Chapter 3

Protection of Traditional Knowledge in India

1. Introduction Biodiversity and associated traditional knowledge are two capital resources of India. 'In

2000 the Council for Scientific and Industrial Research in India found out that almost

80% of the 4896 references to individual plant based medicinal patents in the United

States Patents Office that year related to just seven medicinal plants of Indian origin.

Three years later, there were almost 15,000 patents on such medicines spread over the

United States, UK, and other registers of patent offices. In 2005 this number had grown

to 35,000, which clearly demonstrates the interest of developed world in the knowledge

of the developing countries'. (Menon,2007). The need for protection of India's traditional

knowledge stems from its obligations towards it indigenous and local communities the

traditional knowledge holders whose rights are at stake, and also the need for legal

compliance with international regimes and emerging norms. India's response has so far

included both defensive and positive protection. Introducing the Traditional Knowledge

Digital Library (TKDL) as a form of prior art is an effort towards defensive protection of

Indian traditional knowledge. India has sought to incorporate Access and Benefit

Sharing provisions of CBD through its Biological Diversity Act 2002 and has enacted the

Protection of Plant Varieties and Farmers' Rights Act 2001 as envisaged under the

TRIPS. Besides, several NGOs, civil society organizations and governmental institutions

are working towards documentation of traditional knowledge at the local level. The

question that one seeks to answer in the chapter, are, if domestic efforts are sufficient in

an age of trade liberalization and whether there is a need to first provide for a legally

binding mechanism at the international level.

Traditional knowledge of medicine and agriculture plays an important role in India.

Thus, the number of stake holders who are likely to be affected by the efforts to protect it

or the lack of it, in India is large.

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2. Traditional Medicine System Traditional medicine system in India prevails at two levels-the classical and folk system.

Indian Systems of Medicine(lSM) having a central place in the official Indian healthcare

system are derived from traditional knowledge based on codified systems such as

Ayurveda, Siddha and Unani medicines is referred to as the classical system of medicine.

These are characterized by institutionally trained practitioners, a body of texts originating

since ancient times, and highly developed theories to support the practices. These

traditional medicine systems encompass knowledge of life, health and diseases of all

living forms, not only human but also of plants and animals. 'There exists an estimated

10-30 million manuscripts in Sanskrit alone, many of them relating to

medicine' .(Balasubramaniam,2003:40) In addition, innumerable manuscripts exist with

individuals and families of vaidyas or traditional healers. Thus not all traditional

knowledge is in the public domain.

Parallel to these systems, folk traditions exist, which have been transmitted orally in India

through centuries. These folk traditions are rich and diverse and include specialized

practitioners as well as home remedies for common ailments. The knowledge of

properties of turmeric and neem are examples of such traditions. These traditions include

knowledge and beliefs regarding the relations between food and health, as well as yoga

and other physical practices of a preventive nature. 'There are over 60,000 village bone

setters and 60,000 herbal medicine practitioners (Shankar et aI, 2003:58) in the country.'

In tribal areas the folk medical practices include herbal treatments, often in combination

with reciting certain verses called mantras. There is tremendous depth of tribal

knowledge regarding the use of natural resources. The tribal communities use more than

90,000 plant species, including 75,000 species of plants for medical properties. Besides

this, a significant number of materials of animal and mineral origin are used in traditional

medicine. It is important to note that Ayurveda, Siddha and Unani do not devalue or

suppress these folk traditions but have a symbiotic relationship with them. These codified

medical systems and folk traditions draw from and get enriched by each others' practices

and experiences.

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Traditional medical knowledge is also diverse and specific to each eco system and ethnic

community, because of the special characteristics of resources, health needs and belief

systems. Most healers extend health care irrespective of a patient's personal work, caste,

money and time. Certain prayers and offerings usually follow the collection of the

medical plants and administration. Traditional Indian literature also emphasizes the

spiritual dimension of the use of local plants.

In most cases healers pass on the knowledge to the younger successors who are selected

on an ethical criteria. Though this ethical screening is seen by sociologists as being

secretive, this has its own advantages, that is, as means for intellectual property

protection through customary practices.

3. Traditional knowledge of Agro -biodiversity India like other developing countries is notable for agriculture as the major or only source

of income for majority of its population, and for its wealth of genetic diversity present in

the form of large number of farmer selected varieties. 'With more than 60% of the

population employed in agriculture, seed supply in India fundamentally relies on

decentralized local systems of seed production. These systems operate on the basis of the

free diffusion of the best seed available within the community, with local farmers

ensuring that the local community is supplied with planting material'(Sahai,2003:166).

The traditional ethics and cultural lore followed by these farming communities over long

years value a public rather thari exclusive ownership on propagating material of all plants.

Exchange of seed was and is essential to crop improvement, and the farmers selected the

best seeds in the region with which to plant their field the next season. 'As one of the 12

mega diverse regions of the world, India has over 45,000 wild species of plants and

77,000 wild species of animals recorded' .(Tiwari,2006:49-62)These together constitute

6.5%ofthe world's wildlife. The range of domesticated biodiversity in the country is also

impressive. At least 166 species of crops and 320 species of wild relatives of crops are

known to have originated in India. The diversity of crops within each of these species is

very high. In case of rice, 50,000-60,000 are reported to have been grown in India in the

recent past. Indian varieties and parental lines have been used in many

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countries(Tiwari,I998:91-107) 'For example Indian sugarcane varieties such as the

Coimbatore (Co) varieties like Co 213, 281,290,312,313 and 475 have been were

extensively used as parents of choice in economic breeding programmmes of many

countries specially lava(Indonesia); Louisiana and Hawaii(USA) , Queensland

(Australia) and West Indies. Similar is the case with rice, wheat, chickpea, maize,

sorghum etc. Thus there are numerous such Indian sources already in use internationally'

(Siddiq, 1996:38-40) For instance Intan, Mas, and Peta, the most popular varieties of

Indonesia are the cross of the Indian variety latisail with the Chinese variety Cina. 'It has

been estimated that at least 10% ofIndia's recorded wild flora are on the threatened list.

Several agencies like MSSRF, Chennai have observed and documented enormous

variability and on-farm conserved material in several field and horticultural crops. For

example, in Wayanad in Kerala, a minimum of 50 local varieties of paddy were

cultivated, most of which are lost today. Plant breeders had extensively used many of the

local varieties of paddy for crop improvement programme. The much popular high

yielding "pattambi varieties" of rice had received many valuable genes from the local

paddy varieties that were conserved by the tribals.(Tiwari,2006:49-62)

4. Biopiracy as the Rationale for Traditional

Knowledge Protection 'In India the Traditional Knowledge Task Force created by the department of A YUSH ,

Ministry of Health and Family Welfare, randomly studied selected 762 US patents, which

were granted under A61K 35178 and other International Patent Classification (IPC)

clas~;es, having a direct relationship with medicinal plants in terms of their full text. Out

of these, 374(49%) patents were found to be based on traditional knowledge. 408 patents

were granted by the USPTO during March, 2000 itself on several medicinal plants . A

further study by team experts of TKDL~ studied the USPTO, EPO, and UKPO patent

databases in respect of medicinal plants (with respect to Unani system of medicine) in

April 2003 and found that more than 15,000 patent references against 4896 references

found in 2000, clearly demonstrated threefold increase' . (Gupta, 2006:246)

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4.1.Patent on Turmeric The patent on healing properties of turmeric is a case of undue appropriation of

traditional knowledge in foreign jurisdiction. Seen as a deficiency of the local patent

system , in this case, the United States, with regard to prior art in foreign countries, the

patent on the healing properties of turmeric, has received widespread attention in India

and abroad. Suman K Das and Hari Har P Cohly , two researchers based at the

University of Mississipi Medical Centre in Jackson , Mississipi , applied for a United

States patent on the use of turmeric in wound healing. More specifically, the application

related to the use of turmeric to augment the healing process of chronic and acute

wounds. The inventors claimed to have found "that the use of turmeric at the site of an

injury by topical application and! or oral intake of turmeric will promote healing of

wounds"(US Patent No. 5,401,504, URL: http://patft.uspto.gov/netacgi/nph­

Parser?Sectl 'PTO 1 &Sect2=HITOFF&d=P ALL&p= 1 &u=/netahtmllsrchnum.htm&r= 1&

f=G&I=50&sl=5,40I,504.WKU.&OS=PNI 5,401,504&RS=PN/5,401,504)

The patent application acknowledged that turmeric has been used for long time in India as

a traditional medicine for the treatment of various sprains and inflammatory conditions.

