Dr.

Ram Manohar Lohiya National

Law University
Lucknow

2021-22
Subject- Intellectual Property Rights – Ii

Submission on:
B I O -P I R A C Y : M Y T H OR R E A L I T Y ?

Submitted to Submitted by
Dr. Vikas Bhati Tanurag Ghosh
Asst. Professor of Law Roll No. 180101147

B.A.LLB.(Hons) 2023
 TABLE OF CONTENTS

1. ABSTRACT
2. INTRODUCTION
 Significance of Traditional Knowledge
 Protection of Codified Traditional Knowledge
 Misappropriation of Traditional Knowledge
 Tools for prevention of Misappropriation of Traditional Knowledge
 Convention on Biological Diversity and Nagoya Protocol
 Traditional Knowledge Digital Library and it’s advantage on Biopiracy
3. FAMOUS CASES OF BIPIRACY OF TRADITIONAL KNOWLEDGE
 The Turmeric Cacse
 The Basmati Case
 The Neem Case
 The Ayahuasca Case
 The Kava Case
 The Hoodia Case
4. LEGAL PROTECTION UNDER CONVENTION ON BIOLOGICAL DIVERSITY
AND RELATED LEGAL INSTRUMENTS (CBD)
 Inconsistent Application of Policy Underlying Patent Law
 Blurred Lines - Discovery v. Invention
 Unjust and Unfair Exploitation of Traditional Knowledge: Possibility of
Monetary Losses to Native Communities
 Unjust Superiority of Trips Over CBD
5. LEGAL JUSTIFICATIONS IN SUPPORT OF BIOPIRACY
 No Justification for Granting Complete Control Over Traditional Knowledge
To Indigenous Communities
 Utilitarian Perspective: Universal Benefits from Commodification of
Traditional Knowledge
 Existing Safeguards are Sufficient to Redress All Legitimate Grievances of
Indigenous Communities
6. CONCLUSION: MYTH OR REALITY?
7. SUGGESTIONS
ABSTRACT
“Biopiracy” is a term used to describe the appropriation of traditional knowledge of native
communities regarding the beneficial uses of local genetic resources, for the purpose of
generating commercial profits. Developing countries have voiced strong opinion against this
practice in various global forums, arguing that it leads to exploitation of traditional
knowledge since the native communities get no part of the huge profits generated by
companies through biopiracy. On the contrary, the western countries adopt an instrumentalist
view and question the legitimacy of claims against biopiracy, on the ground that the practice
of using a native community’s traditional knowledge to develop and patent inventions causes
no harm to the community which can continue its traditional use of the resource. This project
analyses this debate by examining the legal justifications for both sides. Various legal
instruments like the TRIPS Agreement and the Convention on Biological Diversity have been
analysed to understand their implications on the issue of biopiracy. The main objective of the
project is to understand the “piracy” element of biopiracy by analysing the actual harm caused
to the indigenous communities whose traditional knowledge is appropriated, thereby reaching
a conclusion regarding whether biopiracy is a myth or reality. The project concludes with
certain suggestions to effectively tackle the issue of biopiracy in a way that reconciles a
community’s cultural rights in their traditional knowledge and rights of others to benefit from
this knowledge for development of drugs etc.

INTRODUCTION
Traditional Knowledge (TK) is a living body of knowledge that is created, maintained, and
passed down from generation to generation within a group, often part of its cultural or
spiritual identity. Biopiracy has emerged as a term to describe how corporations in the
developed world claim ownership or otherwise take unfair advantage or free ride on the
genetic resources and traditional knowledge and technology of developing countries.

Formulations used to treat human diseases from traditional knowledge are time-tested since
they have been in practice for centuries. The efficacy of alternative medicine schemes,
combined with the lack of this knowledge with patent offices, offers a convenient way for
interlopers to gain patents on such medical products originating from conventional medicine
schemes.
Significance of traditional knowledge

Traditional knowledge (TK) is an integral part of the identity of most local communities. It is
a core component of the social and physical climate of a society and, as such, its protection is
of utmost importance. Attempts to manipulate TK for industrial or commercial gain can
contribute to misappropriation of TK and can harm the rights of its legitimate custodians. In
the face of these threats, ways, and means to secure and cultivate TK for sustainable growth
need to be built in line with the interests of TK holders. The preservation, protection, and
promotion of TK-based innovations and practices of local communities are of particular
importance to developing countries. Their rich knowledge of TK and biodiversity plays a
critical role in health care, food protection, community, religion, identity, climate, trade, and
development. Yet, in many parts of the world, this valuable asset is under threat.

There are fears that this knowledge is exploited and retained by third parties without the
explicit written consent of TK holders and that none, if any, of the advantages gained are
communicated with the societies in which the knowledge develops and exists. Such issues
have driven TK to the centre of the international agenda, prompting vigorous discussion on
how to conserve, defend, further grow and sustainably utilize TK. Documenting and
digitizing TK-related details in the form of a TKDL (Traditional Knowledge Digital Library)
continues to be an important way of protecting TK and avoiding its misappropriation by third
parties. India is a leader in the region.

