Protection of Traditional

Knowledge'
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"Education is a liberating force, and in

our age it is also a democratising force,
, cutting across the barriers of caste and
class, smoothing out inequalities imposed
by birth and other circumstances. "
=Indira Gandhi
 G .ignou MIP~'t06
THE PEOPlE'S
~ •. UNIVERSITY Plant Varieties Protection,
Indira Gandhi
National Open University
Biotechnology, and
School of Law Traditional Knowledge

"

fI
Block

4
PROTECTION OF TRADITIONAL KNOWLEDGE
UNIT 13
Significance of and Reasons for Protecting Traditional
~~~ ~

UNIT 14
Current International Efforts for the Protection of TK 20

UNIT 15

Global Issues in the Protection of TK. 36

UNIT 16
Indian Efforts Towards TK Protection 52 .

I I
 Expert Committee
Dr. D.P.S Pannar Prof. K. Elumalai
Technical Member, Director, School of Law
Intellectual Property Appellate Board, IGNOU
Ministry of Commerce & Industry
Dr. Suneet Kashyap Srivastava
Prof.S.K. Verma Assistant Professor, School of Law
Director, ISIL IGNOU
New Delhi
Dr. Gurmeet Kaur
"
Prof. Salim Akhtar Assistant Professor, School of Law
Professor of Law, IGNOU
Aligarh Muslim University
Aligarh, Uttar Pradesh Mr. Anand Gupta
Assistant Professor, School of Law
Dr.Ekbal Hussain
IGNOU
Associate Professor
Jamia Milia Islamia University
Ms. Mansi Shanna
New Delhi
Assistant Professor, School of Law
.
, Mr. T.C. James
Director,
IGNOU

National Intellectual Property Organisation

New Delhi .

Programme Coordinator
Dr. Suneet Kashyap Srivastava
School of Law, IGNOU, New Delhi

.Block Preparation Team

Unit Writer: .Format & Language Editor:
Prof. S. K. Verma Dr. Suneet K. Srivastava
Director, SOL, IGNOU, New Delhi·
Indian Society of International Law, ISIL -

Content Editor:
Dr. Suneet Kashyap Srivastava
Assistant Professor
School of Law, IGNOU, New Delhi

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1
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,-
March - 3017! (Reprint) ,
© Indira Gandhi National Open University, 2013
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j

I I
 BLOCK 4 PROTECTION ·OF
TRADITIONAL
KNOWLEDGE
Traditional Knowledge refers to the long standing traditions and practices
of certain indigenous, or local communities, 'Traditional' however does not
;. mean that the knowledge is ancient. 'Traditional Knowledge' is being created
every day, as it evolves as.a response of individuals and communities to the
challenges posed by their social environment, This Block consists of four units
on traditional knowledge.

Unit 13 of this Course explains the significance of traditionalknowledge and

fI the objective for protecting traditional knowledge. In this context it deals with
prevention of bio-piracy, conservation of environment and the protection of
livelihood of traditional knowledge holders.

Unit 14 of this course explains the current international efforts taken for the
protection of traditional knowledge. Under this pretexts topics like WIPO, WTO/
TRIPs, Doha Declaration, the Nagoaya Protocol, etc are discussed.

Unit 15 of this Course explains the contentious issues for the protection of
TK. It also explains why TK should be defined. It explains the concept of prior
informed' consent, and the tools for protecting TK'under the IP regime.

Unit 16 of this course explain the Indian efforts towards the protection of
Traditional Knowledge. In this unit we will study the Indian position on the
protection of TK and the national efforts made towards its protection. It also
explains the significances of draft rules, 2009 on the protection, conservation
and management of TK. -

I I
 "

fI

·.

I
 UNIT 13 SIGNIFICANCE OF AND
.REASONS FOR PRO·TECTING
TRADITIONAL KNOWLEDGE
Structure
"
13.1 Introduction
13.2 Objectives
13.3 Significance of Traditional Knowledge (TK)
13.4 Aims for Protecting, TK
13.4.1 Prevention of Bio-piracy
fI
13.4.2 Benefits to National Economy
.. 13.4.3 Conservation of Environment
13.4.4 Protection of Livelihood of TK Holders

13.5 Summary ~

13.6 Terminal Questions

13.7 Answers. and Hints
13.8 References and Suggested Readings

13.1 INTRODUCTION
Traditional knowledge refers to the long-standing traditions and practices of
certain indigenous, or local communities. A fundamentally important aspect
of traditional knowledge is that it is "traditional" only to the extent that its
creation and use are part of the cultural traditions of communities. "Traditional",
therefore, does not necessarily mean that the knowledge is ancient. "Traditional"
knowledge is being created every day; it is evolving as a response of individuals
.and communities to the challenges posed by their social environment. In its use,
traditional knowledge is also contemporary knowledge. This aspect is further
justification for legal protection. It is not only desirable to develop a system that
documents and preserves traditional knowledge created in the past, which may
be on the brink of disappearance; it is also important to envisage a system that
contributes to the promotion and dissemination of innovations which are based
on continuing use oftradition. Thus, it is not only about freezing and preserving
knowledge that exists now, but about preserving what exists as an indispensable
and powerful tool for fostering continued innovation and creativity. In many
cases, traditional knowledge has been orally passed for generations from person
to person. It is inter-generational and evolves continuously.

Over the past two decades, traditional knowledge (TK) has received incre-asing
attention on the international agenda and being discussed at the various
intergovernmental bodies. There is heightened concern to protect the traditional
.knowledge of indigenous communities at the national, regional and international
levels. Factors contributing to this include the recognition of TK's importance
in the lives of the majority of the world's population and in the conservation of
biodiversity; concerns about the rapid loss of TK and global cultural diversity;
concerns about unauthorized and inappropriate patenting and use of TK, with 5

I
 Protection of Traditional little or no sharing of resulting benefits with the original holders ofTK; interest in
Knowledge harnessing the potential ofTK forlocal sustainable development; and increasing
attention to indigenous rights.

Intellectual property issues related to genetic resources, traditional knowledge

and folklore have emerged in a wide range of policy areas, including food and
agriculture, biological diversity and the environment, human rights, cultural
'policy, trade and economic development. For example, intellectual property rights
have been granted for uses of plants which form part of traditional knowledge
"
systems in the agricultural, health and environmental fields, Traditional designs,
songs and dances have been used by the entertainment and fashion industries to
create works which are protected by intellectual property. Discussions about such
uses of genetic resources, traditional knowledg-e and folklore have linked the
protection of intellectual property to policy objectives as diverse as the promotion
of free trade, environmental conservation, food security, cultural diversity, etc.
These linkages, established through discussions in several international fora, have
significant technical, administrative and policy implications for the intellectual
property system,

Many countries and communities worldwide are considering how to best address
these issues at the national, regional and international levels. As is apparent
from the wide range of interests and concerns, TK is a complex and multi-
faceted issue. .It is thus being discussed in a range of forums, each with its
own perspective and its own area of competence and expertise, This is useful
and necessary, but will lack a holistic approach, which is needed. For each of
three broad categories of TK-related objectives - preservation, protection and
promotion (harnessing TK for development) - there are a number of possible
.policy tools and measures, which requires a multi-stakeholder policy dialogues
for holistic approach, which is needed.

The preservation, protection and promotion of the traditional knowledge,

innovations and practices of local and indigenous communities (TK) are of
key importance for developing countries. Their rich endowment of TK and
biodiversity plays a critical role in their health care, food security, culture,
religion, identity, environment, sustainable development and trade. It IS
particularly crucial for the most vulnerable segments of their societies, and for
indigenous peoples worldwide. But there are concerns that this knowledge is 1
,
being used and misappropriated/patented by third parties, with few or none of
the benefits being shared with the original TK-holders, and without their prior
I
informed consent. While such concerns have pushed TK to the forefront of the
international agenda, the best ways of addressing the range of issues related
to its preservation, protection, further development and sustainable use are not
yet clear.

Self Assessment Question (Spend 3 minutes)

1) Define the salient features of 'traditional knowledge' .

...............................•.................................................................................

I
 Significance of and
13.2 OBJECTIVES Reasons for Protecting
Traditional Knowledge
After .reading this unit, you should be able to:

• know about the importance ofTK for the over-all developmentof the society;
• .know about the reasons and aims for its protection;'

• find out how the protection of TK ea help-in preventing, bio-piracy;

'. • find out how the protection of TK can benefit the national economy.-

• appreciate the Importance of TK protection in the conservation of

environment and sustainable development; and

• know how the protection of TK can help in the protection of the livelihood
of the TK holders and in their economic upliftment.

13.3 SIGNIFICANCE OF TRADITIONAL

KNOWLEDGE (TK)
It is now a well-documented fact that TK plays an important role rhthe global
economy and is valuable not only to those who depend on it in their daily lives
but to modem industry and agriculture. Most of the traditional societies depend
on this knowledge for their food and healthcare needs. In 2003, WHO reported
that countries inAfrica, Asia and Latin America use traditional medicine (TM)
to help meet society's primary health care needs.· In Africa, upto 80% of the
population uses TM for health care. In. India, this percentage goes up to 70%.
There are no reliable estimates of the total contributions of TK associated with
traditional crop varieties (landraces) to the global economy, but the contribution
of TK in the development and growth of pharmaceuticals and biotechnology-
based industries are widely reported. It is stated that natural product-derived
pharmaceutical alone contributed an estimated $ 120 billion, or 40% of global
pharmaceutical sales in 1997, with global trade in raw botanical materials
I
approximating $ 8 billion in the same year. A recent OEeD study in 2001
outlined the relative importance of biotechnology patent activity by concluding
that the absolute number of USPTO and EPO biotechnology patents has grown
substantially in comparison with the total number of patents.

TK associated with biological resource is an intangible component of the resource

itself. TK has the potential of being translated into commercial benefits by
providing valuable .leads for the development of useful products and processes.
The valuable leads provided by TK save time, money and investment of modem
biotech into any research and product development. It is estimated that a hit-
rate of 80 percent or more can be achieved in developing medical drugs where
the screening of plants is limited to species used by indigenous communities.

Significance of traditional knowledge is much broad-based, impacting many

aspects of national life. Its protection is important for communities in all
countries, particularly in developing and least developed countries. Traditional
knowledge plays an important role in the economic and social organisation
of those countries, and placing value on such knowledge is a viable means of
promoting a sense of national cohesion and identity. Traditional knowledge can
be about medicines and healing practices or in the form of cultural expression
7

I 1
 Protection of Traditional such as folk songs, dances, handicrafts, handlooms, agricultural practices,
Knowledge
etc. The traditional communities, who are the holders of this knowledge and
developed these knowledge bases are generally. ignored while protecting IPRs
based on this knowledge. While the big companies, particularly pharmaceuticals,
make big money' out of the use and commercialization of this knowledge and
getting IP rights over that, the traditional communities do not get any reward
for preserving it for centuries. According to Wendland, discussions on the uses
of TK have linked the protection of IP to policy objectives as the promotion of
" free trade, human rights, health, food, environment and biodiversity conservation,
and cultural diversity.'
le
" Self Assessment Question (Spend 3 minutes)

2) Discuss the significance of 'traditional knowledge' for the countries in

fI general.

13.4 AIMS FOR PROTECTING TK

The issue of protection and preservation ofTK at the international level has been
brought to the fore at the instance of developing countries, because of different
concerns and perspectives expressed by developing countries as owners ofTK-
related resources. The principal concerns expressed about the protection of TK
and TClis at the international level are:

concern about the granting of patents or other IPRs covering TK to persons

other than those indigenous communities/peoples who have originated and
legitimately controlled the TK;

concern that TK is being used without the authorization of the indigenous

communities/peoples who are its holders without proper sharing of the
benefits that accrue from such use.

Underlying these concerns were the issues of bio-piracy, conservation of

environment and eco-system, economic upliftment of the holders ofTK, and the
. national development, even though not all of these concerns and perspectives
are addressable within IP terms. Intellectual property role, in the context of
TK is limited, as it is aimed at excluding the use of protected knowledge by
unauthorized parties, and is not concerned with its promotion or diffusion, the
goals which a!e fundamental for the sustainability of TK. IPRs function on
exclusivity and are limited in time, held by an identifiable natural or legal person.
At. the end, of protection period, they .become part of the public domain. On
the other hand, TK is held collectively (ownership), inherently dynamic, which
grows/alters in response to changing environmental and social circumstances,
1 See, Wend B. Wendland, "Intellectual Property, Traditional Knowledge and Folklore:
WIPO's Exploratory Program", 33 ne 485 (2002).
8

!
 while being in continuity with land and habitat, and mostly exists in an unfixed Significance of and
form (oral). It.originates, preserved and transmitted in a traditional context and is Reasons for Protecting
.-Traditional Knowledge
not limited to any specific field of technology or arts. The enforcement of IPRs
requires to identify and isolate the protected information while the challenging
aspect of TK is its holistic character.

13.4.1 Prevention of Bio-piracy

The term "bio-piracy" encompasses a variety of situations, including:
.
"

The acquisition of GRs or TK without permission of their holder;

Cases where benefits arising from the commercial use of GRs or TK are
not shared with the provider of these resources or knowledge;

Cases where TK is protected by IPRs, mainly patents. The holders of these .

fI
IPRs have not been innovative themselves, but have simply copied this
knowledge.
-
There has been an increasing number of widely reported cases of misappropriation
(bio-piracy) and commercial exploitation of TK under patents and other IPRs,
viz., patents on natural products such as Neem, Turmeric, Basmati rice,
Hoodia cactus, African Potato, Ayahuasca, May Apple, Australian Smoke bush,
Periwinkle. In many of these cases, claims in the patents on plants and their
genetic resources are not fundamentally different from the practices applied by
the traditional communities in the-utilisation of these plants as food, cosmetics
or traditional medicines. Some of these cases have been successfully challenged,
such as Neem and Turmeric but others were not, like patent over ayahuasca.
In this case, Plant Patent on Ayahuasca drink, known as the "vine of the soul"
among the Amazon Quichua people, produced from the bark of the Banisteriopsis
cappi plant used for many medicinal purposes, was granted to an American ,
Loren Miller, in 1986 (patent no. 5751). Upon a request from the Coordinating
Body for the Indigenous Organisations of the Amazon Basin in 1994, the Centre
for International Environment Law (CIEL) filed a case before the USPTO which
revoked the .patent in 1999 on the basis that the drink was not distinguishable
from the prior art presented by the CIEL. On appeal the patent was reinstated
as the patent was, not covered by the new rules in the U.S. on inter partes re-
examination, introduced in 1999, and was not the part of patent law in 1986
on the date of filing the patent. Challenging the misappropriation in foreign
jurisdictions is, however, an expensive and time consuming proposition with
uncertain outcome. -

This raises an important issue of legal protection of TK at national and

international levels. The last few years have seen the right of indigenous
and traditional communities to their knowledge,practices, innovations and
creations being increasingly recognized by law. The recognition and respect of
TK constitute essential tools to fight bio-piracy. There is a need to recognize
and preserve TK in both, the in situ and ex situ manners by taking legislative
measures. In situ preservation is the preservation of TK as a living, evolving
body of knowledge. Steps can also be taken to preserveTK in an ex situ manner,
namely through TK documentation, registries or databases.

The aim of TK protection is not simply to recognise the positive rights in

respect of TK but also to prevent unauthorized appropriation (bio-piracy) and
Q

I I
 Protection of Traditional ensuring benefit sharing out of its use as mandated under the Convention on
Knowledge Biological Diversity (CBD), .Granting of IPRs/patents covering TK may be
prevented by improving the information available to patent offices with regard
to the examination of novelty and inventiveness by preparing databases, as is
being done by India through Traditional Knowledge Digital Library (TKDL) .
. With TK registries; determining access rights is of key importance. There are
some concerns that registries may, in effect, fuel further bio-piracy or TK piracy.
For the moment, keeping the registries as the property of the communities and
governing access' in line with customary access rights to the knowledge may
"
be advisable, This is particularly true for TK not commonly known outside the
community. But for other TK, a national level measures need to be devised.
The TK database of the Tulalip tribe in the United States is an interesting
initiative, as it enables access to each information field to be limited to certain
groups of users. For example, community youth may have access to one subset
of knowledge, community traditional healers to another, and researchers from
outside the community to still another. The database is actually distributed among
the different communities of the tribe, thus giving full local control. .

Even though many initiatives are underway with 'regard to creating databases, but
the databases have inherent limitations in the context of TK. Firstly, while they
may forestall the grant of iIiapproprlat~ patents, they are unable to address .the
problem of the non-accrual to the holders of TK of economic benefits resulting
from the use of that knowledge. Secondly, they will mainly contain the TK,
which is already in the public domain, and in that case prior informed consent
/ .-is-presumed. Thirdly, while documentation may fullfil the important function
in protecting the TK as a part of defensive protection of TK, its role in positive
protection is very much limited. Moreover, databases codify TK as it is identified
and described at a particular time, which does not take into account its-dynamic
nature and it continuously evolve through incremental innovation. As such they
are static and rigid and they would be useful only if being systematically updated
to keep up with the evolution of knowledge. Opinion has also been expressed
that creating databases may clash with the interests of indigenous communities
to keep their knowledge secret and it will only serve the government-induced
strategy of preventing misappropriation, and would not be a solution to a holistic
approach towards conservation of TK.

Another aim to prevent unauthorized or inappropriate use ofTK by third parties

includes unauthorized commercial use as well as applications for IPR that are
based on TK but are made without the prior informed consent (PlC) of the
TK holders and without benefit sharing. Intellectual property protection can be
categorized as defensive (preventing others from' seeking iPR to one's TK) or
positive (establishing IPR to one's TK, with the resulting possibility of preventing
others from using the TK without permission). For both types of protection,
there have been cases where TK holders have been able to use conventional
IPR instruments to protect their TK. However, since these instruments were not-
developed with TK in mind, but rather modem industrial intellectual property,
they are not always perfect to fight bio-piracy, Biodiversity-related TK could
be specifically included in national policies and institutional arrangements on
access to genetic resources and benefit sharing. The Convention on Biological

Diversity stipulates that access to genetic resources should be based on PIe; of

the member
10

I
 State and mutually agreed terms (MAT) with benefit sharing. For TK associated Significanct; of and
with such resources, the national access and benefit-sharing regime could also Reasons for Protecting
Traditional Knowledge
sti~ulate that PlC of the

TK-holding communities (where these can be clearly identified) should be sought

in accordance with their customary laws and on MAT, including benefit sharing.
Where TK holders cannot be clearly identified or the' TK is more or less in the
public domain, fees could be paid by the interested party into a community
"
development fund, as in Peru. India' draft Rules on the protection, conservation
and effective management of TK relating to biological diversity, 2009 have
the similar provisions and provide a mechanism of benefit-sharing. Beside, as
demanded by developing countries, the IP applications r-elated to GRs and TK
should (i) disclose the country andsource of origin of biologicaUmaterial and
. TK; and (ii) must provide evidence that laws and practices of the country of
origin on PlC and benefit-sharing; have been fully complied with. The Nagoya
Protocol on ABS, 2010 has the provision in this regard.

Many reasons for the protection of TK and to remedy this situation of biopiracy
and misappropriation ofTK have been given are based on equity considerations.
