What's in a neem?

A lot, apparently. Neem -Azadirachta indica -and the I?roducts derived from it have traditionally been widely used for centuries, especially in India, for medicinal purposes and pest-control. Recognising its vast potential, Western science and industry has embarked on a flurry of patenting neem's much-valued derivatives, while India, the plant's native land, has been reduced to playing the role of a backbencher

 
By Anil Agarwal
Last Updated: Thursday 11 June 2015 | 11:05:10 AM

What's in a neem?

-- (Credit: Illustrations: Rustam Vania<sc)THE 10-year period from 1985 to April 25, 1995 - according to relevant databases - has been marked by a veritable deluge of us and European patents on neem-related products. The databases also include information on patents which werefiled through the Patent Cooperation Treaty (PcT), a UN body functioning under the World Intellectual Property Organization. Some 28 patents were filed in that period in USA, of which 15 were filed in just the 16 months between January1994 and April 1995 - almost at the rate of one every month. Weeding out all PCT and European patents which were similarto us patents - there were 28 us, 16 European and nine PCT patents (53 in all) - one arrives at a figure of 36 different inventions. The remaining 17 patents can be discounted as they had been filed by the same companies under the same titles for the same products or processes. It can, therefore, be assumed that they would be identical and hence cannot qualify for the 'new inventions' category.The earlier years of the period show an annual rate ofaround one or two patents or none, but the patenting rate builds up to a crescendo by 1994, with some 13 patents in that year alone. And of the 36 new patentsrelating to the new inventions - 28 us,three European and five PCT - Overthree-fourths had been filed in the usalone.

Who are the patentees?
Seventy-two per cent of the 36 patentsare held by corporations, and of these,as many as 22 are held by us corporations. One company that clearly loomslarge is W R Grace and Co of the us,with I I patents, or 42 per cent of all thepatents held by corporations.

With corporations holding nearlythree-fourths of all patents on neem-related products, research institutionstake a distant second place with sixpatents or 17 per cent of all patents;individuals have four or I I per cent ofall patents (Table 1). When the 36patents are classified by the country ofthe agency which has been assigned thepatents, we find 26 of them - or 72 percent - held by USA, three each by Germany and India and one by Japan.The databases do not indicate thecountry of origin of three individualpatent holders. One particularlyintriguing European patent (patent no436257dated July 10, 1991), titled Hydrophobic extracted neem oil - anovel insecticide and fungicide is heldjointly by W R Grace and Co and the usgovernment. Strangely, none of thepatents filed by W R Grace and Co inUSA have the us government as a co-patent assignee, including us patent no 5352672 dated October 4, 1994, whichlooks similar to the European patentreferred to above.

The levels of interest
It is interesting to analyse Tables I and 2 from the standpointof how hustained the interest of different patent holders hasbeen in neem. A Japanese corporation received a patent in usin 1985, but later Japanese researchers do not seem to have followed up with any further work. Germany also demonstrated an early interest in neem; the Max Planck Gesselschaftreceived a patent in 1990. Since then, two separate Germancorporations have received patents in 1992 and 1994.The German interest, too, appears to have been sporadic andSpotty.

The us corporations have, however, shown a consistentinterest, with a few patents appearing every year during the1990building up to two highs in 1994 and 1995. The threeleading us corporations in the neern patenting business are WR Grace & Co, Agridyne Technologies Inc and Rohm andHaas Co. India, with a total of just three patents, clearlyemerges as a late entrant in neem research - the first Indianpateht having been obtained by the National Institute ofImmunology in 1993, the second by a private company,Godrej Soaps Ltd in 1994, and the thirdby the Council of Scientific andIndustrial Research in early 1995.

Obviously, the knowledge aboutthe possible commercial uses of neernwas first obtained from the traditionalknowlcdge of the people of India.Research on neern oil and neern cakebegan in the 1920s at* the IndianInstitute of Science in Bangalore. In1942a scientist of the Council ofScientific and Industrial Research isolated nimbin, a biologically active compound, from neem. But Indian scientists failed to take their work forward tothe stage of industrial or commercialproduction.