The patent was granted in 1995 on the basis of limited searches of prior art which did not

indicate the claims were part of the public domain. The case came to be noticed by some

people about a patent that had been granted on properties of turmeric which were widely

known in India and which were in public domain for centuries. "Since the patent was

granted in United States, the only possible way to object to the patent was to take legal

action in the United States. As there was no specific individual or group affected by the

patent, the Council of Scientific and Industrial Research(CSIR) in India challenged the

patent to have it revoked on the ground that the alleged invention was actually a part of

public domain knowledge in India. The patent was re-examined, all claims were

cancelled and the patent expired on 28 March I 999".(Cullet, 2004:302-303)

Important lessons were learnt from the case. "Firstly, prior art in foreign countries has

been recognized only if it is described in a printed publication. In this case the printed

materials were available, but were not presented. As a result of this and similar cases

57

there has been increased awareness of the need to document traditional knowledge which

is in the public domain and make it available so that patent offices around the world

check claimed inventions against existing sources of information."(ibid)

4.2 Neem Related Patents The case study of neem is an example of indirect appropriation of traditional knowledge

by way of patents which are granted in other jurisdictions on traditional knowledge

derived process or products. In India and the neighboring countries of the subcontinent,

neem has applicability in agriculture as well as households. For centuries farmers have

used neem leaves as pesticides. In recent times, properties of neem have received

attention prompting large scale research for production of commercially viable products.

The natural formulation of pesticides produced from neem has a short shelf life. The

commercially produced ones have longer shelf lives.

Among the many patents applied for, one patent, claiming a method for long term storage

of the active pesticidal ingredient (azadirachitin) became the centre of vigorous debates.

In 1992 USPTO issued a patent to W R grace which covers a method of creating a

stabilized azadirachtin solution itself. ( US Patent No 5, 124,349,

URL:http://www.niscair.res.inlScienceCommunication/ResearchJoumals/rejour/jipr/jipm

ov2k2.htm: )

Subsequently this solution for use on food crops, was registered under the name of

Neemix. WR grace also filed for patent on neem as an anti fungicidal product with the

European Patent Office(EPO) which was awarded in 1994. (European Patent 436257,

method for controlling Fungi on plants by the aid of a Hydrophobic Extracted Neem Oil

URL: http://itt.nissat.tripod.com/ittOl03/tkdl.htm )

This patent was challenged because the extraction process was not sufficiently different

from traditional processes used. The Opposition division of the EPO revoked the patent

in 2000 after the opponents successfully argued that there was prior public use and that

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the claims were therefore not novel. (European Patent office, Opposition Division,

Decision Revoking the European Patent, 0436257, 10 May 2000)

An appeal was filed in April 2001 focusing on some procedural issues and claiming that

the main affidavit on which the decision to revoke the patent was taken should not be

taken into account. The appeal was upheld (Cullet,2004:302-303)

The patents on neem have provided important insights, most importantly that grant of

patents on biotech process or products cannot be challenged by foreigners as long as

patents are validly granted according to legal norms in place in that particular country.

While one specific patent may be eventually revoked in Europe, this has not affected the

standing of other similar patents since each and every patent must be opposed

separately. (ibid)

4.3 Patents Related to Basmati Rice In 1997 United States rice breeding firm Rice Tec Inc was awarded a patent (US 566

3484) relating to plants and seeds, seeking a monopoly over various rice lines including

some having characteristics similar to basmati lines. This happened at a time when the

world over, Basmati was a term used to refer to a variety of rice from the Punjab

provinces of India and Pakistan. Thus, Rice Tec Company's 1997 patent claim for

Basmati rice described it as "an instant invention of a novel rice line" even though all

Rice Tec did was to use Pakistani and Indian basmati rice to derive a Basmati

strain(Shiva,2001 :284)

It was only after severe protests in India, led by various NGOS, and as a result of world

wide citizen campaign against Rice Tec Basmati patents, on August14 2001, the USPTO

struck down large sections of the Basmati patent. Since Basmati Rice is an indication of a

rice variety grown in a geographical region with specific climatic, soil and atmospheric

conditions, Geographical Indications(GI) as means to protect similar products gained

prominence in India.

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5. Efforts to Protect Traditional Knowledge in India

5.1 Reforms in India's Patent system India has had a much longer experience with patents systems than some European

countries because of its colonial past. The Patent Act of 1970 brought about

significant changes. It excluded patentability of life forms and specifically the

patenting of methods of agriculture and horticulture(Section 3, Patents Act, 1970)

The Act specifically mentioned that the general principles governing the use of

patents were that:

(a) patents are granted to encourage inventions and to secure that the

inventions are worked in India on a commercial scale ( .... ); and

(b) they are not granted merely to enable patentees to enjoy a monopoly for the

importation of the patented article(Section 83, Patents Act 1970)

The Act was different from the western model as it sought to control monopoly on

one hand and provide for the health and food needs of India on the other. In the

1990s the national policy developments in the field of patents were influenced by

international developments such as the adoption of TRIPS Agreement

.Subsequently, the Patent Amendment Act 2002, also provided for changes in lieu

of protection of traditional knowledge. A new section 3(j) in the Act rejects

patentability of seeds and plant varieties. In response to growing international

debate on traditional knowledge in CBD and lack of any recognition of IPR

protection for it in TRIPS, the Patent Amendment Act 2002 has sought to address

the problem of biopiracy and protection of TK, though partially. Firstly, section

3(p) says that' an invention which in effect is traditional knowledge or which is an

aggregate or duplication of known properties of traditionally known component or

components' - are not inventions for grant of patents. Patent applicants also have

an obligation to disclose the source and geographical origin of the biological

material used, with complete specification (Section 1 O( 4 )(D). This IS

supplemented by a provision which makes the failure to disclose the source and

60

geographical origin of the biological material used as ground for opposing the

grant of patent (Section 250) , Patent Act, 1970(As Amended upto 2002))

5.2 Plant Varieties Protection and Farmer's Rights Act, 2001

(PPVFR Act) India's policy on IPR protection in agriculture has largely been governed by factors that

include "common heritage", or the principle of free exchange based on the view that the

major food plants of the world are not owned by anyone and are a part of our human

heritage (Kloppenburg 1998, p. 152). Also, there is a focus on ensuring access to

technology and promoting economic development. India did establish IPR laws to protect

the rights of innovators, but attempted to balance this with the need for access to

resources at reasonable prices. The prohibition on the patentability of life forms and

specifically methods of agriculture or horticulture was one of the hallmarks of the Patent

Act 1970 with regard to food security (Section 3, Patents Act, 1970, Act 39 of 1970).

Also, a majority of agricultural research in India has largely been conducted by the

public sector. India's seed policy until the 1980s restricted the role of private sector in

agriculture' . (Ramanna,2003: 7) These factors promoted a system where India did not

provide for Plant Breeders Rights (PBRs) as there was no real demand for such a system

for decades. The absence of PBRs also meant that there was no requirement for farmers

and other indigenous knowledge holder's rights as a counter to IPRs. (Ramanna, 2003:7).

Farmers were free to use, share and exchange seeds and since breeders could not acquire

PBRs, there was no system of benefit sharing or compensation.

