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TRADITIONAL KNOWLEDGE IN THE MANACLES OF INTELLECTUAL
PROPERTY PROTECTION
A Study of Indian Indigenous Communities Rights and Claims
By
Nidhi Kaushal
A thesis submitted in conformity with the requirements for the degree of LL.M
Graduate Department of the Faculty of Law
University of Toronto
Copyright by Nidhi Kaushal (2012)
II
TRADITIONAL KNOWLEDGE IN THE MANACLES OF INTELLECTUAL
PROPERTY PROTECTION
A Study of Indian Indigenous Communities Rights and Claims
Nidhi Kaushal
LL.M
Faculty of Law
University of Toronto (2012)
ABSTRACT
The present thesis focuses on Indian experience in the traditional knowledge sector. It argues
that strong patent protection has not been conducive to the indigenous people and their
traditional medicinal knowledge. Moreover, this protection has supported the pharmaceutical
sector by entitling it with the patents, sourced from traditional herbal medicinal knowledge on
the ground of novelty and usefulness.
The thesis also investigates the scenarios, where time and again it has been proved that the
current patent tool does not provide free hand to indigenous people. It advocates that the
production and dissemination of legal clauses promoted by the Indian patent system is not an
adequate legal tool for the protection of traditional medicinal knowledge. Finally the thesis
explores India’s obligation to protect and preserve traditional medicinal knowledge and proposes
model guidelines for the pharmaceutical sector in order to exploit herbal medicinal knowledge.
III
ACKNOWLEDGMENT
I wish to thank many people for their support and involvement through the process of writing
my Master’s thesis. Firstly, I am thankful to the almighty god, without whom I would not be
able to complete this research.
I would like to express deepest sense of gratitude to a dream team of scholars, i.e. to my thesis
supervisors: Douglas Sanderson and Abraham Drassinower, who guided my research and
writing process from the very beginning. Their painstaking attention to details is highly
appreciated. They have always been there with me when I needed them. Their constructive
comments, friendly banter, endless support in more ways than I can count is commendable. I
Thank my professors, for their patience, time and showing trust in me.
I am also grateful to Megha Jandhyala, my thesis advisor for her efforts well beyond the call of
duty. I am indebted for all insightful discussions, enormous thoughts, directions and guidance
and making my journey possible. Without your support, determination, supervision and splendid
revisions, I would never have been able to complete my dissertation.
Last, but certainly not the least, I sincerely thank several faculty members of the law school. I
could not embark on this project without your help, support, assistance and encouragement.
IV
TABLE OF CONTENTS
Thesis Introduction…………………………………………………………………………. 1
Thesis Structure…………………………………………………………………………….. 5
Methodology………………………………………………………………………………... 9
Selection of Case: Why India……………………………………………………….……… 12
CHAPTER ONE………………………………………………………..…………………. 14
A Walk Through Indian Intellectual Property Regime And Their Footprints on Traditional
Knowledge Sector…………………………………………………………………………...
14
1.1 Introduction…………………………………………………………………………….. 14
1.2 Traditional Medicine…………………………………………………………………… 15
1.3 Indian IPR System……………………………………………………………………… 16
a) Patent Protection……………………………………………………………………… 17
b) Trade Secret Protection………………………………………………………………. 20
c) Indian Biodiversity Act, 2002………………………………………………………... 21
d) Geographical Indications………………………………………..…............................. 22
e) TK Digital Library (TKDL)………………………………………………………..… 23
1.4 Concluding Remarks…………………………………………………………..……….. 24
CHAPTER TWO…………………………………………………………………….......... 26
Extending Concerns for Traditional Knowledge Protection to International Platform:
Journey from National to International Framework; How Far Helpful and Correct?............
26
2.1 Introduction…………………………………………………………………………….. 26
2.2 Role Played By CBD and TRIPS………………………………………………………. 27
a) CBD…………………………………………………………………………………... 27
b) WTO agreement on TRIPS…………………………………………………………… 28
2.3 Relationship between TRIPS and CBD………………………………………………… 30
2.3.1 No Conflict between TRIPS and CBD……………………………………………….. 30
2.3.2 Conflict between TRIPS and CBD…………………………………………………… 31
a) Conflicting objectives and difference in the overall framework………………............ 32
b) Conflicting Provisions relating to foreigners…………………………………………. 33
c) Conflicting rights of IPR and TK holders…………………………………………...... 34
V
d) Modern Technology versus TMK…………………………………………………….. 35
e) Benefit sharing arrangements…………………………………………………...…….. 36
f) Prior informed consent..…………………………...………………………………….. 36
2.3 Harmonization between the two agreements………………………………………….. 37
2.5 Concluding Remarks………………..………………………………………………… 38
CHAPTER THREE…………………………………………………..................................
40
Lifting the Veil from the Reasons behind Imperfect Role of Indian Intellectual Property
System in Protecting the Traditional Medicinal Knowledge of Indian Ingenious
Community……………………...…………………………………………………………..
40
3.1 Introduction…………………………………………………..………………………… 40
3.1.1 Who owns TMK……………………………………………………............................ 40
3.1.2 Need for the protection of TMK……………………………………………………… 42
3.2 Inadequacy of Legal Systems that addresses TMK…………………………………….. 45
3.2.1 Analysis of Indian Patent system……………………………………………………... 45
3.2.2 Analysis of Indian TKDL…………………………………………………………….. 47
3.3 Instances of Exploitation and Misappropriation of Indian TMK………………………. 49
3.3.1. Case studies from India……………………………………………………………… 50
3.4 Concluding Remarks…………………………………………………………..……….. 63
CHAPTER FOUR………………………………………………………..………………..
67
New Wave For A New Century: Concluding Remarks With Proposed Model Guidelines
For The Protection Of Traditional Medicinal Knowledge In India…………………………
67
4.1. Introduction……………………………………………………………………………. 67
4.2 Sui Generis System…………………………………………………………………....... 69
4.3 Bill/Guidelines…………………………………………………..……………………… 72
Bibliography………………………………………………………………………………... 96
1
THESIS INTRODUCTION
Traditional knowledge (TK) is essentially culturally oriented and it is integral to the cultural
identity of the social group in which it is operated and preserved.1 TK has been used for
centuries by indigenous and local communities under the local laws, customs and traditions. It
has been transmitted and evolved from generation to generation. TK plays a vital role in making
a nation more progressive and transforming its society. It provides an open gate for tradition
based literary, artistic or scientific works, performances, inventions, scientific discoveries,
designs, marks, names and symbols, undisclosed information, and all other traditional based
innovations and creations resulting from intellectual activity.
The term TK2 refers to knowledge, “possessed by indigenous people, in one or more societies
and in one or more forms, including, but not limited to art, dance and music, medicines and folk
remedies3, folk culture, biodiversity, knowledge and protection of plant varieties, handicrafts,
designs, literature.”4 There is no fixed definition of ‘indigenous people’ but they are people to
the extent who “comprise with distinct communities, tribes or nations of their ancestral past.
Furthermore, they are essentially referred to the group existing under relatively disadvantageous
conditions”.5 For indigenous people the major concern is the protection of their traditional
1 See, Dr. Elizabeth Varkey, “TK – The Changing Scenario in India” Law.ed.ac (University of Edingburg) at 4.
Online < http://www.law.ed.ac.uk/ahrc/files/67_varkeytraditionalknowledgeinindia03.pdf> 2 Article 8 (j) of the Convention of Biological Diversity defines this term as “Knowledge innovation and practices
of indigenous and local communities embodying traditional lifestyles relevant for the conservation and sustainable
use of biological diversity”. However this article encompasses a wider ambit of traditional knowledge.
Online: <http://www.cbd.int/traditional/> 3 “Medicines and folk remedies have a direct bearing on the product patent regime that TRIPS stand for. Most
countries are not able to afford the high prices for the drugs due to medicines being subject to patent regime.
Where the folk medicines or knowledge about these plants are taken to be used in pharmaceuticals research, it is
argued that the people who first possessed this knowledge should benefit in some way.”
Online <http://papers.ssrn.com/sol3/papers.cfm?abstract_id=310680> 4 See Srividhya Ragavan, supra note 1.
Online: <http://papers.ssrn.com/sol3/papers.cfm?abstract_id=310680>
5 See S. James Anaya, “Indigenous People in International Law” (1996), Oxford University Press, at 3. Online:
2
knowledge which focuses on fundamental justice and the aptitude to preserve and safeguard
their heritage. One such concern is about the protection of traditional medicinal knowledge
(TMK).
TMK has “gained special importance in the past few decades which have seen an explosion in
the demand for herbal medicines in the globalised world.”6 Traditional system of medicine and
its use is an important part of human health care. The studies of such herbal plants, have given a
wide scope of development, to many pharmaceutical industries. With the remarkable growth, in
the use of medicinal knowledge worldwide, the value for ‘herbal plants’ and ‘Intellectual
Property Rights’ has been recognised and debated so far.
INDIA AT A GLANCE7
INDICATOR
DESCRIPTION
YEAR
SOURCE
Political System Democracy
States 28 states and 7 union
territories.
Languages 14 official languages Central Intelligence
Agency8
Population 1,205,073,612 July 2012 estimate. Central Intelligence
Agency
Income Level Lower Middle Income World Bank9
GDP (Current Prices) 1.704 trillion 2010 World Bank
GDP Growth
(Constant Prices,
10.365% 2010 International Monetary
Fund (IMF)
<http://books.google.ca/books?id=WFf6qX8zlFYC&printsec=frontcover&source=gbs_ge_summary_r&cad=0#v=
onepage&q&f=false> 6 See Alimpan Chatterjee, “Traditional Knowledge Herbal Medicine and Intellectual Property: A Debate Over
Rights”, at Pg 1
Online: < http://www.smpborissa.org.in/KIIT%20Papers_PDF/Alimpan%20Chatterjee.pdf> 7 See Central Intelligence Agency for brief overview and some interesting facts about India.
Online: <https://www.cia.gov/library/publications/the-world-factbook/geos/in.html> 8 See Central Intelligence Agency.
Online: < https://www.cia.gov/library/publications/the-world-factbook/geos/in.html> 9 See World Bank.
Online: < http://devdata.worldbank.org/AAG/ind_aag.pdf>
3
National Currency)
GDP Per Capita
(Current Prices, US$)
1475 2010 World Bank10
Unemployment Rate 9.8% 2011 Central Intelligence
Agency11
Government Expenditure
on Heath (% of GDP)
4.2 2009 World Bank12
Health Expenditure Per
Capita(US$)
45 2009 World Bank13
Out of Pocket Health
Expenditure (% of Private
expenditure on Health)
74.4 2009 World Bank14
World Population of
Aboriginal People
300 million World Bank15
Population of Aboriginal
People in India
461 Ethnic Groups.16
International Work
Group for Indigenous
Affairs (IWGIA)17
In this thesis, my central focus is on unlocking the Indian experience on protection of TMK. I
argue that the implementation and enforcement of current Intellectual Property system,
specifically, the Indian Patent system, has not proved conducive for the protection of TMK in
10
See World Bank.
Online:
<http://data.worldbank.org/indicator/NY.GDP.PCAP.CD?order=wbapi_data_value_2010+wbapi_data_value+wba
pi_data_value-last&sort=asc > 11
See Central Intelligence Agency:
Online:<https://www.cia.gov/library/publications/the-world-factbook/fields/2129.html> 12
See World Bank. Online:< http://data.worldbank.org/indicator/SH.XPD.TOTL.ZS> 13
See World Bank. Online: < http://data.worldbank.org/indicator/SH.XPD.PCAP/countries> 14
See World Bank. Online:< http://data.worldbank.org/indicator/SH.XPD.OOPC.ZS> 15
See World Bank.
Online:<
http://web.worldbank.org/WBSITE/EXTERNAL/TOPICS/EXTSOCIALDEVELOPMENT/EXTINDPEOPLE/0,,
menuPK:407808~pagePK:149018~piPK:149093~theSitePK:407802,00.html> 16
In India 461Ethinic Groups are recognised as Scheduled Tribes. These are considered to be India’s indigenous
People. In mainland India Scheduled Tribes are usually referred to as Adivasis or Tribal People. With an estimated
population of 84.3 million, they comprise 8.2% of the total population. There are more ethnic group that would
qualify for Scheduled tribes status but which are not officially recognised. Estimate of total number of tribal groups
are as high as 635. The largest concentrations of indigenous peoples are found in the seven states of north-east
India, and the so-called “central tribal belt” stretching from Rajasthan to West Bengal. India has a long history of
indigenous peoples’ movements aimed at asserting their rights. For list of Scheduled Tribes in India visit,
http://en.wikipedia.org/wiki/List_of_Scheduled_Tribes_in_India 17
IWGIA. Online:< http://www.iwgia.org/regions/asia/india>
4
herbal plants. Moreover this protection has always supported pharmaceutical sector including
massive multinationals by entitling them with the patents, sourced from traditional herbal
medicinal knowledge on the ground of novelty and usefulness. TMK has been exploited
without any benefit or compensation to the custodians of this knowledge. Therefore the need is
felt for establishing a strong and firm guidelines specifically dealing with TMK, which would
help research and development in India and other countries before conducting any research and
patenting TMK in India.
This thesis should not be read as an indictment to the current patent system because the aim is
not to revoke or criticize the Indian patent system but only to address this in the field of TMK,
because the current patent system does not provide the protection clauses for TMK. The
skirmish of the situation is that TMK lies in public domain and Intellectual Property system
does not stop accessing the public domain knowledge and information. Hence, TMK is being
misappropriated by various multinationals by taking advantage of the fact that TMK is in public
domain.
It should be observed that, despite of an intensive Intellectual property regime, it has done
nothing about indigenous community to protect and preserve their valuable knowledge. The
protection system should be such, which could mitigate the misappropriation and exploitation
factors from the traditional medicinal knowledge. Moreover, I am willing to show or present a
set of model guidelines which could work on this track.
5
THESIS STRUCTURE
In order to develop the argument advanced by this thesis, I proceed in four chapters with the
following common theme running throughout: obligation upon India to take firm actions and
steps for traditional knowledge holders, to preserve and protect their TMK, and to workout with
some stringent guidelines on the footsteps of current patent system but unlike the patent system.
The thesis opens with Chapter One, “A Walk through Indian Intellectual Property Regime and
their Footprints on Traditional knowledge Sector.” This chapter will provide an overview of the
existing Indian Intellectual Property law and how does it work or what steps it has taken in the
favour of traditional knowledge including TMK. This chapter emphasizes on the role of Indian
Intellectual Property regime in the protection of traditional knowledge. This chapter identifies
different Indian statues which work for preservation and conservation for traditional
knowledge. The aim of unpinning these statues is to build upon the arguments regarding the
need for a stringent framework for the protection of traditional medicinal knowledge which will
be discussed in upcoming chapters.
Chapter Two, “Extending Concerns for Traditional Knowledge Protection to International
Platform: Journey from National to International framework; how far helpful and correct?” This
chapter will picture out the journey of India, revealing the establishment of IPR and then
signing different international conventions in order to protect TMK. The object behind this
chapter is to give an overview of the international conventions signed by India, mainly
Convention on Biological Diversity (CBD) and Trade Related Aspects on Intellectual Property
Rights (TRIPS) with one aim i.e. to protect, preserve and conserve its traditional knowledge. I
argue in this chapter that in spite of such incredible legal clauses treaties, it is not difficult to
believe that still TMK needs protection from outside exposure as well. I further argue that some
of the international treaties do share some skirmish clauses with respect to protection of
6
“biodiversity” which includes the concern for the protection of TMK. For instance, conflict
between TRIPS and CBD18
.
Chapter Three, “Lifting the Veil from the Reasons behind Imperfect Role of Indian
Intellectual Property System in Protecting the Traditional Medicinal Knowledge of Indian
Ingenious Community.” After completing the journey from national to international platform
and observing the flaws in the legal regime for the protection of TMK, chapter three will figure
out the reasons behind the inadequacy of intellectual property system as a legal tool to protect
TMK. I have divided this chapter into two subparts:
Part I, will demonstrate the problem with the protection system and argues following
sub-issues. Firstly who owns this traditional knowledge? Secondly, why it is important
to protect TMK?
Part II, will critically analyse the efforts made and steps taken towards protecting TMK
both on national and international platform. For instance, on national level, Traditional
knowledge Digital Library (TKDL)19
was established to provide information on
traditional knowledge existing in India in languages and format understable by patent
examiners at international Patent Office’s (IPO’s), so as to prevent the grant of wrong
18
Convention on Biological Diversity. It is also informally known as biodiversity convention which is an
international legally binding treaty. The convention recognised for the first time in international law that the
conservation of biological diversity is a common concern for humankind and is an integral part of the development
process. The agreement covers all ecosystems, species and genetic resources.
Online: <http://www.cbd.int/> 19
“TKDL is an Indian digital knowledge repository of the traditional knowledge, especially about medicinal plants
and formulations used in Indian systems of medicine. It was started in 2001, as collaboration between the Council
of Scientific and Industrial Research (CSIR) and Department of Ayurveda, Yoga and Naturopathy, Unani, Siddha
and Homoeopathy (AYUSH), Ministry of Health & Family Welfare, Government of India. The objective of the
library is to protect the ancient and traditional knowledge of the country from exploitation through bio-piracy and
unethical patents, by documenting it electronically and classifying it as per international patent classification
systems.”
Online: <http://papers.ssrn.com/sol3/papers.cfm?abstract_id=1792541>
For further information on TKDL, See Online:
<http://www.tkdl.res.in/tkdl/langdefault/common/Home.asp?GL=Eng>
7
patent. TKDL thus, acts as a bridge between the traditional knowledge information
existing in local languages and the patent examiners at IPO’s. The argument is here is
that in spite of having such a thousand pages detailed document the problem is yet not
resolved. In fact the country has observed so many misappropriation and exploitation
cases of traditional herbal plants knowledge even having such a mammoth document.
This chapter will answer these questions which will help us in understanding the importance
and value of TMK which is related to our biodiversity.
This chapter will also discuss in detail various case laws supporting the argument that TMK is
being exploited and misappropriated over and over again. The patent owners refused to grant
any kind of share in profits to TMK holders. This showcases the weakness of the patent system
in its first place, by granting the patent to the already existing knowledge and secondly not
recognising the rights of knowledge holders. Some of the land mark case studies to be discussed
in this chapter will include, Neem case, Turmeric Case, Basmati Case, Kani Tribe case, etc.
Chapter Four, “New Wave for a New Century: Concluding Remarks with Proposed Model
Guidelines for the Protection of Traditional Medicinal Knowledge in India”. Finally, this
chapter will conclude all of the above arguments. This chapter argues that several proposals
have been made, within and outside the IPRs system, to “protect” TMK. Such proposals often
fail to set out clearly the rationale for its protection. Any system of protection, however, is an
instrument for achieving certain objectives. As TMK is not the issue concern of any one
particular country, but it matters for every country in which such native people and their
communities continue to exist. Therefore countries should have their own system speaking
itself about their dos’ and don’ts in respect of preserving their traditional heritage. Thus, India
should establish a set of guidelines in form of Sui Generis Legislation.
8
This chapter further illustrates some of the model legislations which already exist in some
countries. Indigenous people of those countries are today enjoying the fruits of their labour by
preserving and conserving TMK, and gaining a share in the profits incurred by big
pharmaceutical companies. The whole point behind sharing the profit is to develop the
indigenous society, as they are considered to be disadvantageous in comparison to the other part
of the society. Therefore, share in profits will help in the development of their community by
having more and easy access to education, employment opportunities etc. This part of the
chapter, focuses more on morality and ethical grounds, but it is important to note that this will
not only help those indigenous or aboriginal people to come in upfront but will also help the
development of the nation.
Here are some examples of other countries legislation, which can act as model guidelines in
order to form Indian guidelines for protection of TMK.
1. Brazilian Legislation on Traditional Medicinal Knowledge.20
2. Chinese Legislation on Traditional Chinese Medicines. (2003)21
3. European Union Legislation on Traditional Herbal Medicines. (2004)22
4. Thailand Sui Generis System23
5. Nagoya Protocol on access to genetic resources and the fair and equitable sharing of
benefits.24
6. Philippine Legislation on Traditional and Alternative Heath Care (this act known as
Traditional and Alternative Medicine Act, 1997)25
7. Panama and Peru Legislation on TMK26
20
Online: http://www.wipo.int/wipolex/en/details.jsp?id=5897 21
Online: <http://www.wipo.int/wipolex/en/details.jsp?id=5482> 22
Online:< http://www.wipo.int/wipolex/en/details.jsp?id=5557> 23
Online: <http://www.thailawforum.com/articles/Thai-traditional-medicine-protection-part1-5.html> 24
Online: < http://www.cbd.int/decision/cop/?id=12267> 25
Online: <http://www.lawphil.net/statutes/repacts/ra1997/ra_8423_1997.html>
9
8. Paris Convention of Industrial Property, 1883.27
METHODOLOGY
Intellectual Property Rights (IPR) is seen as one possible means to protect TK. Most countries
use IPR as a legal mechanism to allocate rights over knowledge, which has a significant role in
the relationship between indigenous and local communities, their knowledge, and the other
societies with which they interact. “TMK plays an important role in the provision of health care
in many cases of patenting of developing countries. Their use is also significant in developed
countries, increasing their commercial value. Several high profile cases of patenting traditional
medicines, without consent from or compensation to their holders, have focused attention on
their importance.”28
Such importance has gained attention not only on international platform
but also on national platform, and thereby calling for a legal step that a country should take in
order to initiate for the protection of traditional medicinal knowledge (TMK).
The growth of the herbal medicine sector and the constant demand for new and saleable
traditional medical plant-based products is new in the field of Intellectual Property and
traditional medical knowledge. The debates over protection being offered to traditional systems
of medicine and the botanical medicine industry has taken place against the backdrop of two
international legal frameworks, namely those created by the Convention on Biological Diversity
(CBD), and the Trade-Related Aspects of Intellectual Property Systems (TRIPS) under the
auspices of the World Trade Organisation (WTO) system. The CBD is the major international
convention that assigns ownership of biodiversity to indigenous communities and individuals,
26
See Tatiana Lopez Romero, “Sui Generis System for the Protection of Traditional Knowledge”, International
Law: Revista Colombiana De Derecho International Pontificia Universdad Javeriana (2005).
Online: <http://redalyc.uaemex.mx/pdf/824/82400609.pdf> 27
Online: < http://www.wipo.int/treaties/en/ip/paris/trtdocs_wo020.html> 28
See Karin Timmermans, “Intellectual Property Rights and Traditional Medicine: Policy Dilemmas at the
Interface.”, 2003, at Pg 1
Online: < http://www.sciencedirect.com/science/journal/02779536/57/4>
10
thereby giving them the right to protect this knowledge.29
Therefore, Plant based biotech
products including Traditional Chinese Medicine(TCM) and Indian systems of medicine like
Ayurveda, that derive their source from Traditional Knowledge of indigenous communities are
protected by the CBD. However this international convention signed by India, has various
loopholes in protecting the traditional medicinal knowledge.
Thus, presenting the legal analysis of the Indian Intellectual Property Law and international
treaties dealing with TMK. It also investigates the loopholes and inadequacy of these systems
which hereby demands a separate and new model guidelines which can also termed as a sui
generis system, solving the traditional ongoing problem of exploitation and misappropriation of
TMK. This will be investigating in the context of India as a case study.
“Case study as a research method excels at bringing an understanding of a complex issue or
objects and extends experience or add strength to what is already known through previous
research.”30
Case study focuses on a specific case like an individual, an organisation, an event,
or a country, in contrast to a research methodology based primarily on collecting and analysing
data from a large set of cases. “Case study emphasise detailed contextual analysis of a limited
number of events or conditions and their relationships.”31
In this study, I will draw on the
analyses, results, conclusions, and recommendations of qualitative and quantitative research,
studies developed in field of Intellectual Property regime. Reference to these fields is necessary
because they will be the grounds upon which I will be building my arguments in respect of
Traditional Medicinal Knowledge. It will help me to evaluate and argue that strong patent
29
India is a member of CBD 30
See, “The Case Study as a Research Method”, 1997
Online: < http://www.gslis.utexas.edu/~ssoy/usesusers/l391d1b.htm > 31
See Larry M Dooley, “Case Study Research and Theory Building”, 2002, at Pg 1
Online: < https://webdisk.ucalgary.ca/~nmstuewe/public_html/CaseStudy/pdf/CStheorybuilding.pdf>
11
protection is not an adequate legal tool to protect traditional medicinal knowledge and some
rigid steps to be taken now to form a concrete protection circle.
In addition, my research limits to the secondary data. Secondary Data are those, which have
already been collected by someone else and which have already been passed through the
statistical process. This data is collected from the following sources like previous literature on
the topic, newspapers or Internet websites. I have conducted an intensive research to understand
and develop the issues on the present problem. Therefore, viewing this theme from the lens of
case study method will be the most appropriate method for studying the complex social
situations or interventions, where multiple variables exist.
“Case study is a research strategy which focuses on understanding the dynamics present within
the single settings.”32
Case studies can be used to accomplish various aims like to provide
description of a scenario or to generate theory. 33
Case studies are particularly relevant when the
aim of is to analyse a single exception that shows the hypothesis to be false.34
Therefore the
legal analyses and conclusions with regard to the obligations on India to take a step forward and
establish a model framework for the protection of Traditional Medicinal Knowledge. With this
central theme, this thesis questions the adequacy of the legal tool in India i.e. Intellectual
Property system specifically the Indian Patent Act, in respect of preserving and conserving the
Indian biodiversity, traditional herbal plants and the knowledge imbibed in them.