In a landmark discovery in the late1970researchers at the University ofKeele, UK, isolated azadirachtin, the keyactive ingredient of neern that mostcurrent patents focus on. Anothercountry that was showing interest inneern at this time was Germany whichhad organised the first internationalneem conference in 1980 (Down ToEarth, Vol 1, No 10).

But ultimately, it fell to the lot of uscorporations to undertake sustainedresearch on neern for developing acommercial market for it as a pesticide.Consequently, Indian scientists appearto have rediscovered neern in the1990Only one Indian name appearsin the list of inventors in the patent databases. These databases, on theirpart, do not reveal how foreign corporations received word about neem.

But it is interesting to scan thereferences that have been cited in thefiled patents; Indian scientists appearto have authored a number of the papers which have been referred to. Papers from the proceedings of the international neem conferences, the Neem Newsletter and journals like Phytoparasitica and Mycologia have been cited extensively.

Recognising the fact that the information about the uses of neem has clearly emerged from Indian tradition and science well-known us activist Jeremy Rifkin has filed a petition with the us government's commissioner of patents and trademarks to re-examine the validity of the patent given to W R Grace for Storage-stable pesticide formulations containing azadirachtin as the active ingredient (patent no 5124349, dated June 23, 1992). The petition cites 'prior art' as the reason for annulling the patent, which includes knowledge that was available at the time of patenting with a person of ordinary skill. The fate of this petition will determine to what extent ipatenting authorities are going to take into account knowledge rights oftraditional communities.

Products and processes
Although classifying patents according to the. type of invention is a difficult proposition, two broad categories can be delineated:

Patents dealing with new extracts, compounds, products or uses;

Patents dealing with new manufacturing processes.

It is apparent from this categorisation that 22 of the 36 patents relate to the first group, and 14 to the second. Of the 14 patents that deal with manufacturing processes, as many as 12 are held by us corporations and one by a German corporation. Thus, out of 22 patents held by us corporations, 12 deal with manufacturing processes, especially those inventions which help increase storagestability, essential for enhancing shelf-life and marketability. Other patents deal with processes which try to increase the concentration of azadirachtin in the final composition, remove contaminants like aflatoxin, and with tissue culture methods to produce azadirachtin in the laboratory.

Interestingly, no Indian agency or individual has yet obtained a patent for developing a manufacturing process that would increase the marketability of neemrelated products. Indian patents focus more on new compounds and new uses.

An analysis of the kind of products these patents relate to also throws forth interesting pointers. As many as 30 out of the 36 patents deal with neem-related substances being used as pest-control agents - as pesticides, insecticides, fungicides or acaricides (substances poisonous to mites and ticks). Corporate interest appears to be almost exclusively devoted to pest-control. Given the fact that the global pesticide industry has been facing - since the early 1980s - a serious crisis because ofthe steady build-up ofbiological resistance to pest-control agents (rendering many pesticides ineffective), and the growing criticism of pesticide use by environmentally-concerned scientists and agencies, the corporate sector in the us probably saw neem as a godsend - a natural pesticide which could kill a wide range of pests and possibly take environmentalists off their backs.

In recent years,. researchers seem to have looked for substances beyond azadirachtin either derivatives of azadirachtin, or extracts substantially free of it - to develop pest-control agents. But little progress appears to have been achieved on them beyond the work done by the Native Plant Institute, USA (patent no 4960791, dated October 2, 1990).

Of the remaining five patents, two deal with anti-cancer and other therapeutic properties of neem, of which one was obtained by a Japanese corporation in 1985 and another by an us citizen in 1994. The later patent claims that purified extracts from neem leaves also have anti-virus and anti-malarial properties. This demonstrates the low level of corporate interest and the interest of public research institutions in developing therapeutic compounds from neem possibly because the money that can be made from such uses is small.

