Intellectual property refers to the right over properties which are creations of the human brain .i.e., intelligence. The owners of intellectual property rights are granted rights to certain intangible assets like music, painting, literature, inventions , symbols ,marks, sounds etc which are the result of the creation of the mind. These type of property are intangible in nature , which means the owner can use the property absolutely and nobody else can use it without the prior permission of the owner. And during the recent past developments have been taken place and in the realm of IPR s can be seen in the field of biotechnology , bio diversity and traditional knowledge . Patent law has been extended to the traditional knowledge of tribal population in the third world countries like human life, animals , plants , micro- organisms etc. There must be free access to these resources for the survival of mankind on the globe. The traditional knowledge is always associated with the biological resources, which is to be preserved and protected from outside agencies from being utilised at the cost of the possessor of such knowledge. This traditional knowledge cannot be separated from traditional people .Patent can also be claimed on traditional knowledge which are new, involves an inventive step and capable of industrial application. But in reality, it is difficult to fulfil as it is very difficult to identify the true inventor of traditional knowledge or the specific community to which it belongs.
The Convention on Biological Diversity (CBD) is the first international treaty that has come into force in December 1994 to recognise the important role of traditional knowledge. The convention states that traditional knowledge includes knowledge, innovations and practices of indigenous and local communities embodying traditional lifestyles important for conservation and sustainable use of bio diversity and promote the wider application with the approval and involvement of the holders of such knowledge, innovations and practices and encourage the equitable sharing of benefits arising from the utilisation of such knowledge innovations and practices.
India is country with vast agricultural and ethnic diversity .It is a hub of traditional knowledge and indigenous culture and ethnicity. There are various activities which are cultural or traditional based with some indigenous spirit, which can be validly called a part of traditional or indigenous knowledge.
The present legal regime n the field of traditional Knowledge is inadequate and incomplete. The reason for this that the tribal people are placed n the disadvantaged position and they are not in a position to enjoy benefit derived out of their traditional knowledge. As many of the traditional knowledge like medicinal plants, folk dance, handicrafts, their music , ceremonies and cultures are not documented , there s scope for pirating of these by others including multinational companies .These companies are making money by fully utilizing their knowledge without sharing the profit to them. Therefore, the government should take immediate measures to document all type of traditional knowledge possessed by the tribal people. If this is not done, then the big companies, at the cost of the tribal people, would conquer the intellectual property of the tribal population.
There must be adequate sharing of profit for utilizing the traditional knowledge for commercial purposes. Committees are to be constituted to promote and preserve Traditional Knowledge. There must be an involvement of indigenous and local communities in applying and utilizing their knowledge to the development of new products. Protection of bio diversity and TK is the inevitable task before the nations in the interest of mankind. There are many challenges before the third world countries.
The Agreement on Trade Related Aspects of Intellectual Property recognises the following categories of intellectual property:-Patents ,Trademarks ,Copyright, Geographical Indication, Undisclosed Information, Layout design of integrated circuits, Industrial designs.
The fact that traditional knowledge has not been covered under this agreement has raised a host of questions and controversies. There are staunch arguments for as well as against extending the protection provided in the existing seven categories of intellectual property to traditional knowledge. These arguments have mainly been moralistic or emotive in nature. The former focuses on the moral rights theory and that every person should reap the benefit of his labour or creativity. The developing countries have argued that their traditional knowledge has been the basis for the research leading to high-priced inventions, the benefit of which is reaped by developed nations. The developing and least developed countries feel that this knowledge is being plundered by the west and even more so because the developed nations have refused to recognise TK as an intellectual property. The latter argument focuses on the economic realities of the developing countries, with both developed and developing nations accusing the other of pirating information.
A patent is an exclusive right granted to a person who has invented a new and useful article or an improvement of an existing article or a new process of making an article, for a limited period. The essential point of overlap between patents and traditional knowledge, research has shown, is in the area of folk medicines. Folk medicines are not limited to the medicinal practices of indigenous people. They include knowledge of traditional cures, the curing properties of herbs, leaves, and other treatments not known hitherto to the rest of the world.
The trend of multinational corporations and developing countries has been to patent this traditional knowledge of local communities by developing them into medicines using their advanced technology and reaping the economic benefits thereof. This clearly puts the developing countries at a major disadvantage. There have been several known incidents which evidence the disadvantage caused to holders of traditional knowledge. The Ayahuasca is a traditional medicine central to the lives of the people in the Amazon basin. Loren Miller via The International Plant Medicine Corporation applied for a U.S patent to be recognised as the 'inventor' and the patent was granted. Similarly, in 1995 the US Patent Office granted a patent for turmeric, a substance used for cooking and healing in India. The Indian
Council for Scientific and Industrial Research (CSIR) opposed the application, proving that the healing properties of turmeric had been in use for thousands of years in India. The patent was, therefore, ultimately rejected.
Most traditional medicines do not qualify for patent protection. In the United States, an item has to be useful, novel and non-obvious to qualify as an invention. The US Patent Act specifies that the invention should not be obvious to one skilled in the art. TK does not qualify this test either. TRIPS adopts a similar approach: Article 27(1) of TRIPS details that patents shall be granted provided they are new, involve an inventive step, and are capable of industrial application. Traditional knowledge often fails to meet the novelty and non-obvious requirement of patent applications. Moreover, as TK is already a part of the public domain, it does not qualify the 'prior art' requirement of patents and is thus, not considered novel. In India, it is statutorily recognised that TK is not patentable.
Thus, we see that this category of intellectual property has proved insufficient to protect TK.
Geographical Indications help identify the place of origin of goods. Where a good is manufactured in a particular region or locality and it owes its quality, reputation and other characteristics largely to that region or locality, the good is eligible for protection under the law of Geographical Indications. For example, a trademark or a geographical indication can be an indicator for a particular tribe or indigenous group, thereby identifying the tribe or group to the consumer. Geographical indications are not author specific nor do they require an element of innovation. Like trademarks, they are meant to protect the producers or the manufacturers of goods. Geographical indications are also better for echoing the communal sense, as it is based on its location and method of production. Traditional Knowledge is usually held collectively by indigenous and local communities and GI can be suitably moulded to protect traditional knowledge. The Geographical Indications of Goods Act rewards efforts of Indigenous and local communities who have evolved their traditional methods over the centuries as long as the natural characteristics of that given product in the place of cultivation are maintained. Moreover, the rights under GI are community rights which easily fit with the collective holders of TK. Some famous examples of GI are Kolhapuri Chappal, Nagpuri Oranges, Darjeeling Tea and Bikaner Bhujia. For instance, use of the DARJEELING word and logo are protected as Geographical Indications in India and
as Certification Trade Marks in UK, USA and India.
It is felt that this category can be used to protect some forms of TK and indigenous art and that this area of law has yet to be exploited in this regard.
The point of intersection between copyright and TK arises in relation to 'folk material' including folklore, folk music, and folk art inter alia. Folk material appeals to a wide market today mainly due to its originality and ethnicity, which is fast disappearing in this age of globalisation and consumerism. There have been several cases of misuse, exploitation, mutilation, or dilution of these materials, threatening the concept of 'originality of expression.' Exploitation ranges from copying songs or mixing songs with other forms of popular music, to displaying and collecting sacred items.
Copyright has proved to be inadequate to protect various indigenous art forms. For example, where a tribal painting is copied with minor modifications, the indigenous tribes will have no rights under copyright law. In another instance of copyright violation, an aboriginal artist discovered that his paintings were reproduced on T-shirts without permission. The court was considering a breach when he sued for copyright violation; however, the company withdrew the shirts from sale, thus putting an end to the matter.
The criteria of fixation and identification of the author are essential for copyright protection. One limitation is that folk material misses out on copyright protection precisely due to the lack of the above-mentioned criteria. Professor Long argues that the criterion of fixation is not a mandatory requirement under TRIPS and that the strict definition of author has expanded to accommodate modern copyright law and technology. Moreover, in addition to the above criteria, TK fails the criteria of originality as it is already within the public domain. Copyright cannot be vested over the entire tribe or community as the law does not recognize community ownership. Copyright will not recognize any form of perpetual protection that is needed to protect the originality of the folk materials. Lastly, Copyright cannot be applied to TK related to biological resources.
Section 14 of the Copyright Act, 1957, in India authorises a copyright holder to do any of the acts stipulated under it. The artistic manifestations of the TK holders, especially artists who belong to indigenous and native communities, against unauthorized reproduction and exploitation of those manifestations can be protected. These moral rights and economic rights could offer an effective means for protecting rights of indigenous peoples in works that derive from indigenous knowledge.
Thus, it is possible to carve out a niche for TK within the existing Copyright law. However, an in depth study is needed to determine whether this is indeed the solution to the existing TK debate and not just a transitory protection until a sui generis system is adopted.
Trade secrets are the best form of intellectual property for protecting any kind of undisclosed information. The object is to lawfully prevent information (which is a secret having commercial value) within the control of a person from being disclosed to, acquired by, or used by others without consent, in a manner contrary to honest commercial practices.
Trade secret protection can be applied to processes, methods and ceremonies practised by traditional healers. The first step towards trade secret protection of the knowledge of the indigenous people is the realization of its value by the holders. The awareness of the rights and long term benefits that will be gained if protected as a trade secret is also essential. Normally, knowledge limited to and secured by an identifiable number of people is subject to trade secret protection provided there is a clear intention to treat it as a secret. Indigenous people have tried to adopt the same strategy employed under Trade Secrets to protect their TK in various incidents.
The limitation to trade secret protection is that it cannot be applied in cases where the TK is ancient as over the years, it is next to impossible to keep such knowledge a secret and it becomes generally known through public use or when it is passed on from generation to generation.
India does not have a specific legislation to protect trade secrets and confidential information. Trade secrets in India are protected either through contract law or through equitable doctrine of breach of confidentiality. Protection under Trade Secret law depends from case to case. In cases where the traditional knowledge is preserved within the local community by passing it on from generation to generation and kept closely guarded, it may be protected as a trade secret. For example, only a few traditional families in Aranmula - a rural area in Pathanamthitta District of the State of Kerala in India, know the method of manufacture of peculiar type of metal mirror called 'Aranmula kannadi'.
Trademark creates an association in the mind of the consumer with the manufacturer of the goods and services. Various goods and services manufactured or produced by indigenous and local communities can be distinguished from similar goods and services produced by others through trademark and service marks. The trademark act, 1999, can be used to protect traditional knowledge and related products thus. Awareness programs can help the local communities to realise how trademark law can be used by them to extract financial gains from their TK and protect it from unfair commercial exploitation. Further, collective marks can be used to protect handicrafts and cultural goods. Certification marks may also be used to identify standards of products derived from traditional knowledge and traditional medicine. Cultural icons, signs, and symbols of indigenous communities can fall under the domain of trademark law for protection.
One disadvantage of trademark protection for TK is that Corporations often utilise trademark registrations as a means of extracting commercial benefits from products derived from TK .This can work against indigenous peoples because they lose control of their signs and symbols to the registered proprietor of trademark.
An industrial design is a form of intellectual property where the focus of the design is on the aesthetic feature of an article due to its visual appearance. The design and shape of furniture, garments, receptacles, articles of wood, leather ceramics, etc prepared by indigenous people or association on the behalf of indigenous people in a traditional fashion can be protected as industrial designs. Traditional craft items like hand- woven articles like carpets, cotton bed covers can also be registered for protection as an Industrial design. Various forms of traditional designs can be found in the diverse cultural heritage of India. For example, hand-block prints known as "baandhnis" of Rajasthan is one famous traditional design of India.
An analysis of the existing intellectual property regime reveals that TK is not fully and efficiently protected by any one category. The international legal fraternity has suggested establishing a sui generis system for the protection of TK. Article 27 of TRIPS also provides protection by sui generis systems. Establishing such a system is an arduous undertaking and whether the terms and conditions demanded by individual countries will be granted remains to be seen.
Chapter 2) Meanings
Traditional Knowledge refers to the knowledge systems, encompassing a wide variety of areas , held by indigenous communities which has significance and relevance not only to its holders but also to the rest of humanity. Traditional Knowledge (TK) is a collectively owned property and is integral to the cultural or spiritual identity of the social group in which it operates and is preserved. Traditional knowledge is now at the centre of the discussions on intellectual property rights and has assumed immense significance. It is transmitted orally from generations to generations. It tends to be collectively owned and takes the form of stories, songs, folklore, proverbs, cultural values, beliefs, rituals, community laws, local language, and agricultural practices, including the development of plant species and animal breeds. Sometimes it is referred to as an oral tradition for it is practiced, sung, danced, painted, carved, chanted and performed down through millennia. Given the objectives of the WIPO, the definition of traditional knowledge excludes any item that is not the result of intellectual activity in the industrial, scientific, literary, or artistic fields.
Traditional knowledge is mainly of a practical nature, particularly in such fields as agriculture, fisheries, health, horticulture, forestry and environmental management in general. This knowledge is valuable not only to those who depend on it in their daily lives, but to modern industry and agriculture as well. Many widely used products, such as plant-based medicines, health products and cosmetics, are derived from traditional knowledge. Other such valuable products include. Agricultural and non-wood forest products as well as handicraft. Certain serious global problems can be solved through practices through local conservation, sustainable use of plants and animal, climate change, desertification and water quality. Traditional knowledge is important both for humans and the environment. It makes the people self sufficient, is a preserver of bio diversity and can provide a source of income.