32
See Kathleen M. Eisenhardt, “Building Theories from Case Study Research, Volume 14, 1999, at Pg 534.
Online:< http://www.jstor.org/stable/258557?seq=3> 33
Ibid, at Pg 535 34
See Robert E. Stake, “The Case Study Method in Social Inquiry”, Volume 7, 1978.
Online:< http://www.jstor.org/stable/1174340?seq=1>
12
SELECTION OF THE CASE: WHY INDIA?
My decision to select India as the case study was influenced by several factors and attributes.
Firstly India is rich in culture and diversity. India is a land of diversity in race, region, language,
mate, landform, flora and fauna and so on. From ancient time till day, India has repainted this
diversity. It is a country which is united in spite of its diversified culture and language as a
barrier. Secondly, it is believed that the divine spirit of India can be found in village’s i.e. rural
sector. The main source of living and income of these rural sector people largely depends upon
agriculture. Therefore India is also known as an agriculture country. About seventy percent of
our population depends upon agriculture. One third of our national income comes from
agriculture. Thus the development of agriculture in India has much to do with the economic
welfare of India. Thirdly, a part from being rich in agriculture India is also rich in serving
natural medication. People in many parts of India believe in treating any kind of disease with
natural herbs and plants. This is often termed as Ayurvedic treatment which can be found in
several parts of India.
Therefore, introducing these attributes about India is to support the fact that the large part of the
population in India, still depends upon old and natural ways to treat themselves which take
them back from the contemporary period to the age old period. It draws out the importance and
value given to the herbal plants and treating methods, which in a way connects this to the
knowledge holders. The knowledge holders who by experimenting the different ways of using
herbal plants for treating any particular kind of disease, have achieved the valuable information
and knowledge which have been passed on from generation to generation.
Glancing at the development part of India, it has achieved a lot till date on economic side,
technology side and etc. The legal system of India helps in preserving or protecting these
developments and to provide opportunity to develop in more areas. Different laws help India to
13
maintain good trade relations with other country. But still there is much room to consider some
more areas where laws are required which will not only help the country to get developed on
national footprint but also internationally. Such a sector of the country which is gaining a
speedy momentum these days is traditional knowledge. It is a diverse sector which relates to
art, music folk, medicines, etc. Its interest is not only bind within national level but its interest
has spread on international level as well.
Indian Intellectual Property system which rewards the creation of an individual by granting him
to rule that particular creation for a specified time period has help in the development of the
nation. But such a development is lacking behind in the traditional knowledge sector and is
being misappropriated and exploited by inside and outside nation’s pharmaceutical industries.
In order to preserve and conserve this diverse knowledge and tradition for which India is
known, it is important to find out some stringent solutions.
14
CHAPTER 1
A WALK THROUGH INDIAN INTELLECTUAL PROPERTY REGIME AND THEIR
FOOTPRINTS ON TRADITIONAL KNOWLEDGE SECTOR
1.1 Introduction
Knowledge is wealth in the hands of an individual. It is a wide and general concept that is
subject to commercial and public interest. Roots of knowledge can be found in strings of
wisdom; “developed over generations towards a homogeneous existence of humanity with key
elements such as natural resources, and environment holistic traditional scientific utilization of
the lands playing an integral role in the existence and sustenance of this knowledge base.”35
Such form of knowledge is Traditional Knowledge (TK). There is no set definition of TK;
however, they overlap in many aspects. According to Warren (1991):
“Indigenous knowledge (IK) or TK is the local knowledge – that is unique to a given
culture or society. IK contrasts with the international knowledge system generated by
universities, research institutions and private firms. It is the basis for local–level decision
making in agriculture, health care, food preparation, education, natural-resources
management, and a host of other activities in rural communities.”36
Health related knowledge also known as Traditional Medicinal Knowledge (TMK) is
considered varied. It is the knowledge related to specific indigenous herbal plants for medicinal
purposes and is an important component of TK, that coexist along with various forms of
35
See Pranjal Puranik, “TK Rights and Intellectual Property Rights: The Tale of Two Rights”, R.K.Dewan & Co.
(25 September 2007).
Online: < http://www.rkdewan.com/articles-traditional-knowledge-ip-rights.jsp> 36
See “What is Indigenous Knowledge?” The World Bank Group.
Online: <http://www.worldbank.org/afr/ik/basic.htm>; D.M. Warren, “Using Indigenous Knowledge in
Agricultural Development” World Bank Discussion Paper No.127. Washington, D.C.: The World Bank.
15
modern medicinal knowledge.37
“The bifurcation of knowledge system along with western and
non western categories and their cosmopolitan and non local correlation are symbolically
illustrated in the distinction usually made between Western orthodox medicine and traditional
medicine.”38
Beliefs, innovations, spirituality, identity, culture, knowledge, folklore and other traditional
elements are the key concern for indigenous people that belong to them worldwide. These key
elements personify traditional lifestyle of ‘indigenous communities’39
. In the context of
biodiversity, these features are relevant for conservation/sustainable use of genetic resources
including knowledge of herbal plants that are being lost at an alarming rate. In addition to this,
many multinational corporations have misappropriated this knowledge of indigenous people
without or inappropriate consent.
1.2 Traditional Medicine
Indians have an age old tradition of using herbal plants based medicines for various treatments.
Traditional Medicine (TM) is recognized as well-known and respected field. It also plays vital
role in human health care as practices and usages of this knowledge by communities have led to
the discovery of new drugs. “Most indigenous and local communities are situated in the world’s
most biologically rich and diverse areas with abundance in natural resources. However, they are
37
See Srividhya Ragavan, supra note 1; Also See Dr. G.Indira Priyadarsini, Sri Padmavathi Mahila Viswa & Dr.
V. Sowbhagya Rani, “Traditional Medicinal Knowledge in India – An Appraisal” Indiasta (December 2010-
January 2011),
Online: <http://www.indiastat.com/article/25/indira/fulltext.pdf>; Also See Rupak Chakravarty, “Preserving
Traditional Knowledge: Initiatives in India” (2010) IFLA Journal 294 at 294.
Online: <http://ifl.sagepub.com/content/36/4/294> 38
See Dr. G. Indira Priyadarsini, Sri Padmavathi Mahila Viswa & Dr. V. Sowbhagya Rani, “Traditional Medicinal
Knowledge in India – An Appraisal” Indiasta (December 2010-January 2011),
Online: <http://www.indiastat.com/article/25/indira/fulltext.pdf> 39
In this thesis, Indigenous Communities and Aboriginal Communities will be used as interchangeable terms.
16
considered economically disadvantaged. To them this natural environment is a way of life and a
part of their cultural existence.”40
This knowledge is being exploited and misappropriated either by fraud or misrepresentation.
Today, massive multinational corporations are making conceivable profits by a mere access to
knowledge base without any compensation and benefit sharing to indigenous people. Protection
of TMK in India has always been a debatable issue. The protection layers encapsulated within
the Indian Intellectual Property Rights (IPR) are well established, but still, unable to recognize
and protect TMK.
In light of the above brief introduction about TMK, this thesis examines the existing legislation
in India for the protection of TMK. However, this examination does not provide a full
evaluation of the competing arguments. Precisely, I intend to show that the legislations in India
for the protection of TMK particularly Indian Patent System, is not adequate enough to protect
TMK.
1.3 Indian IPR System
IPR is seen as one of the possible means to protect TK. “Most countries use IPR as a legal
mechanism to allocate rights over knowledge, which has a significant role in the relationship
between indigenous and local communities, their knowledge, and other societies with which
they interact”.41
There are many approaches in IPR regime to protect TK of indigenous
communities. These approaches include copyright, trademarks, industrial designs, trade names,
geographical indications and patents.
40
Ibid.; See Jayati Ghosh, “Medical Knowledge as a Global Public Goods For Health, Macroscan (June 2002),
Online: <http://www.macroscan.org/anl/feb03/pdf/gpgh.pdf> 41
See David Downes, “Using Intellectual property as a Tool to Protect TK: Recommendations for Next Step”
Center for International Environment Law (2i November 1997)
Online: < http://www.ciel.org/Publications/UsingIPtoProtectTraditionalKnowledge.pdf>
17
In respect of TMK, the protection layers of IPR are as follows:
a) Patent Protection
The patent system is used for the protection of technical solutions that are industrially
applicable, universally novel and involve an inventive step. Indian Patent system grants rights
to the person who invents any new machine, process, article of manufacture or composition of
matter, biological discoveries etc., and that fits to the criteria of above protection. The patent
holder has an exclusive right to restrict others from making, using, selling, or distributing the
patented invention without permission. Generally the term of protection offered by the Indian
Patent Act, for a patented invention is 20 years from the date of filing of an application.42
India amended its Patent Act, 1970 in 2002 and 2005 to meet its Trade Related Aspects of
Intellectual Property Rights (TRIPS) obligations. For instance, the term of patent was made to
twenty years from seven years, which came into force on 20 May, 2003. In the context of
patenting biotechnological inventions, 2002 amendment added section 3 (j)43
to the Indian
Patent Act 1970. This section specified that plants and animals, and any part of a plant or
animal (excluding micro-organisms, but including seeds) are not patentable. Likewise, plant
varieties, species and essentially biological processes used for the production or propagation of
plants and animals were also considered un- patentable.44
For many years, the patent system in India has been observed as under considerable criticism
for its failure to prevent misappropriation of TMK. It is believed that, the positive protection of
42
See Divya Bhargava, “Patent Act: Biopiracy of Traditional Indian Products – An Overview” Countercurrents (14
May 2009)
Online: <http://www.countercurrents.org/bhargava140709.htm> 43
Section 3 (j) - What are not inventions:
plants and animals in whole or any part thereof other than micro-organisms but including seeds, varieties and
species and essentially biological processes for production or propagation of plants and animals. 44
See Swarup Kumar, “Patentability of Biological Material(s) – Essentially Therapeutic Antibodies – In India”
(2008) 5 Journal of Law, Technology & Society 583 at 584.
Online: < http://www.law.ed.ac.uk/ahrc/script-ed/vol5-3/kumar.asp>. Also see, R Ott, “Patentability of Plants,
Animals and Microorganisms in India” (2004) 16 OKLA. J.L. & TECH
Online: < http://www.okjolt.org/articles/2004okjoltrev16.cfm>
18
TMK cannot be successively accomplished through the patent system and thus, this system is
regarded as a defensive measure against misappropriation of TMK.45
The major problem with the protection of TMK lies in the fact that it is not documented and is
orally transferred over generations. Due to the improper and un-standardized documentation of
TMK, patents are often granted to parties who are traditionally not the owners of the
knowledge. Furthermore, a part of the profits made by the patent holders also does not flow
back to TMK holders, thus leading to discontent amongst the latter.46
The argument of inadequacy of the Indian Patent system in protection of TMK is supported by
Divya Barghava. Divya contends that, the Indian Patent law does not provide with a proper
definition of patentable invention. The patent authorities in India are granting patents to
everybody; whether the said innovation and its inventor fall within the ambit of the patent
definition provided in the Patent Act or not. In addition to this, she points out the problem lying
in broad-based provisions on patentability stipulated in the amendments to Patent Act 1970.
This is because the blame of granting patents on a wide base should not be given to the patent
authorities alone, but also to the multiple provisions enshrined in the amendments to the Patent
Act.47
“The government must get its act together and refer the matter of the scope of
patentability covering the definition of patentable invention, patentable pharmaceutical
substance and even patenting of microorganism to the concerned parliamentary committee so
that time is not lost in amending our Patent Act”.48
45
See Dinesh Dayma, “Protection of TK in Indian Patent Act” Go For the Law
Online: < http://www.goforthelaw.com/articles/fromlawstu/article76.htm> 46
See Ashmita Saha, “Role of Patent Act in Protecting & Preserving TK” Authorstream.
Online: < http://www.authorstream.com/Presentation/athor-486578-role-of-patent-act-in-protecting/> 47
See Divya Bhargava, supra note 43. 48
Ibid.
19
The flawed machinery of the Indian Patent system is further compounded by the concept of
prior art in order to protect TMK. Chief Justice Vijender Jain (Punjab and Haryana High Court,
India.) has expressed his opinion on this in a seminar:
“In recent years concerns have been expressed in relation to the recognition of TMK as
prior art. Patents have been granted for TMK related inventions which do not fulfill the
requirements of novelty and inventive step when compared with the relevant prior art. This
prior art consisted of TMK that could not be, identified by the patent granting authority
during examination of the patent application. The term prior art generally refers to the
entire body of knowledge which is available to the public before the filing date of an
application for certain industrial property titles, principally patents, utility models and
industrial designs. The identification of prior art constitutes a cornerstone for the
substantive examination of applications for the titles, since requirements such as novelty
and inventive step are established by comparing the claimed subject matter with the
relevant prior art.”49
The main objective of the current patent system is to develop new knowledge for prosperity of
humanity which is getting diluted day by day. However, it bolsters monopolization of new
knowledge for exploiting mankind. Need of the hour is to grant patents in a way that serves the
public interest. TMK is the result of the hard work of indigenous ancestors and must be used for
the benefit of humanity. Thus, in this competitive world of patents, it needs to be protected.50
Therefore, in summary, the above discussed opinions make the case that the Indian Patent
system is not adequate enough to protect TMK. However, the above discussed opinions are just
49
See Hon’ble Mr. Vijender Jain, Chief Justice of Punjab and Haryana High Court, Chandigarh “Safeguarding the
TK in India”, Seminar on Asia Pacific Jurist Association (APJA) (28 April 2008) Delhi.
Online: < http://highcourtchd.gov.in/right_menu/events/events/apjaspeech.pdf> 50
See Divya Bhargava, supra note 43.
20
the starting point to build the argument; following chapters will elaborate the problem in the
patent system, exemplified with different case studies of misappropriation of TMK.
b) Trade Secret Protection
Some authors suggest the protection of herbal medicine and plant based biotechnological
products by the way of trade secrets. “While there is no precise legislation on trade secret in
India, but excessive attention is being placed on the use of trade secret against the exploitation
of TK by public institutions, private corporations and local communities for which patents offer
a limited scope.”51
Commonly, Trade secrets are protected under the doctrine of unfair competition.52
This helps in
protecting dishonest commercial practices, provided that the knowledge holder takes reasonable
steps, under the circumstances, to keep the knowledge secret.53
Trade Secret protection is considered suitable for setting a high threshold for herbal medicines
and plant based knowledge due to a number of characteristics:
1. Information must be a secret,
2. Should have commercial value on account of its secretive character,
3. There should be some evidence to show that reasonable efforts were made to
maintain the secrecy of such information.54
The main feature is that, this kind of protection does not require any government involvement
or registration. “Particularly in the case of TK, which is known to a small group of people, the
definition of secrecy is of critical importance. Secrecy does not have to be absolute. It is
51
Murray Lee Eiland, “Patenting Traditional Medicine” (2007) 89 J. Pat &Trademark Off. Soc’y 45 at 74-76
Online: <http://heinonline.org/HOL/Page?handle=hein.journals/jpatos89&div=5&g_sent=1&collection=journals> 52
See Carlos M Correa, Protection and Promotion of Traditional Medicine Implications For Public Health in
Developing Countries (Switzerland: South Center, 2002). Also See Article 39.1 of the TRIPS Agreement.
Online: < http://apps.who.int/medicinedocs/en/d/Js4917e/3.html#Js4917e.3> 53
Ibid. Also See Article 39.2 of the TRIPS Agreement. 54
Ibid and Also See Murray Lee Eiland, supra note 52 at 74-76
Online: <http://heinonline.org/HOL/Page?handle=hein.journals/jpatos89&div=5&g_sent=1&collection=journals>
21
possible to disclose the information on a 'need to know' basis as well as under the exceptions
provided for under confidentiality agreements.”55
c) Indian Biodiversity Act, 2002
In order to recognize TMK, India enacted the Biological Diversity Act, 2002. The Act covers
issues like: protection for biological diversity and associated knowledge, sustainable use of its
components, equitable benefit sharing arising out of the biological resources; foreigners, non-
resident Indians, body corporate, association and organisation either incorporated or not
incorporated in India for accessing Indian Biodiversity. However, this is not an exclusive and
precise law to protect misappropriation of TMK, though some initiatives can be observed in this
regard through the lens of this Act. This Act addresses the basic concerns of access to genetic
resources, collection and utilization of biological resources and associated knowledge by
foreign individuals, institutions, and companies to ensure equitable sharing of benefits arising
out of these resources and knowledge to the country and the people56
.
The legislation provides for the establishment of federal management structure including:
National Biodiversity Authority (NBA) at the apex level, State Biodiversity Board (SBA) at
state level, and Biodiversity Management Committees (BMCs) at local community level. NBA
grants approval for access to genetic resources by foreigners, or non-residents Indians, subject
to conditions like ensuring equitable sharing of benefits. By virtue of section 6 of the Indian
Biodiversity Act, 200257
, anybody seeking any kind of IPRs on research based upon a
55
Ibid. 56
See “Biodiversity and Traditional Knowledge: Regulation at National, Regional and International Level”, Legal
Services India (23 August 2008).
Online: < http://www.legalserviceindia.com/article/l266-Biodiversity-and-Traditional-Knowledge.html>
Also See, Dr. Elizabeth Varkey, supra note 2. 57
An Act to provide for conservation of biological diversity, sustainable use of its components and fair and
equitable sharing of the benefits arising out of the use of biological resources, knowledge and for matters
connected therewith or incidental thereto.
Online: < http://www.genecampaign.org/home/Biological%20Diversity%20Act%202002.pdf>
22
biological resource or knowledge obtained from India, needs to obtain prior approval from
NBA58
. Section 18 (iv) of the Act, stipulates that one of the functions of the NBA is to take
measures to oppose the grant of IPRs in any country outside India on any biological resource
obtained from India or knowledge associated with such a biological resource.59
Indians and Indian institutions are required to inform SBA before performing any research
activity on biodiversity. Lastly, The NBA and the SBA are required to consult BMC in
decisions relating to the use of biological resources/ related knowledge within their jurisdiction.
The legislation also provides for the promotion of conservation, sustainable use and
documentation of biodiversity.60
d) Geographical Indications
In order to give recognition and protection to TK, India developed a multi pronged approach to
tackle misappropriation of TK issue. Under this, a product will be defined by a geographical
area to which it traditionally belongs.61
India established Geographical Indications (GI) of
Goods (Registration and Protection) Act, 1999 with one of its objectives to analyze the scope of
GI protection for TK and policy requirements in Indian Context.62
“GI refers to indication that identifies agricultural, natural or manufactured goods originating in
a territory of a country, or a region or locality in that territory, where a given quality, reputation
58
National Biodiversity Authority of India is one of the three tiered structure of Biodiversity Act of 2002. It states
that, all matters relating to requests for access by foreign individuals, institutions or companies, and all matters
relating to transfer of results of research to any foreigner will be dealt with by the National Biodiversity Authority.
Online< http://www.nbaindia.org/faq.htm> 59
Ibid and also see Dr. Elizabeth Varkey, supra note 2. 60
See National Biodiversity Authority, “The Biological Diversity Act, 2002” Nbaindia
Online: < http://nbaindia.org/text/12//TheBiologicalDiversityAct2002.html> 61
See Divya Bhargav, Supra note 43. 62
See Achintya Nath Saxena, “Protection of TK as Geographical Indications: Policy issues” Slide Share.
Online: <http://www.slideshare.net/achintyanath/protection-of-traditional-knowledge-as-geographical-indications>
23
or other characteristics of such goods is essentially attributable to its geographical origin.”63
“Geographical Indications can be applied to tangible manifestations of TK that can be identified
with a geographical area. GI laws have been used to make a policy that facilitates inclusive
growth based on TK across geographical regions of the country.”64
e) Traditional Knowledge Digital Library (TKDL)
The notion of documentation of TMK was acknowledged as a means of giving due recognition
to TMK holders. “TKDL is an Indian digital knowledge repository, especially about medicinal
plants and formulations used in Indian systems of medicine. It was started in 2001, as
collaboration between the Council of Scientific and Industrial Research (CSIR) and Department
of Ayurveda, Yoga, Naturopathy, Unani, Siddha and Homoeopathy (AYUSH), Ministry of
Health & Family Welfare, Government of India. Objective of the library is to protect the
ancient TMK of the country from exploitation through biopiracy and unethical patents, by
documenting it electronically and classifying it as per international patent classification
systems.”65
“Apart from that, the non-patent database also serves to foster modern research
based on TMK, as it simplifies access to this vast knowledge, be it of traditional remedies, or
practices.”66
It is an initiative by India to digitize and document the knowledge available in the public
domain. It has taken India five years to draft these bills. The Patent authorities while granting
patents will check the invention to prior art in the public domain. Such kind of documentation
63
See Prietika Singh and Dheeraj Seth, “TK AND Geographical Indications: Fighting Back” Managing IP (1
September 2011).
Online:<http://www.managingip.com/Article/2897199/Traditional-knowledge-and-geographical-indications-
Fighting-back.html > 64
See Achintya Nath Saxena, Supra note 63. 65
See Surya Mani Tripathi & Anshu Pratap Singh, “Protection of TK Medicinal Plants” (2011) International Crops
Research Insittutie for Semi Arid Tropic, at 7.
Online: <http://papers.ssrn.com/sol3/papers.cfm?abstract_id=1792541> 66
Ibid.
24
of knowledge will help trace the inventions in the public domain and to know whether they are
eligible for patents, preventing misappropriation of TK. This also helps in tracing indigenous
community with whom commercialization benefits are to be shared.67
1.4 Concluding Remarks
The discussion in this chapter provides an overview of the existing IPR Law for the protection
of TK in general. This chapter showcases different provisions added in IPR legislation with a
view to recognize and protect TMK.
This chapter showcases national concern for the protection of TMK. The point to be noticed
here is that, IPR legislation does not: solely recognize TMK, define TMK, and define the scope
of TMK; enlist the rights of indigenous communities, foreign researchers’ rights and massive
pharmaceuticals companies’ rights in order to patent TMK. In addition to this, such different
legislation do not provide: what can be or cannot be patented under TMK, the way of legal
approach that should be taken by indigenous communities whose knowledge has been exploited
and misappropriated, and benefit sharing schemes for indigenous communities whose
knowledge has been shared.
Though much concern about such issues can be found in different literature, by many judges,
NGO’s, in seminars, conferences: national and international, but this is worthless until TMK
has a legal stamp on it. The above situation can be compared to the one where TMK exists in
public domain but its documentation is not enough for its protection. Similarly such concerns
are of no use, no matter where they are made, if they are not stamped as an Act.
67
See Gunmala Suri & Puja Chhabra Sharma, “Intellectual Property Rights for Traditional Healers: Indian
Perception” (2008) 55 Journal of Economic and Business Administration, 210 at 212.
Online: < http://ideas.repec.org/a/aic/journl/y2008v55p210-219.html#cites >
25
Furthermore, enshrining small provisions in different legislation for protection of TMK and
making amendments to it, creates more confusion among the users. Problem aggravates when
the issue is not properly defined in any of the Act, but minor recognitions are made in order to
protect the same. Thus, makes it vague and difficult to understand in order to solve the problem.
Through this chapter, I intend to show that, in spite of so many legislation working as protective
layers within the IPR regime, the problem still persists. Particularly, the Indian Patent system is
not adequate enough to recognize, preserve and protect TMK. The upcoming chapters in this
thesis will support the same view and exemplify with the help of different case studies that
something more than the current Indian Patent system is needed to protect TMK.
26
CHAPTER 2
EXTENDING CONCERNS FOR TRADITIONAL KNOWLEDGE PROTECTION TO
INTERNATIONAL PLATFORM: JOURNEY FROM NATIONAL TO
INTERNATIONAL FRAMEWORK; HOW FAR HELPFUL AND CORRECT?
2.1 Introduction
Conservation and protection of TMK has been discussed as an important matter of concern in a
number of international forums. Various international forums have engaged with this agenda
because many nations are victimized by such issue. Indeed, IPR laws were adopted as the
appropriate forum to conduct international discussions for adequate protection of TMK. This
includes many agreements, conventions and treaties of World Intellectual Property organization
(WIPO)68
and World Trade Organization (WTO);69
consensually signed by different nations
who wish to protect their TMK and biodiversity.
Foremost among these are: Convention on Biological Diversity (CBD) the work of WIPO and
Trade Related Aspects of Intellectual Property Rights (TRIPS), the work of WTO, International
Undertaking on Plant Genetic Resources for Food and Agriculture (now the FAO International
Treaty). Some other international treaties like: International Labor Organization, United
Nations Commission on Human Rights, and United Nations Permanent Forum on Indigenous
Issues have addressed the protection of TMK issue.
In context of recognition and protection of TMK, WIPO working group committee has
established an Intergovernmental Committee on Intellectual Property and Genetic Resources
68
World Intellectual Property Organisation was established in 1967 with the objective to promote innovation and
creativity for the economic, social and cultural development of all countries, through a balanced and effective
international intellectual property system.
