Special issue with the Sunday Magazine
From the publishers of THE HINDU

EARTHSCAPES: May 20, 2001

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Biopiracy and traditional knowledge

R. V. Anuradha

The writer is a lawyer and legal consultant, and active with the environmental action group Kalpavriksh.

In 1995, two U.S. based Indians were granted U.S. Patent 5,401,504 on Use of Turmeric in Wound Healing, (popularly known as the Turmeric patent), which was assigned to the University of Mississippi Medical Centre, U.S. The invention claimed under the patent was the use of turmeric at the site of an injury and/or its oral intake to promote the healing of a wound.

S. Karthikeyan/Wilderfile
Hill turmeric.

The news was greeted with disbelief and surprise by most people in India. Turmeric has been traditionally used in India for its many special properties in wound-healing. For instance, it is used as a blood purifier, in treating the common cold, and as an anti-parasitic for many skin infections. It is also used as an essential ingredient in cooking many Indian dishes. How could someone obtain a patent - i.e., an exclusive right to sell and distribute something that was so commonly known - was the disturbing question.

The media coverage of the patent generated debate and discussion on the issue and the Centre for Scientific and Industrial Research (CSIR), an autonomous institution under the Department of Science and Technology, Government of India, decided to file for re-examination of the patent at the United States Patent and Trademark Office (USPTO).

The challenges before them were many, since the patent had to be challenged in accordance with the specific requirements under U.S. law. The claimed subject matter was the use of "turmeric powder and its administration", both oral as well as topical, for wound healing. As per the requirements of U.S. law, it was necessary to find adequate evidence in the form of printed and published information that would establish that the manner of use of turmeric as in the claimed invention, was known before the patent was claimed and, therefore, the patent was invalid. Despite the fact that the use of turmeric was known to every Indian household for ages, finding published information on the use of turmeric powder through oral as well as topical route for wound healing was a difficult task.

Fortunately, after an extensive search, 32 references were located, some of which were more than 100 years old, and in the languages of Sanskrit, Urdu and Hindi. The USPTO revoked the patent, stating that the claims made in the patent were obvious and anticipated, and agreeing that the use of turmeric was an old art of healing wounds.

IPRs over products of biodiversity

The patent on the "use of turmeric in wound healing" is but one of the many examples of how patents are being sought over various aspects of biological resources and products derived from the same.

What complicates matters in such patents is that the various useful properties and knowledge regarding biological resources have been identified and preserved through consistent skill, observation and usage by various local and indigenous communities through the world. In the field of pharmaceutical research, indigenous knowledge contributes towards the identification of the material in developing the drug, and often provides information of its precise uses in treating particular illnesses, its means of preparation and its dosage. Modern science and patent law, however, do not recognise this as valuable "innovation". Access to such resources and information is, therefore, assumed to be "free".

Some of the other recent examples of patents granted over "inventions" based on biological resources pertain to:

Ashish Kothari
Adivasi with Phyllanthus, traditionally used for jaundice: there is a need for alternative protection regimes for such knowledge.

i) Composition of jamun, bitter-gourd, gur-mar and eggplant for treatment in diabetes.

ii) Various products obtained from the neem tree.

iii) Varieties of basmati which have the characteristics of growing in temperate climate in the absence of sunlight.

iv) Composition of methi as a tonic to bring down blood glucose levels.

v) Compositions comprising of kala jeera or kalonji for increasing immune functions, and in the treatment of diabetes, hepatitis, and asthma.

The basic logic behind patents is that it is a mechanism to promote innovation, by ensuring that the "inventor" would have the exclusive right to sell and distribute the "product" s/he has "invented". While there are arguments both for and against the value of patents in general in promoting innovation, patents over products of biological diversity could pose certain specific problems, not the least of which is: how does one assess the degree to which human innovation has resulted in the final product?

Patents, by definition, cannot be granted over something that is obvious; that is known or anticipated by prior use; that is a product of nature, and not a product of human creativity. However, laws of different countries vary in the criteria used for assessment of the degree of human innovation that is required for qualifying for a patent. In the turmeric case, it was possible for the CSIR to establish that the patent claim was not "new". However, it may not be possible to establish this in each of the examples mentioned. In the basmati patent, for instance, the Government of India has challenged only three of the 20 claims granted to the patent holder, Ricetec; the belief being that there was enough evidence on record only to challenge these. What was being challenged were only claims regarding certain characteristics of basmati (specifically starch index, aroma, and grain dimensions); and not the other claims of the patent pertaining to the novelty of the rice lines and plants cultivated from these.