Commercialization of agriculture, increasing use of high yielding varieties and hybrid

seeds leading to decline in the use of traditional crop varieties and the subsequent entry of

multinational seed companies required a review of agricultural policies to protect the rich

base of plant varieties that India had. The issue of farmers' rights within the F AO and

other forums was another factor that shaped the debate in favor of a PPVFR Act.

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NGOs in India used these developments to make the cause for protecting traditional

knowledge of agriculture

The PPVR Act, 2001, the first legislation of its kind in the world that simultaneously

recognizes and rewards the contribution of breeders and farmers to the development of

new crop varieties, was enacted in the back drop of these various international and

national events. It features a combination of provisions from UPOV 1978 and UPOV

1991 versions(Kochar,2004: 348).The provisions in TRIPS which does not provide for

protection of traditional knowledge or farmers' rights to share of benefits from the

commercialization of their crop varieties, provides for protection of plant varieties

through grant of patent or effective sui generis IPR. The Government of India , therefore

states that one of the reasons for its introduction as the need to protect the IPR associated

with the development of plant varieties in fulfillment of an agreement signed by India

under the WTO .(Bala Ravi,2004:9)

The implementation of this Act is vested with two national apex bodies, one

administrative and other jurisprudential. The administrative apex body is the Protection

of Plant Varieties and Farmers' Rights Authority. The judicial apex body is the Plant

Varieties Protection Appellate(PVPA) Tribunal. However, the Rules of the Act do not

anticipate establishment of the PVP A Tribunal.

Bala Ravi (2004) has enlisted nine rights accorded to farmers under the Act. These

include the right to seed , rights to register varieties ,rights to reward and recognition,

right to benefit sharing, right to information and compensation incase of crop failure,

right to compensation for undisclosed use of traditional varieties, right to adequate

availability of registered material, right to free services and protection from legal

infringement in case of lack of awareness.

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5.2.1 Definition of Farmer and Breeder The legal definition of key words in legislative documents is important in order to keep

the legislative goal in focus. Like the plant variety, the farmer has the central place in the

Act. Therefore how a farmer is defined assumes importance.

The PPVFR Act therefore defines a farmer as 'a person who ........ conserves and

prepares, severally or jointly with any person any wild species or traditional varieties, or

adds value to such wild species or additional varieties through selection and identification

of their useful properties'. In other words the Act identifies the farmer as the cultivator,

the conserver and breeder. This definition embraces all farmers- landed, landless, male

female. Indian farmers usually cultivate many different crops and more than one variety

of each crop. Cultivation in many parts of India goes hand in had with conservation and

selection.

The breeder is defined as 'a person or group of persons or a farmer or group of farmers

or any institution which has bred, evolved or developed a new variety'. The use of the

term "evolved", thus gives recognition to farmer breeders who have experimented on the

crop varieties over a long period of time while at the same time protecting rights of

commercial breeders as well.

5. 2.2 Registration of Varieties The Act allows four types of varieties to be registered, reflecting the interests of various

actors: New Variety, Extant Variety, Essentially Derived Variety and Farmers' Variety.

'Extant variety' refers to Indian varieties bred by the public and private research system

and officially released for cultivation by the state or central government and have not

completed 15 years from the date of release and also farmers' varieties and varieties

about which there is common knowledge or any other variety which is in the public

domain. Protection of extant varieties is a new criteria not found anywhere in the world.

It is an attempt to extend protection to existing varieties rather than for newly developed

innovations. Such protection facilitates the extraction of rent from old innovations and

63

thus caters to the area of traditional knowledge and its holders. The extant variety need

not show novelty and the criteria of distinctness, uniformity and stability (DUS) will be

determined as specified under the regulations made by the authority

(Gopalakrishnan,2001). The Rules state that all extant varieties to be registered within

three years from the date of enforcement of the Act.

Farmers' varieties are those traditional varieties developed and conserved by farmers .

This includes the land races, folk varieties and wild species of crop plants about which

farmers possess useful knowledge. Most of these varieties are usually developed and

conserved collectively by community of farmers rather than by individual farmers. There

are several examples of farmers varieties accepted as equal or better than the varieties

bred by scientists. The Farmers' Varieties (FY) can be considered as an equivalence of ,.

the prior art provision of the Patent Act and it is necessary to provide a legal frame work

to ensure that already known FV are not encroached as New Variety.(Nagarajan et

al,2007) Hence the Act also recognizes that varieties conserved by communities of

farmers are also eligible for registration. Farmers need not pay any fee either to register

their varieties or to renew their registrations ( Sections 18,44 PPVFR Act,200 1)

The PPVFR Act is unique in this respect because plant variety protection laws of many

other countries allow only protection of new varieties bred by professional breeders.

However the Rules of the Act are not explicit in stating the eligibility of farmers'

varieties.

5.2.3 Fa)·mers Right to Reward and Recognition

The PPVFR Act has provisions to reward and recognize individual farmers or

farming and tribal communities for on-farm and ex-situ conservation.(section 39

(1) (iii) PPVFA,2001). According to the Act, a National Gene Fund is to be

created to reward and recognize individual farmers and communities.( section 45,

PPVFA,2001). The main objective of the Gene Fund is to promote on farm and ex-citu

conservation by individuals, communities, panchayats and institutions. This is provided

as an incentive to encourage conservation undertaken by farming and tribal

64

communities. Farmers conservmg traditional varieties and wild speCIes of crop

plants are deemed eligible to receive reward and recognition. The fund shall be

constituted by all receipts from the PPVFR Authority including benefit shares,

registration and annual maintenance fees, compensation payments and other grants

from national international organizations (Bala Ravi,2004:22 ). The obvious

advantage of rewarding conservation efforts is the conservation of traditional

knowledge of crops existing among farmers.

5.2.4 Possible Ownership Conflicts on Registration of Traditional

Varieties The Act is however likely to be problematic due to various reasons. Firstly the criteria for

registration are taken exclusively from the UPOV Convention which was designed

exclusively for the protection of varieties of commercial breeders. Thus even if farmers

varieties are eligible for registration , very few fanners will be able to benefit from the

provisions because their varieties will generally not meet the criteria of distinctiveness,

uniformity, and stability. Explaining these conflicts Ravi(2004:30) explains that long

history of farmers varieties may obscure their origin with no clarity regarding the farming

community initially responsible for its origin. In another situation, old and popular

traditional variety is spread across many villages, districts, or even states . The variety

may have single or multiple identity with one or different names, but with no distinctive

differences. Also there could be a situation when one traditional variety initially

developed a farmer community has moved to other regions , where the difference in

growing situations or practices had resulted in selection and cultivation of different

variants of the initial variety. But each of these variants has retained the generic name of

initial variety leading to apparent duplication.

As Professor S.K. Verma concluded with regard to Section.39(l)(i) in Chapter .VI: "The

extent to which this provision will be meaningful in practice is, however, open to debate.

To obtain protection, farmers' varieties must conform to the UPOV criteria of

distinctness, uniformity and stability. Given that breeding efforts of farmers typically

occur in situ, and that fanners (unlike breeders in formal breeding programmes) cannot

65

entirely control the agroecological conditions in which varieties are bred, it is

questionable to what extent varieties claimed by farmers will meet these qualifying

criteria."(Verma,2004: 149)

5.2.5Access and Benefit Sharing Mechanisms under the PPVFR Act

2001

Some of the major issues relating to the protection of traditional knowledge are

those of Access and Benefit Sharing (ABS). Benefit Sharing has been recognized

by CBD as important mechanisms to ensure the rights of traditional knowledge

holders in the face of increasing bioprospecting of plant genetic resources. It has

generally been devised as a compensation mechanism, as an alternative to IPRs.

Both nationally and internationally the concept has faced debates. While monetary

compensation is controversial, other options in the form of non monetary benefits

have yet to be experimented with

Under the PPVFR the benefit sharing has been provided for new crops developed

with the contributions of farming communities and compensation for undisclosed

use of traditional varieties.

