What's in a neem?

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THE 10-year period from 1985 to April 25, 1995 - accordingto relevant dat:bases - has been marked by a veritable delugeof us and European patents on neem-related products. Thedatabases also include information on patents which werefiled through the Patent Cooperation Treaty (PcT), a uN bodyfunctioning under the World Intellectual PropertyOrganization. Some 28 patents were filed in that period in USA,of which 15 were filed in just the 16 months between January1994and 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 PCTpatents (53 in all) - one arrives at a figure of 36 differentinventions. The remaining 17 patents can be discounted asthey had been filed by the same companies under the sametitles for the same products or processes. It can, therefore, beassumed that they would be identical and hence cannotqualify 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 ratebuilds up to a crescendo by 1994, with some 13 patents in thatyear 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 byGermany 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), titledHydrophobic 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 no5352672dated 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 havefollowed 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 patentdatabases. 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.