It is said that, given the important economic value of TK, the holders of TK
should be part of the economic benefit-sharing, derived from this knowledge.Tt
is also based on the rationale of quid pro quo, i.e. that if the TRIPs Agreement
requires developing countries, with traditional and indigenous communities, to
provide IPRs for a broad range of subject-matters, including biological material,
it is equitable that TK should' have legal recognition _and the holders should
be rewarded for their efforts in conserving and preserving that knowledge- A
significant example of this is the GRs linked to TK.. Traditional communities
developed varieties of GRs through planting, seed production and selecting the r
best adapted varieties through traditional farming. These communities know
the qualities of the products derived from GRs, which could be very useful in-
differenf fields, such as medicine and agriculture. However, this knowledge is
collected by scientists and researchers and they get IPRs and benefit from its
commercial use, without compensating the traditional communities. Similar
arguments apply to other intangible components of TK.

13.4.2 Benefits to National Economy

Protecting TK has the potential to improve the performance of many developing
country economies by enabling greater commercial use of their biological wealth
and increasing export of TK related products. TK and TCEs-based products as
handicrafts, medicinal plants, traditional agricultural products, herbal medicines,
cultural heritage tourism, and non-wood forest products (NWFPs) are traded
. in both domestic and international markets and already provide substantial
benefits for exporter countries. For example, some 150 NWFPs, including rattan,
cork, essential oils, forest nuts, and gum arabic, are traded internationally in , '

significant quantities. TIC is also used as an input into modern industries such as
pharmaceuticals, cosmetics, agriculture, food additives, industrial enzymes, bio- <,

pesticides, and personal care. I~ these cases, most of the value added iscaptured
by firms based in developed countries whose, advanced scientific technological
and marketing capabilities make this possible through bio-prospecting and they
capture much more than the added value to the TK. This situation needs serious
~ .~.
attention so that developing countries could be rewarded from the added value to,
11

I I
 Protection of Traditional their knowledge, There is a need to add value to TK at the local level in order
Knowledge
to convert it into economically profitable enterprises for these communities.

TK can also provide valuable leads for third parties in the development of useful
products and processes, which can save modem industry time and money. This
makes, it necessary that the benefits should be equitably shared with the countries
providing the genetic resources 'and the communities providing the knowledge.
Currently this is often not the case. Therefore, several experts emphasize the
importance of implementing CBD articles, particularly Article 15, related to
"
ABS. Suggestions for benefit sharing include direct contracts with communities,
establishment of national or regional funds to collect revenue on behalf of the
communities, a global bio-collecting society and access fees for TK databases.
There is, however, a view that the financial returns on bio-prospecting have been
overrated and that ABS regimes to date have often focused more on controlling
fI access than on promoting it. This, combined with legal uncertainty has in some
cases discouraged potential involvement by business.

To harness TK for development and trade, developing countries need assistance

to build national capacities in terms of raising awareness on the importance
and potential of TK for development and trade; developing institutional and
consultative mechanisms on TK protection and TK-based innovation; and
facilitating the identification and marketing ofTK-based products and services.
The aim is to promote the use and further development ofTK systems and TK-
based innovations; promote appropriate and sustainable commercialization; and
ensure that a fair and equitable share of the benefits resulting from the use of
TK is captured by the TK holders, and in this process, the country's economy
should also benefit. But to harness TK for trade and development, several steps
required to be taken by the governments at the national/regional levels:

i) To promote the use and further development of TK systems

It must first be recalled that TK has the greatest value to the TK-ho!ding ~
communities themselves. Many of them rely on TK for their very survival,
particularly poor rural communities in developing countries. Thus, any-measures
that can strengthen and further develop this base of knowledge on which the
communities depend will facilitate their movement along their own unique
path of development. This can be done through documentation of TK. Also,
steps must be taken to promote local exchanges and adaptation of TK, such
as "community-to-community exchanges". The IPR implications of these may
need to be worked out (for example, there might need to be an agreement that
shared information is not then passed on to a third party). However, this has
been shown to increase the knowledge bases of both communities involved and
to lead to new ideas and solutions to common problems. The Honeybee Network
in India is interesting initiative in this direction, promoting grassroots TK-based
innovation through TK documentation and dissemination.

Measures aimed at enhancing the capacity of national and regional TK networks

- for example, by facilitating communication between different countries of the
region that are sharing co~on knowledge - could also be quite useful. Attempts
should be made to integrate TK into national. development strategies and
development projects. Involving TK holders in the early stages of development
projects will help ensure that the project IS well suited to local realities and takes
advantage of local TK resources, including knowledge of the environment, local
12

/
 , ,

materials, appropriate technologies, etc. Often, local TK can be Ieveraged by Significance of and
global knowledge for increased project effectiveness and sustainability. , . Reasons for Protecting
Traditional Knowledge
ii) Commercialization
It should be pointed out that commercialization of TK often -refers to the
commercialization of a TK-based or TKvderived product - a tangible
good or service where TK is the "know-how" involved in its production.
Commercialization is a sensitive subject for some TK holders. Many TK holders
are not as interested in commercializing the TK themselves as in preventing the
inappropriate commercial use of it by others. Generally, TK was not developed
with commercial purposes' in mind, 'but rather for local use within the corrimunity. '
Much TK is not an approl'riate subject for commercialization, particularly that
with special spiritual or cultural significance. For TK holders interested in
.exploring commercialization, the first step is to decide which parts of their TK
are off limits and which are not. A next step is the identification, within the latter
category, ofTK that may have value in the marketplace. Commercialization can
.. be done by third parties, with a share of benefits going to the communities; as a
partnership between the communities and third parties; or by the communities
themselves. In general, the more involved the community is in developing,
producing and selling the product, the larger the share of the market value that
will accrue to it. The more funds come into a community, the more likely it
is that the community will be vibrant and that the TK held by that community
wiHbe preserved and further developed.
Thus, it is very important to promote community-based development. The tools
for such development are not exclusive to the domain ofTK. They cover a range
of measures to promote smallenterprise and informal sector development, such
as access to finance; assistance in identifying market opportunities; scaling up
operations, marketing, and export; and promoting .the formation of producers'
associations to create economies of scale and create more bargaining power in
obtaining inputs at lower prices. Partnerships with larger entities in the country's
formal sector or in foreign markets can play an important role. One area where
commercialization has particularly significant potential is traditional medicine.
Measures can be taken to promote the increased involvement of traditional.
communities in this industry - for example, through the cultivation and first-
degree processing of medicinal plants.
Since the' indigenous/local communities may not have the resources to
undertake commercialization on their own, it will become the responsibility
of the government to provide necessary assistance at the initial stages. In the
case of traditional medicine industry, 'the government should create regulatory
frameworks for ensuring the quality, safety and efficacy of these medicines;
measures encouraging a sustainable supply of raw materials for industry
(including prevention of over harvesting of wild resources and cultivation of
medicinal plants); and measures relating to export promotion.
In some cases, conventional IPR instruments may increase the commercial value
of TK-derived products or help protect successful products from unauthorized
copying or use by third parties. This concerns, for example, the use of trademarks
and geographical indications (GIs)., such as the 0.1 for "Darjeeling Tea".
- '

But the value of TK must not be measured in purely economic terms; however,
there are other important reasons, such as environmental or cultural factors that
emphasis the importance of its protection. 13

I I
 Protection of Traditional
Knowledge r-
13.4.3 Conservation of Environment
The protection ofTK is important for the conservation and sustainable development
of environment as much of the world's crop diversity has been conserved and
preserved by the indigenous/local peoples, which has helped in the protection
and conservation of biodiversity, The TK of the indigenous communities/local
peoples is central for their ability to operate in an environmentally sustainable
way and ~~co~ser:e genetic and oth~r natural, re~ources, Most of the indigeno~s
.
" commumnes hve In areas where theI vast majority of .
the world's plant genetic
resourc~s, (PGRs) are found. Th~ir Ifowledge is central, to the conservation and
preservation ofGRs and other bio-resources. For centunes TK has enabled rural
, indigenous communities to survive in balance with their natural environment.
By virtue of providing for this balanced relationship, TK is truly the "science"
of sustainable development at the local level. The Rio Declaration, 1992 clearly
recognizes this by stating that "Indigenous people and their communities, and
other local communities, have a vital role in environmental management and
development because of their knowledge and traditional practices".

Paragraph 26 (1) of the Agenda 21, adopted at the Earth Summit in 1992, accepts
the link between indigenous peoples and the world's need for environmentally
sensitive development, and states: " In view of the interrelationship between
the natural environment and its sustainable development and the cultural,
social, economic and physical well-being of indigenous people, national and
international efforts to implement environmentally sound and sustainable
development should recognize, accommodate, promote and strengthen the
role of indigenous people and their communities." This principle is echoed in
a number of other international environmental agreements, including but not
limited to the Convention on Biological Diversity (CBD), the' Convention to
Combat Desertification, and the Statement of Principles for the Sustainable
Management of Forests. It thus draws the attention to the important role
traditional knowledge (TK) plays in promoting the sustainable management of
natural and environmental resources, and to the urgent need to support capacity-
building efforts aimed at promoting the use of TK,to help ensure sustainable
patterns of trade in goods and commodities deriving from natural resources.

Because TK is closely related to surviv~l and subsistence, it provides a basis

for efficient local decision making in agricultural farming and the exploitation
. of fisheries and forests, ensuring the long-term viability of natural ecosystems
so that the resource needs of future generations can be met. In indigenous
communities throughout the world, TK has prevented land and soil degradation,
fisheries depletion, biodiversity erosion. and deforestation. With the advent of
globalization, however, TK and its environmental benefits are threatened. On the
one hand, world trade has created increased demand from distant markets for
locally. sourced agricultural, fisheries and 'forest products, pushing producers to
harvest resources beyond the s1!stainable limits that TK would normally advise.

There is also the danger that the biological resources, increasingly subjected to
IPRs and paten~s are likely to be plucked to extinction, which raises concerns
over their exhaustibility and loss of habitat, besides the loss of lifestyles and
livelihoods to indigenous communities that have nurtured and used these
resources for long. This may also ultimately affect the food security. International
recognition and protection of TK would help in the protection/conservation of
14 I

I I
 the environment and to manage the biodiversity. Protection of TK is, therefore Significance of and
closely linked to the protection of environment. Reasons for Protecting
Traditional Knowledge
In the recent years, there has been increased mobalisation of traditional
communities from their natural habitat and their increasing assimilation with the
modem society. Global communications and mobility attract younger generations
to a diverse set of non-traditional livelihoods, often in distant urban settings. This'
has affected transmission of TK to current and future generations. This has also
" become a cause of concern for TK protection. It is feared.that this mobility may
lead to the extinction of TK and affect prejudicially the biodiversity. Writirig
on biodiversity, Gray observes that: "the world biodiversity crisis is matched
by a world 'cultural diversity' crisis. Indigenous peoples live predominantly
in areas of high biodiversity while at the same time comprise 95 percent of
the cultural diversity in the world".' The challenges of globalization therefore
include identifying ways for local communities to fully participate in, and benefit
from, globalization in an environmentally sustainable manner while ensuring
that traditional livelihoods and TK are competitively compensated in financial
terms to prevent their erosion.

It has, however, been pointed out that sales of TK-based products provide
important sources of income for local communities and can give them incentives
to preserve their TK and biodiversity resources. The Internet offers new
opportunities for reaching global markets. However, extreme care is needed
to avoid over-harvesting
. ..
of natural resources, which can easily lead to species
extinction. Sustainability has to be-built in at several levels. Key elements of
supporting sustainability include increasing awareness, training in sustainable
harvesting, cultivating medicinal plants, increasing the value added at the
community level, and increasing community control over local resource use.

Self Assessment Question (Spend 3 minutes)

3) How the TK is vital in the conservation of environment?

13.4.4 Protection of Livelihood of TK Holders

TK is often an undervalued and underutilized resource in the development
proce~s. Several experts point out that TK is.in fact the key to sustainable
development at the, local level. TK is valuable first and foremost to TK-holding
local communities who-depend upon it for their livelihoods and well-being,
as well as for enabling them to sustainably manage their local ecosystems.
According to the World Health Organisation, up to 80 per cent of the world's
population depends on traditional medicine for its primary health needs. In
India, for example, there are 600,000 licensed medical practitioners of classical
traditional health systems and over one million traditional community-based

2 A. Gray, Between the Spice of Life and the Melting Pot: Biodiversity Conservation and its
Imact on Indigenous Peoples, IWGIA Document 70 (1991, Copenhagen).
15

I I
 Protection of Traditional . health workers, Over 90 per cent of food in sub-Saharan Africa is produced
Knowledge
using customary farming practices. Fo~ those comprising the poorest segments
of societies, particularly women, indigenous people and rural inhabitants of
developing countries, traditional knowledge is indispensable for survival. This
is especially true in many LDCs. TK is thus a vital element of the social capital
of the poor and constitutes their main asset in their efforts to achieve control
of their own lives.

There is a need to enable these communities to harness TK for their economic

.
" upliftment and growth. Consequently, the demand for an effective protection of
TK has, gained momentum, either through the application of the traditional IPR
system or by means of a new sui generis system such as traditional community
rights or community intellectual property rights, as also by recognising their
cultural/land rights over their habitat. It should be strongly emphasized that
intellectual property, however, is not only about property. It is also about
recognition of and respect for the contributions of identifiable, human creators.
From this perspective, intellectual property has a very important role to play in
protecting the dignity of holders of traditional knowledge and, by conferring
property rights in relation to such knowledge, giving those holders a degree of
control of its use by others.

Indigenous peoples inhabit lands rich in natural reso~ces and are at the same time
.among the poorest of the poor both because of their economical marginalisation
and also because they are deprived ba~ic social, cultural and political rights and
fundamental freedoms, including rights to their lands, territories and resources.
Consequently, they are strongly affected by the operations of national and
transnational companies. It may be argued that biodiversity, and the traditional
knowledge associated with using it in a sustainable manner, are a comparative
advantage of those countries that are biodiversity-rich, enabling them to
\ ~'f participate more effectively in global markets and thus rise above current levels
of poverty and deprivation. This is an example of how protection of traditional
knowledge at the national and the international levels may be seen as a potentially
powerful tooi for advancing the integration of least .developed countries into the
global economy. Involving indigenous peoples and traditional knowledge into
natural resource management produces more equitable and successful outcomes.

A large number of countries - rich in genetic resources (GRs) and TK and

folklore, believe that the traditional communities have been deprived of the
benefits from the use of their knowledge, innovations and practices, which have
been monopolised and used by others, mainly by major companies, without their
authorization and without acknowledging or rewarding them for their knowledge,
that is, there is a perceivable asymmetry between the benefits obtained by the
companies that commercially exploit this knowledge and the lack of benefits
for its true holders. Developed countries have a moral obligation to ensure that
indigenous/local peoples receive a fair and equitable share of benefits arising out
of the use of their TK and commercialization of GRs. Moreover, If the knowledge
assets of developed countries are to be protected by means of an international
agreement (viz. TRIPS) it is only fair and equitable that the knowledge assets
of developing counties ought also to be similarly protected. It is indeed t~~
responsibility of the international community to create an egalitarian system -
for the availability, acquisition, maintenance and enforcement of IPRs, which
does not, a priori, exclude any section of the society. An international regime
16

/
 would give control over the use of their knowledge assets and the capacity to Significance of and
ensure that they are not exploited commercially. Reasons for Protecting
Traditional Knowledge
Industrialized countries have generally been supportive of the notion that
indigenous peoples' rights are mainly about being permitted' to practice their
lifestyle and uphold their sense of identity through adhering to expressions of
their folkore and culture, This, however, takes away attention from the essential
questions of economic rights andthe economic value of TK, some of which
"
comes inextricably linked with their habitat and their title or lack of it to source
livelihood from their habitat.

TK is currently being lost at an alarming rate. There are a number of possible

measures for preserving TK. First, it is important to understand the root causes
of the TK loss in each country. Often the process begins with destruction of the
fI natural environment, which in turn disturbs and even destroys the indigenous and
local communities embodying traditional lifestyles which are the main holders
of the TK. Recognizing the rights of these communities to 'their traditional lands
could help slow this detrimental trend. Often such communities start to decline
owing to poverty, in which case strengthening their economic opportunities is
an appropriate response. Lack of motivation in the younger generation to learn
the traditions is another reason cited for its loss. They no longer feel proud of
their heritage and way of life, considering it to be old-fashioned, and thus have
'little incentive to be recipients of the TK held by the elders. There is a fear that
TK will extinct with the elders of the community. TK is generally viewed with
disdain and inferior, as it does not conform to the accepted scientific methods
of learning in the context of modern reductionist approach of science. In that
case, raising awareness of the value of TK and of the cultural heritage may
help, besides its becoming a tool in engaging them in a gainful employment at
par with other vocations. Only by concerted efforts to protect it and accord it
due respect, this trend can be stopped.

In addition to national systems, the protection ofTK and equitable sharing of the
benefits derived from the use of biodiversity resources and associated TK, may
also require measures by user countries and cooperation at the multilateral level.
It must be ensured that the benefits of cumulative innovation associated with
TK accrue to their holders while enhancing their socio-economic development.
Frequently TK is used and appropriated without the prior informed consent of
the holders. This situation needs a change.

13.5 SUMMARY
• Traditional knowledge refers to the long-standing traditions and practices
of indigenous/local communities. It passes orally from generation to
generation and evolves continuously.

•. Because of its fast erosion due to misappropriation/biopiracy, concerns

are aroused about its protection and efforts are underway to reward the
indigenous/local communities for this knowledge out of its use and
commercialisation.

• Number of tools and mechanisms, including the traditional IPRs and a sui
generis approach, are being discussed to protect it.
17

/' I
 Protection of Traditional • TK protection is vital to curb biopiracy, and to c0!lserve and protect the
Knowledge eco-system.

• To curb bio-piracy, documentation of TK in the public domain can be a

useful mechanism. Disclosure of the source of biological material and TK,
and the evidence of compliance with the local laws on ABS in the IPR-
related application can be very useful.

• TK can help in the growth of national economy, by trading in TK-based

.
" goods. TK plays a vital role in agricultural and medicinal industry, which is
a thriving industry at present. This will also create employment opportunities
: for the indigenous/local communities. j

• TK protection will significantly help in the upliftment of the indigenous/

local communities. They live in lands rich in natural 'resources, but are
deprived basic social, cultural andpolitical rights and fundamental freedoms,
including rights to their lands, territories and resources. By protecting their
'rights to land and helping them' to use their TK in a gainful manner will
.improve their economic and social conditi~ms.

13.6 TERMINAL QUESTIONS

'1)' What is "traditional knowledge' and its significancefor developing countries
in particular.

2) What are the principal objectives of protecting TK and how they can be
attained?

3) What are the vital steps discussed and suggested 'at the regional/international
levels to curb bio-piracy and misappropriation of GRs and TK associated
therewith?

13.7 ANSWERS AND HINTS

Self Assessment Questions

1) Traditional knowledge refers to the long-standing traditions and practices

of certain indigenous/local communities. Its creation and use are part of the
cultural traditions of communities; being created every day and continuously
. evolves as a response of individuals and communities to the challenges
posed by their social environment. In many cases, 'traditional knowledge is'
, passed orally for generations from person to person. It is inter-generational
and continuously created and modified.

I' 2) ,TK plays an important role in the global economy and is valuable not only
to those who depend on it in their daily lives but to inodern industry and
agriculture. Most of the traditional societies depend on this knowledge for
their food and healthcare needs. TK has the potential of being translated'
into commercial-benefits by providing valuable leads for the development
of useful products and processes. The valuable leads provided by TK save
time, money and investment of modem
, .
biotech into any research
~ and product
development.

