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Bio-piracy of Traditional Knowledge

Introduction

Protecting Codified TK

TKDL – A tool for prevention of misappropriation of TK

Annex. 1
 -Turmeric (Curcuma longa Linn.)
 -Neem (Azadirachta indica A. Juss.)
 -Basmati Rice (Oryza sativa Linn.)
 -Kava (Piper methysticum Forster)
 -Ayahuasca (Banisteriopsis caapi Mort.)
 -Quinoa (Chenopodium quinoa Willd.)
 -Hoodia (Hoodia gordonii (Masson) Sweet ex Decne)
 -Other examples

Introduction
Traditional knowledge has always been an easily accessible treasure and thus has been susceptible to misappropriation. The traditional knowledge, particularly, related to the treatment of various diseases has provided leads for development of biologically active molecules by the technology rich countries. In other words, traditional knowledge is being exploited for bio-prospecting.Also Traditional knowledge is often misappropriated, because it is conveniently assumed that since it is in public domain, communities have given up all claims over it. Traditional Knowledge includes both the codified (documented) as well as non-codified information (not documented but may be orally transmitted).
Bio-piracy of codified Indian traditional knowledge continues, since, this information exists in regional languages, and there exists a language barrier due to which the patent offices are unable to search this information as prior art, before granting patents. Formulations used for the treatment of human ailments from traditional knowledge are time-tested since they have been in practice for centuries. The reliability of the traditional medicine systems coupled with the absence of such information with patent offices, provides an easy opportunity for interlopers for getting patents on these therapeutic formulations derived from traditional medicine systems.
Misappropriations of Traditional Knowledge
The grant of patents on non-patentable knowledge (related to traditional medicines), which is either based on the existing traditional knowledge of the developing world, or a minor variation thereof, has been causing a great concern to the developing world. Some of the examples given in Annex. 1 illustrate the bio-piracy of traditional knowledge and in many of these cases the country had to fight for revocation of the granted patents, Revocation, may not be a feasible option possible for all the patents taken on the traditional knowledge since it involves huge costs and time.
Protecting Codified Traditional Knowledge
Patent examiners, in the international patent offices, while examining the patentability of any claimed subject matter, use available resources for searching the appropriate non-patent literature sources. Patent literature, is usually wholly contained in several distinctive databases and can be more easily searched and retrieved whereas non-patent literature prior art is often buried somewhere in the many and diverse sources. Therefore, a need was felt to create more easily accessible non-patent literature databases on traditional knowledge of India.
Traditional Knowledge Digital Library - A tool for prevention of misappropriations of traditional knowledge
TKDL targets Indian Systems of Medicine, viz., Ayurveda, Unani, Siddha and Yoga available in public domain. This is being documented by sifting and collating the information on traditional knowledge from the existing literature existing in local languages such as Sanskrit, Urdu, Arabic, Persian and Tamil in digitized format, which will be available in five international languages which are English, German, Spanish, French and Japanese. Traditional Knowledge Resource Classification (TKRC), an innovative structured classification system for the purpose of systematic arrangement, dissemination and retrieval was evolved for about 5,000 subgroups against few subgroups available in International Patent Classification (IPC), related to medicinal plants. The information is being structured under section, class, subclass, group and subgroup as per the International Patent Classification (IPC) for the convenience of its use by the international patent examiners. Information comprising about 2 lakh formulations has been transcribed for realizing the objective of TKDL Project.
Each Sloka is read and converted into a structured language using Traditional Knowledge Resource Classification by subject (Ayurveda, Unani, Siddha or Yoga) experts. The codes are then filled into the data entry screen. The Slokas are also saved in the database. The translated version of all the TKRC codes is ported in the database. The abstraction is done by the subject experts. The codes once saved in meta data directory are converted in different languages based on Unicode technology. The formulations are presently being converted into English, German, French Japanese and Spanish languages. The converted format of the formulation is readable and can be understood by a layman though it is targeted towards a patent examiner.
TKDL software with its associated classification system i.e., TKRC converts text in local languages into multiple languages as mentioned above. It may be noted that the software does not transliterate, rather it does a knowledge-based conversion, where data abstracted once is converted into several languages by using Unicode, Metadata methodology. Software also converts traditional terminology into modern terminology, for example, Jwar to fever, Turmeric to Curcuma longa, Mussorika to small pox etc.