Online: <http://www.wipo.int/about-wipo/en/> 69
World Trade Organisation (WTO) was established in 1995 under the Marrakech Agreement, replacing the
General Agreements on Tariffs and Trade (GATT). It deals with the global rules of trade between national. Its
main function is to ensure that trade flows as smoothly, predictably and freely as possible.
Online: <http://www.wto.org/>
27
(IGC). “IGC is specially assigned the task of looking at the intellectual Property aspects of
access and TMK, in the context of international instruments, the national laws of member
states, the current debate over balancing interest between commercializing TK, on the one hand,
and protecting it against commercialization on the other hand.”70
2.2 Role Played by CBD and TRIPS
a) CBD (1993)
India is a party to the CBD. It is the first international agreement that has recognized and
acknowledged the role and contribution of indigenous and local communities in conservation
and sustainable use of the biodiversity.71
The Convention has three main principles for the
protection of biodiversity of indigenous people, i.e. Conservation, Sustainable Use, Fair and
Equitable Sharing of Benefits derived from biodiversity (also known as CSF Principle).72
Under this convention each party has an obligation to develop national legislation in order to:
Respect, preserve
and maintain knowledge, innovations and practices of indigenous and local
communities embodying traditional lifestyles relevant for the conservation and
sustainable use of biological diversity,
Promote their wider application with the approval and involvement of the
holders of such knowledge, innovations and practices and encourage the
equitable sharing of the benefits arising from the utilization of such knowledge,
innovations and practices,
Protect and encourage customary use of biological resources in accordance with
traditional cultural practices that are compatible with conservation or sustainable
use requirements,
70
See Johanna Gibson, “TK and International Context for Protection” Script-ed 1:1 (March 2004) 58 at 59
Online: <http://www.law.ed.ac.uk/ahrc/script-ed/docs/TK.pdf> 71
See Dr. Elizabeth Varkey, Supra note 2. 72
See Article 1: Objectives of CBD
Online < http://www.cbd.int/convention/articles/?a=cbd-01>
28
Develop and use indigenous and traditional technologies, in pursuance of the
objectives of this Convention. 73
This convention gives states a right to be recognized as the owners of biological resources and
to exploit the same in their territories. “Access to genetic resources must be consistent with the
parties’ obligation to respect, preserve and maintain TMK, innovation and practices. States
have responsibility under CBD to facilitate access to, and benefit sharing arising from the use of
biological resources and to subject all access to prior informed consent according to mutually
agreed terms.”74
b) WTO Agreement on TRIPS (1994)
TRIPS Agreement is one of the pillars of the global trade regime which was enforced through
World Trade Organization (WTO). India became party to TRIPS in April, 1995.75
The
provisions of TRIPS Agreement provide limited application to the protection of TK.
Further, TRIPS Agreement recognized TK through the protection of Geographical Indications
(GI). The obligation to protect GI can be used to protect TK, if associated with the indication
used for production and sale of goods. It is made clear that a given quality, reputation or other
characteristics of goods essentially attributable to its geographical origin are to be considered in
identifying the GI for protection. Thus, the protection of TK associated goods may be possible
through the protection of the GI.76
73
See Dr. Elizabeth Varkey, supra note 2 at 4. 74
Ibid. 75
See “TRIPS Agreement: An Overview” IP Pro Services (India) (2008).
Online: < http://www.ipproinc.com/admin/files/upload/5638424eba1ffe6d201d715e91034b8b.pdf> 76
See Judson O. Berkey, “Implications of the WTO Protections for Food Geographical Indications” American
Society of International Law (April, 2000)
Online: <http://www.asil.org/insigh43.cfm>
29
TRIPS Agreement requires as a general rule that patents can be granted in all areas of
technology without discrimination. However, Article 27.3 (b) of the TRIPS Agreement
provides a limited exception to the general rule on the scope of patentable subject matter:
“WTO members do not have to, but may, provide protection for plant and animal
inventions and for biological processes for producing plants and animals,
Members must provide patent protection for micro-organisms and non biological
and microbiological processes.
Members must also provide some form of protection for new plant varieties
(patents, a sui generis system such as plant breeders' rights or a combination of
both).”77
Though in the history of international conventions related to Intellectual Property Rights, CBD
and TRIPS are the landmarks, but they do not provide a suitable protection layer for TMK. For
instance, CBD provisions “proved too cumbersome to sustain continued investment by
transnational corporations”78
. They also proved ineffective in developing countries that lack the
means to protect their TK.79
On the other hand, TRIPS provisions’ “have reportedly created
more problems than solutions, thus ineffective as an instrument for addressing the protection of
TK.”80
The other major reason for their ineffectiveness is the conflict between the two
conventions, which is discussed in detail in the relationship between CBD and TRIPS.
77
See Dr. Elizabeth Varkey, supra note 2 at 4. 78
See Thomas Cottier & Marion Panizzon, “Legal Perspective on TK: The Case for Intellectual Property
Protection” (2004) 7 Journal of International Economic Law (JIEL) 371 at 376.
Online:
<http://books.google.ca/books?id=6SGRt2CZNyYC&pg=PA573&lpg=PA573&dq=With+the+adoption+of+TRIP
S+Agreement+in+1994,+the+patenting+of+plant+genetic+resources+for+food+and+agriculture+benefited+from+
a+major+step+towards+global+recognition+and+enforcement.&source=bl&ots=r8ZzObFDTU&sig=xNu2c_B392
SAZ5GvSGlOr_GUW8&hl=en&sa=X&ei=iWS5T431GK_YiQLvnvDcBg&ved=0CEkQ6AEwAQ#v=onepage&q
=With%20the%20adoption%20of%20TRIPS%20Agreement%20in%201994%2C%20the%20patenting%20of%20
plant%20genetic%20resources%20for%20food%20and%20agriculture%20benefited%20from%20a%20major%20
step%20towards%20global%20recognition%20and%20enforcement.&f=false> 79
Ibid. 80
Ibid; Also See Keith E. Maskus & Jerome H. Reichman International Public Goods and Transfer of Technology
Under a Globalized Intellectual Property Regime (New York: Cambridge University Press, 2005) at 573.
30
2.3 Relationship Between TRIPS And CBD
The discussions on relationship between TRIPS and CBD have always gained attention in
international forum. Such discussions have ended up putting discussing panels into a dilemma.
Analysts and representatives of some countries believe that, there is no conflict between the two
international agreements. On the other hand, various analysts and diplomats support the notion
that there are serious inherent tensions and conflicts between the two agreements. These
tensions have been the subject to several analyses for instance, Tansey and Rajottee 2008;
Dronamraju 2001; Bellmann, Dutfield & Ortiz 2003; Khor 2002; GRIAN 1998, etc.
2.3.1 No Conflict Between TRIPS And CBD
Developed countries see no conflict between the two international agreements. According to
Tansey & Rajottee; Piva, and Gallagher; United States (US) and Japan believe that, the two
agreements can be paired together in a mutually supportive manner. In addition to this, US have
criticized the notion of amendment to the TRIPS Agreement by including a disclosure
requirement. Rather, they support the view that, members should focus on the “remedies such
as the use of organized databases, information material to patentability, and the use of post
grant opposition or re- examination system as an alternative to litigation”.81
Online: <
http://books.google.ca/books?id=6SGRt2CZNyYC&pg=PA573&lpg=PA573&dq=With+the+adoption+of+TRIPS
+Agreement+in+1994,+the+patenting+of+plant+genetic+resources+for+food+and+agriculture+benefited+from+a
+major+step+towards+global+recognition+and+enforcement.&source=bl&ots=r8ZzObFDTU&sig=xNu2c_B392S
AZ5GvSGlOr_GUW8&hl=en&sa=X&ei=iWS5T431GK_YiQLvnvDcBg&ved=0CEkQ6AEwAQ#v=onepage&q=
With%20the%20adoption%20of%20TRIPS%20Agreement%20in%201994%2C%20the%20patenting%20of%20pl
ant%20genetic%20resources%20for%20food%20and%20agriculture%20benefited%20from%20a%20major%20st
ep%20towards%20global%20recognition%20and%20enforcement.&f=false> 81
See Geoffy Tansey & Tasmin Rajotte, The Future Control of Food: A Guide to International Negotiations and
Rules on Intellectual Property, Biodiversity and Food Security (London: Earthscan, 2008) at 65.
Online:
<http://books.google.co.in/books?id=i6F_aYS3RYYC&pg=PA65&dq=relationship+between+trips+and+cbd&hl=
en&sa=X&ei=0N_T82fBciqiQKWzvzxBw&ved=0CEEQ6AEwAA#v=onepage&q=relationship%20between%20t
rips%20and%20cbd&f=false> ;Also See Jorge Mario Martinez-Piva, Knowledge generation and Protection:
Intellectual Property, Innovation and Economic Development (London: Springer, 2009) at 197
Online:
31
Also, Norway does not consider any contradiction between TRIPS and CBD and has “indicated
its preference for national actions. However, Norway prefers to discuss the disclosure
requirement in WTO, although possibly with more limited language consistent knowledge, with
its own national regulations”.82
On similar lines, Mehta and Sankar have added to above argument that no amendment is
needed to TRIPS Agreement. Further, in order to give recognition to TK, they have suggested
that, a “national contract-based system should be established outside the patent system to
enforce the access and benefit sharing laws to prevent biopiracy”.83
2.3.2 Conflict Between TRIPS and CBD
Many developing countries have observed the inconsistency between the two agreements; on
protecting the biodiversity and associated TMK. Such incompatibilities of two agreements have
been recognized by many scholars in their writings. For instance: Tansey and Rajottee contend
that, developing countries do not recognize TRIPS IPR system as an appropriate tool to protect
TMK. They argue that the “main concern of the developing countries is that TRIPS does not
require patent applications whose inventions incorporate or use genetic material or associated
knowledge to comply with the obligations of the CBD.”84
To this, developing countries have
<http://books.google.co.in/books?id=cZaa_H2SmtQC&pg=PA197&dq=relationship+between+trips+and+cbd&hl=
en&sa=X&ei=0N_T82fBciqiQKWzvzxBw&ved=0CEgQ6AEwAQ#v=onepage&q=relationship%20between%20t
rips%20and%20cbd&f=false> Also See Sachin Chaturvedi, “Biodiversity, Intellectual Property Rights Regime and
Ingenious Knowledge System at the WTO: Revisiting the Unresolved Issues” in Kevin P. Gallagher, Handbook on
Trade and the Environment (Cheltenham, UK: Edward Elgar, 2008) at 270
Online:
<http://books.google.co.in/books?id=LpHiobgEuMgC&pg=PA270&dq=relationship+between+trips+and+cbd&hl
=en&sa=X&ei=0N_T82fBciqiQKWzvzxBw&ved=0CFoQ6AEwBA#v=onepage&q=relationship%20between%20
trips%20and%20cbd&f=false> 82
See Jorge Mario Martinez-Piva, Knowledge generation and Protection: Intellectual Property, Innovation and
Economic Development (London: Springer, 2009) at 197 83
See Pradeep S Mehta and U. Sankar, “The Convention of Biological Diversity” Madras School of Economics
Online:
<http://www.mse.ac.in/trade/pdf/Compendium%20Part%20B/7.%20The%20convention%20on%20biological%20
diversity.pdf> 84
See Geoffy Tansy & Tasmin Rajotte, supra note 82 at 65
32
repeatedly voiced concern on the incompatibility between the two agreements and differences
in their approach.
Supporting the above argument, Dronamraju states that, there are inherent tensions between the
granting of IPR under TRIPS and the objectives of the CBD. He argues that Article 16 (5)85
of
the CBD recognizes that, patent and other IPRs can have a negative effect on the
implementation of the CBD provisions, and thus, urges parties to cooperate in this regard
subject to national and international law to ensure that IPRs are supportive and do not run
counter to CBD objectives.86
Many scholars have listed some crucial provisions enshrined in the TRIPS Agreement for
consideration that undermines the spirit of CBD:
a) Conflicting objectives and difference in the overall framework
Bellmann presented the most striking point of departure between CBD and TRIPS that lies in
its objectives.87
GRAIN, Khor & Dronamraju support his statement and argue that, the TRIPS
Agreement is an “international agreement drawn up with the encouragement and active support
of the large corporations to promote their technological dominance and to gain profits through
85
Article 16 of CBD: Access to and Transfer of Technology
16 (5): The Contracting Parties, recognizing that patents and other intellectual property rights may have an
influence on the implementation of this Convention, shall cooperate in this regard subject to national legislation
and international law in order to ensure that such rights are supportive of and do not run counter to its objectives.
Online: <http://www.cbd.int/convention/articles/?a=cbd-16> 86
See Krishna R. Dronamraju and also see “Intellectual Property Rights, TRIPS Agreement and the CBD” Thrid
World Network (2nd
meeting of the expert panel on Access to Genetic Resources and benefit sharing) (19 march,
2001)
Online: < http://www.twnside.org.sg/title/benefit.htm > 87
See Biswajit Dhar, “The Convention on Biological Diversity and the TRIPS Agreement: Compatibility or
Conflict” in Christophe Bellmann, Graham Dutfield & Ricardo Melendez-Ortiz, Trading in Knowledge:
Development Perspectives on TRIPS, Trade and Sustainability (London: Eathscan, 2003) at 85. Also See Also See
“TRIPS versus CBD: Conflicts Between the WTO Regime of Intellectual Property Rights and Sustainable
Biodiversity Management” GRAIN (April 1998); See Martin Khor, Intellectual Property, Biodiversity and
Sustainable Development: Resolving the Difficult Issues (London: Zed Books, 2002) at 54.
33
obtaining private monopolies.”88
TRIPS, “intended to provide private property rights over
products and processes, be they biodiversity-based or not, in order to ensure that corporate
interests are safeguarded equally worldwide”.89
Thus, TRIPS is recognized as a “commercial
treaty with commercial objectives that largely benefit strong private firms”.90
On the other
hand, the central objective of the CBD is to conserve, protect and use biological diversity in a
sustainable manner. “The establishment of the CBD was prompted mainly by the growing
concern over the rapid worldwide loss of biodiversity, recognition of the important role of TK
and the rights of local communities that developed and hold the knowledge and the need to
regulate access to and the sharing of benefits. Therefore, the agenda of TRIPS is to privatize,
and not to protect TK related biodiversity.” 91
b) Conflicting Provisions Related to Foreigners
Khor and Dronamraju argue that, national sovereignty principle is enshrined under Article 392
and Article 15.193
of CBD. These provisions assert that, states have the sovereign right to
exploit their own biological resources along with the right to regulate access of foreigners to
biological resources and knowledge, and to determine benefit sharing arrangements. However,
TRIPS enable persons’ or institutions to patent a country’s biological resources in countries
88
See Martin Khor, Intellectual Property, Biodiversity and Sustainable Development: Resolving the Difficult
Issues (London: Zed Books, 2002) at 54.
Online:
<http://books.google.co.in/books?id=Up9qCHTvlrEC&pg=PA51&dq=relationship+between+trips+and+cbd&hl=e
n&sa=X&ei=9I6T4uIKqZiAKXyrGOCA&ved=0CEsQ6AEwAg#v=onepage&q=relationship%20between%20trip
s%20and%20cbd&f=false> 89
See “TRIPS versus CBD: Conflicts Between the WTO Regime of Intellectual Property Rights and Sustainable
Biodiversity Management” GRAIN (April 1998).
Online: < http://www.grain.org/fr/article/entries/20-trips-versus-cbd:> 90
See Krishna R. Domaraju, supra note 87 at 235. 91
See Krishna R. Domaraju supra note 87 at 235 and See Martin Khor supra note 89 at 654. 92
Article 3 of CBD: Principle - States have, in accordance with the Charter of the United Nations and the
principles of international law, the sovereign right to exploit their own resources pursuant to their own
environmental policies, and the responsibility to ensure that activities within their jurisdiction or control do not
cause damage to the environment of other States or of areas beyond the limits of national jurisdiction.
Online: < http://www.cbd.int/convention/articles/?a=cbd-03 > 93
Article 15.1 of CBD: Recognizing the sovereign rights of States over their natural resources, the authority to
determine access to genetic resources rests with the national governments and is subject to national legislation.
Online:< http://www.cbd.int/convention/articles/?a=cbd-15>
34
outside the country of origin of the resources or knowledge. In this manner TRIPS facilitates
the condition for misappropriation of TK and appropriation of ownership rights over living
organisms or knowledge associated with it. Therefore, the sovereignty of developing countries
over their resources including access and benefit sharing arrangements is compromised.94
c) Conflicting rights of IPR and TK holders
Article 2895
of TRIPS Agreement states that, a patent confers exclusive rights to its owner and
prevents third parties from making, using, offering for sale, selling or importing the patented
product and process. Thus, Mehta confirms that, TRIPS recognizes IPR as private right which
often constructs obstacles to the exchange or flow of knowledge and their use of production. To
this, Domaraju argues that, such an exclusive and private right system clashes with the
traditional, social and economic system in which local communities make use of biodiversity
and the associated knowledge. Further he mentions that, the indigenous community knowledge
is not confined to an individual rather it is orally transferred from generation to generation. On
a legal basis, CBD has acknowledged such provisions that are encapsulated in Article 8 (j)96
and Article 1597
of the CBD. However, such contribution and the nature of community
knowledge and rights are not recognized in TRIPS.98
94
See Krishna R. Domaraju supra note 87 at 55 and 235 95
Article 28 of CBD: Adoption of Protocols –
1. The Contracting Parties shall cooperate in the formulation and adoption of protocols to this Convention.
2. Protocols shall be adopted at a meeting of the Conference of the Parties.
3. The text of any proposed protocol shall be communicated to the Contracting Parties by the Secretariat at least
six months before such a meeting.
Online: < http://www.cbd.int/convention/articles/?a=cbd-28 > 96
Article 8 (j) of CBD: each contracting party shall respect, preserve and maintain knowledge, innovations and
practices of indigenous and local communities embodying traditional lifestyles relevant for the conservation and
sustainable use of biological diversity and promote their wider application with the approval and involvement of
the holders of such knowledge, innovations and practise and encourage the equitable sharing of benefits arising
from the utilization of such knowledge innovations and practices.
Online: <http://www.cbd.int/traditional/> 97
Article 15 of CBD:
1. Recognizing the sovereign rights of States over their natural resources, the authority to determine access to
genetic resources rests with the national governments and is subject to national legislation.
2. Each Contracting Party shall endeavour to create conditions to facilitate access to genetic resources for
35
d) Modern technology versus TMK
CBD recognizes the role of TK in conservation and protection of biodiversity. However, TRIPS
denies the role of TK and instead rewards additions made to the knowledge through modern
technology. This different treatment for modern technology and TK is also associated with
discrimination against local community rights. Nijar adds to this argument and states that such a
treatment points out that TRIPS framework selectively favours developed countries and
marginalized developing countries therefore creating more differences between TRIPS and
CBD.99
e) Benefit sharing arrangements
A key aspect of CBD is that, it recognizes the sovereign rights of the states over their
biodiversity and knowledge. This gives the state; the right to regulate access and to enforce its
rights on arrangements for sharing benefits. “Access where granted: should be on mutually
agreed terms (Article 15.4) and shall subject to prior informed consent (Article 15.5). In
addition to this, countries providing the resources should fully participate in the scientific
research (Article 15.6). Each country should take legislative, administrative or policy measures
environmentally sound uses by other Contracting Parties and not to impose restrictions that run counter to the
objectives of this Convention.
3. For the purpose of this Convention, the genetic resources being provided by a Contracting Party, as referred to in
this Article and
Articles 16 and 19, are only those that are provided by Contracting Parties that are countries of origin of such
resources or by the Parties that have acquired the genetic resources in accordance with this Convention.
4. Access, where granted, shall be on mutually agreed terms and subject to the provisions of this Article.
5. Access to genetic resources shall be subject to prior informed consent of the Contracting Party providing such
resources, unless otherwise determined by that Party.
6. Each Contracting Party shall endeavour to develop and carry out scientific research based on genetic resources
provided by other Contracting Parties with the full participation of, and where possible in, such Contracting
Parties.
7. Each Contracting Party shall take legislative, administrative or policy measures, as appropriate, and in
accordance with Articles 16 and 19 and, where necessary, through the financial mechanism established by Articles
20 and 21 with the aim of sharing in a fair and equitable way the results of research and development and the
benefits arising from the commercial and other utilization of genetic resources with the Contracting Party
providing such resources. Such sharing shall be upon mutually agreed terms.
Online: <http://www.cbd.int/convention/articles/?a=cbd-15> 98
See Krishna R. Domaraju supra note at 87 at 237. 99
See Martin Khor, supra note 89 at 654.
36
with the aim of sharing fair and equitable results of research and development, and the benefit
arising from commercial and other utilization of genetic resources with the contracting parties
providing such resources”.100
However, under TRIPS there is no such provision for the “patent holder, on claims involving
biological resources or related knowledge, to share benefits with the state or communities in
countries of origin”.101
f) Prior Informed Consent
Article 15.4 of the CBD recognizes the proviso of prior informed consent and states that,
“access to genetic resources shall subject to prior informed consent of the contracting party
provide such resources, unless otherwise determined by that party. Thus, researchers of
biological resources are obliged to provide sufficient information of their work and should
obtain consent from the owners.102
Some countries have enshrined this provision in their
regulatory framework for the protection of TK. For instance Africa has established
Organization of African Unity (OAU) Model Legislation103
on Access to Biological Resources
and Protection of Community Rights.
India enacted its ‘Indian Biodiversity Act, 2002’,104
that recognizes the provision of prior
informed consent through National Biodiversity Authority (NBA).105
This authority acts as a
100
See Krishna R. Domaraju supra note 87 at 237 to 238 101
Ibid at 238 102
See “Intellectual Property Rights. TRIPS Agreement and the CBD” Third World Network (19th
March 2001)
Online: < http://www.twnside.org.sg/title/benefit.htm> 103
See OAU Model Law, “African Model Legislation for the protection of the Breeders Rights of Local
Communities, Framers and Breeders and for the regulation of Access to Biological Resources”, Algeria, 2000.
Online: < http://www.opbw.org/nat_imp/model_laws/oau-model-law.pdf> 104
See WIPO, Online: <http://www.wipo.int/wipolex/en/details.jsp?id=6058> 105
The National Biodiversity Authority (NBA) was established in 2003 to implement India’s Biological Diversity
Act (2002). The NBA is Autonomous body and that performs facilitative, regulatory and advisory function for
Government of India on issue of Conservation, sustainable use of biological resource and fair equitable sharing of
benefits of use.
Online: <http://nbaindia.org/content/16/14//introduction.html>
37
watchdog over the researches that are performed on biological resources and makes it
mandatory for the foreign researchers to disclose the purpose and utilization of the research.
Nevertheless, in TRIPS, there is no such provision for patent applicants or other IPRs over
biological resources for obtaining the prior informed consent.106
2.4 Harmonization Between The Two Agreements
The most suggested solution to reconcile both the agreements was to amend the TRIPS
Agreement so as to make its provision compatible with CBD. Many developing countries
including Brazil, Cuba, Ecuador, India, Peru, Thailand, and Venezuela, in the first meeting of
the council for TRIPS in 2004, forwarded a proposal to include ‘disclosure requirement’107
.108
On these lines Piva argues that, many countries have realized the need to amend TRIPS
Agreement in order to make it compatible with the CBD provisions. For instance India, Norway
and many other countries support the amendment to TRIPS by introducing a mandatory
obligation to disclose the origin of genetic resources and TK in the patent application. In
addition to this, Norway proposed that a patent application should not be processed unless the
required information has been submitted to the patent office. 109
2.5 Concluding Remarks
This chapter provides literature on role and relationship between TRIPS and CBD for the
protection of TMK. Two different views have been presented by different analysts showcasing
the conflict and no conflict between the two international agreements in order to protect
biodiversity and related knowledge that being subject to IPR.
106
See Intellectual Property Rights, TRIPS Agreement and the CBD, Montreal, 2001.
Online: <http://www.twnside.org.sg/title/benefit.htm> also See Krishna R. Domaraju supra note 87. 107
Disclosure requirement means: at the time of filing of the patent application related to TMK or biodiversity, the
place of origin must be disclosed. Disclosure requirement has been stressed here due to the fact that would
prevents grant of illegitimate patents, ensure the effectiveness against misappropriation. 108
See “Perspective TRIPS and CBD” Wista: Intellectual Property Perspective
Online: <http://www.witts.org/IPR/intelprop_45_jan06/wista_property_prespective.htm> 109
See Jorge Mario Martinez-Piva, supra note 83. Also See Geoffy Tansy & Tasmin Rajotte supra note 82 at 65.
38
I favor the argument supporting the conflict between TRIPS and CBD. I think that, the
provisions of two international agreements are inconsistent with each other for the protection of
TMK. Various reasons that have been listed above for the conflict between the two agreements
clearly make the case for the same. The two agreements exemplify and promote two different
objectives, system of rights and obligations. TRIPS central focus is to privatize the rights over
the innovation whereas; the CBD’s central focus is to protect the biodiversity and associated
knowledge against misappropriation. They both are in direct opposition to each other.
Essentially the conflict derives from the nature and purposes of the agreements that cannot be
reconciled because they derive from fundamentally different ontologies. However, many efforts
have been made to reconcile the two agreements. In this context many developing countries
including Brazil, Cuba, Ecuador, India, Peru, Thailand, and Venezuela presented a proposal to
facilitate a result oriented discussion on the need for coherence between two agreements by
making an amendment to the TRIPS Agreement. In this context proposal was made to include a
disclosure requirement in the TRIPS Agreement. However, after so many efforts and analyses
still the problem persists. In other words, both agreements did not suffice the conditions for
protection of TMK.