Little is known about neem's potential as an anti-cancer agent. It is unlikely that the National Cancer Institute (NCI), an us government research centre, which has screened over 100,000 plant and animal materials from all over the world for determining their anticancer and anti-AIDS properties, would not have done the same for neem products. It is quite possible neem has received adequate attention as a potential anti-cancer agent, but has not proved itself to be a worthy candidate. But the opposite - that neem has not yet received the attention it deserves as a therapeutic substance - can also be the case.

The only patent for neem's anti-fertilityproperties has been obtained by the National Institute of Immunology in Delhi. Besides, there is an individually held patent on using neem to treat head lice in humans. Rohm and Haas Co has a patent for an edible oil extracted from neem seeds.

There also appears to emerge from all these neem-related patents a patenting strategy that different economic agents follow. Individuals appear to be interested in PCT patents exclusively. This is primarily because the PCT prepares search reports on behalf of the applicant, in different countries designated by him - thus saving on the overallcost. Both Peter High Hull and VincentHenry Guerrini only obtained PCT patents,while Iroka J Udeinya obtained - for thesame invention - an us as well as a PCTpatent. us corporations appear to be moreinterested in obtaining an us and anEuropean patent for the same invention. Itis also interesting to note that companieslike W R Grace and Co file applications forpatents for incremental inventions, that is,patents that are almost the same except forminor differences. It seems that companies keep filing new patent applications as they keep making incremental researchgains. This is probably because the lastpatent helps them to extend the length oftheir patent duration.


Has India missed the boat?
There are two critical questions that canbe raised at this stage. Firstly, have wealready missed the neem boat? Secondly,with all patents already filed, is there anything more to be found in neem? May bethere is. If Indian scientists and corporations give adequate attention to the issue,they might find many new compoundsand put them to good use.

One approach could be to lookfor therapeutic products from neem- an area of research that has beenrelatively neglected in the West. Thetraditional neem-based remedies ofAyurveda could also provide usefuldirections for research. One rarelycomes across a plant like neem whichhas the potential to give so much tohumanity. It is indeed sad that Indiahas missed such an important gravytrain.

While there are enough activists inIndia and elsewhere to shout downforeign corporations for their interestin neem, there is almost no effort todemand an explanation from theIndian scientific community ingeneral and the state-dominatedscientific research establishment inparticular on the reasons behind thenegligence. One could, of course, takea cynical view of the whole thing andraise the 'foreign agents' for theirinterest in our traditional knowledge.But can we pardon our own scientistsfor their. disinterest? And even if wehave failed once, are we now sure thatour scientific establishment, our minister of science and technology or ourParliament have learnt their lesson?

Even if neem fails to give us anything more, there is no reason whatsoever to believe that India's traditional knowledgecannot. The former director of the Hyderabad-based Centrefor Cellular and Molecular Biology (CCMB), P M Bhargava,says, "A considerable amount of reliable work on neem and itschemistry has been done by Indian scientists. Many biologicalproperties of neem have also been described in our folklore.Unfortunately, we have never attempted to verify and substantiate what has come to us through folklore by using stringentmodem scientific methodology and criteria." He argues that ifIndia really puts her head and heart into her traditional medicalsystems, she can find at least 100 new drugs which wouldendow her with one of the world's most powerful pharmaceutical industries. Yet, he claims, the department of biotechnology, set up with a key objective to focus on Indian traditionalmedical systems, has failed to take any steps in this direction.

Has India missed the boat?

-- Bhargava adds: "Unfortunately, neem is not the only case where we have lost out. We (at the CCMB) discovered a protein called seminal plasmin (published in Nature and widely publicised in the late 1970s around the world); a few years ago, we showed that it has anti-HIV properties. This work, however, was never permitted to be pursued in the country. It could have made us a leader in this field. Also, the story of development Of DNA fingerprinting technique in the country, and the innumerable blocks that were placed in way of its commercial exploitation, is already well known."

