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Protection of Other Industrial Property

UNIT 8 BIODIVERSITY AND THE INDIAN LAW


Structure
8.1 8.2 8.3 8.4 8.5 8.6 8.7 8.8 8.9 8.10 8.11 8.12 8.13 8.14 Introduction
Objectives

Biodiversity Intellectual Property Rights (IPRs) and Biodiversity Bioprospecting and Biopiracy Legal Frameworks Relating to IPR and Biodiversity The Biological Diversity Act, 2002 Access and Benefit Sharing (ABS) Other Initiatives to Protect Biodiversity in India Impacts of IPR on Biodiversity Current Debate Summary Terminal Questions Answers and Hints Further Readings

8.1

INTRODUCTION

The most striking feature of the Earth is the existence of life, and the most striking feature of life is its diversity. Biodiversity refers to the variability amongst the species, populations, communities and ecosystems, both wild and domesticated, that constitute life of an area or eventually of the entire planet. It occurs at three levels, viz. i) species level which refers to number and kinds of living organisms; ii) genetic level referring to the genetic variation within a population of species; and iii) eco-system level which refers to the variety of habitats, biological communities and ecological processes that occur in such habitats. Biodiversity has long been a source of scientific curiosity, but in recent days it is increasingly becoming a source of concern. Human domination of Earths ecosystems is markedly reducing the diversity of species within many habitats worldwide. Biodiversity is the basis of the process of improving the productivity of plants, animals, fish and all living organisms. It provides the feedstock to the biotechnology industry. While the developing world (referred to as the South) is the home of much global biodiversity, the industrialised world (referred to as the North) is the home of most of the biological technologies essential for converting biological diversity into economic wealth. Issues of biodiversity have different impacts in the developed and the developing world. Though fabulously rich in biodiversity, India had no specific biodiversity law to safeguard biodiversity as national property against unauthorized exploitation, before the Indian Parliament enacted the Biological Diversity Act, 2002, which received the assent of the President of India on February 5, 2003. We will refer to it as the BDA, or the Act, in the following text. However, the Indian Patent Act, and the Protection of Plant Varieties and Farmers Rights Act, had been enacted in 2001 have some provisions bearing on the subject. Objectives After studying this unit, you should be able to:
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define the biodiversity; enumerate the contentious issues related to IPR in the commercial exploitation of biodiversity; justify the requirement of a specific law to address these issues;

describe the international legal framework for protection and regulation of biodiversity; and explain the provisions of the Indian law relating to biodiversity.

Biodiversity and the Indian Law

8.2

BIODIVERSITY

The Act defines biodiversity and biological resources as follows: Biological Diversity means the variability among living organisms from all sources and the ecological complexes of which they are part and includes diversity with species or between species and of ecosystems. Biological Resources means plants, animals and micro-organisms or parts thereof, their genetic material and by products (excluding value added products) with actual or potential use or value but does not include human genetic material. Biodiversity is not evenly distributed over different parts of the world. India is one of the twelve mega biodiversity countries in the world, which attracts international business players to exploit the countrys rich and enormous biodiversity. India is having two biodiversity hotspots, namely the Western Ghats and the Eastern Himalayas, which are included amongst the top eight most important hotspots in the world, ten bio-geographic regions; two major realms called the palaeoarctic and the Indo-Malayan; and three biomasses, namely the tropical humid forests, tropical dry/deciduous forests and the warm deserts and semi-deserts. India has 850 species of bacteria, 14,500 species of fungi, 6,500 species of algae, 2000 species of lichens, 2,850 species of bryophytes, 1100 species of pteridophytes The endemism of Indian biodiversity is high. About 33% of the country's recorded flora are endemic to the country and are concentrated mainly in the North-East, Western Ghats, North-West Himalaya and the Andaman and Nicobar islands. As many as 167 species of crops, 320 species of wild crop relatives, and several species of domesticated animals have originated here. The genetic diversity within these species is astounding. For example, there are 4,000 varieties of Rice, hundreds of varieties of Mango, 27 breeds of Cattle and 18 breeds of poultry. This amazing biodiversity is not a freak of nature, but a result of careful selection and even crossbreeding over centuries by Indias farmers and pastoralists. In crops diversity maintains soil fertility, optimizes soil management in rainfed belts, acts as insurance against crop failure, ensures food security, provides a variety of fodder and assures availability of seeds besides acting as a treasure chest of potentially valuable but as yet unknown resources. Thus plant genetic diversity, both at intraspecies and inter-species levels, is a crucially important part of farming systems and farming economy. SAQ 1 Mark the following statements as True (T) or False (F): a) Biodiversity encompasses diversity at all the three levels: Species, genetic and eco-system b) The countries of the North are rich in biodiversity. c) Biodiversity is more or less uniformly distributed over the globe. d) The Western Ghats and the Eastern Himalayas in India are two of the eight topmost hot spots of the world with respect to biodiversity. Spend 5 min.

