Special issue with the Sunday Magazine
From the publishers of THE HINDU
EARTHSCAPES: May 20, 2001
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.
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:
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.
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.
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.
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