Probably the saddest thing in this entire exercise is that till date our government has not come up - in the ongoing negotiations on the Convention on Biodiversity (CBD) - with a clear proposal demanding that foreign patent holders pay for the knowledge they obtain from the Indian people.

In an increasingly interdependent world in which we all benefit from the knowledge of others, it would probably be unfair as well as impossible to outlaw any foreign interest in our inherited knowledge. But it would be extremely fair and legitimate to demand that if this interest results in a marketable product, a definite share in the royalties and other forms of income that emerge from the marketing of the product should accrue to India.

The international market system is built on the simple principle of pay fb@r whatever you use. But royalties from benefit-sharing in patents, or reliance on our capacity to export raw materials, will not yield us any considerable financial returns. If India prohibits exports or charges higher prices, competing nations will begin producing the required raw materials. For instance, if India is not prepared to export neern seeds or neem seed extracts, west African countries (which have large populations of neem) or Australia (whRh is undertaking neern plantations), will do so.

I Moreover, tissue culture techniques could be used to produce natural products in the laboratory. Rohm and Haas already has a patent on tissue culture techniques for neem. In November 1992, the journal Science reported that the "big agrochernical companies have been slow to jump on the neem bandwagon. The reason? It's extremely costly to extract the insecticide molecule, azadirachtin, from neem seeds, and no one's been able to take out a broad patent covering the molecule because its structure was published way back in the 1970s. What's needed, say business-minded pest-control experts, is a cheap way of making azadirachtin-like compounds that can be patented." And that is exactly what may be happening in Western laboratories.

The article also reported that Steven Ley at the Imperial College of Science and Technology in London had succeeded in synthesising the two chemical structures that together make up the azadirachtin molecule. David Morgan, a chemist from Keele University, who was the first to isolate azadirachtin from neem, suggested that using Ley@s reaction pathways, it may now be possible to make new and effective derivatives of azadirachtin in the laboratory.

Western science, of course, cannot be stopped from following this course. If India wants to enter the global pharniaceutical and agrochemical market in a big way, she must learn to innovate and patent and seize the world market with new products. It is her failure to do precisely this which has resulted in the Indian people having benefited so little from modem scientific research on neem.

Who do we blame? The government? Indian scientists? The politicians? Or just ourselves - members of the educated middle class - who seem to have precious little interest and pride in their own toots and traditions, whom Jean-Paul Sartre would have described as the 'whitewashed' sahibs of the colonised Third World? Partly everyone. But did we not push out the British half-a-century ago? What is to be done?
Bhargava cites "lack of imagination and ad-equate support, the Indian crab syndrome and increasing control of Indian science by a mafia since the mid-'60s" as reasons behind the situation. He adds, "Today, the best policy for u's would be to have all the patents on neem examined carefully in the light of existing knowledge, and contest those patents that are not legally justified. The examination has to be done by a group of comrr4tted patent experts and scientists whose knowledge and understanding of the problem is global."

A three-pronged strategy is the need of the hour'. Firstly, the country has to get its act together on ensuring that India's traditional knowledge becomes a legally valid entity. This is so that anyone who wants to benefit from it - not just W R Grace, but also Indian capitalists like the Sarabhais or the Daburs or the Indian state - is forced to pay royalties to the community from which it derives knowledge for commercial use. Unfortunately, the Indian state and its capitalists are as colonial towards community knowledge as foreign multinationals, Have you ever heard anyone forcing the otherwise great and dynamic cosmetic capitalist Shahnaz Hussian to pay for traditional knowledge? And why should she not? just because she has the same colour of the skin, does she acquire the right to commercialise the knowledge of the Ezhavas of Kerala or the Apatanis of Arunachal Pradesh without paying for it?

