Traditional knowledge" comprises of the vast expanse of knowledge, innovations and practices of indigenous and local communities embodying their traditional life-styles.
'Traditional knowledge' refers to tradition-based literary, artistic or scientific works; performances; inventions; scientific discoveries; designs; marks, names and symbols; undisclosed information; and all other tradition-based innovations and creations resulting from intellectual activity in the industrial, scientific, literary or artistic fields. 'Tradition-based' refers to knowledge systems, creations, innovations and cultural expressions which: have generally been transmitted from generation to generation; are generally regarded as pertaining to particular people or territory; and, are constantly evolving in response to a changing environment. Categories of traditional knowledge could include: agricultural knowledge; scientific knowledge; technical knowledge; ecological knowledge; medicinal knowledge, including related medicines and remedies; biodiversity-related knowledge; 'expressions of folklore'." [1]
This system of knowledge finds its basis in a string of wisdom developed over many generations towards a homegenous existence of mankind with key elements such as natural resources and environment; Holistic traditional scientific utilization of the lands playing an integral role in the existence and sustenance of this knowledge base. Although usually not documented on a material medium, it is generally passed from generation to generation and by word of mouth in strict confidence with a pious basis for such transfer.
Some of the best known forms of Traditional Knowledge are expressed through songs, rituals, stories, and the more recently abused, traditional medicinal knowledge. This body of knowledge is a part of the cultural and ethnic identity of the indigenous peoples. Western style industries have increasingly had recourse to genetic resources and traditional knowledge, In most cases, transnational corporations have exploited this knowledge base and resources of the indigenous peoples without adequate or appropriate consent- and sometimes no consent at all. The health care industry with its overburdening reliance on innovation, and patents, depends on medicinal ecological knowledge to derive eco-friendly products with minimum side effects from plants and other natural genetic resources. Most indigenous and local communities are situated in the world’s most biological rich and diverse areas with abundance in natural resources, however economically disadvantaged. To them this natural environment is a way of life and a part of their cultural existence.
Each community enjoying such a knowledge base has preserved such knowledge over generations. However, today this knowledge, either by fraud or misrepresentation has been exploited by transnational corporations making unconceiva,ble profits by a mere access to such components in the knowledgebase. Assuming that such a community was adequately compensated in respect of the ownership of such a traditional knowledge, members of such communities find the benefit sharing ratio abysmally low. Some view such a knowledge with absolute sanctity and an act of parting with the same to be an act of sacrilege.
The present article seeks to address the position of the law of patents and traditional knowledge.
Aspirin, the most widely used pharmaceutical in the world was derived from salicylic acid discovered in meadowsweet. The cure for cancers like Hodgkin’s disease and acute lumphocytic leukemia was discovered from the rosy periwinkle plant grown in Madagascar. The saliva of the vampire bat of South America opens clogged arteries faster. The list is long and is impressive.[2]
Out of the 120 active compounds currently isolated from the higher plants and widely used in medicine today, 75% show a positive co-relation between their modern therapeutic use and the traditional knowledge of their use from which they were derived.[3]
Biopiracy, as is rampant in recent times, has a great bearing while discussing traditional medicine. The cause of such rampant biopiracy finds its roots in diametrically opposite patent protection systems between the East and the West.
The classic example has been the relations of India and USA with respect to traditional medicine. This can be analyzed with a special reference to the Neem and Turmeric Patents that were granted in the early 90s international pressures and collective action through the support of various non-governmental organizations saw the revocation of these symbols of tradition and culture.
The Neem Patent
(Biological name: Azadirachta indica). In India the neem tree is known as sarva-róga nívarini" or "curer of all ailments," and more recently in English as the “wonder tree.” i.e after its medicinal properties were discovered by the West.
An agricultural chemical company based in Florida was granted a patent in respect of the neem tree. The active ingredient was isolated and a storage friendly version was created. The company owns a patent with respect of the method of creating a stabilized azadirachtin in solution and the stabilized azadirachtin solution itself. This solution was soon introduced as a pesticide in the farms.