I strongly support the argument of inherent tensions between the two agreements because it
should be noted that CBD came into existence three years before the TRIPS Agreement came
into force. However, TRIPS makes no reference to the CBD objectives, i.e. conservation of
TMK and biopiracy. Therefore, the question arises, are the WTO members ignorant of the CBD
provisions while drafting TRIPS Agreement? Is the difference in rationales and objectives
between the two agreements, and no recognition of TMK by WTO members while drafting
TRIPS; intentional? Do CBD and TRIPS meant to address different issues? If the answers to
39
these questions is ‘yes’, then, why today issues of conflict are in so much debate? Why there is
a need to amend the TRIPS Agreement?
On the other hand, if the answer to the ignorance of CBD provisions while drafting the TRIPS
Agreement is ‘no’, then should we blame the member countries who in spite of knowing the
CBD provisions, signed TRIPS Agreements and would know the consequences? Lastly, if this
is correct, then which agreement should prevail and followed, in order to solve the conflict?
Solution to this can be found under Vienna Law of Treaties. Treaty asserts that, the agreement
that came later in time will control, i.e. the TRIPS Agreement. If such thing is followed, this
would mean that CBD will not be recognized any more. Hence, concerns and debates for
recognition, conservation, protection of biodiversity and related TMK will still persists and
attempts to plagiarize and misappropriation TMK will continue.110
Therefore, in my opinion, the conventional Intellectual Property Law does not adequately cover
or protects the knowledge and innovations of indigenous people. I see the conflict between the
two agreements as a conflict between a developing country and a developed country. Where a
developing country wants to protect its TMK, on the other hand the developed country wants to
make their IPR system stronger. These international agreements appear to divide than to unite.
Hence, I think, firm steps must be taken from national level so that countries before signing any
treaty, convention or agreement are clear about what they want.
110
See” TRIPS and Biodiversity Convention: What Conflict?” International Chamber of Commerce the World
Business Organisation (28 June, 1999)
Online: < http://www.iccwbo.org/id418/index.html>
40
CHAPTER 3
LIFTING THE VEIL FROM THE REASONS BEHIND IMPERFECT ROLE OF
INDIAN INTELLECTUAL PROPERTY SYSTEM IN PROTECTING THE
TRADITIONAL MEDICINAL KNOWLEDGE OF INDIAN INGENIOUS
COMMUNITY
3.1 Introduction
As demonstrated in the previous chapters, strengthening and enhancing the IPR standards from
national to an international platform has not really made a difference to the issue of protection
of TMK. The problem still lays the same. In addition to this, two major international
agreements, CBD and TRIPS have failed to convince and instead has many inbuilt conflicting
issues that make the agreements stand against each other. Thus, such developments in IPR have
made the problem worse today, and have created a threat to indigenous communities. Such a
threat is termed as a threat of ‘Biopiracy’111
. This chapter will showcase the threats in the form
of case studies and will also present the notion that the national and international developments
in IPR has not solved the biopiracy problem, but has always supported them and enhanced
privatizing knowledge.
Before introducing the real picture of biopiracy, I think it is important to know and answer few
issues related to indigenous community. Firstly, who owns TMK? Secondly, why it is important
for indigenous community to protect TMK?
3.1.1 Who Owns TMK
In order to protect and preserve TMK it is important to locate the holders of the knowledge.
Who owns TMK? Is it humanity, the nation in which the resources are located, a specific group
111
Biopiracy is a part of the larger problem whereby developing countries rich in biodiversity are exploited by
transnational corporations and industries that make use of these resources. Biopiracy, refers to the appropriation,
generally by means of patents of legal rights over biological materials by international companies to develop food
or medicines, without recompensing the countries from which they are taken.
Online: <http://indigenousknowledgeproject.org/biopiracy>
41
of people or an individual? However, there is no precise answer to this question, but Hansen
and VanFleet’s detailed research on the ownership of TMK, offers a convincing answer. They
contend that, “the knowledge holders are the people who hold or use the knowledge. The
holders of the knowledge can be an individual, multiple individuals or the community as a
whole. Further, the knowledge claims can either be held by no individual, an individual,
multiple individuals, or a community”.112
Hansen and VanFleet have categorised the knowledge claims as:
“Known and used by an individual;
Know and used by several individuals or a community, or
Diffused broadly and in public domain”.113
The issue of ownership is very important and must be considered while dealing with biopiracy.
Johan has analysed this issue, and states that, the answer to this lies in CBD. CBD clearly states
that, “the individual state and its people have right to exploit their own resources pursuant to
their own environmental policies”.114
To put in other words: when interpreting the CBD, owner
of the nature is the group of people or community under which such knowledge has been
developed. Hence, it can be summed, that the owners of the TK are the indigenous people or
communities, who preserved, conserved and developed the knowledge over generations.
Working on the similar lines, Dutifeld argues that, common view regarding the knowledge is
that it exists in public domain, i.e. free for anybody to use, except the knowledge, which is
privatized and protected under IPR laws. The unprotected knowledge that is in public domain
can be and should be protected by customary laws. The application of such customary laws will
112
See Stephen A. Hansen and Justin W. VanFleet, Traditional Knowledge and Intellectual Property: A Handbook
on Issues and Options for Traditional Knowledge Holders in Protecting Knowledge Holders in Protecting their
Intellectual Property and Maintaining Biological Diversity (AAAS, 2003) at 44. 113
Ibid. 114
See Johan Ragnar, “Biopiracy, the CBD and TRIPS – The Prevention of Biopiracy”, Faculty of Law, University
of Lund (2004)
Online: <http://lup.lub.lu.se/luur/download?func=downloadFile&recordOId=1561387&fileOId=1565619>
42
restrict the rights of the third parties to access and use it. These customary laws are practiced by
indigenous communities in order to preserve and sustain TMK. Therefore, indigenous
communities are regarded as the holders of the TMK. He further argues that, it is really
important to respect the holders and their TMK and should be compensated in case their
knowledge is used by others. Such respect and compensation would motivate them to continue
safeguarding and expanding the knowledge.115
There is no universal definition of indigenous people. However, according to Oxford
Dictionary, ‘Indigenous’ means “native, belonging naturally that of the people regarded as the
original inhabitants of an area. Thus, indigenous peoples are generally so-called because they
were living on their lands before settlers came from elsewhere; they are the descendants of
those who inhabited a country or a geographic region at the time when people of different
cultures or ethnic origins arrived, the new, arrivals later becoming dominant through conquest,
occupation, settlement or other means”.116
3.1.2 Need For Protection of TMK
The importance of TMK to indigenous people and its application to the contemporary world is
inevitable. From the above discussion it is proven that even though traditional knowledge is
accessible to the public, it is still protected by the local communities and the people who live
around that knowledge. There is a proven link between indigenous communities and their TMK
because indigenous communities rely on such knowledge for their survival, daily life, healing
or medicinal purposes and other nutrition needs.
115
See Karin Timmermans, supra note 29.
Online: <http://www.sciencedirect.com/science/article/pii/S0277953602004252> 116
See J.K. Das, Human Rights and Indigenous Peoples (New Delhi: A.P.H Publishing Corporation, 2001) at 19.
Online: <
http://books.google.co.in/books?id=KCknz_lXYCEC&printsec=frontcover&dq=definition+of+indigenous+people
&source=bl&ots=wpsVdOOT7j&sig=0D7g0eyQB3VMbE8aFpI2CdNUms&hl=en&sa=X&ei=uGj_T4qIB4WXrA
Hw_bmcBQ&ved=0CDgQ6AEwAA#v=onepage&q=definition%20of%20indigenous%20people&f=false>
43
The importance of herbal plants for the treatment of illness has long been recognised. However,
despite scientific innovations, leading to the development of new drugs and medicines117
, it is
estimated that, “80% of the world’s population relies on traditional medicine in one form or
another. 85% of the traditional medicine involves the use of plants extracts. Moreover, there are
some 200 chemicals extracted in pure form, from approximately 90% plants species used in
medicine throughout the world. About half of the world’s medicinal compounds are still
derived or obtained from plant sources.”118
In addition to this, “traditional medicine is widely
available and affordable, even in remote areas, and generally accessible to most people. In India
for example, 70% of the population uses Indian traditional medicine as reported by Indian
government.”119
Further the study claims that there has been a global upsurge in the use of
traditional medicine and complementary and alternative medicine.120
For example, “the
percentage of the population which has used traditional medicine are as follows: Australia –
48%, Canada – 50%, USA – 42%, Belgium – 40%, India – 70%, France – 75% and the United
Kingdom – 90% as stated in governmental and nongovernmental reports”.121
In a seminal study, Secretariats of CBD reported that the worldwide traditional medicines and
complementary/alternative medicine therapies originate from herbal plants. Furthermore, the
world’s market for herbal medicines, including herbal products and raw material has reached
US$ 43,000 million. As a consequence, today traditional medicine play an increasingly
117
See Dr. Xiaorui Zhang “Traditional Medicine and its Knowledge” World Health Organisation (1 November
2000)
Online: <
http://fepi.ipaam.br/biodiversidade/Organismos%20Internacionais/UNCTAD/Documentos/Ingl%C3%AAs/Who%
20by%20Xiaorui%20Zhang.pdf> 118
See Panumas Kudngaongarm, “Human Rights Standards for the Protection of Intellectual Property: Traditional
Knowledge and Indigenous Resources (Part II)” (2010) 13 Thailand Law Journal.
Online: < http://www.thailawforum.com/articles/traditional-knowledge-part2.html> 119
See Dr. Xiaorui Zhang, supra note at 118. 120
Ibid. 121
Ibid.
44
important role in the health care sector not only globally, but also for those who cannot afford
modern medicines treatments.122
Such an increased awareness of the value of TMK along with the explosion of research, writing
and international focus has induced many organisations, scientific bodies and corporations to
profit from the same. Wretchedly, such modern applications of TMK rarely value it for its
holistic worth as they do for its commercial value.123
Hence, such use of TMK has increased the
misappropriation and exploitation of traditional holder’s knowledge.
The main motive behind the protection of TMK is to prevent unauthorised appropriation of
herbal knowledge. Much has been done until now to shun away with such a critical problem,
however, in vain. Therefore, it is really important to understand, why we need such a
protection, and against what. TK has always been an easily accessible treasure, thus has been
susceptible to misappropriation. Technologically rich countries have been using this treasure for
the development of various advanced medicines which today has gained the shape of ‘bio-
prospecting124
or biopiracy’.125
Also TMK is often misappropriated because it is conveniently
assumed that since it is in public domain, communities have given up all their claims over it.126
This has triggered widespread protest by farmers and indigenous communities. They argue that,
knowledge being in public domain; granting of patents to big companies on biological materials
will earn them large profits. The transnational corporations generate large revenues, while
122
Ibid. 123
See Johan Ragnar, supra note115. 124
“Bioprospecting is an umbrella term describing the process of discovery and commercialization of new products
based in biological resources, typically in less-developed countries. Bioprospecting often draws on indigenous
knowledge about uses and characteristics of plants and animals. In this way bio-prospecting includes biopiracy, the
exploitative appropriation of indigenous forms of knowledge by commercial actors, as well as search for
previously unknown compounds in organisms that have never been used in traditional medicine.”
Online: < http://en.wikipedia.org/wiki/Bioprospecting> 125
See Dr. G.Indira Priyadarsini, Sri Padmavathi Mahila Viswa & Dr. V. Sowbhagya Rani, supra note 39 126
Ibid.
45
leaving the local communities unrewarded, and with a threat in the future, of having to buy
products from those companies at high prices.127
3.2 Inadequacy of Legal Systems That Addresses TMK
The application of IPR to biological resources and associated TMK has been widely criticized.
“The derivation of the conflict over IP lies in the dichotomy between the Western tenet of
individual private property and the non – western ideology of combined property ownership. A
coerced harmonization of property doctrines results in a strong clash of cultures.”128
In
indigenous societies natural resources are considered sacred in number. They believe that
knowledge, ideas and creativity are meant to be shared, exchanges and cultivated in order for
society to progress.
3.2.1 Analysis of Indian Patent System
Tools of IPR were developed to protect innovations and creativity against piracy. The Indian
patent system grants monopoly on an invention if it suffices three major grounds, i.e. Newness
(Novelty requirement), Usefulness (the Utility requirement) and Non Obviousness (the non-
obviousness requirement). Proponents of patent argue that, “they are designed to stimulate
innovation, and credit the hard labor”.129
However, irony of the situation is that, they are now
being used to harbor a new form of piracy, i.e. biological piracy or Biopiracy. It is argued that,
“the patent system is designed to stimulate and protect the commercialization and monopoly of
knowledge by granting exclusive commercial rights for 17-20 years to the one who invents
127
See A.K.Ventura, “Biodiversity and Intellectual Property Rights: Impact on Underdeveloped Countries”
Panmedia (3 January 1997) 128
See Swaireeta Dutta, “The Turmeric Patent is the Just the First Step in Stopping Biopiracy” Nabard.
Online: < http://www.nabard.org/nrmc/pdf/nabard%20turmeric%20survey.pdf> 129
See Malini S. Goel, “Keeping Biopirates at Bay: Creating a new Legal and Institutional Protection Regime for
Traditional Knowledge” The Fletcher School: Tuft University (28 April, 2003)
Online: < http://repository01.lib.tufts.edu:8080/fedora/get/tufts:UA015.012.DO.00021/bdef:TuftsPDF/getPDF >
46
something novel and non obvious”.130
Further, “if indigenous peoples and communities had the
ability to use these forms of protection, they could have possessed patents for their innovative
use and practices of TMK. Further, any attempts at using their information without payment or
permission would constitute an act of legal piracy”.131
Another important feature of Indian patent law is the concept of prior art. Prior art can negate
the novelty requirement because “novelty dictates that an invention in question cannot have
been made public in any way through any published literature, display or other formal
description, nor cited in a previous patent prior to the granting of the patent”.132
If evidence of a
similar invention is found in a printed manner or already in public knowledge, this will
constitute prior art. Practically speaking this is not always true for evidence found in the general
public domain, particularly when it is an international issue. In such case, “US historically has
only considered knowledge within the US or its territories to make a determination of prior art.
Article 102133
of the US patent Law, that defines prior art, does not recognize technology and
methods in the use of other countries”.134
This might be a fundamental error in US patent
system that it disregards global knowledge that may constitute prior art. Nevertheless, it should
be observed that, Indian patent law is not strong enough to provide a firm solution to such a
problem.
The flawed machinery of the patent system is further compounded by the fact that developed
nations are attempting to expand these IP standards worldwide. As a result, “the international
law; UN and other international institutions that promote these laws, international treaties,
130
Ibid. 131
See Swaireeta Dutta, supra note 129. 132
See Malini S. Goel supra note 130. 133
The prior art is defined by Title 35, United States Code, Section 102.
Online: < http://www.uspto.gov/web/offices/pac/mpep/documents/appxl_35_U_S_C_102.htm> 134
See Shiva Vandana, “The US Patent System Legalizes Theft and Biopiracy”, Organic Consumer Association
(July 28, 1999)
Online: <http://www.organicconsumers.org/Patent/uspatsys.cfm> in Keeping Biopirates at a bay
47
distinct national laws, regional declarations and developing countries, and NGO positions that
differ from the established IP regimes”.135
3.2.2 Analysis of Indian TKDL
To protect TMK, many solutions were highlighted and discussed. One of the solutions which
were pioneer in providing legal protection to TMK was the establishment of TKDL. However,
many indigenous communities have stressed that, “registries, databases and intellectual
property systems are not adequate systems for protecting and transmitting TMK, innovations
and practices. For millennia, indigenous people have had their own system of protection and
transmission with help of their customary laws, which should be respected”.136
They have
committed themselves to protect their knowledge and reaffirmed its use in “respecting its
spiritual values and dimensions of such knowledge”.137
Indigenous people have been critical
about the documentation of knowledge, considering that it may lead to the misappropriation of
their knowledge by third parties.
The critics of TMK have argued that “TKDL may be playing into the hands of foreign
companies by providing easy access to India’s TMK. They also complain that the companies
also use the information to develop new products, such drugs, will be under no obligation to
share any profits with local communities”.138
Devender Sharma, president of New Delhi based
135
See Malini S. Goel supra note 130. 136
See “International Indigenous Forum on Biodiversity: Closing Declaration Sixth Conference of the Parties of
the Convention on Biological Diversity Klimabuendnis (April 19, 2002)
Online: <http://www.klimabuendnis.org/closing-declaration0.html> 137
See “Indigenous People’s Plan of Implementation on Sustainable Development” (2002) Online: <
http://www.google.ca/url?sa=t&rct=j&q=respecting%20the%20spiritual%20values%20and%20dimensions%20of
%20such%20knowledge&source=web&cd=1&ved=0CFEQFjAA&url=http%3A%2F%2Fwww.tebtebba.org%2Fi
ndex.php%2Fall-resources%2Fcategory%2F17-rio-10-world-summit-on-sustainable-
development%3Fdownload%3D478%3Aindigenous-peoples-plan-of-implementation-on-sustainable-
development&ei=OmUIUMSmEMW8rQH6luC9BA&usg=AFQjCNFNY97AJksRBg2pFIEpZl8PR5Akkg> in
Yovana Reyes Tagle, “The Protection of Indigenous knowledge Related to Biodiversity: the Role of Databases”
Sylff
Online: ‘http://www.sylff.org/wordpress/wp-content/uploads/2009/03/sylff_p131-146.pdf. 138
See K.S Jayaraman, “Biopiracy Fears Cloud Indian Database” Scidev Net (December 5, 2002)
48
Forum for Biotechnology and Food Security, argues that the “country’s Indigenous Knowledge,
which so far have been protected by language and cultural barriers, is now being handed over
officially to drug companies on a really accessible digital platter”.139
M.D. Nair a Chennai-based consultant on patent issues also doubt that “whether the library will
succeed in protecting India’s TMK because, at present, there is no way to prevent patents on
inventions derived from such knowledge”. He further argues that the “TKDL can benefit India
only if companies agree to share profits form a product that could not have been invented
without access to the library. This is already happening in some areas of biotechnology, he says,
where private and public agencies that have been placed genetic sequences in the public domain
for research purposes require the users to pay royalties if they develop a product”.140
Furthermore Nair argues that the “TKDL cannot prevent ‘Utility’ patents being taken on new
uses that are not mentioned in the TKDL. It will not stop biopiracy unless the sovereignty
granted for bio-resources under CBD is extended to products which are derived from such
resources.” 141
In practice that means, there should more utilization of prior informed consent
and benefit sharing schemes
Vandana Shiva, founder of India`s Navdamya Research Foundation for Science, Technology
and Ecology, which led several international campaigns against biopiracy, including that of
neem, basmati and other products, does not find ‘TKDL as a silver bullet in the biopiracy
wars’142
. She contends that, “whatever is being digitalised cannot be treated as the solid
evidence. It does not become evidence because it is in digital form. So I think it is a
misconception to imagine that just putting it into a digital form now adds additional weight
Online: < http://www.scidev.net/en/news/biopiracy-fears-cloud-indian-database.html> 139
Ibid. 140
Ibid. 141
Ibid. 142
As stated by V.K. Gupta, Director of TKDL.
49
because absolutely the same material in black and white is available, which is how it would
have been taken into the court”.143
Furthermore she holds that “TKDL, which is only accessible to foreign patent office’s under
access agreement is not available to Indian public. Why is it that we have a secret of our own
national heritage? It should be our public knowledge first. The best defense against biopiracy is
in fact to use it and make it more available to the public of India, so more people continue to
use it. The more it stays in the public domain as a living tradition the more stupid a piracy
becomes”.144
Patrick Roy Mooney, executive Director of the ETC Group, points out that “bio product can be
easily transported out of country and not all indigenous knowledge can be recorded or
digitalized. TKDL`s database is presently limited to just 148 classical text and the library has no
plans to record oral traditions”.145
He also argues that “pharmaceuticals companies are presently
bio prospecting hundreds of species so often the plants or the knowledge for relatively similar
purpose exists in several communities. Once a company determines that a particular plant holds
promise, it asks itself which country would be the best source or gives it the best deal, so they
can barter down to get the cheapest deal?”146
Thus, documentation of TMK in order to provide protection to indigenous people’s knowledge
needs to be analysed again. Adding to this, Vandana shiva insists on modifying international
law and need a more stringent law than digitalizing TMK for protection on national platform.147
143
See Anchal Mehra, “Bio-pircay Killer App India’s Traditional Knowledge Digital Library believes it has found
the silver bullet in the biopiracy wars. Critics say it is aiming at the wrong targets” Little India (March 8, 2010)
Online: ‘http://www.littleindia.com/life/6173-biopiracy-killer-app.html. 144
Ibid. 145
Ibid. 146
Ibid. 147
Ibid.
50
3.3 Instances of Exploitation and Misappropriation of Indian TMK
The practice of biopiracy has today become the legal practice done by large multinational
pharmaceutical companies by exploiting the medicinal knowledge of traditional people’s. India
has witnessed the cases of misappropriation of TMK and making active drugs out of it. There is
a lot to be learned from traditional medicine, but some companies adopt hit and run tactic of
taking away the herbal plants knowledge for investigations and earn lucrative profits, rather
than working with the organisations and institutions for future development.
In the past there have been several cases of biopiracy of TMK from India. These cases are
discussed below. In most of the biopiracy cases, patents were granted to the transnational
companies, but were revoked due to the hue and cry raised by Indians for their TMK. In
addition to this, it takes a country on an average, five to seven years for opposing a granted
patent at the international level which may cost US$ 200,000 to US$ 600,000.148
For instance:
in case of Neem and Turmeric discussed later in this chapter; India had to incur huge costs and
it took more than 10 years to get the Neem patent revoked. For Turmeric, the legal cost incurred
by India was US$ 10,000. In case of Jamun and Basmati, the patent was granted, however, the
Indian government took no step to oppose the grant of the patent until it become the
organisations and the indigenous communities forced the government to take steps to revoke
it.149
Similarly the case of Monsanto BT Brinjal, also discussed in detail later in this chapter;
initiated in 2010 is not yet resolved completely.
Such instances showcase that though Indian patent law revoked the patents granted to
multinationals, it is not effective enough to protect Indian TMK completely. The foreign
148
See Imitaz Muqbil, “India Leads Battle Against Biopiracy of Traditional Knowledge” Travel Impact Newswire
(25 March 2011.)
Online: <http://www.travel-impact-newswire.com/2011/03/india-leads-battle-against-bio-piracy-of-traditional-
knowledge/#axzz24mYtAbA8> 149
Ibid.
51
multinationals take advantage of the leniency in Indian Patent law in not protecting TMK and
thus they get a chance to steal and plunder TMK. Furthermore, multinationals are making
lucrative profits, whereas India is suffering by spending large amounts of money and time in
process of revocation. Its ineffectiveness is reflected from the fact that multinationals, are
encroaching the Indian biodiversity, taking away and patenting the TMK. Therefore, this
problem can be better solved by establishing Sui Generis legislation or firm guidelines. This
will help India create a legal fencing against the unethical patenting and misappropriation of
TMK from multinationals. The establishment of Sui Generis legislation has been discussed in
detail in the next chapter.
3.3.1 Case Studies From India
1. TURMERIC
What it is: Turmeric (Curcuma Longa) a plant of ginger family yielding saffron – coloured
rhizomes is multipurpose. It is used as specie for flavouring Indian cooking. It also has
medicinal, cosmetics and dyes properties. Turmeric powder is a renowned tactic to heal
wounds, sprains, and inflammatory conditions, thus is a key component of Ayurvedic
medicine.150
The Case: In 1995, US Patent Trademark Office (PTO) granted the University of Mississippi
Medical Center a patent no. 5,401,504 on the use of Turmeric for healing wounds, claiming it to
be novel. They did acknowledge in their application that “turmeric has long been used in India
150
See Johan Ragnar, supra note 115. Also See Hon’ble Mr. Vijender Jain, Chief Justice of Punjab and Haryana
High Court, Chandigarh supra note 53. Also See “Abduction of Turmeric Provokes India’s Wrath” Good News
India (January 2002)
Online: < http://www.goodnewsindia.com/Pages/content/traditions/turmeric.html> Also See, “Biopiracy of
Traditional Knowledge” Traditional Knowledge Digital Library (TKDL)
Online: <http://www.tkdl.res.in/tkdl/langdefault/common/Biopiracy.asp?GL=Eng> Also See See Divya Bhargava,
“Patent Act: Biopiracy of Traditional Indian Products – An Overview” Countercurrents (14 May 2009)
Online: <http://www.countercurrents.org/bhargava140709.htm> Also See, R.V. Anuradha, “Biopiracy and
Traditional Knowledge” The Hindu (20 May 2001)
Online: < http://www.hindu.com/folio/fo0105/01050380.htm>
52
as traditional medicine for treatment of various sprains and inflammatory conditions”151
.
However they claimed that there was no research on the use of turmeric as a healing agent for
external wounds.152
The Council of Scientific & Industrial Research (CSIR), India, New Delhi filed a re-
examination case with the US PTO challenging the patent on the grounds of existing prior art.
