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CHAPTER 3

CASES OF MISAPPROPRIATION OF TRADITIONAL KNOWLEDGE

Biodiversity represents the very foundation of human existence. Biodiversity is the

most significant of the resources available to man. It has limitless potential for application

for human welfare. Biodiversity-rich nations are also the storehouse of information and

knowledge on various unique applications of biodiversity.110 The economic value of

biological diversity conserved by local and indigenous community is difficult to

quantify.111 However, the modern biotechnological revolution coupled with the demand for

increased intellectual property rights for genetic researches has created a new interest

amongst researchers on biogenetic resources and associated traditional knowledge. The

advent of modem biotechnology coincided with the growing interest of multinational

corporations on biopatents has raised the piquant problem of biopiracy and bioprospecting.

3. 1. BIOPIRACY

3. 1. 1. History

The word 'biopiracy' was coined by the North American advocacy group, Action

Group on Erosion, Technology and Concentration (ETC Group), formerly known as Rural

Advancement Foundation International, to refer to the uncompensated commercial use of

110 See, T.P. Sreedharan, “Biological Diversity of Kerala: A survey of Kalliasseri Panchayat, Kannur

District,” Discussion Paper No. 62; Kerala Research Programme on Local Level Development, Centre for Development Studies, Thiruvananthapuram, 2004.

111See, S. Brush, Providing Farmer’s Rights through In Situ Conservation of Crop Genetic Resources, University of California, 1994.

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biological resources or associated TK from developing countries as well as the patenting by

corporations of claimed inventions based on such resources or knowledge.112

The issue of biopiracy is not new. The piracy of bioresources has a long history of

thousands of years. The recorded history of international plant collecting missions goes

back to 3500 years when Egyptian rulers began bringing plants home after their military

expeditions. Botanists used to take specimens from anywhere in the world without any

ramification. During the voyage of the Beagle, Charles Darwin, from the Galapagos and

elsewhere, collected and brought home all species that interested him. The Royal Botanical

Gardens obtained rubber trees from Brazil and planted in South East Asia. It also took

cinchona seeds from Bolivia, even in violation of Bolivian law, and planted them in India.

Again, Commodore Perry's naval mission to Japan collected a wide variety of plants for the

United States. Richard Shultes during his mid-twentieth century adventures took thousands

of voucher specimens of medicinal plants from shamans, many of which had never

previously been identified taxonomically.113 None of these famous collecting trips was

challenged on any legal grounds whatsoever.

Prior to the Convention of Biological Diversity, 1992, the living resources were

regarded as ‘common heritage of mankind’. The researcher could, without any legal

formalities, arrive at a field site, collect samples of plants, microbes, animals etc., and take

them home. There was no applicable law to regulate as to what one can and cannot take

from nature. As common resources, researchers/private companies could take and use any

112 Graham Dutfield, “Bioprospecting: Legitimate Research or 'Biopiracy'?” at <http://www.scidev.net/

dossiers/index. cfm? fuseaction =policy brief & policy = 40 & section = 171 & dossier=8>, visited on December, 27, 2008.

113 Michael A. Gollin, “Biopiracy: The Legal Perspective,” at <http:/ /www. action bioscience. org/ biodiversity / gollin.html>, visited on December, 27, 2008.

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resource without having any justification or compensation. This led to steady loss of

common peoples’ control over their own common natural resources. This has been going

on for centuries. It is a story of continuous, ongoing exploitation.

3. 1. 2. Definition

Biopiracy is not so much a legal concept as a socio political tool to highlight

situations where indigenous peoples’ TK and their biological resources have been

unlawfully or illegally utilized, usually by researchers and companies who thereafter claim

intellectual property rights over products or processes which have been derived from these

resources and knowledge. It is a useful concept to understand where intellectual property

instruments like patents etc. affect indigenous people’s interests over their rarely

recognized intellectual efforts.114 The concept of biopiracy assumes that it is a natural right

to own plants, animals and human genes.

Biopiracy’, in simple terms, is the modem version of the old approach of take-and-

run. As the name suggests it is the piracy of the various valuable elements in the biosphere

or the biodiversity. Biopiracy is the plunder of nature and its knowledge.115 Biopiracy

refers to unauthorized use of biological resources and/or traditional communities'

knowledge on biological resources. It includes use of plants, animals, organs, micro-

organisms, genes etc. The exploitation of biological and other resources and related

traditional knowledge for commercial use without the consent of their customary holders/

114 Manuel Ruiz, International Debate on Traditional Knowledge as Prior Art in the Patent System: Issues

and Options for Developing Countries, at < http://www.ciel.org/Publications/PriorArt_ ManuelRuiz_ Oct02 .pdf.>, visited on December, 26, 2008.

