Winning the war against bio-colonisation

The euphoria over the revokal last week by the European Patent Office of a patent on a neem product is misplaced. Dr. M. D. Nair, argues that legal action on individual cases of bio-piracy is no substitute for an integrated approach that protects the traditional health systems of the developing countries and prevents their bio-colonisation by global firms.

IN JANUARY 1995, the World Trade Organisation (WTO) came into being with the mandate of implementing a new world trade order, equitable to all member-countries, as agreed to by them under the General Agreement on Tariffs and Trade (GATT). While the deadlines for the necessary amendments to national laws have not been met by many countries, the WTO has been busy with appropriate counselling, negotiations and dispute settlements between its members. Developing countries are, however, confounded not only by the dictates of the various obligations under GATT, but also by their real or perceived fears that using the instruments of the present global regime of Intellectual Property Rights (IPR), much of their natural wealth in the form of biodiversity assets are being exploited by transnational corporations.

What is the nature of these assets?

Traditional health care systems have several components, some tangible in the form of practices and products and others the ultimate intangibles, knowledge and heritage. Developing countries in possession of such assets are keen to ensure that they are not exploited by third parties, without an appropriate sharing of the wealth created in the process. The majority of bio-assets and traditional medicinal remedies in India such as Ayurveda, Siddha and Unani use a multiplicity of indigenous plants, most of them unique to this country.

While their products are in the public domain, much of the technology for their production remains in the realm of `undisclosed information' or `trade secrets', terms which are relevant in the context of the WTO agreement on trade-related aspects of intellectual property rights (TRIPS). (That is, the ingredients that go into the making of these medicines and the processes by which they are made are not known. The TRIPS agreement provides necessary protection for such processes). The sum of the traditional assets of most developing countries comprises the knowledge base, both undisclosed and in the public domain, the medicines themselves and their primary sources, namely the medicinal plants indigenous to them.

Current dilemma

Interest in alternative therapy has taken the world to the doors of traditional treatment modalities, whether based on medicines or practices. Health care providers including pharmaceutical companies are involved in a major way in the incorporation of many of these into their mainstream activities. As traditional medicines are largely based on medicinal plants, endemic to the countries where the system has been in vogue for several centuries, the thrust is to access them directly from these countries or through use of modern tools of breeding and cultivation, including tissue culture, cell culture and transgenic technology or even developing cocktails of secondary metabolites of the plants that are largely responsible for their biological activity.

Developing countries are thus faced with the acute dilemma of their valuable indigenous wealth being taken away and exploited commercially by the resource and technology-rich transnational pharmaceutical companies. UNDP estimates that medicinal plants and microbials from the South contribute at least $3 billion a year to the North's pharmaceutical industry. If developing countries are to become economically strong, they need to capitalise on their unique bio-assets, just as the OPEC countries prospered due to their oil-wealth. In order to achieve this, they need to have systems that will provide them benefits from global development and marketing of their medicinal plant resources.

There are several definitions and interpretations of the term `traditional medicines.' The most comprehensive is the one where the World Health Organisation (WHO) has defined it as ``the sum total of all the knowledge and practices, whether explicable or not, used in diagnosis, prevention and elimination of physical, mental or social imbalance and relying exclusively on practical experience and observations handed down from generation to generation, whether verbally or in writing.''

At a conference held in October 1998, under the aegis of the World Intellectual Property Organisation (WIPO) an agenda for the future of IPR in the field of traditional medicines was prepared, which prioritised activities in this area, namely, development of standards for the availability, scope and use of IPRs on traditional medicine in Asian countries, systematic documentation of traditional medicine for protection purposes, regional and inter-regional information exchange and compilation of requisite data bases.

In this area, the relevant article in TRIPS which fixes the criteria for patentability of invention is Article 27.3(b), which specifies that plants and animals could be excluded from patentability, with the provision that plant varieties may be protected either through patents or under a sui generis system of protection. This clause is now under review at the WTO. However, there is general disagreement even on the scope of the review. While the developed countries maintained that the review should be limited to the status of implementation, the others (the African Group, Egypt and India) feel that the review should include possible revision of Article 27.3(b) itself. The aim of the latter is to ensure that naturally occurring materials, including genes, are declared non-patentable.

The problem is that, with respect to traditional medicines, Article 27.3(b) is inadequate to meet their protection requirements. In order to ensure equity in this area, it becomes incumbent therefore that the TRIPS agreement be made compliant with the Convention of Biological Diversity (CBD) and the FAO International Undertaking. The former stipulates under Article 15 that bio-assets are not the property of the whole world, but only of the sovereign states which possess them, while the latter seeks to `protect the farmers' rights and conserve plant genetic resources'. India has rightly maintained that the CBD provisions should supercede Article 27.3(b) of TRIPS and that patents inconsistent with Article 15 of CBD must not be granted. India has also suggested that multilateral agreements be drafted to legitimise benefit sharing from material and knowledge transfer from traditional communities and systems to third parties, within the country or outside.