Endemic species are confined to a particular region or area.

8.3

INTELLECTUAL PROPERTY RIGHTS (IPRs) AND BIODIVERSITY


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Plants, animals, and other organisms become economically useful to humans when their uses are known. Indigenous people are the source of virtually all our knowledge

Protection of Other Industrial Property

about the uses of the plants and animals, and even of the micro-organisms in their localities. This traditional knowledge about the usage of biological resources has been unethically accessed by many vested interest groups to the detriment of indigenous communities of the South. This has left the original holders and curators of biodiversity with the feeling of having been deceived and exploited. It is now protected as an intellectual property in the form of farmers and plant breeders rights. In many countries patents are granted for plant varieties, micro-organisms and genetically modified animals. You know that, apart from the usual criteria of patentability, namely, novelty, non-obviousness, and utility, patenting of microorganisms has an additional requirement, viz. deposition of micro-organism in an internationally recognized depository authority for patent purposes. Traditional Knowledge, IPR and Biodiversity There is an abundance of local expertise in plant genetic resources that has been in use over a considerable period of time and is still evolving. In agriculture, for instance, this knowledge is shown in the development and adaptation of plants and crops to different ecological conditions (soils, rainfall, temperature, altitude etc.). Traditional knowledge (TK) is peoples awareness and understanding of this and other information, and the life technologies local communities have evolved, besides other cultural products which is passed on from one generation to the next, usually by word of mouth or example within a specified group of people. TK evolved under a totally different set of values and motives than the modern knowledge; the concepts of intellectual property with its monopolistic overtones is totally alien to TK. Traditional knowledge provides useful leads for scientific research, being the key to identifying those elements in a plant with a pharmacological value that is ultimately destined for the international markets. Ironically the very knowledge that forms much of the basis of modern scientific research and development is not regarded as a science. Industry gets the rights and the profits; local communities are merely used as providers of raw materials. For several reasons TK cannot be protected by patents or other instruments of intellectual property, as you will learn in detail in the course on Contemporary Intellectual Property Issues (MIP-008). It is through IPR, and particularly patents, that commercial interests are taking over control and ownership of traditional knowledge. In the patent system, a patent can only be granted if an invention is novel or non-obvious. Novelty and non-obviousness are judged against everything publicly known before the invention, as shown in earlier patents and other published material. This body of public knowledge is called prior art. Prior art means any disclosure of the contents of a claim, prior to the application for patent. Some national laws do not recognise oral knowledge as evidence of prior art. The United States regards oral disclosures as prior art only if they were made in the US. Thus, a therapeutic technique orally handed down from one generation to another by a tribe in India can still be patented in the US, despite it being publicly known for many years. This is why western-styled patent systems are inherently incapable of recognizing the existence of, or providing protection to, traditional knowledge of other countries. Another dimension of the problem is that access and benefit sharing (ABS) arrangements the first step that many governments take to supposedly rectify imbalances are being premised on IPRs, despite the unsuitability of the latter to biodiversity and related traditional knowledge. Transgenics and Biodiversity With the advent of techniques of genetic engineering in the early seventies, the natural barrier to gene exchange has been removed. Sequences from varied sources like bacteria, viruses and eukaryotic systems can be transferred to plants to develop transgenic crop varieties. Thus Genetically Modified Organisms (GMO) are the creations of modern biotechnology in which the genetic make up or genotype of an organism is so engineered by man as to include or exclude certain phenotypes (physical traits or manifestations) for a desired effect.

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The ability to isolate and clone genes, coupled with the development of reliable techniques for introducing genes into plants, has opened a new route to genetic improvements of plants that circumvent the limitations of conventional breeding methods. Once a useful gene is isolated, it can be transferred to many different crops without a lengthy breeding program. Useful traits such as resistance to herbicides and diseases have been identified and gene transfer has produced herbicide-resistant and disease-resistant plants. Moreover crops with improved nutritional quality, heat, stress and salt resistance have been made. The global value of the GM crop market is projected at $5 billion or more in coming years. Genetic Use Restriction Technology (GURT) and Biodiversity Terminator technology is also referred to more generally as Genetic Use Restriction Technology (GURT), or by the industry as a Technology Protection System. It involves the insertion of various gene-switching mechanisms to control the life cycle of a plant or to ensure that any seed saved after harvest will not germinate. For the plant breeders, terminator technology is far more powerful tool than monopoly patents. Exploited in this manner intellectual property becomes a tool of deprivation in the developing countries as the farmers cannot save seed. Besides the implications of such biotechnology for seed sovereignty and seed security, it harms biodiversity. India has taken a lead by introducing legislation to outlaw terminator seeds. The Consultative Group on International Agricultural Research (CGIAR) has promised not to incorporate these terminator technologies on their crop-breeding programme due to its effect on sustainable agriculture. SAQ 2 What difficulties are encountered in patenting traditional knowledge related to plants? Spend 2 min.