115 See, Vandana Shiva, Biopiracy : The Plunder of Nature and Knowledge, South Press, 1997.

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traditional communities is purely an assault to the biodiversity. Vandana Shiva explains the

concept in the following words:

Biopiracy refers to the use of intellectual propery right sytems to legitimise

the exclusive ownership and control over biological resources and bological

products and processes that have been used in centuries in non-industrialised

cultures. Patent claims over biodiversity and indegenous knowledge that are

based on the innovation, creativity and genius of the people of the Third

World are act of ‘biopiracy’.116

Issac and Kerr describe biopiracy as a theft of valuable resources for the

commercial gain by developed counties and multinational corporations.117 It represents a

disingenous repackaging of TK in order to secure monopoly rents for the biopirate while

excluding the original inventor from a claim to these rents. Not only the exploitation but

any unauthorized use by corporations and individuals of biological resources for

commercial gain (i) without the permission of and (ii) without adequate reward going to the

communities that have nurtured the resources and developed the knowledge over

generations will amount to biopiracy. It is largely being done by he developed Northern

countries and the biologically rich Southern countries are the main victims. It raises

significant inequity concerns since much of the world’s traditional knowledge and

associated biodiversity are held by the world’s poorest.118

116 Vandana Shiva, Protect or Plunder: Understanding Intellectual Property Rights, Zed Books Ltd., London,

2001, p. 49. 117 Grant E. Issac and William A. Kerr, “Bioprospecting or Biopiracy,” The Journal of World Intellectual

Property, Vol. 7, No. 1, January 2004, p. 37. 118 William A. Kerr and R. Yampoin, “Adoption of Biotechnology in Thailand and the Threat of Intellectual

Property Privacy,” Canadian Journal of Agricultural Economics, 2000, 48 (4), pp. 597- 566 in Grant E. Issac and William A. Kerr, “Bioprospecting or Biopiracy,” The Journal of World Intellectual Property, Vol. 7, No.1, January 2004, p. 37.

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Thus the term biopiracy refers to any

i. unauthorized use of biological resources including plants, animals, organs,

micro-organisms, genes

ii. unauthorized use of traditional communities' knowledge on biological resources

iii. unequal share of benefits between a patent holder and the indigenous

community whose resource and/or knowledge has been used

iv. patenting of biological resources with no respect to patentable criteria such as

novelty, inventiveness and industrial application.119

3. 1. 3. Causes

Though biopiracy is an old practice, during the last two decades, there has been a

heavy loss of biological resources due to erosion of biodiversity resulting from biopiracy.

The first cause of biodiversity erosion was the improper definition of the rights of

ownership that prevailed prior to CBD treating the biological and natural resources as

common heritage of mankind. This notion, undoubtedly, made the Western countries and

companies to appropriate the nature’s wealth found in abundance in South with no return to

the latter.

The laws in general and the western intellectual property laws in particular

generally regard TK as information in the public domain, freely available for use by

anybody. Moreover, in many cases, diverse forms of TK have been appropriated under

intellectual property rights by researchers and commercial enterprises, without any

compensation to the knowledge’s creators or possessors. The TK thus misappropriated

119 See, < http://encyclopedia.kids.net.au/page/bi/Biopiracy >, visited on December, 27, 2008.

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includes practices and technologies, seed treatment, storage methods and tools for planting

and harvesting, etc.

To exercise every right, the right holder must be aware of the fact that he is entitled

to such a right. Most often, the persons who are responsible for the preservation and

protection of biological resources and the holders of associated TK are ignorant of their

rights. These custodians of biological wealth and TK hardly realize their role and share in

the protection of biodiversity. With little or no knowledge about their right, they often fail

to effectively exercise their right and prevent the misappropriation of these wealth by the

bio-pirates.

The lack of effective and adequate legal system for the protection of biodiversity

and the associated TK also promote biopiracy. The lethargy of the government of under-

developed countries to protect and preserve their wealth in biodiversity and natural

resources through an effective legal mechanism also results in biopiracy.

Yet another cause of biopiracy is the Western trend to justify biopiracy. These

justifications are mainly centered on intellectual property right system. The bio-pirates

consider that natural and biological resources are common public goods and users from all

over the world must be free to access them for manufacturing drugs, compounds etc.

Pharmaceutical companies insist access to biological resources and TK since it allows them

to develop new products that could solve many health and food issues. It is being argued

that research and development require huge investment and that must be balanced by the

protection of the resulting product through patent. It is also argued that high risk of

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uncertainty and loss of capital involves in R&D on biological resources since very few of

the samples collected actually lead to new profitable products.

While most TK cannot be patented due to lack of novelty, some researchers argue

that they have added an 'inventive step' that makes their version of a product patentable.

Such arguments are frequently accepted as legitimate by patent offices. Since patent laws

recognize property right over genetically modified organisms, it is also being contented

that the preservers lose ownership in case of genetic modification.

3. 1. 4 Consequences

For all humans, the first resource for daily life is biodiversity. Biodiversity has, in many

ways, contributed to the development of human culture, and in turn, human communities

have played a major role in shaping the diversity of nature at the genetic, species, and

ecological levels. It provides him crops for food, fibers for clothing, wood for shelter,

medicine and energy for health. Biodiversity is the mirror of mans’ relationship with the

other living species. But, biopiracy leads to biodiversity erosion threatening the very

survival of live forms including human beings in the biosphere. The biopiracy can

i. infringe on the sovereign rights of nations

ii. decrease the economic health of indigenous communities

iii. deplete or destroy species

Moreover, patenting of biological resources restrict or prevent other producers from

using processes or/and products related to TK. For example, a holder of patent on the use

of a plant for certain functions could try to prevent others from using it in the same way.

Classic examples take account of US patent on the use of turmeric for healing wounds

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(although this was successfully challenged by the Indian government), a Japanese patent on

the anti-diabetic properties of banana (traditionally used as herbal medicine in the

Philippines), and the US patenting of a protein from a native strain of Thai bitter gourd

(after Thai scientists found its compounds could be used against HIV infection). As a

result, those who have been using TK for many generations could face restrictions on doing

so as it may constitute patent infringement.120 Further, the patented process or product may

lead to the sale of products at high prices in the very developing countries from which they

originated. The IP protection for TK based products thus rapidly erodes the world’s store of

traditional knowledge and undermines the conservation of TK and sustainable use of

biodiversity. Thus, biopiracy may create a form of ‘reverse technology transfer’, as it is the

developing countries or least developing countries that transfer knowledge and technology

to the rich developed world.

