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Paper 03 Biodiversity and Conservation

Biopiracy

Paper No: 03 Biodiversity and Conservation

Module: 37 Biopiracy

Development Team

Principal Investigator

&

Co- Principal Investigator

Prof. R.K. Kohli

Prof. V.K. Garg & Prof. Ashok Dhawan

Central University of Punjab, Bathinda

Paper Coordinator

Dr. Sunil Mittal


Content Writer

Dr. Felix Bast


Content Reviewer Dr. Sunil Mittal


Anchor Institute

Central University of Punjab

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Biopiracy

Description of Module

Subject Name Environmental Sciences

Paper Name Biodiversity and Conservation

Module

Name/Title Biopiracy

Module Id EVS/BC-III/37

Pre-requisites

Objectives

1. To differentiate between bioprospecting and biopiracy

2. To analyse case studies of famous biopiracy cases across the world,

including Maya-ICGB, Basmati Rice, Darjeeling tea, Quassia, neem,

Turmeric, Tamarind, Okra, Jar Amla, Brazzein Berries, Captopril, Enola

Bean, Quinoa, Rosy Periwinkle, bt-Brinjal, Artemisinin and Hoodia

3. To learn about current slowdown in bioprospecting

Keywords

Bioprospecting, Biopiracy, Patent, Ethics, Colonialization, Traditional

Medicine, Combinatorial Chemistry

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Module XX: Bioprospecting

1. Learning outcomes

1.1 To differentiate between bioprospecting and biopiracy

1.2 To analyse case studies of famous biopiracy cases across the world, including Maya-

ICGB, Basmati Rice, Darjeeling tea, Quassia, neem, Turmeric, Tamarind, Okra, Jar

Amla, Brazzein Berries, Captopril, Enola Bean, Quinoa, Rosy Periwinkle, bt-Brinjal,

Artemisinin and Hoodia

1.3 To learn about current slowdown in bioprospecting

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2. Concept Map

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3. Description

3.1 Introduction

The term biopiracy is oftentimes used as a synonym for bioprospecting,

however, there are subtle differences. The differences are indeed a question of politics

and ethics. While bioprospecting implies that the samples are acquired through proper

legal and ethical frameworks (including equitable benefit sharing and Prior Informed

Consents, PICs), the term biopiracy is used when an indigenous knowledge is patented

for lucrative purposes with neither the knowledge of indigenous community, nor their

consent. However, the difference is so subtle that it is oftentimes an ethical and political

question. Political philosophies that are against globalization (for example, socialist and

left-wing ideologies) oppose any form of bioprospecting and blame it as biopiracy. For

example, Biopiracy is oftentimes defined as “a practice commercially exploiting

naturally occurring genetic material or biochemical”. Even though a consent is obtained

from the chieftain of an indigenous tribe to obtain the sample, how ethical it is to take

the ownership and patent it? However, there is a consensus that biopiracy is exploitation

of marginalized or tribal or indigenous communities. Bioprospecting might or might

not involve such communities; for example as discussed in bioprospecting module,

when a Swiss scientist developed a blockbuster drug from microbes isolated from soil

samples that he collected from Norway on a family holiday, the case had nothing to do

with indigenous community and is not regarded as a case of biopiracy. Biopiracy is

generally regarded as unethical, in contrast with bioprospecting, which is an ethical

practice.

At the heart of this issue lies the concept of ownership. Can a firm or community

or a nation claim ownership for a particular species of organism? Similar situation can

also be found in the discipline of taxonomy; a number of plants extensively used in

indigenous medicine, for instance Tulsi (Ocimum tenuiflorum), had been formally

described by Swedish taxonomist Carl Linnaeus, and he is the taxonomic authority of

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these plants. It is not the case that these plants have had no names in Sanskrit (Tulsi is

the Sanskrit word for this plant; yet the credit for naming this plant had been taken by

the Swedish scientist). Patenting rules differ from country to country. In India, patenting

a plant species (or any living organism) is not allowed; while the US patent office grants

such patents. As India do not come under the purview of US patent office, on first

glance this issue seems irrelevant. However, often times these plants could be

developed into transgenic varieties and become a commodity of multinational

monopolies (three most prominent firms being Monsanto, DuPont and Syngenta).

Oftentimes, the firms make these transgenic plants deliberately infertile such that the

farmers need to purchase the plants again and again from the companies.

The reason why bioprospecting firms often target indigenous knowledge is

obvious; this traditional knowledge with their trial and error approach, albeit the

approach itself is unethical and cumbersome, might offer better prospects for successful

lead discovery rather than random screening of natural products. Random screening is

especially cumbersome; it is estimated that to develop one successful drug candidate,

the company need to screen a very large number of samples, approximately 250000 of

it, and is therefore extremely slow (takes decades to develop a drug) and is very

expensive. Oftentimes, even after screening, the firm would come out with a drug for

which better and cheaper substitutes are already available in the market, rendering the

lead development effectively useless.

