biotechnology & bioprospecting for sustainable development

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BIOTECHNOLOGY & BIOPROSPECTING
FOR
SUSTAINABLE DEVELOPMENT







Ministry of Environment & Forests
Government of India








India’s presentation for the Ministerial Meeting of
Megabiodiversity Countries

Cancun, Mexico
February 16-18, 2002


Biotechnology and Bioprospecting for
Sustainable Development

1. Introduction

2. Bioprospecting
2.1
Bioprospecting Case Studies

(a) The Kani experience- India
(b) The International Cooperative Biodiversity Group
(c) The Bioresource Development & Conservation
Programme (BDCP) – Nigeria.
2.2 Lessons learned
2.3 Future outlook

3. Biotechnology, Intellectual Property Rights, Biodiversity
& Traditional Knowledge.
4. India’s legislation on Biodiversity
5. TRIPS, Biodiversity and Patent issues


Biotechnology and Bioprospecting for Sustainable
Development

1. Introduction

Biotechnology, a modern science is revolutionizing production in both
industry and agriculture in certain areas. One of the main features of
biotechnology is its linkages with human welfare, environment and sustainability.
Two sectors where biotechnology has already made significant contributions are
pharmaceuticals and agriculture. The search for useful products derived from
biological resources coupled with innovative ways to link benefits with
conservation of biodiversity and economic development is attracting attention
worldwide. Bioprospecting describes the systematic search for and development
of new sources of chemical compounds, genes, micro- and macro organisms,
and other valuable products from nature. Bioprospecting incorporates two
fundamental goals, (i) the sustainable use through biotechnology of biological
resources and their conservation, and (2) the scientific and socioeconomic
development of source countries and local communities (Sittenfeld 1996).
For thousands of years, biodiversity has been source of useful compounds
and materials for food, energy, shelter, medicines, and environmental services.
The overall economic value from biodiversity is not known. However, a recent
attempt estimated that biodiversity ecosystem services amounts about US $ 2.9
trillion for the entire world. From those estimates, $ 500 million represents for
ecotourism, $ 200 million for pollination, $ 90 million for nitrogen fixation, and
$135 million for Co2 sequestration, worldwide ( Gordon 1998).
The pharmaceutical industry has benefited from biodiversity through drugs
developed from natural compounds, while the agricultural industry improves
crops by breeding them with wild relatives (Reid et al 1993). As per one study
half of the current best selling pharmaceuticals are natural or related to natural
products. (Demain 1998). The combined market worldwide for pharmaceuticals,
agrochemicals, and seeds is over $400 billion annually, and genetic resources
provide the starting material for a portion of this market (Putterman 1994: Ten
Kate 1995: Thayer 1998a: James 1997).
Agricultural biodiversity provides genetic resources for domestication
through intra-specific genetic variability of cultivated species and agricultural
practices. The introduction of molecular markers to characterize genetic
variance, together with the possibility of introducing genetic material from other
species and genera, to increase crop yields as well as resistance to disease or
environmental conditions, are increasing the potential value of biodiversity for
agriculture. It is considered that from the manipulation of DNA in agricultural
research, the world will obtain most of its food, fuel, fiber, chemicals, feedstock,
and even some pharmaceuticals from genetically modified plants (Abelson
1998).
The megadiversity countries with 60-70% of the world`s known biological
diversity have significant stake for harnessing the potential of biotechnology and
bioprospecting for achieving sustainable economic development. The Convention
on Biological Diversity (CBD), the first international treaty provides opportunities
to biodiversity rich countries to realize benefits arising out of the utilization of their
bioresources. The CBD states that national governments have authority to
determine access to their genetic resources, and calls on governments to provide
for conservation, sustainable use and equitable sharing of benefits from
commercial use of those resources. However, despite the clear articulation of
equitable sharing of benefits by CBD, this has not been furthered and clouded by
issues such as IPRs, conflicts between CBD and TRIPs, and lack of conducive
international environment and commitment.
This paper, based upon some case studies and experience gained in
formulation of biodiversity legislation in India presents a policy framework for
bioprospecting at national level and international action towards linking
bioprospecting and sustainable development.