3. 1. 5 Cases of Biopiracy

In the recent past, there have been quite a few cases of biopiracy of TK from under-

developed biodiversity-rich countries. Developing countries like India, Brazil, and

Malaysia. also faced several cases of biopiracy. Many foreign corporations obtained

patents based on biological materials without acknowledging the source of their knowledge

or sharing the benefits.121 These cases include patents obtained in other countries on haldi

(turmeric), karela (bitter gourd), neem, basmati rice, medicines like Jeevani etc. Many of

these patents were successfully contested and patents were got revoked. All these disputes

have raised the thorniest problems in patent law and rights to traditional knowledge.

120Martin Khor, “Why we Must Fight Biopiracy”, Himalayan Journal of Sciences, Vol. 1, No. 2, 2003, pp. 74

-75. 121 S.K. Tripathi, “Intellectual Property and Genetic Resource, Traditional Knowledge and Folklore:

International, Regional and National Perspectives, Trends and Strategies,” Journal of Intellectual Property Rights, Vol. 8, No. 6, November 2003, pp. 468-77.

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3. 1. 5. 1. INDIAN CASES

3. 1. 5. 1. a. Neem case

Azadirachta indica is the botanical name of the neem Tree. The word has its root

in Persian language, Azad-Darakth. Indians described the tree as azad darakht-i-Hindil,

which literally means ‘the free tree of India’.

Neem trees are attractive tropical evergreens that can grow up to 30 meters tall

and 2.5 meters in girth. The neem tree which can live for more than two centuries is

indigenous to the Indian subcontinent. Over the past century it has been flourished in many

countries of Africa, Central and South America, the Caribbean and Asia too. The tree is

mentioned in Indian texts written over 2000 years ago and has been applied for centuries in

agriculture as an insect and pest repellent, in human and veterinary medicine, toiletries and

cosmetics. Every part of this tree, from its root to bark, leaves and seed, has been used for

medicinal purposes. It has also been used to cure illnesses. Neem oil itself is used for

lighting lamps. It is also venerated in the religions, culture, and literature of the region.

India has shared knowledge of its myriad uses with the world community.

On the one hand, neem cannot be a subject matter of a patent simply because it has

been indigenous to the region of South Asia and a part of its bio-knowledge and hence does

not satisfy the criteria of novelty which is a necessary prerequisite for the grant of a patent.

On the other hand, in the United States, neem seeds and their potent insecticidal extract,

azadirachtin, have been the subject of continuing biotech research and grant of patents.

Consequently, on December 12, 1990 the multinational agribusiness corporation W.R.

Grace of New York and the United States of America represented by its Secretary of

Agriculture filed a patent application with the European Patent Office (EPO) on the basis

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of a U.S. priority application of December 26, 1989, covering a method for controlling

fungi on plants by the aid of a hydrophobic extracted neem oil. Thereafter, a series of

patents for products derived from the neem tree have been filed with the U.S patent office

and EPO for various claims including fungicidal effects, methods of extraction, storage

stable formulations of one of the active ingredients, contraceptives, medical uses and

insecticides. Overall, there were 90 patents on products from the neem tree. (Examples are

patents Nos: 5,298,251; 5,356,628; 5,372,817; 5,405,612 and 5,409,708.)

The patent applications were also filed by transnational pharmaceutical

corporations such as Rohm and Haas. None of these claims involved genetically

engineered products. Nonetheless, more than 90 patents have been granted worldwide in

respect of several claims. For example, an U. S company, AgriDyne has patented two

claims for bioprocessing of neem for bioinsecticidal products. The first patent was for a

refining process that removed fungal contaminants found in extracts from the neem seed

which is used in the manufacture of technical-grade azadirachtin, and in the production of

AgriDyne's neem-based bioinsecticides. The second patent was for a method of producing

stable insecticide formulations containing high concentrations of azadirachtin. W.R. Grace

had patents for neem-based biopesticides, including Neemix for use on food crops.

A legal opposition to these patents was filed jointly by three plaintiffs: Magda

Aelvoet,122 Vandana Shiva,123 and Linda Bullard.124 They claimed that the fungicidal effect

of hydrophobic extracts of neem seeds was known and used for centuries on a broad scale

122 MEP, then President of the Green Group in the European Parliament, Brussels. 123 She opposed the patents on behalf of the Research Foundation for Science, Technology and Natural

Resource Policy, New Delhi, India. 124 She represented the International Federation of Organic Agriculture Movements (IFOAM) based in

Germany.

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in India, both in Ayurvedic medicine to cure dermatological diseases and in traditional

Indian agricultural practice to protect crops from being destroyed by fungal infections.125

Since this traditional Indian knowledge was in fact ubiquitous in Indian culture from

ancient times, they asserted that the patent in question lacked two basic statutory

requirements for the grant of a European patent, viz., novelty126 and inventive step.127 It

was also argued that the patent was contrary to morality128 because the patentees claimed

monopoly property rights on a method which forms part of the Indian traditional

knowledge. The other grounds of challenge for the revocation of the patent included

insufficient disclosure129 and lack of clarity.130 The patent was also challenged under

Article 53 (b) of the EPC since it constituted a de facto monopoly on a single plant variety.