Biodiversity and the Indian Law

8.4

BIOPROSPECTING AND BIOPIRACY

Biodiversity prospecting is the exploration, extraction and screening of biological diversity and indigenous knowledge for commercially valuable genetic and biochemical resources. While it is true that biodiversity prospecting does not always involve the use of indigenous knowledge, it is clear that valuable chemical compounds derived from plants, animals and micro-organisms are more easily identified and are of greatest commercial value when collected with indigenous knowledge and/or found in territories traditionally inhabited by indigenous peoples. Between 1956 and 1976 the U.S. National Cancer Institute screened over 35,000 plants and animals for anti-cancer compounds. The program was terminated in 1981 because of its failure to identify a greater number of new anti-cancer agents. A retrospective study conducted on the project concluded that the success rate in finding valuable species could have been doubled if medicinal folk knowledge had been the only information used to target species. Similarly in another instance scientists found that 86 percent of the plants used by Samoan healers displayed significant biological activity when tested in the laboratory. Biopiracy can be defined as the stealing of knowledge from traditional and indigenous communities or individuals. The term can also be used to suggest a breach of a contractual agreement on the access and use of traditional knowledge to the detriment of the provider and bioprospecting without the consent of the local communities. The Action Group on Erosion, Technology and Concentration [ETC group, Canada (former RAFI)] defines it as the appropriation of the knowledge and genetic resources of farming and indigenous communities by individuals or institutions seeking exclusive monopoly control (usually patents or plant breeders rights) over these resources and knowledge.
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Protection of Other Industrial Property

There is a distinct difference between biopiracy and bioprospecting. The term biopiracy describes the unauthorized and uncompensated taking and use of biological resources. In contrast, bioprospecting refers to the search for valuable active chemical compounds in nature, and involves accessing natural resources through legal means, securing prior informed consent from the custodians of the relevant natural resources and promoting equitable benefit sharing agreements with appropriate parties. Biopiracy deprives not only the custodians of biological resources but also the country concerned. The modus operandi of the MNCs has been to collect the plant varieties and their germplasms from poor countries in order to cross-breed them with other varieties, and claim that they had invented something novel, non-obvious and of practical use (which are the requirements for acquiring patent rights), and then to patent them in their own countries or in any other country of their choice. Thus even though India is rich in biodiversity and has a rich biodiversity related intellectual heritage, biopiracy directs this wealth away from India and denies us our rights to use our resources and knowledge, for our needs and our economic benefits.

8.5

LEGAL FRAMEWORKS RELATING TO IPR AND BIODIVERSITY

India, in making its Acts on biodiversity (and protection of plant varieties and the rights of the farmers and the breeders) has had the benefit of extensive discussions and agreements relating to conservation and protection of biodiversity and plant varieties that preceded it at international level. Major treaties and agreement on the subject are Convention on Biological Diversity (CBD, 1993), the Agreement on Trade Related Aspects of Intellectual Property Rights (TRIPS, 1994), the International Union for the Protection of New Varieties of Plants (UPOV, 1961, revised 1978, 1991), the International Treaty on Plant Genetic Resources for Food and Agriculture (PGRFA Treaty, 2001), the Budapest Treaty on the International Recognition of the Deposit of the Micro-organisms for the Purposes of Patent Procedures (1980), the Bonn Guidelines on Access to Genetic Resources and Fair and Equitable Sharing of the Benefits Arising from their Utilization (2001), and the Inter Governmental Committee on Intellectual Property and Genetic Resources, Traditional Knowledge and Folk Lore. Of particular relevance here is the Convention on Biological Diversity (CBD), which assured the sovereign rights of national over their national resources and right to determine accesses according to national legislation with the aim of facilitating the sustainable use of these resources, promoting accesses and their common cause. It notes that the accesses to genetic resources should be on the basis of prior informed consent and on the mutually agreed terms that ensure fare and equitable sharing of the results of R&D and the benefits of commercial utilization of these results. It also calls for fare and equitable sharing of the benefits derived from the use of traditional knowledge. National Legal Frameworks and Efforts India has taken different kinds of commitments in the field of biodiversity and its management. These include a series of obligations concerning the conservation and sustainable use of biological resources as well as commitments concerning the protection of traditional knowledge and farmers rights and a series of obligations in the field of intellectual property rights regarding the commercial uses of the biological resources. Indian Patent Act, 1970 The Patent Act deals with patents in general and was not specifically related to biological resources. However, it addressed a number of issues that are of relevance in