18

I
 3) TK is important for the conservation and sustainable development of Significance of and
environment as much of the world's crop diversity has been conserved Reasons for Protecting
Traditional Knowledge
and preserved by the indigenous/local peoples, which has helped in the
protection and conservation of biodiversity. The TK is central for their
ability to operate in an environmentally sustainablewayand to conserve
genetic and other natural resources. Most of the these communities live in
areas where the vast majority of the world's plant genetic resources (PGRs)
are found. Their knowledge is central to the conservation and preservation
.. of GRs, and other bio-resources, which help in ensuring the food security
of the nation as well.

Terminal Questions

1) Refer to Section 13.3

fI
2) Refer to Section 13.4

3) Refer to Section 13.5 .

13.8 REFERENCES AND SUGGESTED READINGS

. 1) P. Principe, "Economics and Medicinal Plants", in T.R. Tomlinsonand O.
Olayiwola Akerela (eds), Medicinal Plants: Their Role in Health and
Biodiversity (1998, University of Pennsylvania Press, Philadelphia).

2) Daniel Gervais, "TRIPS, Doha and Traditional Knowledge", 6 JWIP 403

(3: 2003).

3) Ajeet Mathur, Who Owns Traditional Knowledge, Working Paper No. 96,
Indian Council for Research on International Economic Relations ( ICRIER),
Jan. 2003, p 12 et seq.

4) Thomas Cottier, "The Protection of Genetic Resources arid Tradional

Knowledge: Towards More Specific Rights and Obligations in World Trade
Law", 4 JIEL 561 (1998).

5) S. K.Verma, "Protecting Traditional Knowledge - Is a Sui Generis System

an Answer?" 7 JWIP 765 (Nov. 2004).

19

1 I
 UNIT 14 CURRENT INTERNATIONAL
EFFORTS FOR THE
PROTECTION OF TK
'Structure
"
14.1 ' Introduction
14.2 Objectives
i4.3 International Efforts for the Protection of TK
14.3.1 World Intellectual Property Organisation (WIPO)'
14.3.2 'World Trade Organisation (WTO) TRIPS
14.3.3 Convention on Biological Diversity (CBD)
14.3.4 Food and Agriculture Organisation (FAO)
14.4 Need for a sui generis framework for TK Protection
14.5 Summary
14.6 Terminal Questions
14.7 Answers and Hints
14.8 References and Suggested Readings

'14.1 INTRODUCTION
The protection, of traditional knowledge, innovations and practices (hereinafter
referred to as TK) of indigenousllocal communities has received an increasing
international attention since the adoption of the Convention on Biological
Diversity (CBD) in 1992. The CBD, through its Article 80) has broadened the
scope and mandate of protection with wider objectives. It led to heightened
concern to protect the traditional knowledge (TK) of indigenous communities
at the national, regional and international levels. Since then it is actively on
the agenda of different inter-governmental bodies, including the human rights,
bodies, viz., WTO/TRIPS Council, WIPO, UNEP/CBD, FAO, UNCTAD,
WHO, ILO, United Nations Human Rights Commission, UN Permanent Forum '
on Indigenous Issues. A number of countries and regional organisations are
1
proposing or have already adopted measures to protect TK in their respective
jurisdictions. At the level of inter-governmental bodies, the most extensive
work/discussions have taken place in the WIPO, which had established an
Inter-Governmental Committee on Intellectual Property and Genetic Resources,
Traditional Knowledge and Folklore (hereinafter referred to as IGC) in 2000
with the mandate to discuss intellectual property (IP) issues that arise in the
context of (i) access to genetic resources and benefit-sharing; (ii) protection of
TK, whether or not associated with those resources; and (iii) the protection of
expressions of folklore. Its discussions since then have led to an understanding
of the technical dimensions involved in the protection of TK and clarifying
many concepts thereto. Even though no comprehensive document on the
'protection ofTK has been adopted so far, but piece-meal progress in the form
of the International Treaty on Plant Genetic Resources for Food and Agriculture
(ITPGRFA), adopted by the FAO in 2001, and the recently concluded Nagoya
20 Protocol under CBD in October 2010 has been seen:

I
 Current International
14.2 OBJECTIVES Efforts for the
Protection of TK
After reading this unit, .you should be able to:

• know the initiatives undertaken by different inter-governmental bodies for

the protection of TK;
• know the progress achieved by different bodies in their endeavour to adopt
a mechanism to protect TK;
"

• able to know the main demands 'of developing countries in this regard; ,
• scope and mandate of ITPGRFA and whether it really addresses the issue
of protection of TK in a comprehensive manner;
• scope and main plank of the Nagoya Protocol;
• know the global issues in the protection of TK; and
• explain the need of a sui generis system for the protection of TK.

14.3 INTERNATIONAL EFFORTS FOR THE"

PROTECTION OF TK
The first effort to protect TK, specifically folklore, under the IP regime was a
joint initiative taken by WIPOIUNESCO in 1978, which led to the adoption
of the WIPO-UNESCO Model Provisions for National Laws on the Protection
of Expressions of Folklore against Illicit Exploitation 'and Other Prejudicial
Actions in 1982, It was in the nature of guidelines. to WIPO members to protect
folklore in their jurisdictions. Since then, numerous efforts have been initiated
to protect TK by inter-governmental bodies, which are aimed at entrusting legal
control toindigenous/local coinmunities over the exploitation of their TK when
such knowledge has special cultural significance. The human rights bodies also
adopted important conventions in this regard, viz., the ILO Convention No 169
of 1989 and the draft UN Declaration on the Rights oflndigenous Peoples, 1994.

The ILO Convention obliges the, States to "respect the special importance for
the cultures and spiritual values of the peoples concerned of their relationship
with the land or territories or both" (Art. B). States are 'to promote "the full
realization of the social, economic and cultural rights of these peoples with '
respect for their social and cultural identity; their customs and traditions and their
institutions" (Art.2 (2)). The Governments have the responsibility to develop,
"with the participation of the people concerned, co-ordinated and systematic
action to protect the rights of these peoples and to guarantee respect for their'
integrity." (Art. 2 (1)) Their social, cultural, religiousand spiritual values and
practices are to be ,recognized and protected (Art. 5). The concept of cultural
"identity thus provides an important link between cultural. rights and cultural
heritage, implying the collective right of indigenous peoples to the protection
of their own cultural heritage. The Convention, though does not define TK, or
explicitly mention indigenous resources or folklore, nevertheless recognizes the
rights of indigenous peoples over natural resources pertaining to their land, and
to their traditional- activities in order to maintain their culhlres and economic self- '
reliance and development, which are to be safeguarded (Arts. 15 &,23). More
importantly, they can "decide their own priorities for the process of development
as it affects their lives, beliefs, institutions and spiritual well-being and the lands 21

I I
 Protection of Traditional they occupy or otherwise use, and to exercise control, to the extent possible, over
Knowledge their own economic, social and cultural development (Art. 7). The Convention
clearly accepts the inter-relationship between cultural heritage law, land rights,
and cultural rights of indigenous peoples in their own traditions, which includes
TK as well. The Convention is important in providing a model definition of
indigenous and tribal peoples (Art. 1.1).

The draft UN Declaration on the Rights of Indigenous Peoples accepts the

right of self-determination of indigenous peoples (Art. 3). It recognizes their
"
"collective right to live in freedom, peace and security as distinct peoples", (Art.
6(1)); their right to the full recognition of their laws, traditions and customs (Art.
26); and full maintenance, protection and promotion of past, present and future
manifestations of their cultures (Art. 12). The Declaration demands that States
abstain from removing them from their lands or territories (Art. 10), respect
fI their traditions and indigenous knowledge (Part Ill) and restore and protect the
enviromnent (Art. 28). Cultural and intellectual property rights are recognized
in Article 29, by accepting their full ownership, control and protection over
their cultural and intellectual property. The draft includes the right that States
obtain their "free and informed consent" before.any projects affecting their lands,
territories or resources may be approved, "particularly in connection with the
development, utilisation or exploitation of mineral, water or other resources"
(Art. 30). However, there is no explicit mention ofTK and traditional resources
(like with the ILO Convention), but the term "other resources" in Article 30
could be broadly interpreted to cover them.

14.3.1 World Intellectual Property Organisation (WIPO)

The WIPO's direct and positive involvement in the foray ofTKstarted in 1998.
During 1998-1999, the WIPO embarked on nine fact-finding missions (FFMs)
in various parts of the world on exploring the intellectual property aspects of
TK protection, bearing in mind the needs and expectations of TK holders.' In
its 26th session, the WIPO General Assembly established an Intergovernmental
Committee on Intellectual Property and Genetic Resources, Traditional I
~
Knowledge and Folklore (IGC). The IGC's actions (which has so far met in 20
sessions since its inception in 2000) have resulted in three separate texts- on TK,
Traditional Cultural Expressions (TCEs) and Genetic Resources (GRs) , which
will be negotiated in a single negotiating text. The IGCs efforts have focussed on
trying to understand the needs and expectations of traditional/local communities,
ascertaining the adequacy of current methods for protecting TK, and surveying
proposals to enhance such protection. It has produced an impressive number
of documents, including the model clauses for genetic resources contracts, a
toolkit for documentation of TK protection, and elements of a possible sui
generis system. Latest texts contain the draft provisions for an international
instrument to protect the TK and based on the final text of the draft treaty on
TK, the WIPO may decide to convene a Diplomatic Conference for its adoption
in 20l2-2013. In the Draft Articles on the protection of traditional knowledge,
prepared at IWG 2 in March 2011 (wipo/grtkf/ic/18/7), TK has been defined as
"knowledge resulting from intellectual activity in a traditional context including
the know-how, skills, innovations, practices and learning that form part of the

I See Intellectual Property Needs and Expectations of Traditional Knowledge Holders,

WIPO Report on Fact-Finding Missions on Intellectual Property and Traditional Knowledge
22 (1998-1999) Geneva 2001.

I
 traditional knowledge systems of an [indigenous people or local community']. 'Current International
Efforts for the
The draft has also come out with the eligibility critetia for TK protection, scope
Protection of TK
of protection, sanctions, remedies and exercise of rights, and administration of
rights. A contracting party may, in consultation with the holders of traditional
knowledge, establish an appropriate national or regional competent authority or
authorities for this purpose. It has provisions on exceptions and limitations to
TK rights, and on term of protection, which may last as long as the traditional
knowledge fulfills the criteria of eligibility for protection as outlined in the Draft.
"

Beyond the Committee's work, WIPO has also taken steps to enhance the
coverage of documented TK in the minimum documentation of the Patent
Cooperation Treaty (PCT) and to expand the International Patent Classification
(IPC) to contain categories for TK subject matter to provide for more accurate
, and focussed searching for relevant TK during the 'patent examination process.
fI

The WIPO's approach in the matter ofTK protection is mainly IP-related:The

documents produced acknowledge the general difficulties. with protecting the TK
under IP law. The IGC has centred its activities mainly on solutions that tend to
minimize the rigours ofIP criteria. The IP solution is sought for TK in the public
domain, which is a small part of the vast arena of TK that has 'strong moorings in
cultures and traditions/rituals etc. The notion of public domain as understood in
the formal IP system dominated the identification of the definition as fixing the
criteria for the protection of TK. That fundamentally questioned the customary
right of the TK holders. TK was part of the communities and they owned it. The
eligibility conditions were putting the burden on the holders of TK to prove that
it belonged to them, That was against the basic understanding that TK belonged
to the community. The policy objective was to prevent misappropriation and
misuse of valuable TK. This approach would facilitate misappropriation and put
the burden of establishing ownership on TK holders rather than enabling them
to empower, preserve and protect their culture and tradition. But this approach
is not adequate enough to protect and cover all forms of valuable TK. Once
TK qualified, an eligibility condition should not put any further discrimination
on the nature of protection based on further classification of TK because this
might be unfair to the community. Regarding knowledge kept in secret, it was
an accepted fact that knowledge kept in secret would receive higher protection
through the basic principles of trade secrets. This can be taken care in. a sui
generis law, which is different from an IP instrument.

Developing countries desire to protect the holistic character of TK. The IGC's
work has heightened the awareness among the developing countries to safeguard
their valuable knowledge asset. WIPO had earlier proposed a bottom-up approach
under which developing countries first assess how existing national mechanisms
of IP could be more effectively used to protect TK before introducing protection
at the international evel.

Self Assessment Question (Spend 3 minutes)

1) Describe the latest position of negotiation in the IGC on TK protection.

2 The term "indigenous people and local community" is used as a place holder. This term will
be addressed by the group considering beneficiaries of protection. 23

I I
 . Protection of Traditional
Knowledge

14.3.2 World Trade Organisation (WTO)/TRIPS

The TK has come-up on the agenda of the WTO under the TRIPS Agreement.
',. The Agreement, as such deals with the traditional concepts of intellectual
property, and does not have any specific provision on the protection of TK,
rather it is being excluded by virtue of Article 70(3), considering it as a part
of public domain.' The relevant provisions in this context could be Article 39
(protection of undisclosed information), if the TK is kept as secret knowledge,
and Article 22 (protection of geographical indications). Obviously they are of
limited application and are unable to meet the concerns of developing countries.

The issue of protection of TK being brought before the General Council of

the WTO in the context of Article 27(3)(b) of the TRIPS in 1999, which was
"to be reviewed under its terms. Article 27(3)(b) requires Members to protect
plant varieties, " either by patents or by an effective sui generis system or by
any combination thereto". A country while constructing a sui generis regime
may take into account the protection of TK as the plant genetic resources
.have a double nature: they are physical material and the carriers of hereditary
information which is"capable of self-replication and also a part of TK. This
double nature gives rise to a conceptual tension between physical property
in germplasm on the one hand and the IPRsin intangible elements of GRs
(genotype) which constitute inventions, trade secrets or new plant varieties on
the other. TK also .became an issue in the context of patenting on biological
t inventions, which saw a tremendous surge after the adoption of TRIPS, and made
microorganisms, microbiological and non-biological processes as patentable.

At the Third Ministerial Conference of the WTO at Seattle, developing countries

from Latin America and Africa wanted that the TRIPS review , inter alia,
should "establish on a-mandatory basis within the TRIPS Agreement a system
for the protection of intellectual property, with an ethical and economic content,
applicable to the traditional knowledge of local and indigenous communities,
together with the recognition of the need to define the rights of collective
holders", and it should lead ultimately to a multilateral legal framework.
They also called for the harmonization of TRIPS and the CBD, relating to the
protection of TK and use of GRs.

Developing countries arguments centred on clarifications about the exclusions

under Article 27(3)(b). They wanted that the information relating to the origins
. of a biological invention become part of the patent application process and that
the principle of prior informed consent under the CBD, should be incorporated
into TRIPS. There was heightened concern about the grant of patents andlor other
IPRs covering TK to persons other than the indigenous peoples/communities,
who own and control them, and their TK is being used without their authorization
and without sharing benefits with them that a~crue from such use. The United

3 Article 70.3 of the TRIPS reads: "There shall be no obligation to restore protection to subject
matter which on the date of application of this Agreement for the Member in question has
24 fallen into the public domain",

I
 States and other industrialized countries, on the other hand, argued that the CBD's Current International
objectives on access to GRs and TK could best be achieved through national Efforts for the
Protection of TK
legislations and contractual arrangements, based on the national legislation,
which could include commitments on disclosure. But this' does not address the
issue of consequences of non-compliance with the national legislation and the
IPRs granted on GRs and TK.

a) Doha Declaration

.
'0
The strong position taken by the developing countries on the protection of TK,
nevertheless, led to its inclusion ,in Doha Ministerial Declaration in November
2001 in .paragraphs 19 and 32.

Para 19

fI We instruct the Council for TRIPS, in pursuing its work programme including
under the review of Article 27 .3(b), the review of the implementation of
the TRIPS Agreement under Article 71.1 and the work foreseen pursuant
to paragraph 12 of this declaration, to examine, inter alia, the relationship'
between the TRIPS Agreement and the Convention on Biological Diversity,
the protection of traditional knowledge and folklore, and other 'relevant
new developments raised by members pursuant to Article 71.1. In underta
king this work, the TRIPS Council shall be guided by the objectives and
principles set out in Articles 7 and 8 of the TRIPS Agreement and shall take
fully into account the development dimension

Para 32

We instruct the Committee on Trade and Environment, in pursuing work

on all items on its agenda within its current terms of reference, to give
particular attention to:
i) the effect of environmental measures on market access, especially in'
relation to developing countries, in particular the least-developed among
them, and those situations in which the elimination or reduction of trade
restrictions and distortions would benefit trade" the environment and
development;
ii) the relevant provisions of the Agreement on Trade-Related Aspects of
Intellectual Property Rights; and
iii) labelling requirements for environmental purposes.

Paragraph 19 mandated the TRIPs Council that in pursuing its work programme
including under Article 27 .3(b), and the implementation of the TRIPS Agreement
under Article 71.1, it should examine, inter alia, the relationship between the
TRIPS Agreement and the CBD, the.protection of traditional knowledge and
folklore, and other relevant new developments raised by members pursuant
to Article 71. L In undertaking this work, the TRIPS Council should take into
account the objectives and principles of the TRIPS Agreement set out in Articles
7 and 8 and the development dimension.

Under Para 32, the Committee on Trade and Environment was instructed that,
in pursuing its work on items on its agenda, to give particular attention to three
issues, including the relevant provisions of the TRIPS Agreement (Para 32) .. It
25

! I
 Protection of Traditional is, however, to be noted that TRIPS Agreement does not make any reference
Knowledge of CBD in its provisions.Though adopted later in time after the CBD, it failed
to take note of Article 16(5) of the CBD, which clearly states that patents and
other IPRs may have an influence on the implementation of the CBD and the
parties shall ensure that such rights do not run counter to its objectives.

Since the Doha Round, the discussions before the TRIPS Council are centred on
the relationship between the provisions of the TRIPS Agreement and the CBD
and the protection ofTK under the mandated review of Article 27(3)(b). In order
" to assist the Council to discharge its mandate, different nations/national groups
have made submissions, which have reiterated the contrasting approaches on the
issue of protection ofTK under the TRIPS Agreement between the industrialized
and developing countries. Industrialized countries consider WIPO the most
appropriate forum to tackle the issue of legal protection of TK, and WTO is,
- in fact, not the right place to negotiate a full-fledged system of protection for a
fI
complex subject matter like TK or folklore.

The developing countries, on the other hand, do not find the present IP regime
adequate to address their concerns in relation to TK. They find the patent system
faulty as it does not take into account TK as prior art, nor does it take care of
the requirements of benefit-sharing and prior informed consent (PlC). They
are insisting that the TRIPS Agreement should be suitably amended or provide
mechanism requiring that an applicant for a patent on biological material or
TK should, as a condition to acquire patent rights, (a) disclose the source and
country of origin of the biological resources and of the traditional knowledge
used in the invention; and (b) provide evidence of prior informed consent and
fair and equitable benefit sharing under the relevant national regime. Developing
countries, including India, in 2006 moved a draft Article 29bis as an amendment
to the TRIPS Agreement, requiring disclosure of source, PlC and ABS for GR
and TK based applications.

These requirements in patent applications on biological inventions, according to

these countries, will ensure that national legal regimes for preventing bio-piracy
and benefit sharing are effectively implemented when use or commercialization
of TK takes place outside the country. This will also reduce the instances of
bad patents and enhance ability of countries to track down and challenge bad
patents. The disclosure requirement may also be justified on grounds that it would
ensure effective enforcement at the international level, and thus complement
provisions in national patent laws that permit revocation of patents tor failure
_ to disclose material information, or submission of false information with an
1
intend to mislead. Other points made by developing countries can be viewed as
necessary to improve national compliance with treaty obligations regarding PlC
and benefit sharing found under the CBD (Art. 15). They further argue that such
-compliance will be consistent with the' objectives of the CBD as well as with
Article 7 of the TRIPS Agreement. A sui generis system will provide proprietary
right to ensure that market forces will operate to generate fairness and equity.