CSIR argued that “turmeric has been used for thousands of years for healing wounds and rashes
and therefore its medicinal use was not a novel invention. Their claim was supported by
documentary evidence of traditional knowledge, including an ancient Sanskrit text and a paper
published in 1953 in the Journal of the Indian Medical Association.”153
“The Indian
Government challenged the patent as theft”.154
“The US Patent and Trademark Office revoked
the full patent claim in 1997, after ascertaining that there was no novelty, the findings by
innovators having been known in for centuries.”155
Observation: The turmeric case was a landmark case as it was for the first time that a patent
based on the traditional knowledge of a developing country had been successfully challenged. If
granted, the US patents would have prevented Indian companies from marketing turmeric for
wound healing and other medicinal purposes in the USA.156
“The Indian government is
increasingly concerned about biopiracy of other natural resources by foreign companies. Local
communities are already victims, due to high market prices on turmeric.”157
2. NEEM CASE
151
See Johan Ragnar, supra note 115. 152
See Johan Ragnar, supra note 115. Also See Malini S. Goel, “Keeping Bio-pirates At Bay: Creating A New
Legal And Institutional Protection Regime For Traditional Knowledge” Fletcher School, Tufts University (28
April 2003); See R.V. Anuradha, “Biopiracy and Traditional Knowledge” The Hindu (20 May 2001) 153
See R.V. Anuradha, “Biopiracy and Traditional Knowledge” The Hindu (20 May 2001) 154
See Johan Ragnar, supra note 115. 155
See R.V. Anuradha, supra note 154. 156
See Johan Ragnar, supra note 115. 157
Ibid.
53
What it is: Neem (Azadirachta indica) is a tree from India and other parts of South and
Southeast Asia. Neem tree is legendary to India that is used against hundreds of pests and
fungal diseases that Attack food crops. The oil extracted from its seeds can be used to cure cold
and flu and mixed in soap; it provides relief from malaria, skin diseases and even meningitis. In
addition to this, it is useful in many other fields for instance; leprosy, diabetes, constipation,
contraception, and antiseptic toothbrush.158
The Case: In 1971, Robert Larson, a timber importer filed a patent for pesticides based on
Neem and transferred the rights to the American Corporation W.R. Grace and Corporation in
1988. W.R. Grace invented a chemical treatment for pesticides and thus made it possible to be
transported and used worldwide.159
In 1994, the European Patent Office granted a European
Patent No. 436257 (14 September, 1994) to the US Corporation W.R. Grace and the United
States Department of Agriculture for a “method for controlling fungi on plants by the aid of
hydrophobic extracted Neem oil.”160
In June 1995, a legal opposition against the grant of these patents were filed by Green Group in
the European Parliament, Research Foundation for Science, Tecnology, and Natural Resource
Policy, India, and the International Federation of Organic Agriculture Movements, based in
Germany.161
The evidence was submitted that the fungicidal effect of hydrophobic extracts of
Neem seeds were already known and had been used for centuries on a large scale in India. Its
usefulness can be witnessed both in Ayurvedic medicine to cure dermatological diseases and in
158
See Michael Blakeney, “Protection of Traditional Knowledge by Geographical Indications” in Cameron May,
The Law of Geographical Indications (London: The Blissett Group, 2007) at 363
Online: < http://books.google.ca/books?id=8vO0EJled1wC&printsec=frontcover#v=onepage&q&f=false>; Also
See Johan Ragnar, “Biopiracy, the CBD and TRIPS – The Prevention of Biopiracy”, Faculty of Law, University of
Lund (2004). 159
See Sara Hasan, “The Neem Tree, Environment, Culture and Intellectual Property” Ted Case Studies (2002)
Online :< http://www1.american.edu/ted/Neemtree.htm>; Also See Pankaj Kumar Mandal, “Challenges to India’s
Patent Regime – Traditional Knowledge Sharing” (2009) ICFAI Law School, India.
Online: < http://papers.ssrn.com/sol3/papers.cfm?abstract_id=1393363> 160
See Michael Blakeney, supra note 159. 161
Ibid.
54
traditional Indian agricultural practice to protect crops from being destroyed by fungal
infections. It was further argued that the patent application for Neem lacked novelty and
inventive step for the grant of a European patent. It was also pointed out that since the European
Patent Convention explicitly prohibits the patenting of plant varieties, the patent should be
revoked.162
In 1999, the opposition board of the EPO determined that “all features of the present claim have
been disclosed to the public prior to the patent application and the patent was not considered to
involve an inventive step.” Finally EPO revoked the patent in May 2000. “EPO, in March 2006,
rejected the challenge made in 2001 by the USDA and the multinational, W. R. Grace to the
EPO’s previous decision to cancel their patent on the fungicidal properties of the seeds
extracted from the Neem tree.”163
Observation: The Neem tree is a source of Traditional Medicine used in India. Ancient Indian
Aryuvedic Texts have described the Neem tree and its medicinal healing properties as far as
back as 5000 BC. The Neem Patent is one of the few biopiracy patent cases that have been
revoked and it was done so by the European Patent Office.164
3. BASMATI RICE
What it is: Rice is an important aspect of life in the Southeast and other parts of Asia. For
centuries it has been the cornerstone of their food and culture. Basmati Rice is recognised as the
“queen of fragrance or the perfumed one.”165
“This type of rice has been grown in the foothills
of Himalayas for thousands of years. Its perfumy, nut-like flavour and aroma can be attributed
162
Ibid. 163
Ibid. 164
See Dinesh Dyama, “Protection of traditional knowledge IN Indian Patent Act” Go For the Law.
Online :< http://www.goforthelaw.com/articles/fromlawstu/article76.htm >; See Johan Ragnar, “Biopiracy, the
CBD and TRIPS – The Prevention of Biopiracy”, Faculty of Law, University of Lund (2004) 165
See “India-US Basmati Rice Dispute”, TED Case Studies – Agricultural and Processed Food Products Export
Development Authority.
Online: < http://www1.american.edu/ted/basmati.htm>
55
to the fact that the grain is aged to decrease its moisture content. According to Agricultural and
Processed Food Products Export Development Authority (APEDA), India is the second largest
producer of rice after China, and grows over a tenth of the world’s wheat.”166
The Case: In September 1997, Rice Tec. incorporation, a Texas based company was granted a
patent for a strain of Basmati Rice, by the US patent office. Company claimed to have
developed a new strain of aromatic rice by interbreeding Basmati with another variety which
was later named as Texmati and Kasmati167
.168
Rice Tec Inc. made their ways for international
market with these brands that are described as Basmati type rice.169
. Rice Tec. also applied for
registration of a mark Texamati before the UK Trade Mark Registry.170
Rice Tec Inc. was issued the Patent No – 5663484 on Basmati rice lines and grains on
September 2, 1997.171
This grossly affected Indian and Pakistan famers and markets. India not
only lost 45,000 tonne US import market, which forms 10% of the total Basmati exports, but
also its position in crucial market like the European Union, the United Kingdom, Middle East
and West Asia, suffered. In addition to this the patent on Basmati is believed to be a violation of
the fundamental fact that the long grain aromatic rice grown only in Punjab, Haryana, and Uttar
Pradesh (states from India) is called Basmati.172
According to the sources of Economic Times,
166
Ibid. 167
These names were also refereed to be American Basmati. 168
See Utsav Mukherjee, “A Study of the Basmati Case (India-US Basmati Rice Disoute): The Geographical
Indication Perspective (2008) Faculty of Law, National Law University Jodhpur.
Online: < http://papers.ssrn.com/sol3/papers.cfm?abstract_id=1143209 > 169
See “India-US Basmati Rice Dispute”, TED Case Studies – Agricultural and Processed Food Products Export
Development Authority.; Also See Dinesh Dyama, “Protection of traditional knowledge IN Indian Patent Act” Go
For the Law. 170
See R.V. Anuradha, supra note 154. 171
See Utsav Mukherjee supra note 169. 172
See “India-US Basmati Rice Dispute supra note 166.
56
an Indian Newspaper, exclaims that, “Patenting Basmati in US is like snatching away our
history and culture”.173
The Patent was opposed by the two Indian Nongovernmental Organisations (NGOs) – Center
for Food Safety174
and Research Foundation for Science, Technology and Ecology, an Indian
NGO who filed legal petitions in US. The Center for Scientific Research also objected it.
Further, Agricultural and Processed Food Exports Development Authority (APEDA - India)
successfully opposed the Trademark registration of mark Texmati.175
Various issues were raised in this case. For instance:
“Whether the term Basmati is a generic one to describe aromatic rice, or does it refer
specifically to the long aromatic rice grown in India and Pakistan?
Whether the strain developed by RiceTec involves novelty?
Whether RiceTec is guilty of biopiracy?
Whether US government’s decision to grant a patent for the prized Basmati rice violates
the International Treaty on Trade Related Intellectual Property Rights (TRIPS)?
Whether the basmati patent should be revoked in the light of protests from India?”176
After analysing all the above issues, it was observed that the plant varieties and grains already
exist as a staple in India and cannot be patented. The said patent contained 20 claims, out of
which Rice Tec was forced to give up its 15 claims, including those with the most far-reaching
implications related to biopiracy. However, other claims were also revoked after the evidence
was submitted by IARI (Indian Agricultural Institute). Hence, US Patent Office revoked all the
173
See D. Balasubramanian, “Basmati - Identity Crises Solved” The Hindu (9 May, 2002)
Online:< http://www.hindu.com/thehindu/seta/2002/05/09/stories/2002050900070200.htm > Also See “India-US
Basmati Rice Dispute”, TED Case Studies – Agricultural and Processed Food Products Export Development
Authority 174
An international NGO that campaigns against Biopiracy. 175
See Utsav Mukherjee, supra note 169. Also See R.V. Anuradha, supra note 154. 176
See Utsav Mukherjee, supra note 169.
57
claims of the patent made by Rice Tech, most importantly, the right to call their rice as
Basmati.177
Observation: Basmati Rice case is the best example of loss of cultural value. “Basmati is an
instance of Geographical appellation that belongs to India and Pakistan.”178
It was observed that
the patent is not novel and for an invention that is obvious, being based on rice that is already
being imported in US.179
This case also demonstrated the problem as illustrated in TRIPS that
patents are granted to biotechnological processes. Thus, even though Basmati rice has been in
South Asia for centuries, Rice Tec just altered it slightly and successfully claimed it as their
own.
The decision in this case was a huge victory for Indian and Pakistan farmers, who could have
faced enormous economic losses due to the grant of patent over Basmati rice.
4. JAMUN PATENT CASE
What it is: ‘Jamun’ also known as ‘Syzygium Cumini’ is indigenous to India. It is generally
grown as an avenue tree or wind break tree of and hence found all over India. Jamun is rich in
iron and helps preventing heart troubles, liver problems and thyroid. 180
The seeds of Jamun are
known for its anti-diabetic properties. It is a common knowledge used in everyday practice.181
177
See Utsav Mukherjee, supra note 169. Also See V. Anuradha, supra note 154. 178
See Johan Ragnar, supra note 115. 179
See Utsav Mukherjee, supra note 169. 180
See Dr. I.S. Singh, “Jamun” Fruitpedia.
Online:< http://www.fruitipedia.com/jamun.htm> 181
See Johan Ragnar, supra note 115. Also See Vandana Shiva, supra note 135. See GRAIN, “Biopiracy and Prior
Art” GRAIN (August 4, 1999)
Online: << http://www.grain.org/article/entries/1882-Biopiracy-and-prior-art>>
58
The Case: A US patent No – 5,900,240 was granted on May 4, 1999182
to Cromak Research
Inc., based in New Jersey, USA. The assigners were three non-resident Indians, Onkar S.
Tomer, Kripamath Borah , and their colleague, Peter Gloniski.183
The claim by the US Company to use Jamun for anti-diabetic treatment as an invention was
proved to be false since such use has been known and documented in India widely. The patent
was challenged on the ground of prior art.184
“The indigenous knowledge and use consists of
‘prior art’. No patent should be given where prior art exists, since patents are supposed to be
granted only for new inventions on the basis of novelty and non-obviousness. These criteria
establish inventiveness, and patents are exclusive rights granted for inventions”185
.
Observation: The patent was challenged on the ground of prior art and no inventiveness were
found. However, “Article 102 of the US Patent Law, that defines prior art does not recognize
technologies and methods in use in other countries as prior art”186
. Because of this, the Jamun
could be patented in the USA. But it does created hue and cry in India for such a patent as it
was considered to be a biopiracy i.e. theft of Indian TK.187
5. ATTA CHAKKI CASE
What it is: Atta is referred to flour and Chakki is the manufacturing machine that is used to
make Atta. .This is mostly used to make South Asian Breads such as Chapati, Roti, naan and
Puri. Atta is basically extracted from the Wheat Plant. The Semi Hard Wheat varieties are used
and grinded in the Chakkis to produce fine ground Atta.
182
See GRAIN, “Biopiracy and Prior Art” Grain (August 4, 1999)
Online: < http://www.grain.org/article/entries/1882-Biopiracy-and-prior-art> 183
See Johan Ragnar, supra note 115. Also See Vandana Shiva, supra note 135. Also See Devinder Sharma, “India
May Contest U.S. Patent on Diabetic Remedy” Ens-Newswire (August 27, 1999)
Online:< http://www.ens-newswire.com/ens/aug1999/1999-08-27-01.asp> 184
See GRAIN, supra note 185. 185
Ibid. 186
See Johan Ragnar, supra note 115. 187
See Devinder Sharma, “India May Contest U.S. Patent on Diabetic Remedy” Ens-Newswire (August 27, 1999)
59
The Case: In August, 1998, three inventors named Salem Ali, Sarath K. KAtta and Sambasiva
R. Chigurupati through ConAgra Inc. filed a Patent on method of producing‘Atta Flour’.188
The
United States Patent and Trademark Office granted the Patent to ConAgra Incorporation. The
patent no- 6,098,905 was granted for its so-called ‘invention’ i.e. method for producing flour
that’s currently being employed in countless mills across South Asia”189
.190
The Nebraska-
based ConAgra produced an invention that “cracks wheat and subsequently grinds cracked
wheat into flour. The patent covers “changes, variations, modifications, and other uses and
applications that do not depart from the spirit and scope of invention”191
.The novel invention
includes “passing an amount of wheat through a device designed to crack the wheat so as to
produce an amount of cracked wheat, followed by passing the cracked wheat through at least
two smooth rolls designed to grind the cracked wheat into flour, with the smooth roll
importantly grinding the wheat to a smaller particle size and shearing the wheat to cause starch
damage in the finished Atta flour”192
.
Observation: The declaration made by ConAgra does not claim any novel invention in the
plant or machinery needed for processing flour, but on very traditional method for producing
Atta. The method which has been patented is similar to the method being used in Indian Atta
chakkis or thousands of Atta chakkis-roller flourmills through Asia. It already existed in public
188
See “United States Patent” Rfrost People.
Online:<http://rfrost.people.si.umich.edu/courses/SI110/readings/IntellecProp/Patent_for_NaanAtta_Flour_Milling
.pdf> 189
See “India Needs To Document Traditional Knowledge” The World Trade Review (January 15, 2003)
Online: < http://www.worldtradereview.com/news.asp?pType=N&iType=A&iID=48&siD=9&nID=5450> 190
See “Granting of ‘Atta Chakki’ Patent Exposes Absurdity of Patenting Regime” Infochange India
Online: <http://infochangeindia.org/agriculture/news/granting-of-a8216Atta-chakkia8217-patent-exposes-
absurdity-of-patenting-regime.html>; See Ashok B. Sharma, “Now, a US patent for Atta Chakkis” The Indian
Express (December 10, 2002) Online: <http://www.indianexpress.com/storyOld.php?storyId=14493>; See “United
States Patent” Rfrost People. Online:
<http://rfrost.people.si.umich.edu/courses/SI110/readings/IntellecProp/Patent_for_Naan-Atta_Flour_Milling.pdf>;
See Vandana Shiva, “Biopiracy: Watch Out, Monsanto’s Patenting the Chapati”, Laleva (April 8, 2004) Online: <
http://www.laleva.org/eng/2004/04/bio_piracy_watch_out_monsantos_patenting_the_chapati_unleavened_bread.ht
ml> 191
Ibid. 192
See Ashok B. Sharma, “Now, a US patent for Atta Chakkis” The Indian Express (December 10, 2002) Online:
<http://www.indianexpress.com/storyOld.php?storyId=14493>
60
knowledge. This was observed as another case of stealing technique or biopiracy methods.
“This corporation has simply copied the indigenously developed processed and knowledge of
the Third World Communities and taken monopoly rights through biased patent system. Since
ConAgra patent also covers the ‘spirit’ and ‘scope’ of the invention, thus any modification and
variation in the invention is also patented under the scope of the patent. ConAgra has in one
broad sweep ensured that they have a monopoly control over Indian and other South Asian
wheat flourmills. The patent was mainly to capture the mammoth Atta market in India.”193
However, threat of such monopoly control was relieved when it was decided that this patent
will only be valid in US.194
6. MONSANTO BT BRINJAL CONTROVERSY
What it is: Monsanto is an agricultural company, founded in 1901 in USA.195
It has a
subsidiary company in India named as Monsanto India Limited. Bacillius Thuringiensis (BT)
Brinjal, is a “transgenic brinjal created by inserting a gene cry1 Ac from the soil bacterium into
Brinjal. This said to give the Brinjal plant resistance against insects like Brinjal Fruit and Shoot
Borer and Fruit Borer”196
. BT Brinjal is “created by India’s number one seeds company
‘Mahyco’197
in collaboration with American multinational Monsanto, who claims to improve
yields and help in the agriculture sector”198
.
193
See Laurent Ntahuga, “Norway/UN Conference on Technology Transfer and Capacity Building”.
http://www.google.ca/url?sa=t&rct=j&q=&esrc=s&source=web&cd=1&ved=0CE0QFjAA&url=http%3A%2F%2
Fciteseerx.ist.psu.edu%2Fviewdoc%2Fdownload%3Bjsessionid%3D6BE85DA734B71444A7E8EF3D141EEEAB
%3Fdoi%3D10.1.1.196.1065%26rep%3Drep1%26type%3Dpdf&ei=8jD6T8_PE8jVqQGT9cWLCQ&usg=AFQjC
NGJQfLUfa9WJ0cKeI54gzxNKhQdcw&sig2=z1JzPA_6AhkQwej7-XcpRQ 194
See Ashok B. Sharma, supra note 193. 195
See Monsanto Company. Online: <http://www.monsanto.com/Pages/default.aspx> 196
See Center for Environment Education, “National Consultations on BT Brinjal: A Primer on Concerns, Issues
and Prospects” Government of India, Ministry of Environment and Forests.
Online: <http://moef.nic.in/downloads/public-information/Bt%20Brinjal%20Primer.pdf> 197
Mahyco is a Maharastra Hybrid Seed Company. 198
See “All You Wanted to Know About BT Brinjal” Business Rediff (January 27, 2010)
Online: <http://business.rediff.com/slide-show/2010/jan/27/slide-show-1-all-about-bt-brinjal.htm>
61
The Case: In 2010, Monsanto in partnership with Mahyco, developed the BT Brinjal which is
also known as ‘Genetically Modified Organism (GMO)’199
Brinjal. A massive public
opposition was raised by “farmers and scientist concerned about the negative impacts of
Mayhco-Monsanto’s BT Brinjal on livelihoods, human health, the environment and local
varieties. A moratorium on BT Brinjal was subsequently implemented”. 200
In 2011, the National Biodiversity Authority (NBA) issued a legal action against Mayhco-
Monsanto and their collaborators for biopiracy. NBA alleges that Mayhco-Monsanto has
accessed six to nine Indian varieties of brinjal to develop their genetically modified vegetable
without prior permission from the NBA or the relevant state and local boards.201
A complaint
against Monsanto was lodged by the Environment Support Group (ESG) with the Karnataka
Biodiversity Board, “triggering government action, alleges, that Monsanto compromised India’s
sovereign control over its biological resources and also deny economic and social benefits to
the local communities under the Access and Benefit Sharing Scheme”.202
However, a criminal
prosecution is yet to start and will soon be initiated in 2012.203
India’s argument is over the commercialisation of indigenous knowledge and the violation of
Biodiversity Act, 2002. In addition to this, it has been stated that “it is a crime to ‘steal’ an
indigenous crop (in this the brinjal i.e. eggplant) and use it to create a modified version without
199
A GMO is a plant, animal or microorganism whose genetic code has been altered, subtracted, added in order to
give it characteristics that it does not have naturally.
Online: < http://nature.ca/genome/03/d/30/03d_31_e.cfm> 200
See Joseph Zacune, “Combating Monsanto: Grassroots resistance to the Corporate Power of Agribusiness in the
Era of the Green Economy and a Changing Climate” Via Campesina (March 2012)
Online: < http://www.viacampesina.org/downloads/pdf/en/Monsanto-Publication-EN-Final-Version.pdf > 201
See Priscillia Jebaraj, “India probe finds Monsanto Guilty of Biopiracy” One World South Asia (July 10, 2012).
Online: < http://southasia.oneworld.net/todaysheadlines/probe-finds-monsanto-guilty-of-biopiracy/?searchterm= > 202
See Ruhi Rizvi, “Monsanto Biopiracy and Brinjals: A threat to Indian Biodiversity” SciNews (January 15,
2012)
Online: < http://www.iscience.in/news/22/monsanto-Biopiracy-and-brinjals > 203
See Ramoo, “NBA Confirms Monsanto/ Mahyco and Ors. To be Criminally prosecuted in BT Brinjal Biopiracy
Case” Indian Agrarian Crisis (May 24, 2012)
Online :< http://agrariancrisis.in/2012/05/24/nba-confirms-monsantomahyco-and-ors-to-be-criminally-prosecuted-
in-b-t-brinjal-Biopiracy-case/ >
62
permission”.204
Furthermore, Indian farmers also argue that “they developed the strains of
eggplant grown in India over generations and Monsanto has no right to come in and build a
product of their own indigenous species”.205
On the other hand, Monsant denies such an allegation made by Indian Government. It claims
that their main priorities are farmer, integrity, and public health.206
Observation: In August 2011, India succeeded in putting a temporary ban on BT Brinjal.207
NBA in its initial judgment stated that BT Brinjal is a case of biopiracy and placed other
charges against the BT Brinjal’s developers that includes Monsantos’ India partner Mahyco, as
well as Indian universities and research organisations. It is a clear case of Biopiracy of genetic
materials. In addition, it is a clear case of theft of knowledge or genetic resources belonging to a
region, community or country that is later claimed to be someone’ else. The use of such
knowledge or genetic resources may be hampered or sought to be prevented by patent holder,
though unfairly profited from the patent. The case is still open and if India succeeded it will be
the first ever fought GMO case making history.208
The above cases of biopiracy are illustrative of the fact that India’s TMK is in great danger. The
epidemic of biopiracy is an assault on India’s biodiversity and cumulative innovation
embodied in the TMK. However, India is not the only country to be a victim of such plundering
of nature and associated knowledge. There are many other cases existing outside India out-
crying the same story of biopiracy being an epidemic. Some of the famous cases within and
outside of India include: Hoodia Catcus case, Ayahuasca case, pepper, harhar, bahera, amla,
204
See Colleen Scherer, “India Challenges Monsanto; Claims Biopiracy” AG Professional (February 2, 2012)
Online: < http://www.agprofessional.com/news/India-challenges-Monsanto-claims-Biopiracy-138555944.html > 205
Ibid. 206
See Rajeshree Sisodia, “Biopiracy in India: The Case of the Aubergine” Aljazeera (October 31, 2011)
Online: < http://www.aljazeera.com/indepth/opinion/2011/10/2011102994021308862.html> 207
See Joseph Zacune, supra note 201. 208
See “NBA establishes Biopiracy in BT Brinjal” IAS 100 News (July 9, 2012)
Online: < http://www.ias100.in/news_details.php?id=541>
63
mustard, ginger, castor, Quinoa Case, Enola Beans case, Pilocarpus Jaborandi case, Tiki Uba.
These examples showcase the inadequacy of the IPR system to protect TMK. If there were only
one or two cases of biopiracy, they could be dismissed as errors however there are several cases
which implies that the problem is deep within the system.
3.4 Conclusions Remarks
With regard to biopiracy in India, the case studies presented in this chapter indicate that, the
protection and enforcement of strong patent rights in India have not been conducive to its
objective as declared in Section 1 of the Patent Act, 1970, that ‘it will extend to whole of
India’.209
Further Supreme Court of India in case of Bishwanath Prasad Radhey Shyam v. H.M.
Industries210
confirmed the objective of patent law, i.e. “to encourage scientific research, new
technology, and industrial progress. Grant of exclusive privilege to own, use or sell the method
or the product patented for the limited period stimulates new inventions of commercial utility.
The price of the grant of the monopoly is the disclosure of the invention and the origin at the
patent office, which after the expiry of the fixed period of the monopoly passes into public
domain”.
These statements of objects and reasons of Indian Patent Law are not favourable to Indigenous
people and their TMK. The Patent Act does extend its protection for innovation and creativity
to India, but not whole of India because it excludes the indigenous population living in India.
209
See Section 1 of Patent Act, 1970: Short Title Extend and Commencement: subsection (2): It extends to the
whole of India.
