resources in the

first place: the country, the community concerned, the individual or some

association on behalf of the individuals. The ‘rights’ issue, therefore, is

perhaps left for resolution at the national level. The various means through

which this is being achieved at the national level shows the great diversity

of perceptions in this area, as well as the diversity of cultural and traditional

moorings on which rights accrue.

As in the case of access, for benefit sharing also, CBD gives

solutions that need national level implementation. In fact, CBD perhaps

assumes that the exploitation of the right of the holder, irrespective of the

way it is determined, will be ensured through a process of fair and equitable

benefit sharing. There is an implicit recognition that outsiders misappropriate

resources and associated traditional knowledge, and therefore a benefit

sharing mechanism would reverse the wrong. In some of the benefit sharing

agreements that have been concluded between developing country right

holders and developed country corporations, royalties promised range from

0.1% to 3-4%. On the other hand, the royalty proposed to a developed

country right holder by a developed country corporation was as high as

10%. It is this realisation that has perhaps made countries, like India, to

install regimes that provide for State intervention in determining access as

well benefit-sharing arrangements. (Kaushik 2002)

252 Chapter VI

6.2.1 ABS Associated with Biodiversity and Traditional Knowledge

The provisions set forth in the CBD call for empowering indigenous

communities with two fundamental rights: namely, the right to be protected

from having their resources stolen and the right to benefit from any

exploitation of such resources by third parties.4 The latter is subdivided

into: 1) access to the results of research conducted on biological resources

and TK, and 2) equitable sharing of economic benefits flowing from the

exploitation at large of the research results.5 In addition to the general

provisions on equitable sharing results and benefits in article 15(7), the

CBD also provides that:

Each Contracting Party shall take . . . measures . . . with the aim that

Contracting Parties, in particular those that are developing countries, which

provide genetic resources, are provided access to and transfer of technology

which makes use of those resources, on mutually agreed terms, including

technology protected by patents and other intellectual property rights.6

Furthermore, the CBD underlines the need to grant the countries providing

genetic resources effective participation in biotechnological research

activities and priority access on a fair and equitable basis to the results and

benefits arising from biotechnology based upon genetic resources.7

The latter set of rights is firmly grounded in the recognition of the

indigenous community's entitlement to its own tangible and intangible

resources. In particular, the community has the right to economic

compensation for the commercial exploitation of its biological resources, and

this right stems from the property rights local communities have in their own

genetic resources. Conversely, the right to access the results of the research is

based on the view that developed countries merely borrow scientific

knowledge from indigenous people, and according to logic that resonates with

the open source movement, the indigenous community should not be excluded

from benefiting from applications of their knowledge. (Arezzo 2007: 391)

4 CBD (1992): arts. 15(1) and 15(7), June 5, at

http://www.biodiv.org/convention/convention.shtml. 5 Ibid, art. 15(7).

6 Ibid, art. 16(3).

7 Ibid, art. 19(1, 2).


The intangible character of TK makes the recognition of rights to

TK more difficult. Indigenous people have their own system and traditions

for the use and application of their knowledge. However, foreign

companies filter traditional medical knowledge through the lens of

industrialised intellectual property systems, which results in the perception

that TK is free to be exploited.

6.2.2 Debate on ABS

In general terms, ABS refers to institutional arrangements for

access to genetic resources, the uses of such resources, and the fair and

equitable sharing of benefits derived from such resources. Article 3 of the

Convention on Biological Diversity (CBD) defines genetic resources as

"genetic material of actual or potential value of plant, animal, microbial or

other origin containing functional units of heredity." (LaMotte 2006: 242)

Recent advances in molecular biology and genome science have

created an enormous potential market for unique genetic material from

existing organisms and microorganisms in nature. Pharmaceutical,

biotechnology and other industrial sectors have an active interest in

"bioprospecting" for this material, and the commercial applications from

such research can have enormous implications for human well-being. These

commercial applications are in turn being secured through the extension of

intellectual property rights (IPR) over these genetic resources and their

derivatives. Some have expressed concern over the IPR granted to such

resources without complying with regulations on ABS.

Effective conservation of biodiversity which has been recognised as

a global good in its own right, requires that local communities benefit; the

potential value of genetic resources may provide a vehicle for providing

such benefits. But the tremendous potential of these resources has yet to be

fully realised, partly because of barriers and uncertainty in the legal and

political framework for ABS. Just as recognition of the value of these

resources has increased, so too has the sense that the current governance

structure for providing access and use rights over these benefits is

inadequate. (LaMotte 2006: 242-243)

254 Chapter VI

The ABS debate is therefore of significant interest to policymakers,

a broad group of industry sectors (i.e., pharmaceutical, biotechnology;

cosmetics; fragrances; horticultural; crop-protection and agribusiness),

NGOs interested in conservation and sustainable development, and research

scientists. In general, the international community is actively examining

options to improve the legal framework related to the ABS issues. This

activity is going on in several international forums, and appears poised for

significant developments in the near term. The politics surrounding these

issues are polarised, however, leading to an uncertain future about the next

steps. (LaMotte 2006: 243) The different forums include:

CBD to develop a new international regime specifically focused on

this issue;

both WIPO and TRIPS debates to change the global intellectual

property rights regime to reinforce ABS measures;

UN process reviewing the conservation and sustainable use of

marine biodiversity beyond limits of national jurisdiction; and

the FAO International Treaty on Plant Genetic Resources for Food

and Agriculture to elaborate "material transfer agreements" that may

embody both access and benefit-sharing provisions. (LaMotte 2006,

p.243)

6.2.3 ABS under the Convention on Biological Diversity

Discussion and elaboration of ABS issues have been active theme

on CBD agenda since 1998. In 2001, a CBD working group developed the

Bonn Guidelines that were subsequently adopted by the sixth conference of

the parties (COP-6) in 2002. The Guidelines are intended to assist parties

developing legislative, administrative or policy measures on ABS, as well

as contract and other arrangements under mutually agreed terms for ABS.

They provide a detailed framework for developing ABS regimes at the

national level, including an emphasis on obligations of users of genetic

resources. (LaMotte 2006: 244)


In fall 2002, however, the Johannesburg Plan of Implementation

called for action "to negotiate within the framework of the CBD, bearing in

mind the Bonn Guidelines, an international regime to promote and

safeguard the fair and equitable sharing of benefits arising out of the

utilisation of genetic resources." Developing countries pushed for this

mandate because of their perception that the imbalance between providers

and users in negotiating ABS agreements, exacerbated by the lack of

enforcement or monitoring mechanisms, could be corrected only through a

legally binding international regime. (LaMotte 2006, p.244)

In 2004, the CBD COP mandated the Ad Hoc Open-Ended Working

Group on Access and Benefit-Sharing "to elaborate and negotiate an

international regime on access to genetic resources and benefit-sharing with

the aim of adopting an instrument/instruments to effectively implement the

provisions of article 15 and article 8(j) of the Convention and the three

objectives of the Convention." Working group held negotiations at the third

meeting and fourth meeting resulting heavily bracketed draft text that was

forwarded to the Conference of the Parties for consideration and guidance.

(LaMotte 2006: 244)

In brief, developing countries are pushing for rapid adoption of a

legally binding regime that will require users of genetic resources to ensure

fair and equitable benefit-sharing. Developed countries, with some

exceptions (Norway), are resisting the push for a legally binding

instrument, and instead suggest the need for time to gain experience with

the Bonn Guidelines and further develop national ABS regimes before

launching a new international system. (LaMotte 2006: 244)

6.2.4 ABS in the Intellectual Property Rights System

Intellectual property rights are tools to provide incentives for

innovation, by giving owners the exclusive right to control the use of a

work or product. Genetic material has been part of the intellectual properly

landscape since 1980, when the U.S. Patent and Trademark Office granted

a patent on a living genetically modified organism, and intellectual property

rights involving genetic resources have grown significantly since then

along with the growth in genetic sequencing technology.

256 Chapter VI

Developing countries seek to amend the TRIPS patent framework as

a vehicle to enforce the benefit-sharing requirements of CBD. Various

proposals would allow or require national patent authorities to impose

ABS-related conditions on patent applicants: e.g., to disclose the origin or

source of genetic material used in the patent, provide evidence that the

applicant complied with the PIC requirements of the country of origin,

and/or provide evidence that the applicant complied with national laws on

benefit-sharing.

Some developed countries argue that TRIPS and CBD are not

incompatible, and oppose these proposals for mandatory disclosure. They

argue that an effective regime for sharing benefits from the use of genetic

resources will build in requirements at the beginning of the process of

accessing resources, not at the point of commercialisation. They further argue

that developing countries significantly overstate the potential benefits from a

complex IPR system for ABS, given that only a small fraction of

bioprospecting or traditional knowledge uses ultimately result in commercial

application and therefore enter the IPR process. In addition, they highlight

significant feasibility obstacles to such a regime.

Industry is concerned that mandatory disclosure provisions would

increase uncertainty in the intellectual property regime and accordingly

reduce the amount of investment in these resources that is necessary to

develop and commercialise them. Industry contends that it is premature to

incorporate ABS provisions into the intellectual property system when the

basic elements of the ABS system, many of which have nothing to do with

IPRs, are still being developed at the national level and within the CBD.

Developing countries nevertheless succeeded in getting this issue

added as one of the elements of the "Doha mandate" for the current round

of WTO trade negotiations, referred to generically as "the relationship

between TRIPS and CBD." Paragraph 19of Doha Development Agenda did

acknowledge the need of CBD and TRIPS relationship to be looked into,

however most of the developed countries rejected ABS on the pretext that

ABS is not viable option and issues should be addressed at the national

level rather than placing it on the multilateral regime. This issue is therefore


potentially linked to the completion of Doha round. The Hong Kong

Ministerial in December 2005 called for intensification of these talks and

progress by July 2006.

WIPO is also looking at mandatory disclosure issues in its Inter

Governmental Committee on Intellectual Property and Genetic Resources,

Traditional Knowledge and Folklore (IGC). WIPO extended the IGC's

mandate to include discussions on the mandatory disclosure issue,

including in the context of the proposed Substantive Patent Law Treaty.

Developing countries have generally sought to shift the debate outside of

WIPO because developed countries are using the WIPO discussions as a

tool to forestall discussions in the TRIPS Council and CBD.

6.2.5 ABS: Unresolved Issues

In general, the discussions within the CBD are taking place against

the backdrop of those IPR debates. They are also characterised by a wide

diversity of views, including on core objectives and fundamental issues,

such as whether there is a need for a new instrument at all, whether the

"international regime" for ABS already exists and comprises many different

mechanisms in different forums, or whether the international ABS regime

should facilitate or restrict access to these genetic resources. Not

surprisingly, therefore, almost all the basic questions remain the subject of

debate: the legal nature of the regime, its scope, its modalities, and

consequences for noncompliance.

Basic process issues have also been contentious, they include key

questions about how the negotiating process will be structured, such as the

scheduled completion date, the number of meetings, the nature or formality of

the forum, whether indigenous people should have a special role in the

negotiations, what document should be the baseline text for negotiations, etc.

In terms of the substantive elements of the regime, the discussion has

focused primarily on the perceived need for tools to enforce ABS agreements

and measures to insure compliance with Prior Informed Consent (PIC) and

Mutually Agreed Terms (MAT). International certificates of origin have been

discussed as a potential mechanism to trace genetic resource flows and identify

258 Chapter VI

whether PIC requirements for their use have been satisfied. In theory, the

certificates would identify the country of origin or the source of material where

the country of origin cannot be determined. They could also address the legal

provenance of the resources and associated knowledge i.e., evidence of the

right to use the resources. Although implementing such a system could be

costly and might further reduce incentives to conduct research in genetic

resources, it would in theory also provide some benefit to commercial users,

including potentially harmonised ABS rules and legal certainty with respect to

evidence of the right to use genetic materials.

In practice, however, there is no clear understanding of core issues,

such as (1) what information such a certificate would include; (2) how it

would operate e.g., would it accompany the genetic resource from

collection all the way through use, or be required only at designated

enforcement checkpoints, like borders or patent offices, would it be

mandatory or voluntary; if mandatory, how would it be reconciled with

trade rules; (3) when it would be issued; (4) who would issue it; (5) how the

system would handle the situation where the same resource might be

available in multiple countries; (6) what kinds of consequences might exist

for noncompliance; (7) what is actually being certified e.g., the gene, the

sample, the collection activity, etc.

Here the debate focuses on whether the CBD regime should address

the "disclosure of origin" issue in intellectual property rights applications.

There are many open and complex issues that would need to be addressed

in any IPR disclosure scheme, whether within TRIPS or within the CBD.