Biopiracy can be described as the unauthorized use or appropriation of traditional indigenous

knowledge regarding the beneficial uses of plants or animal specimens along with the
chemical and genetic resources contained therein, by third parties for commercial profit
withoutsharing the same with the indigenous community. 1 Many of the least developed
countries are rich in genetic resources but do not have the requisite technology to develop
these resources, while the first world countries are poor in genetic resources but have highly
developedtechnologies, which fuels biopiracy by developed countries.2 Biopiracy can be of
three forms, bio- prospecting that involves discovery of new plants and animals with
beneficial uses, discovery of unknown benefits of a known plant and third, being the most
abusive is the commercial

1
Jim Chen, There's No Such Thing as Biopiracy... and It's a Good Thing Too, 37 McGeorge L. Rev. 1, 7
(2006). 2 Valentina Tejera, Tripping Over Property Rights: Is it Possible to Reconcile the Convention on
Biological Diversity with Article 27 of the TRIPs Agreement?, 33 New Eng. L. Rev. 967, 972 (1998-1999).
exploitation of indigenous knowledge.3 The pharmaceutical and the agricultural industry rely
heavily on traditional knowledge regarding beneficial uses of plant genetic resources and are
often the main drivers of biopiracy.4 Examples of biopiracy include patent on basmati rice by
an American corporation called RiceTec,5 use of neem as a pesticide by W.R. Grace,
medicinal use of turmeric, patent on the Mexican yellow bean etc.
The rhetoric associated with the term “piracy” has been used by both, developed countries
advocating stronger intellectual rights protection for patented and copyrighted works, as well
as third world countries who argue that first world countries commit “bio-piracy” by usurping
endemic genetic resources from their State without authorization and subsequently using
strong intellectual property laws to obtain a patent over inventions based on these genetic
resources without sharing the commercial benefits derived from the same.6 Predictably,
developed and developing countries advocate opposing views in relation to the ill effects of
biopiracy. Developing countries have been campaigning for protection of endemic knowledge
and resources in various global forums like the World Trade Organization (WTO) and WIPO
(World Intellectual Property Organization) and have argued that biopiracy exploits
indigenous communities and their traditional knowledge.8 On the other hand, western
countries argue that acquiring patents based on traditional knowledge is not a cause of
concern since it has no adverse effect on native communities who continue to have the right
to carry on their practices based on traditional knowledge. Question then arises, if no concrete
harm is caused to the indigenous community by such patents, then why must the issue of
biopiracy be considered seriously.
This project scrutinizes this debate by examining the legitimacy of claims and arguments
made against and in favour of “biopiracy” by evaluating the legal justifications of both sides.
Ultimately, the project seeks to understand the “piracy” element of biopiracy by analysing the
actual harm caused to the indigenous communities whose traditional knowledge is
appropriated thereby reaching a conclusion regarding whether biopiracy is a myth or reality.

3
Gavin Stenton, Biopiracy within the Pharmaceutical Industry: A Stark Illustration of just how Abusive,
Manipulative and Perverse the Patenting Process can be towards Countries of the South, 1(2) Hertfordshire
Law Journal, 1(2), 30, 36 (2003).
4
Supra no. 2.
5
Anthony Brown, India fights US Basmati Rice Patent, The Guardian, available at
http://www.theguardian.com/world/2000/jun/25/anthonybrowne.theobserver (Last Visited on 10/03/2021 at
21:30).
6
Cynthia M. Ho, Biopiracy and Beyond: A consideration of socio-cultural conflicts with global patent policies,
39 U. Mich. J.L. Reform 433, 436 (2005-06).
Protection of codified traditional knowledge

Protection of conventional information is important in other respects; the absence of clear

legislative policy structures for the conservation of TK in developing countries creates a gap
for developed and industrialized nations to exploit the TK and indigenous capital. Since the
TK incorporates information and know-how on a wide range of issues, including resource
management, traditional medicines, crafts, artistic and cultural designs, their properprotection
is important to the maintenance of the traditional traditions of Indigenous peoples. It is a right
of cultural heritage that must be protected and shared equitably in the interests of all human
beings.

The need to secure TK is more important today; it has been reported that corporate companies
sometimes infringe on indigenous intellectual property rights. While these breaches do not
legally constitute a breach of established legal norms, because neither national legislation nor
international conventions acknowledge the interests of indigenous peoples, they are
nevertheless subject to indigenous customary law.

Misappropriation of traditional knowledge

The issuance of patents on non-patentable technology (in contrast to conventional medicines),

based either on current medical knowledge in the developed world or on a small difference of
that knowledge, has created a great deal of concern to the developing world. Some of the
examples show the bio-piracy of traditional knowledge and, in many of these cases, the
country has had to fight for the revocation of the patents granted, the revocation of which may
not be a viable option for all patents based on traditional knowledge, since it involves
enormous costs and time.