As the bioprospectors largely hail from rich countries of temperate regions and

they access samples from poorer countries of tropics, the question on how sample was

accessed oftentimes becomes a political question. Analogy is how ethical the British

government possessing Kohinoor Diamond that they ‘accessed’ during the colonial

times, or numerous such cases, accessing Ancient Egyptian Mummy specimen for

instance. One such a case is discussed later on that involves sample acquisition by a

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French firm from a former French colony in Africa. Biopiracy is, therefore, oftentimes

linked with colonialism.

Apart from acquisition of plant or organic materials (such as snake venom, as

discussed later), biopiracy also covers genetic resources. Genes of wild races are

involved with various desirable attributes, such as disease resistance, draught

resistance, tolerance to heat and salt stresses, high yield and so on. These genes obtained

from the nature can be cloned and developed into transgenic organisms possessing such

desirable qualities. Genes coding for desirable proteins can be cloned and expressed in

bacteria for the direct production of such substances in bioreactors (for example,

production of insulin and Taq Polymerase). Therefore, if such genes are obtained from

sample materials that are used as part of indigenous medicinal systems without proper

ethical and legal frameworks, that would construe as a case of biopiracy as well.

3.2 Famous case-studies of biopiracy

Maya-ICGB

This controversy happened in 1999-2000 when two scientists from University

of Georgia, USA established International Corporative Biodiversity Group (ICGB) to

document the biodiversity of Chiapas region of Mexico and ethnomedicinal features of

indigenous Maya people. ICBG established an NGO PROMAYA in Mexico as a

mediator. The controversy was that PROMAYA was wholly under the control of two

US researchers and benefit sharing and PIC merely remained in the paper; a clear case

of unethical exploitation of indigenous knowledge, or a case of biopiracy. The project

was terminated in 2001 without any bioprospecting success; however, this case was the

first to highlight the perils of biopiracy.

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Basmati Rice

Basmati Rice, an indigenous long-grain rice native to India, is one of the major

exporting commodity of India to US, Middle East and EU markets. Rice-Tech an

American firm filed for a patent for certain hybrid of Basmati Rice that they claimed

developed by the firm in 2000, and filed for the exclusive use of their trademark

Basmati in US markets. After the intervention from Indian government, several claims

of the patent were invalidated. As basmati rice is a registered geographical indication,

patenting on this or its hybrids is being protected by the European Commission.

Darjeeling tea

Darjeeling tea is a tea variety cultivated at Darjeeling, West Bengal for the last

two centuries, and is generally regarded as a unique commodity produced by India. Of

course, India is the world’s largest producer of tea, with a global share of about 35%

and Darjeeling tea exports generate a substantial revenue for the tea farmers and

industries in India. However in a number of developed countries (especially Japan and

France), the word “Darjeeling” is awarded a trademark to their own private firms,

although the product itself might not be from the Darjeeling region of India. This

situation is in stark contrast with other GI produces like Champagne (France) Tequila

(Mexico) Shiitake mushroom (Japan) and so on.

Quassia

Quassia amara is an indigenous plant that grows in French Guiana, the former

French colony in Africa. A French institute successfully developed an antimalarial

compound from this plant and received an EU patent in 2015. However, extracts of this

plant was in use for many centuries as part of the indigenous medicinal systems of

French Guiana. The French patent applicants claimed that their extract is alcohol-based,

while that of the traditional medicine was water-based. Indeed this is a valid point for

uniqueness and novelty, two criterions that the patent office check before granting the

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patent. Alcohol based extracts usually isolate different set of compounds from that

obtained from water-based extracts. However, no prior informed consent was obtained

by the French institute before obtaining the plant sample. The case is still subjudice as

of this writing.

Neem

WR Grace, an American firm along with US Department of Agriculture

obtained an EU patent in 1994 for antifungal chemicals that they have extracted from

Neem trees (Azadirachta indica). However, neem is being used for centuries in Indian

traditional system of Ayurveda. Prominent environmentalist groups from around the

world (including Vandana Siva from India) opposed this patent in 2000. Finally, the

EU patent office revoked the patent in 2005.

Turmeric

At least four US patents were granted on the medicinal uses of Indian plant

turmeric, the famous among them is the patent filed by two Indian expatriate scientists

from University of Mississippi Medical Centre, US for the use of turmeric powder in

wound healing. India’s CSIR filed an application with the US patent office to revoke

the patent as the turmeric had been in use in Ayurveda for ‘thousands of years”. The

CSIR even produced ancient Sanskrit texts and previous papers on the medicinal uses

of turmeric powder. In response, the US patent office revoked not only this particular

patent, but also all the rest 3 patents for the uses of turmeric.

