More than 200 organisations from 35 nations challenge US patent on neem

MORE than 200 organisations from 35 nations have mounted an unprecedented legal challenge in the US Patent and Trademark office against a patent granting the multinational chemical corporation, the W R Grace Company, the exclusive use of a pesticidal extract from neem seeds. The global coalition challenging the W R Grace patent has been organised by Jeremy Rifkin and The Foundation on Economic Trends in the United States. Other key petitioners include: Dr Vandana Shiva, President of The Research Foundation for Science, Technology and Natural Resource Policy in India; Dr M D Nanjundaswamy of Karnataka Rajya Ryota Sangha, a farm organisation representing farmers throughout India; Linda Bullard, Vice-President of the International Federation of Organic Agriculture Movements in Brussels; and Martin Khor, Director of the Third World Network. The substance of the challenge is that the pesticidal extract in question has long been known to and used by the Indian people for protecting their crops. The knowledge of this was therefore available at the time of patenting, to any ordinary person and the difference between it and the patented product, if any, was 'obvious'. This challenge is seen as a critical test of the intellectual property laws established by the GATT agreement and the World Trade Organisation (WTO). As transnationals and other enterprises from the North scour remote regions of the South for genetic resources to patent, 'the battle between native peoples and multinationals is' in the words of Jeremy Rifkin 'likely to be the critical North-South political and economic issue of the coming decade'. In what is seen as the opening round in this confrontation, the neem tree has became the symbol of resistance to the creeping power of global capital.

We reproduce an edited version of the petition filed by the coalition of organisations in the US Patent and Trademark office, calling for the revocation of the patent granted to the W R Grace company.FEW organisms have as long a history of widespread human use as the neem tree. Ancient texts refer to the neem as 'the blessed tree' and the 'cure for all ailments'. The tree plays a particularly important role within the Indian culture. Several centuries of Indian learning, creativity and experimentation with the neem tree have resulted in a wealth of information on how to harness the tree's potential for use in medicine, fuel and agriculture.

The neem tree's value as a pesticide has been known to Indian villagers for hundreds of years. Villagers have developed several ways of extracting the neem's pesticidal emulsions without expensive equipment. Typically, they break down the seeds and soak them overnight in water, alcohol or other solvents. The emulsions float to the surface and are then placed directly on crops as a pesticide and insect repellent. Villagers have never needed to store pesticidal compositions because they usually apply the emulsions the following day.

Despite the simplicity of these traditional methods, the pesticidal compounds obtained are extremely effective. They ward off approximately 200 insects, including locusts, nematodes, boll weevils, mosquitoes, beetles and hoppers. Moreover, these compounds are just as potent as pesticides derived from more sophisticated methods. In fact, several studies have demonstrated that compounds derived from these traditional methods are as successful in warding off pests as synthetic insecticides like malathion, DDT and Dieldrin.

These traditional methods of chemical extraction are especially useful in long-term pest control. While insects become tolerant to single chemicals (such as malathion), these indigenous methods yield complex blends of compounds. This blending makes it much less likely that insects will become tolerant to the extract's toxicity.

There has also been considerable research conducted by modern scientists regarding the use of the neem as a pesticide. The neem's ability to repel insects was first reported in the scientific literature in 1928. Two Indian scientists, R N Chopera and M A Husain, reported using neem tree kernels to repel desert locusts. Later, in 1962, New Delhi field tests demonstrated that when ground up neem kernels were mixed with water, the resulting suspended compound served as an effective pesticide. The author of this study, M Pradhan, concluded that the neem kernels were even more potent than industrial insecticides. Moreover, in contrast to W R Grace's assertions, some Indian research has studied the production of stable neem-based solutions and emulsions. Indian scientists made significant advances in the field of neem-oriented stabilisation techniques in the 1960s and 1970s, years ahead of W R Grace's efforts.

Since these early experiments, there has been considerable Indian research devoted to studying the neem tree and developing pesticides, medicines and cosmetic products with the tree's properties. There have been no efforts to patent most of these inventions because Indian patent law forbids the ownership of agricultural and medicinal products. Additionally, much of the research and experimentation has been conducted by small-scale organisations which have no interest or capability of using foreign patents. Now, however, with the acceptance of the GATT/TRIP's provisions, all Indian manufacturers will be forced to adhere to international patent laws. This will require that Indians either stop using their own technology or pay royalties to W R Grace.