Tools for prevention of misappropriations of traditional knowledge

The protection of traditional knowledge (draft articles)

The most recent edition of the Draft Treaty was sent to the Committee at its 39th Session on
22 March 2019, and which was amended between 17 and 21 June 2019. The Preamble
recognizes the right of indigenous and local communities to “maintain, control, protect and
develop their intellectual property over their cultural heritage, including their traditional
knowledge;” promotes “respect.” The independence, cultural identity, and moral principles of
conventional knowledge holders; and acknowledges the need for new laws and qualifications
on the provision of adequate and acceptable means for the protection of existing information
privileges, taking into account disparities in national law systems. The elements of
misappropriation of traditional information which fall within the reach of the Draft Treaty’s
alternative meanings include:

 “Access” or “usage;”
 “Without free, prior and informed consent or consent and participation and, where
relevant, without mutually acceptable terms,” “in violation of customary law and
existing procedures regulating the entry or use of such traditional knowledge” or
“abuse” except in the case of “violation of national law in the provider country;”
and
 For “economic, science, education and technology transfer.”

While there are three alternatives to the objectives of the Draft Treaty, the first addresses
three key issues needed to protect traditional knowledge. In particular, the Draft Treaty states
that ‘the objective of this instrument is to ensure effective protection of intellectual property
against:

 Misappropriated traditional knowledge;

 Uncompensated traditional knowledge use; and
 Error granting of intellectual property rights over tradition.

The extent of (and conditions of) protection affirms the following principles:

 Member States will adhere to the customary laws and practices of TK holders;
 Member States [will/should] take national action to ensure that TK holders have
absolute and collective right to preserve, regulate, use, create, allow or prohibit
access to and usage/use of their traditional knowledge; and receive a fair and
equitable share of the benefits derived from its use; and
 ‘Member States [shall/will] take measures to ensure the integrity of traditional
knowledge’ or to protect the interests (economic and moral)of TK holders.
The Convention on Biological Diversity (CBD) and The Nagoya Protocol on access to
genetic resources and the fair and equitable sharing of benefits arising from their
utilization to the CBD (Nagoya Protocol)

Article 8(j) of the CBD lays out a general duty requiring States to “value, protect, conserve
and encourage awareness” of indigenous communities and to “encourage their broader use
with the permission and participation of the holders of that awareness. The Convention on
Biological Diversity also requires States to “promote an equal distribution of benefits
resulting from the usage of TK”.

The Nagoya Protocol addresses the traditional knowledge of genetics resources with access,
benefit-sharing and compliance provisions. It also tackles genetic opportunities where
aboriginal and local populations have the opportunity to provide access to them. Contracting
Parties shall take measures to ensure prior informed consent and fair and equitable sharing of
benefits for these communities, keeping in mind the laws and procedures of the Community
as well as the customary use and exchange.

Traditional knowledge digital library

TKDL contains information from Indian Medicine Systems, i.e., Ayurveda, Unani, Siddha,
Sowa Rigpa, and Yoga available in the public domain. Traditional knowledge of existing
literature in local languages such as Sanskrit, Urdu, Arabic, Persian and Tamil has been
translated into digital format and is available in five international languages, including
English, German, Spanish, French and Japanese.

Traditional Knowledge Resource Classification (TKRC), an innovative structured

classification system for systematic arrangement, dissemination, and retrieval, has been
developed for approximately 5,000 subgroups against a limited number of subgroups
available in the International Patent Classification (IPC) related to medicinal plants. The
details shall be classified in compliance with the International Patent Classification (IPC)
section, class, category, community, and subgroup for the ease of its usage by foreign patent
examiners. The TKDL database consists of approximately 3.6 lakh formulations/practices
that have been transcribed from the ISM and Yoga texts.
TKDL software with its associated classification system, i.e. TKRC converts text in local
languages to multiple languages as mentioned above. It can be noted that TKDL is not a
transliteration, but rather a knowledge-based conversion, where once abstracted data is
converted into multiple languages using the Unicode, Metadata methodology.

TKDL serves as a link between local language formulations and the patent examiner at the
global stage, as the archive can contain details on both international and traditional terms in a
language and format that is accessible to patent examiners. The issue of the lack of access to
prior art traditional knowledge is expected to be addressed.