Tamarind

World’s largest producer of tamarind is India; with annual production more than

half of the world’s total. Tamarind pulp had been part of the traditional Indian

Ayurvedic medicine for last many centuries as a component of various herbal

formulations for treating various diseases. From 1978 until 1997, there were about 30

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US and Japanese patents each granted for the tamarind-based pharmaceutical

formulations. At the same time, Indian organizations like ICAR and CSIR owns merely

8 patents in India for the applications of tamarind paste. Having granted more than 60

patents worldwide on tamarind paste which Indians consider their traditional

intellectual rights, this case have received lot of media attention in India to such an

extent to call all those international patents as a case of biopiracy.

Okra

In 1999, US firm Cromak Research Inc. Obtained a US patent for an herbal

mixture that contained extracts of Okra (Karela/Bitter guard). However, okra juice had

long been used in indigenous medicinal system of Ayurveda for treatment against

diabetes. This patent received lot of media fury in India and was termed yet another

case of biopiracy.

Jar Amla

Fox Chase Cancer Centre in Philadelphia, USA was successfully awarded an

EU patent for the extracts from Jar Amla plant (Phyllanthus niruri) for treatment against

Hepatitis B. However, this plant had been used for centuries in Indian traditional

medical systems including Ayurveda, Siddha and Yunani for treating Jaundice.

Brazzein Berries

In University of Wisconsin at Madison, US obtained three patents for the

Brazzein berries (Pentadiplandra brazzein), including one for a low calorie artificial

sweetener obtained from this plant which is 2000 times more sweet than the ordinary

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cane sugar. The plant is indigenous to West African country of Gabon and its qualities

were known for the West Africans for centuries. It was said that the researcher noticed

the Gabon people eat the berries and thought that there might be something special

about the berries, to investigate its potentials. The UW-Madison team isolated the gene

from the plant coding for the protein, and they cloned it in the suitable vector to

commercially harvest the sweetener at large quantities without having to go to Africa

to collect the plant or to grow it there, and received yet another patent for this. The turn

over of US artificial sweetener market is estimated to be around 100 billion USD, yet

the UW-Madison shared none of the generated benefits with Africans.

Captopril

The drug Captopril belongs to a family of drugs called Angiotensin Converting

Enzyme (ACE) Inhibitor used to treat hypertension and Congestive Heart Failure.

Captopril was developed from the venom of lance head viper snakes Bothrops jararaca

that are native to Amazonian rainforest. However before the development of this drug,

venom of this snake had been used by the indigenous Brazilian tribes to coat it on the

arrowheads used in hunting and inter-tribal warfare. The drug was developed by the

American firm Bristol-Myers Squibb and patented in 1977; however no profit sharing

was made by them to the Brazilian tribes.

Enola bean

The Mexican yellow bean is an edible bean cultivated throughout Mexico. In

1999 a patent for this bean was granted by the US Patent Office. The bean was named

Enola in the patent application after the name of the wife of the patent applicant, Enola.

The patent holder sued a large number of Mexican exporters who exported these beans

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to the US citing the patent law infringement. The impacts were truly tremendous; over

90% of sales dropped negatively affecting more than 20000 farmers. Mexican farmers

filed an application with the US patent office to revoke the patent. In 2008, the US

patent office ruled in favour of Mexican farmers and revoked the patent.

Quinoa

In 1994, University of Colorado, US obtained a broad-spectrum patent for the

plant Quinoa (Chenopodium quinoa), which is a staple food for many tribal populations

living in Andes ranges, South America. Quinoa is the principal food source for Quechua

tribes of Peru, Chile and Bolivia and they pressurized the University to abandon the

patent in their interest. As the Bolivia exports Quinoa to the tune of USD 1 million per

year, the patent would affect the whole export, and finally to the farmers largely.

Finally, the University of Colorado abandoned this patent.

Rosy Periwinkle

Rosy periwinkle (Catharanthus roseus) is a native poisonous plant from

Madagascar; however, during the days of colonialization, this plant was introduced at

many different countries throughout the world. Its traditional African use was against

diabetes. Various tropical countries where this plant was introduced claimed that the

plant had been part of their indigenous system for the treatment of numerous diseases,

including sore throat, pleurisy, dysentery and so on. At least two potent and

commercially successful chemotherapeutics against cancer were developed from this

plant, viz. Vinblastine and Vincristine, although no benefits were shared by the

American drug firm Eli Lilly either with Madagascar or with other tropical countries

where this plant is used as part of their traditional medicine.