5.2.6 Farmers' Right to Benefit Sharing The Act provides for equitable sharing of benefits earned from a new variety with

farming or tribal communities that have contributed varieties used as

parents(Section 26(5)) Normally, all applicants who seek to register new varieties

are required to declare the sources of the varieties used as parents for breeding

new varieties (Section 18 (e),(h)) . Claims for benefit share is made when the

breeder discloses the use of specific varieties conserved by farmers of a region or

on the basis of strong grounds which may substantiate undisclosed use of specific

farmers' variety by the breeder. Farmers are given opportunity to submit claims

for benefit shares, when their variety is used as parents (Section 26(2)) within six

months from the date of advertisement inviting such claims by the Authority. On

66

examination of such claims by the Authority, applicants eligible for benefit

sharing and the quantum of benefit to be shared are decided.

The PBR holder of the variety is required to remit the awarded benefit share in the

National Gene Fund (section 26(6)). The benefit share may be disbursed by the

Fund to the eligible individual, community or institution. (Section 45(2)(a)).In

case of disagreement the breeder can oppose the claim. The PV A is left to take

decisions on basis of claims and oppositions. Over all the Authority plays a central

role in determining benefit sharing because neither the Act nor the Rules specify

what percentage of benefits is to be shared. The Authority is therefore left to

determine benefit sharing on a case by case basis. On the basis of the general

guidance of the Act, this unpredictability leaves open scope for manipulation.

(Cullet,2004: 176)

Given the illiteracy, awareness and lack of understanding of such institutional

procedures the benefit sharing could prove to be an obstacle for various reasons.

Farmers might fail to get timely information of the varieties being registered under

the Act, or of the notification of on such varieties inviting claims for benefit share.

They might even lack the capability to understand the disclosed characteristics of

the new variety vis-a-vis those of the parental lines.

5.2.7 Farmers' Right to receive Compensation for Undisclosed Use

of Traditional Varieties (section 41) There could be situations when the breeder may not disclose the correct identity of

parental variety or knowledge due to ignorance or dishonest suppression of

identity. Section 41 provides for compensation claim based on contribution to the

evolution of that variety. Under such circumstances anyone or even a third party

who has a reasonable knowledge on the possible identity of the traditional

varieties or knowledge used in the breeding of the new variety, is eligible to prefer

a claim for compensation on behalf of the concerned local or tribal

community.(Section 41 (1 ))The third party could be an NGO, an individual, a

67

government or a private institution. Such compensations claims are to be

submitted to the Plant Variety Authority by such third party. The Authority after

verification decides on the compensation to be awarded. The awarded

compensation is to be remitted to the National Gene Fund by the PBR holder.(Bala

Ravi,2004:23)

Section 41 differs from section 26 in that the procedural conditions for claims are

less stringent and do not include a time frame for the claim or a requirement to pay

a fee. Moreover, the grounds for granting compensation are different from section

26. While the latter focuses only on the use of material provided, section 41 talks

more generally about the contribution to the evolution of a variety. This may be

read as being broader than section 26 since it leaves open the door for recognizing

the contribution of the traditional knowledge embodied in the variety for benefit

sharing. (Cullet,2004: 177). Another difference with section 26 is that compensation

is not specifically based on commercial benefits from the use of the variety. In

keeping with India's commitments it may therefore be understood as being broader

and concerned with the 'use'. Over all section 41 gives nearly more discretion to

the Authority in deciding to grant or to reject claims. This is in particular evident

in the fact that compensation is to be awarded where the contribution IS

'significant' though the threshold for significance is not defined. This lack of

specificity is the weakest point of the compensation system since it gives the

Authority too significant a margin in deciding whether to accept claims or

not.(ibid)

5.2.8 Analysis of the PPVFR Act Besides, the apparent overlapping of provisions of benefit sharing and compensation

provisions has been criticized. As N .S. Gopalakrishnan remarked: "It is clear that there is

overlap between benefit-sharing and compensation to the community, and there is no

provision to avoid this. The breeder is also made to pay more than once for using the

traditional knowledge. The attempt to protect both new varieties on the basis of

individual private ownership and traditional knowledge based on collective ownership

68

together in one law, and the lack of clarity on the issues, created this mess. Given the

social and educational conditions of the local and indigenous communities in India it can

safely be concluded that the provisions to protect the traditional knowledge of the

farming community are not going to work to the advantage of these

communities. "(Gopalakrishnan,2002: 735)

'So Bala Ravi, (Advisor, M.S. Swaminathan Research Foundation) points out that since

there is only one seat to represent farmers in the PPVFR Authority, there is a high chance

that the nomination to this seat by the Government of India may be influenced by

political considerations. He feels that this, by itself, does not weaken the intent of law

makers, if the nominated farmer representative takes a well balanced pro-farmer position

on matters of interest transacted by the Authority. According to him a similar situation

could arise in the case of nominations of the tribal organization and women's association

related to agricultural activities in the Authority.' (Ramanna,2006: 17)

According to Nagarajan et al (2007) 'the 'Traditional Knowledge' associated with the FV

should be recorded and the claims must be experimentally validated. Establishing the

distinctiveness of the FV material based on the claims made by the applicant can be for

the(Extant Variety Recommendation Committee) EVRC a demanding decision. The

public funded agricultural research establishments, said to be dedicated for the cause of

farmers should conduct critical experiments and provide the needed data to farmer/

farming communities on an acceptable term so that they are able to file FV with all

supportive information'.

The Authority has brought out general guidelines and associated specific guidelines to the,

examination of distinctiveness, uniformity, stability (DUS) and the development of

hannonized descriptions of plant varieties (PPVF A, MoA, GoI). Finalized DUS test

guidelines for 12 identified crops, prepared by Indian Council of Agricultural Research

and examined by Task Force 1 for registration in the first phase has been issued 11 ( (crop

II The identified crops are rice, wheat, maize, sorghum, pearl millet, chickpea, mungbean, field pea, rajmash, lentil and pigeon peas.

69

list, Protection of Plant varieties and fanners' Rights Authority of India, available at

http://www.plantauthority.in/)

5.3 The Biological Diversity Act 2002 and Rules 2004 The Biological Diversity Act (BDA) 2002 was adopted following India's

ratification CBD . The CBD states that a member country should facilitate access

to its genetic resources by other parties on mutually agreed terms, but that access

requires the Prior Informed Consent of the country providing the resources. It also

provides for an equitable sharing of benefits arising from these resources or

traditional knowledge about them. But countries must pass domestic legislation to

bring these principles into their own laws. India's Parliament passed the

Biological Diversity Act in February 2003 to address India's obligations under

CBD(Venkatraman,2005). Hence it is defined as " An Act to provide for the

conservation of biological diversity, sustainable use of its components and fair and

equitable· sharing of benefits arising out of the use of biological resources ,

knowledge and for matters connected therewith or incidental thereto" .(Biological

Diversity Act,2002)

Since the issue of protection of traditional knowledge andAccess and Benefit

Sharing is new and still evolving and no other country had enacted a similar

legislation, the enactment of the legislation had been a challenge. With providers

and users of the resources often having opposing interests, the conflicting interests

had to be reconciled. While on the on hand the Act had to regulate access to these

resources by commercial interests of private enterprises, on the other, it had to

ensure free access to biological resources for India's R&D both in agriculture and

plant resources, and academic institutions. Added to this is the fact that India has

a rich system of indigenous medicine both codified and non-codified, with almost

4 lakh registered practioners apart from the local village and tribal medicine men.