They also submitted to the representatives of the EPO packages of signatures of 100,000

Indian citizens demanding that all patents on the neem be revoked. Interestingly, it was

argued by the patentee that as traditional Indian knowledge of the properties of the neem

tree had never been published in any academic journal, such knowledge did not amount to

prior art. However, after examination, the opposition panel found that patentee’s claim of

novelty had been destroyed on the basis of clearly demonstrated prior public use. The

opposition division agreed with the opponents that no patents should be granted for

anything which was known previously, for example as part of common traditional

knowledge since it is a question of novelty or prior public use. The Technical Board of

Appeals also examined the patent with regard to novelty, disclosure and inventive step. In 125 Linda Bullard, “Freeing the Free Tree: A Briefing Paper on the First Legal Opposition to a Biopiracy

Patent: The Neem Case,” at <http://www.patentinglives.org/ Neem Briefing finalaugust. doc> , visited on December 10, 2008.

126 Article 54 of the European Patent Convention. 127 Ibid Article 56 128 Article 53 (a). 129 Article 83. 130 Article 84.

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accepting the challenge and revoking the patent, the four-member panel of the EPO had

agreed that the neem patents amounted to bio-piracy and that the process for which the

patent was granted had been actually in use in India from time immemorial. Thus on March

8, 2005 a legal history was made concluding a ten-year battle in the world’s first legal

challenge to a biopiracy patent, when the Technical Board of Appeals of the EPO revoked

in its entirety the patent on a fungicide made from seeds of neem tree.

3. 1. 5. 1. b. Turmeric case

Turmeric is a tropical herb mostly grown in East India. It has been used for

thousands of years in India and elsewhere for a variety of reasons including food, cosmetic

and medicinal purposes. In the mid-1990s, turmeric became the subject of a patent dispute

when a U.S. patent on turmeric (No: 5,401,504) was granted to the University of

Mississippi Medical Center in 1995, specifically for the ‘use of turmeric in wound healing’.

This patent also granted the patent holder the exclusive right to sell and distribute

turmeric.131

Concerns grew in India, where turmeric has been used medicinally for thousands of

years, about the economic and social impact of this patent. Subsequently, India’s Council

of Scientific and Industrial Research filed a complaint by challenging the novelty of the

University's invention. Then, the U.S. patent office investigated the validity of this

patent.132 Though the invention was non-novel since the process has in fact been

traditionally practiced in India for many years and as such it was a common knowledge in

public domain, the US patent rules do not recognize foreign undocumented knowledge as

131 Anuradha, R.V, “Biopiracy and Traditional Knowledge,” The Hindu, 20 May 2001. 132 See, Biswajit Dhar and Anuradha, R.V, “Access, Benefit Sharing and Intellectual property Rights,” The

Journal of World Intellectual Property, Vol. 7, No. 5, Sept. 2004, pp. 603-05.

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prior art if it is not also known in the United States. It is only when the Indian government

provided written proof including a paper published in 1953 in the journal of the Indian

medical association and an ancient Sanskrit text that documented turmeric’s extensive and

varied use throughout India’s history, the patent on the anti-inflammatory applications of

turmeric was revoked in 1997 on the ground of lack of novelty.

3. 1. 5. 1. c. Basmati rice case

Rice is an important aspect of life in the southeast and other parts of Asia. For

centuries, it has been the cornerstone of the regions food and culture. The farming

communities throughout the region, over the years, have developed, nurtured, and

conserved over thousand distinct varieties of rice. Among these varieties, basmati rice is

known as the queen of fragrance. Basmati is an aromatic long-grain rice which originated

in Punjab. It has been best grown in the foothills of the Himalayas for thousands of years.

For countless generations, Punjabi farmers in India and Pakistan nurtured the fragrant seeds

while improving the yield. Its nut-like flavor and aroma can be attributed to the peculiar

geology where it grows - the deep and fertile soils as well as the exceptional climate.

Basmati is the costliest rice in the world and has been favored by emperors and praised by

poets for hundreds of years. Basmati was thus viewed as a cultural and biological heritage.

India grows 650,000 tonnes of Basmati rice annually. Basmati covers 10-15 per

cent of the total land area under rice cultivation in India. Basmati rice has been one of the

fastest growing export items from India. Indian farmers exported $250 million Basmati

every year. The main importers of Indian Basmati are the Middle East (65 per cent),

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Europe (20 per cent) and USA (10-15 per cent). Indian Basmati is the most expensive rice

imported by the EU compared to Pakistani Basmati and Thai fragrant rice.133

On September 2, 1997, an American company RiceTec Inc. was granted a patent

(No: 5663484) on Basmati rice lines and grains by the USPTO. It related to the crossbred

rice lines and grains developed by the U.S. company. The Basmati variety, on which Rice

Tec claimed a patent, has been derived from Indian Basmati crossed with semi-dwarf

varieties, including indica varieties. Rice Tec gained patent rights on Basmati rice and

grains while already trading in its brand names such as Kasmati, Texmati and Jasmati. This

patent allowed Rice Tec to sell a ‘new’ variety of Basmati, which it claims to have

developed under the name of Basmati, in the US and abroad. In all, the company made 20

claims in the patent application, including a method for the development of novel rice lines.