2. Bioprospecting

In recent years bioprospecting has acquired increased attention as
countries seek to conserve their biodiversity and also share the benefits from
bioprospecting. Agreements in this field are seen as “a means of improving
national capacities to add value to natural resources, to share benefits with
developed countries at the same time ensuring that these resources are
protected and used sustainably” (Sittenfeld 1997)
While bioprospecting offers, in theory, a potentially interesting approach
for linking biodiversity conservation with the biotechnology sector, its success in
practice will depend upon the ability of these efforts in isolating useful
compounds at a cost comparable to other techniques for drug development.
There continues to be great interest in bioprospecting from the academic,
industrial and conservation communities, as well as the general public, and there
have been some significant results in the bioprospecting programmes to date.
However, it is still too early to say how much bioprospecting can contribute to
conservation and economic development ( Sagar and Daemmrich 2000, Rojas
1999).
Bioprospecting is fundamentally tied to scientific interest and commercial
success of natural product derivatives. In the rapidly changing and complex
world of drug discovery, the perceived value of natural products seems to wax
and wane every few years with the entrance of a new technology and the time
since a major new natural product drug has hit the market. Combinatorial
chemistry is the latest perceived replacement for natural products( Service 1999).
However, the very limited number of important leads that combinatorial chemistry
has provided has led some scientists and organizations to seek means of
integrating this technology and rational drug design with natural product leads in
order to gain the best results ( Lahana 1999, Nicolaou et al., 1999)

Success of bioprospecting efforts in megadiversity countries and other
developing countries will depend on the ability of these countries to effectively
monitor and enforce bioprospecting agreements.

2.1
Bioprospecting Case Studies

( a ) The Kani experience- India
In India, a well-known documented example of bioprospecting and benefit
sharing is the Kani - TBGRI - model in Kerala. Kani is a tribal community
inhabiting the Southern Western Ghat region of Kerala State in India. In 1987, a
team of scientists from the Tropical Botanic Garden and Research Institute
(TBGRI) undertook an ethnobotanical field study in the tribal inhabited Western
Ghat region of Kerala. During this expedition, they came across an interesting
ethnomedical information on a wild plant Trichophus zeylanicus, locally called as
“Arogyapacha” by the Kani tribe. The scientists noticed that the Kani tribals
accompanying the team frequently ate some fruits which kept them energetic and
agile. When asked about the source of the fruit, the Kani men were initially
reluctant to reveal the information. The team convinced the Kani men that
information would not be misused and that, they would conduct scientific
investigation. If any marketable drugs/products got developed, the benefits
accrued would be shared with the tribe. The Kani tribe then showed the plant,
which was identified as Trichophus zeylanicus.

Pharmacological investigations of the fruit confirmed its anti-fatigue
properties. Detailed chemical and pharmacological investigations showed that
the leaves contained various glycolipids and some other non-steroidal
compounds with anti -stress and anti-hepatoxic properties. The team developed
a polyherbal formulation by Arogyapacha Ayurvedic pharmaceutical methods
which was named “Jeevni”. After satisfactory clinical evaluation this herbal drug
was released for commercial production.

Many pharmaceutical firms approached TBGRI for getting the licence for
the production of “Jeevni”. After negotiations with various interested parties, the
manufacturing licence of “Jeevni” was transferred to the Aryavaidya Pharmacy
Coimbatore Ltd. for a licence fee of Rs. 10 lakhs for a period of 7 years . The
TBGRI in consultation with the tribal community has worked out an arrangement
for benefit sharing. According to this arrangement, the TBGRI has agreed to
share 50% of the licence fee and royalty with the tribal community. In November
1997, a number of Kanis got together, and with assistance from the TBGRI,
registered a trust called the Kerala Kani Samudaya Kshema Trust, comprising
nine members, all of them tribals. The President and Vice President of the trust
are the two Kanis who were responsible for telling the TBGRI about
Aarogyapacha (MOEF 2000) . The objectives of the trust deed include:

- welfare and development activities for the Kanis of Kerala;
- preparation of biodiversity register to document the Kanis’
knowledge base;
- evolving and supporting methods to promote the sustainable use
and conservation of biological resources.