These deliberations at the WTO/TRIPS Council clearly reveal that no perceptible

achievement has been registered on the issue of protection of TK. Developing
countries, which constitute the three-fourths of WTO. membership, are the
chief holders of TK have demanded the inclusion of TK in TRIPS Agreement
to get a fair return on their resources. WTO may be considered to be the' most
26 appropriate forum with its dispute settlement mechanism.

I
 •

14.3.3 Convention on Biological Diversity. Current International

Efforts for the
The ~BD4 is the principal international instrument which explicitly acknowledges Protection of TK
the role of traditional knowledge, innovations and-practices of .indigcnous and
local communities embodying traditional.lifestyles in biodiversity conservation
and its sustainable development. The scope of the TK, however, is confined
to genetic materials (GRs). It is a framework 'convention that sets out general
principles that the parties agree to be guided by and work towards them in a
"
long-term process. According to Article 8(j) of the Convention, each contracting
party, subject to its national legislation, is required to:

i) 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 resources;

, .
fI

ii) promote the wider application of such knowledge, innovations and practices
with the approval and involvement of their holders; and
iii) encourage the equitable sharing of benefits arising from the utilisation of
such knowledge, innovations and practices. •

Article 8

Each Contracting .Party shall, as far as possible and as appropriate:

(j) Subject to its national legislation, 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
practices and encourage the equitable sharing of the benefits arising from '
the utilisation of such knowledge, innovations and practices
,'(

Apart from Article 8(j), however, no other provision of the CBD requires the
consent or involvement of the indigenous/local communities in granting access
to genetic resources. It, in fact, does not specify that who are the stakeholders
in issues related to genetic resources, but only places binding legal obligations
on national governments, parties to the Convention. Article 15 recognizes the
sovereign rights of States over their natural resources and their authority to
determine access to genetic resources and that access, where granted, shall be on
mutually agreed terms and subject to prior informed consent of the provider party
(a contracting party). Article 15(5) provides that "access to genetic resources
shall be subject to prior informed consent of the Contracting Party providing
such resources", and does not talk about the indigenous communities. But in
giving effect to other provisions of the Convention, the governments have the
authority to determine the mechanism for the involvement of these communities
and other stakeholders and specify their roles and responsibilities (Art. 15(7)).
Article 18(4) states that Contracting Parties shalli'encourage and develop
methods of cooperation for the development and use of technologies, including
indigenous and traditional technologies". But the most controversial provision
is Article 16(5) which requires Parties to cooperate to ensure that patents and
other IPRs "are supportive of and do not run counter to its [CBD's] objectives."
,
4 The Convention came into force on 29 December 1993 and currently has 193 parties. The
major non-party is the United States. 27

I I
 Protection of Traditional In furtherance to this framework, TK is on the agenda of the CBD since 1996
Knowledge and an extensive and complex work programme has grown around the issue of
IPRs and their role in the implementation of the CBD. The COP-IV in 1998
established an "ad hoc open-ended inter-sessional working group" to "provide
advice on the application and development of legal and other appropriate forms
of protection for the knowledge, innovations and practices of indigenous and
local communities". The working group worked towards strategies to protect
TK, based on a combination of approaches, and full respect for customary
," law and practices, including the use of existing IP mechanisms, the use of
contractual arrangements, register of TK and guidelines and code of practices.
It also considered the sui generis mode of protection of TK, by focusing on
the specific needs and interests of indigenous and local communities in the
protection, utilisation and equitable sharing of benefits when access to their
genetic resources are sought.

In another significant development, in 2002, the COP-VI adopted the Bonn

Guidelines on Access to Genetic Resources and Fair and Equitable Sharing of
Benefits Arising out of their Utilisation, which called upon the parties to use
the Guidelines when drafting their laws and policies "on access and .benefit-
sharing, and contracts and other arrangements under mutually agreed terms for
access and benefit sharing". The Guidelines are voluntary in nature, which the
parties may take into account while giving effect to their obligations under the
CBD. The Guidelines suggest that Material Transfer Agreements (MTAs) on
GRs may include conditions under which the user on accessed GRs may seek
IPRs, and monetary and non-monetary benefits may include "joint ownership
of relevant intellectual property rights". Parties have been invited "to encourage
the disclosure of the country of origin of genetic resources in applications for
intellectual property rights, where the subject matter of the application concerns
or makes use of genetic resources in its development, as a possible contribution
to tracking compliance with prior informed consent and the mutually agreed
terms on which access to those resources was granted." They have further been
invited "to encourage the disclosure of the origin of the relevant traditional
knowledge, innovations and practices of indigenous and local communities. _..<

As means to implement the CBD requirements for mutually agreed terms,

the guiding parameters suggested for contractual agreements provide that the
"provision for the use of intellectual property rights include joint research,
obligation to implement rights on inventions obtained and to provide licenses by
common consent" and "the possibility of joint ownership of intellectual property
rights according to the degree of contribution." In order to seek compliance with
the prior informed consent of the contracting party providing such resources
and mutually agreed terms, the countries may take measures to encourage the
disclosure of the country of origin of the genetic resources and the origin of
TK in applications for IPRs.

On some of the more important topics, further information and work was
requested, viz., impact of IPRs on access/use of GRs and scientific research;
role of customary law; relationship between disclosure requirements and
international legal obligations; efficacy of disclosure requirements; feasibility of
an internationally recognized certificate of origin system; monitoring, compliance
and enforcement; and role of oral evidence of prior art in granting IPRs. COP-VII
has further elaborated on these issues and has invited parties to recognize TK,
28

!
 whether written or oral, as prior art, Parties are to ensure under their domestic Current International
Efforts for the
law compliance with the requirement of prior informed consent of the indigenous
Protection of TK
communities and put in place mechanisms to ensure fair .and equitable benefit-
sharing at the national level with relevant stakeholders and indigenous/local
~ommunities, It invites WIPO to take into account the CBD's work on these
topics, and WIPO's work should be supportive of the CBD. These initiatives,
though, to a great extent addressed the concern of developing countries, but did
not create any binding legal obligation.
.
"

The importance of the Bonn Guidelines for developing countries is that it was
a signi~cant step towards the harmonization of the regime of access and benefit
sharing. It is also important to note in the context of the CBD, particularly Article
15, that by emphasising on national sovereignty and the authority of governments
. to regulate access to GRs cannot rule out the bilateral negotiations between

.. , . the biodiversity-rich but technologically- poor countries and those seeking

access to these resources. In other words, CBD promotes bilateral agreements
between the providers and users of resources for which a multilateral "approach
would be mutually beneficial by laying down the framework of fair terms, as
in bilateral negotiations, the biodiversity rich countries-quite often' are not in a
strong position to negotiate a fair deal.

Self Assessment Question (Spend 3 minutes)

.-
2) What ate the salient features of the BOJ}llGuidelines?

.................................................................................................................

a) Nagoya Protocol

Based on the work of its Ad Hoc Open-ended Working Group on Access and
Benefit-sharing, the COP-X on October 29,2010, adopted the Nagoya Protocol
on Access to Genetic Resources and the Fair and Equitable Sharing of Benefits
Arising from their Utilisation (ABS) to the Convention on Biological Diversity.
The Protocol is in the nature of a treaty and would create binding obligations for
the parties. The Protocol is aimed at effectively implement Article 15 (Access
to Genetic Resources) and 8(j) of the Convention and its three objectives. The
Protocol significantly advances the Convention's third objective by providing a
strong basis for greater legal certainty and transparency for both providers and
users of genetic resources. It covers the TK associated with GRs and benefits
arising from their utilisation and aims at creating greater legal certainty and
transparency for both providers and users of genetic resources by establishing
predictable conqitions for access to GRs and ensuring benefit sharing after GRs
leave the country providing GRs. Protocol imposes obligations on parties to take
measures regarding access to GRs, benefit-sharing and compliance.

Its objective broadly is fair and equitable sharing of benefits arising from the
utilisation of GRs, including by appropriate access to GRs and by appropriate
29

/ I
 Protection of Traditional transfer of relevant technologies, taking into account all rights over those
Knowledge resources and to technologies, and by appropriate funding, thereby contributing to
the conservation of biological diversity and the sustainable use of its components,
Towards this objective, it provides fair and non-arbitrary rules and procedures for
prior informed consent and mutually agreed terms. Such terms to be in writing,
including: a dispute settlement clause; terms on benefit sharing, including on
IPRs; terms on subsequent 3rd party use, if any; and terms on changes of intent,
where applicable. Benefits to be shared shall include those arising from the
.
"
utilisation of GRs as well as subsequent applications and commercialization .
Benefits 'shall be shared only with the Party providing such resources (that is
the country of origin) and on the basis of mutually agreed terms (MAT). It also
considers the importance of genetic resources for food and agriculture for food
security.

Benefit-sharing obligations require benefit-sharing measures at domestic-level,

.. I· which should, inter alia, provide for the fair and equitable sharing of benefits
arising from the utilisation of GRs and TK associated therein with the contracting
party providing GRs. Benefits may be monetary or non-monetary such as
royalties and the sharing of research results or joint ownership -of relevant IPRs.
Parties required to take measures to provide access to GRs in accordance with
prior informed consent (PlC), and mutually agreed terms (MATs) as required
by another contracting party; cooperate in cases of alleged violations of these
requirements; encourage contractual provisions on dispute resolution; take
measures regarding access to justice; and take measures to monitor the utilisation
of genetic resources after they leave the country.

For an effective implementation at the domestic level, the Protocol provides

a range of tools/mechanisms for parties to resort which includes establishing
national focal points (NFPs) and competent national authorities (CNAs) to
serve as contact points for information; grant access or cooperate on issues of
compliance; an Access and Benefit-sharing Clearing-House to share information;
and capacity-building to support key aspects of implementation, which may
include (i) Develop domestic ABS legislation to implement the Protocol, (ii)
Negotiate MAT; (iii) Awareness-raising; (iv) Technology Transfer, (v) Targeted
financial support for capacity-building. Financial mechanism envisaged under the
Protocol for capacity building and development stress on the capacity building
needs of developing/least developing countries, and priorities/needs of indigenous
and local communities to be catered. Financial mechanism of the Protocol is
the same as of the CBD. Developed countries shall provide financial and other
resources for the implementation of the Protocol. CBD has now established the
Global Environment Facility (GEF). The Fund is to help developing countries
to implement the Protocol. World Bank will act as the trustee of the Fund.

The Protocol also envisages the need for a global multilat~ral benefit sharing
mechanism to address the fair and equitable .sharing of benefits derived from
the utilisation of GRs and TK associated with genetic resources that occur in
trans-boundary situations or for which it is not possible to grant or obtain prior
informed consent. The benefits shared by use~s of GRs and TK associated
with genetic resources through this mechanism shall be used to support the
conservation of biological diversity and the sustainable use of its components
globally. But TK associated with ex situ GRs, GRs outside the national
boundaries, ex situ collections prior to the entry into force of the Nagoya
30

/ I
 Protocol are not covered under it. The Protocol also talks about the trans- Current International
Efforts for the
boundary cooperation. The IGF's Draft Articles on TK in Art. 12 also insists
Protection of TK
on trans-boundary cooperation by stating that, "where traditional knowledge is
located in territories of different contracting Parties, those contracting Parties
I. shall co-operate by taking measures that are supportive of and do not run counter
to the objectives of this instrument. This cooperation shall be done with the
participation [and consent] of the traditional knowledge holders."
"
Specific obligations to support compliance with domestic legislation or regulatory
requirements of the-Party providing GRs and contractual obligations reflected
in mutually agreed terms are a significant innovation of the Protocol. These
compliance provisions' as well as provisions establishing more predictable
conditions for access to GRs will contribute to ensuring the sharing of benefits
when GRs leave a Party providing GRs. In addition, the Protocol's provisions
,.
'1

on access to TK held by indigenous and local communities when it is associated

with GRs will strengthen the ability of these communities to benefit from the
use of their knowledge, innovations and practices.

14.3.4 Food and Agriculture Organisation (FAO) -,

The FAO; in November 2001, adopted the International Treaty on Plant Genetic
Resources for Food and Agriculture (lTPGRFA)S, which is based on FAO's
International Undertaking, first adopted in 1983. The Treaty is limited to plant
genetic resources (PGRs) for food and agriculture. It is much influenced by the
CBD, but does not encourage the IPRs over PGRs and the TK related thereto.
The use of PGRs for medical and healthcare purposes is outside its scope (and
can be subjected to IPRs). It recognizes the rights of farmers (without defining
who is a farmer) and local/indigenous communities, who have been in the
centres of origin and diversity, in conserving, improving and making available
these resources (Art. 9). The implementation of farmers' rights requires the
"protection oftraditional knowledge relevant to plant genetic resources for food
and agriculture" (Art. 9. 2). It is the responsibility of the national governments -
to involve them equitably in benefit sharing from the utilisation of PGRs (Art.
9.2(b)). Involvement of local/indigenous communities in decision-making has
not been talked about in the CBD. Article 13 details the provisions on-benefit
sharing. Access to PGRs shall be provided solely for purposes of utilisation and
conservation for research, breeding and training for food and agriculture. The
transfer/access to PGRs shall be subject to the multilateral system, according to
the terms of standard Material Transfer Agreement (MTA, Art. 12). The Treaty,
however, does not specifically refer to indigenous people, except in relation
to States' responsibility to " promote in situ conservation by supporting inter
alia, the efforts of indigenous and local communities" (Art. S.l(d)). The Treaty
is limited in its scope and principally aimed at preventing the loss of agro-
biodiversity rather than biodiversity in general, and establishes the farmers'
rights, and not of local/indigenous communities.

Self Assessment Question (Spend 3 minutes)

3) What is the significance of the International Treaty on Plant Genetic

Resources for Food and Agriculture (lTPGRFA) towards the protection
of PGRs and TK? ..

5 The Treaty has entered into force on 29 June 2004. 31

I I
 . Protection of Traditional
. Knowledge

.........................................................................................................................

,"

14.4 NEED FOR A SUI GENERIS FRAMEWORK FOR

TK PROTECTION
As is evident from the above discussions, the focus at the international foras
are centered around numerous legal, economic, policy and scientific issues in
TK protection under, the intellectual property regime and they do not take the
holistic character of TK. There is no legally binding instrument to protect TK
comprehensively as yet apart the FAO's ITPGRFA and the CBD's Bonn
Guidelines and now the Nagoya Protocol on Access to Genetic Resources
and the Fair and Equitable Sharing of Benefits Arising from their Utilisation.
The Ngoya Protocol, a treaty, has a limited scope related to ABS, but does
not talk about the protection of TK as such. It is limited, to the access to
GRs and benefit-sharing and thus relate to physical rather than intellectual or
intangible aspects of these resources, which is mainly related to TK· and is the
subject matter of intellectual property protection. Moreover, these measures are
not comprehensive enough to address the concerns and needs of developing
countries, which desire an international mechanism, acknowledging the holistic
nature of TK and collective rights of indigenous/local communities over it.
According to developing countries a sui generis mode would be most appropriate
to protect the holistic character of the TK and tackle the problem of illegal
acquisition of GRs. It should reaffirm the principle of national sovereignty
over genetic resources; recognize the role of the State in the preservation and
protection of TK and expressions of folklore; recognize the economic rights of
TK holders and custodians as well as their moral rights against the culturally
offensive use of their knowledge; recognize the role of customary law and
protocols in the protection of TK and expressions of folklore; and recognize
the complementary nature of defensive and positive measures relating to the
. protection of GRs, TK and expressions of folklore. This is a long and all-
encompassive agenda for a regime. The views, however, have been expressed
against a single, all-encompassing sui generis regime of protection for TK which
may be too specific and not flexible enough to accommodate local needs. These
views notwithstanding, the demand for a sui generis system is strong enough to
be dismissed, and the latest working draft of the IGC on TK has delineated the
nature and scope of such a regime, and will be adopted ultimately in the form
of a treaty - a long-standing demand of developing countries.

The discussions at the TRIPS CounciIIWTO have revealed two important demands
of the developing countries distinctly, directed mainly to misappropriation ofTK:

• First, the call for recognition of the rights of TK holders relating to their
TK, and,
32

/
 • Second, concerns about the unauthorized acquisition by third parties of Current International
IPRs over TK. Efforts for the
Protection of TK
In this regard, two forms of protection have been developed and applied. These
two approaches should be undertaken in a complementary manner -

Positive protection: giving TK holders the right. to take action or seek

remedies against certain forms of misuse of TK; and

.
"
Defensive protection: safeguarding against illegitimate IPRs being taken by
others over TK subject matters.

In order to give effect to·these demands, an international agreement is required

and national mechanism needs to be put in place.

i) patent applicants must disclose the country and source of origin of the

., biological material and the traditional knowledge; and

ii) must provide evidence that the prevalent laws and practices of country
of origin on prior informed consent and benefit-sharing have been fully
respected.

These demands have been accommodated in the IGC draft in Article 3, which
in one of the alternatives states:

3.1 The beneficiaries of protected traditional knowledge, shall/should have

adequate and effective legal means/measures to exercise control and exploit
their traditional knowledge, to authorize the access and use of their traditional
knowledge, to have a fair and equitable share of benefit arising out ofthe use
of their traditional knowledge and to prevent any unauthorized disclosure,
use, or other exploitation and in particular any acquisitions, appropriation,
or use that fails to meet the prior and informed consent of the traditional
knmyledge holders or infringes the mutually agreed terms.

3.2 In respect of traditional knowledge there should/shall be measures to require

that those using traditional knowledge beyond its traditional context:

a) acknowledge the source of traditional knowledge and attribute the

traditional knowledge holder where known, unless the traditional
knowledge holders decide otherwise; and

b) use traditional knowledge in manner that respect the cultural norms and
practices of its holders.

It is for the country concerned to take measures to see that these obligations
are properly met.

14.5 SUMMARY
• Different inter-governmental bodies are seized with the task of adopting a
viable mechanism to pr~tect the TK, viz., WIPO, WTO/TRIPS, CBD, FAO
and human rights bodies of the United Nations.

• WIPO is actively involved in this matter since 1998. In 2000, it established

an Intergovernmental Committee on Intellectual Property and Genetic
Resources, Traditional Knowledge and Folklore (IGC), which has since
33

7 I
 Protection of Traditional then held 20 sessions, and hope to be ready with a draft text of treaty on
Knowledge TK during 2012.
• TRIPS' Council has focused on the protection of TK under the IP regime.
Developing countries demands are centred around the disclosure requirement
about the source of biological material and evidence on compliance with
the ABS requirements in the patent applications.
• Doha Declaration adopted in 2001·require the TRIPS Council to examine the
"
relationship between the TRIPS Agreement and the Convention on Biological
Diversity, and the protection of traditional knowledge and folklore.
• CBD efforts are related to giving; effect to Articles 80) and 15 of the.Clsl),
particularly on access and benefit sharing out of the use and commercialization
, of GRs, which has now led to the adoption of Nagoya Protocol.
fI • Nagoya Protocol lays down the mechanism of access and benefit-
sharing arising out of the use of GRs and TK related to that out of their
•••• commercialization. Benefit-sharing can be iri monetary and non-monetary
~terms.
• The FAO's International Treaty on Plant Genetic Resources for Food
and Agriculture (ITPGRFA) requires the protection of farmers rights and
protection of traditional knowledge relevant to plant genetic resources for
food and agriculture ..
• These efforts are not comprehensive and does. not cover TK in a
comprehensive manner, which requires a sui generis framework for its
protection. The IGC is currently preparing the final draft of a sui generis
framework.