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the context of biodiversity management. It rejected, for instance, the patentability of all methods of agriculture and was generally much more restrictive than similar laws in western countries. As a signatory to WTO, India is bound to meet the obligation of the TRIPS Agreement which states that the micro-organisms, and non-biological and microbiological processes have to be eligible for patents. Accordingly in the Patents Act, the scope of patentable inventions widens to include micro-organisms. The duration of the term of patent has been extended to 20 years for all process and product patents. The scope of the chemical process is extended to include biochemical, biotechnological, and microbiological processes. The manner of disclosure of the contents of the inventions relating to biotechnological products and processes involving micro-organisms mandates deposit of biological material (micro-organisms) with an approved depository institution and with information on its specifications, including the name and address of the depository institution, number and date of deposit and detailed characteristics and source and origin of the biological material (micro-organisms) to be made on or before the date of the patent application in India. Also, opposition to grant of patent can be made on the ground that the complete specification does not disclose or wrongly mentions the source or geographical origin of biological material used for the invention; another ground for opposition is that the invention so far as claimed in any claim of the complete specification is anticipated having regard to the knowledge, oral or otherwise, available within any local or indigenous community in India or elsewhere. Budapest Treaty and India India has joined the Budapest Treaty as 53rd member on December 17, 2001. Indias Patents (Amendment) Act, 2002 makes micro-organisms patentable in India. The thirty five International Depository Authorities (IDA) worldwide include the Institute of Microbial Technology (IMTech), Chandigarh, India. SAQ 3 What is CBD? What are the two main principles it propounds? Spend 2 min.

Biodiversity and the Indian Law

8.6

THE BIOLOGICAL DIVERSITY ACT, 2002

The Biological Diversity Act, 2002 (BDA) of India received the assent of the President on the February 5, 2003. The BDA complies with the Convention of Biological Diversity (CBD) 1993, to which India is a party. It provides for conservation of biological diversity, sustainable use of its components and fair and equitable sharing of the benefits arising out of the use of biological resources, knowledge and for matters connected therewith incidental thereto. The same objectives are spelt out in the CBD. It has other objectives also, like: Regulating access to biological resources; Respecting and protecting knowledge of local communities; Protection and rehabilitation of threatened species; and Involving self-government institutions in implementation.

The BDA defines biological resources and biological diversity (Refer Sec. 8.2). Other terms as defined in the Act include the following: Benefit claimers means the conservers of biological resources, their byproducts, creators, and holders of knowledge and information relating to the use
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Protection of Other Industrial Property

of such biological resources, innovations and practices associated with such use and application. Bio-survey and bio-utilization means survey or collection of species, subspecies, genes, components and extracts of biological resource for any purpose and includes characterization, inventorisation and bioassay. Fair and equitable benefit sharing means sharing of benefits as determined by the National Biodiversity Authority, (NBA established under the BDA). Sustainable Use means the use of components of biological diversity in such manner and at such rate that does not lead to the long term decline of the biological diversity thereby maintaining its potential to meet the needs and aspirations of present and future generations. Value added products means products which may contain portions or extracts of plants and animals in unrecognizable and physically inseparable form.

Regulation of Access to Biological Diversity The BDA debars certain categories of persons from obtaining, without previous approval of the NBA, any biological resource occurring in India or knowledge associated thereto for research or for commercial utilization or for bio-survey and bioutilization. Such categories of persons are: Persons who are not citizens of India; Persons who are Indian citizens, but non-resident as defined in the Income Tax Act, 1961; and A body corporate, association or organization, which is not incorporated or registered in India, or incorporated or registered in India but which has any non-Indian participation in its share capital or management.