The number of stakeholders has therefore been large. (Arora, 2008)

70

While the Act mandates the scope of the CBD, the most important measures

adopted by the Act focus mostly on access to biological resources and related

issues. This is partly a response to the concerns over biopiracy in the second part

of 1990s and partly in response to other developments such as the adoption of the

TRIPS Agreement. The relatively narrow remit of the measures adopted can also

be explained by the fact that there was no need to adopt a broad Act in a context

where there were already a number of sectoral environmental

laws(Cullet,2004: 101) India has alteast 30 different legislations on biodiversity

apart from the Biological Diversity Act. The positive aspect of this legislation is

that it does not over rule other existing legislations (Venkataraman(2),2008).

The difference between the Biological Diversity Act and PPVFR Act is that while

Biological Diversity Act applies to plants, animals and micro-organisms PPVFR

applies plants of economic value to human beings.(Raj Ganesh,2007) Section 6(3)

of Biodiversity Act states that applicants under the PPVFR Act 2001 are exempted

from getting approval from the National Biodiversity Act. However, PPVFR

Authority must endorse a copy of registration certificate to the NBA.

5.3.1 Access to Biological Resources and Associated Traditional

Knowledge Concerning access to biological resources, the Act focuses mainly on access by

foreigners, thus reasserting its sovereignty over its knowledge and resources as per

the principle of permanent sovereignty over natural resources embodied in the

CBD. It has provided a 3 tier institutional structure - the National Biodiversity

Authority in Chennai 12, State Biodiversity Boards in every state and Biodiversity

management Committees13 at the municipallPanchayat levels. The Ministry of

12 National Biodiversity Authority is the apex national institution headed by Chairperson, vested with authority to regulate access to biodiversity, associated knowledge and database, to issue and implement guidelines forAccess and Benefit Sharing in accordance with the Act and directions of Government of India.

13 Biodiversity Management Committee constituted under Biodiversity Act functions at every Panchayat and is vested with the responsibility of documentation, conservation and sustainable use of local biodiversity, and assisting the State Biodiversity Board inAccess and Benefit Sharing decisions

71

Environment and Forests is the nodal agency through which the Act is

implemented. The route of access to Indian biological resources and associated

knowledge provided in the Biodiversity Act differs depending on whether the party

accessing is (1) a non-Indian or non-resident Indian citizen, or a body

corporate/association/organization not incorporated or registered in India or such bodies

having non-Indian participation in capital or management;

(2) Indian citizen or a body corporate/association/organization registered in India, and

(3) local people and communities inhabiting an area, including traditional medicine

practitioners.(Bala Ravi,2006: 14)

5.3.2 Procedures for Access to Biological Resources and Associated

Traditional Knowledge : The Biological Diversity Act stipulates norms for access to biological resources

and traditional knowledge in three ways:

• access to biological resources and traditional knowledge to foreign citizens

, companies and NRIs based on 'prior approval ofNBA'(Section3)

• Access permits to Indian Citizens , companies , associations and other

organizations registered in India on the basis of 'prior intimation to the SBB'

concerned.(Section 7)

• Exemption of prior approval or intimation for local people and communities

, including growers and cultivators of biodiversity , and vaids and hakims , who

have been practicing indigenous medicine.(Section 7)

This access is facilitated through a structured application and payment of Rs.lO,OOO

(US$ 230) as fee (Bala Ravi,2006: 15) This application largely conforms to the Bonn

Guidelines(Bonn Guidelines, Available at http:// www.biodiv.org/decisions/default.aspx?

m=cop-06&d=24 ). An access request is expected to be decided within six months time.

The parties accessing components of biodiversity or associated knowledge are required to

enter into an agreement in a framework prescribed by the NBA 14.

I~ Rule 14, Biological Diversity Act. This rule sets out administrative procedure under the Act for accessing biological resources and associated traditional knowledge.

72

The NBA is also empowered to, oppose grant of IPR in any country outside India

based on knowledge of biological resource. obtained from India (Section 14(4)

Biological Diversity Act 2002).

One of the biggest drawbacks of the access mechanism as envisaged under the

Biodiversity Act is the separate provisions for access by Indians and foreigners,

allowing Indian nationals "prior intimation" and not "approval" as in the case of

foreigners. The Act assumes the misappropriation of biological resources and

traditional knowledge is not possible by Indians. Indians and Indian Corporations

can also pose a biopiracy threat. For example in 1995 the Regional Centre of the

Indian Council of Medical Research (ICMR) at Port Blair was testing plants that

the Onge tribe of Little Andamans used for medical purposes. One of the plants

used by the Onges for fever and gastric disorders was found to have potential anti­

malarial properties. It was also found that the Onges remained relatively free of

Malaria as compared to the non-tribals settled in Andaman. It then emerged that

the Director of the Regional Centre was trying to obtain a patent on the finding.

After protests by NGOs demanding prevention of monopolization of the plant and

recognition and compensation for the contributions of the Onges, the ICMR

declared that it would not apply for a patent till an official policy on such use and

patenting was formulated (Kothari, 1997 :92).

Also, though the Act asserts India's sovereignty over its biological resources, it

gives not give local holders of such resources and knowledge control over access

to their biological resources and traditional knowledge associated with it. In fact

the Biodiversity Act does not at all refer to the concept of PIC. It provides for

prior approval of NBA which can be understood as a weak fDrm of the principle of

PIC. At the level ofiinter-state relations this may not be significant but the absence

of a condition of Prior Informed Consent as far as the original holders are

concerned, makes the Act much weaker than the general framework proposed by

the CBD. The Act, however, provides for the involvement of Biodiversity Management

Committee, which is instituted at each Panchayat, in the process of decision making

73

onAccess and Benefit Sharing Issues related to local biodiversity and associated

knowledge.

5.3.3 Benefit Sharing under the Biological Diversity Act,2002

5.3.3.1 Types of benefit Sharing

Section 210f the Act provides for "determination of equitable benefit sharing by

National Biodiversity Authority". The benefit-sharing system provided in the

Biodiversity Act is largely in conformity with the Bonn Guidelines on ABS, with case-to­

case variation. It includes provisions of various kinds such as transfer of

technology, monetary returns, joint R&D, venture capital funds and joint IPR

ownership.(Section 21, Biological Diversity Act,2002)

Though different types of benefits can be shared, there is still an important

emphasis on monetary benefits and thus most transactions are likely to take place

in the form of monetary compensation. Where compensation is monetary the NBA

has the power to have the sum deposited in the National Biodiversity Fund set up

under the Act or paid to specific individuals or groups of individuals in situations

where the origin of the biological resource can be specifically traced (section

21(3) and 27, Biological Diversity Act). The powers of the NBA in determining

what the benefit share should be and to whom it is to be directed is further

enhanced by the fact that where monetary benefits are allocated, the Authority will

determine the specific percentage on a case to case basis. As with the PPVFR Act,

the handing over to NBA with such discretionary powers is likely to make the

process of benefit sharing less transparent and efficient.

Where the benefits shared are monetary, they are to be given to the benefit

claimers or are to be used for conservation of biodiversity (section 21 (5)

Biodiversity Rules) Even when the benefit claimers are identified, monetary

compensation is not provided directly, since it is for the NBA to decide whether to

pay money to the claimants directly or to the Biodiversity Fund.

74

Though benefit sharing under the Biodiversity Act is broader than the PPVFR Act,

the lack of attention towards details is likely to make the process less beneficial

for traditional knowledge and resource holders. For example, though the Act

provides a list of monetary and non-monetary benefits it does not list them in

terms of priority. Besides, overarching powers to the NBA to decide the form and

amount of compensation of benefits makes it less attractive for local and

indigenous communities.

5.3.3.2 IPRs as a Form of Benefit Sharing under the Act

Where the benefit claimers can be identified, the NBA can provide for joint

ownership of IPRs. The NBA can allocate itself as the joint owner of the IPR if the

benefit claimers cannot be identified.{Section 21 (2)(a) Biological Diversity Act,

2002) It also implies that the NBA will have the say in granting of patents even if

it is not meant to participate in the implementation of the Patents Act. However,

the NBA has yet to come up with rules and guidelines onAccess and Benefit

Sharing and thus this role in IPRs is yet to be seen.