(b) The International Cooperative Biodiversity Group (ICGB)

The International Cooperative Biodiversity Group (ICGB) was launched in
1991 with funding from the US government sponsored by the National Institute of
Health (NIH), the National Science Foundation (NSF) and the US Agency for
International Development (USAID) Under ICGB eight projects have been
currently funded in Suriname, Costa Rica, Argentina, Panama, Chile, Mexico,
Peru, Cameroon, Nigeria, and Vietnam and Laos. Three interrelated goals of
ICGB include health improvement through new drugs from natural sources,
conservation of biodiversity and sustainable economic development (Rosenthal
1998)
The ICGB has resulted interalia in:
 discovery of numerous bioactive compounds;
 augmentation of technical capacity of developing country participants and
their associated institutions;
 contribution to the scientific and policy process of conservation in
participating countries;
 development of important models for governments and other
organizations for collaborative research that supports multiple objectives,
including those of CBD

The Suriname ICGB`s bioprospecting programme was proposed by the
Suriname office of Conservation International (CI) an International NGO and
Saramaka Maroons, a forest dwelling community of Suriname. The cooperative
partnership also include the Virginia Polytech Institute and State University,
Missouri Botanical Garden, Bristol Myers-Squibb Pharmaceutical Research
Institute and Bedrijf Genessmiddelen Voorziening Suriname (BGVS), a
pharmaceutical company owned by the Surinamese government.
Through a Statement of Understanding, the Suriname ICGB established a
benefit sharing plan with a US$60,000 total advance payment from Bristol Myers
Squibb Pharmaceutical Research Institute into the Forest People’s Fund (FPF),
with additional contributions of $20,000 a year as the ICBG is renewed. The FPF
is a mechanism, which CI Suriname helped broker, through which ‘up front’
benefits and future royalties from new drugs developed can be returned to the
Saramaka people. Along with compensating the Saramaka Maroons for their
ethnobotanical contributions, the FPF creates conservation incentives, finances
sustainable management projects, provides research and technology exchanges
and supports other socially and environmentally sound projects.
A board of directors consisting of two representatives from the local
community, two from CI Suriname, and one from Suriname’s Department of
Interior was created to review proposals for ways to spend the advance payment
and any future royalties from drug sales. It was agreed that funds would be used
for projects involving community development, biodiversity conservation and
health care. If any products are commercialized from ethnobotanical collections,
50% of Suriname’s share of any future royalties will go to the FPF and the other
50% will go to various ICGB partners in Suriname. If a drug is derived from
random collections, the FPF’s share is reduced to 30% while 70% goes to other
ICGB partners (Moran 2000).

(c ) The Bioresources Development and Conservation
Programme (BDCP) - Nigeria

The Bioresources Development and Conservation Programme (BDCP) is
a multi ethnic international NGO based in Nigeria with objectives to use local
bioresources and knowledge to target therapeutic categories for tropical diseases
in Nigeria.
In 1990, Shaman Pharmaceuticals Inc. established a research relationship
with Nigerian scientific institutions, and the BDCP became the focal point for
collaborative research. Four ethnobotanical field expeditions were conducted. By
choice of Nigerian collaborators, immediate and medium-term benefits from the
expeditions took the form of workshops and training programmes on public
health, botany, conservation and ethnobotany; support for a medicinal plant
reserve; supplies for village schools; botanical collection supplies for a
herbarium; laboratory equipment for scientific research on plants that treat
parasitic diseases prevalent in West Africa and support for Nigerian scientists to
apply modern analytical techniques.
In 1997, the BDCP launched the Fund for Integrated Rural Development
and Traditional Medicine (FIRD/TM) during an international workshop on
medicinal plants. The FIRD-TM is the vehicle to receive and channel benefits in
an equitable and consistent manner from many contributors. The Fund has an
independent board composed of leaders of traditional healers’ associations,
senior government officials, multiethnic representatives of village councils and
technical experts from scientific institutions. Diverse culture groups in Nigeria will
receive resources from the Fund through traditional healers’ organizations and
villages consistent with their governing customs. Town associations, village
heads and professional guilds of healers are empowered to make decisions
regarding use of the funds for projects in their localities. Those funded will follow
the criteria of promoting conservation of biodiversity and drug development, as
well as the socioeconomic development of rural cultures (Moran 2000)
In early 1999 Shaman Pharmaceuticals abandoned attempts to take any
of its discoveries through the Food and Drug Administration regulatory process,
as future time and costs for additional clinical trials proved prohibitive. Shaman
Pharmaceuticals leveraged the company’s research and development by
launching its first botanical dietary supplement. The product delivers a
standardized extract from the sap of Sangre de Drago, the Croton lechleri tree, to
prevent fluid loss and promote normal stool formation in the intestine bowel
syndrome.

