This article is written by Anisha Bhandari, pursuing B.A.LL.B (HONS.) from the Institute of Law, Nirma University. This article describes the concept of biopiracy and how it emerged.
Table of Contents
Introduction
Traditional Knowledge (TK) is a living body of knowledge that is created, maintained, and passed down from generation to generation within a group, often part of its cultural or spiritual identity. Biopiracy has emerged as a term to describe how corporations in the developed world claim ownership or otherwise take unfair advantage or free ride on the genetic resources and traditional knowledge and technology of developing countries.
Formulations used to treat human diseases from traditional knowledge are time-tested since they have been in practice for centuries. The efficacy of alternative medicine schemes, combined with the lack of this knowledge with patent offices, offers a convenient way for interlopers to gain patents on such medical products originating from conventional medicine schemes.
The significance of traditional knowledge
Traditional knowledge (TK) is an integral part of the identity of most local communities. It is a core component of the social and physical climate of a society and, as such, its protection is of utmost importance. Attempts to manipulate TK for industrial or commercial gain can contribute to misappropriation of TK and can harm the rights of its legitimate custodians. In the face of these threats, ways, and means to secure and cultivate TK for sustainable growth need to be built in line with the interests of TK holders. The preservation, protection, and promotion of TK-based innovations and practices of local communities are of particular importance to developing countries. Their rich knowledge of TK and biodiversity plays a critical role in health care, food protection, community, religion, identity, climate, trade, and development. Yet, in many parts of the world, this valuable asset is under threat.
There are fears that this knowledge is exploited and retained by third parties without the explicit written consent of TK holders and that none, if any, of the advantages gained are communicated with the societies in which the knowledge develops and exists. Such issues have driven TK to the centre of the international agenda, prompting vigorous discussion on how to conserve, defend, further grow and sustainably utilize TK. Documenting and digitizing TK-related details in the form of a TKDL (Traditional Knowledge Digital Library) continues to be an important way of protecting TK and avoiding its misappropriation by third parties. India is a leader in the region.
Protection of codified traditional knowledge
Protection of conventional information is important in other respects; the absence of clear legislative policy structures for the conservation of TK in developing countries creates a gap for developed and industrialized nations to exploit the TK and indigenous capital. Since the TK incorporates information and know-how on a wide range of issues, including resource management, traditional medicines, crafts, artistic and cultural designs, their proper protection is important to the maintenance of the traditional traditions of Indigenous peoples. It is a right of cultural heritage that must be protected and shared equitably in the interests of all human beings.
The need to secure TK is more important today; it has been reported that corporate companies sometimes infringe on indigenous intellectual property rights. While these breaches do not legally constitute a breach of established legal norms, because neither national legislation nor international conventions acknowledge the interests of indigenous peoples, they are nevertheless subject to indigenous customary law.
Misappropriation of traditional knowledge
The issuance of patents on non-patentable technology (in contrast to conventional medicines), based either on current medical knowledge in the developed world or on a small difference of that knowledge, has created a great deal of concern to the developing world. Some of the examples show the bio-piracy of traditional knowledge and, in many of these cases, the country has had to fight for the revocation of the patents granted, the revocation of which may not be a viable option for all patents based on traditional knowledge, since it involves enormous costs and time.
Tools for prevention of misappropriations of traditional knowledge
The protection of traditional knowledge (draft articles)
The most recent edition of the Draft Treaty was sent to the Committee at its 39th Session on 22 March 2019, and which was amended between 17 and 21 June 2019. The Preamble recognizes the right of indigenous and local communities to “maintain, control, protect and develop their intellectual property over their cultural heritage, including their traditional knowledge;” promotes “respect.” The independence, cultural identity, and moral principles of conventional knowledge holders; and acknowledges the need for new laws and qualifications on the provision of adequate and acceptable means for the protection of existing information privileges, taking into account disparities in national law systems. The elements of misappropriation of traditional information which fall within the reach of the Draft Treaty’s alternative meanings include:
- “Access” or “usage;”
- “Without free, prior and informed consent or consent and participation and, where relevant, without mutually acceptable terms,” “in violation of customary law and existing procedures regulating the entry or use of such traditional knowledge” or “abuse” except in the case of “violation of national law in the provider country;” and
- For “economic, science, education and technology transfer.”
While there are three alternatives to the objectives of the Draft Treaty, the first addresses three key issues needed to protect traditional knowledge. In particular, the Draft Treaty states that ‘the objective of this instrument is to ensure effective protection of intellectual property against:
- Misappropriated traditional knowledge;
- Uncompensated traditional knowledge use; and
- Error granting of intellectual property rights over tradition.