The claims 15 to 17, which defined rice grains without any limitations or territory or

photoperiod insensitivity, were manifestly threatening to India's interest. These claims were

broadly worded so that it could include 90 percent of rice germplasm and even traditional

rice lines like Bas 370, Taraori Basmati, Karnal local and other varieties. On India’s protest

RiceTec withdrew these claims.

RiceTec had got patent mainly for three categories: growing rice plants with certain

characteristics identical to Basmati, the grain produced by such plants, and the method of

selecting the rice plant based on a starch index (SI) test devised by RiceTec Inc. Out of

these three categories, India challenged only the claim on ‘grain quality’ and left the claims

on ‘variety of the rice’ and ‘its method of production’ unchallenged. The government of

133 See,<http://www.publications.parliament.uk/pa/cm199900/cmselect/cmenvaud/45/45ap08.htm>, visited

on December 20, 2008.

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India has challenged the patent through Agricultural and Processed Food Exports

Development Authority (APEDA). The patent was challenged on technical grounds of

novelty, usefulness and non-obviousness. An application for patent re-examination was

filed before the U.S. Patent and Trademark Office (USPTO). Subsequently, RiceTec

withdrew all the claims except those related to the specific rice lines developed by it and

not to any varieties or lines grown in India. During the course of the appeal filed by India

in the U.S., Ricetec dropped 15 out of the 20 claims that it had made in the original patent

application.

Ricetec has been finally granted varietal patents for three strains of superfine rice

developed by the company, but it could not obtain patent for the generic and pseudo-

generic strains of basmati. In the ruling, the USPTO said that RiceTec's grain is equal or

superior to good quality Basmati. This would help the company to label its strains as

superior Basmati rice. The international community treated this as a blatant case of

biopiracy that threatens the genetic material, biological resources and indigenous

innovation of farmers around the world.134 As per Research Foundation for Science and

Technology, the Basmati patent is a clear case of biopiracy and represents a theft in three

ways: (i) theft of collective intellectual biodiversity heritage of Indian farmers who have

evolved and bred Basmati varieties, (ii) theft from Indian traders and exporters whose

markets are being stolen by the theft of Indian aromatic rice varieties, and (iii) theft of the

name "Basmati" which describes the aromatic characteristics of the rice.135

134 See, < http://ictsd.net/i/news/bridgesweekly/5475 >, visited on December 20, 2008. 135 Basmati Biopiracy, Research Foundation for Science, Technology and Ecology India, July 1998.

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3. 1. 5. 1. d. Asian chick pea case

Chick pea (Cicer arietinum ), one of the earliest cultivated vegetables, is the most

important cool season food legume crop grown mainly by small farmers in the semi-arid

tropics of West Asia and North Africa. Farmers from Indian subcontinent grew them

massively all year round. India is the world leader in chickpea production followed by

Pakistan and Turkey. Chickpeas are high in protein, dietary fiber, and zinc. Hence it is a

healthy source of carbohydrates for persons with insulin sensitivity or diabetes.

Two Australian government agencies collected samples of Asian chick pea from the

International Crops Research Institute for the Semi-Arid Tropics (ICRISAT). ICRISAT is

an internationally funded public research center based in Hyderabad. In April 1997, the

agencies representing Australian seed industry applied for patents and plant breeder’s

rights (PBR) on two strains of these chick pea varieties. Neither of these variety were novel

to the farmers. Indeed, both the claimed varieties originated in farmer’s fields in India and

Iran. On protest, the Australian agencies withdrew their patent applications in January

1998.

3. 1. 5. 2. FOREIGN CASES

3. 1. 5. 2. a. Amazonian ayahuasca case

Ayahuasca (Banisteriopsis caapi) plants are native to the Amazon rainforest. The

word Ayahuasca refers to a medicinal drink incorporating two or more distinctive plant

species capable of producing profound mental, physical and spiritual effects when brewed

together and consumed in a ceremonial setting. The plant is well known for its medicinal

and hallucinogenic properties. The Ayahuasca vine has been used by healers and religious

leaders throughout the Amazon for generations. For hundreds of years, shamans have used

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ayahuasca to treat sicknesses. Many indigenous Amazon tribes view the plant as a sacred

symbol of their religion and use it in sacred indigenous ceremonies.

In 1986, an American scientist and entrepreneur obtained a U.S. patent on a strain

of the ayahuasca vine. The scientist obtained samples of a local ayahuasca vine in 1974

from a tribe in Ecuador.136 Upon returning to U.S., he cultivated the plant in Hawaii and

developed a stable variety, which he called Da Vine. He stated in his patent application that

he had originally obtained the ayahuasca from a “domestic garden in the Amazon rain-

forest of South America.” He claimed that Da Vine represented a new and unique variety of

ayahuasca distinct from other forms primarily because of the color of its flower petals.

In 1994, the Coordinating Body of Indigenous Organizations of the Amazon Basin

(COICA) learned about the patent. A council representing more than 400 indigenous tribes

and groups in South America opposed the patent on the ground that the vine was a sacred

religious symbol and a known medicinal herb. On behalf of the COICA, Center for

International Environmental Law (CIEL), filed request for reexamination of the patent. On

November 03, 1999 USPTO rejected the patent by accepting the argument that the variety

was not distinctive or novel though it did not admit the argument that the plant's religious

value warranted an exception from patenting. Surprisingly, in January 2001, the USPTO

reversed its rejection and issued a certificate in April allowing the patent to stand for the

remaining two years of its term.