Martha Johnson of the Dene Cultural Institute in Canada has defined traditional knowledge as "a body of knowledge built by a group of people through generations living in close contact with nature. It includes a system of classification, a set of empirical observations about the local environment, and a system of self-management that governs resource use '
Currently, more than 85% of the world's poor rely on biological resources and its related traditional knowledge as their basic source of livelihood. The exchange of traditional knowledge between various communities has been a significant driver underpinning technological development. This has been a continuous process and drugs have been derived from these medicinal plants with the help of traditional knowledge. Thus, traditional knowledge is the deep knowledge of using the resources of plants and animals which creates an interest from others who do not have this knowledge.
Traditional Cultural Expression.
This term is very much associated with traditional knowledge so it is important to know what it meant to have a detailed study on traditional knowledge. The term traditional cultural expression is used by the international legal community to refer to works of indigenous peoples and traditional communities. But there is no definite definition of Traditional Cultural Expression. The expression of folklore which includes music, dance, art, designs, names , signs, and symbols , performances , ceremonies , architectural forms, handicrafts and narratives and many other artistic or cultural expression can be termed as Traditional Cultural Expression. It can be in any form n which a culture is expressed or can part of the identity and heritage of a traditional or indigenous community which are passed from one generation to the other. Traditional Cultural Expressions are integral to the cultural and social identity of indigenous and local communities. They transmit core values and beliefs.
These expressions generally comprises of the following form of combinations:
' Verbal expressions including legends , stories , epics, epics, legends, poetry, riddles and other narratives, words, signs, names and symbols
' musical expressions such as songs and instrumental music
' expression by action such as dances, plays, ceremonies, rituals and other performances
' expressions which are in tangible form such as productions of art in particular drawings, designs paintings (including body-painting) carvings, sculptures, pottery, terracotta, mosaic, woodwork, metal ware, jewellery, baskets, needlework, textiles, glassware, carpets, costumes, handicrafts, musical instruments and architectural forms,
' individuals and communal creativity which are the products of creative intellectual activity.
' characteristic of a community's cultural and social identity and cultural heritage and
' maintained , used or developed by such community or by individuals having the right or responsibility to do so in accordance with the customary law and practices of that community.
They, sometimes, form a part of a single integrated heritage. There are certain issues regarding the protection of traditional cultural expression as to how these are to be protected. Because folklores are protectable under copyright act while performances of traditional songs and music may come under the WIPO performances and Phonograms Treaty and Beijing Treaty on Audiovisual Performances. And authentic indigenous art can be protected under the Trademark Act, like the Maori Arts. Existing national and international legal protection are not sufficient to deal with the concerns of indigenous people for the creative heritage. There is still a lack of consensus internationally about the type of protection that would best apply universally to these works.
Since the 1960s the international community has tried to find a solution to this issue regarding the legal protection of traditional cultural heritage. The United Nations began to address this issue in the early 1970s, and to consider options for protection, ranging from the customary law of indigenous peoples, to guidelines and recommendations, national laws, regional agreements, protection within the multilateral copyright system, or under a sui generis, or special type of protection, that would be compatible to the nature of TCEs.
Even certain recommendations, guidelines, codes of ethics, and best practices have been developed by indigenous communities, and by non-indigenous groups and professional organizations. Such examples are the Code of Ethics and Code of Practice of the Australian Institute for Conservation of Cultural Material (AICCM), The Code of Ethics of the Pacific Islands Museums Association (PIMA), the Bangui Agreement, The Pacific Regional Framework for the Protection of Traditional Knowledge and Expressions of Culture (2002).
Also certain international efforts have been taken up to protect Traditional Cultural Expression which includes: -Article 15(4) of the Berne Convention,Tunis Model Law on Copyright for Developing Countries (1976),WIPO-UNESCO Model Provisions for National Laws on the Protection of Expressions of Folklore Against Illicit Exploitation and other Prejudicial Actions (1982),Draft international treaty (1982-1985),WIPO Performances and Phonograms Treaty (1996),WIPO-UNESCO World Forum on the Protection of Folklore (1997),WIPO fact-finding missions (1998-1999),WIPO-UNESCO Regional Consultations on the Protection of Expressions of Folklore (1999),WIPO Final Report on National Experiences with the Legal Protection of Expressions of Folklore (2002),United Nations Declaration on the Rights of Indigenous Peoples (2007),WIPO Intergovernmental Committee on Intellectual Property and Genetic Resources, Traditional Knowledge and Folklore (IGC) efforts toward legal protection of Traditional Cultural Expressions (2001),WIPO Creative Heritage Project (2008).
Libraries also play a primary role in identifying, recording, conserving, preserving, and providing access to cultural heritage. Within a legal and cultural policy framework, libraries can play a positive role in the preservation and use of indigenous works. In respecting the rights of indigenous peoples, libraries can contribute toward the greater social good that results from preservation of cultural heritage, promotion of cultural diversity, and cultural development. Digitization is a driving force for addressing issues related to TCEs. While new technologies present great opportunities for communities to document and preserve their cultural heritage for future generations, concerns are greatly magnified by the digital environment. Cultivating library practices for managing and protecting culturally sensitive material that involve collaborative duration with indigenous communities will encourage knowledge and respect for tradition.
This term is very much associated with traditional knowledge and often confused with. However, this is a broader term. Indigenous Knowledge can be referred as the repository of technologies, know how skills , practices and beliefs accumulated over generations which helps local communities to survive over generations. The forms and practices of indigenous knowledge can be found mythological literature, oral history, local artefacts and institutions over an area or a culture .Indigenous knowledge plays a significant role in social development. Indigenous knowledge has also been referred to as the unique, traditional, local knowledge existing within and developed around the specific conditions of women and men indigenous to a particular geographic area.
Often, this knowledge is oral or symbolic in nature and embedded in the culture of its practice, rarely in written form. Its transmission from one generation to the next takes place through modelling, practice, and animation in local languages. There are certain special attributes of indigenous knowledge which are limits, circumstantiality and particularity.
Indigenous knowledge is fundamental to local decision-making regarding daily activities like hunting and gathering, fishing, agriculture, animal husbandry, water conservation, health, etc. Moreover, unlike formal scientific knowledge, indigenous knowledge is generally transferred as oral wisdom from one generation to the other, and is seldom, if ever, documented. Combining all forms of knowledge other than the formal ones as 'indigenous knowledge' would lead to its generalization and oversimplification, and may negate the outstanding contribution local knowledge can make to sustainable development.
There has been discussions regarding the importance of indigenous knowledge .Because Indigenous knowledge plays an important role in intercropping techniques, pest control, crop diversity , and seed varieties in agriculture and plant varieties , techniques in fish breeding , traditional medicine, soil conservation , irrigation , and water conservation, oral tradition and local languages in education. The realization of IK's contribution to these sectors has led to an increasing interest in it by academicians, and policymakers alike.
These roles played by Indigenous Knowledge is greatly appreciated by the UNO, many Government and Non Governmental Organizations, UNESCO , FAO, ILO etc.
World bank in 1997 cited about the importance of Indigenous Knowledge as
'In the emerging global knowledge economy a country's ability to build and mobilize knowledge capital, IK is equally essential for sustainable development as the availability of physical and financial capital'.
Today Indigenous Knowledge systems are at a risk of becoming extinct because of rapidly changing natural environments and fast pacing global changes in economic, political and cultural sectors. Practices are vanishing as they become inappropriate for new challenges or they become adapt too slowly.
Traditional Medicinal Knowledge.
In the case of captopril, a drug used to treat hypertension and heart failure, no benefits have flowed back to the indigenous Brazilian tribe that first used pit viper venom as an arrowhead poison. By contrast, the San people of the Kalahari Desert have a benefit-sharing agreement with South Africa's Council for Scientific and Industrial Research, which is working with pharmaceutical companies to develop dietary supplements based on hoodia, a succulent plant well-known to the San for its appetite-suppressant qualities.
IP protection can take two forms ' positive and defensive protection:
' Positive protection grants IP rights over the subject matter of traditional medical knowledge. This may help communities to prevent others from gaining illegitimate access to traditional medical knowledge or using it for commercial gain without equitably sharing the benefits. It may also enable active exploitation of traditional medical knowledge by the originating community itself, for example, to build up its own enterprises based on that knowledge.
' Defensive protection does not grant IP rights over traditional medical knowledge but aims to stop such rights from being acquired by third parties. Defensive strategies include the use of documented traditional medical knowledge to preclude, oppose or invalidate patents on claimed inventions that are directly based on such knowledge.
Chapter 3) Problems confronted in protection of Traditional Knowledge.
If the 20th century was the age of industry, the 21st century is shaping up to be the age of biology. Bio-piracy means not only the smuggling of diverse forms of flora and fauna, but mainly the appropriation and monopolization of traditional population's knowledge and biological resources causing the loss of control of traditional populations over their resources.
The role of intellectual property systems in relation to TK , and how to preserve, protect and equitably make use of TK, has recently received increasing attention in a range of international policy discussions. These address matters as diverse as food and agriculture, the environment, notably the conservation of biological diversity, health, including traditional medicines, human rights and Indigenous issues and aspects of trade and economic development. In the present submission the author has made attempts to discs the concepts involved in detail by initially introducing the topics i.e. Bio-piracy and TK accompanied by the need to protect such TK. This is followed by the by the discussion on the controversial cases of bio-piracy of TK like Basmati case, Neem Case, etc. Then the concept of bio prospecting has been discussed.
Bio piracy: The term bio piracy originated in the 1980's and Pat Mooney ,invented the term 'bio piracy'. According to him bio-pirate refers to persons and countries that use the intellectual property rights to monopolize and own the right to access, utilize benefit and control biological resources and related indigenous knowledge without proper appropriation of benefit derived and addressing the original innovator. Bio piracy is the illegal appropriation of life 'microorganisms , plants and animals and traditional knowledge which accompanies it .
According to Dr. Vandana Shiva , biopiracy refers to 'the use of intellectual property systems to legitimize the exclusive ownership and control over biological resources and biological products and processes that have been used over centuries in non-industrialized cultures."
The threat from bio-piracy lies in four facts:-
' Knowledge or genetic resources belonging to a region, community or country is stolen or claimed as one's own;
' The use of this knowledge or genetic resource in the area of its origin or traditional usage may be hampered or sought to be prevented;
' The patent holder will unfairly profit from the patent;
' The patent claimed and awarded illegally and unethically is bound to disturb an established system somewhere in the world, be it related to food, medicine, livelihood or lifestyle.
It has been seen that the developing countries are facing threats from the developed countries. The developed countries, with the help of their technological skills, use the natural resources of the developing countries inappropriately. They have the intention of monopolizing the knowledge associated with it and thus patenting the invention out of the knowledge. They do not even acknowledge the holder of such traditional resources which is posing a threat to the developing countries.
Patents on life are biopiracy, either because they involve the 'theft' of nature's creativity and innovation of other cultures. The era of bio piracy began with the first patent on life granted by the US patent office .In 1971, General Electric and one of his employees , Anand Mohan Chakrabarty applied for a US patent on a genetically engineered pseudonomonas bacteria. The first patent on life was granted inspite of the exclusion of plants and animals from patenting under US laws .This raised an issue and a case was filed. The court found that Chakrabarty had produced a new bacteria with markedly different characteristics that found in nature. Currently, well over 190 genetically engineered animals, including fish , cow, mice, and pigs are figuratively standing in line to be patented by a variety of researchers and corporations.
Patents on life were globalised by another undemocratic decision made during the Uruguay Round of GATT to include IPR in trade treaties , and include life in IPR regimes. The TRIPS agreement of GATT allowed for monopolistic control of life forms. This has serious ramifications for bio diversity conservation and the environment
Article 27.3 of the TRIPS agreement states,
' Parties may exclude from patentability plants and animals other than micro organisms, and essentially biological processes for the production of plants or animals other than non-biological and micro biological processes. However, parties shall provide for the protection of plant varieties either by patents or an effective sui generis system or by any combination thereof. This provision shall be reviewed four years after the entry into force of the agreement establishing the WTO.'
Bio piracy case studies.
1) The Turmeric case:
Turmeric is a plant of the ginger family yielding saffron coloured rhizomes as a spice for flavouring Indian cooking. It also possesses properties that make it an effective ingredient in medicines, cosmetics and a colour die. It has been in public domain in India and used as such from time immemorial .In 1995, two Indian nationals at the University of Mississippi, Medical Centre were granted US patents No 5401504 on 'Use of turmeric in wound healing'. The patent was granted by the United State Patent and Trademark Office (USPTO).
This patent was challenged by the Council of Scientific and Industrial Research (CSIR ), India. CSIR challenged that the patent does not fulfil the criteria of Novelty as turmeric has been used in India for years and its healing properties s known to everyone. There is nothing new to his invention. A paper was published in 1953 n the Journal of Medical Association which proved that turmeric is well known in India before the filing of patent application. And then the patent was revoked as there was nothing new to this invention.