The extent of (and conditions of) protection affirms the following principles:
- Member States will adhere to the customary laws and practices of TK holders;
- Member States [will/should] take national action to ensure that TK holders have absolute and collective right to preserve, regulate, use, create, allow or prohibit access to and usage/use of their traditional knowledge; and receive a fair and equitable share of the benefits derived from its use; and
- ‘Member States [shall/will] take measures to ensure the integrity of traditional knowledge’ or to protect the interests (economic and moral)of TK holders.
The Convention on Biological Diversity (CBD) and The Nagoya Protocol on access to genetic resources and the fair and equitable sharing of benefits arising from their utilization to the CBD (Nagoya Protocol)
Article 8(j) of the CBD lays out a general duty requiring States to “value, protect, conserve and encourage awareness” of indigenous communities and to “encourage their broader use with the permission and participation of the holders of that awareness. The Convention on Biological Diversity also requires States to “promote an equal distribution of benefits resulting from the usage of TK”.
The Nagoya Protocol addresses the traditional knowledge of genetics resources with access, benefit-sharing and compliance provisions. It also tackles genetic opportunities where aboriginal and local populations have the opportunity to provide access to them. Contracting Parties shall take measures to ensure prior informed consent and fair and equitable sharing of benefits for these communities, keeping in mind the laws and procedures of the Community as well as the customary use and exchange.
Traditional knowledge digital library
TKDL contains information from Indian Medicine Systems, i.e., Ayurveda, Unani, Siddha, Sowa Rigpa, and Yoga available in the public domain. Traditional knowledge of existing literature in local languages such as Sanskrit, Urdu, Arabic, Persian and Tamil has been translated into digital format and is available in five international languages, including English, German, Spanish, French and Japanese.
Traditional Knowledge Resource Classification (TKRC), an innovative structured classification system for systematic arrangement, dissemination, and retrieval, has been developed for approximately 5,000 subgroups against a limited number of subgroups available in the Internatioknal Patent Classification (IPC) related to medicinal plants. The details shall be classified in compliance with the International Patent Classification (IPC) section, class, category, community, and subgroup for the ease of its usage by foreign patent examiners. The TKDL database consists of approximately 3.6 lakh formulations/practices that have been transcribed from the ISM and Yoga texts.
TKDL software with its associated classification system, i.e. TKRC converts text in local languages to multiple languages as mentioned above. It can be noted that TKDL is not a transliteration, but rather a knowledge-based conversion, where once abstracted data is converted into multiple languages using the Unicode, Metadata methodology.
TKDL features a web tool that allows complete text search and retrieval of typical IPC and keyword information in several languages. Search capabilities provide single or multiple term searches, complicated Boolean expression searches, location searches, area searches, phrase searches, etc. in the context of easy and sophisticated search choices. Easy search enables the consumer to check for a keyword combination. Advance scanning helps the user to scan using Boolean phrases, utilizing phrases such as “close,” “and,” “and not.” Searches are also available for IPC and TKRC codes.
TKDL serves as a link between local language formulations and the patent examiner at the global stage, as the archive can contain details on both international and traditional terms in a language and format that is accessible to patent examiners. The issue of the lack of access to prior art traditional knowledge is expected to be addressed.
Advantages of TKDL on bio-piracy
- It has been estimated that a large number of patents relating to the Indian medicinal system have been wrongly granted by patent offices around the world.
- In 2003, almost 15,000 patents were taken from the Indian Traditional Knowledge International Patent Offices, which increased to 35,567 in 2005 and 85,000 in 2008 (Refs 12, 14). A survey of 4896 references to 90 medicinal plants mentioned in the USPTO database by the TKDL Taskforce found that 80 percent of these references were made to seven medicinal plants of Indian origin, and 360 of the 762 patents on medicinal plants.
- Based on the observations of a third party submitted by the TKDL team, a large number of patent applications have either been set aside or withdrawn, annulled, or declared dead. Innovative TKDL helps India to protect some 0.250 million medical formulations at zero cost.
- Access to the TKDL database helps patent examiners to discover the novelty of patent applications shortly after submission.
- In general, it takes 5-7 years to oppose the patent granted along with a huge cost of between USD 0.2 million and USD 0.6 million. For example, the opposition proceedings against the patent of neem (EP436257), Enola beans (US patent No. 5894079) and Monsanto soybeans (EP301749) took 10 years in each of the first two cases and 13 years in the third case. Because of this, it is clear that TKDL will not only help prevent the patenting of traditional Indian medicine at an early stage but will also reduce expenditure and time.