14.6 TERMINAL QUESTIONS

1) Describe the major features of the ILO Convention and the draft UN
Declaration on the Rights of Indigenous Peoples relating to TK.

2) What are the principal demands of developing countries on IP prot~ction

of TK in the TRIPS deliberations? Describe the mandate of Doha Round
on TK.

3) What are the essential features of the Nagoya Protocol?

4) Why there isa need for sui generis framework for the protection ofTK?

14.7 ANSWERS AND HINTS

Self Assessment Questions

1) The IGC deliberations have resulted in three separate texts- on TK,

Traditional Cultural Expressions (TCEs) and Genetic Resources (GRs),
which will be negotiated in a single negotiating text. Latest texts contain
the draft provisions for an international instrument to protect the TK.
Based on the final text of the draft treaty on TK, the WIPO may decide to
convene a Diplomatic Conference for its adoption in 2012-2013. The text
contains provision of definition, eligibility for protection, scope and duration,
beneficiaries, exceptions and limitations, and remedies.
34

/
 2) . The Bonn Guidelines on Access to Genetic Resources and Fair and Equitable Current International
Sharing of Benefits Arising out of their Utilisation, provide guidelines to Efforts for the
Protection of TK
parties in drafting their laws and policies on access and benefit-sharing,
and contracts and other arrangements under mutually agreed terms in this
'regard. The Guidelines are voluntary in nature, which the parties may take
into account while giving effect to their obligations under the CBD. The
Guidelines suggest that Material Transfer Agreements (MTAs) on GRs may
include conditions under which the user on accessed GRs may seek IPRs. It
'. emphasizes on the disclosure of the country of origin of GRs in applications
for IPRs, and compliance with prior informed consent and the mutually
agreed terms on which access to those resources was granted.
3) The ITPGRFA is the first international treaty on the protection of farmers'
rights and protection of traditional knowledge relevant to plant genetic
resources for food and agriculture. It is limited to plant genetic resources
"
• (PGRs) for food and agriculture. It does not encourage the IPRs over
PGRs and the TK related thereto. It recognizes the rights of farmers and
local/indigenous communities, who have been in the centres of origin and
diversity, in conserving, improving arid making available these 'resources
(Art. 9). It is the responsibility of the national governments to involve them
equitably in benefit sharing from the utilisation ofPGRs (Art. 9.2(b)), and
details the provisions on benefit sharing. The transfer/access to PGRs shall
be subject to the multilateral system, according to the terms of standard
Material Transfer Agreement (MTA).
Terminal Questions
1) Refer to Section 14.3
2) Refer to Sub-section 14.3.2
3) Referto Sub-section 14.3.3
-J

3) Refer to Section 14.4

14.8 REFERENCES AND SUGGESTED READINGS

1) UNCTAD- ICTSD, Resource Book on TRIPS and Development,
Cambridge University Press, 2005, eh. 21.
2) Burton Ong (ed.) Intecllectual Property and Biological Resources,
Marshall Cavendish Academic, 2004, eh. 6.
3) Christoph Antons (ed.) Traditional Knowledge, Traditional Cultural
Expressions and Intellectual Property Law in the Asia-Pacific Region,
Wolters Kluwer, 2009.
4) S. K.Verma, "Protecting Traditional Knowledge - Is a Sui Generis System
an Answer?" 7 JWIP 765 (Nov. 2004).

35

I I
 UNIT 15 GLOBAL ISSUES IN THE
PROTECTION OF TK
Structure
15,1 Introduction
15.2 Objectives
.
"
15.3 Global Issues in the Protection ofTK
15.3.1 Definition ofTK
15.3.2 Prior Informed Consent (PlC)
15.3.3 Access and Benefit Sharing (ABS)

., 15.4 Tools for Protecting TK

15.4.1 Application of Existing IPRs
I' 15.4.1.1 Copyright
15.4.1.2 Patents
15.4.1.3 Geographical Indications (GIs)
15.4.1.4 Trade Secrets
15.4.1.5 Trademarks/Trade Names
15.4.2 Adaptation 'of Sui generis Regime

15.5 Summary
15.6 Terminal Questions
15.7 Answers and Hints
15.8 References and Suggested Readings

"'" 15.1 INTRODUCTION

Ever since the Convention on Biological Diversity (CBD) was adopted in 1992
(it currently has 193 parties and it cameinto force in December, 1993), the
protection ofTK has become a major issue at the intemationallevel. Article 8(j)
of the Convention states: "Each Contracting Party shall, as far as possible and
as appropriate: subject to its national legislation, respect, preserve and maintai~
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 practices
and encourage the equitable sharing of the benefits arising from the utilisation
of such knowledge, innovations and practices." Thus, each contracting party is
I" required to: '

i) 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 resources;

ii) promote the wider application of such knowledge, innovations and practices
with the approval and involvement of their holders; and

iii) encourage the equitable sharing of benefits arising from the utilisation of
36 such knowledge, innovations and practices.

, I

I
 Increasing instances of bio-piracy made protection of TK an international Global Issues in the
issue. As the developing countries are the principal. holders of TK and the Protection of TK
indigenous communities were denied any benefit arising out of the use and
commercialization of plant genetic resources (PGRs) and TK associated by the
multinational biotechnological firms, developing countries strongly championed
for TK's protection at international level. As' a result of pressure from developing
countries, a number of inter-governmental bodies have been working since the
adoption of the CBD to evolve a viable )nternational instrument to protect the TK.
" The WIPO embarked on adopting a sui generis through its Intergovernmental
Committee on Intellectual Property and Genetic Resources, Traditional
Knowledge and Folklore (IOC), established in 2000. The subject is also actively
on the agenda of the CBD, WTO, FAO, UNCTAD since then. Because of
differences among the parties on different vital issues, that have emerged in
these negotiations, viz., definition, scope, beneficiaries, mechanism of access
fI
and benefit sharing relating to the use and commercialization of GRs1 and TK
It associated therewith, the deliberations have not led to any binding international
instrument so far, except the Nagoya Protocol, with its limited ambit related to
access and benefit sharing arising from the utilisation of GRs. Currently, the
IGC is working on the final negotiating text for a sui generis regime, which
the WIPO General Assembly may take up for adoption in 2013, addressing the
icontentious issues, which include the definition of TK, prior informed consent
(PlC), access and benefit-sharing, and tools for its protection.

15.2 OBJECTIVES
After reading this unit, you should be able to:

e know the contentious issues in according protection to TK in a comprehensive

manner;

• whyit is necessary to define TK;

• what is the significance of prior informed consent (PlC) and whose consent
matters;

• how to ensure ac~ess and benefit sharing related to GRs;

• know about the tools of protection under the existing IP regime; and

• how the sui generis mode will be more effective in protecting TK.

15.3 GLOBAL ISSUES IN THE PROTECTION OF TK

The deliberations on at different inter-governmental fora have brought to the
fore certain contentious issues for adopting an agreed framework on TK. These
issues, among others, relate to the definition of TK, a mechanism of access and
benefit sharing on TK and an appropriate tool to protect the TK, which may not
necessarily be under the existing IPRs.

J The CBD defines 'genetic resources' as 'genetic material of actual or potential value', and
'genetic material' as 'any material of plant, animal, microbial or other origin containing
functional units of heredity' (Art. 2).
37

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 Protection of Traditional 15.3.1 Definition of TK
Knowledge
TK is a very broad term referring to various knowledge systems, encompassing
several components, held by traditional communities or to knowledge acquired in
a non-systematic way. What characterizes traditional knowledge is the fact that,
generally, it is not produced systematically, but in accordance with the individual
or collective creators' responses to and interaction with their cultural environment.
They embrace different aspects and forms of information's expressions, making it
.
"
difficult to agree on a legally and scientifically acceptable definition. In addition,
traditional knowledge, as representative of cultural values, is generally held
collectively. This results from the fact that what can be sometimes perceived
'. as an isolated piece of literature (like a story or a song) or an isolated technical'
invention (the use of a plant resource to heal wounds, for instance) is actually
an element that integrates a vast and mostly coherent complex of beliefs and
know ledge, control of which is not in the hands of individuals who use -isolated
pieces of knowledge, but is vested in the community collectively. Furthermore,
I'
most traditional knowledge is transmitted orally from generation to generation
and is thus inter-generational, and remains largely undocumented. For these
reasons, there is no formally agreed definition of 'traditional knowledge', but
the commonly accepted view is that the traditional knowledge comprises the
'knowledge, innovations, and practices of indigenous and local communities
accumulated over generations of living in a particular environment., developed
from experience gained over centuries and adapted to the local culture and
environment, which is transmitted orally from generation to generation. It
tends to be collectively owned and takes the form of -stories, songs, folklore,
proverbs, cultural values, beliefs, rituals, and agricultural.practices, including
the development of plant species and animal breeds among others'.

e-, 'f This definition encompasses all forms of knowledge - technologies, know-
how skills, practices and beliefs - that enable the community to achieve stable
livelihoods in their environment. A number of terms are used interchangeably
to refer to the concept ofTIK, including Indigenous Knowledge (IK), Indigenous
Technical Knowledge (ITK), Local Knowledge (LK) and Indigenous Knowledge
System (IKS). TK is unique to every culture and society and it is embedded in
community practices, institutions, relationships and rituals. IK is considered a
part of the local knowledge in the sense that it is rooted in a particular community
and situated within broader cultural traditions. It is a set of experiences generated
by people living in those communities. TK is based on, and is deeply embedded
in local experience and historic reality, and is therefore unique to that specific
culture; it also plays an important role in defining the identity of the community.
It has developed over the centuries of experimentation on how to adapt to local
conditions. It therefore represents all the skills and innovations of a people and
embodies the collective wisdom and resourcefulness of the community.

Precisely how the term TK is defined has important implications for the kind and
scope of a possible protection regime of TK. It is important for the purposes of
establishing the criteria for protection, scope of protection and the beneficiaries.
There are several characteristics which are:

~ TK consists in innovations, creations and practices originated and used by

indigenous and local communities;

~ It is inter-generational, transmitted from generation to generation;

38

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 ~ It is transmitted in oral form; Global Issues in tn.
Protection of TK
~ It is usually held by the community in general;

~ It is not static and constantly being evolved, improved and adapted to the
changing needs of the users.

Categories ofTK could include - agricultural knowledge; scientific knowledge;

technical knowledge; ecological knowledge; medical knowledge, including
.
" related medicines and remedies; biodiversity related knowledge, expressions
of folklore in the form of music, dance, songs, handicrafts, designs, stories and
artwork; elements of languages, such as names, geographical indications and
symbols; and movable cultural properties. Thus, there are three main items which
encompass the general term TK, including TK, genetic resources and traditional
fI
cultural expressions/folklore. The attributes listed above are common to all of
them , but they have their clear area of thrust, TK is understood as the group
of practices acquired by a community through the observation and coexistence
with the ecosystem in which it lives. GRs are the existing biological material
in a certain ecosystem, that are used, for example, in agriculture and medicine.
It may have close connection and co-exist with TK. TCEs are understood as
the accumulation of fixed and unfixed cultural expressions of a community,
such as artistic works, handicrafts, designs, dances and musical and dramatic
performances.

WIPO's IGC had created three working groups on the three substantive themes
on the protection of TK, GRs and TCEs, which have come out with draft texts.
WIPO's Draft Articles on the Protection of Traditional Knowledge prepared at
IWG 2 (WIPODoc. WIPO/GRTKF/IC/1817, 17 March 2011) provides a draft
definition and the eligibility criteria of protection of TK. A formal definition is
yet to be adopted, but broadly it means knowledge resulting from intellectual
activity in a traditional context including the know-how, skills, innovations,
practices and learning that form part of the traditional knowledge systems of
an [indigenous people or local community]. It is dynamic and evolving. It is
the result of the intellectual activities in diverse traditional contexts, including
knowledge, skills, innovations, practices and teachings in a collective framework
of [indigenous peoples and local communities]. It is transmitted from generation
to generation in diverse forms and is inalienable, indivisible and imprescriptible;
and is intrinsically linked to biodiversity and sustains cultural, social and human
diversity embodied in traditional lifestyles.

WIPO Doc. WIPO/GRTKF/ICI1817

Article 1

Definition of Traditional knowledge

Option 1

1.1 Traditional knowledge means knowledge resulting from intellectual

activity in a traditional context including the Jmow-how, skills,
innovations, practices and learning that form part of the traditional
knowledge systems of an [indigenous people or local community'].

2 The term "indigenous people and local community" is used as a place holder. This term will
be addressed by the group considering beneficiaries of protection. 39

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 Protection of Traditional
Knowledge Option 2

1.1 (a) Traditional knowledge is dynamic and evolving. It is the result

of the intellectual activities in, diverse traditional contexts, including
knowledge, skills, innovations, practices and teachings in a collective
framework of [indigenous peoples and local communities];

(b) Traditional knowledge is part of a collective, ancestral, territorial,

"
spiritual, cultural, intellectual and material heritage;

(c) Traditional knowledge is transmitted from generation to generation

in diverse forms and is inalienable, indivisible and imprescriptible;

(d) Traditional knowledge is intrinsically linked to biodiversity and

sustains cultural, social and human diversity embodied in traditional

,. lifestyles.

Criteria for eligibility for protection of TK is that: it is the unique product of

or is distinctively associated with an indigenous people or local communities;
collectively generated, preserved and transmitted from generation to generation;
is integral to the cultural identity of an indigenous people or local community;
that is recognized as the ,owner through a form of custodian or collective
and cultural ownership responsibility. Such a relationship may be established
formally or informally by customary practices, la~s or protocols. Beneficiaries
of protection are holders of traditional knowledge who generate, preserve and
transmit knowledge in a traditional or intergenerational context [in accordance
with Article 1]. Holders of traditional knowledge include, but are not limited
to, indigenous peoples, local communities [and nations]. In sum, it is possible
to characterize TK as information which has been developed in ancestral times
~,~ among indigenous people from generation to generation, and actually is subject
to improvement and adaptation, without necessarily being codified, and is
primarily collective in nature. It may possess commercial value depending on
its potential or actual use.

15.3.2 Prior Informed Consent (PlC)

One of the principal demands of developing countries against unauthorized
acquisition of GRs and TK by third parties of intellectual property rights is
that their applications for IPRs (patents) must provide evidence on compliance
with the country of origin's taws on PlC and benefit sharing. Article 15 of the
CBD while recognizes the sovereign rights of States over their natural resources
and the authority to determine access to genetic resources rests with the
national govemments and is subject to national legislation, but Art. ,15.3 states,
"Access to genetic resources shall be subject to prior informed consent of the
Contracting Party providing such resources, unless otherwise determined by that
Party." Para 7 of Art. 15 states: "Each Contracting Party shall take legislative,
administrative or policy measures, as appropriate, and in accordance with Articles
16 and 19 .. , 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 utilisation of genetic resources with the Contracting Party providing such
resources. Such sharing shall be upon mutually agreed terms." Thus, what is at
stake is the possibility of detecting commercial gains from the use of genetic
40 resources (GRs), so that countries supplying those resources can demand their

I
 share in the benefits. But Article 15 talks about the prior informed consent of Global Issues in the
the contracting party providing access to such resources and not of traditional/ Protection of TK
indigenous communities, the holders of TK. However, the country providing
such resources may put a system in place, which may require the involvement
and the PlC of the holder/s of the TK. The FAO's International Treaty on Plant
Genetic Resources for Food and Agriculture (ITPGRFA) recognizes the rights
of farmers (without defining who is a farmer) and local/indigenous communities,
and imposes responsibility on the national governments to involve them equitably
..
in benefit sharing from the utilisation ofPGRs (Art. 9.2(b)). The transfer/access
to PGRs shall be subject to the multilateral system, according to the terms of
standard Material Transfer Agreement (MTA, Art. 12).

In order to have an international framework on PlC and ABS, the recently

adopted Nagoya Protocol, 2010, in Article 6 provides:

Access to Genetic Resources

1) In the exercise of sovereign rights over natural resources, and subject to
domestic access and benefit-sharing legislation or regulatory requirements,
access to genetic resources for their utilisation shall be subject to the
prior informed consent of the Party providing such resources that is
the country of origin of such resources or a Party that has acquired the
genetic resources in accordance with the Convention, unless otherwise
determined by that Party.

2) In accordance with domestic law, each Party shall take measures, as

appropriate, with the aim of ensuring that the prior informed consent or
approval and involvement of indigenous and local communities is obtained
for access. to genetic resources where they have the established right to
grant access to such resources.

3) Pursuant to paragraph 1 above, each Party requiring prior informed

consent shall take the necessary legislative, administrative or policy
measures, as appropriate, to:

a) Provide for legal certainty, clarity and transparency.of their domestic

access and benefit-sharing legislation or regulatory requirements;
b) Provide for fair and non-arbitrary rules and procedures on accessing
genetic resources;
c) Provide information on how to apply for prior informed consent;
d) Provide for a clear and transparent written decision by a competent
national authority, in a cost-effective manner and within a reasonable
period of time;
e) Provide for the issuance at the time of access of a permit or its
equivalent as evidence of the decision to grant prior informed consent
and of the establishment of mutually agreed terms, and notify the
Access and Benefit-sharing Clearing-House accordingly;
f) Where applicable, and subject to domestic legislation, set out criteria
and/or processes for obtaining prior informed consent or approval
and involvement of indigenous and local communities for access to
genetic resources; and
41

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 Protection of Traditional
Knowledge g) Establish clear rules and procedures for requiring and establishing
mutually agreed terms. Such terms shall be set out in writing and
may include, inter alia:

i) A.dispute settlement clause;

ii) Terms on benefit-sharing, including in relation to intellectual

property rights;
.
"
iii) Terms on subsequent third-party use, if any; and

iv) Terms on changes of intent, where applicable,

Article 7 of the protocol specifically talks about the PlC ofthe indigenous people.

fI
Article 7. Access to Traditional Knowledge Associated with Genetic
I , Resources
In accordance with domestic law, each, Party shall take measures, as
appropriate, with the aim of ensuring that traditional knowledge associated
with genetic resources that is held by indigenous and local communities is
accessed with the prior and informed consent or approval and involvement.
of these indigenous and local communities, and that mutually agreed terms
have been established.

Thus, even though Article 15.3 of the CBD talks about the PlC of the contracting
parties, the Nagoya Protocol requires the PlC or approval and involvement ofthe
indigenous and local communities. In this regard, the governments have to put in
place the legislative and administrative machinery in place. For the involvement
-, I' of the local or indigenous communities, their empowerment is necessary, so that
they can meaningfully participate in the negotiation and provide an informed
consent. Article 21 of the Protocol talks about the awareness raising in this
regard. It provides that "Each Party shall take measures to raise awareness of
the importance of genetic resources and traditional knowledge associated with
genetic resources, and related access and benefit-sharing issues. Such measures
may include, inter alia: ... (g) Education and training of users and providers of
genetic resources and traditional knowledge associated with genetic resources
about their access and benefit-sharing obligations; (h) Involvement of indigenous
and local communities and relevant stakeholders in the implementation of this
Protocol; and (i) Awareness-raising of community protocols and procedures of
indigenous and local communities." Article 22 talks about the capacity-building
and capacity development. In support of the implementation of this Protocol,
capacity-building and development may address, inter alia, the following key
areas:

a) Capacity to implement, and to comply with the obligations of the Protocol;

b) Capacity to negotiate mutually agreed terms;

c) Capacity to develop, implement and enforce domestic legislative,

administrative or policy measures on access and benefit-sharing; and

d) Capacity of countries to develop their endogenous research capabilities to

add value to their own genetic resources.