The CBD'S contention that all biodiversity is national property means nothing in terms of the knowledge of use of that biodiversity and the community's rights to that knowledge. It is like saying that Dhanbad's coal is a national resourcei but the knowledge (technology) for burning that coal efficiently will still be private property - an invention that win be patented by an individual or a corporation. The CBD's declaration clearly allows a nation to formulate its own laws also on the ownership of the knowledge of how to use the biodiversity - as drug, as pesticide or as a cosmetic.

The CBD, in fact, clearly stipulates that nations should develop 'benefit -sharing' systems with traditional communities. If anything, India's politicians and bureaucrats are guilty of not developing and implementing a commitment they have made in favour of their traditional communities internationally.

There is considerable confusion whether the wTo (World Trade Organization) agreement, which strengthens the patents regime. worldwide, goes against community rights on traditional knowledge of uses of biodiversity. The agreement as yet speaks mainly of an effective system for cultivated plant varieties and microorganisms. On the face of it, there is nothing in the WTo agreement which would prevent India from developing a strong patent system that would respect community rights to the knowledge about the use of plants. And even if this is not the case, there is no reason why developing countries cannot fight together in the wT6 far such a system.

There are other aspects OfCBD which could be cause for a conflict between it and wTo, For instance, the cBD states that if a foreign company takes biodiversity from another country, it must share its research results on that 'biodiversity with the biodiversity-donor nation. But the entire developing world put, together does not have the international clout to get the West to accept such clauses, which is why. cBD as an international convention remains in trouble.

The real problem in developing a system for protecting community knowledge arises not out of wro but out of the legal principles on which patent law Jtself is built. There are two problem areas. Firstly, patent law respects only private inventils; corporate inventions are respected only because corporations are accepted as individuals in patent law through a legal legerdemain. Community knowledge is therefore, by that very definition, knowledge in the public domain. How can that knowledge be patented under patent laws? But if legal jugglery can make a corporation an indiVidwl, then surely it can also turn the Gonds of India into an individual.

But what is a community? Are the Dasguptas of West Bengal and the Goenkas of Marwar examples of communities? Is an Indian village a community? In fact, in different cases, they may all be separate communities. And all Indians constitute a community, because the knowledge of neem was nationwide. Who will then receive. the royalties on behalf of these communities? These are undoubtedly complex legal issues and only a committed group of legal. scholars, given a clear charter by the government, can come up with solutions.

A problem that the author faced during the preparations to the Rio Conference is that of the bleeding heart 'liberal opinion', which holds that this pro- posed system, oft~n called the counter- patent system, pushes traditional com- munities into the evils of international commercial practices and that they should be kept away from this. The Centre for Science and Environment's (CSE) statement on global environ- mental&overnailce prepared before the Rio Conference had specifically demanded this. But many Indian non- governmental organisations felt that this could expose Indian tribals to exploita- tion. The then minister for enyi:ron- ment, Kamal Nath, did not understand either, although a few officials in the ministry of environment were more sympathetic to the idea but felt clueless on how to proceed with it.

It is now being widely recognised that such an opinion is totally against the economic interests of indigenous communities, because without a legal system that protects community r1ghts on the knowledge of biodiversity use, everyone will steal that knowledge. Fortunately, this false liberal opinion is now withering away. It is clear that clarification of the issue involved and developing a counter-patent system is the first step that needs to be urgently taken in this case.

The second pointer that neem patents specifically raise is how do we ensure-that the benefits of our traditional knowledge accrue to India and a not to afor- eign multinational. This brings us to the Tealm of research. Simply doing basic and applied research, as India has done in the past, will only mean that foreigners will pick it up and take it through the later stages, which will allow them to exploit a world market. India has an immense knowledge abo1.!t plants. As-an industrial giant, she must exploit the full world market by developing and launching products on her own.

Once there is clarity on this second issue, there will have to be a third component of our national strategy. India's research programme must go beyond basic and simple applied research on to industrial and product research. This cannot be done simply by state.owned researchlaborato!ies; nor can this be done by Indian private companies. A CSE staffer who inter- viewed managers in Dabur was told that they were not inter- ested in developing any new product because ~t was too expen - sive. Essentially, Indian companies want to limit their research costs to formulation and packaging so tl1at someth~ng can be sold in the market in a bottle or as a pill. A cooperative indus- try research programme is, therefore, vitally needed.