136 Leanne M. Fecteau, “The Ayahuasca Patent Revocation: Raising Questions about Current U.S. Patent

Policy” at <http://www.bc.edu/bc_org/avp/law/lwsch/journals/bctwj/21_1/03_TXT.htm>, visited on 21-12-08.

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3. 1. 5. 2. b. Bolivian Quinoa case

Quinoa (Chenopodium quinoa) is a high protein cereal which is an important

dietary component of millions in Andean countries, especially indigenous people. Since

pre-Incan times, indigenous people in Argentina, Chile, Bolivia, Peru, and Ecuador have

been developing varieties of quinoa suitable for the wide variety of harsh conditions in the

Andes. Quinoa is an extremely hardy and drought resistant plant which can be grown

under harsh ecological conditions _ high altitudes, relatively poor soils, low rainfall and

cold temperatures. Scientists have demonstrated that quinoa has equal, if not superior,

protein to powdered milk. Furthermore, quinoa has more than three times more calcium

and two times more phosphorous when compared to wheat. Bolivia exports quinoa worth

an estimated $1 million each year.137

In 1994, two scientists from Colorado State University received a US patent (No:

5,304,718) on Bolivian quinoa. The patent was on male sterile plants of the traditional

Bolivian Apelawa quinoa variety and its use in creating other hybrid quinoa varieties. The

broad-spectrum patent was not limited to a single hybrid but covered any quinoa hybrid

derived from Apelawa, the male sterile cytoplasm found in Quinoa, including 36 traditional

varieties. The ‘inventors’ admitted that they have done nothing to create male sterile

varieties of Apelawa quinoa and its use in creating other hybrid quinoa varieties. However,

they claimed they were the first to identify and use a reliable system of cytoplasmic male

sterility in quinoa for the production of hybrids although Andean farmers have long known

that the male flower of the Apelawa variety is sterile.

137 See, <http://www.publications.parliament.uk/pa/cm199900/cmselect/cmenvaud/45/45ap08.htm>, visited

on December 20, 2008.

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The indigenous community staged much protest against the patent. In May 1998,

after a protracted fourteen-month campaign, Andean farmers succeeded in forcing

Colorado State University to surrender the Apelawa quinoa patent.

3. 1. 5. 2. c. Brazzein berries

Pentadiplandra brazzeana baillon is a wild vine native to Gabon and Cameroon

countries. The berries of the plant are amazingly sweet and African locals call them oubli

which means ‘forgot’ because their taste helps nursing infants forget their mothers' milk!

The fruit has been consumed by the apes and local people for a long time and its qualities

have long been known by West Africans. The berries consist of a single chain of 54 amino

acid residues with no carbohydrate and it is 2000 times sweeter than sugar.

The scientists of Wisconsin-Madison University discovered in 90’s that the secret

of this indigenous berry's sweetness was a stable protein which retains its sweetness even

after it had been cooked or placed in an acidic solution like diet cola. This stability made

the protein a perfect candidate for a low-calorie sweetener. In 1993, two researchers from

the university sequenced brazzein's amino acids and developed a synthetic gene which

allowed them to grow the protein in laboratory yeast thereby eliminating the need to grow

it in Africa. Thus, Brazzein, ‘the super sweet protein’ was first isolated and extracted, from

the West African climbing plant Pentadiplandra brazzeana, as an enzyme by University of

Wisconsin-Madison. The university won four U.S. patents (No. 5,741,537 issued on April

21, 1998; No. 5,527,555 issued on June 18, 1996; No. 5,346,998 issued on September 13,

1994 and No. 5,326,580 issued on July 5, 1994) on the brazzein protein between 1994-1998

on the use of brazzein as an artificial sweetener on the claim that they were the first to

isolate, sequence, and synthesize the DNA encoding for the production of P. brazzeana’s

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sweet protein. Though the sweet taste of the berries was well known in West Africa, the

university claimed that the sweet compound (brazzein) was its own invention. All the

patents were assigned to the Wisconsin Alumni Research Foundation, the organization that

handles patents for the university. Brazzein represented an excellent alternative to available

low calorie sweeteners. The protein could be used alone or in combination with other

sweeteners to sweeten the taste of foods. The invention also included the gene encoding the

Brazzein protein and a recombinant host cell capable of producing large quantities of the

protein.

3. 1. 5. 2. d. South African Hoodia Gordonii

Hoodia Gordonii is a leafless spiny succulent plant that grows naturally in the

Kalahari Desert of South Africa. The medicinal use of Hoodia for treating indigestion and

small infections has long been known by the indigenous populations of South Africa.

Bushmen of South Africa, who are known as the San, have been also using Hoodia plants

as a natural appetite suppressant for thousands of years. The Bushmen habitually go out on

long hunting trips and chew Hoodia plant to reduce their hunger and thirst and increase

energy. By chewing on Hoodia, the San hunters are able to go days without eating and still

remain strong and energetic. In order for Hoodia Gordonii to have its appetite suppressant

effect, it needs the right climate and soil of the Kalahari desert.138

Research of indigenous plants had been going on at the Council for Scientific and

Industrial Research (CSIR) since 1960s. In 1996, CSIR undertook a study of indigenous

138 See, Rachael Wynberg, “Rhetoric, Realism and Benefit Sharing – Use of Traditional Knowledge of

Hoodia Species in the Development of an Appetite Suppressant,” The Journal of World Intellectual Property, Vol. 7, No. 6, Nov. 2004, pp. 851-76.