2) The Neem Case:
On 10th May , The European Patent Office (EPO) struck down a Patent No 046257 B1.This was jointly held by the US government and the multinational W.R Grace as based on the piracy of existing knowledge which also lacked novelty and inventiveness. USDA and W.R Grace jointly fled the Patent on 12th December ,1990.And the patent was for a method for controlling on plants comprising contacting the fungi with neem oil formulation. And this patent was granted on 14th September , 1994.However, this patent was challenged on 5th June 1995by a group on international NGOs and representatives of Indian farmers. A 'Neem Campaign' in India was launched and also a 'Neem Team' was formed to support the campaign. The argument was that the use of neem extracts to remove pesticides and fungicide was known for decades in India .Neem is an important tree in India which as Medicinal and agricultural purposes. In India, Neem extracts has been used against hundreds of pests and fungal diseases that attack food crops ;the oil extracted from its seeds is used to treat colds and flu and when mixes with soap it is believed that it cures skin diseases and even treats meningitis and malaria. Hence the claim for patent does not involve an inventive step and the claim was not novel. So, in 1999, the European Patent Office determined that the invention was already known to the public prior to patent application and the patent was revoked in 2000.
This is powerful symbol of biopiracy where US government and a big MNC tried to monopolise the traditional knowledge of India.
3) The Basmati Case.
Rice Tec. Inc. had applied for registration of a mark 'Texmati' before the UK Trade Mark Registry. Agricultural and Processed Food Exports Development Authority (APEDA)
successfully opposed it. One of the documents relied upon by Rice Tec as evidence in support of the registration of the said mark was the US Patent 5,663,484 granted by US Patent Office to Rice Tec on September 2, 1997 and that is how this patent became an issue for contest.
Evidence from the IARI (Indian Agricultural Research Institute) Bulletin was used against claims 15-17. The evidence was backed up by the germplasm collection of Directorate of Rice Research, Hyderabad since 1978. CFTRI(Central Food Technological Research Institute) scientists evaluated the various grain characteristics and accordingly the claims 15-17 were attacked on the basis of the declarations submitted by CFTRI scientists on grain characteristics.
Eventually, a request for re-examination of this patent was filed on April 28, 2000. Soon after filling the re-examination request, Rice Tec chose to withdraw claims15-17 along with claim 4.Biopiracy of TK is not limited to India alone. In fact, there have been several examples from other countries where TK bio- piracy has become a concern.The most important victory as India could see in this regard is the change of nomenclature from Basmati lines and grins to rice lines BAS 867, RT 1117,RT1121.
4) Wheat Patent Case
The patenting of wheat gene by Monsanto caused much apprehensions .The new variety was developed fm the primitive Indian race Nap Hal which s deal for making bakery products .The issue was the possibility of future infringement cases against farmers from non payment of royalties to Monsanto .The Green Peace , RFSTE and Barat Karshak Samaj jointly challenged the patent.The patent was finally revoked on 5th Oct , 2004.European data base showed that Nap Hal was collected from Uttar Pradesh in 1948.
5) Amazon Basin and the Banisteriopsis caapi case.
A wrong patent that was given on a plant species called Banisteriopsis caapi and its traditional medicine uses led to lots of protests among the indigenous tribes in the Amazon Region.This plant is native to the rain forests For generations, shamans of indigenous tribes throughout the Amazon Basin have processed the bark of Banisteriopsis caapi to produce a ceremonial drink known as "ayahuasca". The shamans use ayahuasca (which means "vine of the soul") in religious and healing ceremonies to diagnose and treat illnesses, meet with spirits, and divine the future. An American, Loren Miller obtained US Plant Patent 5,751 in June 1986, granting him rights over an alleged variety of B. caapi he had called "Da Vine". The patent description stated that the 'plant was discovered growing in a domestic garden in the Amazon rain-forest of South America.' The patentee claimed that Da Vine represented a new and distinct variety of B. caapi, primarily because of the flower colour.
The Coordinating Body of Indigenous Organizations of the Amazon Basin (COICA) ' an umbrella organisation representing over 400 indigenous groups ' learned of the patent in 1994. On their behalf the Centre for International Environmental Law (CIEL) filed a re-examination request on the patent. CIEL protested that a review of the prior art led that Da Vine was neither new nor distinct. They argued also that the granting of the patent would be contrary to the public and morality aspects of the Patent Act because of the sacred nature of Banisteriopsis caapi throughout the Amazon region. Extensive, new prior art was presented by CIEL, and in November 1999, the USPTO rejected the patent claim agreeing that Da Vine was not distinguishable from the prior art presented by CIEL and therefore the patent should never have been issued. However, further arguments by the patentee persuaded the USPTO to reverse its decision and announce in early 2001 that the patent should stand.
It has been observed that because of the date of filing of the patent, it was not covered by the new rules in the US on inter partes re-examination. CIEL were therefore unable to comment on the arguments made by the patentee that led to the patent being upheld.
6) Fiji and the Kava case
Kava has been cultivated in Fiji and Vanuatu since times immemorial ,However, the L'Oreal group (a French company)has now patented the use of kava to stimulate hair growth .The patented company can now obtain exclusive rights to the plant, thereby demanding full profits associated with usage , ultimately creating a monopoly of ownership over the plant.
7) Africa and the Hoodia cactus case
The San, who live around the Kalahari Desert in southern Africa, have traditionally eaten the Hoodia cactus to stave off hunger and thirst on long hunting trips. In 1937, a Dutch anthropologist studying the San noted this use of Hoodia. Scientists at the South African Council for Scientific and Industrial Research (CSIR) only recently found his report and began studying the plant. In 1995 CSIR patented Hoodia's appetite-suppressing element (P57). In 1997 they licensed P57 to the UK biotech company, Phytopharm. In 1998, the pharmaceutical company Pfizer acquired the rights to develop and market P57 as a potential slimming drug and cure for obesity (a market worth more than ??6 billion), from Phytopharm for up to $32 million in royalty and milestone payments.
On hearing of possible exploitation of their traditional knowledge, the San People threatened legal action against the CSIR on grounds of 'biopiracy.' They claimed that their TK had been stolen, and CSIR had failed to comply with the rules of the Convention on Biodiversity, which requires the prior informed consent of all stakeholders, including the original discoverers and users. Phytopharm had conducted extensive enquiries but were unable to find any of the 'knowledge holders'. The remaining San were apparently at the time living in a tented camp 1500 miles from their tribal lands. The CSIR claimed they had planned to inform the San of the research and share the benefits, but first wanted to make sure the drug proved successful. In March 2002, an understanding was reached between the CSIR and the San whereby the San, recognised as the custodians of TK associated with the Hoodia plant, will receive a share of any future royalties. Although the San are likely to receive only a very small percentage of eventual sales, the potential size of the market means that the sum involved could still be substantial. The drug is unlikely to reach the market before 2006, and may yet fail as it progresses through clinical trials.
8) Alice Community of South Africa and Pelargonium case
In a place called Alice in South Africa ,tinctures have been produced right from historical days to treat respiratory infections including tuberculosis .These are produced from the roots of pelargonium sidoides .Now , this TK has been exploited by Schwabe pharmaceuticals which markets a syrup by name Umckaloabo form these rots .The Alice Community has fought against this exploitation .
9) Jeevani case.
The Kani tribals belong to a traditionally nomadic community, who now lead a primarily settled life in the forests of the Agast-hyamalai hills of the Western Ghats (a mountain range along south-western India) in the Thiruvananthapuram district of Kerala. Kanis are the traditional collectors of non-timber forest products from the forest. Living close to nature, the Kanis have acquired unique knowledge about the use of the resources, particularly the biological resources around them.
In December 1987, a team of scientists working on the All India Co-ordinated Research Project on Ethnobiology (AICRPE) led by P. Pushpangadan was introduced to the 'magical' plant, which was subsequently identified as Trichopus zeylanicus ssp. travancoricus. Detailed chemical and pharmacological investigations showed that the leaf of the plant contained various glycolipids and some other non-steroidal compounds with profound adaptogenic and immuno-enhancing properties. The fruits showed mainly anti-fatigue properties. The Tropical Botanical Garden Research Institute (TBGRI) was successful in developing a scientifically validated and standardized herbal drug, based on the tribal lead. The drug was named as 'Jeevani' and it was released for commercial production in 1995 in Arya Vaidya Pharmacy for a period of seven years. While transferring the technology for production of the drug to the pharmaceutical firm, TBGRI agreed to share the license fee and royalty with the tribal community on a fifty'fifty basis. The prime concern of the tribals in the beginning was to evolve a viable mechanism for receiving such funds. With the help of TBGRI, some government officials and NGOs, the tribal formed a registered trust. About 60% of the Kani families of Kerala are members of this trust. From February 1999, the amount due to them has been transferred to this Trust with an understanding that the interest accrued from this amount alone can be used for the welfare activities of the Kani tribe. What the Kani model does highlight is the potential for benefit sharing in the context of plant based biotech products. While there is a patent involved in the Jeevani case, the benefit sharing dimension highlights a way forward for partnerships between TK holders and herbal manufacturers. It is significant to note that while the issue of material transfer and benefit sharing was discussed and debated after CBD, India has already pioneered one of the first models.
The searching of bio diversity for valuable wild genetic resources and then the information found from them can be termed as bio prospecting .The information received is used by the bio technology industry to develop new and improved drugs , crop varieties , industrial techniques and other commercial products worth billions of dollars each year.
One of the major beneficiaries of bio prospecting is the pharmaceutical industry where the most successful bio piracy is the discovery of the Madagascar Rosy Periwinkle. .It is profitable for the research based industries to use biological resources such as soil samples, marine waters, insects , tropical plants and animals and TK in developing countries because bio prospecting ,when it is based on TK ,may significantly cut costs of pharmaceutical R&D as it s cheaper than the conventional system of screening millions of synthesized chemicals.
The process of bio prospecting is basically governed by four models of bio prospecting which are mainly working in the United States: namely ,
1) National Cancer Institute Model (NCI),
2) Shamans Pharmaceuticals Model.
3) The INBio-Merck Model and
4) International Cooperative Biodiversity Group (ICBG) Model.
The model which is used by NCI is to collect the bio logical products throughout the world , ship them to their laboratories in the US and utilise its scientific infrastructure to analyse natural products .
Under Shaman pharmaceuticals raw materials are shipped to the US laboratories and the company shares the profits at an unspecified low percentage with the source countries .
In the INBio Model the raw material is not shipped from the source countries , rather INBio extracts locally alkaloids from the flora and fauna of the source countries and ship them NCI and to multinational pharmaceuticals .
In the ICBG model , the extracts of the raw materials are shipped to the US pharmaceutical industries for more research and analysis and in return the source country receives some undisclosed royalty and some limited training to their scientists.
In these models the source country and the indigenous and local communities get very minimal and sometimes no share in profit earned by the MNC by using the biological resource.
Medicinal plants are found in nature and have been in use for pharmaceutical purposes in different parts o the world for centuries. Also, active ingredients from flora and fauna are found to be dominant in a large number of drugs. In the past many of the known useful drugs have been derived from leads provided by these medicinal plants. Examples of deriving drugs plants are numerous and a common knowledge.
There have been many controversies regarding the values of bio prospecting. Whether it provides with an incentive for preservation of ecological habitats in resource rich regions. If the value of bio diversity in an undisturbed habitat for pharmaceutical research exceeds the opportunity cost of conservation, it may result in market based preservation of the habitat without external intervention on the land use. If this is the case , then the policy needed for eco system preservation will have to be considered differently. With this motivation as governing factors , a number of estimations of benefits of medicinal plants have been considered. Recently ,the value of bio prospecting was estimated .It was advocated that the incentive for bio diversity conservation on the basis of benefits of bio prospecting is not tenable because the value of the benefits is very small.
In another significant study , present a contrasting finding and explain that if the search for a useful lead is based on scientific inputs and information , rather than being a process of brute testing , then he value of bio diversity can be significant.
Bio prospecting is a process of sequential search on species (or leads ) for the discovery of a new product which has the potential to provide a genetic information useful for the new product.
Chapter 4) Protection of Traditional knowledge: Different perspectives.
i. International Perspective
Convention on Biological Diversity (CBD).
National Biodiversity regimes are coming up for the protection of Traditional Knowledge in conformity with the objectives of CBD .These regimes would provide legal protection to biological resources and Traditional Knowledge at the National Level.
Article 8(j) of CBD provides that , 'Each contracting party shall as far as possible and as appropriate subject to its national legislation respect and maintain knowledge ,innovations and practices of indigenous and local communities embodying traditional lifestyles relevant for the conservation and sustainable use of biodiversity and promote the wider application with the approval and involvement of the holders of such knowledge , innovations and practices and encourage the equitable sharing of benefits arising from the utilisation of such knowledge , innovation and practices'.
In CBD, there are voluntary guidelines for the Access and Benefit Sharing System (ABS)and implementing this ABS arrangement. Article 8j of CBD read together with decision V/16 , which was adopted at the fifth meeting of the conference of the parties to the CBD in 2000, require that Prior Informed Consent of TK holders should be obtained before accessing their knowledge .Article 8(j) does not clearly specify about the involvement of TK holders .Decision V/16 was adopted to specify that PIC of TK holders should be obtained .
Now there can be question as to what Prior Informed Consent means.
'The principles of consultation and consent together constitute a special standard that safeguards and functions as a means for the exercise of indigenous peoples' substantive rights. It is a standard that supplements and helps effectuate substantive rights' including the right to property ' and other rights that may be implicated in natural resource development.'