Advantages of TKDL on bio-piracy

 It has been estimated that a large number of patents relating to the Indianmedicinal
system have been wrongly granted by patent offices around the world.
 In 2003, almost 15,000 patents were taken from the Indian Traditional Knowledge
International Patent Offices, which increased to 35,567 in 2005 and 85,000 in 2008
(Refs 12, 14). A survey of 4896 references to 90 medicinal plants mentioned in the
USPTO database by the TKDL Taskforce found that 80 percent of these references
were made to seven medicinal plants of Indian origin, and 360 of the 762 patents
on medicinal plants.
 Based on the observations of a third party submitted by the TKDL team, a large
number of patent applications have either been set aside or withdrawn, annulled, or
declared dead. Innovative TKDL helps India to protect some 0.250 million medical
formulations at zero cost.
 Access to the TKDL database helps patent examiners to discover the novelty of
patent applications shortly after submission.
 In general, it takes 5-7 years to oppose the patent granted along with a huge cost of
between USD 0.2 million and USD 0.6 million. For example, the opposition
proceedings against the patent of neem (EP436257), Enola beans (US patent No.
5894079) and Monsanto soybeans (EP301749) took 10 years in each of the first
two cases and 13 years in the third case. Because of this, it is clear that TKDL will
not only help prevent the patenting of traditional Indian medicine at an early stage
but will also reduce expenditure and time.
FAMOUS CASES OF BIO PIRACY OF TRADITIONAL KNOWLEDGE

The Turmeric case (Curcuma Longa Linn.)

Turmeric rhizomes are used as a flavouring spice for Indian cooking. It also has properties
that make it an effective ingredient in medicines, cosmetics, and dyes. It has historically
beenused as a treatment for the curing of cuts and rashes for decades.

In 1995, two expatriate Indians at the University of Mississippi Medical Center (Suman K.
Das and Hari Har P. Cohly) were granted a US patent (# 5, 401,504) on the use of turmeric in
wound healing. Council of Scientific of Industrial Research (CSIR), India, New Delhi, filed a
re- examination case with the USPTO challenging the patent on the rationale of the prior art.
CSIR claimed that turmeric had been used for the treatment of wounds and rashes for
thousands of years and that its medical usage was not a discovery. They were backed by
historical documentation of mainstream expertise, including an ancient Sanskrit text and a
paper written in the Bulletin of the Indian Medical Association in 1953. Given an appeal by
the patent owner, the USPTO accepted the arguments of the CSIR and revoked the patent.
The Turmeric case was a landmark case, as it was the first time that a patent based on the
traditional knowledge of a developing country had been successfully challenged. The US
Patent Office revoked this patent in 1997, after finding that there was no novelty; the findings
of innovators have been known for centuries in India.

The Neem case (Azadirachta indica A. Juss.)

Neem extracts are often used against hundreds of pests and fungal diseases that pounce food
crops; oil extracted from its seeds can be used to cure colds and flu; and mixed in soap, it
provides relief from malaria, skin diseases and even meningitis. In 1994, the European Patent
Office (EPO) awarded a patent (EPO patent No.436257) to the US Company W.R. Grace
Company and the US Department of Agriculture for a process to manage plant fungi using
hydrophobic extracted Neem oil. In 1995, a group of international NGOs and representatives
of Indian farmers filed legal opposition to the patent.

They submitted evidence that the fungicidal effect of extracts of Neem seeds had been known
and used for centuries in Indian agriculture to protect crops and was therefore unpatentable.
In
1999, the EPO held that all the characteristics of the present argument had been revealed to
the public before the patent application and that the patent was not deemed to require an
innovative move. The patent granted on Neem was revoked by the EPO in May 2000. In
March 2006, the EPO rejected the request made in 2001 by the USDA and the chemical
multinational, W. R. Thanks to the previous decision of the EPO to cancel the patent on the
fungicidal properties of the seeds derived from the needed seeds.

The Basmati case (Oryza Sativa Linn.)

Rice Tec, man. Inc. applied to register the trademark “Texmati” before the United Kingdom
Trade Mark Registry. The Agricultural and Processed Food Export Development Authority
(APEDA) successfully opposed it. One of the records relied on by Rice Tec as proof infavour
of the approval of the aforementioned trademark was the US Patent 5,663,484 issued to Rice
Tec by the US Patent Office on 2 September 1997 and this is how this patent became a
subject of controversy. This US usefulness patent was unusual in that it argued that the rice
plant had features identical to the typical Indian Basmati Rice lines and had a regional range
spanning North, Central, or South America or the Caribbean Islands. The USPTO issued the
patent to Rice Tec on 2 September 1997. The patent concerned 20 claims covering not only a
novel rice plant but also a variety of rice lines; resulting in plants and grains, claims for seed
deposits, the method for the selection of a rice plant for breeding and reproduction. Its claims
15-17 were for rice grains with characteristics similar to those of Indian Basmati rice lines.
These arguments 15-17 may have gotten in the way of Indian exports to the US if lawfully
applied.

Data from the IARI (Indian Agricultural Research Institute) Report regarding arguments 15-
17 was included. The finding was confirmed by the germplasm selection of the Rice Research
Directorate, Hyderabad, in 1978. CFTRI (Central Food Technological Research Institute)
scientists assessed the different grain characteristics and therefore the claims 15-17 were
attacked based on statements made by CFTRI scientists concerning grain characteristics.