They include:

What elements would be required to be disclosed: e.g., (1) geographical

origin or source of genetic material; (2) evidence of prior informed consent

from source country and or local community; (3) evidence of compliance

with benefit sharing agreements, etc. What the legal nature of the disclosure

requirement is, and what are the legal consequences for noncompliance:

e.g., civil proceedings by opposing parties; non-processing of a patent

application; loss or transfer of patent rights; criminal penalties for false

declarations, etc.


How would the regime apply to so-called derivative materials?

What kind of link between the genetic resource and the patented product

would trigger such a requirement: e.g., if the invention makes immediate

use of the genetic resource; if access to the genetic resource is necessary to

make the invention or replicate it; if the genetic resource were used in the

research that led to the invention and were essential to deriving the

invention; if the genetic resource were used in the research but were

incidental in deriving the invention; if the genetic resource were used to

facilitate development of the invention; etc.

The CBD mandate includes so-called "article 8(j) issues," which

refers to the interests of indigenous and local communities regarding

traditional knowledge, practices or innovations in connection with genetic

resources. These interests are not easily recognised or protected under the

existing intellectual property regime, and the ABS process has come under

pressure to ensure that these communities are included in the benefit-

sharing arrangements being developed.

It remains to be seen whether the instrument will reflect the full

scope of benefits that provider countries might receive from providing

access to genetic rights, or whether there is instead a narrow focus on

financial benefits in the form of royalty payments or access fees.

How will the mechanism supplement and enhance rather than supplant

or undermine national ABS systems? Scope of application/Variability of

Rules: Should the mechanism set different rules for ABS depending upon

the end use of the genetic material: e.g., limited applicability for academic

and scientific research, compared to research for commercial application;

different applicability for use of genetic material for food and agricultural

uses, given the extensive existing resources of ex situ genetic resources

for those uses, etc. The regime for sharing genetic material is more

developed in some areas e.g., plant genetic resources for food and

agriculture than in other areas, and a tailored regime that takes account of

the different needs of different sectors may be valuable.

How will the regime build on existing guidelines, such as the

Bonn Guidelines as well as those developed by industry sectors, such as

260 Chapter VI

the Biotechnology Industry Organisation's Guidelines for Bioprospecting?

For each of these elements, there are fundamental debates about the

degree to which their implementation would enhance a functioning ABS

system, or undermine it with unworkable requirements that ultimately

would discourage the sustainable use of genetic resources.

6.2.6 Risks and Opportunities in an International ABS Regime

The main risk is that the regime will impose excessive and

unworkable burdens or increase the already considerable legal

uncertainties associated with the development of these resources. If that

happens, it could effectively stall further progress in this promising field.

In the worst-case scenario; such a result could lead to a permanent loss of

access to and use of this material due the loss of habitat and extinction of

biodiversity. That result is in nobody's interest, but it is one that is quite

possible.

The main opportunity is that a well-designed ABS regime could

minimise existing obstacles to genetic research in a way that would maximise

the sustainable use of these resources, while at the same time ensuring their

conservation and the equitable sharing of benefits associated with their

development. A well-designed ABS regime could resolve current obstacles at

the national level to bioprospecting. These current obstacles include regulatory

uncertainty e.g., lack of clarity on permit application process, failure to identify

a point of contact with authority to grant PIC and political resistance flowing

from the impression that the current international system is imbalanced and

that developing countries are unlikely to receive adequate benefits in return for

access to genetic material. (LaMotte, 2006)

6.3 Constitutional and Legislative initiatives

Modern India, tribes have been drawn in by the politics of economic

development, rapacious "consumerisation" of cultural lifestyles, and the

allurement of "better" lives in an integrated environment. So the tribes are

now facing the prospect of extinction, the processes of subjugation,

dispossession, and usurpation of traditional rights live in their collective

memory. (Padel 2000: 897)


Discourses on the erosion of tribal rights and cultures generally

concentrate on an assimilation-autonomy, development-deference

dichotomy which operate through the colonial-tribal conflict over the

usurpation of forest rights, movements by dominant sections to influence

tribal cultures, and the intrusion by the Indian State into tribal areas on

grounds of economic "development." The effect of these processes has

been an erosion of tribal identity and tribal "integration" into the

"civilised" Indian State. Tribals should have the right to live under

conditions that allow them to preserve their cultural life-style. The Indian

State has a duty to "eliminate inequalities in status, facilities and

opportunities, not only amongst individuals but also amongst groups of

people residing in different areas ". This conundrum presents a need to

move beyond the development-deference dichotomy and explore the

viability of a rights-based approach for adjudicating conflicts between the

State's duty and tribal rights. (Kashyap 1998: 29)

The constitutional polity of India, including tribal communities,

has a fundamental right of access to justice. It is critical also because the

nature of the tribal groups' right of access to justice will have significant

implications for the content and constitutionality of current and future

legislation relating to the commercial exploitation of traditional

knowledge, biodiversity, and other related matters. (Dam 2006: 298-299)

The assurances made by the national leaders and the concessions they

granted were important in securing the consent of the tribes. But formal

colonial rule prior to the Assembly infiltrated the social and legal systems

of the tribal communities. When the Assembly decided to bring the tribal

communities within the larger constitutional framework of the Indian sub-

continent, they were pursuing the policies they inherited from their

colonial masters. (Suresh Sharma 1994)

The Assembly was not oblivious to the fact that State

administration of tribal lands had become "legitimate" through a series of

colonial legislations that forced an alien legal system on the tribal

communities. When the Assembly began functioning, it was bound by the

terms of the Cabinet Mission's Statement, which provided, inter alia, that

262 Chapter VI

a Committee containing due representation of affected parties be formed

to advise on the incorporation of provisions relating to their

administration under the new Constitution.8

The Sub-Committee on Assam noted the highly democratic

character of the tribal village councils, created by general assent and

election, and the mechanisms for dispute settlement, usually by the chief or

headman or Council of Elders. The Committee added, "In the areas where

no right of the chief is recognised, the land is regarded as the property of

the clan, including the forests."(Rao 1967: 691-695) The Joint Report of the

Sub-Committees on Minority and Tribal Rights observed that the tribes had

their own way of life with institutions like the tribal and village Panchayats

(or councils), which were more than capable of administering village

matters and personal disputes. Moreover, the Committee noted that the

disruption of the tribal customs was capable of doing great harm.

"Considering past experiences and the strong temptation to take advantage

of the tribal communities' simplicity and weakness," the Committee

concluded, "it was essential to provide statutory safeguards for the

protection of the land which was the mainstay of the aboriginals' economic

life and for his customs and institutions which, apart from being his own,

contained elements of value." (Rao 1967: 774)

The draft Constitution and the debates thereon also proceeded on

the premise that it was important to recognise the right of tribes to be

governed by a system that was effectively part of their own culture. The

reports of the Sub-Committees clearly highlight the existence and

developed nature of the tribal adjudicatory processes and the need to enact

provisions on the principle of maximum non-interference.9

Some argued in favor of the Central Government assuming full

responsibility for the administration of these areas, while others argued that the

concept of Scheduled Tribes and Scheduled Areas amounted to racism

8 Statement by the Cabinet Mission to India and His Excellency the Viceroy, May 16,

1946, reprinted in 2 Sir Maurice Gwyer and A. Appadorai, Speeches and Documents

on the Indian Constitution: 1921-47, (1957): 577-584. 9 For the Constituent Assembly Debates on Fifth Schedule, see IX Constituent Assembly

Debates, (1950): 965-1001.


disguised as tribal autonomy. Still others argued that the scope of

administrative control was not sufficient and the tribal communities required a

greater voice at the state level. The draft Constitution rejected the assimilation

model in favor of substantial deference to the tribal communities, subject only

to a gradual self-involvement with India's national life. The Constituent

Assembly recognised the right of tribal communities to decide for themselves

what the appropriate pace of "involvement" with "national" life should be.10

As a result the final version of the Indian Constitution included the

Sixth schedule dealing with tribal regions and the Fifth Schedule established

Tribal Advisory Councils, which have jurisdiction to advise the Government

on matters pertaining to the welfare and advancement of tribes. Subsequent

amendments to the Constitution have expressly recognised the right of some

tribal communities to self-governance within the framework of traditional

customary legal systems. Article 371A and Article 371G of the constitutional

provisions, though limited to certain states of Northeast India, do expressly

confer the right of tribal communities to be governed by the customary

practices of the regions.11

6.3.1 The Constitution of India

The Constitution of India provides fundamental rights to equality,

equal opportunity, right to life and personal liberty and to conserve distinct

language, script or culture. The Directive Principles enjoin the State inter-

alia to direct its policy towards securing that the ownership and control of

material resources of the community is so distributed as to sub-serve the

common good. The Panchayati Raj was introduced in the Constitution

through an amendment in 1976.

Article 243 enables the State to make laws to empower Panchayats

to deal with certain matters including schemes of economic development

and social justice. The areas in which the Panchayats could implement such

schemes include agriculture, social forestry and farm forestry, minor forest

produce and maintenance of community assets. (Kaushik 2002)

10

Ibid, 977-1025. 11

India Constitution Article 371A (Thirteenth Amendment Act, 1962), § 2; See India

Constitution Article 371G (Fifty-third Amendment Act, 1986) § 2.

264 Chapter VI

6.3.2 Laws prior to the CBD

The Transfer of Property Act, 1882 in defining property in Section

2(6) includes intangible assets. Section 47 covers the concept of ‘common

property’ in the scope of the Act. The Contract Act 1972, similarly, defines

a contract as valid only when it is between parties who have agreed of free

will, and where there has been an informed acceptance of the offer for a

lawful consideration and a lawful object. An agreement without

consideration is void under the Act.

The Indian Forest Act 1927 regulates the use of forests and forest

produce; its scope would include almost everything that may constitute

biodiversity. Only notified forests come under regulation. For such

regulated forests, Government makes rules for cutting of trees and

collection, removal and manufacture of forest produce as well as granting

of licenses to the local communities to use the forest produce. Rights over

forests and forest produce can be acquired either by succession or through a

valid contract with the Government. Village forests have a special place as

village community is given the right to govern the forest as well as to

administer the forest produce. Forests and wildlife are in the concurrent list;

hence many states have passed laws on these subjects.

The Wildlife (Protection) Act 1972 allows the Government to notify

certain plants etc. that need to be protected by State intervention. It

prohibits the collection and transfer of such plants or their derivatives,

except by the Scheduled Tribes (indigenous communities), who can collect

them for their personal use but not for commercial exploitation. Exceptions

to this prohibition can however be made on application to the authorities

for limited purposes such as education; scientific research; collection,

preservation and display in a herbarium of any scientific institution; and

propagation by a person or an institution approved by the Government.

Some regulation exists at the product stage also, in so far as forest produce

is concerned.

The Seeds Act 1966 allows the Government to declare any variety

of seed to be a notified variety, and controls the sale of such variety for the

purpose of maintaining purity of the variety. It also controls the import and


export of seeds of notified varieties by insisting upon conformity with

standard of purity and marking/labelling them as such. Under the Drugs

and Cosmetics Act. 1940, manufacturer or seller of a drug has to inform

where he got the drug. For Ayurveda, Siddha or Unani drugs (Indian

system of medicine), although quality standards are prescribed, these do not

apply to Vaids and Hakims (traditional medicine dispensing doctors).

A common feature of all the laws discussed above can be said to be

that they have some regulation of access to resources, but little on benefit

sharing. One positive feature of these laws, not discussed above, however,

is that most of them have institutionalised systems of regulation and

monitoring in the from of Committees or Boards, who may come in handy

once access and benefit sharing mechanisms are put in place through the

upcoming biodiversity related laws, leading to lesser implementation costs

than would be imagined for greenfield applications. (Kaushik 2002)

6.4 Tribal Autonomy in the Post-Independent Decades

Despite the constitutional protections of tribal autonomy,

confrontations between the Indian State and the tribal communities have

marked the post independence decades. "The wider goals of state and

nation have overridden the particular interests of such poor populations on

the assumption that wider gains far outweigh local costs." (Marsden 2000)

"In the name of development, people have been pushed off land;

and their forests and water have been taken over by the state," leaving them

no alternative but wage labour to sustain their communities resulting a loss

of cultural autonomy, knowledge, and power." This loss of cultural

autonomy has been devastating and has resulted in the degeneration of

traditional legal systems, infringing on the fundamental right to culture

guaranteed by the Indian Constitution. (Baviskar 2000: 36)

In particular, tribal property rights have been disregarded.