Prior means consent is sought sufficiently in advance of any authorisation or commencement of activities. Prior refers to a period of time in advance of any activity or process when consent is sought or consent is given or withheld. Prior implies that the time is provide to understand , access and analyse information on the propose activity. The amount of time given will depend upon the decision making process of the right holders. That consent should be free from all sources, i.e., there should not be any force, coercion, intimidation or manipulation. And information refers to the nature of the engagement and type of information that should be provided prior to seeking consent and also a part of the ongoing consent process.
There are certain guidelines for a free and prior informed consent .They say that information should be such that it is accessible, clear, consistent, accurate, constant, and transparent. The information should be delivered in appropriate language and culturally appropriate format (including radio, video, graphics, documentaries, photos, oral presentations).It should be objective, covering both the positive and negative potential of the activities. And all the consequences which may arise as a result of giving or withholding consent should be conveyed to the parties. The required information should be complete, covering the spectrum of potential social, financial, political, cultural, environmental impacts, including scientific information with access to original sources in appropriate language. It should be delivered in a manner that strengthens and does not erode indigenous or local cultures .A culturally appropriate person should deliver the information in a culturally appropriate location. Sufficient time should be given to the parties to understood and verify before giving their consent.
The objective of Prior Informed Consent (consultation) processes shall be to reach an agreement (consent) between the relevant parties, this does not mean that all Free Prior Informed Consent (FPIC) processes will lead to the consent of and approval bythe rights-holders in question. At the core of FPIC is the right of the peoples concerned to choose to engage, negotiate and decide to grant or withhold consent, as well as the acknowledgement that under certain circumstances it must be accepted that the project will not proceed and/or that engagement must be ceased if the affected people decide that they do not want to commence or continue with negotiations or if they decide to withhold their consent to the project.
Article 1 of CBD states the objectives of CBD .It says that its aims are the conservation of biological diversity, the sustainable use of its components and the fair and equitable sharing of the benefits arising out of the utilization of genetic resources. So ,these three are the main objectives of the convention which is different from the TRIPs agreement.
TRIPS is an agreement on a legal framework. It is said that the impact of TRIPS varies according to countries depending on their economic and technological development. TRIPS has a very important provision which provides for Technology Transfer. It is beneficial for the developing countries. Now Technology Transfer means the transfer of technological developments from the developed countries to the developing countries.
The agreement on Trade Related aspect of Intellectual property Rights is a concomitant of WTO set up annexed to the GATT, 1994 by which WTO has been established. All the members of WTO are bound by the TRIPS Agreement. The TRIPs Agreement provides for the applicability of basic GATT principles and relevant international intellectual property agreements; the provisions of adequate intellectual property rights; the provisions for effective measure for those rights; multilateral disputes settlement and transitional agreements. The TRIPs agreement stipulates that every member nation shall give effect to the provisions of the agreement. It leaves open for the member nations to implement in their respective domestic laws more extensive protection than is required by the agreement. The Agreement lays down that the member countries shall be free to determine the appropriate method of implementing the provisions of the agreement within their own legal system and practices.
When the third world countries are given access to technologies, then they develop economically and socially. Or otherwise these countries face great difficulties while dealing with the developed countries.
Article 27.3(b) of TRIPs, has given the member countries the discretion either to implement a patent system for the protection of plant varieties or to adopt their own sui generis system. A sui generis system would allow WTO members to adopt their own system of protection for plant varieties.
By 2000, most of the countries had signed TRIPS. Certain debates regarding the modification of TRIPS agreement are going on .One of the major areas of debate is regarding the protection of Traditional Knowledge .It is felt that TK can be protected within the framework of TRIPS , without a substantial overhaul of its provision through a declaration of 'Traditional Knowledge and Trade' . So , it is felt that this instrument can apply without any modification to TK which are being exploited commercially .So , it is suggested that before TRIPS is sought to be amended , one must look as to how TK holders can be provided protection within the current framework of TRIPS.
So , one suggestion was providing a sui generis system. It is felt that sui generis system will benefit in various ways. It will raise the profile of the knowledge and encourage respect for it inside and outside the knowledge holding communities .The younger members of the community will then contribute for the further development of the knowledge .When traditional knowledge will be used by others there will be economic prospects which will be an incentive for the community members .The members will then continue to engage in their practice in that TK which will further also can be treated as a respect to that knowledge. When the TK will be in the use then the fear of forgetting that knowledge will not be eroded.
There is always a conflict between CBD and TRIPS .These international agreement became the two important instruments to regulate the affairs of this moral world and to show the way for future .Article 27(3) of TRIPS which talks about IPR rights over living resources, has explained the subject matter of patentability , but at the same time mad a provision for sui generis protection qualified with a provision that it must be an effective form of protection.
There is a conflict between TRIPS and CBD.TRIPS in particular Article 27.3(b) of the agreement , is n direct conflict with CBD.The first debate relate to '
a. Private right Vs Public Right.
b. Rights of the indigenous community Vs. Rights of the multinational pharmaceuticals corporation.
c. Rights of the commercial breeders Vs rights of the farmers.
The second thing is that CBD says is that national states have sovereign rights over their biological resources where TRIPS ponder that biological resources may be subject to Intellectual Property Rights. The conflict arises that CBD gives developing countries a legal basis to demand a share of benefits and TRIPS negates that legal authority .The same conflicting interest is applied on the use or exploitation of a Traditional Knowledge CBD says that to access to biological resources requires the Prior Informed Consent of the country of origin. It also requires that approval and involvement of local communities whereas in TRIPS there is no provision requiring PIC for access to biological resources which may be subsequently be protected by IPR.CBD now gives stats legal authority to diminish the incidence of biopiracy requiring Prior Informed Consent. TRIPS ignore this authority and thus promote biopiracy.CBD recognises the promotion ,conservation and sustainable use of bio diversity as a common concern of human kind taking into account all rights over biological resources ,whereas under the TRIPS the safeguarding to public health and nutrition and the private interest of IPR holders as reflected in the provisions of TRIPS agreement. So CBD places the public interest and common good over private property and vested interest and TRIPS does the exact opposite.
The basic reason of the above controversies between TRIPS and CBD is that both international legal instruments are based on socialism and another is on capitalism and individualism.CBD talks about the community at large and TRIPS concentrates on individual.
The rapid development of world is backed by the capital market which represents the individualism but very few in numbers and the rest world is controlled by them. In this pattern, the individual interest is more important than social interest which is resulted into imbalances of interest and ultimately sufferer in society at large.In later years , there has been an increasing evidence of many social , economic problems, some quite dramatic and serious caused by TRPS .This has increased public awareness that the WTO /TRIPS system is heavily in favour of IPR holders and the big corporations of the industrialised world and against public interest. All this has created a crisis of legitimising for the WTO and TRIPS and in a number of cases around public outrage and street demonstrations.
Developing countries are under pressure not to exercise their rights under TRIPS to relax IPRs in certain circumstances .They also seek clarification that in implementing their option on plant varieties protection, developing countries should be able to have a sui generis law that protects the knowledge and innovations of indigenous farming communities , and for continuation of traditional farming practices.
WIPO was established by a convention signed at Stockholm in 1967 which came into force in 1970.Membership in WIPO s open to any state which is a member of the Paris or Berne Convention and to any other state which satisfies the conditions established in the convention. Basically the main objectives of WIPO is to administer various multinational treaties through international bureau of WIPO and to promote protection of intellectual property internationally through co-operation among states. The WIPO has its headquarters in Geneva and is a specialised body of UNO .Mainly the aims of WIPO are to promote the protection of intellectual property throughout the world through co-operation among states and to ensure administrative co-operation among the Unions.
WIPO has also taken several attempts to protect Traditional Knowledge .WIPO has drafted an Inter Governmental Committee on Intellectual Property and Genetic Resources , Traditional Knowledge and Folklore. The main objectives of this draft is to recognise the value of traditional knowledge which may be social, economic, scientific, technological, commercial, educational value. And to promote respect for traditional knowledge systems to conserve and maintain these systems .Another aim is to meet the needs of the traditional knowledge holders and contribute to their welfare and economic social and cultural benefit and to give reward to the holders of traditional knowledge for their contribution towards protecting the Traditional knowledge. A balanced and equitable protection of Traditional Knowledge which will empower the TK holders to exercise due authority over their own knowledge .To respect and facilitate the customary use and development of TK between TK holders and to promote the continued development of TK systems. Also to preserve and safeguard TK for their development , preservation and promote the conservation, maintenance application and wider use of TK which will benefit the use of TK holders. Steps will also be taken against any misappropriation of TK and unfair commercial activities. It also recognises and operates various international and regional instruments which are associated with TK regarding access to and benefit sharing from genetic resources. Another important activity is encouraging, rewarding and protecting tradition based creativity and innovation respecting holders and users of Traditional Knowledge. Promoting access and wider application of TK for the general public interest and to promote fair and equitable distribution of monetary and no monetary benefits arising out of TK .Also to enhance certainty, transparency, mutual respect and understanding relation between TK and its holders.It has certain other core principles regarding the needs and expectations of TK holder, recognising of rights , effectiveness and accessibility of protection , equity and benefit sharing , consistency with existing legal systems , respect and co-operate other international and regional instruments, recognising specific characteristics of TK .And in case of any misappropriation of the TK , certain legal means are made available.
Another step taken by WIPO is the draft of documentation of Traditional Knowledge toolkit which provides guidance as how to undertake a TK documentation exercise. It will also address critical questions relating to IPR issues. This is to protect mainly the Traditional Knowledge and Traditional Cultural Expression (TCE).Special attention has been given to documentation and the role of databases and registers in this regard .Documentation is said to identify , collect and organise TK which will guarantee rights to indigenous people and local communities .It will help in their social , cultural and economic interest. Documentation will in impeding further loss of TK to maintain TK over time, to support benefit sharing and this protecting TK and TCE from any unauthorised or unwanted uses. Though documentation alone cannot act as the strategy in protecting Traditional Knowledge and Traditional Cultural Expression, yet it is a welcoming effort.
Uruguay Round of Multilateral Trade Negotiations of the GATT (General Agreement on Tariffs and Trade) ' initiated in 1986 in Punta del Este, and concluded in 1994 with the Ministerial approval of the Final Act of Marrakesh ' created the WTO and adopted a package of important agreements. WTO Agreements subsume the old GATT with all the amendments and decisions taken by till 31 December 1994. The multilateral agreements are related to subjects, such as, goods, agriculture, sanitary and phytosanitary measures, textiles and clothing, technical barriers to trade, trade-related investment measures, anti-dumping, customs valuation, pre-shipment inspection, rules of origin, import licensing, subsides and countervailing measures and safeguards. They also include rules for services, intellectual property rights, trade-policy review mechanisms and dispute settlement processes. Furthermore, there are four plurilateral agreements, including the areas of government procurement, civil aircraft, bovine meat and dairy (milk) products, which were signed only by some members of WTO. For the purposes of this document some provisions of the Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPs) are considered. The WTO's Ministerial texts have instructed the TRIPS Council, "to examine, inter alia, the relationship between the TRIPS Agreement and the CBD, the protection of traditional knowledge and folklore. Similarly, WIPO's Intergovernmental Committee on Genetic Resources, Traditional Knowledge and Folklore is discussing models for provisions in access contracts on intellectual property rights, the possibility of a requirement for the disclosure of origin of biological resources in the draft of the Substantive Patent Law Treaty; and methods for defensive and positive sui generis protection of traditional knowledge. WTO suggested for Disclosure of the source of the traditional knowledge and biological materials and disclosure of information about compliance with prevailing laws and practices on genetic resources of the country of origin.
The Food and Agriculture Organization (FAO) was founded in October 1945 with a mandate to raise levels of nutrition and standards of living, to improve agricultural productivity, and to improve the condition of rural populations. The Organization offers direct development assistance, collects, analyses and disseminates information, provides policy and planning advice to governments and acts as an international forum for debate on food and agriculture issues. FAO is active in land and water development, plant and animal production, forestry, fisheries, economic and social policy, investment, nutrition, food standards and commodities, and trade. It also plays a major role in dealing with food and agricultural emergencies. A specific priority of the Organization is to encourage sustainable agriculture and rural development, with the goal to achieve a long-term strategy for the conservation and management of natural resources. A number of instruments which are relevant for the issues of access to genetic resources and the equitable sharing of benefits have been adopted by the FAO Conference. These documents contain internationally recognized principles and recommendation to States, but are not legally binding.
UNCTAD could yield potential benefits to developing countries, including the link between public health and development. This should focus on issues such as:
'''Taking into account the objectives and provisions of the Convention on Biological Diversity and the TRIPS Agreement, studying ways to protect traditional knowledge, innovations and practices of local and indigenous communities, and enhance cooperation on research and development on technologies associated with the sustainable use of biological resources;
'''Support developing countries' efforts in promoting production of and trading opportunities for environmentally preferable products;
'''Ways to promote and to support investment and trade contributing to economic growth and sustainable development, inter alia, in biological resources, such as the Bio trade Initiative;
'''Strengthening the importance of adequately valuing natural resources with a view to enhancing the competitiveness of goods and services generated by those resources;
'''Helping developing countries in enhancing understanding of trade, environmental, including biodiversity, and developmental implications of biotechnologies.
Established in 1945, UNESCO has developed, within its fields of competence.
In addition, UNESCO is currently elaborating a proposal for an integrated action in this key area and involving its sectors for Natural Sciences, Social & Human Sciences, Culture, Education and Communications .
The World Health Organization (WHO) was founded in 1948. It helps in promoting the technical cooperation for health among nations and programmes are carried out to control and eradicate diseases and also to improve the quality of its quality.
ii. Approaches in different countries.