On a review of the patentability provisions and following the concept of “products of nature” as has been followed in the United States, on the face of it, the invention appears new and novel. The whole exercise of isolating and purification of the substance satisfies the grounds of novelty and inventive step as required under US Patent laws. Under Section 102 of the U.S. Patent Act, prior foreign use can invalidate a U.S. patent only where such use "is fixed in a tangible, accessible form such as by a description in a printed publication, or in a document related to either the applicant's own foreign patent or some other person's foreign patent.[4]
The validity of the patent can be challenged and revoked only on the ground that the said use is in a fixed tangible form and well documented in a printed publication.
The U.S. patent law poses serious obstacles to indigenous communities outside the US to initiate such a revocation proceeding. Most of the knowledge of the indigenous peoples is undocumented and passed from generation to generation only by the word of mouth and in strict confidence. The provisions regarding revocation of patents on the grounds of prior art by a foreign litigant having to satisfy the requirement in a publication or any other tangible form has been severely criticized by Vandana Shiva. She comments that
“Novelty exists mainly in the context of the ignorance of the West."
In 1986, Ayahuasca, a vine native to the Amazon Rain Forest, was patented by Loren Miller, an American scientist and entrepreneur. This plant has been used by healers and religious leaders throughout the Amazon for generations and since time immemorial. Shamans have used ayahuasca to treat sicknesses, contact spirits, and foresee the future. Many indigenous Amazon tribes also view the plant as a sacred symbol of their religion.
The natives and the tribal leaders learnt of the existence of such monopoly right granted several years after it was so granted. Antonio Jacanamijoy, the leader of a council representing more than 400 indigenous tribes and groups in South America, stated,
"[o]ur ancestors learned the knowledge of this medicine and we are the owners of this knowledge."
In 1999, Jacanimijoy's council applied for and obtained a rejection of the ayahuasca patent from the U.S. Patent and Trademark Office. The controversy over the patent generated considerable hostility between the United States and Ecuador. However a substantial issue in question remained unaddressed-whether the rejection was based on the property being prior art, a part of the traditional knowledge or because it was sacred to the indigenous community.[5]
These instances force the reader to examine the necessity of a provision in the American patent law regarding public order, morality, and protection of Indigenous knowledge, It also forces the reader to analyse the breadth and scope of “novelty” as understood under the US law and its insufficiency.
The Kani Tribe
The concept of benefit sharing in the development of herbal medicines and traditionally obtained medicines has begun to find its place in the realm of property.
“Jeevani” is a herbal medicine developed by the scientists of the Tropical Botanic Garden and Research Institute (TBGRI) located in the State of Kerala, Jeevani is based on the traditional medicinal knowledge of the Kani tribe found in the Thiruvananthapuram district of the State of Kerala in South India. It is derived from the arogyapaacha plant (trichopus zeylanicus) a small rhizomatous, perennial herb found in Sri Lanka, Southern India, and Malaysia.
Jeevani is reported to have the following indications:
- Activates the body’s natural defenses
- Activates delayed type hypersensitivity reactions and antibody synthesis
- Increases the number of polymorphonuclear granulocytes.
- Activates the cellular immune system
- Exhibits hepato-protective and cholorectic activities
- Has adaptogenic properties as evidenced by anti-peptic ulcer and anti-fatigue effects
The fruit of the arogyapaacha plant was shared with members, to the Western Ghats Kani tribals in 1987 who felt “charged and full of energy and vitality” following eating the fruit. The effects of Jeevani have been reported in the popular press. Jeevani has also found a place for itself in Japanese herbal medicines. Investigations were undertaken to isolate the active elements in the arogyapaacha plant –followed by clinical trials to demonstrate the effect of arogyapaacha in improving athletic performance, mental alertness and work output. It was observed by researchers at TIBGRI that “without intellectual property protection they would not be able to generate much revenue by licensing the drug they developed. This necessitated some legal protection to be afforded to the plant in question.