42

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 Thus, for an effective participation of indigenous communities to givng their Global Issues in the
informed consent for an access to GRs and TK; their empowered a pre-requisite. Protection of TK

Self Assessment Question (Spend 3 minutes)

1) What is the mandate of CBD on PlC and how it is given effect under
the Nagoya Protocol?

"

.•...............................
! .

fI

15.3.3 Access and Benefit Sharing (ABS)

Access and benefit-sharing' is a thorny issue in the protection ofTK. Developing
countries, holders of TK, are asking for fair and equitable benefit sharing in
return for access to GRs and TK associated therewith. They want that access
to in situ and ex situ genetic resources (GRs) held at CGIAR (Consultative
Group on International Agricultural Research) Centres, should be on terms that
recognize the contribution made by indigenous communities in developing
countries in c~nserving, improving and making available these resources.
Article 15(7) of the CBD, while impressing upon the regulatory framework for
the access to GRS, states that access will be accorded 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 utilisation of genetic resources
with the Contracting Party providing such resources. Such sharing shall be upon
mutually agreed terms (MAT). The CBD in 2002, at COP-VI adopted Bonn
Guidelines on Access to Genetic Resources and Fair and Equitable Sharing of
Benefits Arising out of their Utilisation, which the parties may use in drafting
their laws and policies "on access and benefit-sharing, and contracts and other
arrangements under mutually agreed terms for access and benefit sharing". The
Guidelines are voluntary in nature and legally not binding, which the parties
may take into account while giving effect to their obligations under the CBD
on ABS. They provide some background to the discussion on the practical
interaction between the IP system and the CBD. The Guidelines suggest that
Material Transfer Agreements (MTAs) on GRs may include conditions under
which the user in accessed GRs may seek IPRs, and monetary and non-monetary
benefits may include "joint ownership of relevant intellectual 'property rights
according to the degree of contribution". Parties have been invited "to encourage
the disclosure of the country of origin of genetic resources in applications for
intellectual property rights, where the subject matter of the application concerns
or makes use of genetic resources in its development, as a possible contribution
to tracking compliance with prior informed consent and the mutually agreed
terms on which access to those resources was granted." They have further been
invited "to encourage the disclosure of the origin of the relevant traditional
knowledge, innovations and practices of indigenous and local communities in
applications for IPRs." The guidelines to a great extent address the concerns
of developing countries, which have not been rewarded for their contribution.
But in contrast to ITPGRFA, which envisages a multilateral system of benefit
43

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 Protection of Traditional sharing, the CBDIBonn Guidelines are premised on bilateral approach, which
Knowledge may not be fair enough when the parties to an agreement would be unequal.

The recently concluded Nagoya Protocol on Access to Genetic Resources and

the Fair and Equitable Sharing of Benefits Arising from their Utilisation, 2010 at
the COP-X has elaborate provisions on ABS. Article 5 of the Nagoya Protocol
also talks about it and the Protocol lays down the framework in this regard.

Article 5. Fair and Equitable Benefit-sharing

"

1) In accordance with Article 15, paragraphs 3 and 7 of the Convention

(CBD), benefits arising from the utilisation of genetic resources as well
as subsequent applications and commercialization shall be shared in a
fair and equitable way with the Party providing such resources that is
the country of origin of such resources or a Party that has acquired the
genetic resources in accordance with the Convention. Such sharing shall
be upon mutually agreed terms.

2) Each Party shall take legislative, administrative or policy measures,

as appropriate, with the aim of ensuring that benefits arising from the
utilisation of genetic resources that are held by indigenous and local
communities, in accordance with domestic legislation regarding the
established rights of these indigenous and local communities over
these genetic resources, are shared in a fair and equitable way with the
.
communities concerned, based on mutually agreed terms.
.

3) To implement paragraph 1 above, each Party shall take legislative,

administrative or policy measures, as appropriate.

4) Benefits may include monetary and non-monetary benefits, including

but not limited to those listed in the Annex.

5) Each Party shall take legislative, administrative or policy measures,

as appropriate, in order that the benefits arising from the utilisation of
traditional knowledge associated with genetic resources are shared in a
fair and equitable way with indigenous and local communities holding
such knowledge. Such sharing shall be upon mutually agreed terms.

Annexure to the Protocol enlists the monetary and non-monetary benefits.

Monetary benefits may include: access fees; up-front payments; milestone
payments; payment of royalties; licence fees in case of commercialization;
special fees to be paid to trust funds supporting conservation and sustainable
use of biodiversity; salaries and preferential terms where mutually agreed;
research funding; joint ventures; joint ownership of relevant intellectual property
rights. Non-monetary benefits may include, among others: sharing of research
and development results; strengthening capacities for' technology transfer;
institutional capacity-building; access to scientific information relevant to
conservation and sustainable use of biological diversity, food and livelihood
security benefits; social recognition; (q) joint ownership of relevant intellectual.
property rights. J

However, question of benefit sharing arises only after the GRs and the TK
associated with that have been commercially utilised. Art. 3 of the Protocol
44

I
provides, "This Protocol shall apply to genetic resources within the scope of Global Issues in the
Article 15 of the Convention and to the benefits arising from the utilisation of Protection of TK
such resources.
. This Protocol shall also apply to.- traditional knowledge associated
with genetic resources within the scope of the Convention and to the benefits
arising from the utilisation of such knowledge." If the TK does not lead to any
benefit, there will be no benefit sharing.

The protocol is, in the nature of a treaty and once it is ratified by 50 States, it
will be binding' on the parties.

Self Assessment Question (Spend 3 minutes)

2) What is the mandate of Nagoya Protocol on ABS?

15.4 TOOLS FOR PROTECTING TK

In choosing, the tools for the protection of TK, two approaches are looked into
by the proponents of the TJ<.protection ~ positive protection and defensive
protection ..Positive protection requires legal recognition of rights over TK, either
under existing IPR regime or sui generis regime. Defensive protection is aimed
at safeguarding against illegitimate IPRs, particularly patents, being taken by
others over Tk-subject matter. Systems for protecting TK include customary
law, IPRs such as patents, plant variety rights, copyrights, etc. and concepts'
existing in civil and common law systems and contracts such as licensing and
material transfer agreements. Protection to TK is also.being provided through
sui generis systems such as through bio-diversity related regulations such as
access and benefit sharing regimes or a conservation framework legislation or a
combination of all the above systems. None of them is comprehensive enough
and have its own limitations.

15.4.1 . Application of Existing IPRs

15.4.1.1 Copyright

Copyright has its relevance in the realm of TCEs/folklores, such as artistic

works, handicrafts, designs, dances, and musical and dramatic performances.
Its protection is on the agenda of the IGC. A group of countries from Latin
America and the Caribbean considers that copyright can be used to protect the
artistic manifestations ofTK holders, especially artists who belong to indigenous
and native communities, against unauthorized reproduction and exploitation.
However, copyright has some fundamental limitations in the folklore context,
since it excludes some expressions from eligibility for copyright protection,
such as

~ copyright requires an identifiable author, which is a problematic concept

in case of TCEs;
45

I I
 Protection of Traditional ~ copyright gives protection for a limited period oftime and some communities
Knowledge
do not want their knowledge to be released in public domain which 'may
be appropriated by others; "

~ copyright normally requires works to be fixed, whereas inost TClis are not
fixed and passed on orally from generation to generation.

15.4.1.2 Patents
"
The patent system could be used for the protection of technical solutions that
are industrially applicable, new and involve and inventive step. For example,
patents may be granted for products .isolated, synthesized or developed from
"genetic structure, micro-organisms and organisms existing in nature. Patents
may be granted to protect some elements of traditional medicine. However,
fI there are some major difficulties in affording patent protection to an invention
based on TK, viz.:

~ TK is collectively held and generated while patent law treats invention as

an achievement of individuals. In the context of TK, it is difficult to identify
unequivocally the inventor;

~ Patent specification mU,stbe written in a technical language that examiners

can understand, and it is difficult to do so with the TK;

~ Applying for patents, maintaining and enforcing them once they have been
granted is an expensive affair. This may not be possible for traditional
communities to do so on their own.

15.4.1.3 Geographical Indications (GIs)

-,'f
} GIs may, in some cases, be a suitable means to enhance the value of agricultural
products, handicrafts and other TK based products, GIs do not protect a specific
technology or knowledge as such, but only prevent the false use of the GI and
thus its scope in protection TK is very limited. They may be used to enhance
the commercial value of natural, traditional and craft products, if their particular
characteristics can be attributed to their geographical origin, resulting from the
traditional processes and knowledge of certain communities in the given region.
GIs, if exploited effectively, may afford better protection of the economic
interests of the communities and regions from where such products originate.

15.4.1.4 Trade Secrets

Trade secrets are used to protect un-disclosed TK, including secret and sacred
TK. Under this modality, all information is protected against unauthorized
acquisition or use by third parties, In many traditional societies, it common for
some healers or shamans to protect their knowledge through secrecy they do
not want to share, The protection of the trade secret is the responsibility of the
holder of the secret, and knowledge should be confidential. As the knowledge
of the community is diffused among the various members of a community, it is
difficult to gain protection of TK through this method, unless it is kept secret
by one person, as is the case of healers, then the system can work to protect
TK.

46

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 " 15.4.1.5 Trademarks/Trade Names Global Issues in the
Protection of TK
Trademarks may be used to protect signs or symbols of commercial interest for
local and indigenous communities. They may protect all goods manufactured
and services offered by manufacturers, craftsmen, professional and traders in
local and indigenous communities. Similatly, trade names may protect any
manufacturer, craftsman, professional person or trader in a native or indigenous
community, and may also be used to identify the bodies that represent such
., persons or in which they are grouped.

In conclusion, taking into account the reality of these communities, whether IPRs
exist or not, indigenous communities are likely to face serious challenges in the
process of acquiring, maintaining, and enforcing these rights, while protecting
their TK. These may discourage them to take advantage of these rights.

Self Assessment Question (Spend 3 minutes)

3) Why patents are not it satisfactory mode of protection of TK?

....................................................................................................... :..:~ .

15.4.2 Adaptation of Sui generis Regime

As is evident that the existing IPR regime is not sufficient to protect the holistic
character of TK and it merely provides piecemeal positive protection. Intellectual
property role, in the context of TK is limited, as it is aimed at excluding the use
of protected knowledge by unauthorised parties, and is not concerned with its
promotion or diffusion, the goals which are fundamental for the sustainability of
TK. IPRs function on exclusivity and are limited in time, held by an identifiable
natural or legal person. At the end of protection period, they become part of
the public domain. On the other hand, TK is held collectively (ownership),
inherently dynamic, which grows/alters in response to changing environmental
and"social circumstances, while being in continuity with land and habitat, and
mostly exists in an unfixed form (oral). It originates, preserved and transmitted
in a traditional context and is not limited to any specific field of technology
or arts. The enforcement of IPRs requires to identify and isolate the protected
information while the challenging aspect ofTK is its holistic character. Hence, it
is necessary to clarify the identifiable subject matter of TK in any international
regime.

The WIPO's approach in the matter of TK protection is mainly lP-related. The

documents produced acknowledge the general difficulties with protecting the TK
under IP law. The IGC has centred its activities mainly on solutions that tend to
minimize the rigours of IP criteria. The IP solution is sought for TK in the public
domain, which is a small part of the vast arena of TK that has strong moorings
in cultures and traditions/rituals etc. The issues of access and benefit-sharing,
prior informed consent, bio-piracy and misappropriation of TK, need to harness
TK for the economic upliftment and growth of indigenous communities and
47

/ I
 Protection of Traditional their empowerment are significant aspecfs to be considered in any mechanism
Knowledge
to protect TK. This can be possible only through a sui generis regime.
A number of countries like Brazil, Costa Rica, India, Peru, Philippines, Andean
Community (Bolivia, Colombia, Ecuador, Peru and Venezuela), some African
initiatives (based on model DAU Law) are either providing or propose to
provide protection to TK through a combination of various systems, including
sui generis systems. These legislation contain provisions for prior informed
consent, benefit sharing, some restrictions on applying for IPRs based on
.' biological resources and associated TK without PlC and protection through
'various other means like registration of TK, systems of contract, recognition
.of customary laws, etc. However, the actual measures provided or proposed
are different in each country. There is no uniformity in the provisions and each
country's legislation is developed based on the specific requirements of individual
country and its communities, their lifestyles and types of traditional knowledge
and the way it is being protected or held by the traditional communities and
the way it is being accessed for modem scientific purposes. It is very clear
that a uniform international system for protection of TK would not be able to
cater to the -requirements of individual country. Rather, the need is for a system
which recognizes such diversity, while at the same time lays down common
norms for the protection of TK for all countries. At the national level also,
to have a sui generis system, the first step is to assess the current TK-related
situation in the country. including, for example, determining the main types of
TK, who the TK-holders are, how the TK is being used, what are the current
policies and institutional frameworks, and who are the main stakeholders and
interested parties. The next step could be to have a national multi-stakeholder
policy dialogue (with full participation by TK holders) in order to share the
assessment findings and discuss the objectives that a national sui generis system
should address. For each of three broad categories of TK-related objectives ~
preservation, protection and promotion (harnessing TK for development) - there
are a number of possible policy tools and measures. Possible instruments for the
protection ofTK include traditional/customary law, modem intellectual property
rights instruments, sui generis systems, documentation of TK, and instruments
directly linked to benefit-sharing. This non-exhaustive menu of options is
intended to serve as a starting point for further exploration and discussion. A
holistic- approach to the problem is essential.
Any regime to be effective must have a viable enforcement mechanism without
which it will not meet with the desired objectives. There should be a monitoring
system to see its implementation in the form as laid down. The enforcement
of TK is closely related to the issues of identifying the stakeholders, how the
right will accrue and who will be competent to enforce the right. In the case of
IPRs, the protected information is also to be identified. The nationallegislations -
need to address these aspects to make the system exact. This will require the
determination of the objectives to be achieved through the protection of TK for
a
which proper definition of TK would have to be attempted. All these aspects
together will require a human- right- centric approach.
The concerns of local/traditional communities on this matter can be addressed
under a sui generis regime on plant varieties in an appropriate manner, while -
according access to genetic resources, as mandated by the CBD. It has been
observed that access regimes created by some developing countries have proved
48 to be very restrictive, at the cost of genuine research, which may prove to be

I
 detrimental to national interests.' The national regime must provide a distinct Global Issues in the
approach to facilitate the access to genetic resources for purely commercial Protection of TK
purposes and that for scientific purposes for further research and development in
this field. The procedure needs to be transparent and less cumbersome for genuine
parties. A distinct authority be designated to grant permission to researchers to
access and remove biological specimens. The involvement of local/traditional
communities must be ensured in decision-making in the matter of access and
sharing of benefits arising out of the use of their TK in genetic resources.
"

The IGC's current deliberations/texts

. ~ are confined to a sui generis regime on
, '

TK and have the negotiated text on the definition, eligibility, scope, term and
beneficiaries of TK protection. It has the provisions related to sanctions, remedies
and .administration of TK, but it relates to TK in the public domain ..

15.5' SUMMARY
..
• Since the adoption ofCBD, the protectionof Tk has become an international
issue and different inter-governmental bodies are working towards this end,
including the WTO/TRIPs, CBD and WIPO. The deliberations at these
bodies have highlighted certain contentious issues on which developed and
developing countries hold different approach.
• These issues mainly centred on the definition, prior informed consent and
mechanism for access and benefit sharing.
• ' Definition is crucial to identify the subject matter of protection, eligibility
and scope of protection, beneficiaries of the protection and their capability
to enforce their rights related to protected TK.
• Developing countries demand that any application for IPR related to TK
subject matter should provide evidence of PlC andABS as mandated under
national law of the provider country.
• The IGC's latest negotiating draft on TK has provision in this regard.
• So far the approach of inter-governmental bodies in the protection ofTK is
lop-sided and is confined to positive protection in the context of IPRs, such
as copyright, patents, trade secrets, geographical indications, and trade marks
• Existing IPR regime is of limited utility in the protection of TK and is not
very useful for indigenous community, who do not have means to acquire,
maintain and enforce those rights. IPR regime also does not cover TK in
a holistic manner, which has cultural, environmental and national food
security aspects.
• A sui generis regime, which should take into account the specific features
ofTK, viz., collectively owned, inter-generational, continuous improvement,
infinite 'duration etc., will be best suited
• Under a sui generis regime, countries shall be able to. cater the specific
needs of their indigenous communities.

2 See Heath and Weidlich, op. cit. 61,. at 83; Jose Maria A. Ochave, The Anticommons in
Bioprospecting: Regulation of Access to Genetic and Biological Materials in the Philippines,
The World Bulletin, Vol. 15, Nos. 1-6, Jan. -Dec. 1999, 150, at 157; C. Fowler, "Sharing
Agriculture's Genetic Bounty", Science 297 (2002: 157). 49

I I
 Protection of Traditional
Knowledge 15.6 TERMINAL QUESTIONS
1) Describe the contentious issues in the protection of TK. What is the
significance of definition for the protection?
. -
2) What are the principal tools of protection for TK? Describe the shortcomings
of existing IPR regime in the protection of TK.

3) Why a sui generis regime will be better suited. for the protection ofTK and
"
what should be its salient features?

'·15.7 ANSWERS AND HINTS

Self Assessment Questions

1) Article 15 of the CBD recognizes the sovereign rights of States over their
natural resources and the authority to determine access to genetic resources
rests under their national law. But the access to genetic resources shall be
subject to prior informed consent of the' Contracting Party providing such
resources, unless otherwise determined by that Party (Art. 15.3). The Nagoya
protocol reiterates this and provides that each Party shall take measures In
accordance with domestic law for access to GRs and TK with the prior
and informed consent or approval and involvement of their indigenous and
local communities.

2) Article 3 of the NagoyaProtocol provides that in accordance with

Article 15, paragraphs 3 and 7 of the Convention (CBD), benefits arising
. from the utilisation of GRs as well as their subsequent applications and
commercialization shall be shared in a fair and equitable way with the Party
that is the country of origin of such resources and providing such resources
or a Party that has acquired the GRs in accordance with the Convention.
Such sharing shall be upon mutually agreed terms. If the TK does not lead
to any benefit, there will be no benefit sharing. Benefits may be in the form .
of monetary and non-monetary terms.

3) Patents are granted for any technical invention industrially applicable,

new and involve and inventive step. For example, patents may be granted
for products isolated, synthesized or developed from genetic structure,
micro-organisms and organisms.existing in nature. Patents may be granted
to protect some elements of traditional medicine. But, in the case of TK,
patent protection may not be affordable, because TK is collectively held and
generated while patent law treats invention as an achievement of individuals.
For TK, it is difficult to identify unequivocally the inventor; it is difficult
to write patent specification for TK in technical language; and applying ,
maintaining and enforcing a patent is an expensive proposition, which these
indigenous communities may not be able to do.

Terminal Questions

1) Refer to Section 15.3

2) Refer to Section 15.4

3) Refer to Sub-section 15.4.2

50

I
 .Global Issues in the
. 15.8 REFERENCES AND SUGGESTED READINGS Protection of TK

1) UNCTAD- ICTSD, Resource Book on TRIPS and Development,

'Cambridge University Press, 2005, eh. 21
2) Burton Ong (ed.) Intellectual Property and Biological Resources,
Marshall Cavendish Academic, 2004, ch. 6
3) Christoph Antons (ed.) Traditional Knowledge, Traditional Cultural
"
Expressions and Intellectual Property Law. in the Asia-Pacific Region;
WoIters Kluwer, 2009
4) S. K.Verma, "Protecting Traditional Knowledge - Is a Sui Generis' System
an Answer?" 7 JWIP 76>5(Nov. 2004).