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Bt-Brinjal

US agricultural firm Monsanto, through its Indian subsidiary May Co, obtained

the seeds of Indian varieties of vegetable brinjal (aubergine/eggplant) without Prior

Informed Consent from National Biodiversity Authority (NBA) of India. The firm

developed insect resistant transgenic varieties of brinjal by cloning CRY protein genes

from Bacillus thuringiensis that express a potent toxin (delta enterotoxin) specifically

targeted to the insects while harmless to humans. The firms, in collaboration with local

agricultural universities, undertook large-scale field trials in Tamil Nadu and Karnataka

in 2005-06. However, there was no permission obtained from NBA before conducting

field trials as well, an obvious case of biopiracy. Subsequently, NBA initiated judicial

trials against Monsanto. However, it turned out that the firm had already obtained

permission from India’s Department of Biotechnology in 2005. This case reveals

administrative inadequacy and lack of effective inter-departmental communication.

Artemisinin

Extracts of the wormwood plant Artemisia annua had been part of the traditional

Chinese medicine for more than two millennia for treating malaria. In 1979, Chinese

researcher Tu Youyou isolated the compound artemisinin from the plant extracts and

immediately published the findings in Chinese Medical Journal (instead of patenting

it). Since then, the artemisinin and its other synthetic derivatives have become a

standard drug for the treatment against malaria, and saved millions of life worldwide.

As the drug was not patented, no drug firm held monopoly and generic medicines were

readily and immediately available worldwide, albeit patenting could have earned China

billions of dollars in revenue. This case illustrates a recurring ethical theme involved

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with life-saving drugs; is patenting ethical? However, most of the drug screening and

bioactivity investigations for the drug development are being undertaken by private

R&D firms, and for their sustenance, profit generation via patenting is required. Tu

Youyou won Nobel prize in 2015 for this discovery.

Hoodia

Hoodia (Hoodia gordonii) is a leafless succulent plant native to Kalahari Desert

in South Africa, and grows abundantly in Botswana, Namibia and South Africa.

Indigenous tribes (San people) used extracts of this plant as a panacea (magical

medicine against various ailments) and as an appetite suppressor. Samples of this plant

were acquired by American multinational firm Unilever and they signed MoU with

South African Council for Scientific and Industrial Research to develop a dietary

supplement. While San people were not part of this deal, later on they were invited and

made part of the benefit share. After a decade of research and spending nearly 20

million USD, Unilever finally abandoned the programme because of the toxicity of the

plant and negative results. This example illustrates problems with bioprospecting in

general; success rate is extremely low indeed.

3.3 Current slowdown

The case of Hoodia just discussed highlight a major issue with bioprospecting;

it is immensely a slow process, there is a large scope for potential controversies,

extremely expensive and chances of success very low. Post implementation of CBD

and Nagoya protocols, sample acquisition from third-world tropical countries have

become a major bureaucratic huddle for bioprospecting firms from rich temperate

countries. In the last two decades or so, a far better and straightforward approach of

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combinatorial chemistry have started emerging. Combinatorial chemistry aims at

synthesizing key ligands that specifically targets certain molecules of a disease

pathway. Instead of screening a large number of natural products, this approach first

look inward, the disease itself. Structures of key molecules involved in disease

progression are generated, and ligands that best bind with those molecules are

chemically synthesized. This approach is far more specific and directional, unlike trial

and error approaches used in screening of natural compounds. Yet another approach is

instead of screening the natural products, a number of pure compounds are isolated

from each extract, these pure compounds subjected to structure elucidation, and the

resulting structures housed in a public database. Researchers would now be able to dock

structures of potential target molecules of disease pathways with that from the database,

an in-silico approach known as molecular docking.

4. Summary

4.1 Bioprospecting firms often aim to develop high-value natural products such as

pharmaceuticals in their screening programmes. As the success rate is very low for

random screening of natural compounds, they often make use of indigenous

knowledge, especially folk medicine.

4.2 The term Biopiracy is used when an indigenous knowledge is patented for lucrative

purposes with neither the knowledge of indigenous community, nor their consent.

4.3 Legal frameworks of CBD and Nagoya protocols were enforced to minimize

incidences of biopiracy. However, there are a number of examples of biopiracy

worldwide.

4.4 A central redundant theme with cases of biopiracy is the issue of ownership of natural

resources and ethics of patenting life-saving drugs. While biopiracy of traditional

Ayurvedic ingredients is a much-discussed issue in India, the blockbuster antimalarial

drug Artemisinin was developed from traditional Chinese medicine. Instead of

patenting this life-saving drug and monopolise the profits, the discoverer Nobel

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laureate Tu Youyou chose to immediately publish the findings saving millions of lives

worldwide.

4.5 Political ideologies that are against globalization oppose any effort of bioprospecting

as biopiracy.

4.6 At present, there is a great slowdown in bioprospecting, in part contributed by

bureaucratic hurdles in sample acquisition post CBD and Nagoya protocol.

Remarkable progresses in the field of combinatorial chemistry made it the preferred

choice for all the major pharmaceutical companies worldwide.

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