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foods that the Bushmen ate in South Africa. Part of the study was to test for toxic effects of

any plants that were consumed by the Bushmen. They found that Hoodia Gordonii was

non-toxic, and it also helped animals to lose weight. By 1997, the CSIR isolated the

bioactive compound in Hoodia responsible for appetite suppression and obtained a patent.

The patent was licensed to Phytopharm and they named the molecule, responsible for

reducing appetite, as ‘P-57’ since it was their 57th product. P-57 was clinically tested to

reduce caloric intake by over 1,000 calories a day.

The patent based on the age old herbal knowledge raised an international outcry.

Representatives of San clans demanded restitution of their right to communal intellectual

property. In 2002, CSIR officially recognized the San tribes’ rights over Hoodia, allowing

them to take a percentage of the profits and any spin-offs resulting from the marketing of

Hoodia. After persistent legal threat, CISR signed an agreement with the San Council

agreeing to pay royalties and share benefits arising from the commercialization of P57 and

announced it at the World Summit on Sustainable Development.

3. 1. 5. 2. e. Mexican Enola Beans

The Mexican farmers grow the Mexican yellow beans (Phaseolus vulgaris;

commonly known as Azufrado bean) for centuries in Mexico. Various varieties of the

beans were developed by generations of Mexican farmers and by Mexican plant breeders.

The yellow beans are the principal source of vegetable protein and a basic food in Mexico.

In 1994, Larry Proctor, the owner of a small seed company and president of POD-NERS,

L.L.C bought a bag of commercial bean seeds from Sonora, Mexico and brought it to

America. He then selected the yellow-colored beans and allowed them to self-pollinate.

Proctor selected yellow seeds for several generations until he got what he described as a

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‘uniform and stable population’ of yellow bean seeds. The segregating population resulted

in the color of the beans was uniform, stable and changing little by season. He applied for a

US patent for on November 15, 1996 for “a new field bean variety that produces distinctly

colored yellow seed which remain relatively unchanged by season.”139 He won the patent

(No. 5,894,079) on April 13, 1999 on the Enola bean variety making it illegal for anyone to

buy, sell, and offer for sale, make, or import the yellow Phaseolus vulgaris of that

description. The patent claim was established on any Phaseolus vulgaris dry bean having a

seed color of a particular shade of yellow.140 Subsequently, on May 28, 1999 he also won a

US Plant Variety Protection (PVP) Certificate (No. 9700027) on the Enola bean variety.

The PVP certified the Enola dry bean variety as ‘distinctly colored seed which is unlike

any dry bean currently being produced in the United States’.

Armed with the patent and the PVP Certification, Proctor sued in late 1999 two

companies, Tutuli Produce (Nogales, Arizona, US) and Productos Verde Valle

(Guadalajara, Jalisco, Mexico), that sell Mexican beans in the US, charging that they

infringed his patent monopoly.

The DNA analysis conducted by the Mexico's National Research Institute for

Agriculture, Forestry and Livestock (INIFAP) of POD-NERS' patented bean indicated that

the Enola variety is genetically identical to Mexico's Azufrado bean. Moreover, the

Mexican Azufrado bean variety was identified by the International Center for Tropical

Agriculture (CIAT) and was designated under "in-trust" materials. CIAT had signed an

agreement with FAO in 1994 wherein it was stipulated that the Center could use designated

139 Michael Blakeney, “Regulating Access to Genetic Resources,” in S. K. Verma & Raman Mitttal (ed.),

Intellectual Property Rights A Global Vision, Indian Law Institute, New Delhi, 2004, p. 7. 140 Supra note 23 at 605-07.

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germplasm and related information through FAO for purposes of scientific research, plant

breeding, or genetic resources conservation without restriction but would not seek any

intellectual property rights over that germplasm or related information.

On 20 December 2000, CIAT filed a formal request for re-examination of the patent

and for invalidating all the 15 claims in the patent on the ground of want of novelty and

inventiveness. On 11 July 2001, the patent owner withdrew 1 to 15 claims but added

claims 16 to 58. In November 2001, Proctor again sued 16 small bean seed companies and

farmers in Colorado for infringing his patent. On 21 December 2005 the USPTO issued

Final Rejection and on 29 April 2008 the USPTO’s Board of Patent Appeals affirmed the

rejection of all standing claims by striking down the patent.

These biopiracy cases involving misappropriation and commercial exploitation of

traditional knowledge and biogenetic resources reveal the fundamental tension between

IPRs and TK.141 In many of these cases, claims for patents on plants and their genetic

resources are not fundamentally different from the practices applied by the traditional local

communities in the utilization of these plants as food, cosmetics or traditional medicines.

Some of these cases have been successfully challenged, such as in the cases of neem and

turmeric, but others were not, such as in the case of the patent over ayahuasca.142 This

raises an important issue of the legal protection of TK.

141 Other cases include, Andean Nunu bean patent granted on 21 March 2000 to a U. S. Corporation ( US

Patent No. 6,040,503 and PCT patent No: W099/11115; Peruvian Maca Patent (US Patent No. 6,093, 421 issued on 25 July 2000 to Biotics Research Corporation etc.