Also there are various approaches of different countries in protecting this traditional knowledge .These are :
The Organisation of African Unity (OAU), now The African Union.
It attempts to implement the provisions of CBD and thus provides a guide to member states of OAU wishing to promulgate domestic legislation that implements the Bio diversity convention. Like the Bio diversity convention , the main objective of the model legislation s to ensure conservation of biological diversity , sustainable use of its components and equitable distribution of benefits arising out from its utilisation .It also seeks to protect TK of local communities , plant breeders right and to recognise and reward the particular contribution of women to bio diversity .Part 4 of the model legislation establishes community rights as the sui generis framework for the protection of Traditional Knowledge .Under the model legislation the state should recognise traditional or indigenous societies as legitimate custodians and users of Traditional Knowledge. Part 5 of the model legislation establishes a sui generis regime for the recognition and protection of farmer's right.
The Andean Community.
The Andean Community's regional decision 345, provided a sui generis approach that simultaneously met UPOV requirements. Decision 391 of the Andean Community (Common regime on access to genetic resources , July,1996) deals with some aspects of Traditional Knowledge .It establishes the basis upon which Traditional Knowledge may be protected within the Andean Community .However, this rule falls short of creating a comprehensive regime only determining that in the future such a special regime a rule allowing for the harmonisation of national laws on the matter should be enacted. One of the reasons for protecting the distinctiveness of sui generis regime over IP is that indigenous people are against the use of IP because of its market orientation and that it creates monopolies .While indigenous knowledge is perceived as a commonly shared resource by indigenous population who are more often than not , happy to share their knowledge as long as they receive some recognition. There are essentially four strategies defended by the Andean community when it comes to protection of TK and intangible heritage. One of the adoptions of 100% sui generis regime . Another is the predominant use of sui generis regimes but having IP tools as a fall back mechanism. The third one is leaving the matter up to national legislations. Finally, the use of indigenous customary law, which seems to be the preferred alternative by the indigenous people in the region.
The ASEAN Framework Agreement.
The ASEAN framework agreement on access to biological and genetic resources was drafted from 24 February 2000. The Association of South East Asian Nations (ASEAN) has certain principles with regards to access to biological and genetic resources. The Member States have sovereignty over biological and genetic resources within their territories in accordance with the provisions of the Convention on Biological Diversity. They shall recognize, respect, preserve and maintain the knowledge, innovations and practices of indigenous peoples and local communities embodying traditional lifestyles to their natural resources, including
genetic resources. They shall ensure the conservation and sustainable utilization of the biological diversity in the ASEAN region. There should be fair and equitable sharing of benefits arising from the utilization of biological and genetic resources at the community, at national and regional levels .Biological and genetic resources shall be regarded as a sacred heritage for all humankind and reject the application of the patent system thereon. The importance of ensuring that food security shall be recognised in the region is and the importance of the exchange and utilization of food crop germplasm shall be utilized.
The Framework Agreement has also certain objectives. Like to ensure the conservation and sustainable use of biological and genetic resources and equitable sharing of benefits arising from access to those resources, consistent with the principle of prior informed consent. Secondly, to accord recognition and protection to traditional knowledge of indigenous peoples and local communities, and to facilitate fair and equitable sharing of benefits with the said communities where traditional knowledge is utilized. Thirdly , To ensure that the peoples of ASEAN derive maximum and fairly shared benefits from the development and uses of biological and genetic resources within their territories .Also to promote cooperation among ASEAN Member States in the utilization of, and providing access to biological and genetic resources and encourage the sharing of resources. To ensure that regulations within the ASEAN region are uniform and consistent in accordance with identified minimum requirements as set out in this Framework Agreement. To set minimum standards in regulating access to biological and genetic resources and strengthen national initiatives towards this objective; and to promote technology transfer and capacity building at the regional, national and community levels. Lastly, effective and participatory measures for the grant of prior informed consent up to the local level taking into account national perspectives and priorities shall be established.
The Brazilian sui generis measure.
In Brazil there is Provisional Measure No. 2186-16 of 2001 Regulating Access to the Genetic Heritage, Protection of and Access to Associated Traditional Knowledge. Here the main objectives are to legislate on access to components of the genetic heritage, access to traditional knowledge relating to the genetic heritage; the fair and equitable sharing of the benefits deriving from exploitation of associated traditional knowledge; access to and transfer of technology for the conservation and use of biological diversity. The subject matter is Traditional knowledge of indigenous and local communities relating to the genetic heritage. Associated traditional knowledge is defined as: 'information or individual or collective practices of an indigenous or local community having real or potential value and associated with the genetic heritage. The Conditions for Accessing traditional knowledge is defined as the acquisition of information pertaining to knowledge or individual or collective practices, associated with the genetic heritage, of an indigenous or local community for purposes of scientific research, technological development or biological prospection, with a view to its application in industry or elsewhere. The special authorization of access to associated TK for a national institution that carries on research and development activities in the biological and related fields, and for a national university, for a term of up to two years, renewable for equal periods, as provided in the regulations .Access to associated traditional knowledge, shall be had by collection of information respectively, and authorization shall only be given to a national research institution in the biological and related fields by prior authorization.
Accredited institutions may be granted the powers to analyze applications for access to TK, subject to the PIC of the owners from the area .Access to TK associated with the national heritage shall be had by collection of information and authorization shall be given to a national institution that researches in the biological or related fields by prior informed consent. Conditions of Protection of TK must be related to the genetic heritage, belong to an indigenous or local community, and have real or potential value . Indigenous or local communities are guaranteed the rights granted under Art.9 on the condition that they created, developed, held or preserved the TK . Traditional knowledge associated to the genetic heritage is protected 'against illicit use and exploitation and other actions that are harmful or have not been authorized' by the Management Council or an accredited institution. Communities that create, develop, hold or preserve TK associated to the genetic heritage are guaranteed the right to have the origin of the access to TK mentioned in all publications, uses, exploitation and disclosures and to prevent unauthorized third parties from using or carrying out tests, research or investigations relating to associated TK and disclosing, broadcasting or re-broadcasting data or information that incorporate or constitute associated TK .And to derive profit from economic exploitation by third parties of associated TK the rights in which are owned by the community. TK holders are allowed to license or assign their rights in TK. TK protection shall not affect, prejudice, or limit rights pertaining to intellectual property. Protection shall not impede preservation, use and development of TK. The customary uses by communities should be preserved in all cases.
The Indigenous people's Right Act of 1997(Philippines).
Indigenous Peoples Rights Act of 1997 (IPRA). To recognize, protect, and promote the rights of Indigenous Cultural Communities and Indigenous Peoples. The aim is to provide for a system of community intellectual rights protection in respect of the innovative contribution of both local and indigenous cultural communities in the matter of development and conservation of genetic resources and biological diversities. The subject matter which ICCs/IPs have the right to control, develop and protect includes 'their sciences, technologies and cultural manifestations, including human and other genetic resources, seeds, including derivatives of these resources, traditional medicines and heath practices, vital medicinal plants, animals and minerals, indigenous knowledge systems and practices, knowledge of the properties of fauna and flora, oral traditions, literature, designs, and visual and performing arts. The subject matter that shall be protected by the State includes 'the past, present and future manifestations' of their cultures. Access to indigenous knowledge related to the conservation, utilization and enhancement of biological and genetic resources , shall be allowed within ancestral lands and domains of the IPs only with a free and prior informed consent of such communities, obtained in accordance with customary laws of the concerned community. The State shall protect the right to the restitution of cultural, intellectual, religious, and spiritual property taken without their free and prior informed consent or in violation of their laws, traditions and customs.
The Plant Varieties Protection Act (Thailand).
It is an effective plant variety protection system can be adopted as an instrument of development policy designed to promote development of agriculture in Thailand. The TRIPS Agreement also supports this rationale by authorizing WTO Members to develop any form of plant variety protection suited to their development needs and priorities. Thailand passed the Plant Variety Protection Act in 1999 as a means to promote agricultural development in the country to establish and protect intellectual property rights in new plant varieties so as to foster the development of agriculture by creating a regime for the breeding and utilization of such varieties, as well as to recognize the rights of farmers and local communities as custodians of crop cultivars by allowing them to register local plant varieties. The Thai PVP Act recognizes the vital role of farmers and local communities in protecting traditional knowledge by allowing them to register local domestic plant varieties as a means to create community property rights in contrast to breeders' varieties. In summary, an effective plant variety protection system seems to be the most suitable type of IP development strategy for Thailand because agriculture represents a fundamental economic activity and livelihood for a large section of the Thai population. It touches the crucial question of economic development, agricultural management, and livelihood of the majority of the Thai population. The TRIPS Agreement of the WTO, which regulates the rule of plant variety protection at international level, also supported this rationale and provided for the implementation of effective plant variety protection as development policy. With a view to promote agricultural development as a national agenda, Thailand has enacted the Plant Variety Protection Act in 1999 by taking advantage from the TRIPS flexibility.
The Act on the promotion and protection of Traditional Thai Medicinal Intelligence.
The scope of subject matter protected under the Act includes 'formulas of traditional Thai drugs' and 'texts on traditional Thai medicine. .Text on traditional Thai medicine is defined as the technical knowledge concerned with traditional Thai medicine which has been written or recorded in Thai books, palm leaf, stone inscription or other materials or that have not been recorded but passed on from generation to generation. Formula of traditional Thai drugs is defined as 'a formula stated as the production process and ingredients which contain Thai traditional drugs, no matter what form the ingredients are.
In general, traditional Thai medicinal intelligence means the basic knowledge and capability concerned with traditional Thai medicine. Traditional Thai medicine is defined as 'the medicinal procedures concerned with examination, diagnosis, therapy, treatment or prevention of, or promotion and rehabilitation of the health of humans or animals, obstetrics, traditional Thai massage, and also includes the production of traditional Thai drugs and the invention of medical devices, on the basis of knowledge or text that has been passed on from generation to generation.
Protecting Traditional Knowledge under a sui generis system.
It has been suggested that only a system of protection of traditional knowledge that provides proprietary rights can ensure that market forces will operate to generate fairness and equity. A proprietary protection approach could provide protection erga omnes, in the sense that, even if the knowledge is in some way publicly disclosed, there could be mechanisms available to prevent its use by all third parties.
In response, it has been said that any discussion of such a system would require clarity as to the definition and scope of the term traditional knowledge. There would also be considerable hurdles to overcome regarding issues of the determination and modalities of ownership. It has also been said that careful thought would need to be given before establishing different systems of intellectual property protection for public domain traditional knowledge developed by industrial and non-industrial communities. In response, it has been argued that the absence of clarity as to the meaning of some terms or the limited amount of experience with national legislation should not be used to justify a refusal to discuss, any more than they had deterred Members from agreeing to the protection of a range of subjects in the TRIPS Agreement that were new to many Members.
The point has been made that there is nothing in the TRIPS Agreement that prevents WTO Members from setting up a specific protection regime for traditional knowledge that regulates or enforces access to, prohibition of, and rewards for the use of traditional knowledge. Support has been expressed for developing an international model for such legislation.
With regard to action at the multilateral level, views have been expressed that national systems will not be sufficient and that there is a need to explore an international system of minimum standards of protection of traditional knowledge, drawing on synergies with the work of CBD, WIPO, FAO and UNCTAD. Another view in this connection is that once WIPO has completed work on model national legislation, attention could be focused on how and to what extent the protection of traditional knowledge can be included in the TRIPS Agreement.
Some more specific suggestions have been made on what such a sui generis system should cover:
- a possible definition put forward states that traditional knowledge consists largely of innovations, creations and cultural expressions generated or preserved by its present possessors, who may be defined and identified as holders of rights who are either individuals or whole communities, natural or legal persons. It should cover products as well as services;
- the rights provided should follow those provided in Article 28 of the TRIPS Agreement so as to give exclusive rights to prevent third parties not having the owner's consent from the acts of making, using, offering for sale, or importing the covered product or process;
- creating a system for registration of innovations and giving the registered owner the right to challenge any use of the innovations without prior permission. It has been said that for novel and useful innovations, some kind of a petty patent system should be implemented.
Chapter 5) Protection of Traditional Knowledge : Indian perspective
In view of the inefficiency of the intellectual property rights to protect TK, India has enacted the following sui generis legislations:
The Biological Diversity Act, 2002
This is India's reaction to the Convention on Biological Diversity, 1992. The Act reaffirms the sovereign rights of states over their biological resources and provides for conservation, sustainable utilisation and equitable sharing of benefits arising out of the utilisation of genetic resources. The Act is supplemented with the Biological Diversity Rules, 2004, which further deals with access, knowledge transfer and intellectual property rights. The formula for benefit-sharing shall be determined on a case-by-case basis and notified in the Official Gazette . If the compensation or benefit sharing is paid in money, the National Biodiversity Authority may direct these funds to individuals, groups or organisations that can be identified as the source of the resource or knowledge. If that is not possible, the benefits shall be deposited in the National Biodiversity Fund.