Online: < http://www.aswal.com/images/downloads/The%20Patents%20Act,%201970.pdf> 210
A.I.R. 1982 S.C. 1444 at Paragraph 17.
Online: < http://ipindia.nic.in/ipr/patent/Patent_Manual_Feedback/WO_Ga_34_China.pdf>; Also See Jakkrit
Kuanpoth, Patent Rights in pharmaceuticals in Developing Countries; Major Challenges for the Future
(Cheltenham, UK: Edward Elgar Publishing, 2010) at 48.
Online: <
http://books.google.co.in/books?id=xqbGQd93q08C&pg=PA48&lpg=PA48&dq=Biswanath+Prasad+Radhey+Shy
am+v.+H.M.+Industries+A.I.R.+1982+S.C.+1444+at+Paragraph+17.&source=bl&ots=VpBLui9Bvj&sig=5goohkr
lGU9R7sUn9Rf_jFZVIMQ&hl=en&sa=X&ei=8KsJUPu-
BYW4rQH7za2kCg&ved=0CFAQ6AEwAg#v=onepage&q=Biswanath%20Prasad%20Radhey%20Shyam%20v.
%20H.M.%20Industries%20A.I.R.%201982%20S.C.%201444%20at%20Paragraph%2017.&f=false>
64
For the protection of TMK, it is important to have the active participation of indigenous
communities. I believe that their participation can bring fundamental changes to the existing
protection system or forthcoming protection system. It should be coordinated by the people for
whom such laws are to be made.
After analysing the arguments of critiques, I think, the biggest drawback in the TKDL system is
the lack of active participation of indigenous communities. I believe that, in order to respect the
rights of indigenous people over their TMK, it is important to include them for their
development. Listing out the names of thousands of plants existing in nature, and making the
biggest document ever will not solve the problem. The makers of TKDL, should have also
included who indigenous people are? and what are their rights? This would have cleared the
importance, intentions and purpose behind making such a document. Concept of benefit sharing
should also have been included in that, which have always been raised as an issue by
indigenous communities. Therefore, absence of these tools and no easy access to law for the
protection of TMK, has today aggravated the crime of biopiracy. Vandana Shiva has summed
up the threat of biopiracy in three ways:
1. “It creates a false claim to novelty and invention, even though the knowledge has
evolved since ancient times as part of the collective and intellectual heritage of India.
2. It divests scarce biological resources to monopoly control of corporations thus depriving
local communities the benefits of its use.
3. It creates market monopolies and excludes the original innovators (farmers) from their
rightful share to local, national and global markets.”
Further the current Indian IPR system cannot protect TMK for three main reasons:
1. The current system seeks to privatize ownership and encourages unethical practices
which can earn mammoth profits.
2. The Patent protection is time bound, whereas TMK is held in perpetuity from generation
to generation.
65
3. The patent system protects newness, non obviousness and usefulness that do not fit for
the protection of TK as it is public domain.
In addition to this, these cases of biopiracy and feebleness of the Patent system has affected and
in future will continue to affect India in several ways:
Firstly, as accused by Shiva, the stealing of biological resources associated with TMK, affects
Indian economy, livelihood, and food security. India being an agricultural economy, the plant
varieties are essential to Indians and their knowledge to Indigenous community. The knowledge
is not only related to food, but also for the medicinal purposes. Theft of such knowledge will
definitely pose a threat to indigenous communities and consumers.
Secondly, patenting of TMKS will encourage monopolizing plant material and the knowledge
associated with it, by western transnational companies. This will lead to rise in prices of the
medicines and essential drugs. Particularly for the developing countries, who cannot afford such
expensive medicines and rely on the traditional based knowledge. Such privatizing knowledge
would mean, no more conservation, preservation, sustaining, and sharing of herbal knowledge
that would finally affect the development of Indian economy.
Thirdly, the patenting of TMK and adopting no stringent steps for its prevention would give rise
to more biopiracy cases. Other countries would take India for granted and will patent the TMK
holder’s knowledge. Other countries like U.S will amend their patent law in such a manner that
patenting TMK will not constitute biopiracy in their country. Therefore, developing countries
like India are left with the choice of protection of TMK.
Lastly, it will invite more problems for the country on ethical grounds. Ethically, it will enhance
such practices of patenting biological materials. The respect for indigenous communities, their
rights, and knowledge will vanish. Today, at least indigenous people are recognised for benefit
66
sharing schemes. However, probably in near future these big multinationals pharmaceuticals
immune the patent system in such a manner that owning knowledge will be novel without
recognising the indigenous for profit sharing.
Therefore, after analysing the problem in: Indian Patent System (or IPR system as whole), the
role of International conventions, and the solutions to protect TK, I think, now the message is
loud and clear that India needs something just more than Patent system. If India wants to
protect its biodiversity from bio-pirates both existing within or outside the country, it needs a
law that is firm and can act to keep bio-pirates at a bay.
It is important for India to have an act of its own because declaring biopiracy illegal is not
enough and will not solve the problem, but important to have a legal stamp over it. Hence, I
hereby propose for a Sui Generis legislation. . I believe that it will be a possible solution to start
all over, particularly from national level to develop a specific law in India to deal with
biopiracy.
67
CHAPTER FOUR
NEW WAVE FOR A NEW CENTURY: CONCLUDING REMARKS WITH
PROPOSED MODEL GUIDELINES FOR THE PROTECTION OF TRADITIONAL
MEDICINAL KNOWLEDGE IN INDIA
4.1 Introduction
This thesis has investigated, and taken as its starting point; the obligation for India to step ahead
forward and establish a Sui Generis system for protection of TMK. In particular, this thesis has
focused on the Indian experience in TK sector i.e., instances of misappropriation and
exploitation of TMK by obtaining patents on them and without due recognition and benefits to
the indigenous communities, who are the holders of such knowledge; by multinational
pharmaceuticals industries. This thesis concludes that the implementation and enforcement of
strong patent protection has not proved effective and conducive to the protection of TMK.
Indeed, it has always enhanced and favoured privatizing and monopolizing TMK and growth in
its economic and commercial utilization.
This thesis has investigated the scenarios; where time and again the current patent tool has been
unable to meet the standards for protection of TMK. Indian patent law as a protection
mechanism protects, novelty, non-obviousness, and utility. However, TMK being in public
domain does not carry such attributes, still requires protection because, it contains distinct
cultural identities of indigenous community along with that of nation. It is the knowledge that
has been preserved, conserved and practiced for millennia by our ancestors over generations. It
is the blend of our socio-political, cultural, economic system and institutions, ethics, moral
values and our customary laws and norms.
The concepts, knowledge and utilization of Ayurveda, Unani, and herbal plants have been
practiced since the ages, by generating, refining and passing them from generation to
68
generation. The ideal intentions of our ancestors were to safeguard the knowledge to make it
sustainable for future generations for their health benefits. Nevertheless, today, this knowledge
is usually practiced and shared by and among different nations respectively. Such practices and
sharing is not the result of peaceful exchange of TMK, rather plundering of the knowledge
without recognizing and intimating the knowledge holders. Thus, today the sharing of
knowledge is observed as trade concerns, and for that; having a legal fencing is really
important.
The issue of protection of TMK has also gained international attention. The international
agreements like TRIPS and CBD tried to formulate guidelines for protection of indigenous
TMK and harmonization between the nations regarding such issue however, proved futile. On
national platform, Indian Biological Diversity Act, 2002 does contain some provisions
regarding protection, but still ineffective in protecting TMK. Indian TKDL the biggest digital
library containing list of thousands of herbal plants, Ayurvedic medicines etc., also not
favourable for protection of TMK.
One cannot stop researchers from researching on anything that exist in nature, like in present
case TMK; however, it is important to stop the commercial exploitation and misappropriation
of TMK resulting from the research. Hence, the main argument of this thesis is that, the tools of
current Indian IPR system, particularly patent law is inadequate to protect TMK from being
exploited for its commercial utilization, and therefore, it needs something more than that; i.e. a
Sui Generis system of protection.
The recommendation of Sui Generis system is not new. It has been suggested many times in
different writing by different scholars about the issue of protection of TMK. Nevertheless, in
this thesis, I am proposing a Sui Generis system, but in detail and in form of a bill or guidelines.
69
I am presenting a model Sui Generis system with terms to be defined, rights of indigenous
communities, and various responsibilities for the authorities on protection of TMK, along with
the legal penalties.
4.2 Sui Generis System
Because of the difficulties identified above in the application of IPR particularly patent system
to the protection of TMK, hereby I am proposing to establish Sui Generis system of protection
for TMK.
Sui Generis literally means, “of its own kind and consists of a set of nationally recognized laws
and ways of extending plant variety protection (PVP) other than through patents.”211
They are
considered an alternative model created outside the prevailing IPR regime. It is specially
designed to address the needs and concerns of a particular issue. “It is a new system of legal
rights encompassing concepts such as traditional resources rights and the right to self
determination.”212
Such system will create a relationship between the “interest in biodiversity
and the traditional control of resources necessary to the protection of cultural diversity”.213
The genetic resources and associated TMK, being public goods exist outside the pail of
markets. They are not amenable to pricing. “Where both genetic resources and associated TK
are sought to be accessed through bioprospecting activities matter gets complicated. One of the
most ticklish issues is to segregate value of genetic resources from its associated TK. Since
biodiversity legislation largely view TK as an associated feature of genetic resources, the
211
See Stephen A. Hansen and Justin W. VanFleet, supra note 113. 212
See IPGRI, “Key Questions For Decision Makers: Protection of Plant Varieties under the WTO Agreement on
Trade Related Aspects of Intellectual Property Rights” Google Books (October, 1999)
Online:
<http://books.google.co.in/books?id=LPlAb5h9OYC&pg=PA5&lpg=PA5&dq=what+is+sui+generis+system&sou
rce=bl&ots=T3qH6yix9y&sig=RXc8B-kHU-
xoO5UyJSFQh_AmOAw&hl=en&sa=X&ei=XBMTUNOsHpGZqQHP34HABg&ved=0CD4Q6AEwAg#v=onepa
ge&q=what%20is%20sui%20generis%20system&f=false> 213
See Johanna Gibson supra note 71.
70
former is likely to be devalued in comparison to the latter.”214
Sui Generis legislation on TMK
will recognize economic, cultural, social development in order to ensure a more objective
valuation of TMK along with a benefit sharing prospective.
Supporting the Sui Generis system Damodaran advocates that:
“A Sui Generis law for protecting TK is also necessitated by the fact that, discussions that
narrowly focus on TK related to biological and non biological resources do not cover the
knowledge that is non-functional. A Sui Generis regulation that covers all facets of TK will
be wider in scope and comprehensive in approaching TK in its totality. To this extent it will
encourage a more objective system of valuation of TK that respects its aggregate value, than
the value of a small component. While national Sui Generis legislation would facilitate a
robust system of TK protection, international action to frame guidelines and compacts is
desirable, given the global character of knowledge and resource flows. International
guidelines and compacts not only guarantee reciprocity but also ensure that norms of TK
protection and benefit sharing are harmonized within the framework of a multilateral
regime.”215
I agree with the argument made by Damodaran, and therefore in the conclusion of this thesis I
am proposing for a national Sui Generis legislation. I agree with Damodaran on establishing an
international guideline for protection of TMK; however, I believe that initiating such a step
from home country would be more effective than establishing an international Sui Generis
system.
214
See A. Damodaran, “Traditional Knowledge, Intellectual Property Rights and Biodiversity Conservation:
Critical Issues and key Challenges” (2008) 13 Journal of Intellectual Property Rights 509 at 512.
Online: < http://nopr.niscair.res.in/bitstream/123456789/2039/1/JIPR%2013(5)%20509-513.pdf > 215
Ibid.
71
Such an initiative is not new and many other countries have already established there Sui
Generis system of legislations’ for protection of TMK. For instance: Brazilian Legislation on
Traditional Medicinal Knowledge216
, Chinese Legislation on Traditional Chinese Medicines
(2003)217
, European Union Legislation on Traditional Herbal Medicines. (2004)218
, Thailand
Sui Generis System219
, Philippine Legislation on Traditional and Alternative Heath Care (this
act known as Traditional and Alternative Medicine Act, 1997)220
, Panama221
and Peru222
Sui
Generis System for TMK223
, South Africa Policy on Indigenous Knowledge System and
legislation on Biodiversity 2006.224
I have referred to these Sui Generis legislations as model laws for preparing Sui Generis
legislation for India. Along with this I have also referred to some international agreements and
conventions for the same as: Nagoya Protocol on access to genetic resources and the fair and
equitable sharing of benefits225
, Paris Convention of Industrial Property, 1883.226
I believe that, Sui Generis systems of other countries are worth studying for several reasons.
Firstly, similar to India; Panama and Peru are rich in natural resources and the population of
indigenous people in both countries are significant.227
Secondly, Brazil, China, Thailand,
Panama, Peru, Philippine are developing countries like India and all these countries are willing
to attract foreign investment in order to bring economic development to their citizens, but
216
Online: <http://www.wipo.int/wipolex/en/details.jsp?id=5897> 217
Online: <http://www.wipo.int/wipolex/en/details.jsp?id=5482> 218
Online:< http://www.wipo.int/wipolex/en/details.jsp?id=5557> 219
Online: <http://www.thailawforum.com/articles/Thai-traditional-medicine-protection-part1-5.html> 220
Online: <http://www.lawphil.net/statutes/repacts/ra1997/ra_8423_1997.html> 221
See Law No 20 of June 26, 2000 on Special System for the Collective Intellectual Property Rights of
Indigenous Peoples for the Protection and Defense of their Cultural Identity and their Traditional Knowledge.
Online: < http://www.wipo.int/wipolex/en/text.jsp?file_id=177308> 222
See Peru Law on Indigenous Knowledge.
Online: < http://www.wipo.int/tk/en/documents/word/peruvian-law-27811.doc> 223
See Tatiana Lopez Romero, supra note 27. 224
Online: <http://www.wipo.int/edocs/mdocs/tk/en/wipo_grtkf_ic_9/wipo_grtkf_ic_9_11.pdf> 225
Online: <http://www.cbd.int/decision/cop/?id=12267>. 226
Online: < http://www.wipo.int/treaties/en/ip/paris/trtdocs_wo020.html> 227
See Tatiana Lopez Romero, supra note 27
72
without any loss and danger to their biodiversity.228
Thirdly, due to the active participation of
indigenous people in these countries for establishment of Sui Generis legislation, the system as
a result has responded actively to the cultural, economic and social expectations of indigenous
communities for the protection of their TMK. For instance, in Panama and Peru the system has
made “possible a potential dynamic role for customary law and practice in defining the
parameters of positive protection of TMK”.229
Fourthly, Thailand regulations have provided for
measures aimed at conservation and sustainable utilization of the medicinal plants especially
those at the high risk of extinction. This has helped Thailand in maintaining and recording the
utilization of herbal plants for making drugs.230
Lastly, these countries Sui Generis system have
proved to be beneficial for indigenous communities and the society in outweighing the
misappropriation, exploitation and unethical patenting of TMK.231
For instance: the South
African Policy on Indigenous Knowledge System acted as a watchdog against the
misappropriation of TMK cases and detected thirty-six cases of biopiracy after a single month
of investigating patent granted in the developed world and working on solving the issue.232
4.3 BILL / GUIDELINES
Statements of Objects and Reasons
The issue of exploitation and misappropriation of Traditional Medicinal Knowledge is frequent
and regularly reported. With no rights and rules to fall back on, most of the traditional
knowledge has become contemporary slave. The spate instances of biopiracy in the name of
research are increasing day by day.
228
Ibid. 229
Ibid. 230
See Carlos M. Correa, “Protection and Promotion of Traditional Medicine – Implications for Public Health in
Developing Countries” World Health Organisation (August, 2002)
Online: < http://apps.who.int/medicinedocs/en/d/Js4917e/> 231
Ibid. 232
See Lorna Dwyer, “Biopiracy, Trade and Sustainable Development” Cjielp.
Online:< http://www.cjielp.org/documents/cjielp_art125.pdf>
73
Traditional Knowledge has played and still plays, vital role in the daily lives of vast majority of
people. Traditional knowledge is essential for human health care, food security in the
developing world. However, the developed countries are deriving their products from
developing countries traditional knowledge about the use of plants for medicines. Indian system
of medicine like Ayurveda, Unani, Siddha and others are largely derived from traditional
knowledge that broadly exists in public domain. This has provided a window to pharmaceutical
industries to assume that herbal sector in developing countries operate on an assumption that
traditional medicinal knowledge is available for and all to commercialize without the
consideration such as benefit sharing or customary ownership and without recognition to
indigenous communities.
Absence of any legal protection has to lead to severe exploitation of traditional medicinal
knowledge. It has also affected the fundamental justice and the ability to protect, preserve and
control one’s natural heritage. Further, it has deprived indigenous communities from their right
to receive a fair return on what these communities have developed and preserved. Thus,
indigenous communities are losing their identity and due to this the nation’s identity as being
rich in culture, biodiversity and traditional knowledge related to bio resources is in danger.
The need to enact Sui Generis legislation is necessary; to protect biodiversity and associated
knowledge as:
They are being collected and patented.
Valuable gens are isolated from bio-resources and patented. These genes are then used
to generate commercial products.233
233
See Vinay Kumar and Bandana Peters Lazarus Tragets 2011, A Complete Refresher Biology (New Delhi: Tata
McGraw Hill, 2010) at 300
Online: <
http://books.google.ca/books?id=aGJjU1wNF30C&pg=PA300&lpg=PA300&dq=Useful+genes+are+isolated+fro
m+the+bioresources+and+patented.+These+genes+are+then+used+to+generate+commercial+products.&source=bl
&ots=ZCWEVu6wtH&sig=VOODSKJDQSiCX2Zn5bzmCg7UE&hl=en&sa=X&ei=1lkUUKT5CsPPqgG644GY
Dw&ved=0CFgQ6AEwAA#v=onepage&q=Useful%20genes%20are%20isolated%20from%20the%20bioresource
74
The traditional knowledge related to bio-resources is utilized to achieve above
objectives. In some cases Traditional Knowledge itself may be subject to patent.234
Therefore, only a comprehensive central legislation specially designed to meet the standards of
protection for TMK can ensure the end of such exploitation or biopiracy.
CHAPTER ONE
PRELIMINARY
Article 1 Short Title, Extent and Commencement
a. This Act may be called The Traditional Medicinal Knowledge Act, 2012.
b. It extends to whole of India
c. It shall come into force on such date as the Central Government of India may, by
notification in the Official Gazette, appoint.
CHAPTER TWO
TERMS TO DEFINE
Article 2. In addition to the concepts and definitions contained in Convention of Biological
Diversity and Indian Biodiversity Act, 2002, the following terms are defines for the
purposes of this guidelines:
a) Associated Traditional Knowledge: Knowledge preserved, developed and practice over
generations by individual, indigenous or local communities with real or potential Value,
associated to genetic heritage.
b) Biological resources: means, genetic resources and other biotic components of ecosystems
with actual and potential value for humanity. 235
s%20and%20patented.%20These%20genes%20are%20then%20used%20to%20generate%20commercial%20prod
ucts.&f=false > 234
Ibid. 235
See Konard Becker, “Patents and Genetic Resources/ Traditional Knowledge” Aippi Online:
<https://www.aippi.org/download/reports/forum/forum07/2/ForumSession2_Presentation_Konrad_Becker.pdf
Also see CBD, Article 2. Online: <http://www.cbd.int/convention/articles/?a=cbd-02>
75
c) Biopiracy: means, large corporations adopting legal practices by using tools of Intellectual
Property Rights to legitimize the exclusive ownership and free ride over biological
resources and traditional medicinal knowledge without giving recognition and share in
profits.236
d) Benefit Sharing: means, fair and equitable sharing of profits incurred by outsiders or users
of traditional medicinal knowledge; determined by board or body authorised for benefit
sharing to indigenous people.
e) Benefit sharing schemes: means, compensatory justice schemes run by authorised body
for welfare and development of indigenous community.
f) Benefit Claimers: means, preserves and holders of biological resources and associated
knowledge, innovations and practices.237
g) Biological diversity: means the variability among living organisms from all sources and the
ecological complexes of which they are part and includes diversity within species or
between species and of eco-systems.238
h) Country of origin of genetic resources: means the country which possesses those genetic
resources in in-situ conditions.239
236
See International Expert Workshop on Access to Genetic Resources and Benefit Sharing, “Identification of
Outstanding ABS Issues: Access to GR and IPR; What is Biopiracy?” Moderncms. Ecosystem Market Place
Online: <http://moderncms.ecosystemmarketplace.com/repository/moderncms_documents/I.3.pdf>; Also see
Vandana Shiva, Protector or Plunder? Understanding Intellectual Property Rights (New Delhi: Penguin Books,
2001) at 49. Online:
<http://books.google.co.in/books?id=ghwTDbc4uYoC&pg=PA49&lpg=PA49&dq=what+is+biopiracy&source=bl
&ots=TaCHOPhQlB&sig=lWXXnKax5w7oksUyNgeNB4gWFzM&hl=en&sa=X&ei=EEwPUJ3TDtDciQKm44H
YBg&ved=0CDwQ6AEwAg#v=onepage&q=what%20is%20biopiracy&f=false>
Also See Paul Sumpter, Intellectual Property Law: Principles in Practice (New Zealand: CCH, 2006) at 255-156
Online:<http://books.google.co.in/books?id=0Xhc5krNZ3AC&pg=PA255&lpg=PA255&dq=what+is+biopiracy&
source=bl&ots=F2haJvuckH&sig=uJNiKNhuQvg7Em8VO94_DWoCaTs&hl=en&sa=X&ei=EEwPUJ3TDtDciQ
Km44HYBg&ved=0CGAQ6AEwCA#v=onepage&q=what%20is%20biopiracy&f=false> 237
See Biological Diversity Act, 2002, Section 2 (a).
Online: <http://www.genecampaign.org/home/Biological%20Diversity%20Act%202002.pdf> 238
See Biological Diversity Act, 2002, Section 2 (b).
Online: <http://www.genecampaign.org/home/Biological%20Diversity%20Act%202002.pdf> 239
See CBD, Article 2.
Online: < http://www.cbd.int/convention/articles/?a=cbd-02>
76
i) Commercial utilization: means end uses of biological resources for commercial utilization
such as drugs, industrial enzymes, food flavours, fragrance, cosmetics, emulsifiers,
oleoresins, colours, extracts and genes used for improving crops and livestock through
genetic intervention, but does not include conventional breeding or traditional practices in
use in any agriculture, horticulture, poultry, dairy farming, animal husbandry or bee
keeping.240
j) Contract for use of traditional medicinal knowledge: means, legal instrument that
identifies the parties; their rights and duties, object of research, conditions of access of
genetic resources and associated traditional knowledge, and their utilization, as well as
conditions for benefit sharing.241
k) Genetic resources: means, genetic material of actual and potential value for humans that
includes, genetic material from plants, animals and microorganisms.242
l) Indigenous people: means, individuals belong to disadvantageous, marginalized, or poor
segment of population, associated with rich, ancient, culture, and are entitle to the rights of
self-determination and identification.
1) Explanation: Indigenous people are recognised as those who are geographically
attached to distinct traditional habitats or ancestral territories. They over generations
maintain and develop their cultural-social identities and social, cultural, economic and
political institutions separate from mainstream or dominant society. They have right to
240
See Biological Diversity Act, 2002, Section 2 (f).
Online: <http://www.genecampaign.org/home/Biological%20Diversity%20Act%202002.pdf> 241
See Brazilian Traditional Knowledge law, PROVISIONAL ACT NO. 2,186-16, (AUGUST 23, 2001), Article 7
(XII).
Online: <http://www.wipo.int/wipolex/en/details.jsp?id=5897> 242
See CBD, Article 2.
Online: < http://www.cbd.int/convention/articles/?a=cbd-02>; Also See Konard Becker, “Patents and Genetic
Resources/ Traditional Knowledge” Aippi Online:
<https://www.aippi.org/download/reports/forum/forum07/2/ForumSession2_Presentation_Konrad_Becker.pdf
77
preserve and conserve their cultural-social identities, traditional knowledge, biological or
genetic resources. 243
m) Indigenous Community: means, individuals joining together and having common
historical continuity with pre-invasion and pre-colonial societies, developed on their
territories, and consider distinct from dominant society.
n) In-situ conditions: means, conditions where genetic resources exist within ecosystems and
natural habitats, and, in the case of domesticated or cultivated species, in the surroundings
where they have developed their distinctive properties.244
o) Outsiders: means, any legal entity or juristic person, or any individual for research
purposes.
p) Traditional knowledge: means, knowledge of culture, religion, ecosystem, know-how
skills, practices, and beliefs, preserved and developed over generations and promote wider
application with the approval and involvement of holders of such knowledge, innovations
243
See World Health Organisation. Online: < http://www.who.int/topics/health_services_indigenous/en/>; Also See
United Nations. Online: <http://www.un.org/esa/socdev/unpfii/documents/5session_factsheet1.pdf>; Also See
IFAD, Online: <http://www.ifad.org/english/indigenous/index.htm> Also See R.N. Pati Jagnnath Dash Tribal and
Indigenous People of India; Problems and Prospects (New Delhi: S.B. Nagia, A.P.H Publishing, 2002) at 11.