The South Korean approach may be useful and instructive here. Based on it, industrial and product research on neem could be declared an area of National Research Importance and given a specific budget over the next 10 years amounting to, say, Rs 300 crore. The programme could then be thrown open to any public or private sector scient~st to develop a research project that involves public and private laboratories, or a collaboration of both. While the scientific andindustriaf merit of the pro- posal would, of course, receive due consi - deration by the peer review group, whose deliberations ol;lce finalised will always be open to public scrutiny, the government could try to push the programme towards industrial participation by giving greater weight age to those proposals in which industry is prepared to put a greater per- centage of research costs.

To raise funds for !esearch on planr products, a cess can be levied on all pro- ducts that call themselves ayurvedic or , herbal; the funds can be used to finance this research and t,hus reduce direct government subsidies, though the programme should get as much g,overn- ment financial support as necessary. The fund could be overseen by a joint com- Jr.ittee of industry, public-s~irited citizens, scientists and (as few as possi- ble} government officials. The cess should be directly committed by the government to this fund so that it does not get lost in general administration and salaries of government officials.

There is one particular issue that would have to be taken account of while developing the above research strategy. According to several Indian neem researchers, many products of neem can be made using very simple processing techniques, which would be pa!ticularlyhelpful to India's poor ecC?nomy; if farmers can just mix neem leaves in water 'and use the material as a pesticidal spray, why should one worry about expensive processes which involve extraction of azadirachtin?

India cannot afford to neglect either approach. ,f she r~stricts herself to the appropriate technology route, then foreign companies will be left free to sell azadirachtin allover thewo;rld, and Indians can at best demand royalties for their traditional knowledge. The government could, however, pro- vide free legal service to researchers who develop new plant products of this kind, to explore if patent possibilities exist. If they do,. the government coufd become a joint partner in the patent to ensure that no Indian individual or company is restricted from using the knowledge, and to disallow foreig- tiers from developing such a product/use' without prior benefit-sharing agreements.

To understand the issue further, we have to see the global and national systems as a three-layered sandwich. The bottom layer consist;s of intelligent and active people who have, over centuries, given India her traditioJ!al knowledge resource base and who can even today give us an enormous range of plant products for human welfare and growth. The middle layer is made up of relativel.y slow, unambitious and tardy Indian scientists and industrialists who are interested in maktng use of the nation's traditional knowledgetoptoduce new products for the national market and needs -something like the marketing of Chyavanprash by ayurvedic companies. The top layer is made up of Western scientists and corporations who are making use of the traditional knowledge created by the two bottom layers in the developing world to identify and create new active principles and production processes, for acquiring a world market.

Indian activists can generate a lot of heat, by arguing that the top layer is feeding off the bottom layer and demand financial compensation in the form of royalities, which is definitely fair and just, and must be sharply fought for in both national and international political arenas. This itself requires a well- organised governmental effort. But big money and economic power Res, in beating the top layer in its own objectives, at least in areas where our own traditional knowledge has given us the initial edge. To do that, the middle layer of Indian scientists and industrialists cannot just aim to be panwalas trying to capture the village hdat. There is, in principle, nothing wrong with that objective. Bui Indians at the same time, have to organise themselves to beat the top layer at its own game in the world market. And the government has to play an aggressive and single- minded promotional and supportive role in triggering off such an effort. If we can do that, we can even plan to take over W R Grace of neem fame and Ciba Geigy of reserpine fame, and turn them into Indian companies, in a matter of few decades - just as what Malaysia has more or less done to Dunlop.

The sum and substance of all this is that the time has come for India to evolve a proactive strategy - legally, scientifically and industrially - to develop her traditional knowledge. If the experience with neem can propel India to take up such a challenge then she may have lost very little as yet.

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