Lessons learned

 The lesson from Suriname case study shows how smoothly the
bioprospecting process can move along when time and resources have
been spent beforehand and when stated goals are not in conflict, but
interrelated. In Suriname the drug discovery process creates economic
value for biological diversity, which in turn creates development funds and
incentives for conserving biodiversity, satisfying the goals of stakeholders
 The Nigerian case study highlights the opportunities brought about
through bioprospecting. A major lesson of this case study is the time,
costs and risks associated with drug discovery, a burden shouldered
primarily by the company, but with critical implications for benefit sharing
to source countries and culture groups. Spreading the risks and benefits
among all stakeholders increases opportunities for benefits and lessens
risk. Royalties may never materialize due to the tremendous costs, long
time frame, unpredictability and volatility of the market and the many other
potential pitfalls of drug discovery. Some sort of up-front benefits,
monetary or non-monetary, as well as ‘milestone’ payments such as those
that went to Nigeria, are essential.
 This case study also demonstrates how biodiversity rich but financially
poor tropical countries, such as Nigeria, can increase conservation and
research funding and gain valuable training and technology. Since the
economic values of biodiversity are seldom accountable in market
valuations, strategies like bioprospecting bring added financial support for
conservation.
 The Kani case study brings to light the need for multi-stakeholder
framework for discussing the scope of access, value addition and benefit
sharing.
 The case also illustrates that while intellectual property rights play a
crucial role in generating benefits from biological resources and traditional
knowledge, their role should be balanced with the conservation objective.
 In the early stages of the case when many people started buying this plant
at the rate of Rs. 100 per kilogram, the Forest Department had to impose
restriction when they confiscated illegally collected leaves and whole
plants. The offer of the Arya Vaidya Pharmacy of giving a buy back
guarantee to the Kanis alongwith the technology to cultivate and extract
leaves in a sustainable manner was a solution to this problem.
 The effective protection of intellectual property is a necessary condition for
generating benefits, but it is not a sufficient condition for benefit sharing.
Several additional measures are needed to supplement the role of
intellectual property rights in benefit sharing over biological resources and
traditional knowledge.
 The degree of involvement of various tribal settlements and groups could
have been increased. The rights of informants vis-à-vis the communities
requires more discussion among the communities themselves.
 The non-material contribution of benefits by way of empowerment of local
communities deserves to be noted, but several more such benefits could
have been considered. For instance health check-ups for the local
communities were urgently needed given the very poor health condition of
many women, children and also some male adults.
 The objective of the Kani Samudaya Kshema Trust to establish a
biodiversity register to document the knowledge base of the Kanis must be
pursued with the intellectual property implications of such a register in
mind. Intellectual property questions to be resolved for the creation of
such a register include who operates the register, who provides access to
its contents to which parties on what terms, who conducts documentation
of the knowledge, who has the right to authorise documentation on behalf
of the tribes, which knowledge elements will be documented in which
format, how to deal with local language documentation in relation to
national and international use of the register etc.
 In order to meet the demand of regular supply of plant to the
manufacturing unit, it needs to be grown in large quantities. Since, it is a
shade loving plant, it has to be cultivated as an understorey vegetation of
trees in the forests. Local tribals have been encouraged to take up
cultivation of “Arogyapacha” with the active cooperation of Integrated
Rural Development Programme (IRDP) and Forest Department.
Cultivation of these plants provides protection to the associated tree
species, in addition to securing economic uplift of the tribal people in terms
of employment and additional income. Thus modern economic working of
the local knowledge and use of plants leads to conservation of the plant
species as well as its associates. This case study clearly establishes that
conservation and sustainable utilization are dependent on long-term
benefits. It illustrates the point that sharing of benefits leads to
conservation and sustainable utilization of biological resources.