Three patents claiming processes for the preparation of herbal drugs based on arogyapaacha were filed in India. TGBRI, the sole patent holder on Jeevani as an immunomodulator committed to share royalties with the Kani. In turn TGBRI issued a seven year license to Arya Vaidya Pharmacy which produces herbal extracts from Jeevani. TIBGRI negotiated agreements to transfer technology related to arogyapaacha to interested parties on payment of a license fee. With the assistance of TIBGRI, a trust was created to promote both the welfare of the Kanis in Kerala, and for the sustainable use and conservation of biological resources. Monetary benefits, in the form of a percentage of the royalties received by TIBGRI for the use of its arogyapaacha-related technology, have been paid into this Trust. The creation of a trust is viewed as a welcome decision which installs trust and confidence amongst the members of the indigenous community. A number of questions pertaining to intellectual property arose during the development work done in respect of the arogyapaacha plant and its commercialization. They may be enumerated as under:
- Whether the kanis are entitled to the patent. If yes, whether as inventor, or joint inventor or traditional healers?
- The proportion of the benefits awarded to the Kanis in light of the initial work by the kanis themselves, and subsequently the TIBGRI who undertook the task of identification and isolation of compounds and other related processes.
- The high demand may result in an increase in the rate of cultivation of the plant which may cause ecological and environmental concerns.
- Should programs for the sharing of benefits be managed at the level of the individual, sub-clan, clan (Kanis), state (Kerala) or nation (India)?;
- the plant, arogyapaacha is native to India, Sri Lanka, and Malaysia, hence there seems to be a moral responsibility to share the benefits with other nations and other groups of indigenous peoples. The geographical proximity gives rise to such issues which need to be tackled with sensitivity and a balanced approach.
It was evident that traditional intellectual property rights were insufficient to answer the questions raised hereinabove and also ill equipped to protect the rights of the holders of traditional knowledge.
The western concept of Intellectual Property law is based on author/inventor centric concepts. The knowledge system of the indigenous peoples is based on the creation of a work by the community as a whole with community right in such works and no absolute monopoly of an identifiable sole individual or group of individuals. The works have been created by their forefathers, and worked upon by subsequent generations. The work has been subject to constant innovation and “improvement”. But this improvement takes place in the very course of life, hardly noticeable, but never recorded and noticed as such, unlike strict parameters of IP. Thus none can be identified as a sole inventor, author of the intellectual property or the knowledge created. The existing Intellectual property regime does not provide for the currently visible cultural misappropriation of imitating songs, dances and practices of the indigenous groups. The IPR regimes are neither designed nor equipped to cater to the question of cultural dilution and misappropriation. However it is to be remembered that Intellectual Property is not solely about rewarding the creator or the inventor, but it also looks at the recognition and respect for the contribution of the human creators.
The constraints that may be identified in respect of patentability of traditional medicinal knowledge may be enumerated and elucidated as follows. A substantial collection of traditional medicinal knowledge is “ancient”, passed down from generation. This property of being ancient and the fact that it is most likely to be known to most persons in the community, fails to meet the requirement of novelty and inventive step under patent law in any jurisdiction. There exists the option of granting petty patents which grant a special treatment to invention with regard to the priority date and measurement of inventive step. This option was seen to be not very favourable.
Traditional knowledge is held collectively by the community as one whole legal entity. The invention is not limited to a sole individual or a group of individuals that can be said to be inventors. The community as whole enjoys the right to enjoy and practice such knowledge. The lack of an identifiable person, individual, or a definite body or group of individuals makes an application for a patent under patent laws a difficult task. Patent laws across the globe, and international conventions and treaties are all centered around the ‘inventor’ and his rights and obligations under the contract between him and the state with respect to the monopoly right so granted.
The complexity and cost of drafting and prosecuting patent applications is beyond the means of the holders of traditional knowledge. that which holders of traditional knowledge can manage and afford. [6]
Each of these constraints was identified by WIPO in fact-finding missions conducted in 1998 and 1999 on the intellectual property needs and expectations of holders of traditional knowledge.