W R Grace's patent has sparked an outcry among Indian farmers, scientists and political activists. They object to the fact that the patent grants the company a right to a product which is the accumulation of centuries' worth of Indian knowledge and effort. Additionally, Indian citizens are very concerned that W R Grace's patent will deprive local farmers of their ability to produce and use neem-based pesticides by altering the price and availability of the neem seeds themselves. There is already evidence that W R Grace's patent has forced many Indian farmers out of the market for this locally-developed technology.

* Patent No. 5,124,349 is barred by Prior Art:

Under Sections 301 and 302 of the US Patent Code, any individual may file a request for the re-examination of an existing patent if the requester believes 'prior art' would have a bearing on the patentability of any claim of the patent. Prior art includes knowledge that was available at the time of patenting to a person of ordinary skill in the art. An invention is not patentable if the differences between it and the prior art would have been obvious at the time of patenting. Patent No. 5,124,349 (W R Grace's patent ) should be overturned because: the company's method of extracting stable compounds has been widely used prior to the patent's issuance and because the extraction methods have been previously described in printed publications.

W R Grace's patent gives the company exclusive rights to methods of extracting stable chemical compounds for use in pesticides. Yet, Indian villagers have been extracting the tree's chemical for pesticidal uses via similar processes for several centuries. Indian villagers used water and alcohol solvents years ahead of the company's patented processes. Even W R Grace itself acknowledges that India's traditional knowledge inspired the company's patent. This prior use is well documented and should invalidate the patent.

Although W R Grace's processes are more technical, they are mere extensions of the same processes that Indian villagers have been using for hundreds of years. Patents cannot be granted for trivial changes to known products and processes. In addition to these prior uses, Indian researchers documented the use of the seed's compounds as a pesticide over 50 years ago. This prior use should also invalidate the patent. As early as 1928, Indian researchers published the value of the neem seeds as a pesticide. Additionally, the Indian Agricultural Research Institute conducted formal scientific studies of the neem tree for use in insecticides and insect repellents over a decade ahead of W R Grace's and Robert Larson's earliest efforts. This organisation had completed many studies, demonstrating the effectiveness of neem tree seeds in pesticides, years before Larson and W R Grace even became interested in neem seeds. This pre-existing body of knowledge and research generated by Indian scientists renders W R Grace's patent claims invalid. Even though Western scientists may have been ignorant of this body of research, the Indian research must be credited and the patent revoked. A patent applicant is held accountable for prior art whether or not the applicant had actual knowledge of its existence.

* Patent No. 5,124,349 Is Obvious in Light of Prior Art:

The issuance of a patent is prohibited if the patent would have been 'obvious' in light of prior art. The standard for patentability requires that the differences between a patentable invention and its prior art must be great enough so that a person with ordinary skill in the art would not consider the invention to be obvious at the time of patenting. Patent No. 5,124,349 does not meet this standard.

W R Grace claims that Patent No. 5,124,349 is non-obvious in the light of prior art because in contrast to the traditional chemical extraction techniques, the company's processes obtain storage-stable azadirachtin formulations. There are several reasons why this argument lacks merit.

First, several Indian scientists had developed stabilisation techniques prior to W R Grace's patent application. Stabilisation research occurred within India in the 1960s and 1970s. This pre-existing body of work alone should invalidate Patent No. 5,124,349.

Second, in determining whether an invention is obvious, it is necessary to consider the possibilities and capabilities of pre-existing technologies. Inventions are unpatentable if the possibilities raised by prior technologies would make the patent obvious to a person with ordinary skill in the art. This standard disqualifies the validity of Patent No. 5,124,349. Because Indian researchers had already developed the knowledge and technology necessary to make storage-stable azadirachtin formulations possible, this pre-existing knowledge subsumes Grace's patent claims. Patents may not be granted for trivial changes to known products and processes.

W R Grace asserts that its claims are non-obvious because there are no pre-existing references identical to W R Grace's patent processes. Apparently, the company expects that there should be specific formal references identifying storage-stable azadirachtin formulations. This argument fails for two reasons.