Patents over herbal mixtures and compositions (such as the examples above), however, present greater scope for argument for revocation, since the properties of each of the ingredients in the composition, and sometimes the composition itself, is not "novel".

Another issue for consideration is that while in the case of turmeric, the use was commonly held knowledge, there would be many instances when use/s of a specific plant or herb is known only to a particular community or tribe or individual. "Patenting" products developed from such biological material poses further challenges.

Ajay Mahajan
The hardy, indigenous Himalayan Wild Apricot . . . one of the nature's spectacular gifts to the Himalayas, unlike the non-indigenous apple, which survives on a cocktail of chemicals. The delicious, tangy fruit yields jam, chutney and juice. The fruit kernels yield the celebrated Apricot Oil (edible, variously cosmetic and medicinal) and the Apricot Scrub. While urban India and much of the world use apricot scrub and oil from the West, Himalayan communities have been using them for centuries. It's a similar story with many other plant products, e.g. Aloe Vera, or ghitrakamari, as it is known here, used in shampoos, conditioners, sunscreens and lotions. This commonly found plant has been used for centuries to moisturise skin, on the scalp and is even eaten as a vegetable in many parts of India.

Though in effect, the turmeric case was a "success story", it also revealed a variety of "problem areas" in challenging what was obvious to people in India, based on the laws of a foreign jurisdiction. The lessons learnt and problem areas can be summarised thus:

* There is a wide gap in the availability of information in countries like the United States for patent examination purposes pertaining to traditional knowledge base from biodiversity-rich countries. The insistence on written published information, as opposed to oral knowledge, could make challenges to such patents difficult. The need for greater scrutiny of patent applications pertaining to biological resources, and the need to consult the source of the biological resource and knowledge pertaining to the same is, therefore, imperative. Efforts towards documenting peoples' knowledge in Biodiversity Registers, if structured carefully, could help to establish "prior use" of a particular resource/ product derived from it. (See Box on Biodiversity Registers).

* Although remedy is available in the laws of developed countries, such as the re-examination proceedings in the U.S., the financial, technical and legal costs for initiating such proceedings are exorbitantly high. As pointed out by India in one of its papers to the WTO, it would be more cost-effective to establish an internationally accepted solution to prevent biopiracy than to divert national resources to expensive judicial processes for the revocation of patents.

Currently, there is no requirement under patent laws of most countries for the holder of the patent, or any intellectual property rights for that matter, to share the benefits with those who had collected, preserved or initially identified the biological material as potentially worthy of investigation. The TRIPS Agreement that seeks to harmonise the Intellectual Property laws of various countries does not mandate this either.

India and other developing countries have emphasised in various communications to the World Trade Organisation (WTO) that the rights of holders of traditional knowledge to share benefits arising out of innovation on the basis of their knowledge and the biological resources nurtured by them, should be recognised. They have also have recommended that applications for patents should mandatorily disclose the source of origin of the biological resource and knowledge pertaining to it, so as to facilitate benefit sharing with the originators of the knowledge and resource. The United States has strongly opposed this as a "legal and administrative nightmare". This kind of a stand by the U.S. would only lead to greater misappropriation of biological resources and knowledge pertaining to the same.

Biological Diversity Legislation

At the Earth Summit held in 1992, the Convention on Biological Diversity (CBD) was concluded, to which India is a party. The basic objectives of the CBD are: conservation, sustainable use of biological diversity and equitable sharing of benefits arising from the use of biodiversity. It further mandates the signatories to it to respect, preserve and maintain knowledge, innovations and practices of indigenous and local communities and encourage the equitable sharing of benefits arising from the utilisation of such knowledge, innovations and practices. As a legally binding treaty, the CBD can be expected to have some influence on these issues.

Pankaj Sekhsaria
Jarawas in Andaman Islands, one of India's smallest tribes, now threatened by "contact" parties: will their resource and knowledge rights be protected?

To ensure that there are legal mechanisms in place to ensure that this knowledge is not freely appropriated, the Indian government is in the process of finalising a law titled the Biological Diversity Bill. The bill contains various provisions for regulating access to biological resources, patent claims, and indigenous knowledge protection (see Box in article on Legal Spaces). This bill is a beginning, though inadequate.

Of simultaneous and critical importance are legal mechanisms to ensure right to control for indigenous and other local communities over the biological resources and related knowledge , of which they have been the custodians.

