The neem tree (Azadirachta indica) is regarded as one of mother nature's gift to the world. In India , it is commonly found in house compounds in both villages and cities. Green twigs are used as toothbrushes to combat teeth decay. Its extracts have a powerful pesticidal activity and are used by both households and farmers to control a wide variety of pests (insects, fungi, bacteria, viruses, nematodes, rodents etc.). These extracts have considerable antiseptic affects and are used as a skin care agent in soaps and shampoos. The leaves are often mixed with rice and consumed as a cure all and prophylactic against bacterial and helminthic infections. Neem leaf pastes are used to repair scarred skins arising from the effects of chicken pox. Not surprisingly, many believe that the neem tree itself can ward off demons. The pesticidal and medicinal properties of extracts from the neem tree have been exploited for at least the last 2500 years. Sanskrit texts dating back to the sixth century BC, document the microbicidal and prophylactic effects of neem extracts. Charaka in the 6th Century BC recommended the oral consumption of neem extracts to ward off pimples, leprosy and edema. Sushruta in the 5th century BC recommended the use of neem-leaf smoke for fumigation and maintenance of general hygiene. He also recommended it as a "krimihara", an agent effective against insects, grubs and maggots and detailed the ability of neem leaves to cure gangrenous and otherwise difficult to cure wounds. The neem tree appears to be a biochemical factory producing a mixture of over 135 biologically active compounds. As a pestticide, the oil from neem seeds are believed to break the life cycle of pests and deters them from feeding and/or hatching. Studies have shown that active compounds iin the oil inhibited the secretion of hormones into the blood inhibting the moulting and reproductive function in insects.
Neem oil is known to be active on over 400 insect pests. It has for example been found to be effective against fleas, head lice, ticks, termites, plague locusts, mosquitoes and sheep blow flies. It is believed to be particularly active against chewing and sucking insects such as caterpillars and beetle larvae.
Neem extracts have also been shown to be effective against nematode pests. Neem cake, the by product from neem seed processing appears to be effective on nematodes, snails and certain fungi. The neem tree and its extracts surprisingly appear to be benign to bees and other nectar feeding insects. Seed extracts are not known to have any toxic effect on plants, mammals and birds and in fact in studies by the US EPA, no LD-50 could be established even at high doses.
These remarkable properties have attracted considerable interest from both researchers and pharmaceutical companies. This renewed interest in neem created no more than amusement in India where the beneficial properties of neem have been known for countless generations. This mood however has recently changed with Grace Horticultural Products, a unit of Grace Speciality Chemicals (USA) acquiring the patent and trademark rights to produce and sell insecticidal neem extracts. Their product, Margosan-O Concentrate, is protected under US patent No. 5124349.
In 1995, a group led by Mr. Jeremy Rifkin, president of the Foundation of Economic Trends in the US, Dr. Vandana Shiva of the Research Foundation for Science Technology and Natural Resource Policy and Professor, Nanjundaswamy of the Karnataka Rajya Ryot Sangha in India contested the decision of the US Patent and Trademark Office. They claim that the neem product has long been used as a pesticide in India and is not a new invention as claimed under the patent. They claim that Grace's patent does not satisfy the criterion that the invention must not be obvious to one of ordinary skill in the art. They assert that the Grace process only slightly differs from that used by farmers in India.
Grace on the otherhand claims that its patent relates to a formulation based on neem-seed extract. They assert their formulation overcomes the problems associated with the instability of azadirachtin, the primary active pesticidal ingredient from the plant, in traditionally used water or alcohol based emulsions. Further the awarding of patents based on the purification or modification of naturally occurring substances is not new. For example, in 1979, the US Court of Customs and Patent Appeals reversed a decision by the Patent and Trademark Office to award a patent for a compound purified from strawberries. In fact, more than 40 patents have already been award for inventions relating to a compound found in neem seeds alone.
Regardless of its outcome, the legal battle ensuing between Grace and its opponents will have significant ramifications for the natural products industry. Rifkin and partners assert that the patent and other similar patents will mean that "indigenous populations around the world, will be excluded from freely using many of the local biological resources that have been carefully developed and nurtured over hundreds of years". It has even been claimed that in a worst case scenarios that indigenous farmers would have to pay royalties to carry on their centuries-old farming practices. Unfortunately the latter argument fails to consider that no universal patent exists and as such Grace's patent is not valid in India. Indian farmers can thus choose to pay a premium for Grace's formulation or continue to produce their own.
As a result of this case, developing countries are now more concerned about the consequences of the loss in sole proprietary of a biological resource. Recently, a senior official from the Indian Council of Agricultural Research voiced his concern on the "pilfering" of traditional plant varieties from India. "The neem is ours and nobody can take it away". His claim may be a case of closing the door after the horse has bolted and is indeed somewhat curious, given that neem trees have been successfuly grown in over 17 countries. They can in fact be obtained here in Singapore.
The Indian government is in the process of formulating a Plant Varieties Protection Act which will seek to protect over 2,300 currently unprotected Indian plant varieties. Whether other countries follow India's lead will certainly have a significant influence on both research and production of natural products.
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