First, it is obvious that indigenous village traditions would not be recorded in formal publications. To expect Indian villagers to formally publish centuries-old learned traditions is unrealistic and unfair. The accumulated knowledge is the result of many anonymous and individual efforts carried out over hundreds of years. By citing a lack of formal publications as proof of non-obviousness, the company holds the villagers to a standard that is clearly unobtainable.

Second, it is immaterial that no reference makes the same specific claims as W R Grace's patent because the proper test in determining patentability is whether the invention would have been obvious from a combined teachings of prior references. Rather than seeking specific patents or publications that mirror W R Grace's claims, a proper examination of prior art should conduct a broad and interpretive analysis of all prior references. Considering: that Indian villagers developed neem-based pesticides years before W R Grace obtained its patent; that scientists from around the world documented the effectiveness of the neem tree in pest control prior to the W R Grace company and that Indian scientists initiated and developed the research on stable neem compounds - there can be no question that Patent No. 5,124,349 was obvious in light of the combined teachings of the prior art. A broad and interpretive analysis of the pre-existing research and chemical extraction techniques reveals that the vast majority of work and intellect used in W R Grace's patent application had been completed before the company sought its patent. W R Grace merely appropriated the knowledge and wisdom generated by other individuals. Thus, even if there were no references that make claims identical to those of W R Grace, the combined teachings of the prior art makes W R Grace's patent obvious.

* First in time does not make first in right:

W R Grace may argue that even if the company's invention was similar to pre-existing processes and research, the patent should still be upheld because W R Grace was the first to secure patent protection. This argument ignores India's culture and legal framework.

Indian villagers have never sought stable azadirachtin formulations because they have no need to store the pesticidal solutions. The villagers apply the emulsions directly to plants without delay. Although Western culture was the first to commercialise a stable form of azadirachtin compounds, this does not negate the fact that W R Grace's process was an obvious extension of prior art. A new use of the same knowledge does not justify exclusive patent rights. A patent monopoly should not be granted on trivial improvements which are new, but obvious modifications of known products and processes. Additionally, many Indians oppose the patenting of life-forms and agricultural products. The fact that Indian researchers failed to obtain patent protection on stabilisation techniques is attributable to India's cultural and legal opposition to such patenting. Not only does Indian law prohibit the patenting of agricultural products, but many Indian citizens are ethically opposed to the patenting and ownership of nature. These feelings are especially strong in regard to the neem tree because the tree has played such an important role within Indian culture and religion.

There have been numerous protests - involving hundreds of thousands of Indian citizens - against the patenting of indigenous plants like the neem tree. It is important to remember and indicative of the country's sentiments that several Indian manufacturers vehemently refused to participate in W R Grace's initial patenting plans.

W R Grace has jumped into an area of international patent protection which Indian citizens, manufacturers and legislators deliberately chose to forego. Unfortunately, according to the GATT/TRIPs provisions, Indians will be forced to recognise W R Grace's international patent rights. This fact makes the issuance of Patent No. 5,124,349 even more disturbing. Not only has W R Grace unjustly reaped the benefits of Indians' prior art, but now those same Indian citizens are being forced to recognise a patent they refused to claim.

Besides the prior art overlooked in the issuance of Patent No. 5,124,349, there is also a broader problem to consider, that is, whether existing intellectual property laws adequately recognise the accumulation of knowledge brought about by generations of learning and creativity.

The neem tree is but one of countless instances in which many people, over several generations, added to a wealth of valuable information concerning the use of biological resources. No single person or company can claim credit for the end product of years and years' worth of learning, invention and innovation. To give credit where credit is due, any control over such knowledge should be a collective right of ownership - communally created and communally held. When a monopolistic right of ownership is conferred over a product that many people created or added to, the patent holder unfairly receives the rewards of other peoples' labour.

Moreover, when a monopolistic right of ownership is granted over collectively created products, the rest of society is either deprived of utilising its own intellectual property or must pay for its use. In light of these problems, the Patent and Trademark Office must recognise that all human beings have rights to collectively created property. No person or company should receive exclusive rights to products or resources that everyone contributed to.

For the reasons presented above, the claims in Patent No. 5,124,349 are not allowable.