The Act can be extended to protect the TK of Ayurveda and other indigenous medicines. Various provisions of the Act are aimed toward protection of TK and benefit sharing. The Act states that no foreigner, non-resident or body corporate, shall, without previous approval of the National Biodiversity Authority, obtain any biological resource occurring in India or knowledge associated thereto for research or for commercial utilization or for bio-survey and bio-utilisation . As far as intellectual property is concerned, No person can apply in or outside India for any invention based on any research or information on a biological resource obtained from India without obtaining the previous approval of the NBA before making such application. But if a person applies for a patent, permission of the NBA may be obtained after the acceptance of the patent but before the sealing of the patent by the patent authority concerned . The NBA may, while granting the approval under this section, 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 . Any person who intends to apply for a patent or any other form of intellectual property protection whether in India or outside India has to make an application in the prescribed form to the NBA. The NBA may, after making such enquiries as it may deem fit and if necessary after consulting an expert committee constituted for this purpose, by order, grant approval subject to any regulations made in this behalf and subject to such terms and conditions . Further, the NBA while granting approvals must ensure that the terms and conditions subject to which approval is granted secures equitable 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 relating thereto in accordance with mutually agreed terms and conditions between the person applying for such approval, local bodies concerned and the benefits claimers . Other than monetary benefits, benefit sharing may be done in several ways, one of which is granting of joint. ownership of intellectual property rights may be given to the National Biodiversity Authority, or where benefit claimers are identified, to such benefit claimers.
'Prior Consent' provisions are not so strong under the Act. No person can obtain any biological resource for commercial utilization, or bio-survey and bio-utilisation for commercial utilization except after giving prior intimation to the State Biodiversity Board concerned, but this provision is not applicable to the local people and communities of the area, including growers and cultivators of biodiversity, and vaids and hakims, who have been practising indigenous medicine . The Act has also drawn criticism in that even an Indian citizen or company registered in India will have to obtain permission in order to utilize biological resources according to Chapter II (7). Chapter II (7) states this will not apply to local communities as well as those practicing Traditional Medicine. Nevertheless, the fear is that this may in fact prevent basic research by non-local groups (such as universities) in India . Chapter 5 (4) of the Bio-diversity Act states that the NBA shall give public notice of every approval for use of biological resources. This public scrutiny serves as a safety valve to allow other right holders to come forward. This is in keeping with India's proposal to revise the TRIPS agreement. The Bio-diversity Act clearly signals India's intention of asserting rights to both biological resources and Traditional Knowledge. It specifically addresses the problem of foreign companies patenting Indian Traditional Medicine . The overall effect of the act remains to be determined. If the law is too restrictive it could hamper research with burdensome administrative procedures. At best, however, it could protect national sovereignty in biological resources, including Traditional Knowledge.
The Protection of Plant Varieties and Farmer's Right Act ,2001
This Act seeks to provide for the establishment of an effective system for protection of plant varieties, the rights of farmers and plant breeders and to encourage the development of new varieties of plants. India, having ratified TRIPS enacted this legislation interalia to make provision for giving effect to sub-paragraph (b) of paragraph 3 of Article 27 in Part II of TRIPS relating to protection of plant varieties. Under the Act, The Central Government shall, by notification in the Official Gazette, establish an authority to be known as the PPVR Authority for the purposes of this Act. It shall be the duty of the Authority to promote, by such measures as it thinks fit, the encouragement for the development of new varieties of plants and to protect the rights of the farmers and breeders.
The relevant measures in relation to plant based medicinal products that may be provided for are: The registration of extant and new plant varieties subject to such terms and conditions and in the manner as may be prescribed. Developing characterisation and documentation of varieties are registered under the Act. There is documentation, indexing and cataloguing of farmers' varieties. Also there is compulsory cataloguing facilities for all varieties of plants. And collecting statistics with regard to plant varieties, including the contribution of any person at any time in the evolution or development of any plant variety, in India or in any other country, for compilation and publication. Lastly, to ensure the maintenance of the National Register of plant variety. Further, under the Act a register shall be maintained, all the names of all the registered plant varieties with the names and addresses of their respective breeders, the right of such breeders in respect of the registered variety, the particulars of the denomination of each registered variety, etc shall be entered into . A new variety or an extant variety shall be registered under this Act if it conforms to the criteria novelty , distinctiveness , uniformity and stability .
Under the Act, an essentially derived variety may also be registered. The Authority shall get examined such essentially derived variety to determine as to whether the essentially derived variety is a variety derived from the initial variety by conducting such tests and following such procedure as may be prescribed. When the Authority is satisfied on the report of the tests that the essentially derived variety has been derived from the initial variety, it may direct the Registrar to register such essentially derived variety and the Registrar shall comply with the direction of the Authority . The Act then seeks to protect the right of the breeders and benefit sharing with the breeders. This Act does not directly deal with intellectual property for Plant based medicinal products or Ayurveda, but lays down protection for new varieties of plants that must be kept in mind as well.
Drugs and Cosmetics Act , 1940
The Drugs and Cosmetics Act, 1940 is an Act to regulate the import, manufacture, distribution and sale of drugs and cosmetics. It does not deal with the intellectual property regime regarding plant based medicinal products and Ayurveda, but this is the only Act that imposes some standardization and quality control on Ayurveda. But it is strange to see that despite the completely different nature of Ayurveda from other kind of medicinal drugs, there is no separate standard developed for Ayurvedic products. Chapter IVA of the Act deals with Ayurveda, Siddha and Unani. The Act prevents the manufacture for sale and distribution any spurious , misbranded or adulterated Ayurvedic Product. Thus it can be clearly seen from this Act, that there are no specific standards evolved for products of the nature of Ayurveda and other traditional medicine. In the absence of specific standards, the regulation of the ayurvedic sector becomes vague and complicated.
The Patents Act , 1970
India's Patents Act prohibits patents on derivatives of known substances, unless such derivatives display significantly enhanced efficacy. Section 3(d) of the Patents Act, 1970 (2005), provides:
The following are not inventions within the meaning of this Act,-
(d) the mere discovery of a new form of a known substance which does not result in the enhancement of the known efficacy of that substance or the mere discovery of any new property or new use for a known substance or of the mere use of a known process, machine or apparatus unless such known process results in a new product or employs at least one new reactant.
Explanation.- For the purposes of this clause, salts, esters, ethers, polymorphs, metabolites, pure form, particle size, isomers, mixtures of isomers, complexes, combinations and other derivatives of known substance shall be considered to be the same substance, unless they differ significantly in properties with regard to efficacy'.
India's restrictive position is in sharp contrast with the U.S., which broadly permits the patenting of any new use for a known product so long as that new use meets the requirements of novelty, non-obviousness, and utility. The question accordingly arises whether Section 3(d)'s broad exclusion of new use patents complies with TRIPS. Although Article 27.1 of TRIPS mandates that patents be available for "processes in all fields of technology," TRIPS nowhere defines "processes." Moreover, Art. 27.3 of TRIPS explicitly permits member countries to exclude "diagnostic, therapeutic and surgical methods for the treatment of humans or animals" from patentability.
India's Patents Act already excludes such methods of treatment in Section 3(i), so one must conclude that the Section 3(d) exclusion covers broader ground; i.e., methods of use even beyond those contemplated within Section 3(i) . India now defines an "invention" as a 'new product or process involving an inventive step and capable of industrial application,' thus codifying in its laws the TRIPS-required substantive minima of patentability .
Section 3(j) of the Indian Patents Act excludes from patentability 'plants and animals in whole or any part thereof other than micro-organisms but including seeds, varieties and species and essentially biological processes for production or propagation of plants and animals.' This provision added to the Act via the 2002 amendment harmonizes the Indian law with the TRIPS-permitted exclusion from patentability of 'plants and animals other than micro-organisms, and essentially biological processes for the production of plants or animals other than non-biological and microbiological processes.' As TRIPS also contemplates, India has chosen to exclude seeds as well as varieties and species of plants and animals from patentability, but provides sui generis protection for this subject matter under the PPVR Act, 2001 .
Section 3(p) of the Act protects TK. It excludes from patentability 'an invention which in effect, is TK or which is an aggregation or duplication of known properties of traditionally known component or components.' This exclusion is inserted into the new Act in order to prevent the exercise of proprietary rights in India's indigenous knowledge and would cover Ayurveda as well. This exclusion is but one of several provisions inserted into the new Act in an effort to prevent the exercise of proprietary rights in India's genetic resources and indigenous knowledge.
In the case of Traditional Medicine, section 3 (d) still applies. Traditional Medicine will continue to be difficult to patent in India. The Amendment lists what are not inventions: the mere discovery of a new form of a known substance which does not result in the enhancement of the known efficacy of that substance or the mere discovery of any new property or new use for a known substance or the mere use of a known process, machine or apparatus unless such known process results in a new product or employs at least one new reactant .
The Act's disclosure requirements mandate inclusion of the source and geographical origin of biological material used in the claimed invention , and interested parties may oppose or petition to revoke an Indian patent on the ground that the invention claimed therein is anticipated "having regard to the knowledge, oral or otherwise, available within any local or indigenous community or elsewhere." Such provisions provide India with explicit statutory bases for fending off future attempts to obtain Indian patents that exploit Indian natural resources and knowledge.
Seed Bill, 2010
The proposed legislation with the aim of ensuring quality and thus requiring compulsory registration of all farmers' varieties seems to be a move towards pushing farmers to a dependency on corporate seeds as it is beyond the capacity of small farmers to meet the myriads criteria, complex processes and high costs of registration. The proposed law prohibits exchange of unregistered seeds, a traditional practice still being followed in large parts of the country. The traditional practice of barter in many parts of the country, for various reasons, has been partly replaced by sale and purchase either within the community or in haats (local village market). The traditional practice of seed exchange is still very common among the mountain communities where the community bonding is strong.
Communities are not being able to come to grips with the new situation. The agrarian communities find it difficult to believe that such a law could be enacted which will take away their right to save, sow, exchange and sell their seed. This is a new experience for India but many developed countries have had seed laws of this nature for over a decade and it is worth learning from those experiences. Introduction of IPRs prevent farmer from exchanging unregistered seeds and engaging in their own seed production which eventually leads to extinction of the farmers' varieties thus leading to a loss of agro-biodiversity.
Also hampers/ curtails their right to self determination of what they would like to grow, what inputs they would like to use, it affects their right to follow their own practices which are closely linked to their socio-cultural ethos.
Enactment of such laws by the Parliament of a country which infringe upon the rights of the farming community which forms the majority of population in a country raises grave concern and questions to the constitutional mandate of a welfare state. Such IP laws in area of plant variety and seed protection affect the community rights of the farmers to their collective and cumulative innovations. Such laws overlook the role of farmers as breeders and conservers. In the era of globalization, there is a role back of the function of the state where national governments in the developing countries across the globe are losing sight of their role as a welfare state and are being pushed to promote and protect the rights of the corporate plant breeders instead of the indigenous and traditional plant breeders who have ensured food sovereignty and food security thus far.
The Patent (Amendment) Act, 2005
It has made an addition in the area of specification of inventions which are not patentable that 'an invention which is mere new use for a known substance' and 'an invention which , in effect , is traditional knowledge or which is and aggregation or duplication or known properties of traditionally known substances' will not be an invention. Section 25 of the Act, which deals with post grant opposition, has also been amended to provide that any person can make an opposition on the ground of lack of novelty and anticipation of the invention by the knowledge, oral or otherwise available within any local or indigenous groups. This Act of 2005 provides a form of defensive protection under patent law in India and positive protection has been recommended by way of sui generis legislations over and above this amendment.
India, a country rich in traditional knowledge and biodiversity, has seen various attempts to regulate access to and ensure equitable benefit sharing with the traditional communities. In January 2009, a congregation of like minded people with the aim to conserve traditional knowledge, met in Bangalore to deliberate on the most practical ways to conserve traditional knowledge in what was formally called 'The First National Consultation on TK and IPR'. This congregation witnessed an active participation from the Delhi based Forum for Biotechnology and Food Security, Thanal: a Kerela based NGO and the National Law School of India University, Bangalore.
Deliberations were held over on the basic structure of a sui generis legislation to protect TK and to establish a transparent and viable PIC and ABS mechanism. Emphasis was laid on defining traditional knowledge, the PIC/ABS mechanism and enforcement of the rights and
Traditional Knowledge Digital Library (TKDL).
The government of India has taken the initiative of establishing the Traditional Knowledge Digital Library (TKDL) so that all the documented knowledge about the medicinal plants in Indian traditional system become accessible to the patent examiners globally with the objective to prevent the grant of patents for non original inventions. The project set out to start with documenting selected plants, which have direct o r indirect relation with the expectancy. The starting point is to match the Traditional Knowledge with the International Patent Classification (IPC) system. This will aim at identifying various classes , sub classes, groups and sub groups that are applicable to medicinal plants. The TKDL will enable identification of information on patents in the category of traditional plants indicating the prior art. The traditional knowledge is to be placed in the structured form that can be quickly retrieved on processes for the preparation of drugs and its uses, details of plants used, therapeutical compound formulations , compositions ,doses and diseases. The TKDL aims to establish its own internal classification system that is transparent to patent examiners, permitting total functionality and search facility. The classification system renders support to R&D scientist in identifying latest inventions and technological advances. The proposed classification system of TKDL can be useful to R&D scientists in obtaining leads based on the prior art in Indian traditional knowledge system. Classification system should facilitate access of information for use by R&D scientist that integrate all the three classification system : the biological classification of plant based knowledge ,applications of plant based inventions and the classification system practised by the patent offices for quick retrieval of information.
After a series of meetings and conferences, India has drafted 'The Traditional Knowledge (Protection and Regulation to Access) Bill, 2009.