Future outlook

Benefit sharing can take financial, conservation, social and scientific forms
and must be decided during the prior informed consent process, before any
bioprospecting permits are issued. As case studies demonstrate, opportunities
for financial compensation include up-front payments and medium term benefit
sharing as research progresses. Many companies offer stakes in equity, profit
sharing and joint ventures opportunities. Royalties occur only if and when a drug
is marketed, but it is risky to rely only on resources that may never materialize.

Case studies also illustrated how cultural, environmental and biodiversity
conservation can be accomplished, with careful planning. Acknowledging the
contribution of healers supplies proof of the continuation of a traditional
profession. It promises an economic future from preservation of the cultural
patrimony by which healers train and pass on their heritage to future generation
of practitioners.
Bioprospecting is a complex and long – term undertaking. Supportive
macropolicies tied to an integrated programme for biological research, business
development and technology transfer can link biodiversity and biological resource
users in modern bioprospecting. This new breed of research and development
ultimately depends on implementation of adequate frameworks, good
coordination, multisectoral collaboration.
The economic impact of bioprospecting should not be overestimated.
Bioprospecting can only complement other activities designed to advance human
development and therefore cannot solve conservation and development issues in
and by itself. It is important that complemented by science and technology,
bioprospecting can work together with other tools to improve national capacities,
support economic growth and generate financial income to conservation
activities.
Collecting bioresources, extracting and testing their constituents (either
chemicals or genes) for biological activity, and further developing a product is
long and expensive process, with high opportunities for failure as well as success
(Reid et al 1993).It is estimated that only 1 in 10,000 samples show promising
activity; only 10 percent of those may go to clinical trials, and only 10 percent of
those are likely to reach market. The time and cost of developing new medicines
is up to 15 years and about $500-600 million per product (Thayer 1998 a). On the
other hand , bioprospecting requires careful design and strategic planning in
order to maximize nondestructive uses. At the same time it encourages the
investment benefits for the acquisition of knowledge and the improvement
biodiversity conservation and management. These factors present significant and
immediate challenges to countries and institutions implementing bioprospecting
programmes. Clear procedures will substantially reduce risks of those interested
in conducting research into development of natural resources.
3 Biotechnology, Intellectual Property Rights, Biodiversity &
Traditional Knowledge

IPRs for biotechnological inventions raise related but quite distinct sets of
issues concerning equity. Northern firms are accused of pirating and patenting
biological material and traditional knowledge from the gene-rich developing world
for profit, without fair and equitable sharing of benefits or the appropriate transfer
of the new technologies as called for by the Convention on Biological Diversity
(CBD). The link to IPRs arises from the fact that in many instances, the
bioprospectors or their licensees are granted patent rights over these products,
without any acknowledgement of the contribution of countries/regions of origin or
of indigenous communities ( Watal 2000).

