Historically, all medicinal preparations were derived from plants, whether in the simple form of plant parts or in the more complex form of crude extracts, mixtures, etc. Today, a substantial number of drugs are developed from plants. The majority of these involve the isolation of the active ingredient (chemical compound) found in a particular medicinal plant and its subsequent modification. A semi-synthetic analogue of such a compound could typically be a useful pharmaceutical product.
A large proportion of such drugs have been discovered with the aid of ethno- botanical knowledge of the traditional uses of the plant. The pharmaceutical company that makes such a drug applies for some form of intellectual property protection, the most favoured being the patent. If granted, the patent gives the company the right to prevent anyone else from manufacturing or selling the product. The company gets, in effect, a commercial monopoly. In addition, the source of the ethno-botanical knowledge is generally not mentioned. Thus both the credit for the product and the financial reward generally go to the company. The country from which the knowledge is obtained is simply treatedz as a source of raw material, whether of knowledge or of a biological resource. This has led some activists to coin the term “bio-piracy” to refer to a commercially useful product that is derived from traditional knowledge without any return to the knowledge holder. Bio-piracy is a major issue in developing countries today.
The rich knowledge base of countries like India in medicinal plants and health care has led to a keen interest by pharmaceutical companies to use this knowledge as a resource for research and development programs in the hope of discovering and producing new drugs. In such a situation, the country is faced with a dilemma. On the one hand, there is often a wish to share biological resources and knowledge, especially in relation to medicinal plants, although different communities may have different conditions for imparting such knowledge. On the other hand, there is a natural wish for some return. This includes not only a wish for some benefit, whether financial or non-financial, but also for credit or acknowledgment for contributing to the final product.
The intellectual property laws do not protect traditional knowledge adequately, so as to ensure benefit sharing with and credit to the concerned community. India is presently considering certain legislative and other measures to safeguard these rights. The main legislative measures are the Biological Diversity Bill, 2000, the Patents (Second Amendment) Bill, 1999 and the Protection of Plant Varieties and Farmers' Rights Act, 2001.
The knowledge holder may be a source of biological material (where the medicinal plant itself is obtained) or a source of knowledge only (where information as to the properties of a plant is sufficient for research purposes as the plant is available from other sources), or both (where a plant sample as well as the information relating thereto is needed). Where biological material is sought to be obtained, the main protective framework is supplied by the legislation. Where reward for knowledge is in question, the protective framework in India involves both legislative and non-legislative measures. The protection for these two categories is therefore being dealt with separately. Where both the biological material and the knowledge pertaining thereto are sought to be obtained, both forms of protection would be available.
The purchase of plants in bulk to supply a manufacturing unit is increasingly uncommon, especially with the advent of biotechnology in the pharmaceutical field. Even where a plant source is essential, as when adequate synthetic substitutes are not available for a particular compound, the plant need not necessarily be purchased from the country where it originated, or even purchased from the country from which the sample was originally taken. Plants may be cultivated in another country, or outside their natural environment under controlled conditions. Many plants are available in one country even though originally from another. Similarly, samples of botanical species have been taken and kept in collections in different countries of the world. For example, Indian plant specimens are lodged at the Kew Herbarium in London.
Where biological resources, including specimens of medicinal plants are sourced from India, some biological material measure of protection and control against bio-piracy is sought to be provided under the Biological Diversity Bill, 2000. Under this Bill, a National Biodiversity Authority would be set up, with similar authorities at the State and local levels. Chapter II of this Bill, entitled 'Regulation of Biological Diversity', provides that a foreigner or a non-resident Indian requires the previous approval of the National Biodiversity Authority for obtaining any biological resource occurring in India for research or for commercial utilization or for bio-survey and bio-utilization. An Indian can obtain a biological resource for commercial utilization or bio-survey and bio-utilization after giving prior intimation to the State Biodiversity Board concerned. A local person or community need not do this. The Bill further provides that whenever an intellectual property right is sought in or outside India based on an Indian biological resource (except in the case of a plant variety), the previous approval of the National Biodiversity Authority would be necessary.
The requirement of benefit sharing would apply whenever biological resources are obtained from India. The National Biodiversity Authority has regulatory powers and is required to ensure equitable benefit sharing in relation to biological resources. The Protection of Plant Varieties and Farmers' Rights Authority under the Protection of Plant Varieties and Farmers' Rights Act, 2001 also has the power to determine benefit sharing, in relation to a registered variety. But these benefit sharing provisions are not identical. The National Biodiversity Authority shall, at the time of giving approval, determine the benefit sharing. The Protection of Plant Varieties and Farmers' Rights Authority, on the other hand, shall, after the plant variety is registered, invite claims of benefit sharing. It will then dispose of such claims. Thus in the case of a plant variety, the onus is on the community to raise the issue of benefit sharing, whereas under the Biological Diversity Bill, 2000, the onus is on the Authority to ensure equitable benefit sharing. Further, each legislation provides for its own fund where the amount of benefit sharing may be deposited (in some cases it may be given directly to the community concerned). It remains to be seen whether these two Authorities co-ordinate smoothly in the case of benefit-sharing relating to a medicinal plant that is also registered as a plant variety.