Interestingly, the Government of India did not have a "Rehabilitation

Policy" for displaced persons until 1997. Almost all States in India have

passed laws prohibiting the transfer of tribal lands to non-tribal people. Yet,

despite these legislative protections, transfer continues unabated. The

266 Chapter VI

continuing tribal experiences of dispossession, displacement, and

discrimination bring into question the government's success at living up to

the promise of the Constituent Assembly. The formal structures of justice

administration in India have failed to adequately protect the tribal

communities' right of equal access. (Dam 2006: 306-308)

In Kerela, an official inquiry in 1976, revealed that a total of 9,859

acres of tribal land were alienated to non-tribe members "through various

means of borrowing for domestic expenses, debt clearance, marriage,

treatment of disease, encroachment, cheating, and dispute." The 1975 Act

could not provide relief to the dispossessed tribals. "Virtually no land was

restored to the erstwhile tribal owners even though the Act had provided for

restoration of all lands alienated since 1960." The tribes' failure to

effectively use the positivist "mainstream" mechanism of justice

administration in many ways illustrates the limitations of the fundamental

right of access to justice unless it is construed in a culturally specific way.

(Sivanandan 2002: 57)

Interestingly, Part III of the Indian Constitution recognises a

fundamental right of access to justice. The literal text is unclear as to

whether the right of access to justice is limited to the formal structures of

justice administration or includes variants of justice administration

including traditional tribal legal systems. However, the framers did intend

that tribes have a right to a socio-cultural existence based on the principle

of substantial deference, including the right to administer justice within the

parameters of traditional customary legal systems. However, the formal

structures of justice administration are limited vis-a-vis the tribes' right of

access to justice and an alternative conception of the right of access to

justice within the fundamental right to culture must be developed to ensure

the realisation of this right. (Baxi 2000: 156-209)

The Indian Constitution recognises 12,000 tribes in its schedule.

Not all are separate and distinct tribes; some are sub-tribes or isolated forest

communities. Accordingly, the discussion of the legal systems as part of

tribal culture that follows is only illustrative of the many tribes that exist in

India. (Singh 1994: 42)


6.4.1 Tribal Legal system

Structurally, the tribal systems may be classified as single and

multi-tiered processes. Typically, tribal legal systems do not incorporate an

"appellate" forum for a reassessment of the decision. This is at least

partially attributable to their conception of justice based on the "wisdom" of

the elderly in contradistinction to the systems that have an elected

"judiciary." While the former typically is single tiered, the latter often has a

multi-tiered process of dispute resolution. Since the source of legitimacy in

the tribal systems comes from hereditary wisdom, there is clearly great

faith in the ability of the wise and elderly to arrive at the "just" decision. In

the case of an elected judiciary, where legitimacy is premised on the

consent of community members, there is no element of divinity in their

decision making, and, therefore, in tribal understanding, their decisions are

more susceptible to errors. (Dam 2006: 318)

The manner of adjudication differs substantially between tribal

systems as some recognise "adjudication," while others emphasise the

"negotiation" character of their resolution process. Judging is a welfare

function they perform as part of tribal governance. Judges do not merely

apply laws to a given factual situation; they seek more flexible solutions

that bring harmony to the tribe. There is neither any "separation of state

from religion" nor any obligation on judges to avoid religious

determinations. The procedures of dispute resolution are completely oral.

Neither is the law nor the evidence required to be in writing; nor are

judgments given in writing. The law (i.e., customary law) is part of social

consciousness which partly explains why the experienced and the elderly

have an authoritative say in resolving matters. These systems are premised

on values wholly different from the hierarchical, disinterested, and secular

processes of dispute adjudication commonly found in the Anglo-Saxon

practices of "mainstream" India. (Dam 2006: 318-319)

The tribal dispute resolution processes are impressively holistic,

with vastly differing adjudication processes. The customary nature of the

laws and the wholly different processes clearly make traditional tribal legal

systems distinguished processes. Therefore, it would seem that the

268 Chapter VI

fundamental right of access to justice would mean something different for

tribal communities than it does for "mainstream" Indian citizens. If the

fundamental right of access to justice is to be realised for the tribal

communities, it can mean nothing less than a right to adjudication under the

customs-based traditional legal system. However, this construction of the

right of access to justice has the potential to interfere with the relationship

between the tribes and mainstream communities. (Dam 2006: 319)

Article 29(1) of the Indian Constitution confers on "any section of

the citizens . . . having a distinct language, script or culture of its own" the

right to conserve the same. In other words, unless the language, script, or

culture is "distinct," it does not enjoy protection as a fundamental right

under Article 29(1).12

The traditional customs-based legal system is a

distinct aspect of tribal culture and also a vehicle for protecting the

distinctness of tribal culture. Indeed, the mainstream judiciary, in its

decisions, has formally recognised the traditional customs-based legal

system as an integral part of tribal culture. (Dam 2006: 320) The customary

laws of a tribe not only govern its culture, but also succession, inheritance,

marriage, worship of Gods, etc. Quite clearly, in recognising the customs

and traditions of the tribal communities the Supreme Court acknowledged

the institutions that sustain and enforce these customs and traditions. To

require the tribal communities to enforce their customs within the

"mainstream" framework of law may effectively deny them their right of

access to justice. These judicial pronouncements, in other words, recognise

the right of tribals to have both their spiritual and temporal disputes

resolved within systems that are a part of tribal culture. (Dam 2006: 323)

6.4.2 Supreme Court’s Interpretation of International Law

It is now well settled by a series of Court decisions that international

law which is not contrary to the provisions of the Constitution or other enacted

law may be considered part of Indian jurisprudence and enforceable in Indian

courts. In the light of these pronouncements, in elucidating the nature of the

right to culture under Article 29(1) of the Constitution, it may be appropriate to

12

India Constitution Article 29(1).


use the body of international law that recognises cultural rights, either

generally or specifically for indigenous people. 13

The I.L.O. Convention, No. 169 of 1989, expressly guarantees

specific cultural rights of indigenous people. Article 4 of the Convention

provides that "special measures shall be adopted as appropriate for

safeguarding the persons, institutions, property, labour, cultures and

environment" of the indigenous people in accordance with their own "freely

expressed wishes." Thus, it seems that in interpreting the scope of "culture"

in Article 29(1) of the Indian Constitution, the additional criteria mentioned

under Article 4 of Convention 169 must be regarded as relevant factors.

Article 5 of the Convention reiterates that "the integrity of values, practices

and institutions of these peoples shall be respected;" while Article 8

specifically recognises "the right of tribal groups to retain their own

customs and institutions." These rights over their institutions are

supplemented by Article 7 that recognises their right to control to the extent

possible, "their own economic, social and cultural development."14

The Draft United Nations Declaration on Rights of Indigenous

People expressly recognises that "indigenous peoples have the right to

maintain and strengthen their distinct political, economic, social and

cultural characteristics, as well as their legal systems." Article 22 of the

Universal Declaration of Human Rights recognises that "everyone, as a

member of society" is entitled to cultural rights, while Article 27 reaffirms

that "everyone has the right to freely participate in the cultural life of the

community." Article 27 of the International Covenant on Civil and Political

Rights recognises that "minorities shall not be denied the right, in

community with other members of their group, to enjoy their own culture."

Taken together, the international law conventions and draft declaration

provide a sufficient basis for analysing the consequences of recognising a

fundamental right to a traditional customs-based legal system as part of the

13

U.N. Conference on Environment and Development (1992): Rio Declaration on

Environment and Development, June 14, U.N. Doc. A/CONF.151/5/Rev.1. 14

“Convention Concerning Indigenous and Tribal Peoples in Independent Countries

(1989),”Convention No. 169, June 27, International Labour Organisation, 76th

Session, at http://www.ilo.org/ilolex/english/convdisp1.htm. 3.

270 Chapter VI

larger right to culture under Article 29(1) of the Indian Constitution. (Dam

2006: 325-326)

Until recently, it was almost inconceivable that "traditional

knowledge," including arts and folklore, could be the subject of intellectual

property. However, as part of the TRIPS agreement, matters that were part

of the cultural lives of people have increasingly found a place within the

scope of intellectual property and, consequently, is increasingly the subject

of commercial exploitation. In accordance with the international mandate,

India has enacted and is contemplating further legislation that affects tribal

culture in significant ways. Therefore it follows from the fundamental right

to a traditional legal system that consent of tribal groups must be sought

within the structures of the traditional legal systems and not through the

formal "positivist" structures created by the State. (Asebey & Kempenaar

1995: 717)

6.4.3 The Protection of Plant Varieties and Farmers’ Rights Bill, 2001

This Act also has some access and benefit sharing provisions. As

regards access, the breeder has to furnish information on the geographical

location from where plant genetic material has been taken for development

of the new variety. Registration would not be allowed if the variety in

question involves any technology such as ‘Genetic Use Restriction

Technology’. Provision has also been made for any person, group of

persons, or any governmental or non-governmental organisation to file any

claim attributable to the contribution of the people of a village or local

community in the evolution of any variety for the purpose of staking a

claim on behalf of such village or local community. The authority after

satisfying itself of the claim, may ask the breeder to deposit a sum of

compensation to the claimant (through the Gene Fund, mentioned below).

The competent authority, after receipt of a certificate of registration,

is required to publish the contents of the certificate and invite claims for

benefit sharing. Any person, group of persons or NGO can be a claimant. In

determining the amount of claim, the authority shall take into consideration

(a) the extent and the nature of the use of genetic material of the claimant in

the development of the variety relating to which the benefit sharing has


been claimed, and (b) the commercial utility and demand in the market of

the variety. The claim is to be deposited in the ‘Gene Fund’ created under

the law. Gene Fund is also the receptacle of royalties to be paid by the

breeders for staying registered and any contribution from any national or

international organisation. Funds in this receptacle are to be used payments

of benefit sharing, of compensation, for supporting conservation and

sustainable use and for administrative expenses for running the benefit

sharing mechanism. (Kaushik 2002)

6.4.4 The Biodiversity Act 2002

The Biodiversity Act 2002 has the object of providing for

conservation of biological diversity, sustainable use of its components and

equitable sharing of the benefits arising out of the use of biological

resources. Chapter II of the Bill deals with the regulation of biological

diversity and is the basic Chapter on access to biological resources. It

states:

3(1) No person referred to in sub-section (2) shall without previous

approval of the National Biodiversity Authority obtain any biological

resource occurring in India or knowledge associated thereto for research or

for commercial utilisation or for bio-survey and bioutilisation.

(2) The persons who shall be required to take the approval of the

National Biodiversity Authority under sub-section (1) are the following,

namely: -

(a) person who is not a citizen of India;

(b) a citizen of India, who is a non-resident as defined in clause (30) of

section 2 of the Income-tax Act,1961;

(c) a body corporate, association or organisation –

(i) not incorporated or registered in India; or

(ii) incorporated or registered in India under any law for the time being in

force which has any non-Indian participation in its share capital or

management.

272 Chapter VI

4 No person shall without the previous approval of the National

Biodiversity Authority, transfer the results of any research relating to any

biological resources occurring or obtained from India for monetary

consideration or otherwise to any person who is not a citizen of India or a

body corporate or organisation which is not registered or incorporated in

India or which has any non-Indian participation in its share capital or

management.

5 (1) The provisions of section 3 and 4 shall not apply to collaborative

research projects involving transfer or exchange of biological resources or

information relating thereto between institutions, including Government

sponsored institutions of India, and such institutions in other countries, if

such collaborative research projects satisfy the conditions specified in sub-

section (3).

(2) All collaborative research projects, other than those referred to

in sub-section (1) which are based on agreements concluded before the

commencement of this Act and in force shall, to the extent the provisions of

agreement are inconsistent with the provisions of this Act or any guidelines

issued under clause (a) of sub-section (3), be void.

(3) For the purposes of sub-section (1) collaborative research

projects shall, (a) conform to the policy guidelines issued by the Central

Government in this behalf; (b) be approved by the Central Government.

6 (1) No person shall apply for any intellectual property right by

whatever name called in or outside India for any invention based on any

research or information on a biological resource obtained from India

without obtaining the previous approval of the National Biodiversity

Authority before making such applications:

Provided that if a person applies for a patent, permission of the

National Biodiversity Authority may be obtained after the acceptance of the

patent but before the sealing of the patent by the patent authority

concerned.

(2) The National Biodiversity Authority may, while granting the

approval under this section, impose benefit sharing fee or royalty or both or


impose conditions including the sharing of financial benefits arising out of

the commercial utilisation of such rights.

(3) The provisions of this section shall not apply to any person

making an application for any rights under any law relating to protection of

plant varieties enacted by Parliament.