Online:
<http://books.google.co.in/books?id=qxxnZ4XxUbsC&pg=PA11&lpg=PA11&dq=who+are+indigenous+people&
source=bl&ots=fDJeLQMeG&sig=6xEDgNqqCmuAi78509s53oKcqw&hl=en&sa=X&ei=W_kNUPe_MYW6rQ
G4qoDwBA&sqi=2&ved=0CEUQ6AEwAw#v=onepage&q=who%20are%20indigenous%20people&f=false>
Also See Tony Simpson, Indigenous Heritage and Self Determination (Denmark: Centraltrykkeriet Skive, 1997).
Online:
<http://books.google.co.in/books?id=g3sH9iEn0oC&pg=PA22&lpg=PA22&dq=definition+of++indigenous+peopl
e&source=bl&ots=HirqYjTuku&sig=gj9OB3lLJoO4RM2qmVn1xYyOXOE&hl=en&sa=X&ei=7foNUOH8B8mZ
qAHH7oCIDw&sqi=2&ved=0CDkQ6AEwAQ#v=onepage&q=definition%20of%20%20indigenous%20people&f
=false>
Also See Niles Elderedge, Life on Earth: An Encyclopedia of Biodiversity, Ecology and Evolution (California:
ABC-CLIO, 2002) at 456
Online:<http://books.google.co.in/books?id=iVEWPg8vnxgC&pg=PA436&lpg=PA436&dq=definition+of++indig
enous+people&source=bl&ots=GipllPLfCR&sig=mZ2GVGMDaLIo9UGVbPB6nVMaGio&hl=en&sa=X&ei=7fo
NUOH8B8mZqAHH7oCIDw&sqi=2&ved=0CEoQ6AEwBA#v=onepage&q=definition%20of%20%20indigenous
%20people&f=false> 244
See CBD, Article 2.
Online: < http://www.cbd.int/convention/articles/?a=cbd-02>
78
and practices and encourage the equitable sharing of benefits arising from the utilization of
such knowledge innovations and practices.245
q) Traditional medicine: means, sum total of herbal plants, Ayurvedic plants, acupuncture,
spiritual therapies, their practices, skills and knowledge; preserved, and developed over
generations; used to maintain health, prevent illness, and improve or treat physical and
mental illness.246
r) Traditional Knowledge Holders: means, indigenous people or community under whose
observation traditional knowledge is conserved, preserved and developed over generations.
CHAPTER THREE
PROTECTION TO ASSOCIATED TRADITIONAL MEDICINAL KNOWLEDGE
Article 3. This Act protects biological resources and associated TMK of the indigenous
community within the country, from illicit use and exploitation and other harmful actions of
outsiders and those actions which are restricted by Management council i.e. National
Biodiversity Authority or State Biodiversity Authority.
245
See Wilhelm Kirch, Encyclopedia of Public Health, (New York: Springer Science Business Media, 2008) at
1406
Online:
<http://books.google.co.in/books?id=eSPK7CHw7oC&pg=PA1406&lpg=PA1406&dq=definition+traditional+kno
wledge&source=bl&ots=kzb15TJoSg&sig=EidLfgKlVhXNSMS1UQR4BkkTIts&hl=en&sa=X&ei=XwcOUNfH
NcXJqgHmkIHQAw&ved=0CDUQ6AEwAQ#v=onepage&q=definition%20traditional%20knowledge&f=false>
Also See WIPO. Online: <http://www.wipo.int/tk/en/tk/> Also See, United Nations Environment Programme.
Online: <http://www.unep.org/ik/> Also See CBD. Online: <http://www.cbd.int/traditional/> 246
See World Health Organisation. Online: < http://www.who.int/mediacentre/factsheets/fs134/en/> Also See See
Wilhelm Kirch, Encyclopedia of Public Health, (New York: Springer Science Business Media, 2008) at 1406
Online:<http://books.google.co.in/books?id=eSPK7CHw7oC&pg=PA1406&lpg=PA1406&dq=definition+traditio
nal+knowledge&source=bl&ots=kzb15TJoSg&sig=EidLfgKlVhXNSMS1UQR4BkkTIts&hl=en&sa=X&ei=Xwc
OUNfHNcXJqgHmkIHQAw&ved=0CDUQ6AEwAQ#v=onepage&q=definition%20traditional%20knowledge&f
=false>
79
CHAPTER FOUR
RIGHTS OF INDIGENOUS COMMUNITIES
Article 4. The state should recognize and respect the rights of indigenous communities for
the protection of their TMK and to decide on how to use TMK.
1. Right to protect: Indigenous communities or local communities, peoples or individual,
should have the right to protect their TMK against any exploitation, misappropriation and
unauthorised use of the knowledge and to report the same to the management committee.
2. Right to restrict outsiders: Indigenous communities or local communities, peoples or
individual, should have the right to restrict outsiders from researching or collecting
information about biological resources and associated TK; if they know the information
provided or research permitted will prove harmful for the community, society or the country
as the whole.
3. Right to claim: Indigenous communities, local people or individuals should have the right
to claim share in profits or benefits incurred by outsiders from commercial utilization of
TMK.
4. Right to participate: indigenous communities, local people or individuals should have
right to participate in the :
a. management committee to be the part of the protection system,
b. in making amendments to the bill or protection system
c. in the hearing of the exploitation of TMK cases
5. Right to revoke the contract of TMK: Indigenous communities, local people should have
the right to revoke the contract of sharing TMK at any point of time, if it comes to their
knowledge that the research done on their biological resources or associated TMK, is
80
unethical or can be harmful for the indigenous community, local people, society or country
as a whole or for some other nation as well.
a) Explanation: such revocation of contract can be done at any point of time during
research, or in some cases, even after the research has been performed, and after the
consultation with the management committee. However, such revocation should be put
on hold before giving any final verdict, and should be investigated properly by the
management committee in order to assure that the permit of research can cause harm to
indigenous community, local people, society or country as a whole or for some other
nation as well.
b) Cases, in which revocation of contract declared is done after the research performed,
should be termed as emergency revocation scenarios.
6. Right to report: indigenous communities, local people or individuals should have right to
report the unethical, immoral, fraudulent practices with TMK, running within the
management committee or outside to the complaint authority or to government of India.
7. Right to prior intimation: Indigenous communities, local people or individuals should
have the right to be informed prior to conducting any research or permitting any research by
management or board on biological resources and associated TMK for commercial
utilization or bio-survey.
a) Provided that the provisions of this section shall not apply to the local people and
communities of the area, including growers and cultivators of biodiversity, and vaids
and hakims, who have been practicing indigenous medicines247
, except for those who
among them are involved in immoral, unethical and fraudulent practices of exploiting
TMK for commercial usage.
247
See Section 7 of Indian Biodiversity Act 2002.
Online: < http://nbaindia.org/content/25/19//act.html >
81
8. Right to appeal for revocation of IPR on TMK in other country: Indigenous
communities, local people or individuals should have the right to appeal for the revocation
or oppose the grant of intellectual property rights in any other country outside India on any
biological resource and associated TMK obtained or derived from India. 248
CHAPTER FIVE
REGULATORY AUTHORITIES FOR MANAGEMENT AND PROTECTION OF
TRADITIONAL MEDICINAL KNOWLEDGE
Article 5. The regulatory body as described in Indian Biological Diversity Act, 2002, shall
be National Biodiversity Authority, State Biodiversity authority and Biodiversity
Management Committee.
Article 6. National Biodiversity Authority (NBA)
1. The NBA shall consist of the following members namely:
a) “a Chairperson, who shall be an eminent person having adequate knowledge and
experience in the conservation and sustainable use of biological diversity and in matters
relating to equitable sharing of benefits, to be appointed by the Central Government;
b) there ex officio members to be appointed by the Central Government, one representing
the Ministry dealing with Tribal Affairs and two representing the Ministry dealing with
Environment and Forests of whom one shall be the Additional Director General of
Forests or the Director General of Forests;
c) seven ex officio members to be appointed by the Central Government to represent
respectively the Ministries of the Central Government dealing with –
i. Agriculture Research and Education;
248
See Section 18 (4) of Indian Biodiversity Act 2002.
Online :< http://www.wipo.int/wipolex/en/text.jsp?file_id=185778>
82
ii. Biotechnology;
iii. Ocean Development;
iv. Agriculture and Cooperation;
v. Indian Systems of Medicine and Homeopathy;
vi. Science and Technology;
vii. Scientific and Industrial Research;
d) five non-official members to be appointed from amongst specialists and scientists having
special knowledge of, or experience in, matters relating to conservation of biological
diversity, sustainable use of biological resources and equitable sharing of benefits arising
out of the use of biological resources, representatives of industry, conservers, creators
and knowledge-holders of biological resources.”249
2. The Central Government may remove from the National Biodiversity Authority any
member who, in its opinion, has –
i. been adjudged as an insolvent; or
ii. been convicted of an offence which involves moral turpitude; or
iii. become physically or mentally incapable of acting as a member; or
iv. so abused his position as to render his continuance in office detrimental to the public
interest; or
v. acquired such financial or other interest as is likely to affect prejudicially his
functions as a member.”250
Article 7. Powers and Functions of NBA
NBA should:
1) Form guidelines for outsiders to access biological resources and associated knowledge and
for prior informed consent from indigenous communities.
249
See Section 8 (4) of Indian Biodiversity Act 2002.
Online: < http://www.wipo.int/wipolex/en/text.jsp?file_id=185778> 250
See Section 11of Indian Biodiversity Act 2002.
Online: << http://www.wipo.int/wipolex/en/text.jsp?file_id=185778>>
83
2) Form guidelines for fair and equitable sharing also known as benefit sharing schemes for
indigenous communities.
3) To access samples of genetic heritage components and of associated TMK.
4) To ship samples of genetic heritage components and information about the associated
knowledge outside the country of origin to a research institution for national development
purposes.
5) Approving contracts for use of genetic heritage and benefit sharing with regard to their
compiling with the requirements of these guidelines.251
6) Forming grounds for approving or revocation of IPR obtained on particular TMK.
7) Forming guidelines for participation of indigenous people in protection of their TMK.252
8) Operating as the biggest appeal body in regard to decision making and dispute solving
authority after state biodiversity authority. 253
9) “When the activity of collecting genetic heritage components and of accessing associated
traditional knowledge, which contributes to the progress of knowledge and which is not
associated to biopiracy, involves the participation of a foreign legal entity, shall be
authorized by the body responsible for the Indian scientific and technological research
policy,” in keeping with the true spirit of these guidelines.254
10) Should direct duties and responsibilities to state biodiversity board and to Biodiversity
Management Committee.
11) Responsible for carrying out detailed investigation and making detailed report for any
misappropriation or exploitation of TMK instance. Should also address and entertain the
251
See Article 10 (V) of Brazilian Legislation on Traditional Medicinal Knowledge
Online: < Online: http://www.wipo.int/wipolex/en/details.jsp?id=5897> 252
See South African Policy on Indigenous Knowledge System
Online: <http://www.wipo.int/edocs/mdocs/tk/en/wipo_grtkf_ic_9/wipo_grtkf_ic_9_11.pdf> 253
Article 10 (VII) of Brazilian Legislation on Traditional Medicinal Knowledge
Online: < Online: http://www.wipo.int/wipolex/en/details.jsp?id=5897> 254
Article 12 of Brazilian Legislation on Traditional Medicinal Knowledge
Online: http://www.wipo.int/wipolex/en/details.jsp?id=5897>>
84
complaints made directly to the board. In some cases depending on the sensitivity of the
case, should order SBA to carry out actions for the same.
12) To plan and carry out research and development activities in the areas of traditional and
alternative health care and its ultimate integration into the national health delivery
system.255
13) To organise educational campaigns in order to make them aware about the importance of
TMK, its protection and for the overall development of the community.
14) To organise training programs for indigenous communities in order to make them actively
participate and a part of TMK protection.
15) “To formulate policies that would create public awareness through educational activities,
conventions, seminars, conferences, and the like by focusing on the promotion of healthy
living for preventing diseases, thereby uplifting the health care industry.” 256
16) “To acquire or obtain from any governmental authority whether national or local, foreign or
domestic, or from any person, corporation, partnership, association or other entity, such
charters, franchises, licenses, rights, privileges, assistance, financial or otherwise, and
concessions as are conducive to and necessary or proper for the attainment of its purposes
and objectives.”257
17) To formulate a code of ethics and standards for the practice of protection traditional
medicinal knowledge and to follow governing principles.
18) To coordinate with other institutions and agencies involved in the research on traditional
medicine.
255
See Section 6 of Philippine Legislation on Traditional and Alternative Heath Care 1997.
Online: <http://www.lawphil.net/statutes/repacts/ra1997/ra_8423_1997.html> 256
Section 6 (e) Philippine Legislation on Traditional and Alternative Heath Care 1997.
Online: <http://www.lawphil.net/statutes/repacts/ra1997/ra_8423_1997.html> 257
Section 6 (f) Philippine Legislation on Traditional and Alternative Heath Care 1997.
Online: <http://www.lawphil.net/statutes/repacts/ra1997/ra_8423_1997.html>
85
a) To adopt and use a corporate seal
b) To sue and be sued in its corporate name
c) To succeed by its corporate name
19) To adopt its bylaws and promulgate sue and rules and regulations as may be necessary or
proper to implement these guidelines, and to amend or repeal the same from time to time.
Article 8. State Biodiversity Authority (SBA)
1) “Advice the State Government, subject to any guidelines issued by the Central Government,
on matters relating to the conservation of biodiversity, sustainable use of its components
and equitable sharing of the benefits arising out of the utilization of biological resources.”258
2) “Regulate by granting of approvals or otherwise requests for commercial utilization or bio-
survey and bio-utilisation of any biological resource by Indians”259
after holding a
preliminary inquiry regarding the use of TMK.
3) “Any citizen of India or a body corporate, organization or association registered in India
intending to undertake any activity of commercial utilization of biological resources; shall
give prior intimation in such form as may be prescribed by the State Government to the
State Biodiversity Board.”260
4) “On receipt of an intimation, the State Biodiversity Board may, in consultation with the
local communities concerned and NBA and after making such enquiries as it may deem fit,
by order, prohibit or restrict any such activity if it is of opinion that such activity is
detrimental or contrary to the objectives of conservation and sustainable use of biodiversity
or equitable sharing of benefits arising out of such activity
258
See section 23 of Indian Biodiversity Act 2002.
Online: < http://www.wipo.int/wipolex/en/text.jsp?file_id=185778> 259
See Section 23 of Indian Biodiversity Act 2002.
Online: < http://www.wipo.int/wipolex/en/text.jsp?file_id=185778> 260
Section 24 of Indian Biodiversity Act 2002.
Online: < http://www.wipo.int/wipolex/en/text.jsp?file_id=185778>
86
a) Provided that no such order shall be made without giving an opportunity of being heard
to the person affected.
5) Any information given in the form for prior intimation shall be kept confidential and shall
be disclosed, either intentionally or unintentionally, to any person not concerned thereto.”261
6) Should submit a monthly report to NBA regarding the developments, dispute settlements,
new addition of herbal plants to BMC.
7) Responsible for opening medical institutions of TMK for indigenous communities in the
areas needed and shall meet the standards for setting up medical institutions of TMK and
the local regional sanitation planning, in consultation with the state health care centers
established under the state council, by government of India.262
a) Provided, engaging in the activities of TMK treatment and opening TMK centers
without practicing permit or valid licence of medicinal institution shall be illegal and
punishable
i. Explanation: Establishing medical centers will involve the active participation of
indigenous communities as they being better knower’s of the traditional herbal plants.
This will also help in developing the areas needed medical centers and treatment that
are often unapproachable by these disadvantageous communities. SBA shall timely
report to NBA about the establishments of medical centers in each state.
8) “The medical institutions of indigenous communities shall, when undertaking the activities
of medical treatment service, bring the characteristics and advantages of TMK into full
play, follow the law of the development of TMK, make full use of the functions of TMK in
prevention of diseases, health care and recovery, etc. by using traditional theories and
261
Ibid. 262
Article 8 of Chinese Legislation on Traditional Chinese Medicines. (2003)
Online: <http://www.wipo.int/wipolex/en/details.jsp?id=5482>
87
methods and in combination with modern scientific and technological means, and provide
the masses with services of TMK at reasonable prices and good quality.”263
9) “Responsible for taking measures to develop the undertaking of education on TMK in each
state along with each state where indigenous communities reside. Various educational
institutions of TMK shall strengthen:
a) The teaching of basic theories of TMK;
b) Stress the combination of the basic theories with the clinical practices and advance
quality education”;264
c) Teaching about the commercial utilization and history of exploitation of TMK;
d) Teaching about the IPR tools to privatize TMK and the preventive measures as
underlined in these guidelines.
10) Responsible for establishing a benefit sharing authority.
Article 9. Biodiversity Management Committee (BMC)
1) Local State Government institutions are responsible for establishing BMC in their
respective areas for promoting conservation and preservation, sustainable use and
documentation of biological diversity and associated TMK including “preservation of
habitats, conservation of land races, folk varieties and cultivators, domesticated and breeds
of animals and micro-organisms and chronicling of knowledge related to biological
resources”.265
263
See Article 9 of Chinese Legislation on Traditional Chinese Medicines. (2003)
Online: <http://www.wipo.int/wipolex/en/details.jsp?id=5482> 264
See Article 14 Chinese Legislation on Traditional Chinese Medicines. (2003)
Online: <http://www.wipo.int/wipolex/en/details.jsp?id=5482> 265
See Section 41 of Indian Biodiversity Act 2002.
Online: < http://www.wipo.int/wipolex/en/text.jsp?file_id=185778>
88
2) “The National Biodiversity Authority and the State Biodiversity Boards shall consult the
BMC while taking any decision relating to the use of biological resources and knowledge
associated with such resources occurring within the territorial jurisdiction of the BMC.”266
3) “The BMC may levy charges by way of collection fees from any person for accessing or
collecting any biological resources for commercial purposes from areas falling within its
territorial jurisdiction.”267
4) Responsible for maintaining People’s Biodiversity Register (PBR): the documentation of
PBR by BMC includes information on Bio-resources and associated knowledge gathered
from individuals, vaids and hakims who practice this for generations.
5) Must maintain and register the new and old herbal plants and their utilization as medicines
for treatment purposes
6) Responsible for :
a) “Coordinating implementation of genetic heritage management policies;
b) Establishing Technical standards;
c) Criteria for access and shipment authorizations;
d) Criteria for creation of a database for recording information on associated TMK”268
CHAPTER SIX
RESPONSIBILITIES FOR RESEARCH COUNCILS OF INDIA AND FOREIGN
RESEARCH COUNCILS
Article 10: Research Councils Within and Outside India
266
See Section 41 (2) of Indian Biodiversity Act 2002.
Online: < http://www.wipo.int/wipolex/en/text.jsp?file_id=185778> 267
Section 41 (3) of Indian Biodiversity Act 2002.
Online: < http://www.wipo.int/wipolex/en/text.jsp?file_id=185778> 268
Article 11 of Brazilian Legislation on Traditional Medicinal Knowledge
< Online: http://www.wipo.int/wipolex/en/details.jsp?id=5897>
89
1. For scientific research of TMK, research councils in India shall carry out basic theory
research and clinical research of TMK in both traditional and modern ways and that TMK
theories and modern science and technology shall be used to carry out the research on
prevention and treatment of common diseases, frequently occurring diseases as well as
difficult and complicated diseases.269
2. Shall register with NBA or any other registration authority responsible for managing and
preservation of TMK in order to conduct research.
3. “Those who donate diagnostic and treatment methods of TMK as well as literatures,
esoteric recipes and proved recipes of TMK, which are of great significance to the
scientific and technological development of TMK and the nation, shall be granted awards
with reference to the Regulation on Scientific and Technological Awards of the State.”270
4. Research councils shall maintain the records of the research done in indigenous areas and
shall submit a detail report to NBA indicating:
a) Purpose of research;
b) Utilization of research if any;
c) Date, time, day or days of the research conducted;
d) Involvement if any, of the individuals from indigenous areas, BMC or SBA in helping
or carrying out research;
e) Names of the plants on which research was conducted;
f) Survey conducted on TMK or particular herbal plants;
g) Results or outcomes of the research.
h) Detail procedures of conducting research including chemical ingredients, technology
used etc.
Also should submit the report anytime ordered by NBA or SBA.
269
See Article 22 of Chinese Legislation on Traditional Chinese Medicines. (2003)
Online: <http://www.wipo.int/wipolex/en/details.jsp?id=5482> 270
See Article 23 of Chinese Legislation on Traditional Chinese Medicines. (2003)
Online: <http://www.wipo.int/wipolex/en/details.jsp?id=5482>
90
5. Shall not deliver or export the research done on TMK, or shall not engage in any kind of
contract to and with (respectively) any other nation with or without consideration; without
intimating NBA or government of India. Such an act done without the prior permission of
NBA or government of India shall be punishable.
6. Shall carry out research with extreme care and caution that do not harm the biological
resources, associated TMK and that do not harm the feelings of indigenous communities.
7. Shall not use any kind of chemicals and scientific technology at the time of research being
performed within indigenous areas that can prove harmful to the ecosystem and the
indigenous communities.
8. Shall not file an application for IPR on the outcome of the research or new invention from
the research performed on Indian TMK, without notifying NBA or SBA or government of
India. Any such application filed for IPR without prior informing NBA or SBA or
government of India, will be declared invalid. (Write about more grounds should be
precisely stated in order to declare such an application invalid.)
9. Shall enter into the contract with indigenous communities and shall abide by all terms of
the contract before conducting any research on Indigenous communities TMK.
10. Have right to file complaint to the complaint authority or in sensitive cases directly to
government of India regarding non-cooperation of indigenous communities and designated
authorities in conducting research on TMK otherwise research being unethical and
immoral.
CHAPTER SEVEN
RESPONSIBILITIES FOR FOREIGN BASED MULTINATIONAL
PHARMACEUTICAL COMPANIES
91
Article 11. Foreign Based Pharmaceutical Companies
1. Shall register with NBA or any other registration authority responsible for managing and
preservation of TMK; to conduct research in India.
2. Shall not file an application for IPR on the outcome of the research or new invention from
the research performed on Indian TMK, without notifying NBA or SBA or government of
India. Any such application filed for IPR without prior informing NBA or SBA or
government of India, will be declared invalid. (Write about more grounds should be
precisely stated in order to declare such an application invalid.)
3. Shall enter into the contract with indigenous communities and shall abide by all terms or
clauses of the contract including the term or clause of benefit sharing schemes before
conducting any research on Indigenous communities TMK.
4. Shall inform and submit detail report to NBA or SBA of the profits incurred by the
commercial exploitation or utilization of TMK.
5. Have right to negotiate on sharing of the profits incurred by commercial exploitation or
utilization of TMK if seems excessively expensive.
6. Have right to file complaint to the complaint authority or in sensitive cases directly to
government of India regarding non-cooperation of indigenous communities and designated
authorities in conducting research on TMK otherwise research being unethical and
immoral.
7. Shall recognize and state the original source of the final product i.e. the outcome of the
research of TMK and recognize indigenous communities in filling of the application for IPR
on TMK.
a) Provided, if above application does not meet this requirement shall not be processed.
92
CHAPTER EIGHT
BENEFIT SHARING SCHEMES
Article 12. The Benefits Sharing Schemes should include
1) The profits and benefits incurred from the commercial utilization or economic use of the
product or process developed from the samples or research of biological resources and
TMK components, obtained by research councils within and outside India or
pharmaceuticals within and outside India, shall be shared in a fair and equitable manner
among the contracting parties i.e. indigenous communities or government of India.
2) The amount of fair and equitable sharing of benefits if received by government of India
shall be used for the development of indigenous communities.