Famous cases of bio-piracy of traditional knowledge
The Turmeric case (Curcuma Longa Linn.)
Turmeric rhizomes are used as a flavouring spice for Indian cooking. It also has properties that make it an effective ingredient in medicines, cosmetics, and dyes. It has historically been used as a treatment for the curing of cuts and rashes for decades.
In 1995, two expatriate Indians at the University of Mississippi Medical Center (Suman K. Das and Hari Har P. Cohly) were granted a US patent (# 5, 401,504) on the use of turmeric in wound healing. Council of Scientific of Industrial Research (CSIR), India, New Delhi, filed a re-examination case with the USPTO challenging the patent on the rationale of the prior art. CSIR claimed that turmeric had been used for the treatment of wounds and rashes for thousands of years and that its medical usage was not a discovery. They were backed by historical documentation of mainstream expertise, including an ancient Sanskrit text and a paper written in the Bulletin of the Indian Medical Association in 1953. Given an appeal by the patent owner, the USPTO accepted the arguments of the CSIR and revoked the patent. The Turmeric case was a landmark case, as it was the first time that a patent based on the traditional knowledge of a developing country had been successfully challenged. The US Patent Office revoked this patent in 1997, after finding that there was no novelty; the findings of innovators have been known for centuries in India.
The Neem case (Azadirachta indica A. Juss.)
Neem extracts are often used against hundreds of pests and fungal diseases that pounce food crops; oil extracted from its seeds can be used to cure colds and flu; and mixed in soap, it provides relief from malaria, skin diseases and even meningitis. In 1994, the European Patent Office (EPO) awarded a patent (EPO patent No.436257) to the US Company W.R. Grace Company and the US Department of Agriculture for a process to manage plant fungi using hydrophobic extracted Neem oil. In 1995, a group of international NGOs and representatives of Indian farmers filed legal opposition to the patent.
They submitted evidence that the fungicidal effect of extracts of Neem seeds had been known and used for centuries in Indian agriculture to protect crops and was therefore unpatentable. In 1999, the EPO held that all the characteristics of the present argument had been revealed to the public before the patent application and that the patent was not deemed to require an innovative move. The patent granted on Neem was revoked by the EPO in May 2000. In March 2006, the EPO rejected the request made in 2001 by the USDA and the chemical multinational, W. R. Thanks to the previous decision of the EPO to cancel the patent on the fungicidal properties of the seeds derived from the needed seeds.
The Basmati case (Oryza Sativa Linn.)
Rice Tec, man. Inc. applied to register the trademark “Texmati” before the United Kingdom Trade Mark Registry. The Agricultural and Processed Food Export Development Authority (APEDA) successfully opposed it. One of the records relied on by Rice Tec as proof in favour of the approval of the aforementioned trademark was the US Patent 5,663,484 issued to Rice Tec by the US Patent Office on 2 September 1997 and this is how this patent became a subject of controversy. This US usefulness patent was unusual in that it argued that the rice plant had features identical to the typical Indian Basmati Rice lines and had a regional range spanning North, Central, or South America or the Caribbean Islands. The USPTO issued the patent to Rice Tec on 2 September 1997. The patent concerned 20 claims covering not only a novel rice plant but also a variety of rice lines; resulting in plants and grains, claims for seed deposits, the method for the selection of a rice plant for breeding and reproduction. Its claims 15-17 were for rice grains with characteristics similar to those of Indian Basmati rice lines. These arguments 15-17 may have gotten in the way of Indian exports to the US if lawfully applied.
Data from the IARI (Indian Agricultural Research Institute) Report regarding arguments 15-17 was included. The finding was confirmed by the germplasm selection of the Rice Research Directorate, Hyderabad, in 1978. CFTRI (Central Food Technological Research Institute) scientists assessed the different grain characteristics and therefore the claims 15-17 were attacked based on statements made by CFTRI scientists concerning grain characteristics.
The motion for the re-examination of this patent was eventually submitted on 28 April 2000. Shortly after completing the proposal for re-examination, RiceTec decided to remove claims 15-17 along with claim 4.Biopiracy of conventional information is not limited to India alone.
The Ayahuasca case (Banisteriopsis Caapi Mort.)
For centuries, B Caapi Mort has been cultivated by the Shamans of indigenous groups in the Amazon basin. To make a ritual cocktail known as “Ayahuasca.” Ayahuasca (which means “wine of the soul”) is used by the Shamans in mystical and curing rites to cure and manage sickness, attract ghosts, and foresee the future.