(4) Where any rights is granted under sub-section (3), the concerned

authority granting such right shall endorse a copy of such document

granting the right to the National Biodiversity Authority. (Kaushik 2002)

The Biological Diversity Act of 2002’s Statement of Objects and

Reasons notes that the Central Government, after an "extensive and intensive

consultation process," has decided to bring legislation, inter alia, "to respect

and protect knowledge and information of local communities related to

biodiversity and to secure sharing of benefits with local people as conservers

of biological resources and holders of knowledge and information relating to

the use of biological resources." The Act establishes a National Biodiversity

Authority with plenary powers to administer the Act.15

Any person who is not a citizen of India, a non-resident citizen or a

corporate body not registered in India, or registered under law having non-

Indian participation in its share capital or management, is not authorised to

obtain any biological resource or knowledge without the previous approval

of the National Authority. It is interesting to note that the provision, while

empowering the National Authority to grant approval, does not in any way

refer to the necessity of consent of the communities whose resources are

being approved. (Dam 2006: 331)

Provided that the provisions of this section shall not apply to the

local people and communities of the area, including vaids and hakims, who

have been practicing indigenous medicine. It would be noted that access is

granted to citizens only after prior intimation, while it is granted to

foreigners after prior approval. The different approaches appear to have

been necessitated because while it might be easy to bring a citizen under

the jurisdiction of the competent authorities and the Courts, this would be

15

“The Biological Diversity Act, 2002, No. 5 (2002),” India Code (2000).

274 Chapter VI

impossible for foreigners. Secondly, not only access to the resource, but

even transfer of research results abroad are prohibited without approval of

the competent authority. This appears to be a recognition that knowledge

about the resources is as important as the resources themselves for the

purpose of ensuring conservation.

Of course, this prohibition does not extend to ‘collaborative

research’. Thus, research conducted with the approval of the Government,

and that meets the guidelines to be laid down by the Government, is

permitted by foreigners also. Thirdly, No one can apply anywhere in the

world for an IPR on knowledge based on a resource obtained in India

without approval of the competent authority. This is an important clause for

the purpose of the debate on enforceability abroad, as will be seen in the

last part of the paper. (Kaushik 2002)

The National Authority's discretion to grant approval is limited by a

necessity to ensure "equitable sharing of benefits in accordance with

mutually agreed terms and conditions between the person applying for such

approval, local bodies concerned and the benefit claimers." The limitation

contained in this provision is of little consequence though because it does

not address the issue of consent of the communities per se. On the contrary,

the provision presumes the existence of a standing consent and imposes an

obligation on the National Authority to evolve a formula for "equitable

sharing of benefits." By not allowing communities, tribal or otherwise, to

decide whether to allow aspects of their cultural life to be made subject

matter of commercial utilisation, the provision infringes the communities'

fundamental right to culture. (Dam 2006: 332)

Below the National Authority and the State Boards, the Act does

permit local bodies to create a "Biodiversity Management Committee for

the purpose of promoting conservation, sustainable use and documentation

of biological diversity including preservation of habitats, conservation of

land races, and folk varieties." However, the National Authority and State

Boards are only required to consult these Management Committees while

making a decision relating to the use of biological resources and knowledge

associated therewith. (Dam 2006: 332)


Local bodies have been relegated to a consultative entity, both with

reference to the National Authority and State Boards, and they have been

given no authority to veto decisions permitting the commercial utilisation

of cultural knowledge. The actual consent of a community to commercial

utilisation of its cultural property has been made irrelevant by the

presumption of consent. By presuming a standing consent, the Biological

Diversity Act effectively denies tribal communities any meaningful

realisation of their fundamental right to culture. The Act does not recognise

any traditional dispute resolution mechanism to resolve differences arising

from decisions permitting the commercial utilisation of such cultural

property. (Dam 2006: 333)

The Biological Diversity Act does not take into account the

possibility of a dispute between the National Authority, State Boards, and

tribal communities. Consequently, the Act does not recognise the

availability of traditional dispute resolution mechanisms already in place in

such communities. First of all, if traditional tribal legal systems are seen as

evidence of culture per se, the fundamental right to culture, if it means

anything to tribal life, must include the right to a traditional legal system as

the dispute settlement mechanism for all conflicts between the tribes and

non-tribe members and institutions. Second, if such a system is seen as a

cultural "enforcement" process, the fundamental right of access to justice

for the tribal communities, if it means anything, must mean the right of

access to justice in the form of the customary practices of their traditional

system. (Dam 2006: 334)

Due to globalisation of production systems, increase in population

and due to decreased motivation amongst the local communities to

conserve and protect biodiversity and associated traditional knowledge is

declining. Misappropriation of biological resources and associated

traditional knowledge not only violates the rights of communities who

conserve them, but also adversely affects their conservation and sustainable

use. (Kaushik 2002)

276 Chapter VI

6.5 Major Initiatives

An important aspect relating to TK is the need for value addition to

this knowledge for converting it into economically profitable investments

or enterprises. Many of the innovators however do not have the capacity for

value addition. Thus there is a need for providing institutional support

through public funding in scouting, spanning, sustaining and scaling up of

grassroot innovations and to enhance technical competence and self

reliance of these innovators, through establishment of green venture

promotion funds and incubators. It was also proposed as part of the 1999-

2000 national budget of India that a National Innovation Foundation would

be set up. This foundation, with an initial corpus of Rs.200 million (about

US$ 4 million), is intended to build a national register of innovations,

mobilise intellectual property protection, set up incubators for converting

innovations into viable business opportunities and help in dissemination

across the country.

Apart from this, the Ministry of Environment and Forests has

established a National Biodiversity Strategy and Action Plan (NBSAP),

which is undertaking a number of activities including identifying access and

benefit sharing methods that are easy to follow and take into account the

concerns of the innovators. The NBSAP is being run by an NGO, showing

the extent of civil society involvement in the effort. (Kaushik 2002: 6)

6.5.1 Documentation of Traditional Knowledge

In India, preparation of village-wise Peoples’ Biodiversity Registers

(PBRs) and Community Biodiversity Registers (CBRs) for documenting all

knowledge, innovations and practices has been undertaken in a few States.

In the first such initiative, the concept of Community Register (CR) was

launched by the Foundation for Revitalisation of Local Health Traditions

(FRLHT) amongst South Indian NGOs in 1994. (Gadgil & Ghate 1999:

327-347) Gradually, a loosely knit nationwide movement evolved that is

mapping traditional knowledge all over India. There have also been some

initiatives that focus on accrual of rights on individual innovators rather

than of communities, such as Srishti and Honeybee. These efforts to

prepare PBRs and CBRs were later taken up by the respective State


Governments also and now, for example in the State of Karnataka, these

are being prepared with State funds and assistance also.

For preventing instances of bio-piracy in future a need was felt for

developing digital databases of prior art related to herbs, which are already

under public domain. Thus an exercise was initiated to prepare easily

navigable computerised database of documented TK relating to use of

medicinal and other plants known as Traditional Knowledge Digital

Library (TKDL). Such digital database would enable Patent Offices all over

the world to search and examine any prevalent use/prior art, and thereby

prevent grant of such patents and bio-piracy. The preparation of TKDL is

being done in conformity with the classification system being developed by

WIPO, so that it is easily used by patent examiners the world over in order

to prevent bio-piracy.

It has also been recognised that documentation of traditional

knowledge (TK) is one means of giving recognition to knowledge holders.

Documentation of traditional knowledge may only serve a defensive

purpose, namely that of preventing the patenting of this knowledge in the

form in which it exists. Documentation per se, however, will not facilitate

benefit sharing with the holders of traditional knowledge, unless it is

backed by some kind of mechanism for protecting the knowledge.

(Kaushik 2002: 4-5)

6.5.2 Background of Kani Model of ABS Mechanism

The indigenous communities in many part of the world were voicing

against lack of acknowledgement to their contribution which directly or

indirectly benefited the production of new products. 'Declaration of Belem',

the out come of the first International Congress on Ethnobiology held in

1987, recognised a basic obligation that procedures to be developed to

compensate the native people on their knowledge on the biological resources.

The Second Congress on International Congress on Ethnobiology, called for

a specific and urgent action to stop destruction of biological and cultural

diversity as mandated in the 'Declaration of Belem'. This meeting also

resulted to the establishment of global coalition for Biocultural Diversity to

unite the indigenous people, scientists and environmentalists concerned with

278 Chapter VI

the protection of indigenous/local people's rights. Powerful persuasion of

some scientists like Dr. Durrel Posey of International Society for

Ethnobiology (ISE) made it possible to include the legal protection of

traditional or local community rights in the text of the Convention on

Biological Diversity at Rio De Janeiro 'Earth Summit'.16

Such a background urged Dr. Pushpangadan to experiment the

benefit sharing mechanism with the Kani Tribe. This benefit sharing model

has acclaimed world fame at many international forums as the first of its

kind, which implemented, in letter and spirit the Article 8(j) & 10 (c) of the

Convention on Biological Diversity (CBD), and is now recognised as the

'Kani Model'. So far, the Kerala government has not officially recognised

the model. The ABS mechanism with the Kani is based on a mutual trust

rather than a legal agreement between TBGRI and the Kani trust. The CBD

came into force in 1993, and subsequently India enacted the Indian

Biodiversity Act in 2002. However, there is confusion, as to whether the

ABS mechanism with Kani are obliged to follow those legal provisions

which are currently discussed under the CBD and of the Indian Biodiversity

Act 2002.

6.5.3 Institutions and Organisations behind the Kani Model of ABS

It was in 1976 that Dr. M.S. Swaminathan initiated steps to

undertake ethnobiological survey to study about the indigenous

communities of India so as to record and document their fast eroding

lifestyle and knowledge. In course of time, in collaboration with the

Department of Science & Technology (DST) under the Man & Biosphere

programme (MAB) along with the Ministry of Environment & Forests

(MoEF), Govt. of India, initiated a project named All India Co-ordinated

Research Project on Ethnobiology (AICRPE) at the Regional Research

Laboratory (RRL) and Dr. P. Pushpangadan was appointed as the Chief

Coordinator of this project. As part of the project, AICRPE programme was

implemented in 27 R&D institutions and university research centres in

different parts of the country and documented the rich knowledge system of

16

“Pushpangadan Model of benefit sharing,” at

http://www.nbri-lko.org/director%20data/index1.htm



the tribals about the use of over 10,000 plants and many wild animal at

birds etc.

The Tropical Botanic Garden and Research Institute (TBGRI) was

established at Palode, Thiruvananthapuram in 1979 under the aegis of the

Science, Technology and Environment Committee (STEC), Government of

Kerala. The Chief Minister of Kerala is the President of the KSCSTE. The

overall research and development (R&D) activities of the TBGRI are

geared to achieve the most tangible results of conservation as well as value

added and product oriented sustainable utilisation of plant genetic resources

of the region. This project has facilitated in developing the benefit sharing

experiment by way of providing administrative and financial support

through AICRPE. The financial assistance provided by DANIDA

facilitated TBGRI in building Phytochemistry & Ethnopharmacology

research laboratories with modern facilities. The establishment of modern

Phytochemical and Ethnopharmacology labs and the trained scientists

helped in undertaking scientific investigation on the medicinal plants

suggested by the 'Kani' tribe and that finally led to the development of a

scientifically validated and standardised herbal drug which was

subsequently commercialised.

The Kerala Institute for Research, Training and Development of

Schedule Castes and Schedule Tribes (KIRTADS), an independent institution

under the Kerala Government’s Schedule Caste and Schedule Tribes

Development Ministry acted as most vociferous critic to the entire project and

suggested that the government should facilitate production of the drug by the

tribal community members themselves instead of transferring their knowledge

to a private company.

6.5.4 Tribals in India

India has over 70 million tribals belonging to over 550 communities.

They inhabit in about 5000 villages, which are located in and around forests of

high mountainous regions of the country. The tribal communities who live in

the forest mostly lead a nomadic or semi nomadic life subsisting mainly on

forest produces. The vocation of the tribal ranges from hunting and gathering

to organised tribal societies with settled life and culture. Each tribal

280 Chapter VI

community has a distinct social and cultural identity and has its own language

and dialect. There are about 116 different dialects spoken by the indigenous

tribal communities of India. The tribal communities have their own unique

culture, customs, traditions, rituals & beliefs which are uniquely distinct for

each tribe. Some of them have very elaborate and highly fascinating ritual

dances, with colourful customs, which they make with flowers, plant parts,

feathers/plumes and natural colours.

The forests play a very significant role in tribal's life, particularly to

those nomadic and semi-nomadic groups who live inside forests and

depends forest flora and fauna heavily for food, medicine and other

material requirements. They also depend on Non Timber Forest Products

(NTFPs) like gums, dyes, resins, medicine, cane, reed, etc. These items

were either bartered or sold to the middlemen for procuring things from the

market. The exploitation of the forest resources by outsiders has degraded

the forest causing great hardship to the tribals. Besides, various restrictions

and regulations imposed by the Forest department have also caused great

misery and unrest among the tribal communities in the country.

The tribal communities in India inhabit mostly in the forested

regions with a perfect harmony with nature. Before the arrival of Britishers

the forest dwelling tribals were not disturbed by any local rulers. They had

complete freedom. The colonial rulers began to make greater inroads into

tribal heartlands for exploitations. Initially the British rulers tried to

superimpose their conventional administrative pattern directly or through

intermediation. Various forest laws initiated by the colonial rulers began to

erode the freedom of tribals in forests.