From the bio-rich developing countries' point of view, the desirable scenario should be one in which their bio-assets are not exploited without appropriate rewards by third-parties. To achieve this objective, what are the possible strategies and modalities? Within the framework of current agreements and negotiations, it should be possible to have the following approaches:

Enact an appropriate Bio-diversity Protection Legislation including benefit sharing consistent with Article 15 of CBD.

Negotiate international agreements to ensure that provisions under CBD are TRIPS compliant and will be implemented in defined timeframes.

Wherever appropriate, invoke geographical indications to protect plants and germ plasms specific and unique to geographical regions.

For new varieties of medicinal plants developed through new breeding technologies, Plant Varieties Protection under a `sui generis' system should be applied.

Provisions under undisclosed information or trade secrets should be invoked to protect traditional knowledge not available in the public domain.

Novel informal Intellectual Property Regimes including utility models and petty patents should be developed.

It is clear that to ensure effectiveness, the country needs to document and catalogue its bio-assets in all details and make the databases available to all international search engines. Multilateral agreements either in a new WTO round or as part of a TRIPS plus deal should be negotiated to cover all aspects of protection of traditional knowledge and traditional products. Countries of the bio-rich South should develop common strategies to protect their common interest and heritage from the economically-rich North.

Patenting rationale and status of neem

The most talked about story of `unauthorisied' exploitation of a highly valued bio-asset is the case of the neem-tree, known in India for over 4,000 years as the `village pharmacy' because of the reported usefulness of its bark, seeds, leaves, gum and oil, for a variety of ailments. Though reportedly indigenous to India, presumably due to its many uses in health care and agriculture, many countries such as Fiji, Australia, East and Sub-Saharan Africa, Far East, Central and South America, the Caribbean and even West Asia started growing this tree and using its beneficial properties for various purposes. The best-known scientifically validated activity is the insect anti-feedant properties of the active principle Azadiractin.

In view of the importance of neem products for a variety of applications in health and agriculture, products from neem, processes for `novel' neem-based preparations and 'new' uses of products derived from neem have been the subject matter of several patents and patent applications. At last count, over 60 patents have been issued primarily by the U.S., European and Indian Patent Offices. As of now, the patenting rationale and status of neem and neem-based products are as follows: The neem tree or any of its parts is not patentable under the `Doctrine of Nature' principle applicable to the patent laws of all countries. Products from neem, which are already known, for example, Azadiractin, are not patentable as they lack novelty.

Known uses of neem and/or products derived therefrom by physical processes, example, aqueous or solvent extraction, are not patentable as they lack novelty and inventiveness. Chemically modified new derivatives from constituents of neem are patentable if they possess useful properties better than the known products. New varieties of neem that satisfy the requirements of a new plant variety as defined in Plant Varieties Protection Act are protectable under that Act.It is obvious that under such conditions, practically all the neem patents issued so far would be invalid patents, which do not warrant any legislative interference for revokal. An exception would be the case of the two patents on azadiractin granted to W.R. Grace, wherein the patentee claims the development of stable formulations using appropriate solvent mixtures and surfactants.

The inventive part rests with the new formulations which have satisfied the long-felt need to have stable products from neem, which can be stored and applied at ambient temperatures. The patent, however, is restricted to the preparation and use of products specified in the claims and does not cover any other neem or azadiractin-based preparations.

It is a common myth that a patent issued, for example by the U.S. Patent Office assures validity of the patent. The validity of any issued patent can be challenged right up to the highest court in the land during the life time of the patent. Alternatively, prima facie, if a patent is invalid due to its not satisfying any one or more of the basic pre-requisites of novelty, inventiveness or utility, it can be ignored or `infringed' with the onus of the challenge transferring to the `patent' owner. In the case of the European Patent No. 436,257 on the method for controlling fungi on plants by the aid of hydrophobic- extracted neem oil, on May 10 this year, the European Patent Office (EPO) decided to revoke the patent after two days of oral proceedings in which the patent proprietors, W.R. Grace and the USDA, and the opponents consisting of two NGOs and one Member of the European Parliament were heard. It was decreed that the patent was being revoked, since the patentee's claims lacked novelty in view of the known prior public use of the product in India.

In effect, such cases including the patent on turmeric, jamun, brinjal and several hundred others are all invalid under the patent system. But getting them revoked is equivalent to winning small battles at high cost with little impact on the war being waged over the entire system of `bio-colonisation'. The real solution will come only out of an integrated strategic approach to protect the bio-assets of developing countries through globally accepted formal and informal protection regimes.

The author is a pharma industry consultant.

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