Advances in biotechnology and their commercial applications have raised
a variety of difficult issues, including the morality of patents relating to life-forms
and the lack of legal protection for biodiversity and traditional knowledge that
may contribute to an invention. Controversy around the nature and role of
patents grows from a number of sources. There are genuine philosophical
objections to granting monopolies on the uses and products of biodiversity by
some. Similarly, there are concerns that the scope of biotechnology patents is
expanding with potentially negative impacts such as the hindering of future
research. Others argue that there is an unjust imbalance between the expansive
patent rights available for biotechnological inventions and the lack of incentives
available to those conserving biodiversity and associated traditional knowledge
that may serve as an important resource enabling those inventions (Rosenthal et
al 1999)

A general perception that gained currency in developing countries has
been that patents on technological advances derived from the study of biological
organisms represent unfair expropriation of the rights of source countries and
communities. It is, in part, to provide for and define this protection that the ICBGs
and other modern bioprospecting ventures have relied on contractual
agreements, frequently referred to Access and Benefit Sharing Agreements.
These agreements typically define, among other things, the objectives of the
partnership, terms of material transfer, the rights and responsibilities of the
collaborating organizations, and the types and amounts of benefits to be shared.

Perhaps even more complex than the rights over biological materials and
their products is the contribution of traditional knowledge to the invention
process. Significant anxiety exists among traditional peoples and others that
even when benefits are defined, patents relating to such knowledge may rob
these people of credit for their innovations and infringe on their ability to carry out
traditional practices and make innovations based on that knowledge. There is a
need to formally recognize the value of this knowledge, protect the rights of the
providers, and compensate them for the use of the information. The policy of the
any bioprospecting programme should be that when traditional ethnomedical
knowledge is involved in a patentable invention, if the traditional knowledge
provider cannot be recognized as an inventor, the contribution should be treated
as valuable ‘know how’ and the contribution should be credited in any related
publications and in the patent as prior art, and the providers should be
compensated for their contributions, as appropriate. Prior art citations formalize
the contribution of such knowledge but do not claim any monopoly rights to its
use. The absence of important prior art citations may constitute grounds to deny
or invalidate a patent.

4. India`s legislation on biodiversity

India has been in the process of formulating a legislation on biodiversity
since 1994, when India became a Party to the Convention. Extensive,
transparent and participative consultations were held with eminent experts,
NGOs, different departments of Central Government and State Governments.
The biological diversity legislation introduced in the Parliament is an outcome of
extensive and intensive consultation process involving all stakeholders.

Salient features of the biodiversity legislation are as follows:

- The legislation primarily addresses the issue concerning access to genetic
resources and associated knowledge by individuals, institutions or companies,
and equitable sharing of benefit arising out of the use of these resources and
knowledge to the country and the people.

- The legislation provides for setting up of a three tiered structure at
national, state and local levels.
The National Biodiversity Authority will deal with matters relating to
requests for access by foreign individuals, institutions or companies, and
all matters relating to transfer of results of research to any foreigner;
imposition of terms and conditions to secure equitable sharing of benefits
and approval for seeking any form of Intellectual Property Rights (IPRs) in
or outside India for an invention based on research or information
pertaining to a biological resource obtained from India.
State Biodiversity Boards will deal with matters relating to access by
Indians for commercial purposes and restrict any activity which violates
the objectives of conservation, sustainable use and equitable sharing of
benefits.
Biodiversity Management Committees will be set up by institutions of self-
government in their respective areas for conservation, sustainable use,
documentation of biodiversity and chronicling of knowledge relating to
biodiversity. Biodiversity Management Committees shall be consulted by
the National Biodiversity Authority and State Biodiversity Boards on
matters related to use of biological resources and associated knowledge
within their jurisdiction.
- All foreign nationals/organisations require prior approval of NBA for
obtaining biological resources and/or associated knowledge for any use. Indian
individuals/entities require approval of NBA for transferring results of research
with respect to any biological resource to foreign nationals/organisations. Indian
citizens and organisations are required to give prior intimation to the concerned
SBB about obtaining any biological resource for commercial use, and the SBB
may prohibit or restrict the activity if found to violate the objectives of
conservation, sustainable use and benefit sharing. However, local people and
communities of the area, including vaids and hakims to have free access to use
biological resources within the country. While granting approvals for access, NBA
will impose terms and conditions so as to secure equitable sharing of benefits.
These benefits interalia include:
 grant of joint ownership of intellectual property rights to the National
Biodiversity Authority, or where benefit claimers are identified, to
such benefit claimers;
 transfer of technology;
 location of production, research and development units in such
areas which will facilitate better living standards to the benefit
claimers;
 association of Indian scientists, benefit claimers and the local
people with research and development in biological resources and
bio-survey and bio-utilization;
 setting up of venture capital fund for aiding the cause of benefit
claimers;
 payment of monetary compensation and other non-monetary
benefits to the benefit claimers as the National Biodiversity
Authority may deem fit.
- The legislation provides for setting up of biodiversity funds at central, state
and local levels. Benefits will be given directly to individuals or group of
individuals only in cases where biological resources or knowledge are accessed
directly from them. In all other cases, monetary benefits will be deposited in the
Biodiversity Fund which in turn is used for the conservation and development of
biological resources and socio-economic development of areas from where
resources have been accessed.
- Before applying for any form of IPRs in or outside India for an invention
based on research or information on a biological resource obtained from India,
prior approval of NBA will be required. The NBA while granting the approval
impose benefit sharing fee or royalty or both or impose conditions including the
sharing of financial benefits arising out of the commercial utilisation of such
rights.