The question of acknowledgment of the source of the biological material is addressed in the Patents (Second Amendment) Bill, 1999, which has been passed by both houses of Parliament. This Bill provides that an Indian patent may be opposed or revoked on the ground that the complete specification does not disclose or wrongly mentions the source or geographical origin of biological material used for the invention. It is accordingly restricted to cases where a patent has been applied for in India.
Knowledge relating to medicinal plants
Mere knowledge is difficult to protect legally, as it is intangible. One kind of protection is by means of asserting an intellectual property right, such as a patent, copyright, or trade secret. In the case of medicinal plants, traditional knowledge relating to these plants does not fall within any of these established categories. On the other hand, the use of technology, including biotechnology, to develop a useful product using this traditional knowledge is generally protected. The issue of bio-piracy in relation to such useful and financially productive knowledge has come into Knowledge relating to medicinal plants prominence as a result of the cases challenging the patent granted on neem and on turmeric.
In the turmeric case, the US Patent and Trademark Office granted a patent on the “use of turmeric in wound healing”. India successfully challenged this patent by showing that this use of turmeric was well known and that nothing new had been invented. The documents relating to this traditional knowledge of India were unknown to the US Patent and Trademark Office. When they were brought to the attention of the Office they were considered to be “prior art” and the patent was revoked.
In the case of neem, the patent challenged referred to improving the storage stability of an insecticide containing neem seed extracts. This patent could not be revoked as the patent holder (W.R.Grace & Co.) had improved on existing knowledge. While neem-based insecticides were well known, they did not have the storage-stability claimed in the patent. The patented composition could thus be distinguished from the traditional knowledge.
The cases of turmeric and neem are illustrative of the dilemma facing India in relation to the traditional knowledge of medicinal plants. On the one hand, traditional knowledge is not documented in an easily accessible form so as to be considered “prior art”. On the other hand, where traditional knowledge is available as to the property of a particular plant, it can be modified so as to be distinguishable from the original traditional knowledge for legal purposes. The end result is that a particular company may get the sole right to manufacture and sell the active chemical compound derived from a plant, although communities may have used the plant for the same or similar purpose over a long period of time.
To prevent this, the preparation of databases of traditional knowledge is being actively pursued. This would solve the problem of showing traditional knowledge to be “prior art” (the turmeric case). But this does not solve the problem faced in the neem case that of the modification of traditional knowledge. Information as provided by traditional knowledge is often all that is needed to provide the necessary input for research and development by a pharmaceutical company, which may use it to make a product that is legally “new”, but is considered to be bio-piracy by the community concerned.
One solution to this would be to have pre-conditions in place for access to the databases. This would take the form of a legal contract between the researcher and the database owner. This contract may necessarily vary from region to region or community to community, but it would nevertheless be based on certain common provisions. For example, the contract would require the researcher to give an undertaking to give credit to the community as the source of the information, to share any future benefits arising out of the use of such knowledge, etc. The contract would be have to be signed by every person accessing the database, irrespective of country or community or reason for access, before he or she is permitted to look at the database.
Apart from the above non-statutory methods of protecting knowledge, the Biological Diversity Bill, 2000 requires prior approval of the National Biodiversity Authority for any foreigner or non-resident Indian who wishes to obtain knowledge associated with any biological resource occurring in India. Its prior approval is also necessary for any person who wishes to apply for any intellectual property right anywhere in the world for an invention based on information on a biological resource obtained from India (except in the case of a patent application, where the approval may be obtained anytime before the sealing of the patent). The Parliamentary Standing Committee that considered this Bill has recommended that a ceiling of 90 days be provided to the Authority for granting its approval.
The Patents (Second Amendment) Bill, 1999 has a limited form of protection for traditional knowledge. It states that an Indian patent may be opposed or revoked if the invention was anticipated having regard to the knowledge, oral or otherwise, available within any local or indigenous community in any country. This would need to be reciprocated by other countries for Indian traditional knowledge to be adequately protected.
India has adopted a combination of methods for the protection of medicinal plants. Wherever a pluralistic legislative framework is adopted, the efficacy of the system depends to a large extent on the amount of friction between the parts. As each legislative proposal has been promoted by a different Governmental Department, it could be difficult for the national interest to be promoted without close co-operation between the different Authorities involved.
This work was funded by Infosys Foundation.
The author is an Advocate and Infosys scholar, National Law School of India University, Bangalore.