The piracy of human genetic material Most alarming is the increasing trend to claim patents even on human genetic material. This came to the public eye when, in the mid-1990s, a patent claim on a cell line of a Panama indigenous woman, by American scientists, was internationally exposed. The sheer embarassment of this exposure caused the patent claim to be withdrawn, but there are perhaps dozens of other such claims pending in various patent offices around the world . . . without the knowledge, much less the consent, of the person whose blood, tissue, or hair sample has been taken and used in the patent. Also of dubious validity is the claim that the properties of human genetic material are "inventions" that can be patented; they are more in the nature of "discoveries" of properties already existing in nature. Suspicions have been raised about whether the global human genome project, in which body samples are being collected from hundreds of communities across the world, is also lending itself to such misappropriation. Particularly targeted are the so-called "vanishing" tribes, as researchers hope to find unique characteristics that may have valuable leads to medical and scientific discoveries. Ashish Kothari

Biodiversity registers NGOs and institutions in India are attempting to document the knowledge, skills and techniques of local communities related to biological resources through the Community (or People's) Biodiversity Register, in the belief that such documentation would be a deterrent to biopiracy ; as well as for instilling a greater sense of pride among local communities over the knowledge they possess. Ashish Kothari Villagers who have prepared Community Biodiversity Registers in Andhra Pradesh: safeguarding and re-affirming pride in traditional knowledge. The Register processes documents of community and individual knowledge of occurrence, practices of propagation, sustainable harvests and conservation, as well as economic uses of biodiversity resources. All information accumulated in the Register can be used or distributed only with the knowledge and consent of the local community, so that it is in a position to refuse access to the register and to set conditions under which access would be allowed. The community, while consenting, can charge fees for access to the Register and collection of biological resources. Decisions on how to disburse the funds are to be made through village community meetings. The fear about biodiversity registers is they may place knowledge hitherto regarded as "secret" by communities, in the public domain, and that once this is done, it would be an open invitation for corporate and research interests to freely use it. On the positive side, these registers are expected to function as tools to establish claims of individuals and communities over knowledge and uses of biodiversity resources, and to bring to them an equitable share of benefits flowing from the use of such knowledge and resources. This, however, can be achieved only when legal mechanisms of control over the register are put in place, which is not yet the case. R.V. Anuradha

Towards benefit sharing: the Kani-TBGRI arrangement The Kani tribals in Thiruvannathapuram district, Kerala, claim that one can live for days together without food, and still be able to perform rigorous physical work, by eating a few fruits of a plant called Aarogyapaccha everyday. The term means the greener of health, the one that gives very good health and vitality. Scientists from the Tropical Botanic Garden Research Institute (TBGRI), learnt about the use of the plant from the Kanis and conducted detailed investigations on the same. Study of the leaves of the plant revealed it had anti-stress, anti-hepatotoxic and immunodulatory/ immunorestorative properties. Eventually, the drug Jeevani was formulated by TBGRI with Aarogyapaccha and three other medicinal plants as ingredients. Thereafter, a license to manufacture Jeevani was given to Arya Vaidya Pharmacy, Coimbatore (AVP) in 1995, for a period of seven years, for a fee of Rs. 10 lakhs. TBGRI decided that the Kani tribals would receive fifty per cent of the licence fee, as well as 50 per cent of the royalty obtained by TBGRI on sale of the drug. TBGRI Mallan Kani, one of the informants of Aarogyapaccha's properties. In November 1997, some of the Kanis, with assistance from TBGRI, registered a trust called Kerala Kani Samudaya Kshema Trust with the objectives of: welfare and development activities for Kanis in Kerala, preparation of a biodiversity register to document the knowledge base of the Kanis, and evolving and supporting methods to promote sustainable use and conservation of biological resources. Although all the Kanis of Thiruvananthapuram district are yet to become members of the Trust, efforts are on to achieve the same. Fifty per cent of the licence fee received by TBGRI has been transferred to the Trust. However, manufacture of Jeevani, and therefore flow of royalties, has run into problems for a number of reasons. The Kanis mostly live in and around the Reserved Forest areas of Thiruvananthapuram district. They would, therefore, require the permission of the Forest Department (FD) for harvesting the plant, which has not been forthcoming because of fears that commercial harvesting would threaten conservation of the plant. This has also been compounded by incidents of pilferage of the plant by non-tribals. There is also no uniform view among the Kanis, some of whom have objected to the manner in which the "arrangement" with TBGRI evolved. Activists have also raised issues of whether indigenous knowledge is being adequately protected and rewarded in this arrangement. TBGRI and AVP, however, believe that there are means to sustainably harvest the plant in the forest area, that are not being sufficiently explored. This and other issues of benefit-sharing and equity will need to be resolved, if this novel initiative is to become a model for the country. R. V. Anuradha