5. TRIPS, Biodiversity and Patent issues

In the recent past, there have been several cases of biopiracy of
Traditional Knowledge from India. First it was the patent on wound healing
properties of haldi (turmeric), now patents have been obtained in other countries
on hypoglyceimic properties of karela (bitter gourd), brinjal etc. An important
criticism in this context relates to foreigners obtaining patents based on Indian
biological materials. There is also the view that the TRIPS Agreement is aiding
the exploitation of biodiversity by privatizing biodiversity expressed in life forms
and knowledge.

Patents are granted under national patent laws and have territorial
application only. The TRIPS Agreement provides minimum standards of
protection for intellectual property rights including patents, while WTO Members
are free to grant a higher level of protection under their national laws. Thus, India
is free to deny patents on life forms, except on microorganisms and
microbiological and non-biological processes, as per the provisions of the TRIPS
Agreement. At the same time if, for example, USA chooses to grant patents on
plants or other life forms, we can not object. Nevertheless, such patents will have
force only in USA and can not be enforced in India.

To assess the WTO compatibility of a patent granted by a foreign patent
office to an invention based on biological material obtained from India, we need
to check whether the criteria of patentability (novelty, non-obviousness and
usefulness) are satisfied, and to challenge it where the criteria are not met. A
patent granted in USA on the wound healing properties of turmeric, for example,
was got revoked after such an examination.. The exercise could be extended to
other such patents also. Another possibility, like in the basmati case, is that a
geographical indication specific to India may be subject to misuse abroad. In
such cases, the affected parties (like exporters of basmati rice) could take up the
matter in courts abroad for restraining companies abroad from such misuse. This
has been done, for example, by successfully challenging some trademark
registrations in UK and other countries.

The problem of bio-piracy may not be resolved with such revocation
actions and domestic biodiversity legislation alone. There is a need to provide
appropriate legal and institutional means for recognizing the rights of tribal
communities on their traditional knowledge based on biological resources at the
international level. There is also a need institute mechanisms for sharing of
benefits arising out of the commercial exploitation of biological resources using
such traditional knowledge. This can be done by harmonising the different
approaches of the Convention on Biological Diversity on the one hand and the
TRIPS Agreement on the other as the former recognizes sovereign rights of
States over their biological resources and the latter treats intellectual property as
a private right. India has proposed, in this context, that patent applicants should
be required to disclose the source of origin of the biological material utilized in
their invention under the TRIPS Agreement and should also be required to obtain
prior informed consent of the country of origin. If this is done, it would enable
domestic institutional mechanisms to ensure sharing of benefits of such
commercial utilization by the patent holders with the indigenous communities
whose traditional knowledge has been used. The proposal has not met with
success in the WTO yet, but efforts are on to forge a consensus on the issue.
Simultaneously, provisions have been introduced for disclosure of the source of
biological material and obtaining prior informed consent for access to such
material in the amendments proposed to the Patents Act 1970 through the
Patents (Second Amendment) Bill 1999.

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