5) Marcelin M. Tonye, "Sui Generis Systems for the Legal Protection of
Traditional Knowledge and Biogenetic Resources in Cameroon and South
.. Africa", 6 JWIP 763 (Sept:2003).

51

I I
 UNIT 16 INDIAN EFFORTS TOWARDS
TK PROTECTION
Structure
16.1 Introduction
16.2 Objectives
.
"
16.3 India's Efforts for the Protection of TK
. 16.3.1 Patents Act
16.3.2 Protection of Plant Varieties and Farmers' Rights Act
16.3.3 Biological Diversity Act
163.3.1 Draft Rules on TK, 2009
16.4 Traditional Knowledge Digital Library (TKDL)
16.5 Summary
16.6 Terminal Questions
16.7 Answers and Hints
16.8 References and Suggested
,
Readings

16.1 INTRODUCTION
India is one of the 12 mega-biodiversity countries of the world and rich in
traditional and indigenous knowledge, both coded and informal. It has not
brought out any TK -specific regime so far. It is a party to the TRIPS Agreement,
CBD and Plant Genetic Resources for Food and Agriculture (PGRFA 2001)
Treaty. The laws adopted to give effect to its obligations under the TRIPS,
CBD and ITPGRFA have reiterated India's stand in different intergovernmental
bodies working on the protection of TK. Issue of bio-piracy is central to all
the legislative efforts of the Government of India. It has adopted three statutes
relevant to the issue of TK and biological resources, which are in force and
are as follows:

• Patents (Amendment) Act, 2005;

• The Protection of Plant Varieties and Farmers' Rights Act, 2001; and

• The Biological Diversity Act, 2002.

There are strong linkages between these three pieces of legislation and some
. over-lapping. Whereas the Patents Act grants patents on biotechnology, the
Plant Variety Protection law provides a sui generis regime' on plant breeder's
rights (PBRs) and the Biologicai Diversity Act provides a mechanism to protect
and share plant genetic resources (PGRs). In December 2009, the Government
of India framed 'The Protection, Conservation and Effective Management of
Traditional Knowledge relating to Biological Diversity Rules, 2009' and sought
the comments of the public, primarily to evolve a sui generis system for the
protection of TK in India. The draft Rules are still being deliberated.

52

I
 Indian Efforts Towards
16.2 OBJECTIVES TK Protection

After.reading this unit, you should be able to:

• know India's position on the protection ofTK and the national efforts made
in this direction;

• identify the principal provisions of the Patents Act related to protection of

.
"
TK;

• know the role of Protection, of Plant Varieties and Farmers' Rights Act
(PPVFRA) and the extent of involvement of indigenous communities in
the protection of TK;.
,
• find out the extent and scope of Biological Diversity Act in the protection
of TK related to GRs originating in India and the compliance with the
provisions of CBD on TK;

.• significance of the draft Rules, 2009 on the protection, conservation and

management of TK; and r

~.\. explain the position ofIndia after the adoption ofNagoya Protocol to which
a
India is signatory (not yet ratified).

16.3 INDIA'S EFFORTS }?OR THE PROTECTION

OFTK
16.3.1 Patents Act
The Patents (Amendment) Act, 2005 has made biotechnological processes as
patentable. The amended Act had changed the earlier .position, wherein under
'Section S of the 1970, Patents Act only methods or processes of manufacture
were patentable. In the 2005 amendment to the Patents Act of 1970, this
provision has been dropped in compliance with India's obligation under Article
65(4) of the TRIPS Agreement. It makes biological processes as patentable,
including biochemical, biotechnological and microbiological processes. Plants
and animals in whole or any part thereof are not patenable, including seeds,
varieties and species and essentiallybiological processes for the propagation of
plants and animals, but micro-organisms are made patentable (Section 30)), An
invention which, in effect, is traditional knowledge or which is an aggregation
.or duplication of known properties of traditionally known component/s is also
non-patentable (Section 3 (P)). The traditional Indian forms of medicines are
thus out of its purview.

The Act makes it mandatory for patent applicants to disclose in the patent
application the source of origin of the biological material and associated
knowledge used in the invention (Section lO.4(d)(D)). It also allows opposition
to a patent application for a patent due to the failure of an applicant to disclose
or wrongly mention in the specification the source of origin of the biological
- material for _the invention. Section 25(1 )(h), 0) and (k) further provide that
failure to disclose to the Controller any information required under the Act as
provided in Section 8 (which deals in information and undertaking regarding
foreign applications) or the complete specifications, or to provide the wrong
53

I I
 Protection of Traditional source of the geographical origin of the biological material used for the invention,
Knowledge or knowledge, oral or otlierwise, available within any local or indigenous
community in India or elsewhere, can be grounds for opposition to a grant of
patent.

The Act also incorporates p~ovisions for the protection of biodiversity and
traditional knowledge by refusing to grant patent or revoke a patent if the
application wrongfully mentions the source of geographical origin of biological
.
"
material, or the invention claimed was related to TK oral or otherwise, of any
local or indigenous community in India or otherwise (Section 64(P) & (q)).
This measure is taken to protect folklore or knowledge belonging to local or
.mdigenous community of any country. This provision is in line with the Bonn
Guidelines on Access to Genetic Resources and Fair and Equitable Sharing of
the Benefits Arising out of their Utilisation (adopted by the Conference of Parties
to the Convention on Biodiversity, 2002), Para. 16(d)(ii), suggesting Parties
to adopt 'measures to encourage the disclosure of the country of origin of the
genetic resources and of the origin of traditional knowledge, innovations and
practices of indigenous and local communities in applications for intellectual
property rights'.
.t:
16.3.2 Protection of Plant Varieties and Farmers' Rights Act
(PPVFR Act), 2001
The PPVFR Act though not directly related to protection of TK, has important.
provisions on benefit sharing and farmers' rights. The plant varieties, which are
not patentable under the Patents (Amendment) Act, are specifically dealt with
under the PPVFR Act. The main focus of the Act is on defining 'plant breeder's
rights (PBRs). The Act is extended to all categories of plants, excluding micro-
organisms (which are .patentable). The Act is primarily based on the UPOV
Convention, providing a sui generis regime for PBRs, but it includes a number
of provisions, not present in the UPOV Convention. For instance, it recognizes
the role of farmers as cultivators and conservers, and the contribution of
traditional, rural and tribal communities in the country's agro-biodiversity by
making provision for benefit sharing and compensation, and also protecting the
traditional rights of the farmers (Section 39 and 41).

The Act creates a regulating body - the' Protection of Plant Varieties and
Farmers' Rights Protection Authority (the Authority), which is empowered to
(among other things) determine the applicable benefit sharing (Section 3 and 26).
Benefit sharing is meant to provide individuals or groups with the possibility
of receiving financial compensation when a protected variety is developed. The
Authority, while determining the amount of financial compensation, will take
into account whether the variety is extant and nature of the use of the genetic
material of the claimant in the development of the variety; and the commercial
utility of and demand in the market for the variety so developed (Section 26).
The Act also provides for a National Gene Fund (the Fund), to which the amount
accruing from the benefit sharing will be credited. The amount collected in the
Fund shall be utilised for the payment of benefits to the claimant, compensation
to the village community for exploitation of their variety, for conservation and
sustainable use of genetic resources, and purposes as defined in the Act (Section
45). To- give effect to the rights of village or local communities and for benefit
sharing, the Central Government may devise one or more schemes as provided
54 in the Act (Section 46).

I
 Chapter VI of the Act is devoted to fanners' rights, which protect the traditional Indian Efforts Towards
rights of fanners to save, use, exchange, share or sell their farm produce of a TK Protection
protected variety, which is in line with Article 15(2) of the 1991 Act of the UPOV
Co~vention. However, the farmer is not entitled to sell branded seed. It also
acknowledges the rights of a fanner to register a new variety, bred or developed
by him/her, and accords him/her (the fanner) protection like any other breeder
under the Act (Section 39), A fanner who is engaged in the conservation of
· GR of land races and wild relatives of economic plants and their improvement
'. through selection and preservation is entitled to recognition and reward from
the Fund. The Act also recognizes the rights of the communities, and, once
their contribution is quantified, they will be entitled to compensation from the
Fund: The Act only talks about the compensation to the community if their
contribution in the evolution of a variety is verified and accepted, but it falls
· short of granting them any proprietary right. It allows communities to file claims
for their contribution to the development of a protected variety (Section 41).

The registration of a variety is not allowed in cases where prevention of

commercial exploitation of such variety is necessary t0 protect public order or
public morality or human, animal or plant life and .health or to avoid serious
prejudice to the environment (Section 29), The Central Government can exclude
any genera or species from the purview of protection' in public interest. The Act
makes provisions for compulsory license of protected varieties in the public
interest if the right-holder does' not arrange for the production and sale of seeds.
This ensures that the protected seeds are available to the fanners (chapter VII).
In line with the patent law, the PPVFR Act provides that the Authority shall
determine the duration of the license (which may vary from case to case), terms
and conditions of the license, viz. royalty and other remuneration to the breeder
· of the variety, and ensure that the compulsory licensee of such variety possesses
the adequate means to provide to the fanners the seeds or its propagating material
at reasonable market price (Sections 48-51). The provisions on benefit sharing
and compensation will be subject to the rules, guidelines and schemes framed
by the Central Government and the Authority.

Self Assessment Question (Spend 3 minutes)

1) .Discuss the role of the Protection of Plant Varieties and Fanners' Rights
Protection Authority in the protection of benefit sharing.

16.3.3 Biological Diversity Act

The Biological Diversity Act, 2002, gives effect to the mandate of CBD and, to
some extent, to the Treaty on Plant Genetic Resources for Food and Agriculture
(PGRFA). It addresses the issues which are relevant to biodiversity management
in general. and PGRs management in specific. The Act is more explicit in its
approach towards TK. It contains elaborate provisions on benefit sharing but is
weak in relation to PlC and the involvement of communities in decision-making. 55

I \ I
 Protection of Traditional The main focus of the Act is to regulate access to GRs and associated (traditional
Knowledge
knowledge by foreign individuals, institutions or companies with the purpose 'of
securing equitable sharing of benefits arising out of the use of these resources
with the local people, who are conservers of biological resources and holders of
knowledge and information relating to the use of these resources, and to protect
knowledge of local communities related to biodiversity, On benefit sharing, the
Act takes into account the Bonn Guidelines (Section 21): The different provisions
of the Act address the problem of bio-piracy. However no definition of 'TK' or
"
'community' has been attempted.

The main focus of the Act is to regulate access to GR and associated knowledge
by foreign individuals, institutions or companies with the purpose of securing
equitable sharing of benefits arising out of the use of these resources with the
local people (who are the conservers of biological resources and holders of
fI knowledge and information relating to the use of these resources), and to protect
knowledge of local communities related to biodiversity. For this purpose, the Act
has created the National Biodiversity Authority (NBA) at the national level, and
the State Biodiversity Boards and Biodiversity Management Committees at the
state and local levels respectively (Section 8; 22 and 41). The NBA is the apex
body to oversee the implementation of the Act, and issue guidelines for access
to and equitable benefit sharing from GRs (Section 18). The Act also proposes
to set-up BiodiversityFunds at central, state and local levels - known as the
National Biodiversity Fund, the State Biodiversity Fund, and Local Biodiversity
Fund respectively. The proceeds from the National Biodiversity Fund will be
used to channel benefits to benefit claimers, and for conservation and promotion
of biological resources and for the socio-economic development of areas from
where the resources have been accessed; such socio-economic development to
be done in consultation with the local bodies concerned (Section 27).

Traditional knowledge of people related to biodiversity shall be respected and

protected by the Government, through such measures as recommended by the
NBA. These may include registration of such knowledge at the local, state or
national levels, and ot~er measures of protection, including a sui generis sys!em
for possible IP protection (Section 36(5)). The state governments will notify
. National Heritag~ Sites (which are important from the biodiversity standpoint),
in consultation with institutions of local self-government, in order to identify and
monitor areas rich in biological resources, and for in-situ and ex-situ conservation
of biological resources (Section 37) .: ~ .-

To address the problem of bio-piracy, the Act has, elaborate provisions to grant
access to biological resources by non-resident Indians, foreign individuals,
companies or associations, or local companies or associations with non-Indian
shareholders or management who cannot obtain any biological resources
occurring in India or knowledge associated thereto for research or for commercial
utilisation or for bio-survey and bio-utilisation without the prior approval
of the NBA (Section 3). Similarly the research results relating to biological
resources occurring in or obtained from India cannot be transferred for monetary
consideration without the approval of the NBA. However, publication of
research papers or dis~emination of knowledge through seminars or workshops
is exempted provided such publications conform to the policy guidelines of
the Central Government (Section 8::!-). Similarly, collaborative research projects
involving transfer or exchange of biological resources or related information
56

I
 between institutions, including government sponsored institutions, are exempted Indian Efforts Towards
from these obligations, if such transfer or exchange conforms to these guidelines. TK Protection
/

A foreigrr or other party referred to in the Act under Section 3{2), if intending
to obtain any biological resources occurring in India or knowledge .associated
thereto for research or for commercial utilisation or for bio-survey 'and bio-
utilisation or transfer of results of any research relating to biological resources
occurring in or obtained from India, is required to obtain prior approval from the
NBA after making. an application and on payment of a prescribed fee (Section
19). A person, who has been granted approval, cannot transfer any biological
resources or knowledge associated thereto without the permission of the NBA
(Section 20).' .

The Act creates a system of benefit sharing for TK holders. In this regard, the
fI NBA is empowered (among other responsibilities) to frame guidelines on ABS
(Section 18); The NBA, while granting approval, shall ensure equitable sharing
of benefits on mutually agreed. terms and conditions between the person applying
for such approval, local 'bodies concerned and the benefit-claimers (Section
21(1)). The NBA will consult the local bodies to ensure the equitable sharing
of benefits. Forms/modes of benefit sharing are elaborated under Section 21.
Such benefit sharing can be in monetary and, non-monetary terms, such as a
royalty, joint ventures, technology transfer, product development, education and
awareness raising activities, institutional capacity building and venture capital
funds, and the. Act also envisages joint ownership of IPRs with the NBA or
with identified claimers (Rule 20, 2004 Rules). Five per cent of the assessed
monetary benefits will be earmarked for the NBA or the local Board towards
administrative and service charges (Rule 20, para. 9). In the matter of IPR, the
Act is very stringent. It requires that an inventor seeking any kind of IPR in or
. outside India for any invention based on any biological research or information
on a biological resource obtained from India, obtain prior permission of the NBA.
In case a person applies for a patent, prior permission of the NBA is required
after the acceptance of the patent but before the sealing of the patent by the
concerned patent authority. Further, the NBA, while granting the approval, may
impose benefit-sharing fee or royalty or both or impose conditions including
the sharing of financial benefits arising from the commercial utilisation of
such rights. But this provision will not be applicable to a person making an
application for any rights under the plant variety protection legislation (Section
6). The NBA is also empowered to take necessary measures to oppose the grant
in any country outside India of IPRs on any biological resource or associated
knowledge derived/obtained from India (Section 18(4)). But this scheme has
an interface with the Patents Act if the patent is sought in India. It is doubtful
whether the Act will have extra-territorial jurisdiction in this regard.

State Biodiversity Boards will deal with matters relating to access by Indians
to GR for commercial purposes and restrict any activity that is contrary to the
objectives of conservation, sustainable use and equitable sharing of benefits.
However, the local people and communities of the area, including those who have
been practising indigenous medicine, will not be subjected to the rigours of the
Act (Section' 7). Any contravention of these provisions' is an offence which is
punishable with fine or imprisonment or both (Section 55, para. 2). The functions
of the Biodiversity Management Committees are related 'to conservation,
sustainable use and documentation of biodiversity at the local level, in order to
57

I I
 Protection of Traditional monitor and protect bio-resources to curb biopiracy and effectively challenge the
Knowledge
IPRs granted wrongfully in foreign jurisdictions (Section 41). Though the State
Biodiversity Boards and the Biodiversity Management Committees will monitor
and protect the bio-resources at their.1evels and will be consulted in facilitating
access to those resources, the final decision in this regard lies with the NBA.

It is, however, noticeable that on benefit sharing, separate bodies have been
constituted under the PPVFR Act and under the Biological Diversity Act. These
" have similar functions, related to similar activities that are access to GR and
traditional knowledge. But the Biodiversity Act focuses mainly on biopiracy
and benefit sharing' and does not provide any mechanism to check the impact
of monoculture on biodiversity, generated by the introduction of IPRs in
, biotechnology; nor does the PPVFR Act address this issue. In benefit sharing, fine
tuning needs to be done. The amount of royalty, based on some agreed formula,
fI
transfer of technology tools - with or without patent or sui generis system
protection, training of the local scientists community, the other monetary benefits
and so forth, require a clear understanding. It is, however, doubtful whether
the provision on joint ownership of IPRsf incorporated in Section 21, will be
acceptable to private multinational companies in the business of biotechnology
unless there are clearly perceptible advantages to the technology-holder or the
I~R pertains to orphan and neglected crop, which does not hold much value
. for the technology-holder. Furthermore, no machinery has been provided for
dispute resolution on ABS,

The idea of a Fund under the Act in fact makes it evident that creators and
holders of knowledge do not have proprietary rights 'to their knowledge. Their
only reward is a potential financial contribution from this Fund to be decided
by higher authorities. However, it is not clear whether the reward will be in the.
.'1' form of only monetary benefits or also be in kind. There are also a few other
pertinent questions, such as whether the benefit (monetary/non-monetary) is to
be a 'one-time' payment or a continuous process, for their contributions towards
the future activities of conservation and cultivation of GRs? As most of the TK
holders are resource-poor, often landless farm labourers, the reward in the form
of land would help improve their condition as well as assist the protection of
the environment and the conservation and cultivation of GRs, along with the
protection of TK, which normally has close connection with the land. The Act
also does not recognize the biodiversity related community IPRs. The provision
for such a right could have been made under a sui generis system like that of the
PPVFR Act, as a patent system is inherently incapable of doing so. The grant
of specific IPR to the community, which is monopolistic in nature, will also be
. fraught with certain administrative and legal problems, particularly in its ambit
and enforceability. Moreover, in the case of patents, it is doubtful whether the
local communities will be able to withstand the challenges from formal breeders,
who are well-equipped to defend their rights.

The issues of the mode of benefit sharing and the probable stakeholders, on
the other hand, are fraught with many problems as is evident in the case
of Arogyapaacha (trichopus zeylanicus travancoricus) experiment which
resulted into an immune-enhancing, anti-stress and anti-fatigue drug Jeevani
on the knowledge provided by Kani tribe of Kerala related to the plant. The
scientists working with the Government of Kerala's Tropical Botanical Garden
and Research Institute (TBGRI) helped to develop the drug from the active
58

/
 . ingredients of the plant. The rights to manufacture Jeevani was transferred to a Indian Efforts Towards
private manufacturer, the Arya Vaidya Pharmacy (Coimbatore) Ltd. for a license TK Protection
fee of Rupees ten lakhs for 7 years and a 2% royalty on sales. The TBGRI
decided to give 50% of the fee and royalty to the Kanis. Involving numerous
stakeholders (including the Kerala's Forest Department as the plarit was grown
only in protected area), the benefit-sharing deal became very controversial.
Once the product became commercially viable, the problem of over-extraction
of the plant also came to light, raising concerns for its sustainable extraction
from its natural habitat. Scientists also realized that without IP protection, the.
drug would not generate enough revenue by mere licensing.