The UNCTAD also expressed the above-mentioned constraints with respect to the protection of traditional knowledge in the following terms.:
“While individual TK holders could in theory acquire a patent, it is generally the case that TK is passed on orally from generation to generation and evolves incrementally. Thus, it would be difficult to meet the criteria of novelty and inventive step. Second, TK tends to be generated collectively to the extent that no inventors are identifiable. Indeed the source of much TK cannot be traced to a specific community or even to a geographical region. Even if these obstacles were somehow overcome, most traditional communities do not have the resources to file patent applications or to take legal action to prevent patent infringement.” [7]
Indigenous communities follow an approach different compared to modern society. We as inhabitants of the developed and developing world refer to knowledge as a means of conversion to economic prosperity. Indigenous communities take a very traditional approach and believe that the knowledge, as passed to them through their ancestors is sacred. The knowledge is held in trust till the lifetime of the individual, which then will be passed to the next in kin, who will also hold it in trust till it is passed further and so on. The knowledge thus contains a large content of sanctity and religious significance in addition to custom and tradition. It is pertinent to note that the medicinal knowledge along with the access to plant and biological resources as whole along with the ecological ingredients is the component of the knowledge base that is transferred in trust.
Indigenous peoples are the sole guardians of the vast, little –disturbed habitat that modern scientists depend on more than they realize to regulate water cycles, maintain stability of the climate, and provide valuable plants, animals and genes. They possess in their ecological knowledge, an asset of incalculable value: a map to the biological diversity of the earth on which life depends. Encoded in indigenous languages and customs, and practices may be as much understanding of nature as is stored in the libraries of modern science.
Traditional healing practices such a Yoga and Tai ji have developed over the years and most often viewed as an anthropological knowledge base free from commoditization and commercialization. This makes protection very difficult. It is protected as confidential information by the practitioners. Most often, an action contrary to this knowledge base in terms of violation is viewed as a taboo and not “infringement of proprietary right” in the legal sense of the term. For Example, Yoga as a traditional form of healing is practiced in the early hours of the morning. A failure to follow this regime,if it constitutes a taboo, will not raise any cause of action in the courts. Against this backdrop, the very existence of a right in such forms of knowledge is questioned.
In the case of the Kani tribe or for any community in possession of such a knowledge base, the closely guarded knowledge has been passed on from generation to generation as a spiritual sacred possession within the members of the community. Indigenous knowledge is essentially embedded in culture. Culture, being subject to constant change requires a perpetual right against degradation and appropriation. The protection is sought against misappropriation at all the stages of development of culture. Today groups afraid of cultural dilution or demise seek to counter with legal rights that ensure cultural survival with a desire to maintain and cherish the distinctiveness, not just now, but for ever. We are all concerned about our identity, whether we belong to the group of indigenous peoples or otherwise. There is no more legitimate cause and purpose for protection needed.
Integrated Rights: Traditional Resource Rights
Traditional knowledge in its entirety, including traditional medicinal knowledge, was sought to be protected as an Intellectual property right and as a cultural right. Both seemed diametrically opposite to each other, offering little or no relief or redressal to the indigenous communities and holders of traditional knowledge. Jurists have tried to balance both concepts and derive a novel method system of protection through the mode of Traditional resource Rights. [9] Traditional resource rights seek to go beyond the concept of intellectual property rights and try to describe various rights existing and that can be developed with a view to afford protection to traditional Knowledge and compensation for use of such knowledge. Traditional resources include plants, animals, other material objects like tangible and intangible rights. Traditional resource rights inter alia include, public law rights and customary law defined or accommodated in national and international laws.
Traditional knowledge rights or traditional resource rights, the panacea to these unresolved questions, runs parallel to the concept of Intellectual property rights; protects the base of knowledge, traverses beyond intellectual property rights and embraces the cultural fabric of a people embodying religion, custom and tradition.
Written By: Pranjal Puranik
Publish Date: 25-Sep-2007