The motion for the re-examination of this patent was eventually submitted on 28 April 2000.
Shortly after completing the proposal for re-examination, RiceTec decided to remove claims
15-17 along with claim 4.Biopiracy of conventional information is not limited to India alone.
The Ayahuasca case (Banisteriopsis Caapi Mort.)

For centuries, B Caapi Mort has been cultivated by the Shamans of indigenous groups in the
Amazon basin. To make a ritual cocktail known as “Ayahuasca.” Ayahuasca (which means
“wine of the soul”) is used by the Shamans in mystical and curing rites to cure and manage
sickness, attract ghosts, and foresee the future.

American, Loren Miller was granted US Plant Patent (No.5, 751 issued in 1986), granting
him rights over the alleged variety by B Caapi Mort which he had collected from the Amazon
Domestic Garden and called “Da Vine” and analyzed for potential medicinal properties. The
patent stated that Da Vine embodied a new and distinct B type. Caapi Mort., mainly because
of the colour of the flower.

The Coordinating Body of Indigenous Organizations of the Amazon Basin (COICA), which
includes more than 400 indigenous groups in the Amazon region, along with others, has
protested against the incorrect patenting of a plant product. They objected to the fact that
Ayahuasca was known to natives of the Amazon rainforest and is used in traditional medicine
and has been cultivated for generations to come, so that Miller could not have discovered it
and should not have been granted those rights which, in effect, appropriated traditional
indigenous knowledge.

USPTO withdrew this patent on 3 November 1999 at the point of re-examination. However,
on 17 April 2001, the inventor was able to convince the USPTO thereby the original claims
being reconfirmed and the patent rights restored to the innovator.

The Kava case (Piper Methysticum Forster)

Kava is an important cash crop in the Pacific, highly prized as a source of the ceremonial
beverage of the same name. Over 100 varieties of Kava are grown in the Pacific, especially in
Fiji and Vanuatu, where it was first domesticated thousands of years ago. Kava is now being
sold for several uses in North America and Europe. French corporation L’Oreal – a
multinational conglomerate with revenues of US$ 10 billion a year – invented the use of Kava
to minimize hair loss and promote hair development.
Hoodia case (Hoodia Gordonii (Masson) Sweet ex Decne)

For thousands of years, African tribesmen have consumed Hoodia cactus to stave off
starvation and thirst on long hunting trips. The Kung bushmen, San who reside across the
Kalahari Desert in Southern Africa, used to hack off a cactus stem around the size of a
cucumber and to munch it.

In 1995, the South African Council for Science and Industrial Research (CSIR) copyrighted
Hoodia’s appetite suppressant factor (P57) and hence its possible remedy for obesity. In
1997, P57 was licensed to the British Biotech Firm, Phytopharm.

In 1998, Pfizer purchased the rights to produce and sell P57 as a possible slimming
medication and fat treatment (a demand worth more than £ 6 billion) from Phytopharm for
$32 million. The San people eventually learned from this exploitation of their traditional
knowledge and began legal action against the South African CSIR and the pharmaceutical
industry on the grounds of bio-piracy in June 2001.

They claimed that their traditional knowledge had been stolen and that the South African
CSIR had failed to comply with the provisions of the Convention on Biodiversity, which
requires the prerequisite informed consent of all stakeholders, including the original
discoverers and users. Phytopharm performed detailed inquiries but was unable to locate any
information holders. The surviving San were reportedly staying in a tent camp 1500 miles
removed from their tribal lands at the time. The South African CSIR claimed that they had
planned to inform the San of the research and share the benefits, but wanted to ensure that the
drug was successful.

The two parties entered into agreements for a benefit-sharing arrangement, given the
complexities about who would be compensated: the individual who initially exchanged the
details, their heirs, the tribe, or the whole nation. San is a nomad distributed across four
continents. However, a landmark agreement was reached in March 2002, in which the San
would receive a share of any future royalties. Since then, though, hoodia has penetrated the
grey economy and the degree to which the San society is benefited by the exchange of
benefits needs to be seen.
LEGAL PROTECTION UNDER CONVENTION ON BIOLOGICAL DIVERSITY
AND RELATED LEGAL INSTRUMENTS (CBD)
Convention on Biological Diversity is the chief international legal instrument that deals with
the sustenance, conservation and equitable use of biodiversity and related genetic resources.7
Article 3 of the Convention recognizes the sovereign right of each State to exploit their
resources in accordance with their own environmental policies. 8 Article 8(j) of the CBD
provides for conservation of traditional knowledge and practices of indigenous communities
with respect to their genetic resources. Article 15 of CBD recognizes national sovereignty
rights over genetic resources thereby, making access to these resources subject to national
legislations. It also provides that access and commercial use of genetic resources would be
based on mutually agreed conditions regarding equitable sharing of benefits and with prior
consent.9 Interestingly, Article 16(5) lays down that the intellectual property rights systems
should not run counter to the objectives of the Convention.10 While Article 16(2) states that
technology transfer process should be consistent with the protection under intellectual
property rights, this sanction granted to intellectual property rights is limited since it is still
subject to the limitations under Article 15 and Article 16(5). 11 Thus, CBD provides
developingcountries with a legal basis to seek a share in the benefits obtained by utilization of
their genetic resources. The framework provided in the CBD reconciles the preservation and
utilization of biological or genetic resources for profitable use.12 The objectives underlying
the CBD can be achieved through Access and Benefit Sharing Agreements between the State
and the entity that seeks to use the traditional knowledge and indigenous resources for
commercial purposes.13 The Nagoya Protocol to the CBD was adopted in 2010 and it requires
all State parties to take legislative and policy measures to implement provisions of CBD.
Further, the Bonn Guidelines on Access to Genetic Resources, 2002 provide a blueprint for
policies and national legislations to achieve the goals of CBD.14 Thus, indigenous
communities have a legal recourse as they can