6.5.5 The Kani Tribe

The Kanis, a nomadic tribal community currently settled across the

state of Kerala in southern India, have a population of a little over 25,000,

and live mainly in the Agasthya forest region of Thiruvanathapuram

district. A small number Kanis also reside in the neighbouring state of

Tamil Nadu. (Pushpangadan et.al, 1998) They are believed to be the

descendants of Agasthya Muni, founder of Sidha, the Tamil system of

medicine. The Kanis maintained that they can live actively only on the


unripe fruit of the Arogyapacha for over 15 days. They believe the fruit is a

gift from their ancestor Agasthya Muni, to help them survive in the forest.

Although they have a tribal chief called the 'Moottukani' who used to

combine the role of law giver, protector, dispenser of justice, physician and

priest, now such function of the 'Moottukani' has been almost eroded and

his role only a nominal one. Today the system of governance is linked to

that of the non-tribals, mainly the forest department officials who engage

them as labourers in forestry operations. The government system of

governance has been brought to the tribal hamlets under the nearby village

administration called 'Village Panchayat'.

6.6 The Benefit Sharing Experience of the Kani Tribe17

6.6.1 Accidental Discovery

In order to implement AICRPE project, scientists of TBGRI sought

the permission of Kani tribe to accompany them as guide in the Agasthy

hills, the Western Ghats in South India. Adichan Kani, then head or Mottu

Kani, assigned Mallan kani and Kuttimathen kani to help the scientists in

their ethnobotanical survey. Thus, in December 1987, two scientists Dr

Pushpangadan and Dr Rajasekharan conducted the exploration with the

help of two kanis. During the visit, the scientists got exhausted and the

Kani men were quite energetic and agile even without food. Then the Kani

men offered the scientists some dry fruits which were being chewed by the

kani men during the trekking. The kani men told that if consumed it would

reduce fatigue and would make them energetic. On consuming those dry

fruits, the scientists felt a sudden flush of energy within 10-15 minutes.

When asked about the source of the fruits, the Kani men were very

reluctant to reveal source of the fruits, saying that it was sacred information

of the community and not to be revealed to outsiders. The scientists assured

them that they would not misuse this information, but would carry out

scientific investigation and if any positive results were obtained the Kanis

would be rewarded appropriately. However, it was after much persuasion

17

The case study is prepared on the basis of personal interaction with Dr. S

Rajashekaran, during the visit of TBGRI on a number of occasions during the research

as part of field work (herein after fieldwork).

282 Chapter VI

they showed the plant from which they collected the fruits. The plant was

growing very much in that very forest where the scientists were trekking.

The Kani's named this plant 'Arogyapacha', meaning evergreen health,

which was later identified as Trichopus zeylanicus spp. travancoricus.

Although this species was documented and described earlier by TBGRI, its

traditional use and special properties were not known to the scientific world

until then.18

The first scientific test to validate the Kani's claim on the antifatigue

property of Arogyapacha was conducted at Regional Research Laboratory,

(RRL), Jammu. The scientist conducted the standard 'swimming

performance' on Swiss mice under three different conditions. The mice

were given swimming test in tubs of water under Control (mice fed with

synthetic steroidal drug - Amphetamine - to boost stamina), and Experiment

2 (mice ingested with macerated Kernels of the fruits of Arogyapacha). The

controlled ones after 3 hrs exhausted and sink in water, and the mice kept at

experiment 1 (fed with Amphetamine) were found exhausted and sank after

6 hrs. Whereas the mice under experiment 2 (ingested with Arogypacha

Kerrels) swam for a period of 18 hrs.

After the successful completion of the swimming test, scientists used

detailed phytochemical and pharmacological studies on Arogyapacha in which

they discovered the presence of certain glycolipids and non-steroidal

compounds (Polysaccharides) with profound adaptogenic immuno-enhancing

antifatigue properties. However, harvesting tender fruits of Arogyapacha for

large scale production of Jeevani was found unsustainable as each plant could

bear only a few fruits of three to six that too for a critically short period in its

phonological timeframe.19

Detailed chemical and pharmacological

investigations showed that the leaf of the plant contained various glycolipids

and some other non-steroidal compounds with profound adaptogenic and

immuno-enhancing properties. It was an additional knowledge from the Kani

practice of using fruit for anti-fatigue purpose. Since Arogyapacha is a

perennial rhizomatous herb that produce a rosette of 10-15 weighting 100-200

18

Ibid. 19

Ibid.


gm evergreen leaves with two or three flush in every year, the leaves were

recommended as a sustainable source of materials required for commercial

production of the herbal, 'Jeevani'.20

The scientists soon realised that the classical pharmacological

approach to study the traditional remedies of medicinal plants by isolating

single compounds may not be satisfactory and an ethno-pharmacological

approach was adopted to evaluate this plant. By this time Dr. Pushpangadan

was transferred to TBGRI as Director during November, 1999. At TBGRI,

he established a full-fledged Ethno-pharmacology Division and recruited

scientists from disciplines of Botany, Pharmacology, Phytochemistry,

Biochemistry, Pharmacy and Ayurveda.

Within a period of two years a scientifically validated, standardised

herbal formulation 'Jeevani'21

was formulated with 'Trichopus zeylanicus'

as major ingredient and withanis somnifera (ashwagandha), piper longum,

evolvalus alsinoides are the other medicinal plants used as its ingredients.22

Evaluations related to toxicity efficacy, shelf life and clinical properties

were carried out by TBGRI, and the drug was ready by the end of 1994.

The kani tribe used the fruits of the plant as anti-fatigue whereas Jeevani is

developed from its leaves. The final product was further tested for eight

months in different cities of India over 100 people of both non-healthy and

healthy. (Sachin Chaturvedi, 2007: 3) Besides modern pharmacology

efficacy tests, it was also evaluated on the basis of Ayurvedic dravya guna

and rasa shastra. It is classified under the health promoting (swasthahita)

group of drugs. In Ayurvedic literature of Charaka Samhita and Surutha

Samhita which is written in BC and published in 1931, Arogyappacha is

considered as one of the 18 divine herbs.23

20

Ibid. 21

Jeevani is a Sanskrit term mentioned in Ayurvedic literature and derived from the term

‘Jeevaniya’ meaning ‘elixir of life’ (“Jeevane Sanjeevane hitam” – Ref 1. A Hand Book of

Ayurvedic Material Medica with Principles of Pharmacology and Therapeutics, 1950,

vol.I, by Dr.H.V.Savanur published by Dr.Jadhar, Maruti Street, Belglum: 21. Ref 2. A

Sanskrit- English Dictionary by Sir. Monier Monier-Williams, 1899, pp 423). 22

Field Work. 23

Ibid.

284 Chapter VI

6.6.2 Five applications for Process Patents

After the clinical trials, twelve active compounds were isolated

from Arogypacha and five process patents were filed since 1994. All the

five process patent applications never mentioned about prior informed

consent of the Kanis and the source or the certificate of origin of the

product as these provisions were not legally binding by then. No Kanis are

included as applicants in the process patent applications.24

Five applications for Process Patents

Application

number Applicants Derivative process Product Patent

959/MAS/199

6

Pushpangadan P,

S. Rajasekharan

and George V

A process for the

preparation of a

novel

immunoenhancing,

antifatigue, antistress

and hepatoprotective

herbal drug

Jeevani

The process

patent published

in Indian Patent

Gazette No.31

dated August 3,

2002 and sealed

in 2005 due to

non renewal

88/Del/1994

Bhutani K K,

Gupta D K,

Jaggi B S,

Amanda K K,

Kapil R S,

Pushpangadan P,

Sreedharan Nair,

S.Rajasekharan

for isolation of a

Glycolipid Fraction

from Trichopus

Zelyanicus

possessing

adaptogenic activity

Process patent

Awarded

957/MAS/199

6

For the preparation

of diabetic medicine

958/MAS/199

6

For the preparation

of sports medicine Vaji

MAS/650/200

1

Appian

Subramonium,

Sreedharan

Rajasekharan,

Palpu

Pushpangadan,

Varghese George

and Gopalapillai

Sreekandan Nair

for the process to

prepare an herbal

preparation for

cancer

Awarded Patent on

22

September2006.

(Source: Data compiled after the personal interaction with Dr. S. Rajasehkaran)

24

Ibid.


6.6.3 Transfer of Technology to Arya Vaidya Pharmacy (AVP)

As the first step towards the commercial production of the product

and transfer of technology, the scientists of TBGRI thought of a legal

institution to share the benefits with the 'Kani' tribe as promised earlier. A

proposal was prepared to get the approval of the competent authority of

TBGRI for sharing the benefits on 1:1 basis deriving from the technology

transfer with the Kani tribe. Dr. Pushpangadan personally presented the

proposal and explained the whole story of the development of the 'Jeevani'

and also highlighted mandatory provision of the Article 8(j) of the CBD in

which India is legally bind to provide a benefit sharing mechanism as CBD

has been ratified by Government of India in February, 1994. Executive

Committee and Governing Body of TBGRI finally approved the proposal

and subsequently, it was ratified by the Governing Body of TBGRI.

In order to commercially produce the pharmaceutical product, a

licence has to be obtained according to the Drug Control Act either in the

modern pharmacology framework or through the codified formula of Indian

system of medicine. The former procedure would require huge investment

and minimum of fifteen years to formulate a pharmaceutical drug. So

TBGRI applied for license under the codified formulary of Indian system of

medicine which is very easy to obtain in short time but does not recognise

local knowledge. Therefore, the product Jeevani was explained in the

codified Ayurvedic formulary and license was obtained from Drug Control

Department, Government Kerala in 1996 for commercial production of the

product.

When the product was developed, the TBGRI invited companies to

bid for the product’s commercial production. The Arya Vaidya Pharmacy

(AVP), Coimbatore was short listed for production of the drug after they

agreed to establish a GMP (Good Manufacturing Process) facility

according to WHO standards. Then leader of the Opposition, Mr. V.S.

Achuthanandan, wrote a letter to the Chief Minister of Kerala, who was

also chairman of the Governing Body of TBGRI, raising objection against

the small amount of lump sum amount offered by the private company and

286 Chapter VI

favoured for public limited companies owned by the Government over

private companies.25

In order to study about these two objections, TBGRI constituted a

Committee of scientists to study about the issues. The Committee found

that both companies of Kerala State Drugs and Pharmaceuticals, Alappuzha

and Oushudhi, Trichur in Kerala are not capable for GMP standard

productions and they are not even marketing herbal products. With regard

to the second objection, no other institution in India has ever got greater

than Rs. 1 Million as license fee. But the committee did not specify whether

the license fee is for marketing at the national level or global level. In turn,

the next Governing Body meeting of the TBGRI cleared transfer of

technology to AVP on 20 October 1995 (Sachin Chaturvedi, 2007).

The next major issue was whether to follow the Council of

Scientific & Industrial Research (CSIR) pattern of transfer of technology or

not. The Executive Committee of TBGRI decided to follow the CSIR

model of benefit sharing in which, 60 per cent of the license fee and royalty

goes to the scientists and 80 per cent of the remaining 40 per cent goes to

inventors and 20 per cent to supporting staff. Due to special consideration,

TBGRI decided to deviate from the CSIR model and decided to share 50-

50 per cent basis. Thus, an arrangement was worked out at 1:1 basis that is

50 per cent to tribal community and 50 per cent to the Institute.

In 1996, the technology for commercial manufacture of 'Jeevani'

was transferred to AVP for a period of seven years against a licence fee of

Rs. 10,00,000 (US $ 25000 approx.), and for a royalty of 2 per cent on ex-

factory sale of the product. After transfer of the technology for

manufacturing Jeevani to the AVP, in 1996, the TBGRI earned US$50,000.

Fifty per cent of the license fee as well as fifty per cent of royalties from

sale were given to the Kani tribes.

The seven year licence period ended in 2002 and the AVP and

TBGRI have not made any fresh deal either with AVP or with any other

company. But the negotiation for the second ABS agreement is progressing

25

The Hindu (1995) “TBGRI Pact with Private Firms Put Off,” July 25.


in the recent past in a more democratic and transparent manner. In 2004,

then Director at the TBGRI constituted a Business Management

Committee (BMC), which comprised of seven persons, two from its

faculty, three outside experts and two representatives of the Kani Trust.

The BMC was established to negotiate fresh bids with companies

interested in the commercial production of the drug. In this regard,

advertisements were placed in the leading newspapers and a number of

proposals have been received by the BMC. A set of minimum conditions

are placed for the new ABS arrangement. Both license fee and royalty has

been doubled to Rs. 20, 000, 00 and 4 per cent respectively.26

They were

entrusted to explore the possibilities of manufacturing the drug ‘Jeevani’

by establishing a tie-up with Kani trust with a view to ensuring the

supply of the raw materials required for the production so that they may

get double benefit through the sales of ‘Jeevani’ as well as the supply of

the leaves of ‘Arogyapacha’ through cultivation.

