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.

Dr.M.D. Nair.

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