7
Article 1, Convention on Biological Diversity, 1992
8
Article 3, Convention on Biological Diversity, 1992.
9
Article 15, Convention on Biological Diversity, 1992.
10
Article 16(5), Convention on Biological Diversity, 1992.
11
Sebastian Oberthür, Thomas Gehring, Institutional Interaction in Global Environmental Governance: Synergy
and Conflict among International and EU Policies, The MIT Press, available at
http://www.unibamberg.de/fileadmin/uni/fakultaeten/sowi_professuren/politikwissenschaft_insb_int/Dateien/Mi
tarbei ter/Publikationen_Texterkennung/InstitutionalInteraction_text.pdf (Last Visited on 10/03/2021 at 21:47).
12
Valérie Boisvert and Armelle Caron, The Convention on Biological Diversity: An Institutionalist Perspective
of the Debates, 36(1) Journal of Economic Issues, 151, 152 (2002).
13
Michael A. Gollin, Biopiracy: The Legal Perspective, available at http://www.actionbioscience.org/
biodiversity/gollin.html (Last Visited on 11/03/2021 at 21:45).
14
Bonn Guidelines on Access to Genetic Resources (Bonn Guidelines), 2002.
rely on these instruments to fight for their rights in their traditional knowledge.

Inconsistent Application of Policy Underlying Patent Law

Reward theory on patent protection states that such protection is granted to reward the
inventor for his labour and expense in creating the invention. If the purpose underlying patent
law is to reward those who invested time and labour into the invention, then right of the
indigenous communities over their traditional knowledge cannot be denied, since they
perform all the development steps with respect to the invention other than the isolation of the
active substance.15

Blurred Lines - Discovery v. Invention

Granting of patents to applications of traditional knowledge on genetic resources has been
criticized on the ground that it overlooks the distinction between discovery and invention in
patent law. For example, Section 1(2) (a) of UK’s Patent Act 1977 excludes “discoveries”
from protection under patent law, however by granting patents to applications based on
traditional knowledge, discoveries are being treated as inventions. In fact, many countries like
Brazil and Argentina do not even allow naturally subsisting materials to be patented. Another
requirement under patent law that has been diluted for such traditional knowledge based
patents is the requirement of “novelty” in the invention. Interestingly, the novelty requirement
with respect to patents based on plant genetic resources is only to show that the substance was
not available in its pure form i.e., thus if indigenous communities use the active substance in a
dilute form then a pure form of the substance fulfils the “novelty” requirement. An unjust
interpretation has been given to the “non obviousness” requirement in relation to
biotechnology based patents. For example, while the traditional knowledge with respect to
use of neem as an insecticide is widely known, the identification and isolation of the active
substance; azadirachtin is still treated as non-obvious despite it being quite clear that the
isolation would not have occurred without the traditional knowledge on the neem seeds.
In the author’s opinion, the validity of these patents can also be challenged under the “tainted
research doctrine” which was laid down in the Regents of the University of California v. Eli
Lilly & Co. according to which a case for fraud can be made against those who seek patents
based on stolen research material.16

15
Lester I. Yano, Protection of the Ethnobiological Knowledge of Indigenous Peoples, 41 UCLA Law Review
443, 463(1993).
16
119 F.3d. 1559 (Federal Circuit ).
Unjust and Unfair Exploitation of Traditional Knowledge: Possibility of Monetary
Losses to Native Communities
Multi-national companies (MNCs) of developed countries end up making huge profits with
small investment into the research and development of their products as they exploit the
readily available traditional knowledge about the beneficial uses of plants. In most cases, the
indigenous groups assist MNCs in identifying medicinal and other beneficial uses of plants
thus saving their time and money but get no part of the large profits made by these companies
stemming from their monopoly through patents. 17 There is also a fear amongst the developing
countries that MNCs will use the patented genetic material to develop cheaper products that
will directly affect the market for goods produced by tribal communities. 18 MNCs often
appropriate traditional knowledge of indigenous communities to create products to be later
sold to the country of origin making the original inventors pay for it. For example, ever since
western companies started patenting various beneficial aspects of neem, the price of neem
seeds has gone up considerably, thereby making it more expensive for local farmers to
acquire the raw material and also puts him in competition with western industries providing
products based on neem.19