The AVP was again selected for the second agreement but

someone raised the objection that the selection process is not transparent

as the tender was advertised in only an English national daily and no

vernacular medium was used for the advertisement. So the selection

process had been renewed. In the meantime, though AVP withdrew from

the selection process, they are still buying fresh leaves from Kanis and

ready to pay the royalty to the Kani accordingly.

There are two viable alternatives available to the Kani and the

TBGRI to market the products. First option is to look for a government

owned national company especially from Kerala for the second

Agreement. In this regard, the Executive Vice President of Kerala State

Council for Science, Technology and Environment (KSCSTE), Govt. of

Kerala, instructed Director of TBGRI to constitute vide order

NoTBGRI/Estt.2/ 3829/08 dated 30/07/2008 a five member team of

experts from the different scientific fields including a representative from

the head quarters of KSCSTE to visit ‘Oushadhi’ a Govt. owned public

undertaking Pharmaceutical Cooperation Ltd. exclusively engaged in the

26

The Hindu (2006) “Tribals to Benefit Renewal of License from Herbal Drug,” March 28.

288 Chapter VI

production of Ayurvedic drugs including other plant based products like

herbal drugs, neutraceuticals etc.

Second option could be as early suggested by KIRTADS that the

government should facilitate production of the drug by the tribal

community members themselves instead of transferring their knowledge

to a private company. This suggestion seems to be more meaningful as

many of the educated Kanis could be accommodated in the production

and distribution of the product. But the major obstacles in this regard are

the financial side to make the infrastructure.

6.6.4 Kerala Kani Smudaya Kshema Trust

The prime concern of the tribals was to evolve a mechanism for

receiving such funds because neither the Kani tribe was an organised

community, nor they had any institutional mechanism to receive such a

fund. Though the informers claimed the information as their family

knowledge and claimed for the exclusive control over it, the scientists

considered the knowledge as the collective knowledge of the community

in respect customary practices of the tribe. So any benefits derived from

the knowledge should be beneficial to the tribe as a whole. Several ways

of transferring the benefits to 'Kani' tribe was discussed. Prof. Anil K.

Gupta, the founder and co-ordinator of SRISTI and the Honey Bee

Network, Ahmedabad suggested to form a trust of Kani tribe to transfer

the money. Subsequently, a trust was formed in November 1997 with

support from TBGRI, local Government officials and NGOs. Mr.

Pradeep, active social worker engaged in the upliftment of tribals, drafted

the constitution for the Kani welfare trust with the help of some legal

experts.


The Kani tribesmen who provided information and

knowledge about Arogyapacha

(Source: Photo collected during the field work)

The Trust that began with nine Kanis as its members has gone upto

thousand Kanis from the Thiruananthapuram and Kollam districts of

Kerala. A kani has to be above 18 years to become a Trust member without

any registration fee. Two guides were kept as permanent life members

while rests of the positions are open to election that is scheduled to take

every third year. Kuttimathan was the secretary of KKSKT right from the

inception of the Trust and up to 18/05/2008. Recently, through the

democratic process of election conducted under the surveillance of TBGRI

scientists, Mr. Rajendran Kani was elected as its President and Mr.

Naraynan Kani as its General Secretary.27

In order to implement certain effective measures, the newly

elected office bearers are now in touch with local self Government for

getting financial support especially for the cultivation of ‘Arogyapacha’.

In this connection, with the technical support of TBGRI, the Trust has

prepared a project exclusively for the cultivation of ‘Arogyapacha’ and

submitted to the District Panchayath authorities for necessary financial

assistance. Another problem that they are facing is the lack of managerial

skill of trust members especially maintaining the accounts, expenditure

27

Field Work.

290 Chapter VI

etc. Therefore, the Trust is now exploring the possibilities of getting

proper training with the help of Department of Scheduled Castes and

Scheduled Tribes especially for improving the managerial skill, capacity

building, personality development etc.

As of now, the total money transferred to the Trust both as licence

fee and royalty are list below:

A Jeevani –License fee paid

Sl. No. Name of the Bank/ Cheque No. Date Amount paid

(in Rupees)

1. SBT, 092496 22/02/1999 5,00,000/-

B Jeevani – Royalty paid

Sl. No. Name of the Bank/ Cheque No. Date Amount paid

(in Rupees)

1. SBT, 092496 22/02/1999 19062.00

2. SBT, 098845 04/12/2003 30000.00

3. SBT, 109446 03/03/2004 30000.00

4. Cheque No. 031056 24/10/2005 37382.00

5. SBT, Palode cheque No.866555 31-12-2008 24728.50

6.

Total Royalty received from

Coimbatore Aryavaidya Pharmacy

from 1999 to 2008

282345.00

7.

50% of the Royalty given to the Trust

as per the agreement

(Rupees one lakh forty one thousand

one Hundred and Seventy Two and

fifty paise only)

141172.50

8. The amount donated to the Trust by

Dr.P.Pushpangadan 1,00,000.00

9. The amount donated to the Trust by

Dr.Anil K. Gupta 5000.00

Total asset of the trust A + B = Rs.7,46,172.50 (Rupees Seven Lakhs Forty Six

Thousand One Hundred and seventy two and fifty paise) which excludes interests

accrued from the above amount.

(Source: Data collected during the fieldwork from Dr. S Rajasekharan on 19/06/2009)

The first executive committee of the Trust in consultation with TBGRI

decided to give Rs. 20,000 each to Mallen Kani and Kuttimathen Kani, the

prime informers to the scientists and Rs.10,000 to Eachen Kani who was also

deputed in the initial stage of trekking. The executive committee also decided to


put Rs. 500,000 as fixed deposit with an understanding that only the interest

accruing from this amount will be used for the welfare activities of the Kani

tribe. (Khwaja, R.H 2001) The major functions of the trust are to facilitate

sustainable supply of Arogypacha to AVP as well as to undertake the social

welfare activities of its members. In this regard, Trust has built an office cum

community hall at Chonampara tribal settlement, Kottoor, Thiruvananthapuram

District. The Trust has opened its bank account at the Union Bank of India,

Kuttichal which is under control office bearers.

Some of the social development activities the trust engaged since its

inception are listed below;

6.6.5 Post Benefit Sharing Effects

• Rs. 2500 is maintained as a fixed deposit in the name of two Kani girls aged 8 and 10

whose mother was killed by a wild elephant in 2002.

• Constructed a Community Hall (Arogyapacha Bhavan) with necessary infrastructure

facilities including table, chairs etc.

• Facilities provided for running single teacher school in the community hall for the last

three years and now it has been shifted to the new building.

• Solar lamp was installed with the help of ANERT

• Purchased a new Jeep for transportation of people, marketing goods and Non Wood

Forest Produce

• KKSKT has given employment to two Kani tribesmen as Driver of the Jeep and

Helper and both of them are drawing salary every month.

• Telephone facilities have been provided to the office of the Trust.

• Construction of a small building for providing computer education to the school

children is in progress.

• Established Rain Water Harvesting System

• Established reading room for the benefit of the tribal community.

• TBGRI in association with KKSKT implemented a ‘Pilot Participatory Programme on

Conservation and Sustainable Utilisation of Medicinal and Aromatic Plants’ under the

Kerala Forestry Programme aided by World Bank.

• Recently Kerala Forest Department have already started implementing a novel

scheme entitled Cultivation of Medicinal Plants for Improving the Livelihood of Kani

tribes residing in the Agastyar Vanam Biological Park (Kottoor forest) with the

support of National Medicinal Plant Board Govt. of India. Arogyapacha is one of the

medicinal plants included for large scale cultivation under the above programme. This

will definitely help the tribal community to generate considerable income.

(Source: Data collected from Dr. S Rajasekharan on 19/06/2009 through the personal

interaction at TBGRI)

292 Chapter VI

6.6.6 Issues associated with cultivating the plant and

commercialisation of the product

Product Jeevani

'Jeevani' as a pharmaceutical drug was able to capture the market in

India at Rs. 160 for 75 gram as well as abroad, including countries like

USA and Japan. This necessitated a regular supply of fresh leaves of

Trichopus zeylanicus. Since the wild collection may not be dependable,

TBGRI scientists developed a protocol for cultivating this plant.

Cultivation studies revealed that the plant is habitat-specific and that the

therapeutically active principles are produced only when it is cultivated in

and around its natural habitat.28

28

“Pushpangadan Model of benefit sharing,” at




Leaves of Arogyapacha

(Source: Photo collected during the fieldtrip)

Unfortunately, the Forest Department objected to the cultivation

with the observation that the tribals might remove the plants from the

natural population of the species in the forest and make it endangered. Such

a fancy argument could never withstand as only leaves are required for the

drug manufacture and the plant is a perennial one. Not only the Forest

Department came up with another objection that this plant is not in the

official list of the plant materials permitted to be collected by Kani Tribe

but also demanded a license fee and royalties for cultivation. Since the

Forest department did not allow the tribals to collect the leaves from the

wild, they asked to provide financial assistance for the cultivation of

Arogyapacha with the technical support of TBGRI which was assured and

training was provided to Kani tribe members under the Integrated Tribal

Developmental Programme (ITDP) of Directorate of Tribal Welfare. This

programme provided support to 50 Kani families with Rs.1000 each for

cultivation of plants. In the meantime TBGRI developed fast multiplication

by both vegetative and tissue culture methods to produce large scale

planting materials to be supplied to the tribals.

294 Chapter VI

During 2002, Kerala Forest Department has allowed to cultivate

‘Arogyapacha’ (Vide the approved minutes of meeting held on 31/10/2000,

No.5751/E3/2000/F & WLD dated 23/11/2000) in their own hamlets and to

collect the leaves of the plants and to hand over the same to the Kani Trust

though eco-development committees. They will also be allowed to collect

the leaves from the forest except the core areas of the Wild Life Protected

Areas through eco-development committees after obtaining permission

from forest officials and as per their direction. Permission was also issued

to supply the same to the concerned agencies for generating income for

their livelihood. As part of the new arrangement the Kerala Forest

Department and TBGRI worked together to develop mechanisms for

periodically assessing the production and cultivation practices among the

Kani tribe. As of now, the Kanis have their land under long term lease by

the forest department. The proposed new tribal policy of the Govt. of India

(2007) and the Scheduled Tribes and other Traditional Forest Dwellers

(Recognition of Forests Rights) Act, 2006 may help Kanis get proprietary

legal right for the land they have engaged in cultivation.

The Kani tribe has initiated the large scale cultivation of

Arogyapacha during the first phase of the benefit sharing. During the

transition period to the second benefit sharing phase which is yet to be

finalised, Kanis are approximately getting Rs. 150 per kg for selling fresh

leaves to the AVP and they earned about 1 Lakh rupees during the month

of July 2007.

6.6.7 Equator Initiative Prize

The Kani model of benefit sharing received the first Equator

Initiative Prize of 2002, for the sustainable utilisation and sharing of

Kerala's biodiversity. The Equator Initiative Prize was established by the

UN for the most outstanding programmes that successfully address issues

of conservation, sustainable use and equitable sharing of the benefits of

biodiversity and associated knowledge systems, thereby helping eradicate

poverty in the equatorial belt in which are concentrated the world's greatest

wealth of biodiversity where also have the greatest concentration of

poverty. (UNDP 2002) In 2002, the UN Environment Programme and the


World Trade Organisation even accepted the Kerala model on Jeevani as a

global model in benefit sharing and recognising intellectual property rights

of indigenous people in accordance with the guidelines of the UN

Convention on Biodiversity Treaty.

6.6.8 Issues and Concerns

The first successful benefit sharing model of the world not only

attracted appreciation but has been attended with certain crucial issues and

concerns. There is an open discontent regarding the compensation package

offered under ABS arrangement for the sacred community knowledge.

Participants of the agreement do not have an equal bargaining position and

most of the decisions, it is criticised, are taken by TBGRI on behalf of

Kanis. The concept of benefit sharing also raises critical questions about

the perception towards a biological resource and the knowledge pertaining

to it. Is it a mere raw material in the path of modern scientific progress;

should it be accorded the same respect as the scientific knowledge base of

another corporate entity, which would then mean that the terms of negotiation

would then be far more equitable. When you compare the Kanis 2% royalty

agreement, a fairly common level for Latin America and Asian countries, to

the 10% royalty received by Yellow Stone Park, USA, for similar bio-

prospecting activities something of the variable remit of such agreements

becomes apparent, as well as the fact that the bargaining positions of the

parties involved is a crucial determinant. (RV Anuradha 1999)

The challenge therefore would be for the mechanism to define and

limit the role of the State in a manner such as to ensure control by the

affected interests: in other words, ensure decentralisation in the decision-

making process to the local level. This derives its basis from the belief that

a resource is best protected when the decision regarding it is left to the

people having a stake in its conservation. Such an authority could act as a

facilitator and capacity-builder in situations wherein the access and benefit-

sharing debate is between a bio-prospector and a defined community; and

as a trustee in a situation wherein the biological resource and the

knowledge pertaining to it cannot be traced down to a particular areas, and

communities. In the latter situation the objective for benefit sharing could

296 Chapter VI

be achieved by the constitution of a biodiversity fund into which every bio-

prospector would have to contribute specified amounts, with the State as a

trustee of the fund.29

Majority of Kanis do not have membership at the Trust and no

institution is taking serious steps to increase its membership. All the

members of the Kani tribe deserve the social welfare outcome of the ABS

arrangement as the knowledge was collectively held by the community.