Similarly the results of any research relating to any biological resources occurring in, or obtained from India can not be passed on, without the previous approval of the NBA, to a person who is not a citizen of India or to an NRI, or a body corporate or organization which is not registered or incorporated in India or which has non-Indian participation in its share capital or management. However, the aforesaid prohibitions do not apply to collaborative research projects involving transfer or exchange of biological resources or information relating thereto between institutions, if the projects conform to policy guidelines of the Central Government or have been approved by it. It is necessary to obtain prior approval of the NBA if an application is to be filed for any IP rights, in India or outside, for any invention based on any research or information on a biological resource obtained from India. However, if a person applies for a patent, permission of the NBA may be obtained after the acceptance of the patent application but before the sealing of a patent. The NBA is required to dispose of the application for permission within ninety days of its receipt; it may impose benefit sharing fee or royalty or both or impose conditions including the sharing of financial benefits arising out of the commercial utilization of such rights. However, these provisions do not apply to a person who makes an application for any right under any law relating to protection of plant varieties enacted by parliament. Permission of State Biodiversity Board (SBD) is needed before an Indian citizen, or a body corporate etc. registered in India can obtain any biological resource or take up bio-survey for commercial utilization. But this shall not apply to the local people and
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communities including growers and cultivators of biodiversity and vaids and hakims who have been practicing indigenous medicine. National Biodiversity Authority Under the BDA the Central Government has to establish National Biodiversity Authority (NBA) by notification in the Official Gazette, with its head office at Chennai. Similarly, at the level of states, state biodiversity Boards (ABBs) will be established. The functions and powers of the NBA include: i) to regulate activities with regard to - access to biodiversity; - transferring the results of research relating to any biological resources occurring in, or obtained from India to a person who is not a citizen of India, or to an NRI, or to a body corporate/organization which is not registered or not incorporated in India or which has any non-Indian participation in its share capital or management; - approval of NBA for filing applications for IPRs for inventions based on research or information on a biological resource obtained from India. ii) Advise the Central Government on matters relating to the conservation of biodiversity and sustainable use of the components of biological resources; Advise the State Governments in the selection and management of heritage sites; Perform such other actions as may be necessary to carry out provisions of the BDA.

Biodiversity and the Indian Law

iii) While granting approval to any activity under (i) above, the NBA shall secure sharing of benefits arising out of the use of accessed biological resources, their by-products, innovations and practices associated with their use and applications and knowledge in accordance with mutually agreed terms and conditions between the applicant for the approval, local bodies concerned and the benefit claimers. The Act mandates constitution of a National Biodiversity Fund (NBF) which shall be used for: channeling benefits to benefit claimers; conservation and promotion of biological resources and development of areas from where such resources or associated knowledge has been accessed; and socio-economic development of these areas.

State Biodiversity Board (SBB) The State Government shall constitute a Biodiversity Board for the State. However, the National Biodiversity Authority shall exercise the power and perform the function of a State Biodiversity Board for a Union Territory. The SBB shall consist of a Chairperson who will be an eminent person having adequate knowledge and experience in the conservation and sustainable use of biological diversity and in matters relating to equitable sharing of benefits. Besides the Chairperson the State Government shall also appoint not more than five ex-officio members to represent the concerned Departments of the State Government and not more than five expert members. The functions of the SBB shall be as follows: to advise the State Government subject to any guidelines issued by the Central Government on matters relating to the conservation of biodiversity, sustainable use and equitable sharing of benefits;
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Protection of Other Industrial Property

to regulate requests for commercial utilization or bio-survey and bio-utilization by Indians; to perform such other function as may be necessary or as may be prescribed by the State Government.