Thus the Act makes special reference to IPR in an indirect acknowledgement of

their increasing importance in the TRIPS era. From a conceptual point of view,

one of its most significant contributions is to also recognize that benefit sharing

can also include sharing of IPRs. (Cullet,2004)

The Act also gives local communities a say in the use of resources and knowledge

within their jurisdiction, and to charge fees from parties who want to use these

resources and knowledge through the Biodiversity Management

Committees.{Section 41, Biological Diversity Act). Section 36(5) of the

Biological Diversity Act) also recognizes the need to protect traditional knowledge

through a sui generis mechanism. It provides for the designation of institutions as

repositories of biological resources. Moreover, biodiversity funds at the National

(Section 27) , State{Section 32) and local level{Section 43), have been stipulated

to support conservation and benefit sharing.

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5.3.4 Implementation of the Act As with the plant varieties legislation, implementation of the Biological Diversity Act has

been slow. The legislation was enacted by the Indian Parliament in February 2003, but

the assessment of the applications under the Act for access to biological resources only

began after the necessary expert committees were formed and guidelines for their

procedure were drafted and approved during 2005. Meanwhile the NBA has held 10

meetings (the last known meeting was in November 2007). As on November 2007, the

NBA has received and approved 15 applications for access to biological resources for

research and commercial purposes. It has approved 232 applications for IPRs and 12

applications for collaborative research (Venataraman, 2007) Out of these applications

approved for IPRs, 203 were from CSIR, while 27 were from industries and 13 from

individuals.

6. Interrelationship of Benefit Sharing and Protection of

Traditional Knowledge under the PPVFR Act, 2001 and

Biological Diversity Act, 2002 and the Patents Act 1970 (as

Amended Upto 2002) In as far as protection of traditional knowledge are concerned, the PPVFR Act,

The Patents Act and the Biological Diversity Act are related. There is a distinction

between the Patents Act and the PPVFR Act in that Patents Act clearly prohibits

patentability of plant varieties.{Section 3m, Patents Act, 1970, (As amended upto

2002)However in compliance with the TRIPS commitments, the Patents Act now

allows patentability of micro-organisms. This is however likely to lead to a

conflict between the two in situations where it becomes acceptable for a patented

micro-organism to make the plant into which it is patented also

protected.(Cullet,2004:280). With regard to the Biological Diversity Act and

PPVFR Act also there are linkages, in that the specific nature of the Biological

Diversity Act, i.e. focus on Access and Benefit Sharing of traditional knowledge

related to biological resources is also the subject matter of the PPVFR Act. Also

76

the Biological Diversity Act makes references to IPRs related to biological

resources.

Though two parallel benefit sharing scheme have been introduced, according to

Cullet(2004:280), little effort has been made to coordinate the two schemes into a

coherent whole. This has resulted in a number of overlaps between the two benefit

sharing regimes. Also, one would conclude that there is no need to have two

benefit sharing mechanisms as the subject matter of the two Acts is similar despite

the differences in the scope. Thus even if two Acts exist, the benefit sharing and

institutions implementing it should be one.

In fact the need for a single benefit sharing regIme and a single institution

administering the scheme becomes all the more important when Patent Act is also

relevant in this context even though benefit sharing is not taken up in the patents

legislation. Since benefit sharing has been devised as an alternative, due to lack of

IPRs to traditional knowledge holders, there is a direct link between patents and

benefit sharing. There is no mention in the Patent Act of the link between a patent

application and benefit sharing. Making this link and making the disclosure of

resources used in an invention a condition of patentability would make the over all

benefit sharing much more effective. Benefit sharing would be better administered

if it was applied as apart of an overall IPR strategy.(ibid)

There is a need for coordination of the three Acts. In practice the two IP Acts do

not even mention the Biological Diversity Act, even though the Biodiversity Bill

was introduced in the parliament in 2000, much before the PPVFR Act and Patents

(Amendment) Act 2002 were adopted.(Cullet,2004:281) . The two IP Acts are

coordinated only to the extent that patentability is excluded for plant varieties. The

Biodiversity Act is the only one that makes a specific mention of the Plant Variety

Act to demarcate their respective roles as far as benefit sharing is

concerned.(Section 6(3) Biodiversity Act 2002) . Besides, though plant variety

protection has been envisaged under a separate Act, the subject matter also falls

77

under the Biological Diversity Act. The definition of biological resources under

the Biodiversity Act includes plants, animals and micro-organisms and parts

thereof and therefore does not exclude plant varieties. (Section 2(c) Biological

Diversity Act 2002). The fact that the Biological Diversity Act covers IPRs and

benefit sharing related to biological resources, increases the chances of conflict

with the other two Acts. This is more so when both the PPVFR Act and the

Biological Diversity Act have their own respective national authorities to

implement their provisions. Both Acts having their own benefit sharing

mechanisms while they cater to almost the same subject matter of traditional

knowledge related to biological resources, including plant varieties might cause

problems once the Acts are implemented.

The PPVFR Act and the Biological Diversity Act state that protection and rewards for

those conserving genetic resources should be provided, but more in terms of intent rather

than any specific stipulations. Recognition and rewards for individual farmers or

communities for conservation efforts are to be channelled through the National Gene

Fund under the National Biodiversity Act, but there are no conditions laid down for

identifying such recipients neither under any time frame nor any mention of amounts to

be granted.' (Ramanna,2006:20)

However, according to Cullet,(Cullet, 2004: 178) the intent of the PPVF A Act is

'to foster conservation activities' and this speaks well for protection of traditional

agricultural knowledge.

7. The National Innovation Foundation Model of

Benefit Sharing Another model for benefit sharing has been developed by the National Innovation

Foundation (NIF). An autonomous society established under the Department of

Science and Technology, Government of India in 2000 , along with Honey Bee

Network under SRISTI (Society for Research and Initiatives for Sustainable

78

Technologies and Innovations) , an NGO based in Ahmedabad, NIF has been

scouting traditional knowledge and linking these with Science and Technology

experts, investors and entrepreneurs for further valorization.{www.nifindia.org).

The Prior Informed Consent model seeks the traditional knowledge holders

consent for partial or full disclosure of their knowledge and disseminate them

through print and web media, and provide NIF mediation for value addition,

patenting and other kinds of IPR generation based on traditional knowledge and

for fixing criteria and the terms and conditions for sharing monetary and non

monetary benefits, if any, arising from the value addition, patenting on traditional

knowledge (Pushpangadan and Nair,2006: 135). Empowering communities with

knowledge and awareness about the values and potentials of the knowledge they

hold is an important exercise, which NIF does through scouting programmers and

awareness campaigns. NIF suggests the knowledge holder to share information on

the conditions with restrictions imposed on commercial basis on terms of

technology transfer, up front payments, royalties, license fees etc on non-cost basis

for personal application or household use only.

The Prior Informed Consent model of NIF however, has both advantages and

disadvantages. It still remains to be examined whether the process of disclosure of

traditional knowledge would lead to eventual exclusion of knowledge holders from

IPR claims or the misappropriation of the knowledge thus depriving the

knowledge holder of his or her intellectual property right.

The benefit sharing mechanism suggested by NIF's Prior Informed Consent model

includes 4 kinds of benefits:

Monetary Individual- this includes monetary awards, license fees or royalty from

commercial exploitation of traditional knowledge .This will be firstly paid to

individuals who may in turn share it with the community or institutions.

79

Monetary collective - this covers trust funds, mIcro venture funds, common

property infrastructure and such other initiatives to be shared with the

communities.

Non-Monetary Individual- this includes public acknowledgement of the knowledge

holders' contribution through media, or public appellation or using appellation on

the product developed.