This Bill is the first ever attempt made in India for a separate and complete regime for protection of Traditional knowledge in India. India is one of the most diversely rich countries with a number of traditions and cultures absorbed in it. The vast pool of traditional knowledge includes the use of herbs and plants as medicines, folklore, artistic works, etc. The controversy pertaining to Neem and turmeric has brought the concern for protection of this traditional knowledge in the lime light. The present draft Bill aims to provide for protection, conservation and effective management of traditional knowledge. It further provides the need for protection of integrity and sentiments of communities against distortions and disrespectful representations of forms of traditional knowledge and protection from improper commercial exploitation of such forms. It emphasizes the need for sustainability of resources on which traditional knowledge is based, as well as ensures the continuation of the customary practices of the traditional knowledge. Further the bill provides for a mechanism to access and share such traditional knowledge along with the rights of the communities who hold such knowledge.
The bill is divided in 9 difference chapters: the Short title, commencement and applicability of the Act is mentioned at first. ; The definitions and interpretations which includes the definition of traditional knowledge, abuse, access, accessor, benefit, informed consent, misappropriation, prior informed consent, traditional community, etc. The rights and duties of the traditional communities; chapter 4 provides for Establishment of authorities such as Traditional knowledge authority, functions of the TK authority, committees on the TK authorities, State traditional knowledge board, etc. Regulation of access to traditional knowledge and informed consent, traditional knowledge register, procedure for registration of traditional knowledge, constitution of traditional knowledge fund, national strategies for conservation and development of traditional knowledge, etc. The finance, accounts and audits of TK Board ;The duties of Central and State governments ; The offenses, penalties and procedure, protection of action taken in good faith, etc .Miscellaneous provisions such as which documents are open for public inspection, annual reports of the TK authority, TK authority to be bound by the directions of the central government, powers of TK authority, appeal mechanism, power of central government to make rules, power of TK authority to make regulations, etc The decision of the IPAB can be challenged by appeal to Supreme Court of India.
Thus, we see that India has enacted specific legislations in order to provide protection to TK even in the absence of a single comprehensive framework. In addition to this is also submitted that criterions of novelty, non-obviousness and originality etc. cannot be satisfied by TK. In the present system patents and copyrights can be granted only if the invention or creation is fixed in a certain medium or if there is material evidence of the same. Unfortunately, TK is based on oral traditions and there is very little documentation of it. Simply put, IPRs such as copyright and patent are legal mechanisms to encourage innovation - the creation and disclosure of new knowledge or new expressions. These rights are granted to a defined individual or group of individuals identified as the inventor or creator, although they can be transferred to another by sale or gift. TK and practices, in contrast, are often handed down from generation to generation, and have no clearly identifiable individual inventor. Thus, it has been widely stated that IPRs are not suitable for TK because they protect new knowledge that is created by individuals and do not recognize collective rights. Therefore it may be concluded that the present IP regime is not capable of handling traditional knowledge.
Chapter 6). Conclusion and Suggestions.
Biodiversity and Traditional Knowledge are integral to the well being of individual countries and the world as a whole .Introduction of IPR in bio diversity lead to enhanced use of technology .The application of technology , genetic engineering and biotechnology give rise to many environmental , economical and social issues .Economics and trade are imminent , so is the IPR and patent .However , economic activity must be ecologically sustainable .It must not degrade the integrity of the bio sphere or biological systems in the present or in the foreseeable matter. This should be of paramount importance in order to sustain human life and maintain the diverse ecological web that human life depends on. There are moral ethical issues too.WTO is a very potential trade regulating body .Unlike other international organisation it allocates one vote for every country with no discrimination based on wealth or population .This could be very beneficial in standing up for the rights of developed countries if power were as equitably distributed as it should be in WTO .Unfortunately , the developed nations are much in a better bargaining position and therefore it is not uncommon for a small concession by them to be treated for a much larger concession by desperate developing countries. TRIPS treaty was created by the WTO in 1995 .Most of the member countries of WTO had previously banned patent of biological resources but TRIPS make it mandatory to allow some of these patents .Although bio piracy has been an old issue, TRIPS has drastically increased its prevalence and the patentability of life forms and genetic material .There are a number of economic concerns associated with bio piracy and TRIPs in developing countries .The debate over whether TRIPS will boost or blight in a complex one. Advocates of TRIPS assert that the agreement could provide benefits of GMO'S and other fruits of life patents hat could drastically improve living standards in the poorer countries of the world through increased agricultural productivity .
Opponents of TRIPS argue that stealing TK , patenting it and selling it back to its creators will do nothing to the world's poor .Nevertheless bio piracy may lead to improved crop yields to improve life of billions of poor people .But the fact that these improved crops was already used by the world's poor in the first place is effectively stolen and used to benefit a corporation rather than locals .To protect the rights of all people TRIPS should provide a framework for stopping theft to plant genetic resources .There should be a clear and strict regulation n this kind of stealing .The theft of TK limits the freedom of the poor to use their own Intellectual property and deprives them of a valuable asset. If the provisions of TRIPS are not revised all the benefits will go to the developed nations. It will mean an unjust ,unfair world with the burden of the cost on the poor and unrepresented.
The economic , environmental and social concerns of TRIPS and biopiracy need to be given serious thought. The matter of conflicting aspects of the CBD and TRIPS need to be resolved. The provisions of CBD does not have equal weight as TRIPS have. Upholding the statutes of CBD or at least finding a workable solution between the two treaties would provide an amicable formulae and opportunity to develop simultaneously for all the nations of the world.
Therefore TRIPS and CBD should be on the same premises that the sustainable use of bio diversity and fair and equitable sharing of the benefits arising out of the utilisations of genetic resources.
It is also possible to allow for continuation of the farmer's practices in the presence of a sui generis system to protect TK. The sui generis option makes nation aware of the need to define clear policies with regard to simulating commercial plant breeding and access to foreign varieties and biotechnologies.
The government and citizen should come together to protect the knowledge to our traditions from unethical perspectives .It is often difficult to check unscrupulous patenting on Traditional Knowledge and patenting of plants from their place of cultivation because documentation, validation and recognition of Traditional Knowledge , Geographical Indication etc is lacking and the present Patent Act does not allow patenting of products per se.
' If the patent is sought for the item based on Traditional Knowledge , then consent from the concerned group must be taken of .If permission is refused , then no patent should be granted .If consent is given , a benefit sharing agreement should be entered into between the two parties on just , equitable and fair terms.
' The cost of getting patent is very high that may be reduced for the traditional communities. Even assuming that they may obtain patents, indigenous and local communities who are the custodians of bio diversity , cannot compete in the patenting arenas. The costs are too high , around $20,000 for patent preparation , $1000 per language translation , up to $250,000(or even more ) if the patent is legally challenged.
' It is also proposed that there should be some increase in the patent fee that corporations must pay for patent on genetic resources that may be put in a fund. This fund could be used to pay for a portion or all of the legal costs of a traditional community challenging a patent when based on unauthorised appropriation .Obviously , for these regulations to be helpful, the global patent system would have to be standardised to the point of inclusion of these stipulations. Therefore it is important to develop alternative knowledge protection systems which protect the generated innovations. These systems should take into account the underling ethos and traditional practices of communities, which keep innovating from generation to generation largely for social and domestic purposes.
' The sui generis community rights should be developed .The innovations to be protected by such a system which will bear the following characteristics. Collective as distinct from individual or corporate ownership based on a free exchange and not restricted in nature .A collective rights system would best suit the needs of indigenous communities to protect their knowledge about and their use of biological material community intellectual rights could bridge the gap between the CBD and TRIPS. The proposed system recognised and protects the knowledge system of traditional people and local communities .Furthermore , it acknowledges and preserves the social and cultural life of traditional societies which embodies knowledge and practices supportive of bio diversity .Access restrictions and benefit sharing rights of Prior Informed Consent System should form an integral part of the sui generis system .If communities want to optimise the remuneration they might make their resources available only to highest bidder.
' The protection f TK will serve the twin purpose ' Firstly , to prevent abuse and secondly , the people having this knowledge will have the autonomy to decide by themselves anything happening with regard to this knowledge and finally it is important that this knowledge can live on that the cultural entity and what endangered this knowledge is supported .They will receive just compensation and equitable benefits from such use. Community healers may not know the exact bacteria or fungi , but they know the anti- tumour , anti-biotic and steroid characteristics of the soil they use to treat wounds and diseases .When companies collect these informations, these communities and developing countries are not compensated for either the material nor the knowledge.
' Different objectives to be combined are such as promotion of commercial Research and Development , conservation of agro 'bio diversity and equity in natural resource distribution .To allow this creativity to flourish and to remunerate inventions that are crucial to the preservation of bio diversity , the knowledge system of indigenous people and local communities have to be acknowledge .
' There are significant environmental , economical and social issues associated with the globalised patent system in the in the developing world. One of the most continuous issues that has cropped up from patent regime in the issue of bio piracy, patents of Traditional Knowledge and DNA by western corporations and government agencies .This bio piracy as developing countries deem it or bio prospecting , as western countries label it is entangled in a number of ethical and economic pitfalls .Most of the worlds diversity is in developing countries 'providing a vast untapped economic resource for medical , agricultural and bio tech companies .Industrial countries own 97% of the world's patent .But if the developing countries that account for 90%of the world's biological resource on which many of the patents depend.
' Taking into account the problems which developing countries are facing , it does not mean that IPR should not be introduced .In fact, these countries and LDC should concentrate on adopting domestic IPR legal framework which serves their needs and simultaneously strengthen their capabilities to compete with developed countries .Patent, in fact , has a great potential to further country's economy. The developing countries may be united as to get some of the controversial provisions of TRIPS to be revised.
' Preservation of TK is more important than exploitation to maintain biological and cultural diversity .
' Issues that should be addressed include the contradictions between CBD and TRIPS, protection and preservation of plant varieties , TK , food security , health concerns , ecological sustainability ,equity and equitable distribution and others.
' Developing countries should protect the knowledge of indigenous people and local communities on the ground that it would be necessary to enhance their socio economic and indigenous technological developments.
What is needed to be done in India.
India is a vast country with 6 crore acres of land having many rivers, streams, reservoirs and mountains like the Himalayas. It is a country rich in flora and fauna resources. Various medicinal plants grow in India having amazing healing properties. This knowledge of these plants has been known to India to different communities for years. Various Multi National Corporations (MNC), are trying to get patents on various usages of medicinal plants all over the world .And they are trying this in India too .So this is a threat to India and an immediate measure is necessary to stop these bio piracies by the MNCs. And also technology is growing at a rapid pace. The enhanced use of technology and bio technology has given rise to many issues ' environmental, economic, social, moral, ethical etc. These technologies have affected Traditional knowledge too.
The Traditional Knowledge is owned by the entire community and hence when a patent is granted on an invention relating to Traditional Knowledge, such community should get some benefit out of it .They should get some share out if it .There is a need to revise the TRIPs treaty to prevent bio piracy and thereby protecting Traditional Knowledge. The contradictions between the Convention on Biological Diversity and TRIPs should be streamlined with a multi pronged approach. Human rights should be recognised and the natural world should be utilised in a sustainable manner so that our future generations can use these resources. To help this, various steps can be taken with the advice of the economists, environmentalists, civil society, indigenous groups, ordinary people and the government. Economic activity must be ecologically sustainable in order to sustain human life and to maintain the diverse ecological web that human life depends on.
India and many other countries have introduced a sui generis system to protect their plant varieties. Obviously, there is a need to include other issues in these sui generis system that go beyond the framework of the TRIPS agreement.
Another option can be to develop a bundle of rights for the different fields of protection: a right system that is in compliance with the legal requirements of TRIPS. In India there is rapid growth of population and there is reduction in the agricultural resources. So biotechnology needs to be judiciously deployed. Additional legislation should be taken into account in protecting Traditional knowledge and the equitable sharing of benefits arising out of the use of agro bio diversity. A valuable information on Plant Genetic resources and traditional plants products need protection by the way of legislations and developmental benefits and for encouraging farmers and youth for diversity protections.
Traditional Knowledge should be respected in all patent laws .Since the IP is often owned by an entire community, the entire community should have some share in the patent rights. This is one of the surest way to fight bio piracy .This is also proposed that traditional communities should be integrated mainstream of the country of origin. The TRIPs treaty needs to be revised to protect TK and bio piracy .Additionally, the TRIPs and CBD treaties should be streamlined to alleviate contradictions and inconsistencies in the two agreements .A multi pronged approach would be essential to deal with the myriad complexities. An effective strategy involving government, economists, environmentalists, civil society , indigenous groups and ordinary people is needed to help more , the world toward a sustainable future where human rights are recognised and natural world is utilised in the present so as to impede the rights of future generations or further degrade the amazing natural heritage.
In addition the following suggestions may be made:
' When there is misappropriation of Traditional Knowledge, it must be stopped.
' India should encourage research and development in the field of Traditional Knowledge.
' There should be stricter laws in India to stop or prevent bio piracy so as to ensure appropriate returns to traditional communities.
' When a patent is sought on an item based on Traditional Knowledge, prior consent should be taken. There should be Prior Informed Consent for any use of Traditional Knowledge whether it is commercial or not. If no consent is given, then TK should not be used. Neither any patent should be granted without prior consent.
' Proper documentation is necessary to recognise Traditional Knowledge and plant genetic resources of an individual or community or locality or country or geographical area on an international level. This will minimise the unscrupulous capitalisation on such information and possession.