Though one can justify that majority of the Kani model of ABS agreement

was started much before CBD but the prior informed consent that is

acquired from the Kanis are not supported by customary laws or do not

have the endorsement of the head of the tribe.

Not only Kanis are excluded from the patent applicants list but also

never educated to participate in the R&D process of the product

formulation and technical know-how. As a result, Kanis were merely

limited to the cultivators of plants in the forest on which they do not have

any rights which not only broken their conformity with nature and

sustainable indigenous knowledge making under the holistic framework but

also annihilated their customary law system and rich oral tradition of the

tribal community.

Issues at international level started when some companies of the US

started to apply Jeevani as Trademark under the USPTO. A New York

based company named NutriScience Innovations LLC Ltd, a global

supplier of herbal drugs, is found to have registered Jeevani as Trade Mark

bearing a serial No.75692281 under the US Trademark Rules but the

company withdrew its claim following an uproar over the issue in India.

This company along with Herbal Holistics International has been selling

herbal medicine under the name Jeevani. Some say there is a foul play in

the whole issue because NutriScience has been sourcing Jeevani in bulk

quantities from AVP with the knowledge of TBGRI. (P A Francis 2004)

Gene Campaign, the New Delhi based NGO was the first organisation to

openly come against this piracy by describing the NutriScience' act as a

29

Ibid.


deliberate act of theft and misappropriation. The NGO has also called for

an international agreement against bio-piracy to protect the IPR rights of

poor and developing countries. Without such an agreement, these countries

will have to constantly fight to protect their patent rights in the US and

European courts at unaffordable costs. (P A Francis 2004)

Since the term is mentioned in the Ayurvedic/Sanskrit literature

(available in the public domain) the term Jeevani cannot be considered

under the Trade Mark protection. So, in January 2006, US food supplement

manufacturer and vitamin store chain, Great Earth Companies Inc, secured

the trademark rights for ‘Jeevanijolt’ and started marketing 'Jeevani Jolt

1000' in the US market. Great Earth reportedly applied for the trademark in

December 2000 and USPTO granted the same in March 2002. The

formulation mentioned in the label of 'Jeevani Jolt 1000' are same as in the

original 'Jeevani' including 'Arogyapacha'. Currently, 'Jeevani' is used as an

active ingredient in several herbal products marketed in the US by a

number of companies. It is widely argued that there are 11 products that

actively use Jeevani as major ingredient. What is being objected by the

scientific community now is the use of the term 'Jeevani' as part of the

trademark and also listing it as a major ingredient on the label of 'Jeevani

Jolt 1000' by Great Earth. (P A Francis 2004)

The herbal compound does not have a global patent and what it had

was an Indian process patent which also expired in 2005 due to lack

initiative to renew the patent. It is also argued by many that attempts by the

US MNCs to freely commercialise the 'Jeevani' trademark and its

composition in the world's largest pharmaceutical market is a result of the

inaction by TBGRI and the commerce ministry. What India is losing, in the

process, is billions of dollars. It will not be late even now for the

government to move an international patent application for 'Jeevani' under

the Patent Cooperation Treaty administered by WIPO. (P A Francis 2006)

The executive committee of TBGRI did not give approval for filing of an

international patent due to the scarcity of funds. TBGRI claims that the

American companies have wrongfully used the name Jeevani in order to

sell their products. However, the US companies are selling Jeevani in

298 Chapter VI

foreign markets for $16 to $39 per pack. There is much potential gain for

the Kani tribe and the Indian government to re-capture their control over

then drug Jeevani.30

Reacting to the row, Jacob Pallathra, the president of NutriScience

Innovations, Connecticut, claimed in an e-mail message that the product

being marketed was purchased from Kerala and made in association with

TBGRI. (John Mary 2004) “A layperson tends to believe that the trademark

registration means it is a patent. We do not have any patents on Jeevani and

we respect the patent in Kerala and we are selling the same Jeevani made in

Kerala,” he said. Pallathra stated that his company has been importing

Jeevani through a proper and legal channel and promoting it overseas to

benefit both the Kani tribe and the Institute. G M Nair, then Director of

TBGRI, said he did not know about any agreement between his institute

and NutriScience and the legal actions by the US firm. If NutriScience had

any altruistic or even a justifiable commercial interest in promoting

Jeevani, as claimed by Pallathra, they should have had the courtesy to enter

into a formal contract with us, he argued. (John Mary 2004)

Unlike the Korean Ginseng, Jeevani is devoid of traces of steroid or

any other addictive substance. But the Kanis tell a different story. "There

are about 300 people working with TBGRI, but no tribal has been

appointed," says Shaji Kani of Vithura village. Appukuttan Kani, the

former elected chief of the village local government, says, "The Botanical

Garden uses our people to collect plants and herbs. They are given only

daily wages of Rs.30 (less than $1), and never compensated for the value of

the plants and herbs. Moreover, we do not know what they do with the

plants and herbs," he adds. TBGRI scientist Rajasekharan says the Kani

tribe "never used Arogyappacha as a medicine. And Arogyappacha is only

one of the ingredients of Jeevani." But biodiversity campaigner Suman

Sahay feels that TBGRI, by taking out a patent for Jeevani, has "effectively

challenged the principle of Common Heritage of mankind, which considers

30 “India: Jeevani Anti-Fatigue Drug,” at

http://www.lightyearsip.net/ip_india_jeevani.shtml


all genetic resources the property of everybody, with no particular

ownership." (Sachin Chaturvedi 2007)

The ongoing controversy raises a further question: did TBGRI

observe a critical component of Article 15 of CBD seeking Prior Informed

Consent of the Kanis in this case before acquiring the knowledge base and

using it for commercial production? In an interview after receiving the

Borlaug award, Pushpangadan said that "Biological diversity is the

sovereign right of a nation. It cannot be acquired without the prior informed

consent of those who possess the knowledge." Whether this right should

also extend to communities within nations is currently a hotly debated

issue. Campaigners say there is an urgent need for developing countries to

enact patent laws that would recognise the intellectual property rights of

indigenous communities. Many hold that the Kanis are eminently suitable

candidates to be accorded just such a right.

A further area of critical importance and controversy is that of

Intellectual Property Rights with regard to products derived from biological

resource, and through reliance on knowledge of local and indigenous

communities. Attempts to achieve an equitable structure for local and

indigenous communities within existing IPR regimes is exemplified

through suggestions for the following changes to be brought into IPR laws:

Any application regarding anything derived from a biological resource or

from the knowledge of local and indigenous communities would

necessarily have to be referred to the National Biodiversity Authority,

who’s decision would be binding. (RV Anuradha 1999)

The norms of disclosure in respect of an application for an IPR

should reveal: (a) disclosure of place and community of origin in relation to

the subject matter of the application; (b) a statement of prior informed

consent from the community in relation to their knowledge, and from the

community/competent authority in relation to the biological resource.

While granting any patent on the basis of reliance on knowledge of

indigenous communities or on the resource obtained from such

communities, one of the conditions should be that the applicant be

mandated to give the provider a non-exclusive, royalty free license under

300 Chapter VI

any inventions it may patent that derive from the or transferred material or

improvements or derivatives thereof. (RV Anuradha 1999)

A percentage share of sales or profits from any products that might

be developed through use of the resource/knowledge transferred from a

local/indigenous community to the applicant for the patent (termed as

‘reach-through’ royalties) should be shared with such community;

Provisions to prevent access to the material by third parties from the

receiver, and to make it mandatory for third parties to approach the

provider. (RV Anuradha 1999)

Random screening of plant materials for new product of economic

value could prove to be very expensive. On the other hand, if one takes the

traditional knowledge system-based route, the chances of success are high.

It is estimated that in random screening the chance of getting a positive hit

is one in 10,000, whereas the path of ethno-medicinal value assigned by

traditional societies, the chance for a positive hit rate is suggested to be one

in 1000, or even less. (Sachin Chaturvedi 2007)

The successful hit rate that the author and his team got while

screening plants of the Western Ghats was in the range of 10-12

percentage. This means the money and time invested in screening can be

reduced significantly. The revival of interest in natural products the world

over, the rich knowledge base of traditional communities offers enormous

opportunities for developing a range of value added products - herbal

drugs and refined pharmaceutical products, pesticides, gums, resins and

dyes, etc. Whilst doing so, it is equally important to protect the

intellectual property rights of the traditional communities, who are the

ultimate custodians of this knowledge. Further, it is also realised that

indigenous technical knowledge holders would have difficulty in availing

themselves of benefits of IPR systems as well as IPR-like rights because

of the cost associated with acquisition, maintenance and enforcement of

IPRs. (Arunachalam 2002)


6.7 Policy and IPR bill of Kerala during 2001

The Kerala government has decided to introduce legislation during

2001 to protect the intellectual property rights of its tribes people who have

been practising traditional nature-based medicine for centuries. The Bill,

according to its preamble, is to provide for the determination, preservation,

protection and improvement of the tribal traditional system related to

medicine, agricultural practices and knowledge of wild flora and fauna used

for food as well as shelter. "The Kerala government has identified 35

scheduled tribal communities and 13 other tribal communities with a

number of traditional medicines and other agricultural practices. Many

more are to be identified," said M. Viswanathan Nair Forum Director of the

Kerala Institute for Research, Training and Development Studies of

Scheduled Castes and Scheduled Tribes (KIRTADS). Though M.A.

Kuttappan, the Minister for Welfare of Backward and Scheduled

Communities and Youth Affairs, made an announcement regarding the bill,

such a bill has never been materialised. (Liz Mathew 2001)

Of late, the Kerala government has come out with an IPR policy to

protect Traditional Knowledge associated with Ayurveda. The basic

elements of the legal arrangement suggested for the protection of traditional

knowledge are the following: i) all traditional knowledge, including

traditional medicine, the practice of which sustains livelihoods, must

belong to the domain of “knowledge commons”, and not to the “public

domain”; ii) in the case of knowledge of the first category which has a

community or family custodian, this custodian will be deemed to have

rights over the knowledge, while in the case of the second category, the

Kerala state will be deemed to have rights over the knowledge; iii) no entity

that is registered as a medium or large enterprise may be deemed to have

any rights over traditional knowledge. iv) the right-holders will have two

kinds of rights: first, the right, where applicable, to a “brand name” or a

name associated with the unique practice of an institution or community or

family, such as “Kotakkal massage”; and secondly, the right to the use of

the knowledge; v) everybody else, other than the right-holder to the

traditional knowledge, who wishes to use this knowledge will have to do so

302 Chapter VI

under a “commons license” described below; vi) any use of traditional

knowledge or practice in violation of the “commons license” within or

outside the state of Kerala will be considered a violation of the rights of the

right-holders and will invite prosecution. For operationalising this legal

arrangement a body called the Kerala Traditional Knowledge Authority

(KTKA) is proposed, with which all practitioners of traditional knowledge

of the first category will have to be registered. The KTKA will give general

notice to the public, regarding all applications being made to it by

practitioners, so that any contestations of applicants' claims, or challenges

to claims of uniqueness, or prevalence of similar practices in more than one

location or community, can be brought to its attention. It is only after

scrutinising all such cases of dispute that the KTKA can finally register a

community/group/ individual as knowledge-practitioners of the first

category pursuing a unique set of practices. (Prabhat Patnaik 2008)

All right-holders of traditional knowledge will be deemed to be

holding their rights under a “commons license”. Under this license the

right-holder permits others the use of the knowledge over which the right

is held for non-commercial purposes. If any development is made using

this knowledge, then under the conditions of this license this development

will have to be put back into the traditional knowledge “commons” and

cannot be patented anywhere. If any commercial use of traditional

knowledge is to be made by any entity other than the right-holder, then

the terms and conditions under which this can be done will have to be

negotiated between the right-holder and the other potential user. In the

case of traditional knowledge of the second category, where there is no

specific knowledge-custodian and the Kerala State is deemed to be the

right-holder, it will be presumed that all actual practitioners of this

category of knowledge in Kerala, provided they are not classifiable as

medium or large enterprises, have an automatic license for right of

commercial use given by the Kerala State which is the original right-

holder, but are not empowered to transfer this right of commercial use to

anybody else. Only the Kerala State, the original right-holder enjoys that

right. (Prabhat Patnaik 2008) Minister for Law and Parliamentary Affairs

M. Vijayakumar has said that the State government will include


“traditional knowledge protection” as a major component of its policy on

Intellectual Property Rights (IPR).31

This IPR policy fails to define ‘creative commons’ in the context of

existing IPR regimes. The ‘creative commons’ are more of utopian idea in

the current terrain of globalisation. Because utilitarian and natural rights

perspective consider ‘common’ under public domain as necessary

prerequisite to privatisation of property rights. This policy seems to give

certain amount of authenticity to the TK holders in terms of Benefit

Sharing but never mention about the cultural and legal context of

indigenous community under which such knowledge is formulated. By and

large this policy seems to facilitate bio-piracy as ‘prior art’ is recognised

only within jurisdictional territory of a state in certain countries like US.