TKDL includes a search interface providing full text search and retrieval of traditional knowledge information on IPC and keywords in multiple languages. The search features include single or multiple word searches, complex Boolean expression search, Proximity search, Field search, Phrase search, etc in the form of simple and advance search options. Simple search lets the user search a combination of keywords. Advance search lets the user search using Boolean expressions, using the expressions like “near”, “and”, “and not”. Searches are also available on IPC and TKRC codes.
TKDL acts as a bridge between formulations existing in local languages and a Patent Examiner at a global level, since the database will provide information on modern as well as local names in a language and format understandable to Patent Examiners. It is expected that the issue of the gap on lack of access to prior art traditional knowledge shall get addressed.
Annex. 1
Some examples of bio-piracy of traditional knowledge
Turmeric (Curcuma longa Linn.)
The rhizomes of turmeric are used as a spice for flavouring Indian cooking. It also has properties that make it an effective ingredient in medicines, cosmetics and dyes. As a medicine, it has been traditionally used for centuries to heal wounds and rashes.
In 1995, two expatriate Indians at the University of Mississippi Medical Centre (Suman K. Das and Hari Har P. Cohly) were granted a US patent (no.5, 401,504) on use of turmeric in wound healing. The Council of Scientific & Industrial Research (CSIR), India, New Delhi filed a re-examination case with the US PTO challenging the patent on the grounds of existing of prior art. CSIR argued that turmeric has been used for thousands of years for healing wounds and rashes and therefore its medicinal use was not a novel invention. Their claim was supported by documentary evidence of traditional knowledge, including ancient Sanskrit text and a paper published in 1953 in the Journal of the Indian Medical Association. Despite an appeal by the patent holders, the US PTO upheld the CSIR objections and cancelled the patent. The turmeric case was a landmark judgment case as it was for the first time that a patent based on the traditional knowledge of a developing country was successfully challenged. The US Patent Office revoked this patent in 1997, after ascertaining that there was no novelty; the findings by innovators having been known in India for centuries.
Neem (Azadirachta indica A. Juss.)
Neem extracts can be used against hundreds of pests and fungal diseases that attack food crops; the oil extracted from its seeds can be used to cure cold and flu; and mixed in soap, it provides relief from malaria, skin diseases and even meningitis. In 1994, European Patent Office (EPO) granted a patent (EPO patent No.436257) to the US Corporation W.R. Grace Company and US Department of Agriculture for a method for controlling fungi on plants by the aid of hydrophobic extracted Neem oil. In 1995, a group of international NGOs and representatives of Indian farmers filed legal opposition against 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 therefore, was unpatentable. In 1999, the EPO determined that according to the evidence all features of the present claim were disclosed to the public prior to the patent application and the patent was not considered to involve an inventive step. The patent granted on was Neem was revoked by the EPO in May 2000. EPO, in March 2006, rejected the challenge made in 2001 by the USDA and the chemicals multinational, W. R. Grace to the EPO’s previous decision to cancel their patent on the fungicidal properties of the seeds extracted from the neem tree.
Basmati Rice (Oryza sativa Linn.)
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.
This US utility patent was unique in a way to claim a rice plant having characteristics similar to the traditional Indian Basmati Rice lines and with the geographical delimitation covering North, Central or South America or Caribbean Islands. The US PTO granted the patent to Rice Tec on September 2, 1997. The said patent covered 20 claims covering not only novel rice plant but also various rice lines; resulting plants and grains, seed deposit claims, method for selecting a rice plant for breeding and propagation. Its claims 15-17 were for a rice grain having characteristics similar to those from Indian Basmati rice lines. The said claims 15-17 would have come in the way of Indian exports to US, if legally enforced.
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 traditional knowledge is not limited to India alone. In fact, there have been several examples from other countries where traditional knowledge biopiracy has become a concern. Some of these examples are given below:
Kava (Piper methysticum Forster)
Kava is an important cash crop in the Pacific, where it is highly valued as the 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. In North America and Europe, Kava is now promoted for a variety of uses. French company L'Oreal - a global giant with US $10 billion a year in sales - has patented the use of Kava to reduce hair loss and stimulate hair growth.
Ayahuasca (Banisteriopsis caapi Mort.)
For generations, Shamans of indigenous tribes throughout the Amazon basin have processed the bark of B. caapi Mort. to produce a ceremonial drink known as “Ayahuasca”. The Shamans use Ayahuasca (which means “wine of the soul”) in religious and healing ceremonies to diagnose and treat illness, meet with spirits, and divine the future.