Non Monetary collective includes recognition to communities at appropriate level

for their collective wisdom, knowledge and social or cultural organizations(

ibid: 134)

The NIF model ensures that Access and Benefit Sharing involving traditional

knowledge holders would provide motivation to conserve and promote the

knowledge. The Prior Informed Consent model evolved by NIF is a complex one

and cannot be compared to the formal Prior Informed Consent model of the

Biodiversity Act. However, the existing complexities in the structure of the

traditional knowledge domain itself, the nature of existing IPR system that accord

protection only for the formal innovation based on the criteria of novelty , non­

obviousness and utility , are some of the major impediments in evolving any

uniform guidelines for access protection and benefit sharing involving traditional

knowledge held in traditional communities even with the NIF model.

8. Benefit Sharing in Practice Even though CBD was adopted more than a decade ago very few examples of

actual benefit sharing has taken place outside the formal legal system. India is the

first country in the world to experiment a benefit sharing model that implemented

the Article 8(j) of CBD in letter and spirit.

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8.1 The Kani Benefit Sharing Model The Kani model relates to the sharing of benefits with a tribal community in

Kerala, the Kanis, from whom a vital lead for developing a scientifically validated

herbal drug (Jeevani) was obtained by scientists of Tropical Botanic Garden

Research Institute (TBGRI) Kerala. The TBGRI model has gained popularity

because it the first of its kind that has recognized the resource rights and IPR of a

traditional community by way of sharing equitably the benefits derived out of the

use of knowledge developed and maintained by the community for many

generations. (Anand 1998, Anuradha 1998, Gupta2002)It also demonstrates the

vast and untapped potential of the Indian traditional knowledge systems

particularly the traditional health care practices of the local and indigenous people.

"Recognizing the role of modernization in changing lifestyles and knowledge

systems of tribal communities, Indian Council of Agricultural Research (lCAR)

under M.S. Swaminathan, mooted the idea of research programme to document the

knowledge system of the tribal communities of India in 1976. Consequently an All

India Coordinated Research Project on Ethno biology (AICRPE) was launched

under the man and Biosphere Programme in 1982. The overall objective of the

project was to make in depth study and analysis of the multidimensional

perspectives of the life, culture, tradition and knowledge systems of the tribal

communities of India. The AICRPE project documented various aspects of the life,

culture, tradition and knowledge systems including those associated with the use

of over 10000 wild plants used by tribes for meeting a variety of their

requirements" (AICRPE final technical Report 1982-1998; Pushpangadan 2002)

8.2 The Kanis and Arogyapacha The Kanis, a forest dwelling tribe live in and around Agasthyamalai hill of

Western Ghat mountain region in the Thiruvanathapuram District of Kerala.

Numbering about 16000 (Puspangadan(1 ),2002: 134), they are a nomadic

community now leading a settled life in tribal hamlets on land allotted in the forest

81

area by the state government. Living in the forests, the Kanis have acquired a

unique knowledge about the biological resources around them. A small number of

members also reside in the neighboring state of Tamil Nadu. Most members are

now engaged in cultivation of mixed crops. The areas they occupy now are on long

term lease from the forest department. Their choice of cultivation is thus

dependent on the list of Non Timber Forest Product(NTFP) issued and amended

from time to time by the Forest Department.(Gupta,2004) The level of knowledge

about the plants varies across settlements and between individuals. Earlier they

had experts called Plathi who had a good knowledge of medicinal plants in the

forests. However, this practice is disappearing giving way to new practices for

managing this knowledge system. For example, several individuals have taken

over the art from the plathis (Chaturvedi,2008)

The plant Arogyapacha endemic in the Southern part of the western Ghats which

includes a part of the Thiruvanathapuram district and straddles a nearby district in

Tamil Nadu.(Puspangadan and Nair,2005: 136) The plant was widely used by

Kanis for its anti fatigue properties but seems to have been unknown to outsiders

till 1987. It is called Arogyapacha (elixir of health) by the Kanis.

In one of the field expeditions to mountainous Western Ghats in Kerala, afew

young Kani men accompanied the AICPRE team. They were intrigued by the fact

that the Kani guides they had hired ate some fruits and were not feeling fatigued.

After consuming the fruit leading sudden flush of energy and strength', the team

persuaded the Kanis to share their knowledge with the assurance that after

scientific investigation, if any marketable drug was developed from this plant, the

financial benefit accrued would be equally shared with the

community(Chaturvedi,2008). This was therefore a clear case of transfer of

traditional knowledge to outsiders who knew neither about the plant nor about its

properties.

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8.3 The Process of Benefit Sharing The transfer of knowledge eventually led to the development of a herbal

formulation'leevani' with Arogyapacha as one of the ingredients. After necessary

clinical trials the drug was transferred to Arya Vaidya Pharmacy (A VP)

Coimbatore Ltd. against a license fee of Rs.l 0 lakh and a royalty of 2% at ex­

factory sale rate for 7 years. IS While transferring the technology TBGRI agreed to

share the license fee and royalty received from A VP with the Kani tribe.

(Puspangadan, Nair,2006: 138)

Finally a trust fund, Kani Samudaya Kshema Trust, owned and managed by the

Kanis was set up. About 60% of the Kanis are now its members. In Feb 1999, the

amount due to them, (Rs 6.5Lakh) was transferred to the Trust. As per the rules of

the Trust the licence fee and royalty received from the sale of Jeevani drug will be

in fixed deposit and only the interest accrued will be utilized for the welfare of the

members of Kani tribe(Puspangadan, Nair,2006: 138) The model was developed

over a period of 12 years from 1987 to 1999.

In the second phase of the Access and Benefit Sharing agreement, . TBGRI

rendered the process more democratic and transparent( Chaturvedi, 2007: 13)This

phase also formalized the presence of the Trust representatives in the new

negotiation process. In 2004, the new Director of TBGRI constituted a Business

Management Committee(BMC) with a membership of seven persons, two from its

faculty, three outside experts and two representatives of the Kani Trust. The role •

of BMC was to negotiate fresh bids with companies interested in commercial

production of the drug. As minimum condition for Access and Benefit Sharing

arrangement, it suggested that licence fee be doubled to Rs2.1 million and the

royalty payment also be doubled to 4% (The Hindu,2006) TBGRI had applied for a

patent on process for Jeevani, titled, ' a process for the preparation of a novel ,

immuno enhancing, anti fatigue, anti stress and hepatoprotective herbal

I " th ) Agreement of 10 November 1995 between the TBGRI and A VP

83

drug(Jeevani). This was received III 1996(File no.959/MAS/1996)(

Chaturvedi,2007: 14)

However, after all these efforts, in 2000, Nutri Science Innovations LLC, a US

based supplier of nutritional and functional food ingredients rendered the efforts

futile by acquiring a trade mark on leevani(serial No. 75692281 )Without the

knowledge of TBGRI or A VP from whom it was importing the drug, it registered

leevani under the US trademark rule and sold the product at a much higher price

than originally charged by AVP.(Varshney, 2004)

8.4 Issues and Outcomes of the Access and Benefit Sharing

Experiment Various issues have received attention through the experience of this benefit

sharing experiment .These range from issues of Prior Informed Consent to

complementarities of international mechanisms with domestic legislations.

Chaturvedi(2007) enumerates these issues in terms of PIC, nature of benefits,

identification of beneficiaries and vulnerability of the Kanis.

8.4.1 Prior Informed Consent Questions have been raised on the mode of access to the information on the

traditional knowledge and whether it was actually based on Prior Informed

Consent of the CBD. While it is important to note that the knowledge was shared

in 1987 (before the CBD) the product was released in 1994(when the CBD had just

entered into force). The Kani case initially lacked a clear and transparent process

of acquiring consent. Since there were few members of the larger community

involved, the ones not benefiting from the experiment rejected the mechanism. It

was felt that those who divulged the IKS secret had no legitimation from the rest

of the community and yet were the ones rewarded most by the TBGRI arrangement

(Bijoy,2007: 1-19). Some observers have discussed the lack of awareness among

several Kanis which led to their exploitation and adversely affected their

84

interests.( John and Menon, 1998)However these drawbacks were addressed in the

later stages.