142 A plant patent on ayahusca drink, known as the “vine of the soul” among the Amazon Quencha people, produced from the bark of the Banisteripsis cappi plant, used for many medicinal purposes, was granted to a U.S. citizen, Loren Miller, in 1986 (patent no. 5751). Upon a request from the Coordinating Body for the Indigenous Organizations of the Amazon Basin in 1994, the Centre for International Environment Law (CIEL) filed a case before the United States Patents and Trademarks Office, which revoked the patent in 1999 on the basis that the drink was not distinguishable from the prior art presented by the CIEL. On appeal,

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3. 2. BIOPROSPECTING

The term ‘bioprospecting’ has recently been coined to describe the centuries’ old

practice of collecting and screening plant and other biological material for commercial

purposes, such as the development of new drugs, food, seeds and cosmetics.

Bioprospecting is a type of biotechnology research. It is a core activity of the

biotechnology industry in its search for biological materials for various undiscovered

applications. Bioprospecting refers to the search of biological products with characteristics

that are of interests for humankind. Broadly defined, it includes downstream testing and

development of biological materials, protecting and commercializing intellectual property

and manufacturing and marketing a useful substance. In the past, bioprospecting has

focused on the quest for new chemical compounds with medicinal or anti-microbial

properties. Now, any examination of biological resources (for example, plants, animals or

micro-organisms) for features that may be of value for commercial development is being

traded as bioprospecting. It is the exploration of wild plants and animals for commercially

valuable genetic and biochemical resources and denotes scientific researches aimed at

finding a useful and profitable application for a process or product in nature.

Bioprospecting focuses on the discovery and commercialization of valuable biological

features. .It is different from genetic modification although this is one of many possible

research and development techniques that could be applied to a bioprospecting discovery.

Bioprospecting has been going on for decades and it has yielded significant commercial

returns for a vast array of foreign individuals, companies and countries.

the patent was reinstated, as it was not covered by the new rules in the United States on inter parties re-examination, which was introduced in 1999 and was not the part of patent law in 1986 on the date of the filing of the patent.

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3. 2. 1. Bioprospecting vis-a vis Indigenous Peoples’ Right

Bioprospecting involves accessing the aboriginal land and obtaining samples of

biological material143 and as such it affects the rights of indigenous people in many ways.

The native, tribal, indigenous people live in or near tropical forests possess information on

the use of plants for medicinal purposes. Therapeutic plants are free commodity for these

local communities which meet their medicinal requirements. Generally, researchers obtain

free information from the shaman about the medicinal use of these plants. This kind of drug

discovery researches and the subsequent bioprospecting are treated as a form of piracy.

Because bioprospecting leads to loss of power of indigenous people over their own

resources, which is particularly threatening to their lifestyle since most of these people

heavily depend on the local biodiversity for their survival.

Companies support bioprospecting expeditions in pharmaceutical and food

industries with a hope to find information from the biological resources which will lead to

new products and novel drugs.144 They consider bioprospecting as a necessary component

of innovation since in their justification it allows search for organisms with commercially

desirable traits in order to bring human health benefits to all and not just those fortunate

enough to benefit from the traditional knowledge because they live in a particular

geographic or cultural zone.

The researchers acquire useful and crucial information about such resources from

local people and native healers which in turn would help them in identifying and isolating

143 In 1958, for example, a research group was able to isolate two new therapeutic agents from a Madagascar

plant called the rosy periwinkle. 144 The drug Jeevani – a tonic to strengthen the immune system and provide energy - developed by TBGRI

from Trichopus zeylanicus (arogyapacha) using the TK and bio resources provided by Kani tribe of Kerala provides the classic example for the bioprospecting for new drugs.

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the highly useful plants. It is estimated that a hit-rate of 80 percent or more can be achieved

in developing medical drugs where the screening of plants is limited to species used by

indigenous communities.145 Studies reveal that using TK has increased the efficiency of

screening plants for medical properties by more than 40 percent.146 TK also plays an

important role in identifying genetic material with beneficial characteristics that can be

isolated and extracted from the original organisms and used in the development of novel

products such as nutraceuticals or pharmaceuticals.

When the researchers involved in bioprospecting use traditional knowledge about

indigenous plants to invent and patent new substances, with no benefit to the indigenous

population, it would result in blatant bio piracy and misappropriation of traditional

knowledge. Though bioprospecting has the potential to uncover highly valuable

commercial discoveries, it poses a serious question as to how are the countries or the

indigenous communities that traditionally preserve and use the beneficial natural resource

going to be acknowledged or rewarded for their contribution? The bioprospectors often fail

to compensate adequately the countries and communities that provide access to their

resources and associated TK. The patents on products developed as a result of

bioprospecting based on TK are, in fact, a form of intellectual piracy. Biodiversity

prospecting and ethnobotanical researches based on the medicinal knowledge of traditional

societies are to be converted as mechanisms of drug discovery with the potential to reward

the conservers of biological resources.147

145 See, J. W. Sheldon, M.J. Balick and S.A. Laird, “Medicinal Plants: Can Utilization and Conservation Co-

exist?” Advances in Economic Botany, Vol. 12, 1997, pp. 1-10. 146 Vandana Shiva, Patents: Myths & Reality, Penguin Books, New Delhi, 2001, p. 52. 147 Roger Alex Clapp, “Drowning in the Magic Well: Shaman Pharmaceuticals and the Elusive Value of

Traditional Knowledge,” The Journal of Environment & Development, Vol. 11, No. 1, 2002, pp. 79-102.

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Though some critics argue that bioprospecting plays a wider role in encouraging the

conservation of biodiversity, for developing countries, preserving biodiversity is a luxury

something which they cannot afford, especially when these natural resources can provide a

quick profit.