American, Loren Miller obtained US Plant Patent (no.5, 751 issued in 1986), granting him rights over an alleged variety of B. caapi Mort. which he had collected from a domestic garden in Amazon and had called “Da Vine”, and was analyzing for potential medicinal properties. The patent claimed that Da Vine represented a new and distinct variety of B. caapi Mort., primarily because of the flower colour.
The Coordinating Body of Indigenous Organisations of the Amazon Basin (COICA), which represents more than 400 indigenous tribes in the Amazon region, along with others, protested about a wrong patent that was given on a plant species. They protested that Ayahuasca had been known to natives of the Amazon rainforest and it is used in traditional medicine and cultivated for that purpose for generations, so Miller could not have discovered it , and should not have been granted such rights, which in effect, appropriated indigenous traditional knowledge. On reexamination, USPTO revoked this patent on 3rd November 1999. However, the inventor was able to convince the USPTO on 17th April 2001, the original claims were reconfirmed and the patent rights restored to the innovator.
Quinoa (Chenopodium quinoa Willd.)
Quinoa is a staple food crop for millions in the Andes, especially Quechua and Aymara people who have bred a multitude of quinoa varieties. One traditional quinoa variety, Apelawa, is the subject of US patent 5,304,718 held by two professors from Colorado State University who claim the variety's male sterile cytoplasm is key to developing hybrid quinoa. The patent claims any quinoa crossed with male sterile Apelawa plants.
Hoodia (Hoodia gordonii (Masson) Sweet ex Decne)
For thousands of years, African tribesmen have eaten the Hoodia cactus to stave off hunger and thirst on long hunting trips. The Kung bushmen, San who live around the Kalahari desert in southern Africa used to cut off a stem of the cactus about the size of a cucumber and munch it.
Hoodia is now at the centre of a bio-piracy row. In 1995, South African Council of Scientific & Industrial Research (CSIR) patented Hoodia’s appetite-suppressing element (P57) and hence, its potential cure for obesity. In 1997 they licensed P57 to British Biotech Company, Phytopharm. In 1998, 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 $ 32 million. The San people eventually learned of this exploitation of their traditional knowledge, and in June 2001, launched legal action against South African CSIR and the pharmaceutical industry on grounds of bio-piracy. They claimed that their traditional knowledge has been stolen, and the South African 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 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 away from their tribal lands. The South African CSIR claimed that they have planned to inform the San of the research and share the benefits, but wanted to make sure that the drug proved successful.
The two sides entered into negotiations for a benefit-sharing agreement, despite complications regarding who should be compensated: the person who originally shared the information, their descendants, the tribe, or the entire country. The San are nomads spread across four countries.
However, in March 2002, a landmark was reached in which the San will receive a share of any future royalties. The settlement will not directly affect Phytopharm or Pfizer since the San would be paid out of the CSIR’s royalties, as South African CSIR is the patent holder. South African CSIR will probably receive a royalty of around 10% from Phytopharm, which itself will receive royalties from sales from Pfizer. Thus San are likely to end up with only a very small percentage of eventual sales.
Other examples
To cite some more examples of biopiracy, the plant Phyllanthus amarus Schum.et Thonn. is used for Ayurvedic treatment for jaundice, a US patent has been taken for use against Hepatitis B. The plant Piper nigrum Linn. is used for Ayurvedic treatment for vitiligo (a skin pigmentation disorder). A patent has been taken in UK for the application of a molecule from Piper nigrum Linn. for use in treatment of vitiligo.
The appropriation of elements of this collective knowledge of societies into proprietary knowledge for the commercial profit of a few is one of the concerns of the developing world. An urgent action is needed to protect these fragile knowledge systems through national policies and international understanding linked to IPR, while providing its development and proper use for the benefit of its holders. What is needed is a particular focus on community knowledge and community innovation, enterprise and investment is particularly important.
The local communities or individuals do not have the knowledge or the means to safeguard their property in a system, which has its origin in very different cultural values and attitudes. The communities have a storehouse of knowledge about their flora and fauna, their habits, their habitats, their seasonal behaviour and the like-and it is only logical and in consonance with natural justice that they are given a greater say as a matter of right in all matters regarding the study, extraction and commercialization of the biodiversity. A policy that does not obstruct the advancement of knowledge, and provides for valid and sustainable use and adequate intellectual property protection with just benefit sharing is what is needed.
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