Similar to NBF, State Biodiversity Funds, (SBFs) will be constituted at the state level. The SBF shall be used for the management and conservation of heritage sites, compensation to and rehabilitation of people economically affected by government notification of biodiversity heritage sites, conservation and promotion of biological resources and socio-economic development of relevant areas from where bio-resource and associated knowledge are acquired. Duties of Central and the State Government The BDA requires the Central Government to develop national strategies, plans, programmes for the conservation, promotion and sustainable use of biological diversity. If an area rich in biodiversity, bio-resources and their habitats is under threat from over-use, abuse or neglect, the Central Government is obliged to issue directives to the concerned state to take immediate ameliorative measures offering it technical or other assistance, as may be possible or required. The Central Government shall, as far as practicable and deemed appropriate, integrate the conservation, promotion and sustainable use of biological diversity into sectoral plans, programmes and policies. The Central Government shall take measures, where necessary, to assess environmental impact of projects which may adversely affect biodiversity, with public participation, where appropriate. It shall also undertake measures to regulate, manage and control the risks associated with the use or release of living modified organisms. The Central Government shall endeavour to respect and protect the knowledge of local people relating to biodiversity. The measures may include registration of such knowledge and sui generis system for protection. The State Governments may, in consultation with the local bodies, notify areas of biodiversity importance as biodiversity heritage sites, and frame, in consultation with the Central Government, rules for management and conservation of all heritage sites. They shall also frame schemes for compensating or rehabilitating people affected by such notification. The Central Government in consultation with the State Government may notify any species, which are on the verge of extinction or may become extinct in near future and take steps for their rehabilitation and preservation. Repositories The Central Government may in consultation with the NBA, designate certain institutions as repositories for different kinds of biological resources. Any new taxon discovered by any person has to be notified to a repository. The Central Government may exempt any item(s) including biological resources which are normally traded as commodities from the applicability of the BDA. Biodiversity Management Committees Every local body shall constitute a Biodiversity Management Committee (BMC) within its area for the purpose of promoting conservation, sustainable use and documentation of biological diversity. This includes preservation of habitats, conservation of land races, folk varieties and cultivars, domesticated stocks and breeds of animals and micro-organisms, and chronicling of knowledge relating to biodiversity.
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Cultivar has been defined as a variety of plant that has originated and persisted under cultivation or was specifically bred for the purpose of cultivation. Folk variety means a cultivated variety of plant that was developed, grown and exchanged informally among farmers. Land race means primitive cultivar that was grown by ancient farmers and their successors. There is provision in the BDA for constituting Local Biodiversity Fund (LBF). Settlement of Disputes In case of a dispute between the NBA and an SBB, any party may appeal to the Central Government. SAQ 4 What is meant by the following terms under the BDA, 2002: Sustainable Use; Biodiversity heritage site; cultivar. Objectives of the act In the preamble of the act it clearly states that it is intended to provide conservation of Biological diversity, sustainable use of its components and equitable sharing of the benefits arising out of the use of biological resources and for matters connected therewith or incidental thereto. Spend 2 min.

Biodiversity and the Indian Law

Safeguards and exemptions Free access to Indians to use biological resources within the country for research; Use of biological resources by vaids and hakims; and Traditional knowledge to be protected.

Authorities The Act establishes the following authorities: National Biodiversity Authority (NBA) to deal with requests for access from foreigners; to grant approval for seeking IPRs in or outside India for any invention pertaining to biological resources obtained from India. State Biodiversity Boards (SBBs) to deal with matters relating to access by Indians for commercial purposes and restrict activities violating objectives of conservation, sustainable use and equitable sharing of benefits.

8.7

ACCESS AND BENEFIT SHARING (ABS)

When the United Nations Convention on Biological Diversity (CBD) entered legal force in late 1994, national sovereignty replaced the old Common Heritage of Mankind view of biodiversity. Overnight, animals, plants, micro-organisms and possibly even human genes were turned into a resource for governments to regulate and watch over. It was argued that one of the main advantages of this shift was that it would enable Southern countries, where most of the worlds biodiversity is found, to benefit more from these resources. One of the three central pillars of the Convention relates to benefit sharing: its very first article stipulates that the CBD will ensure the fair and equitable sharing of the benefits arising out of the utilisation of genetic resources. Almost without exception, benefit sharing examples focus on bilateral and contractual agreements, generally between some company or institute from an industrialised country interested in a resource or knowledge, and some country or community from

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Protection of Other Industrial Property

the South that can provide it. Benefit sharing is defined from the perspective of the bioprospector: how much money is paid, and whether other non-monetary benefits flow to the Provider. India is the member of CBD and it truly complied with the basic objectives of CBD for fair and equitable benefit sharing through the enactment of the Biodiversity Act, 2002. It clearly spelt out the various authorities (like National Biodiversity Authority or NBA and State Biodiversity Boards SBBs etc) for accessing biological resources and these authorities will also determine equitable benefit sharing to benefit claimers (i.e. the conservers of biological resources; creators and holders of knowledge and information relating to the use of biological resources, innovations and practices associated with such use and application.