8.4.2 Benefit Sharing

Apart from the monetary returns, there were other issues that came up during the

experiment. It was realized that Prior Informed Consent would have been more

effective had there been some prior effort for capacity building and awareness

creation (Chaturvedi, 2007, 16)More focused attention on addressing information

gaps may also facilitate confidence building and awareness creation. The fact that

Kanis could oppose transfer of money to the tribal community department and the

blockade by forest department to prevent picking of Aarogyapacha leaves shows

that the awareness about rights has been raised in a community which was

previously largely passive(ibid).

In the Kani case IPR emerged as a crucial impediment (Reddy,2006,

Gupta,2004)The fact that TBGRI never thought of protecting jeevani as a

trademark(Varsney,2004)and did not include tribal informants as co-inventors in

the patent is largely seen as a violation of ethical norms. However, Gupta

elaborates that many of these observers overlook the fact that that the patent

applications from the TBGRI were only for the process of making the drug

because Indian patent law did not permit product patent at that

time.(Gupta,2004)Thus it did not affect anybody's right to resources available in

the public domain. With the Patent Amendment Act 2002, making disclosure of

Prior Informed Consent and related traditional knowledge mandatory this problem

has been rectified.

8.4.3 Identification of Beneficiaries

The Kanis are among the poorest communities in the world and though the Trust

has helped alleviate poverty in the Agasthyar hills, the beneficiaries are still

limited to a small number of this community. There are discussions about

decisions taken being not representative (Reddy,2006, Bijoy,2007). Many Kanis

85

also complained about their lack of awareness about the Trust and also the

medicine developed without their knowledge and programmes undertaken for their

development. (Anuradha,2001)However, the efforts made by the Kerala

government and the TBORI , particularly the meeting of Kani tribes at Kottur

settlement on 21 feb, 1999 which was convened by the secretary of the SC/ST

department of Kerala government suggests that the aim was to broaden the

coverage of the beneficiaries.

The Kerala Institute for Research, Training and Development of Scheduled Castes

and Schedule Tribes (KIRTADS), an independent institute under the Kerala

governments Scheduled Castes and Scheduled Tribes Development Ministry,

which had initially been the most vocal critique of the A VP and TBORI

agreement, had also suggested that TBORI should amend the terms and conditions

of the agreement in such a way that Kani tribes get access to technical know-how

and are able to manufacture jeevani on their own terms and

conditions.(Oupta,2004). At this stage the membership of the trust has expanded to

3000 families. But efforts need to be intensified to improve representation of

remaining Kani families.(Chaturvedi,2007)

8.4.4 Vulnerability Kanis vulnerability to external institutions has been often debated. Moving from a

nomadic to settled life due to restricted access to forests over the years , with a

need to acquire livelihood security has broken down the social fabric of the

community. A communal and unified culture has paved way for individualism.

Added to this is the role played by the conflicting interests of the TBORI and

KIRTADS. When the KIRTADS and TBORI took opposite positions on the Access

and Benefit Sharing issue - the Kanis ended up being instruments for carrying out

institutional arguments. (Chaturvedi, 2007)The TBORI scientists accused the

KIRTADS of trying to overtake the Arogyapacha project. It also emerged that

these different institutions had different groups of Kanis to support their positions

and thus efforts were not made to resolve the issue. The Director of KIR T ADS

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also complained that IPRs were not being sought by the tribe but was being

granted to private entities. The 'story of Arogyapacha also illustrates how various

government institutions try to push their own agenda in the name of an ethnic

community' (Martin, 1998).

9. Analysis of Benefit Sharing Mechanisms in India Global efforts at Access and Benefit Sharing benefit sharing have focused on

monetary means.(Glowka,1998: xiii+98) These efforts are concentrated in tropical

developing countries. Unlike India these countries have strong and discreet

territorial community resource rights over forests and water, their economy

depends greatly on forests. Limited history of civilization coupled with low levels

of education and infrastructure imply that substantial biota and the traditional

knowledge associated with it remains to be discovered.(Ghate,2003: 192) Thus

legislations in these countries have encouraged contractual arrangement for

monetary benefit sharing. For example, in Peru, Aguarana tribals share their

knowledge through know how licenses with Searle, a subsidiary of Monsanto,

thus bringing Aguarana all the above benefits.(ibid) Indian situation differs due to

i)lack of community rights over forests and waters ii) substantial territorial overlap

between communities iii)substantial traditional knowledge being available

publicly . In such a situation defining the beneficiaries of the benefit sharing

agreement becomes difficult. Indian legal and policy framework before the

Biological Diversity Act revealed lack of any benefit sharing systems Besides,

some like P.V . Satheesh are of the opinion that Access and Benefit Sharing

mechanisms would mean the acceptability of IPRs as legitimate, and thus

commodification of traditional knowledge which has been so vehemently been

opposed in the past, as acceptable.

10. Conclusion The legislations are still in a very preliminary stage in terms of implementation in India.

The institutions (such as the Protection of Plant Variety and Farmers' Authority or the

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Biodiversity Authority) that are given the mandate to implement the laws are still in the

process of being established.

Nationally, the three Acts fall under the responsibility of different ministries.

Ministry of Commerce and Industry handles the patents related issues, Ministry of

Agriculture handles the plant variety issues and the Ministry of Environment and

Forests handles the biodiversity issues. Hence when decisions are taken at the

national level, it is likely that conflict of jurisdiction will arise as there is an

apparent lack of coordination between the various laws.

The lack of coordination between the various Acts intended to protect traditional

knowledge can be attributed both to national and international factors. While the

Plant Variety Act was enacted as a response to the developments in TRIPS, the

Biological Diversity Act was enacted due to India's obligations under the CBD.

Though the two treaties carry same weight in legal terms, as mentioned in Chapter

2, there is a lack of coordination between the two. Besides, no mechanism has

been evolved yet to resolve issues arising out of a case of contradiction between

the two. While the effort to address the issue of protection of traditional

knowledge has led to the enactment of the three Acts, the efforts also are a

reflection to redefine property rights in favour of traditional knowledge holders.

While the three Acts assert India's sovereignty over its biological resources and

associated knowledge, debates on the role of the state in determining access to

biological resources and benefit sharing thereof are still on. There are those like

Anil Gupta and Madhav Gadgil, who prefer adapting to the current IPR regime to

ensure protection of traditional knowledge, and thus NIF model of benefit sharing

on the one hand. On the other there are those like Vandana Shiva and P.V.

Satheesh who are opposed to the idea of an IPR protection of traditional

knowledge, since though it might ensure the property rights of the state over its

resources, it does not ensure the sovereign rights of traditional knowledge holders

on their resources.

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These provisions would ensure prevention of bio-piracy in India and equitable sharing of

benefits. However, this will not prevent persons from seeking patents on traditional

knowledge and also using traditional knowledge without prior informed consent and

benefit sharing in other countries. This is demonstrated by the Kani case when Nutri

Science, an American company registered a trademark on Jeevani, the drug

developed with Indian traditional knowledge provided by the Kanis.

As provisions of Article 8(j) of CBD are subject to national legislation, India is of the

view that securing benefits arising out of the use of traditional knowledge related to

biodiversity beyond national borders necessitates recognition of terms of benefits sharing

though an international instrument. In order to ensure that national level systems for

protecting traditional knowledge and benefit sharing are effectively implemented for use

of traditional knowledge outside the country, international recognition should be

provided to such national level systems. The onus of benefit sharing must also be shared

by the user country to create an enabling environment and confidence through legislative

measures so as to ensure compliance of prior informed consent stipulations, for ensuring

equitable sharing of benefits as visualized in the CBD. While the effort to address the

issue of protection of traditional knowledge has led to the enactment of the three

Acts, the efforts also are a reflection to redefine property rights in favour of

traditional knowledge holders.

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