3) The benefit sharing contract or agreement shall include:
a) Name of both the parties,
b) Detail description of both the parties,
c) Rights and responsibilities of both the parties,
d) Negotiation of profits,
e) Withdrawal of contract,
f) Penalties and damages
CHAPTER NINE
LEGAL LIABILITIES AND DAMAGES
Article 13. Authorities shall be legally liable
1. “If any functionary in the department responsible for the administration of TMK violates
the present regulation in his administration of TMK, by taking advantage of his post to
accept the properties of others or to obtain other’s benefits, by abusing his power or
neglecting his duty, or by failing to investigate the illegal acts he has found, and thus
causing severe consequences, if a crime has been constituted, he shall be investigated for
93
criminal liabilities in accordance with the law; if the consequences are not serious enough
for criminal punishment, he shall be imposed upon the administrative sanction of demotion
or dismission from his post in accordance with the law.”271
2. “If a medical institution of TMK violates the present regulation and is under any of the
following circumstances, it shall be ordered by the department responsible for the
administration of TMK under the local people’s government at or above the county level to
make a correction within a time limit; if it fails to make a correction before the expiry of the
time limit, it shall be ordered to cease its business for rectification, or its practicing permit
of medical institution shall be revoked and its qualification as a medical institution
designated to treat patients of urban and town employees enjoying basic medical insurances
shall be cancelled by the original approving organ, and the liable persons in charge and
other directly liable persons shall be imposed upon disciplinary sanctions in accordance
with the law:
3. It does not meet the standards for the establishment of medical institutions of TMK.”272
4. “If an educational institution of TMK violates the present regulation and is under any of the
following circumstances, it shall be ordered by the department responsible for the
administration of TMK under the local people’s government at or above the county level to
make a correction within a time limit; if it fails to make a correction before the expiry of the
time limit, it shall be revoked by the original approving organ:
a) it does not meet the prescribed standards for the establishment;
b) it has not established a clinical teaching base conforming to the prescribed
standards.”273
271
See Article 31 of Chinese Legislation on Traditional Chinese Medicines. (2003)
Online: <http://www.wipo.int/wipolex/en/details.jsp?id=5482> 272
See Article 32 of Chinese Legislation on Traditional Chinese Medicines. (2003)
Online: <http://www.wipo.int/wipolex/en/details.jsp?id=5482>
94
5. “Whoever violates the present regulation, and thus causing heavy losses to biological
resources and the resources of TMK medicines or divulging scientific and technological
secrets of the state, and the case is severe, and a crime is constituted, he shall be
investigated for criminal liabilities in accordance with the law; if the consequences are not
serious enough for criminal punishment, he shall be ordered by the department responsible
for the administration of traditional Chinese medicines under the local people’s government
at or above the county level to make a correction, and the liable persons in charge and other
directly liable persons shall be imposed upon disciplinary sanctions in accordance with the
law.”274
6. “The economic use of a product or process developed from samples of genetic heritage
components or from associated traditional knowledge, accessed in a manner contrary to the
provisions of these regulations, shall subject the offender to payment of compensation
corresponding to the amount as decided by the authorities; of the gross income obtained
from commercialization of the product or of the royalties obtained from third parties by the
offender, as a result of licensing the product or process or use of the technology, whether or
not they are protected by intellectual property, without prejudice to administrative sanctions
and the appropriate penalties.”275
The above proposed Sui Generis legislation will ensure protection to the nation’s unique
national knowledge, benefits to indigenous communities and prevent misappropriation of their
TMK. This will be a legal way to recognize the ownership of knowledge and reward
community’s rights to indigenous community. This will also help in promoting harmonization
273
See Article 34 of Chinese Legislation on Traditional Chinese Medicines. (2003)
Online: <http://www.wipo.int/wipolex/en/details.jsp?id=5482> 274
See Article 35 of Chinese Legislation on Traditional Chinese Medicines. (2003)
Online: <http://www.wipo.int/wipolex/en/details.jsp?id=5482> 275
See Article 26 of Brazilian Legislation on Traditional Medicinal Knowledge
Online: http://www.wipo.int/wipolex/en/details.jsp?id=5897>
95
between nations as they will abide by the terms of the legislation and recognize the rights of
indigenous communities.
This is just a small step towards making the nation a better place for its residents (in this thesis:
indigenous communities). The above included clauses or provisions are the important ones, that
I believe must be included when framing such guidelines. I have focused mainly on the rights
of indigenous communities, their identification and protection of TMK.. By keeping this mind,
I have proposed some additional duties for the already established NBA, SBA and BMC under
Indian Biodiversity Act, 2002. In addition to this, I have proposed some responsibilities and
legal penalties for the third parties also.
The idea of resolving such an issue and making this proposal a successful legislation; is still a
long way off and requires indebt study and research. It will require some practical surveys and
interviews of indigenous communities, in order to better understand their problems and their
needs. Therefore, the stability of the recommendations of this thesis may be an uphill battle, but
can succeed if firm and serious action and steps are taken by the government of India to standup
for the rights of indigenous communities.
96
BIBLIOGRAPHY
I. LEGISLATION:
A. Statutes:
1. The Indian Patent Act, 1970
2. Indian Biological Diversity Act, 2002
3. Indian Geographical Indications of Goods (Registration and Protection) Act 1999.
B. Conventions and Treaties:
1. Convention on Biological Diversity (CBD 1994)
2. Agreement on Trade Related Aspects of Intellectual Property Rights (TRIPS 1994)
3. International Plant Protection Convention (1979)
4. Paris Convention (1883)
5. International Undertaking on Plant Genetic Resources for Food and Agriculture (FAO)
6. International Labor Organization
7. United Nations Commission on Human Rights
8. United Nations Permanent Forum on Indigenous Issues.
C. Regulatory Framework for TK:
1. Regulation on Genetic Heritage and Traditional knowledge (Brazil Provisional Act)
Online: http://www.wipo.int/wipolex/en/details.jsp?id=5897
2. Regulation of People’s Republic of China on Traditional Chinese Medicines (China
Legislation on Traditional Knowledge)
Online: http://www.wipo.int/wipolex/en/details.jsp?id=5482
3. Regulation on Traditional Herbal Medicinal Products (European Union)
Online: http://www.wipo.int/wipolex/en/details.jsp?id=5557
4. Thailand Sui Generic System
Online:http://www.thailawforum.com/articles/Thai-traditional-medicine-protection-
part1-5.html
5. Indian Traditional knowledge Digital Library
Online: http://www.tkdl.res.in/tkdl/langdefault/common/Home.asp?GL=Eng
6. Tanzanian Legislation on Traditional Medicinal Knowledge
97
Online:http://www.tanzaniabiodiversity.com/archivio/html/File/MANUAL%20FOR%2
0PATENT_FINAL%20VERSION.pdf
7. Philippine Legislation on Traditional and Alternative Heath Care 1997.
Online: <http://www.lawphil.net/statutes/repacts/ra1997/ra_8423_1997.html>
8. Panama Law No 20 of June 26, 2000 on Special System for the Collective Intellectual
Property Rights of Indigenous Peoples for the Protection and Defense of their Cultural
Identity and their Traditional Knowledge.
Online: < http://www.wipo.int/wipolex/en/text.jsp?file_id=177308>
9. Peru Law on Indigenous Knowledge.
Online: < http://www.wipo.int/tk/en/documents/word/peruvian-law-27811.doc>
II. SECONDARY MATERIAL
1. Ragavan, Srividhya, Protection of Traditional Knowledge
Online: < http://papers.ssrn.com/sol3/papers.cfm?abstract_id=310680>
2. Dr. Varkey, Elizabeth, TK – The Changing Scenario in India
Online
<http://www.law.ed.ac.uk/ahrc/files/67_varkeytraditionalknowledgeinindia03.pdf>,
3. Anaya, S. James, Indigenous People in International Law
Online:
<http://books.google.ca/books?id=WFf6qX8zlFYC&printsec=frontcover&source=gbs_
ge_summary_r&cad=0#v=onepage&q&f=false>
4. Chatterjee, Alimpan, Traditional Knowledge Herbal Medicine and Intellectual Property:
A Debate over Rights
Online:
< http://www.smpborissa.org.in/KIIT%20Papers_PDF/Alimpan%20Chatterjee.pdf>
5. Romero, Tatiana Lopez, Sui Generis System for the Protection of Traditional
Knowledge
Online: <http://redalyc.uaemex.mx/pdf/824/82400609.pdf>
6. Timmermans, Karin, Intellectual Property Rights and Traditional Medicine: Policy
Dilemmas at the Interface
Online: < http://www.sciencedirect.com/science/journal/02779536/57/4>
7. Dooley, M. Larry, Case Study Research and Theory Building
Online:
<https://webdisk.ucalgary.ca/~nmstuewe/public_html/CaseStudy/pdf/CStheorybuilding.
pdf>
98
8. Eisenhardt, M. Kathleen., Building Theories from Case Study Research
Online: < http://www.jstor.org/stable/258557?seq=3>
9. Stake, E. Robert., The Case Study Method in Social Inquiry
Online: < http://www.jstor.org/stable/1174340?seq=1>
10. Vaus, A. de. David, Research Design in Social Research
Online:
<http://books.google.ca/books?id=wImwZZXzPIkC&printsec=frontcover&dq=inauthor
:%22D.+A.+De+Vaus%22&hl=en&sa=X&ei=P7RrT4jPBarA0AGfv3dBg&ved=0CDg
Q6AEwAQ#v=onepage&q=inauthor%3A%22D.%20A.%20De%20Vaus%22&f=false>
11. Puranik, Pranjal, TK Rights and Intellectual Property Rights: The Tale of Two Rights
Online: < http://www.rkdewan.com/articles-traditional-knowledge-ip-rights.jsp>
12. Dr. Priyadarsini, Indira G; Sri Viswa, Mahila Padmavathi & Dr. Rani, V. Sowbhagya,
Traditional Medicinal Knowledge in India – An Appraisal
Online: <http://www.indiastat.com/article/25/indira/fulltext.pdf>
13. Chakravarty, Rupak Preserving Traditional Knowledge: Initiatives in India
Online: <http://ifl.sagepub.com/content/36/4/294>
14. Ghosh Jayati, Medical Knowledge as a Global Public Goods For Health
Online: <http://www.macroscan.org/anl/feb03/pdf/gpgh.pdf>
15. Downes, David, Using Intellectual property as a Tool to Protect TK: Recommendations
for Next Step
Online: < http://www.ciel.org/Publications/UsingIPtoProtectTraditionalKnowledge.pdf>
16. Bhargava, Divya, Patent Act: Biopiracy of Traditional Indian Products – An Overview
Online: <http://www.countercurrents.org/bhargava140709.htm>
17. Dayma, Dinesh, Protection of TK in Indian Patent Act
Online: < http://www.goforthelaw.com/articles/fromlawstu/article76.htm>
18. Saha, Ashmita, Role of Patent Act in Protecting & Preserving TK
Online: < http://www.authorstream.com/Presentation/athor-486578-role-of-patent-act-
in-protecting/>
19. Hon’ble Mr. Jain, Vijender, Safeguarding the TK in India
Online: < http://highcourtchd.gov.in/right_menu/events/events/apjaspeech.pdf>
20. Eiland, Lee Murray, Patenting Traditional Medicine
Online:
<http://heinonline.org/HOL/Page?handle=hein.journals/jpatos89&div=5&g_sent=1&col
lection=journals>
99
21. Correa, M, Carlos Protection and Promotion of Traditional Medicine Implications For
Public Health in Developing Countries
Online: < http://apps.who.int/medicinedocs/en/d/Js4917e/3.html#Js4917e.3>
22. Biodiversity and Traditional Knowledge: Regulation at National, Regional and
International Level
Online: < http://www.legalserviceindia.com/article/l266-Biodiversity-and-Traditional-
Knowledge.html>
23. Saxena, Nath Achintya, Protection of TK as Geographical Indications: Policy issues
Online: <http://www.slideshare.net/achintyanath/protection-of-traditional-knowledge-
as-geographical-indications>
24. Singh, Prietika and Seth, Dheeraj, TK and Geographical Indications: Fighting Back
Online:<http://www.managingip.com/Article/2897199/Traditional-knowledge-and-
geographical-indications-Fighting-back.html >
25. Tripathi, Mani Surya & Singh, Pratap Anshu, Protection of TK Medicinal Plants
Online: <http://papers.ssrn.com/sol3/papers.cfm?abstract_id=1792541>
26. Suri, Gunmala & Sharma, Chhabra Puja, Intellectual Property Rights for Traditional
Healers: Indian Perception
Online: < http://ideas.repec.org/a/aic/journl/y2008v55p210-219.html#cites >
27. Gibson, Johanna, TK and International Context for Protection
Online: <http://www.law.ed.ac.uk/ahrc/script-ed/docs/TK.pdf>
28. Berkey, O Judson, Implications of the WTO Protections for Food Geographical
Indications
Online: <http://www.asil.org/insigh43.cfm>
29. Cottier, Thomas & Panizzon, Marion, Legal Perspective on TK: The Case for
Intellectual Property Protection
Online:
<http://books.google.ca/books?id=6SGRt2CZNyYC&pg=PA573&lpg=PA573&dq=With
+the+adoption+of+TRIPS+Agreement+in+1994,+the+patenting+of+plant+genetic+resou
rces+for+food+and+agriculture+benefited+from+a+major+step+towards+global+recognit
ion+and+enforcement.&source=bl&ots=r8ZzObFDTU&sig=xNu2c_B392SAZ5GvSGlOr
_GUW8&hl=en&sa=X&ei=iWS5T431GK_YiQLvnvDcBg&ved=0CEkQ6AEwAQ#v=o
nepage&q=With%20the%20adoption%20of%20TRIPS%20Agreement%20in%201994%
2C%20the%20patenting%20of%20plant%20genetic%20resources%20for%20food%20an
d%20agriculture%20benefited%20from%20a%20major%20step%20towards%20global%
20recognition%20and%20enforcement.&f=false>
30. Maskus, E. Keith & Reichman, H. Jerome International Public Goods and Transfer of
Technology under a Globalized Intellectual Property Regime.
Online:
100
<http://books.google.ca/books?id=6SGRt2CZNyYC&pg=PA573&lpg=PA573&dq=Wit
h+the+adoption+of+TRIPS+Agreement+in+1994,+the+patenting+of+plant+genetic+res
ources+for+food+and+agriculture+benefited+from+a+major+step+towards+global+rec
ognition+and+enforcement.&source=bl&ots=r8ZzObFDTU&sig=xNu2c_B392SAZ5G
vSGlOr_GUW8&hl=en&sa=X&ei=iWS5T431GK_YiQLvnvDcBg&ved=0CEkQ6AEw
AQ#v=onepage&q=With%20the%20adoption%20of%20TRIPS%20Agreement%20in%
201994%2C%20the%20patenting%20of%20plant%20genetic%20resources%20for%20
food%20and%20agriculture%20benefited%20from%20a%20major%20step%20towards
%20global%20recognition%20and%20enforcement.&f=false>
31. Tansey, Geoffy & Rajotte, Tasmin, The Future Control of Food: A Guide to
International Negotiations and Rules on Intellectual Property, Biodiversity and Food
Security
Online:
<http://books.google.co.in/books?id=i6F_aYS3RYYC&pg=PA65&dq=relationship+bet
ween+trips+and+cbd&hl=en&sa=X&ei=0N_T82fBciqiQKWzvzxBw&ved=0CEEQ6A
EwAA#v=onepage&q=relationship%20between%20trips%20and%20cbd&f=false>
32. Piva, Martinez Mario Jorge Knowledge generation and Protection: Intellectual
Property, Innovation and Economic Development
Online:
<http://books.google.co.in/books?id=cZaa_H2SmtQC&pg=PA197&dq=relationship+be
tween+trips+and+cbd&hl=en&sa=X&ei=0N_T82fBciqiQKWzvzxBw&ved=0CEgQ6A
EwAQ#v=onepage&q=relationship%20between%20trips%20and%20cbd&f=false>
33. Chaturvedi, Sachin, Biodiversity, Intellectual Property Rights Regime and Ingenious
Knowledge System at the WTO: Revisiting the Unresolved Issues
Online:
<http://books.google.co.in/books?id=LpHiobgEuMgC&pg=PA270&dq=relationship+be
tween+trips+and+cbd&hl=en&sa=X&ei=0N_T82fBciqiQKWzvzxBw&ved=0CFoQ6A
EwBA#v=onepage&q=relationship%20between%20trips%20and%20cbd&f=false>
34. Mehta, S. Pradeep and Sankar, U, The Convention of Biological Diversity
Online:
<http://www.mse.ac.in/trade/pdf/Compendium%20Part%20B/7.%20The%20convention
%20on%20biological%20diversity.pdf>
35. Dhar, Biswajit, The Convention on Biological Diversity and the TRIPS Agreement:
Compatibility or Conflict
Online:
<http://books.google.co.in/books?id=Up9qCHTvlrEC&pg=PA51&dq=relationship+bet
ween+trips+and+cbd&hl=en&sa=X&ei=9I6T4uIKqZiAKXyrGOCA&ved=0CEsQ6AE
wAg#v=onepage&q=relationship%20between%20trips%20and%20cbd&f=false>
36. Hansen, A. Stephen. and VanFleet W Justin., Traditional Knowledge and Intellectual
Property: A Handbook on Issues and Options for Traditional Knowledge Holders in
Protecting Knowledge Holders in Protecting their Intellectual Property and Maintaining
Biological Diversity.
101
Online: < http://shr.aaas.org/tek/handbook/handbook.pdf>
37. Timmermans Karin, Intellectual Property Rights and Traditional Medicine: Policy
Dilemmas at the Interface
Online: <http://www.sciencedirect.com/science/article/pii/S0277953602004252>
38. Das, J.K., Human Rights and Indigenous Peoples
Online: <
http://books.google.co.in/books?id=KCknz_lXYCEC&printsec=frontcover&dq=definiti
on+of+indigenous+people&source=bl&ots=wpsVdOOT7j&sig=0D7g0eyQB3VMbE8a
FpI2CdNUms&hl=en&sa=X&ei=uGj_T4qIB4WXrAHw_bmcBQ&ved=0CDgQ6AEw
AA#v=onepage&q=definition%20of%20indigenous%20people&f=false>
39. Dr. Zhang, Xiaorui Traditional Medicine and its Knowledge
Online: <
http://fepi.ipaam.br/biodiversidade/Organismos%20Internacionais/UNCTAD/Document
os/Ingl%C3%AAs/Who%20by%20Xiaorui%20Zhang.pdf>
40. Kudngaongarm, Panumas, Human Rights Standards for the Protection of Intellectual
Property: Traditional Knowledge and Indigenous Resources
Online: <http://www.thailawforum.com/articles/traditional-knowledge-part2.html>
41. Dutta, Swaireeta, The Turmeric Patent is the Just the First Step in Stopping Biopiracy
Online: <http://www.nabard.org/nrmc/pdf/nabard%20turmeric%20survey.pdf>
42. Goel, S. Malini Keeping Biopirates at Bay: Creating a new Legal and Institutional
Protection Regime for Traditional Knowledge
Online: <
http://repository01.lib.tufts.edu:8080/fedora/get/tufts:UA015.012.DO.00021/bdef:Tufts
PDF/getPDF >
43. Vandana Shiva, The US Patent System Legalizes Theft and Biopiracy
Online: <http://www.organicconsumers.org/Patent/uspatsys.cfm>
44. Tagle, Reyes Yovana The Protection of Indigenous knowledge Related to Biodiversity:
the Role of Databases
Online: <http://www.sylff.org/wordpress/wp-content/uploads/2009/03/sylff_p131-
146.pdf>
45. Jayaraman, K.S, Biopiracy Fears Cloud Indian Database
Online: < http://www.scidev.net/en/news/biopiracy-fears-cloud-indian-database.html>
46. Mehra, Anchal, Bio-pircay Killer App India’s Traditional Knowledge Digital Library
believes it has found the silver bullet in the biopiracy wars. Critics say it is aiming at the
wrong targets
Online: <http://www.littleindia.com/life/6173-biopiracy-killer-app.html>
102
47. Blakeney, Michael, Protection of Traditional Knowledge by Geographical Indications
Online:
<http://books.google.ca/books?id=8vO0EJled1wC&printsec=frontcover#v=onepage&q
&f=false>
48. Hasan, Sara, The Neem Tree, Environment, Culture and Intellectual Property
Online :< http://www1.american.edu/ted/Neemtree.htm>
49. Dyama, Dinesh, Protection of Traditional Knowledge in Indian Patent Act
Online :< http://www.goforthelaw.com/articles/fromlawstu/article76.htm>
50. Mukherjee, Utsav, A Study of the Basmati Case (India-US Basmati Rice Dispute)
Online: < http://papers.ssrn.com/sol3/papers.cfm?abstract_id=1143209 >
51. Balasubramanian D., Basmati - Identity Crises Solved
Online:
< http://www.hindu.com/thehindu/seta/2002/05/09/stories/2002050900070200.htm >
52. Nkhata, Abraham Bimo; Mosimane Alfons; Downsborough Linda; Breen, Charles and
Roux, J Dirk., A Typology of Benefit Sharing Arrangements for the Governance of
Social-Ecological Systems in Developing Countries
Online: < http://dx.doi.org/10.5751/ES-04662-170117>
53. Wilder, Richard, Protection of0 Traditional Medicine.
Online:
<http://www.whoindia.org/LinkFiles/Commision_on_Macroeconomic_and_Health_04_
04.pdf>
54. Dr. Mashelkar R.A., Intellectual Property Rights and The Third World Council
Online:
<http://www.sristi.org/material/1.2intellectual%20property%20and%20the%20third%2
0world.pdf>
55. Sharma, B., Ashok Now, a US patent for Atta Chakkis
Online: <http://www.indianexpress.com/storyOld.php?storyId=14493>
56. Ntahuga, Laurent, Norway/UN Conference on Technology Transfer and Capacity
Building
Online:
<http://www.google.ca/url?sa=t&rct=j&q=&esrc=s&source=web&cd=1&ved=0CE0QF
jAA&url=http%3A%2F%2Fciteseerx.ist.psu.edu%2Fviewdoc%2Fdownload%3Bjsessio
nid%3D6BE85DA734B71444A7E8EF3D141EEEAB%3Fdoi%3D10.1.1.196.1065%26
rep%3Drep1%26type%3Dpdf&ei=8jD6T8_PE8jVqQGT9cWLCQ&usg=AFQjCNGJQf
LUfa9WJ0cKeI54gzxNKhQdcw&sig2=z1JzPA_6AhkQwej7-XcpRQ>
57. Zacune Joseph, Combating Monsanto: Grassroots resistance to the Corporate Power of
Agribusiness in the Era of the Green Economy and a Changing Climate
103
Online: < http://www.viacampesina.org/downloads/pdf/en/Monsanto-Publication-EN-
Final-Version.pdf >
58. Jebaraj Priscillia, India probe finds Monsanto Guilty of Biopiracy
Online: < http://southasia.oneworld.net/todaysheadlines/probe-finds-monsanto-guilty-
of-biopiracy/?searchterm= >
59. Rizvi Ruhi, Monsanto Biopiracy and Brinjals: A threat to Indian Biodiversity
Online: < http://www.iscience.in/news/22/monsanto-Biopiracy-and-brinjals >
60. Ramoo, NBA Confirms Monsanto/ Mahyco and Ors. To be criminally prosecuted in BT
Brinjal Biopiracy Case
Online :< http://agrariancrisis.in/2012/05/24/nba-confirms-monsantomahyco-and-ors-to-
be-criminally-prosecuted-in-b-t-brinjal-Biopiracy-case/ >
61. Scherer, Colleen, India Challenges Monsanto; Claims Biopiracy” AG Professional
Online: <http://www.agprofessional.com/news/India-challenges-Monsanto-claims-
Biopiracy-138555944.html >
62. Sisodia, Rajeshree, Biopiracy in India: The Case of the Aubergine
Online:
< http://www.aljazeera.com/indepth/opinion/2011/10/2011102994021308862.html>
63. Damodaran A., Traditional Knowledge, Intellectual Property Rights and Biodiversity
Conservation: Critical Issues and key Challenges
Online: < http://nopr.niscair.res.in/bitstream/123456789/2039/1/JIPR%2013(5)%20509-
513.pdf >
64. Kumar, Vinay and Lazarus, Peters Bandana Tragets 2011, A Complete Refresher
Biology
Online:
<http://books.google.ca/books?id=aGJjU1wNF30C&pg=PA300&lpg=PA300&dq=Usef
ul+genes+are+isolated+from+the+bioresources+and+patented.+These+genes+are+then
+used+to+generate+commercial+products.&source=bl&ots=ZCWEVu6wtH&sig=VOO
DSKJDQSiCX2Zn5bzmCg7UE&hl=en&sa=X&ei=1lkUUKT5CsPPqgG644GYDw&ve
d=0CFgQ6AEwAA#v=onepage&q=Useful%20genes%20are%20isolated%20from%20t
he%20bioresources%20and%20patented.%20These%20genes%20are%20then%20used
%20to%20generate%20commercial%20products.&f=false >
65. Becker, Konard, Patents and Genetic Resources/ Traditional Knowledge
Online:
<https://www.aippi.org/download/reports/forum/forum07/2/ForumSession2_Presentatio
n_Konrad_Becker.pdf>
66. Simpson, Tony, Indigenous Heritage and Self Determination).
Online:
<http://books.google.co.in/books?id=g3sH9iEn0oC&pg=PA22&lpg=PA22&dq=definiti
on+of++indigenous+people&source=bl&ots=HirqYjTuku&sig=gj9OB3lLJoO4RM2qm
104
Vn1xYyOXOE&hl=en&sa=X&ei=7foNUOH8B8mZqAHH7oCIDw&sqi=2&ved=0CD
kQ6AEwAQ#v=onepage&q=definition%20of%20%20indigenous%20people&f=false>
67. Elderedge, Niles Life on Earth: An Encyclopedia of Biodiversity, Ecology and
Evolution
Online:<http://books.google.co.in/books?id=iVEWPg8vnxgC&pg=PA436&lpg=PA436
&dq=definition+of++indigenous+people&source=bl&ots=GipllPLfCR&sig=mZ2GVG
MDaLIo9UGVbPB6nVMaGio&hl=en&sa=X&ei=7foNUOH8B8mZqAHH7oCIDw&s
qi=2&ved=0CEoQ6AEwBA#v=onepage&q=definition%20of%20%20indigenous%20p
eople&f=false>
68. Kirch Wilhelm, Encyclopedia of Public Health
Online:
<http://books.google.co.in/books?id=eSPK7CHw7oC&pg=PA1406&lpg=PA1406&dq=
definition+traditional+knowledge&source=bl&ots=kzb15TJoSg&sig=EidLfgKlVhXNS
MS1UQR4BkkTIts&hl=en&sa=X&ei=XwcOUNfHNcXJqgHmkIHQAw&ved=0CDU
Q6AEwAQ#v=onepage&q=definition%20traditional%20knowledge&f=false>