8.8

OTHER INITIATIVES TO PROTECT BIODIVERSITY IN INDIA


The Council of Scientific and Industrial Research (CSIR), India, in early 1996, initiated action with the USPTO (the US Patent and Trade Mark Office), for the re-examination and revocation of the US patent granted on turmeric as a wound healing agent. After great efforts to dig up, compile and evaluate voluminous scientific data, garnered inter alia, from old literature in Indian languages, and marshalling legal opinion, India presented a convincing case to the USPTO. The patent was revoked in 1997. Recognising the widespread piracy of traditional knowledge of developing countries, CSIR in 1999 canvassed at diverse international fora for the inclusion of Traditional Knowledge (TK) in patent literature search. CSIR devised a novel Traditional Knowledge Resource Classification (TKRC) system to dovetail with the International Patent Classification (IPC) system. You will learn about this effort of CSIR in the unit on Protection of Traditional Knowledge in MIP-008 course. The Kerala government has decided to introduce legislation to protect the intellectual property rights of its tribal people who have been practising traditional Nature-based medicine for centuries. The bill, according to its preamble, is to provide for the determination, preservation, protection and improvement of the tribal traditional system related to medicine, agricultural practices and knowledge of wild flora and fauna used for food as well as shelter. NGOs (Non Governmental Organization) and institutions are attempting to document the knowledge, skills and techniques of local communities related to biological resources through the community (or peoples) Biodiversity Register, in the belief that such documentation would be deterrent to biopiracy and can be used as an instrument for fair and equitable benefit sharing. As for example villagers of Andhra Pradesh have prepared Biodiversity Register and re-affirming pride in traditional knowledge. The Foundation for Revitalisation of Local Health Traditions (FRLHT), a NGO has established Indian Medicinal Plants Genetic Resources Network (INMEDGERN) to coordinate conservation activities. In another initiative a community register is being developed in seven Indian states coordinated by the center for Participatory Management of Biodiversity, based at FRLHT and the Centre for Ecological Sciences (CES) of the Indian institute of Science (IISc, Bangolore). Moreover plant genetic wealth is being conserved in Indian National Gene Bank (NGB) at National Bureau of Plant Genetic Resources (NBPGR), New Delhi.

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8.9

IMPACTS OF IPR ON BIODIVERSITY

Biodiversity and the Indian Law

It is simply a tough task to offer an estimate of impacts of IPR on biodiversity. The benefits of genetic diversity are long term and rarely predictable. Humanity shares a common bowl containing only 20 cultivated crops that sustain 90% of our calorie requirements (FAO,1991). All 20 crops originate in developing countries. All are alarmingly vulnerable to pests and diseases and depend on genetic diversity for their continued survival. During this century, most authorities believe that an alarming proportion of the genetic variability of our major food plants as it is available in the field has become extinct. The conservation and development of the remaining crop diversity is a matter of vital global concern. When farmers look to increase their sale they often sow more commercially viable seeds. Sometimes various government schemes force them to adapt specific seeds or new plant varieties. Thus commercial agriculture tends to increase genetic uniformity and this, in turn leads to genetic erosion. IP system encourages commercial agriculture that accelerates genetic erosion. Biotechnology research focuses on commercial agriculture and leads to demand for IP protection with the same potentially negative consequences for genetic diversity. The criteria for awarding PVP (Plant Variety Protection) certificate involve lower thresholds than the standards required for patents. Similarly, the requirements for uniformity (and stability) in UPOV type systems exclude the local varieties developed by farmers that are more heterogeneous genetically, and less stable. But actually these are the characteristics that make them more adaptable and suited to the agro-ecological environments in which the majority of poor farmers live. Another concern is the criteria for uniformity. While proponents argue that PVP, by stimulating the production of new varieties, actually increases biodiversity but in reality requirement for uniformity, and the certification of essentially similar varieties of crops, will add to uniformity of crops and loss of biodiversity. Moreover similar concerns have arisen in respect of greater uniformity arising from the success of Green Revolution Varieties, leading to greater susceptibility to disease and loss of on-field biodiversity. In addition, the privatization of genetic resources that have been engineered and patented accelerates the trend toward monocultural cropping. Furthermore an engineered organism may produce unanticipated harmful impacts on other species in its new environment that may cause further erosion and ecological degradation. Improved seeds require more fertilizer and pesticide consumption, which has tremendous contribution towards biodiversity loss, and have direct impact on floral, faunal and microbial population. Moreover substantial royalties payment to the developed countries and multinational seed companies will greatly increase the debt burden that could further intensify the environmental and social disruption if we consider the debt repayment such as the export of natural products.

Reduction of genetic diversity is called genetic erosion.

8.10 CURRENT DEBATE


Several critical issues related with biodiversity and IPRs are still unresolved and go beyond the various international legal frameworks like TRIPS and CBD. These are outlined below: The differences between the developed and developing countries in the WTO, with regard to the question of patenting life remains unresolved. The Developing countries have opposed the patenting of life, and seek revision of article 27.3(b) to that effect. They also regard the provisions of TRIPS are inconsistent and in
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Protection of Other Industrial Property