Unjust Superiority of Trips Over CBD

The main objective of The Agreement on Trade-Related Aspects of Intellectual Property
Rights (TRIPS) is to reduce barriers to International Trade by considering the need of
effective protection of intellectual property rights.44 The TRIPS agreement also places an
obligation on its signatories to create new intellectual property laws in accordance with the
agreement or the WTO may impose sanctions on them.45 Article 27(3)(b) of TRIPS provides
that plant varieties can be a subject of either patent protection or a sui generis system of
protection. Nations like the United States have argued that requirements of prior consent and
benefit-sharing agreements conflict with Article 27(3)(b) of TRIPS. Hence, there is an
inherent conflict between CBD and TRIPS, while one recognizes the rights of native
communities to their traditional knowledge and resources; the other seeks to protect
individual ownership rights in the same.46 The biggest conundrum for those opposed to
biopiracy is that TRIPS definitely

17
Lakshmi Sarma, Biopiracy: Twentieth Century Imperialism in The Form Of International Agreements, 13 Temp.
Int'l & Comp. L.J. 107, 113 (1999).
18
John Vidal, Can you really patent a tree?, The Guardian, 27 November, 1999,
http://www.theguardian.com/science/1999/nov/27/genetics.wto.
19
Vandana Shiva, The neem tree - a case history of biopiracy, available at http://www.twnside.org.sg/ title/pir-
ch.htm (Last Visited on 12/03/2021 at 19:10).
wins the battle amongst the two, especially in terms of its legal binding value and strong
enforcement mechanism.47 While TRIPS casts specific legally binding obligation on its
member states, CBD only lays down vague and aspirational goals and no legally enforceable
right.

LEGAL JUSTIFICATIONS IN SUPPORT OF BIOPIRACY

No Justification for Granting Complete Control Over Traditional Knowledge To
Indigenous Communities
The current intellectual property regime does not protect already existing knowledge and
information (except for trade secrets to a certain extent),20 and scholars in favour of bio-
prospecting, often argue that protection cannot be granted to existing traditional knowledge
about plant genetic resources.21 In Graham v. John Deere Co., the U.S Supreme Court
reiterated this principle and stated that patents that remove existing knowledge from the
public domain should not be granted.22 One of the most important justifications for
intellectual property rights is that the monopoly granted therein acts as an incentive to
creation and this also fails to sustain claims for protection of traditional knowledge which
already exists. It is also argued that economist theories justifying property rights to increase
clarity in relation to ownership also fail in justifying protection of traditional knowledge due
to the diverse nature of the knowledge concerned and the impracticality of identifying
ownership.

Utilitarian Perspective: Universal Benefits from Commodification of Traditional

Knowledge
Ever since the landmark decision in “Diamond v. Chakrabarty” that allowed a patent on
genetically altered Pseudomonas bacterium, 23 the Supreme Court of the United States has
consistently upheld grant of patents on genetically engineered life forms. Such patents have
been justified by taking a utilitarian position and emphasizing on the need to disseminate
information regarding beneficial use of genetic resources etc. which otherwise would remain
unknown to the world. Arguably, native communities do not have the resources to make the
most utilitarian use of their knowledge. The best example to support this argument is the
development of a drug named Oncovin, essentially based on traditional knowledge regarding

20
Article 27(1), Agreement on Trade Related Aspects of Intellectual Property, 1994
21
Paul J. Heald, The Rhetoric of Biopiracy, 11 Cardozo J. Int'l & Comp. L. 519, 522, (2003-04).
22
383 U.S. 1 (1966).
23
447 U.S. 303 (1980).
medicinal uses of the rosy periwinkle plant, for the treatment of leukemia.24

Existing Safeguards are Sufficient to Redress All Legitimate Grievances of Indigenous

Communities
Some believe that the current intellectual property law regime may be sufficient to redress the
legitimate grievances of the developing countries. Thus, if any indigenous community is
legitimately suffering any harm due to these patents then the current intellectual property
regime redressal mechanism is sufficient to address their concerns. For example, EU
interprets “prior art” to include traditional knowledge of communities belonging to foreign
states, thereby making acquisition of patents for products that are based on traditional
knowledge stricter and difficult, which itself would prevent cases such as controversial patent
granted to “Neemix” or on medicinal uses of haldi as described above.

CONCLUSION: MYTH OR REALITY?