6.8 Summary

The foregoing discussions reveal that traditional societies all over

the world have rich ethnobiological knowledge that is particularly linked to

the biological resources around them. Thus, an important aspect of

protecting biodiversity is the protection of TK of local communities. The

TK base of Indian ethnic and local communities is perhaps the richest in the

developing countries and has the potential to capture the world drug and

pharmaceutical markets, provided the country strives to bring in substantial

improvement and value addition to the existing TK base through

appropriate scientific and technological intervention and policy support.

As discussed in detail in this chapter, as also in the previous

chapters, there have been several cases of bio-piracy of TK from India.

Many of these claims with minor modifications in methods of extraction

and processing could amount to bio-piracy of the centuries old TK of

Indian system of medicine. There is also the view that the TRIPS

Agreement permits patenting of organisms that encourages 'bio-piracy'.

Whilst the corporations stand to make huge revenues from this process, the

local communities are unrewarded and in fact face the threat in future of

having to buy the products of these companies at high prices.

31

The Hindu (2009): “Traditional knowledge to be protected: Minister,” Saturday, June

13, at http://www.hindu.com/2009/06/13/stories/2009061359180200.htm

304 Chapter VI

A benefit sharing approach based on legally binding contracts

would allow for flexible solutions on a case-by-case basis. A problem to the

contractual approach is that the owner of a patent for a new product that is

based on TK must be obliged to state the source of origin in order for the

indigenous communities to be aware of how their TK was used. Today

article 27 provides for patentability irrespective of the source of origin.

Thus benefits will not be shared equally amongst the innovator and the

indigenous community.

Using some form of IPR or sui generis systems for protection of TK

based on prior informed consent and benefit sharing are certain

supplementary efforts available for the prevention of bio-piracy. It is almost

clear that a uniform international system for protection of biological

resources and associated TK would not be able to cater to the requirements

of individual country. Rather, the need is for a system which recognises

such diversity preserved through national legal systems. Action at the

national level would be inadequate for achieving the stated objectives of

CBD unless an international recognition is given to these national systems,

through an enforceable instrument. Hence, an internationally accepted

solution to such bio-piracy is being considered necessary.

At the national level, number of initiatives has been made to protect

biodiversity associated traditional knowledge. It includes Indian Forest Act

1927, Wildlife (Protection) Act 1972, Seeds Act 1966 and the Drugs and

Cosmetics Act 1940. Of late The Protection of Plant Varieties and Farmers

Rights Act of 2001 and Indian Bio-Diversity Act 2002 enacted to protect

the biodiversity and associated resources.

In India, preparation of village-wise Peoples’ Biodiversity Registers

(PBRs) or Community Biodiversity Registers (CBRs) for documenting all

knowledge, innovations and practices has been undertaken in a few States.

For preventing instances of bio-piracy in future a need was felt for

developing digital databases of prior art related to herbs, which are already

under public domain. TKDL is one means of giving recognition to

knowledge holders. Documentation of TK may only serve a defensive

purpose, namely that of preventing the patenting of this knowledge in the


form in which it exists. Documentation per se, however, will not facilitate

benefit sharing with the holders of traditional knowledge, unless it is

backed by some kind of mechanism for protecting the knowledge. TK in

India has been preserved through smriti and shruti, that is through the word

of the teacher, which is heard and remembered, not documented, nor

converted into a statutory right in favour of the teacher or his disciple.

Although this form of right is enshrined in the common law principles, and

recognised through jurisprudence in India, and at times even converted into

a statute for a more predictable rights regime, it is not necessarily

recognised outside the jurisdiction of India.

The UN Convention on Biological Diversity changed this, and

genetic resources and associated TK can no longer be treated as a free good

and that there is scope for the framing of regulations for controlling access

to such resources in the interest of the national and local communities. But

CBD does not clarify who has the rights on the resources in the first place:

the country, the community concerned, the individual or some association

on behalf of the individuals. The ‘rights’ issue, therefore, is perhaps left for

resolution at the national level.

ABS issues has been active topic on CBD and in 2001, a working

group developed the Bonn Guidelines to assist parties developing

legislative, administrative or policy measures on ABS, as well as contract

and other arrangements under mutually agreed terms for ABS. In 2004, the

CBD COP mandated the Ad Hoc Open-Ended Working Group on Access

and Benefit-Sharing "to elaborate and negotiate an international regime on

access to genetic resources and benefit-sharing with the aim of adopting an

instrument to effectively implement the provisions of article 15 and article

8(j) of the Convention and the three objectives of the Convention." In brief,

developing countries are pushing for rapid adoption of a legally binding

regime that will require users of genetic resources to ensure fair and

equitable benefit-sharing. Developed countries, except Norway, are

resisting the push for a legally binding instrument, and instead suggest the

need for time to gain experience with the Bonn Guidelines and further

306 Chapter VI

develop national ABS regimes before launching a new international

system.

Developing countries seek to amend the TRIPS patent framework as

a vehicle to enforce the benefit-sharing requirements of CBD. Some

developed countries argue that TRIPS and CBD are not incompatible, and

oppose these proposals for mandatory disclosure. However, Paragraph 19

of Doha Development Agenda did acknowledge the need of CBD and

TRIPS relationship to be looked into, however most of the developed

countries rejected ABS on the pretext that ABS is not viable option and

issues should be addressed at the national level rather than placing it on the

multilateral regime.

Developing countries have generally sought to shift the debate

outside of WIPO because they are concerned that developed countries are

using the WIPO discussions as a tool to forestall discussions in the TRIPS

Council and CBD. In general, the discussions within the CBD are taking

place against the backdrop of those IPR debates. Not surprisingly,

therefore, almost all the basic questions remain the subject of debate: the

legal nature of the regime, its scope, its modalities, and consequences for

noncompliance. International certificates of origin have been discussed as a

potential mechanism to trace genetic resource flows and identify whether

PIC requirements for their use have been satisfied. There are many open

and complex issues that would need to be addressed in any IPR disclosure

scheme, whether within TRIPS or within the CBD.

The main risk is that the regime will impose excessive and

unworkable burdens or increase the already considerable legal uncertainties

associated with the development of these resources. The main opportunity

is that a well-designed ABS regime could minimise existing obstacles to

genetic research in a way that would maximise the sustainable use of these

resources, while at the same time ensuring their conservation and the

equitable sharing of benefits associated with their development. A well

designed ABS regime could resolve current obstacles at the national level

to bioprospecting.


There is an implicit recognition that outsiders misappropriate

resources and associated TK, and therefore a benefit sharing mechanism

would reverse the wrong. It is this realisation that has perhaps made

countries, like India, to install regimes that provide for State intervention in

determining access as well benefit-sharing arrangements. In 1976 Dr. M.S.

Swaminathan felt the urgent need to undertake ethnobiological survey to

study about the indigenous communities of India for recording and

documenting their fast eroding lifestyle and knowledge. In this regard a

project was constituted and the Kani model of ABS evolved out of this

project.

Within a period of two years a scientifically validated, standardised

herbal formulation 'Jeevani' was formulated and proposal was prepared to

get the approval of the competent authority of TBGRI for sharing the

benefits on 1:1 basis deriving from the technology transfer with the Kani

tribe. In 1996, the technology for commercial manufacture of 'Jeevani' was

transferred to AVP for a period of seven years. Fifty per cent of the license

fee as well as fifty per cent of royalties from sale were given to the Kani

tribes. The seven year license period was ended in 2002 with AVP and

TBGRI has not made any fresh deal either with AVP or with any other

company. But the negotiation for the second ABS agreement is progressing

in the recent past in a more democratic and transparent in nature.

A trust was formed in November 1997 with support of TBGRI,

local Government officials and NGOs. The major functions of the trust are

to facilitate sustainable supply of Arogypacha to AVP as well as to

undertake the social welfare activities of its members. This benefit sharing

model has acclaimed world fame at many international forums as the first

of its kind, which implemented, in letter and spirit the Article 8(j) & 10 (c)

of the CBD, and is now recognised as the 'Kani Model' or 'Pushpangadan's

Model'. But neither the Kerala government has officially recognised the

model, nor there is any legally binding agreement between TBGRI and the

trust.

Participants of the agreement do not have an equal bargaining

position and most of the decisions are taken by TBGRI on behalf of Kanis.

308 Chapter VI

Then majority of Kanis do not have membership at the trust and no

institution is taking serious steps to increase its membership. Though one

can justify that majority of the Kani model of ABS agreement was started

much before CBD but the prior informed consent that is acquired from the

Kanis are not supported by customary laws or do not have the endorsement

of the head of the tribe. Not only Kanis are excluded from the patent

applicants list but also never educated to participate in the R&D process of

the product formulation and technical know-how. As a result, Kanis were

merely limited to the cultivators of plants in the forest on which they do not

have any rights which not only broken their conformity with nature and

sustainable TK making under the holistic framework but also annihilated

their customary law system and rich oral tradition of the tribal community.

TBGRI failed to protect the IPR of 'Jeevani' at the global level and

what it had was an Indian process patent which also expired sometime back

due to lack of logistical support. TBGRI claims that the American

companies have wrongfully used the name Jeevani in order to sell their

products. Biodiversity campaigners say the U.N. got it wrong for

commending the institute for its adherence to the U.N. The row centers

around what TBGRI calls its "accidental discovery".

The issue of benefit sharing cannot be resolved unless these rights

are assured, and unless the community is provided the legal means and

incentives to conserve the resources for long-term sustainable benefit to

themselves. Given the fact that bilateral deals between a community and

the bio-prospector may not always be feasible or advisable given the

unequal bargaining positions, another area of concern is the manner in

which the role of the State is envisaged in the legal mechanism.

A further area of critical importance and controversy is that of IPR

with regard to products derived from biological resource, and through

reliance on knowledge of local and indigenous communities. Further, it is

also realised that indigenous technical knowledge holders would have

difficulty in availing themselves of benefits of IPR systems as well as IPR-

like rights because of the cost associated with acquisition, maintenance and

enforcement of IPR.


A benefit sharing approach based on legally binding contracts

would be a flexible solution to bio-piracy. Action at the national level

would be inadequate for achieving the stated objectives of CBD unless an

international recognition is given to these national systems, through an

enforceable instrument. Hence, an internationally accepted solution to such

bio-piracy was considered necessary. Developing countries seek to amend

the TRIPS patent framework as a vehicle to enforce the benefit-sharing

requirements of CBD. There is an implicit recognition that outsiders

misappropriate resources and associated traditional knowledge, and

therefore a benefit sharing mechanism would reverse the wrong. The

experience of the Kani Tribe in Kerala on matters related to Prior Informed

Consent and Access and Benefit sharing suggest that legal mechanisms at

the international and at the national level that give recognition to both

customary laws and ABS system may be a flexible solution to bio-piracy as

well as for blending two system knowledge for the generation of new IP

innovations.

In brief, the forgoing discussion summarised above emphatically

suggest that the bio-piracy cases and infringement of rights over

biodiversity associated traditional knowledge have been on the increase in

India, as also in other bio-rich developing societies. The mismatch in the

provisions related to the protection of such resources in the international

conventions especially those in the CBD and TRIPS Agreement have

served the corporate interests of the multinational companies and countries

that have monopoly over biotechnology innovations. The provisions related

to ABS and PIC in the CBD are capable of offering remedy to many of the

grievances advanced by the victims of bio-piracy. Paradoxically, a viable

solution remains to far away in view of the overlapping and mutually

contradictory nature of the provisions in various conventions and

international initiatives. A ray of hope apparently visible in regional and

national levels of regulatory framework attempted. Indian experience in

this direction suggest that there is ample scope for effective protection of

such challenged resources and proprietary rights over it as illustrated by

TKDL, National Biodiversity Act and Register as well as PPVF.

310 Chapter VI

The ABS experience of the Kani Tribe, initially, appeared to be

encouraging and emulative. The custodians of Arogyapacha did receive

certain amount of benefits but the prevailing arrangements and mechanisms

seem to be silent on many vital questions related to ABS and PIC.