This case, however, has' hi~hlighted the potential of GRs and associated TK as
well as the role of indigenous and local communities in their beneficial use,
which has also helped in the improvement and development of the indigenous
fI
communities. Effective protection through IPR is, nevertheless, a necessary
condition for generating funds, which will be subject to benefit sharing. But
.. other measures are also required. to supplement the IPRs in order to ensure
equitable benefit sharing, such as identifying the stakeholders and defining their
role, ensuring the sustainable extraction of the bio-resources, acknowledging the
local informants in the patent applications, modes of benefit sharing and so forth.

The Biological Diversity Act outlines the framework of benefit sharing, mainly
when the foreign party is involved (whether seeking or granted access to genetic
resources), but does not deal adequately with a case similar to Arogyapaacha,
where the stakeholders are entirely local or Indian citizens.

16.3.3.1 Draft Rules on TK, 2009 .

Under the Biological Diversity Act (Sections 36(5) and 62), the Government
of India is required to frame guidelines/rules on the protection of TK relating
to biological diversity and benefit sharing. In December 2009, on the
recommendation of the NBA, the government brought out 'The Protection,
Conservation and Effective Management of Traditional Knowledge relating
to Biological Diversity Rules, 2009'. The Rules are aimed to establish an
access and benefit sharing regime which will be based on the principles of
prior-informed consent ofthe community holding the traditional knowledge in
question. The Rules define TK and Traditional Community. TK is defined as
"the collective knowledge of a traditional community including of a group of
families, on a particular subject or a skill and passed down from generation
, to generation, either orally or in written form, relating to properties, uses and
characteristics of plant and animal genetic resources; agricultural and healthcare
practices, food preservation and processing techniques and devices developed
from traditional materials; cultural expressions, products and practices such
as weaving patterns, colors, dyes, pottery, painting, poetry, folklore, dance and
music; and all other products or processes discovered through a community
process, including by a member of the community individually but for the
common use of the community". The definition is very broad which goes
beyond the mandate of the Biological Diversity Act, confined to biological
resources only. "Traditional Community" means a community holding the
TK. Similarly, "prior informed consent" is defined as a written authorisation
given by the traditional community to an applicant in the prescribed manner.
NBA to oversee the rights of the traditional communities (TCs), ~llowing them
to exercise their rights. 59

I I
 Protection of Traditional In the absence of any representing body of the community, NBA, through State
Knowledge
Biodiversity Boards (SBBs) 'and Biodiversity Management Committee (BMC)
will help communities to set up .representative body, ,NBA has the ultimate
authority to prevent abuse/misuse/misappropriation of TK, and shall institute
legal proceedings, NBA is to maintain' a TK Register for registration of TK.
All details about the TK :- name, location, description, of TK, revealed by the
traditional community, will be entered in the Register, or by suo motu efforts
of the NBA, SBB" BMC with the permission of the traditional community.
"
The permission of the traditional community is not needed if the TK is already
in the public domain. TK has to be marked 'PUBLIC' or 'CONFIDENTIAL'.
Details about the accessor of TK shall also be entered into the register. All
existing/future databases shall be part of the register. If TK is not registered, no
application for access will be allowed; if already accessed, then the accessor
must approach appropriate bodies. For seeking permission for access, an
application, in prescribed form is to be made to the NBA.

Before access is granted, provision has been made for National/State Standing
Committees (SSCs) to advise on the viability of the application to advise NBN
SBB. The SBB to obtain the informed consent from the community in whose
name TK is registered through the BMC. If communities are from three or
more state, then the NBA has to obtain informed consent. Upon receiving the
willingness of the traditional communities to participate in negotiation, the
matter is to be referred to the SSC, which will assess the sustainability of the
resources and other implications. Based on the report, the SBB has to facilitate
consultations among the applicant, traditional community and BMC. Once the
consensus emerges, then the SBB will set the terms and conditions for access,
use and benefit sharing of TK, on which applicant and traditional community
will sign. Based on this agreement, NBA will issue the "License of Use",
incorporating PlC and terms and conditions. The term of the License will be
of three years, renewable for another three years.

If TK is in the public domain or spread over in more than three states, National
Standing Committee (NSC) will issue the PlC and negotiate benefit sharing.
The agreement will be signed by the applicant and NBA, which will issue the
"License of Use". NBA will allow access to PUBLIC TK, after assessing its
sustainability, value of TK and other implications. Access to CONFIDENTIAL
TK will be allowed after identifying the traditional communities and their
consent. In case the TK .is registered as CONFIDENTIAL, then the SSB to
obtain PlC and access and benefit sharing agreement. Any third party or civil
rights groups can approach the NBA in case of misuse/misappropriation/abuse
on unregistered TK. License of Use is non-assignable and non-transferable. Any
interested person may within 6 months of publication, apply for its opposition
or revocation. NSC will examine such claim after hearing both the parties and
submit its report to NBA. In case of misuse, license can be revoked. Benefit
share as negotiated be paid directly by the applicant to TC and report about it
annually to NBA. Under the Agreement concluded with the NBA, benefits will
go to the Traditional Knowledge Fund, created under the Rules. '

Licensee has to pay 'Milestone payments' of not less than 10% of the gross
revenue in the Fund. Access fee charged by the NBA will also go to the Fund.
The Fund has to be used for the protection, conservation and development of
TK and TCs (Rule 11(2)). NBA has to develop plans/programmes/strategies for
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 the sustainable use of TK. It shall make plans' in consultation with the TCs for Indian Efforts Towards
the protection of TK or resources on the verge of extinction. It shall also notify TK Protection
TK heritage zones of areas of importance. National/State Standing Committees
shall also be constituted. Any contravention/attempt to contravene/ abettinK_
the contravention of the Rules shall be punishable with imprisonment up to
5 years or fine up to ten lakh rupees or both. Court will entertain. complaints
only if made by the government or any authority so authorized; or made by the
benefit claimer, An appeal against any order of the NBA can be made only to
:. the Supreme Court.

The Dra~ Rules, to a great extent, 'are in consonance with the Nagoya Protocol,
2010 on access and benefit-sharing and provides for the designated Authority
for these purposes. But the Draft Rules, which were to be adopted in 2010, are
still being under deliberation.
r-

Self Assessment Question (Spend 3 minutes)

2) Who is a traditional community under the draft Rules, 2009 and how
the NBA will protect their interest?
..
.................................................................................................................
.

..................................................................................................................
- .

These legislative measures of the government to protect TK together, however,

fail to address the participation of farmers or local communities in decision
making or in the protection ofTK. The main focus of the legislation is confined
to checking biopiracy and providing positive protection through IPRs. The actual
operation and impact of the relevant legislation on TK protection, however, is
yet to be seen. Furthermore, fine tuning on benefit sharing is yet to be done.

16.4 TRADITIONAL KNOWLEDGE DIGITAL

LIBRARY (TKDL) .
In the recent past, there have been several cases of bio-piracy of TK from India.
First it was the patent on wound healing properties of haldi (turmeric) by the
United States Paterit and Trademark Office (US PTO), then patents were obtained
in other countries ori.hypoglyceimic properties of karela (bitter gourd), brinjal
etc. There is also the view that the TRIPS Agreement is aiding the exploitation
ofbiodiversity by privatizing biodiversity expressed in life forms and knowledge.
Similarly, a patent granted on the neem as a fungicide was revoked by the
European Patent Office in May 2000. But the time, effort and money involved
in getting individual patents examined and revoked in foreign patent offices is
prohibitive. Hence, an internationally accepted solution to such bio-piracy is
necessary, beside legislation by individual countries.
. .
However, it is often difficult to check unscrupulous patenting of TK because
of lack of documentation and validation. It is sometimes believed that proper
documentation of associated TK could help in checking bio-piracy. It is assumed
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 Protection of Traditional that if the materials/knowledge is documented, it can be made available to patent
Knowledge examiners the world over so that prior art in the case of inventions based on
such biological materials/traditional knowledge is readily available to them. It
is also hoped that such documentation would facilitate tracing of indigenous
communities with whom benefits of commercialization of such materials/
knowledge has to be shared. On the other hand, others believe that documentation
may facilitate bio-piracy. Nevertheless, documentation has one clear benefit. It
would check patents based on TK in public domain that is today difficult to
"
prevent due to lack of availability of information with patent examiners. After
the CBD came into force, in India, preparation of village-wise Community
Biodiversity Registers (CBRs) for documenting all knowledge, innovations and
.practices has been undertaken in a few States. The objectives of these registries
range from TK and biodiversity preservation at the local community level, to
establishing rights to produce and sell indigenous indigenous products/handicrafts
at the national level, to providing evidence of prior art to prevent inappropriate
patents at the international level.

To prevent bio-piracy, there is a need for deyeloping digital databases of prior

art related to herbs which is already under public domain, and which can be
accessed by the patent offices while processing patent applications related to
GRs/TK. Section 36(iv) of the BD Act provides for protection of knowledge of
local people relating to biodiversity through measures such as registration of such
knowledge, and development of a sui generis system. In India an exercise has
been initiated to prepare easily navigable computerized database of documented
TK relating to use of medicinal and other plants (which is already under public
domain) known as Traditional Knowledge Digital Library (TKDL). Such digital
database would enable patent offices all over the world to search and examine
any prevalent use/prior art, and thereby prevent grant of such patents, such as
on haldi and neem, and bio-piracy.

The Biological Diversity Act, in Section 41, talks about the documentation of
the biodiversity at the local level by the Biodiversity Management Committees,
in order to check probablebio-piracy and also to effectively challenge they
IPRs granted in foreign jurisdictions. There are some private initiatives on
TK documentation, such as Sristi (the Society for Research and Initiatives
for Sustainable Technologies and Institutions) and the Honey Bee Network.
There are also varied experiments on documentation undertaken by the village
communities, particularly in Kerala, which is one of the richest biodiversity states
in India. In the Pattuvam (village in Kerala) experiment, the village undertook
to register all its natural resources and knowledge pertaining to these resources.
The Register was accompanied by the People's Biodiversity Declaration asserting
that no monopoly claims on life forms will be accepted by people living. in that
area. Other provisions detailed the conditions under which experiments on life
forms collected in the territory of Pattuvam can be undertaken. The Register was
kept secret and information sharing was allowed only in exceptional cases. The
Register is thus not aimed at containing the commercial exploitation of local'
resources by others but mainly to prevent their asserting rights over prior local
knowledge. But there are problems with documentation, and it is evident that
registers have limited utility.

First, while registers can be very effective to counter patent claims by others
on knowledge held locally, they cannot stop the utilisation of genes from plants
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 produced in a given village by outsiders who will then be able to patent novel Indian Efforts Towards
products and processes after prospecting those genes: Secondly, a register does TK Protection
not help anyone claiming rights to knowledge. On the contrary, the register is
meant to show that it is in public domain and, therefore, is not patentable. Thirdly,
open registers could be accessed at a charge by anyone. Closed registers, as in
Puttuvam experiment, would be confined to local communities. They are useful
for the limited purpose of profiling the TK of a region. They also have very
narrow utility because merely acknowledging the knowledge of local people
.
"
has no bearing on the fact that the conservers of biological resources, creators
and holders of knowledge and information relating to the use of biological
resources are _also the owners of these resources and should thus have the right
to determine their sale and access. The ultimate decision-making body under the
Act is the NBA, which may over-ride the interests of the knowledge holders.
To avoid bio-piracy, it thus sacrifices farmers and local communities' rights and
denies them any right over their knowledge and inventions.
.. India has also created digital databases of prior art related to medicinal plants
used in Indian systems of medicines, Ayurveda, Unani and Sidda. In 2001;
Government of India, set up the Traditional Knowledge Digital.Library
(TKDL) as repository of 1200 formulations of various systems of Indian
medicine, such as Ayurveda, Unani and Siddha and 1500 Yoga postures
(asanas), translated into five international languages - English, German, French,
Spanish and Japanese, which converts Indian TK (Ayurveda, Unani, Sidda, Yoga,
among others) from existing prior art TK formulations or knowledge available
in Hindi, Sans it, Arabic, Persian and Urdu. TKDL thus provides information
on traditional knowledge existing in the country, in languages and format
understandable' by patent examiners at International Patent Offices (lPOs), so
as to prevent the grant of wrong patents. TKDL thus, acts as a bridge between
the traditional knowledge information existing in local languages and the patent
examiners at IPOs.

TKDL is a collaborative project between Council of Scientific and Industrial

Research (CSIR), Ministry of Science and Technology and Department of
AYUSH, Ministry of Health andFamily Welfare, and is being implemented by
CSIR. An inter-disciplinary team of Traditional Medicine (Ayurveda, Unani,
Siddha and Yoga) experts, patent examiners, IT experts, scientists and technical
officers are involved in creation ofTKDL for Indian Systems of Medicine. The
project TKDL involves documentation of the TK available in public domain in
the form of existing literature related to Ayurveda, Unani, Siddha and Yoga, in
digitized format in five international languages. Traditional-Knowledge Resource
Classification (TKRC) , an innovative structured classification system for the
purpose of systematic arrangement, dissemination and retrieval-has been evolved
for about 25,000 sub,groups against few subgroups that was available in earlier
version of the International Patent Classification (IPC), related to medicinal
plants, minerals, animal resources, effects and diseases, methods of preparations,
mode of administration, etc.

Presentation on Traditional Knowledge Resource Classification (TKRC) at IPC

Union led to the creation ofWIPO-TK Task Force consisting of US PTO, EPO,
JPO, China and India by IPC Union for enhancing the sub-groups in IPC for
classifying the TK related subject matter and considering the linking of TKRC
with IPC. In February 2002, ~ Committee of Experts recommended the inclusion
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 Protection of Traditional of approximately 200 subgroups on TK against the few existing sub-groups on
Knowledge medicinal plants, and linking of TKRC to IPC and thus, a new main group and
its subgroups were included in IPC covering different categories of plants.

, Till August 2011, 2,44,860 medicinal, form~lations have been transcribed. In

2009, Access Agreements related to TKDL were concluded by the CSIR with
major patent offices in the world, viz., USPTO, EPO, Japan Patent Office,
German Patent and Trade Mark Office. As a result, more than ,lOO patent
applications based on, TK have been rejected by these offices.
.
"

Documentation of traditional knowledge (TK) is one means of giving recognition

to knowledge holders, But mere documentation may not enable sharing of
" benefits .arising out of the use of such knowledge, unless it is backed by some
kind of mechanism for, protecting the knowledge. Documentation of traditional
knowledge may only serve a defensive purpose, namely that of preventing the
patenting of this knowledge in the form in which it exists.

Self Assessment Question (Spend 3 minutes)

3) Discuss the significance of documentation in TK protection.

-, 16.5 SUMMARY
• India is rich in traditional knowledge asso~iated with biological resources.
The traditional knowledge is both coded, as in the texts of Indian systems
of medicine; or is non-coded, which is oral and undocumented.

• India is a party to the CBD, but there is no TK-specific legislation in this

regard, but the Government has' enacted three significant statutes related
to TK and access and benefit sharing.

• The Patent (Amendment) Act, 2005, provides for: 'exclusion of plants and
animals from the purview of patentability); exclusion of an invention which
in effect is traditional knowledge from patentability; mandatory disclosure
of the source and geographical origin, of the biological material in the
specification when used in an invention ; and provision for opposition to
grant of patent or revocation of patent in case of non-disclosure or wrongful
disclosure ofthe source of biological material and any associated knowledge,

• The Plant Varieties Protection and Farmers' Rights Act (PVPFRA) 2001
deals primarily with the protection of plant breeder's rights over the new
varieties developed by them and the entitlement of farmers to register new
varieties and also to save, breed, use, exchange, share or sell the plant
varieties, which the latter have developed, improved and maintained' over
many generations. It also provide for benefit sharing with the indigenous
communities for their share in this regard.
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 , • The Biological Diversity Act, 2002 primarily aims at regulating access to Indian Efforts Towards
biological resources and associated traditional knowledge so as to ensure TK Protection
equitable sharing of benefits arising out of their use, in accordance with the
provision of Article 15 of the CBD.

• The draft Rules, 2009, drafted under the Biological Diversity Act, provides
a morerefined mechanism on ABS. .

• India has also signed the Nagoya Protocol, not yet ratified, which will put
.., binding obligations on India on ABS .

• There have been attempts for creating databases on TK at the village and
state levels. The Government of India, with the involvement -of CSIR,
has developed the TKDL, which is a value added digital database for (i)
preservation of traditional knowledge; (ii) prevention of misappropriation
of traditional knowledge; and (iii) creation of linkages with modem science
.. to initiate active research projects for new drug discovery and development.
It helps in checking the bio-piracy and misappropriation of the TK, by
preventing bad patents by foreign patent offices over knowledge ,which is
in the public domain.

16.6 TERMINAL QUESTIONS

1) Discuss, the main provisions of the Patents (Amendment) Act that have the
relevance .in.protecting the Traditional Knowledge. Do they reflect India's
position on TK protection at the TRIPs deliberations?

2) What is the role of the National Biodiversity Body (NBA) under the BD
Act in giving effect to ABS and checking the bio-piracy?
~,

3) Describe the significance of TKDL in the protection of TK and providing

defensive protection to TK-holders.

16.7 ANSWERS AND HINTS

Self Assessment Questions

1) Benefit sharing under the Act is meant to provide individuals or groups

with the possibility of receiving financial compensation when a protected
variety is developed. The PVFRP Authority is empowered to determine the
applicable benefit sharing, and while determining the amount of financial
. compensation, the Authority will take into account whether the variety is
, extant and nature of the use of the genetic material of the claimant in the
development of the variety; and the commercial utility of and demand in the
market for the variety so developed. The Act also provides for 'a National
Gene Fund (the Fund), to which the amount accruing from the benefit-sharing
will be credited, which will be utilised, among others, for the payment of
benefits to the claimant.

. 2) "Traditional Community" (TC) under the draft Rules means a community

holding the TK. The NBA has to ensure that the prior informed consent
of the TC is obtained before granting access to the TK, through the SBBI
BMC and based on the report of the SSC assessing the sustainability of the
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 Protection of Traditional resources and other implications. The SBB will set the terms and conditions
Knowledge for access, use and benefit sharing of TK, on which applicant and traditional
community will sign. Basedon this agreement, NBA will issue the "License
of Use", incorporating PlC and terms and conditions.

3) Documentation helps in checking unscrupulous patenting of TK. It is

sometimes believed that proper documentation of associated TK could help
in checking bio-piracy, It is assumed that if the materials/knowledge is
documented, it can be made available to patent exaininers the world over
'. so that prior art in the case of inventions based on such biological materials/
traditional knowledge is readily available to them. It is also hoped that such
documentation would facilitate tracing of indigenous communities with
whom benefits of commercialization of such materials/knowledge has to
be shared. Documentation of traditional knowledge (TK) is one means of
giving recognition to knowledge holders.

Terminal Questions

1) Refer to Sub-section 16.3.1

2) Refer to Sub-section 16.3.1

3) Refer to Sub-section 16.3.1

16.8 REFERENCES AND SUGGESTED READINGS

1) UNCTAD- ICTSD, Resource Book on TRIPS and Development,
Cambridge University Press, 2005, eh. 21

2) Burton Ong(ed.) Intellectual Property and Biological Resources,

Marshall Cavendish Academic, 2004, eh. 6,

3) Christoph Antons (ed.) Traditional Knowledge, Traditional Cultural

\. ,

Expressions and Intellectual Property Law in the Asia-Pacific Region,

Wolters Kluwer, 2009

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 Notes

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