Biopiracy is certainly a reality especially in light of its broader global repercussions. As
discussed before, western countries often downplay the “piracy” element of biopiracy on the
ground that existence of patents on applications of traditional knowledge does not conflict
with the continued exercise and use of the resource in its natural form by the native
communities.61 However, this instrumentalist view fails to recognize the derogatory effects
of the same on the cultural rights of the indigenous communities. While the perpetuation of
traditional knowledge by natives is aimed at communal good, the idea behind patents is
granting individualised monopolies for commercial purposes. The western perspective also
fails to address that despite the significant role played by the indigenous communities in
identification of the genetic resource that forms the primary basis for the application for
which a patent has been acquired, the patent would be in the name of the multi-national
company providing no legal entitlements to the community.62 In most cases, communities
have to fight for getting any kind of compensation, and even in cases where compensation is
granted, it forms a miniscule amount when compared to the profits the company makes. This
certainly gives the indigenous communities legitimate grounds to argue that their traditional
knowledge has been pirated. Thus, Biopiracy is no myth and is as real as the suffering of the
indigenous community due to the commodification of their knowledge.

24
Chris Kilham, Rosy periwinkle: A life saving plant, Fox News, available at
http://www.foxnews.com/health/2013/07/31/rosy-periwinkle-life-saving-plant/, (Last Visited on 13/03/2021 at
21:00).
SUGGESTIONS
1) Reconcile CBD And Trips
To effectively deal with the issue of biopiracy, there needs to be a reconciliation of
community’s cultural rights in their traditional knowledge and other’s rights to benefit from
this knowledge for development of drugs etc. The first step that can be taken in this regard is
reconciliation of TRIPS and CBD. In fact, developing countries are pushing for amendments
in the TRIPS agreement that makes granting of patents subject to or conditional upon
compliance with Convention on Biological Diversity (CBD). One way of reconciling the
objectives of TRIPS and CBD would be to make granting or validity of patents conditional on
compliance with obligations under CBD i.e., amending the patent requirements. India has
vehemently argued amending Article 27(3)(b) of TRIPS to indicate that patents that are
essentially based on traditional knowledge should not be granted or it should be supported by
a disclosure with respect to the origin of the biological resource it relies upon and the proof
that prior consent of the community and the State concerned has been acquired. 25 The
requirement of “novelty” for grant of patents needs to be defined in a way that ensures that
publication or knowledge even outside the national boundaries of the patent granting State are
considered before the awarding of the patent.

2) Creation of National Gene Funds/Digital Libraries

Creation of digital libraries of traditional knowledge will assist in protection of traditional
knowledge of indigenous communities. A traditional knowledge database makes it harder for
multinational companies to get patents based on the same, as the “knowledge” recorded in the
database would act as a “publication” making it easier to argue that it is a “prior art”, for
which a patent cannot be granted. The Traditional Knowledge Digital Library of India
establishedby the Council of Scientific and Industrial Research (CSIR) is an example of such
libraries created for the protection of traditional knowledge.26

3) Protect Traditional Knowledge Through National Legislation or A Sui Generis

System
Developing countries should enact national legislations that grants native communities

25
Council for TRIPS, Review of the Provisions of Article 27.3(b), Communication from India, available at
http://www.wto.org/english/tratop_e/trips_e/art27_3b_e.htm (Last Visited on 13/03/2021 at 22:01)
26
Traditional Knowledge Digital Library, Council of Scientific and Industrial Research, available at
http://www.tkdl.res.in/tkdl/langdefault/common/Home.asp?GL=Eng (Last Visited on 13/03/2021 at 21:25).
complete rights over their traditional knowledge and resources. For example, Philippines
enacted the Indigenous Peoples Rights Act, 1997 which grants indigenous communities
control and rights over their traditional knowledge and genetic resources. 27 Various
associations and groups of developing countries like ASEAN, G-15 have also initiated efforts
to protect traditional knowledge of their native communities.28

It should be noted that the IP world has recognized the importance of successful
documentation of indigenous TKs such as India’s TKDL-playing a role in defensive
protection within the existing IP system. The following strategies are discussed, as suggested
by the World Intellectual Property Organization (WIPO) as a global measure to curb bio-
piracy and misappropriation of TK. Inventions focused on or produced utilizing genetic tools
(associated or not with conventional knowledge) may be patentable or covered by the rights
of plant breeders.

The other two initiatives considered, addressed and established by WIPO7 are, in the first
place, protective defence of genetic resources aimed at preventing patents from being
awarded on genetic resources (and relevant conventional knowledge) that do not fulfil the
current criteria of innovation and inventiveness. This measure also involves the possible
disqualification of patent applications that do not comply with the obligations of the
Convention on Biological Diversity (CBD) regarding prior informed consent, mutually
agreed with terms, fair and equitable sharing of benefits, and disclosure of origin. Second,
WIPO leaders intend to make it mandatory for patent applications to reveal the origins or
roots of genetic capital, as well as proof of mutual informed consent and a benefit-sharing
arrangement.

27
The Indigenous Peoples Rights Act 1997.
28
Raghavan Chakravarthi, Asean for Protecting Indigenous/Traditional Knowledge, available at
http://www.twnside.org.sg/title/asean.htm (Last Visited on 13/03/2021 at 21:20)