American, Loren Miller was granted US Plant Patent (No.5, 751 issued in 1986), granting him rights over the alleged variety by B Caapi Mort which he had collected from the Amazon Domestic Garden and called “Da Vine” and analyzed for potential medicinal properties. The patent stated that Da Vine embodied a new and distinct B type. Caapi Mort., mainly because of the colour of the flower.
The Coordinating Body of Indigenous Organizations of the Amazon Basin (COICA), which includes more than 400 indigenous groups in the Amazon region, along with others, has protested against the incorrect patenting of a plant product. They objected to the fact that Ayahuasca was known to natives of the Amazon rainforest and is used in traditional medicine and has been cultivated for generations to come, so that Miller could not have discovered it and should not have been granted those rights which, in effect, appropriated traditional indigenous knowledge.
USPTO withdrew this patent on 3 November 1999 at the point of re-examination. However, on 17 April 2001, the inventor was able to convince the USPTO thereby the original claims being reconfirmed and the patent rights restored to the innovator.
The Kava case (Piper Methysticum Forster)
Kava is an important cash crop in the Pacific, highly prized as a source of the ceremonial beverage of the same name. Over 100 varieties of Kava are grown in the Pacific, especially in Fiji and Vanuatu, where it was first domesticated thousands of years ago. Kava is now being sold for several uses in North America and Europe. French corporation L’Oreal – a multinational conglomerate with revenues of US$ 10 billion a year – invented the use of Kava to minimize hair loss and promote hair development.
Hoodia case (Hoodia Gordonii (Masson) Sweet ex Decne)
For thousands of years, African tribesmen have consumed Hoodia cactus to stave off starvation and thirst on long hunting trips. The Kung bushmen, San who reside across the Kalahari Desert in Southern Africa, used to hack off a cactus stem around the size of a cucumber and to munch it.
In 1995, the South African Council for Science and Industrial Research (CSIR) copyrighted Hoodia’s appetite suppressant factor (P57) and hence its possible remedy for obesity. In 1997, P57 was licensed to the British Biotech Firm, Phytopharm.
In 1998, Pfizer purchased the rights to produce and sell P57 as a possible slimming medication and fat treatment (a demand worth more than £ 6 billion) from Phytopharm for $32 million. The San people eventually learned from this exploitation of their traditional knowledge and began legal action against the South African CSIR and the pharmaceutical industry on the grounds of bio-piracy in June 2001.
They claimed that their traditional knowledge had been stolen and that the South African CSIR had failed to comply with the provisions of the Convention on Biodiversity, which requires the prerequisite informed consent of all stakeholders, including the original discoverers and users. Phytopharm performed detailed inquiries but was unable to locate any information holders. The surviving San were reportedly staying in a tent camp 1500 miles removed from their tribal lands at the time. The South African CSIR claimed that they had planned to inform the San of the research and share the benefits, but wanted to ensure that the drug was successful.
The two parties entered into agreements for a benefit-sharing arrangement, given the complexities about who would be compensated: the individual who initially exchanged the details, their heirs, the tribe, or the whole nation. San is a nomad distributed across four continents. However, a landmark agreement was reached in March 2002, in which the San would receive a share of any future royalties. Since then, though, hoodia has penetrated the grey economy and the degree to which the San society is benefited by the exchange of benefits needs to be seen.
Conclusion
It should be noted that the IP world has recognized the importance of successful documentation of indigenous TKs such as India’s TKDL-playing a role in defensive protection within the existing IP system. The following strategies are discussed, as suggested by the World Intellectual Property Organization (WIPO) as a global measure to curb bio-piracy and misappropriation of TK. Inventions focused on or produced utilizing genetic tools (associated or not with conventional knowledge) may be patentable or covered by the rights of plant breeders.
The other two initiatives considered, addressed and established by WIPO7 are, in the first place, protective defence of genetic resources aimed at preventing patents from being awarded on genetic resources (and relevant conventional knowledge) that do not fulfil the current criteria of innovation and inventiveness. This measure also involves the possible disqualification of patent applications that do not comply with the obligations of the Convention on Biological Diversity (CBD) regarding prior informed consent, mutually agreed with terms, fair and equitable sharing of benefits, and disclosure of origin. Second, WIPO leaders intend to make it mandatory for patent applications to reveal the origins or roots of genetic capital, as well as proof of mutual informed consent and a benefit-sharing arrangement.
References
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