contradiction with provisions of CBD and FAOs PGRFA Treaty in terms of protection of traditional knowledge and farmers rights. They propose that measures be taken to ensure that the TRIPS provisions are consistent with and supportive of these international obligations. The CBD asserts that the right to biological resources is a sovereign issue and at the same time CBD details how the nation should, by national legislation, provide for access to genetic resources, which is highly contradictory. CBD does not provide the exact mechanism of benefit sharing and the mandatory requirements of the agreement between the parties. In article 8(j), the convention emphasizes the requirement of prior informed consent but it does not specify it. It says nothing about the extent of information that should be provided by the multinationals to the community. Whether the community has complete knowledge about the possible commercial benefit that may be derived from the intellectual property (IP) protection of the multinationals is not clear from the text of the convention. CBD does not provide any right to the nation or people regarding biogenetic resources exchanged before 1992. The TRIPS Agreement does not recognise traditional knowledge while most of the biological resources are parts of traditional knowledge. It does not require mentioning of the source of biological material and associated traditional knowledge and any commitment for fair and equitable sharing of benefits with the country of origin or holders of traditional knowledge. The issue is, however, being debated amongst the member countries at the World Intellectual Property Organisation (WIPO), Geneva. Another basic problem relates to the philosophy of IPR regime, which is based on Western ethics and values. Questions are being raised as to why IPRs should be rewarded only on the basis of the ethics and values of western culture and market economics.

8.11 SUMMARY
Biodiversity refers to the totality of species, populations, communities and ecosystems. Human activity is reducing biodiversity. Developing countries are generally endowed with rich biodiversity; developed countries are rich in biotechnology that commercially exploits biodiversity. India is among the twelve maga biodiversity countries. Biodiversity sustains soil productivity, ensures food and fodder security and economic security. Difficulties are faced when existing IPR concepts are applied to traditional knowledge and biodiversity giving rise to complex issues like benefit sharing. The Biological Diversity Act, 2000, is concerned with conservation and sustainable use of biological resources and equitable sharing of the benefits arising out of the use of biological resources. The Traditional Knowledge Digital Library initiative is particularly noteworthy in the management of biodiversity treasure. Spend 15 min.

8.12 TERMINAL QUESTIONS

1. Define Biodiversity and Biological resources. How intellectual property rights (IPRs) are related with biodiversity?
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2. What is biopiracy? Give some examples of biopiracies from India. Do you think that biopiracy is different from bioprospecting? 3. Which international and national legal frameworks related with intellectual property rights (IPRs) have influenced biodiversity?

Biodiversity and the Indian Law

8.13 ANSWERS AND HINTS


Self Assessment Questions 1. i) T 2. Refer to Sec. 8.3 3. Refer to Sec. 8.5 4. Refer to Sec. 8.6 Terminal Questions 1. Biodiversity refers to the totality of species, populations, communities and ecosystems, both wild and domesticated that constitute the life of one area or on entire planet. Biological Resources means plants, animals and micro-organisms or parts thereof, their genetic material and by-products with actual or potential use or value. It does not include human genetic material. The relationship of biodiversity with intellectual property rights (IPRs) is multifaceted: Plant breeders rights Biopiracy of various biological resources. Misappropriation of traditional knowledge. Transgenics, Terminator technology and biodiversity. Impacts of IPRs on biodiversity. ii) F iii) F iv) T

2. Biopiracy can be defined as the misappropriation of knowledge from traditional and indigenous Communities or individuals. Examples: Plant biopiracy/ Animal biopiracy/microorganisms biopiracy Differences in between biopiracy and bioprospecting: Biodiversity prospecting is the exploration, extraction and screening of biological diversity and indigenous knowledge for commercially valuable genetic and biochemical resources. There can be ways to workout mutually benefiting arrangements in case of bio-prospecting. But Bio-piracy can be defined as the misappropriation of knowledge from traditional and indigenous Communities or individuals. 3. There are many international legal frameworks that influence the IPRs aspects of biodiversity. These are as follows: TRIPS CBD PGRFA Treaty UPOV Budapest Treaty

As a signatory of the international frameworks India is bound to comply with these agreements/treaties etc. Thus Indias legal frameworks have also attuned
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Protection of Other Industrial Property

with the international obligations. India has the following frameworks that influenced IPRs aspects of biodiversity: Indian Patent Act, 1970 and its amendments. Plant Variety Protection Act, 2001. Biodiversity Act, 2002.

8.14 FURTHER READINGS


1. Drahos, Peter & Blakeney, Michael (editors), IP in Biodiversity and Agriculture, (2001), Law Text Publishing. 2. Dutfield, Graham, Intellectual Property Rights, Trade and Biodiversity, (2002), Eathscan. 3. The Crucible Group, People, Plants, and Patents: The Impact of Intellectual Property on Trade, Plant Biodiversity, and Rural Society, (1994), IDRC. 4. Querol, Daniel, Genetic Resources: Our Forgotten Treasure, Third World Network and ZED books. 5. Correa M. Carlos, Implementing the TRIPS Agreement: General Context and Implications for Developing Countries, Third World Network.

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