' India should develop an easy registration and innovation system of Traditional Knowledge.
' The benefit sharing provision contemplated under CBD and Plant Varieties Protection and Farmer's Right Act should be implemented faithfully.
' Although it is desirable to create sui generis legislation which takes into account all the different needs and aims , its implementation will still depend n a number of factors such as structural capacities , financial resources and expertise.
' The government has now recognised the importance of IPR and need for motivation to transfer the technology for commercialisation to reward the innovators through encouragement for updating research and development for building competence on IPR and related issues.
' There is a need to prevent piracy of TK built around bio diversity to seek harmonisation of the TRIPS agreement with the CBD and FAO so as to ensure appropriate returns to traditional communities.
' There may be scope for protection of Traditional Knowledge recognised Intellectual Property System. This is particularly where the knowledge becomes integral part of bio prospecting and invention development process. Where this is not in case protection may need be sui generis in nature.
' Creation of a sui generis approach to an all encompanying protection of the skills , innovations , practices of indigenous people s a need of hour.
' Sui generis provisions must be flexible enough to suit each country's seed supply system.
' Efforts should be made at global , regional and national level to provide easy , accessible and fair opportunities for the registered TK to be negotiated.
' There is an urgent need for proper documentation validation and recognition of TK and plant genetic resources of an individual , community , locality , country , geographical area on international level to minimise the unscrupulous capitalisation of such information or possession.
' While giving any kind o protection to TK proof of legitimate access should be asked for.
' It is necessary to create inventories of TK in order to fix the memory and present day use of all kinds of knowledge know how belonging to different indigenous people and local communities in all regions of the world and relating to all fields of technologies .This will both assist in conserving this knowledge for future generations.
' Registers or inventories or natural registers for TK may be established.
' Certification of bio prospecting should be established .Academics use should be distinguished.
' Special rules should apply when indigenous communities are involved in research. The community should benefit for participators in genetic research. Research partnership should be experimented .Industry should be engaged in establishing bio partnership with indigenous communities and traditional healers in trying to protect Intellectual Property. Indigenous people will gain more from building long term strategic research partnership with scientists and industry than for merely exercising the power to sell and withhold their knowledge .
' Some bilateral arrangements may also be made .But strictly, the bilateral approach to genetic resources ,Traditional Knowledge should not hamper Research and Development.
' Traditional Knowledge and related material must have been acquired rightfully for good ethical reasons.
' The cost of seeking Intellectual Property protection by communities and individuals must be reduced.
' Public awareness is vital. Every policy /bill/rules etc should be thrown upon for public discussion and subsequent consensus.
For these suggestions t be meaningful, it has be implemented to serve the interest of different groups .The government should do a great service by amending or enacting a new appropriate legislation on the lines suggested by the researcher. Further , international bodies can formulate policies base on the suggestions .Universities , institutions and academicians can debate over the suggested remedies and help in benefitting the community. India needs to protect Traditional Knowledge by enacting suitable legislations. It must be sui generis in nature in character as Traditional Knowledge has different characteristics.
A Primary Sources
' WTO, Agreement on Trade-Related Aspects of Intellectual Property Rights, 1994
' Convention on Biological Diversity (CBD).
' Biological Diversity Act, 2002
' The Patents (Amendment) Act, 2005
' United Nations Declaration on Rights of Indigenous People, 1994.
' World Intellectual Property Organisation.
' The International Convention for the Protection of New Varieties of Plants (UPOV), 1991.
' The Protection of Plant varieties and Farmers Right Act,2001
' The Food and Agricultural Organisation,1945.
' United Nations General Assembly in the field of Trade and Developmen,1964.
' United Nations Educational Scientific Cultural Organisation,1945.
' World Health Organisation,1948.
' The Organisation of African Unity(OAU), now the African Union.
' The Andean Community,1996.
' The Asean Framework Agreement,2000.
' The Brazilian Sui generis measure.
' The Indigenous people's Right Act of 1997 (Philipines).
' The Plant Varieties protection Act, Thailand,1999.
' The Act on the promotion of Traditional Thai Medicinal Intelligence.
' The Copyright Act,1957.
' The Patent Act,1970.
' The Industrial Designs Act,2002.
' The Geographical Indication of Goods Act,1999.
' The Trademarks Act,1999.
' Seed Bill ,2010.
' The Traditional Knowledge (Protection and Regulation to Access) Bill, 2009.
' Drugs and Cosmetics Act,1940.
B Secondary Sources
' Gervais, Daniel, (ed) 'Intellectual Property, Trade and Development' (Oxford University Press, 1st Edn , 2007).
' Ganguli Prabhudda, Intellectual Property Rights Unleashing the Knowledge Economy 138 (Tata Mc Graw-Hill Publishing Company Limited, New Delhi, 2001).
' Nijar Gurdial Singh, TRIPS and Biodiversity. The threat and Responses : A Third World View (Third World Network, 1996).
' Reid Walter V., et. al., A New Lease on Life, in Biodiversity Prospecting: Using Genetic Resources For Sustainable Development (WRI, Washington, DC, 1993).
' Sengupta, Nirmal,(ed.) 'Economics of Indigenous and Traditional Knowledge'(ILI, New Delhi, 1st Edn ,2010).
' Shiva Vandana, Protect or Plunder, Understanding Intellectual Property Rights, (Zed Books Ltd., London, 2001).
' Verma, S.K and Mittal, Raman (eds.), 'Intellectual Property Rights: A Global Vision' (ILI, Delhi, 2004).
Articles and Reports
' Anu Bala, 'Traditional Knowledge and Intellectual Property Rights: An Indian
Perspective', available at: http://ssrn.com/abstract=1954924. (visited on 09/04/14).
' Arunachalam, V 'Indigenous Knowledge and Intellectual Property Rights : The talent Logistics and the overt concerns'7 JIPR 222-232(2002).
' Ananda,Pamela, 'Striking a balance between IPR Protection of TK , cultural preservation and access to knowledge' 17 JIPR 547-558 (2012).
' Bodeker Gerard, 'Traditional Medical Knowledge, Intellectual Property Rights & Benefit Sharing', 11 Cardozo J. Int'l & Comp. (2003).
' Cottier , Thomas. 'The Protection of Genetic resources and Traditional Knowledge : Towards more specific rights and obligations World Trade Law' 555 JIEL 1-32 (1998).
' Cullet, Phillipe, 'Human Rights , Knowledge and Intellectual property Protection' 11 JIPR 7-14 (2006).
' Damodaran ., A, 'Traditional Knowledge, IPR, Bio diversity conservation, critical issues and challenges',13 JIPR (2008).
' Deepak, J.Sai, 'Protection of Traditional Handicrafts under the Intellectual Property laws' 13 JIPR 197-207(2008).
' Downes David R., 'How Intellectual Property could be a tool to protect TK' 25 Colum. J. Envtl. L. (2000).
' Dutfield, 'Protection of Traditional Knowledge and Folklore', 6 Intellectual Property Rights and Sustainable Development Series (2003).
' Eiland Murray Lee, 'Patenting Traditional Medicine', 89 J. Pat. & Trademark Off. Soc'y (2007).
' Garcia,Javia, 'Fighting Bio piracy : the legislative protection of TK'18 Berkerley La Raza Law Journal 25-28(2007).
' Gopalakrishnan ., NS, 'Protection of Traditional knowledge ' Need for a Sui Generis Law in India' 5 The Journal of World Intellectual Property 725-742 (2002).
' Gopalan ,raghuvaran & Sivakumar, Sindhu 'Keeping Cashmere in Kashmir 'The interfacre between GI and TK ' 12 JIPR 581-588(2007).
' Gervais , Daniel J, 'Traditional Knowledge : a challenge to the International Intellectual property system',7 Intl.Intel.Prop.Law and Policy 76(2002).
' Gupta ,V.K 'Report of the Task Force on Traditional Knowledge Digital Library :A gist'6 JIPR 121-144 (2012).
' Halewood Michael, 'Indigenous and Local Knowledge in International Law' 44 McGill L.J. (1999).
' Janak Rana Ghose, 'Access and Benefit Sharing Systems: An overview of the Issues and the Regulation', 11 JIPR 25-28 (2003 ).
' J. Janewa OseiTutu. 'An International Instrument to Protect Traditional Knowledge: Is Perpetual Protection a Good Idea'? 50 IDEA 697 (2010).
' Kalluri Shravan, 'Traditional Knowledge and Patent Strategy'17 JIPR 430-436 (2012).
' Kothari Ashish, 'Politics of Bio-piracy' 23 EPW (1992).
' Krishna ,G.A & Prakash ,V, 'Functional Foods 'The IPR angle' 6 JIPR 286-291(2001).
' Krishnaswamy, Mohana, 'The Basmati Patent 'a blessing in disguise'3 JIPR 347-351(1998).
' Latha ,S,Swarna, 'Biopiracy and Protection of Traditional Medicine in India'22 European Intellectual Property Review 1-17(2009).
' Lalitha ,N ' Protecting traditional Knowledge in Siddha System of Medicine'18 JIPR 271-282(2013).
' Livingston., David J, 'India need an idea bank to lead world in intellectual property protection' 8 Journal of Intellectual Property Rights 213-221(2003).
' Long , Doris Estelle , 'Traditional Knowledge and the fight for the public domain'John Marshall Review of Intellectual Property Law(2006).
' Manly,Rhys, 'Developmental Perspectives on the TRIPS and TK debate' 3 MqJICEL (2006).
' Mashelkar R.A, 'Intellectual Property Rights and the Third World' 81 Current Science (2001).
' Maran, Murasoli, 'Intellectual Property : Policy and Strategy for 21st Century' 6 JIPR 211-214(2001).
' M. Ho Cynthia, 'Bio-piracy and beyond: A Consideration of socio-cultural conflicts with global patent policies', 39, University of Michigan Journal of Law Reform (2006).
' Mueller Janice M., 'The Tiger Awakens: The Tumultuous Transformation of India's Patent System and The Rise Of Indian Pharmaceutical Innovation', 68 U. Pitt. L. Rev. (2007).
' Mukherjee, 'Protection and preservation of TK' Enthabotany and medicinal plants(2012)
' Nair, MD, 'TRIPS, WTO and IPR: Protection of bio resources and traditional knowledge' 16 Journal of Intellectual Property Rights 35-37 (2011).
' Nwabueze Remigius N., 'Traditional Knowledge, Intellectual Property and Indigenous Culture' 11 Cardozo J. Int'l & Comp. L. (2003).
' Prajneshu , Meenaksh, 'Traditional Knowledge Database: IPR and Opportunities for R&D' 6 JIPR 449-458(2001).
' Pushpagandan,P & Nair ,K.Narayan, 'Value Addition and Commercialization of Biodiversity and associated Traditional Knowledge in the context of Intellectual Property Regime' 10 JIPR 41-453 (2005).
' Pilch ,Janice T, 'Traditional Cultural Expression'11 Library Copyright Alliance (2009).
' Ruiz ., Manuel , 'The international debate on traditional knowledge as a prior art in the patent system: issues and options for developing countries'. available at : www.ciel.org/Publications/PriorArt_ManuelRuiz_Oct02.pdf.(visited on 3/04/14)
' Ragavan, Srividhya 'Protection of Traditional Knowledge', 2 Minn Inntel. Prop. Rev. 1-4 (2001).
' Singh, R.D, 'Intellectual Property Rights in relation to Plant Genetic Resources' 4 JIPR 63-66 (1999).
' Stephen R. Munzer and Kal Raustiala, 'The Uneasy Case for Intellectual Property Rights in Traditional Knowledge' 27 Cardozo Arts & Entertainment Law Journal 37-97 (2009).
' Sridharan., Sunita, 'Bridging the Time and Tide- Traditional Knowledge in the 21st Century' 15 Journal of Intellectual Property Rights 146-150 (2010).
' Subbiah Sumathi, 'Reaping what they sow: The Basmati Rice controversy and strategies for protecting TK' 27 B.C. Int'l & Comp. L. Rev. (2004).
' Swanson,Todd, 'The existence of the right to TK in medicinal systems: from hoodia to frog slime'4 MJIEL (2007).
' Tripathi., SK, 'Intellectual property and genetic resources, traditional Knowledge, Folklore: International, regional and national perspectives, trends and strategies',8 Journal of Intellectual Property Rights 468 -477 (2000).
' Venkataraman K, 'Intellectual Property Rights, Traditional Knowledge and Biodiversity in India'13 Journal of Intellectual Property Rights 326-335 (2008).
' Varkey., Elizabeth, 'Traditional Knowledge ' the changing scenario in India', available at : www.law.edu.uk/ahrb/publication/online/varkey.htm.(vitited on 17/4/14).
' Vaish Varun and Haji Mustafa, 'Is there a need to substantially modify th terms of the TRIPS Agreement'17 JIPR 195-208 (2012).
' Watal Jayshree, 'Intellectual Property and Biotechnology, Trade Intrests of Developing Countries', 2 Int. J. Biotechnology (2000).
' Woods Michael, 'Food for Thought: The Bio-piracy of Jasmine and Basmati Rice' 13 alb.L J. Sci. & Tech. (2002).
' Yala ,Fundacion Dbbo and Ors, 'Sui Generis system for the protection of TK' Information for the Secretariat of the Convention on Biological Diversity1-27(2005).
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