The Indian government finally moves to challenge the grant of a patent on basmati rice to a U.S. company, in a case that shows up the conflicts and contradictions between commerce and science in the Indian context.
R. RAMACHANDRANMORE than 30 months after RiceTec Inc., a Texas-based company, was granted the controversial patent (U.S. Patent No. 5,663,484 dated September 2, 1997) on "Basmati Rice Grains and Lines", the Indian government has decided to challenge the decision in a U .S. court of law.
On April 24, the Centre told the Supreme Court that it would file within two months a patent re-examination petition in the U.S. Patent and Trademark Office (U.S. PTO) based on technical grounds. That is, it would argue that the patent was invalid on tec hnical grounds of novelty, usefulness and non-obviousness. The Indian agency that will file the petition on behalf of the government is the Agricultural and Processed Food Exports Development Authority (APEDA).
The government's statement to the apex court came in response to a writ petition filed last year by the Research Foundation for Science, Technology and Ecology (a non-governmental organisation run by activist Vandana Shiva). The writ petition noted that although the government had stated in 1998 that the patent would be challenged, nothing had been done so far.
The reasons for the government's delay in filing a patent re-examination petition are, however, not entirely scientific and techno-legal. The commercial and trade interests of basmati rice exporters in the country appear to be a significant contributory factor. In fact, the case shows up starkly the conflicts and contradictions between commerce and science in the Indian context, and how the governmental machinery yields readily to the trade and commercial lobby but does not recognise and reward the achi evements of scientific research.
From a scientific and techno-legal viewpoint, the basmati patent may be an extremely difficult one to contest, unlike in the case of turmeric, in which the Council of Scientific and Industrial Research (CSIR) contested the grant of a U.S. patent and had it revoked (Frontline, October 3, 1997). According to experts in rice research, the basmati patent document is a skilfully drafted and "well-knit" one; it covers as many as 20 claims and extremely broad parametric ranges in the attributes that bas mati rice varieties are associated with. The case is rendered more complex by the fact that a U.S. patent is open to challenge only after it is granted and not immediately after the patent claim is filed.
The decision whether the patent is to be challenged against all its claims or only parts thereof is a difficult one and has to be made after considering the technical issues involved and determining which of the claims can be defeated definitively and co nclusively. For while challenging the entire body of claims, if one loses even on one count, the patent will be upheld. Besides available evidence - physical, geographical and genetic - from the 200-odd varieties of basmati that exist in the country, a g reat deal would depend on the skill with which patent attorneys present a watertight case for re-examination based on such evidence, experts feel.
Scientists who form part of the Technical Committee constituted by the Ministry of Commerce and Industry believe that the assembled evidence, from research publications and the different varieties under cultivation, demonstrates beyond doubt that the cla ims made are not at all new. The Technical Committee had compiled and collated all the necessary scientific evidence quite some time ago; however, the legal exercise by the patent attorneys (Sagar and Kumaran) has been time-consuming, according to CSIR D irector-General R.A. Mashelkar, who heads the high-power inter-Ministerial committee constituted to go into the basmati patent issue. Details of the review petition have not been disclosed, for obvious reasons; however, it was reliably learnt that the pe tition would have been filed before this issue of Frontline hits the stands. Indications are that the patent may be challenged in two phases: first, those claims that can be conclusively defeated will be challenged; later, on the basis of the outc ome and the strength of evidence presented by the defence, the remaining claims will be challenged.
The RiceTec patent relates to ostensibly novel rice lines (obtained by crossing a selected basmati seed with a semi-dwarf variety of long-grain American rice) and to plants and grains of these lines and to a method of breeding these lines. The "invention " also relates to a novel means of determining the cooking and starch properties of rice grains and its use in identifying desirable rice lines. It was claimed that the plants thus bred were of semi-dwarf variety, substantially photo-insensitive and high -yielding. The stated objective of the invention was to develop a new rice line with plants that produce grains that have characteristics similar or superior to those of good quality basmati from India and Pakistan.
Although there is no single precise definition of basmati rice, good quality basmati has a unique combination of attributes and traits. It has a distinctive and pleasant aroma, long (4-7 mm) and slender grains (with a length-to-breadth ratio of over 4), extreme grain elongation on cooking by over 75 per cent, and dry and fluffy texture when cooked. In terms of physico-chemical characteristics, good basmati has an intermediate percentage of amylose (PA) content (a measure of starchiness) of 20-25 per cen t (22 per cent is considered ideal); it also has an intermediate (4-6) to high (7-9) alkali spreading value (ASV), which is a measure of the intermediate to high gelatisation temperature (when the shape and volume of the cooked rice get firmed).
What contributes chiefly to basmati's distinctive aroma is the 2-acetyl-pyrolline (2-AP) content, but it is not 2-AP alone (which, incidentally, is also present in tiger's urine) that is responsible for it. The aroma is a combined effect of the 40-odd co mpounds present in basmati. The claims of the RiceTec patent attempt to encompass a wide range of the parameters in these attributes and also propose a new one - which the patentees call the Starch Index (SI), the sum of PA and ASV. This, it is claimed, is a useful parameter in identifying the cooking quality of grains from the bred basmati lines, and therefore an index for selecting good quality seed for propagation. While traditional basmati crops are tall, water-lodging, photo-sensitive and low yield ing, the patented lines belong to semi-dwarf, non-photo-sensitive, non-lodging and high-yield category. The claims include plants, grains therefrom and rice lines derived therefrom, which have the above properties in the specified parametric ranges.
According to scientists of the Indian Council of Agricultural Research (ICAR) and the Indian Agriculture Research Institute (IARI), none of these claims is novel in a patentable sense, but the excessively broad nature of the claims makes the patent a dif ficult one to challenge. For example, the 2-AP range in the patent extends from 150 parts per billion (ppb) to 2,000 ppb, which virtually covers all flavoured rice, not just basmati. While good basmati varieties would fall in the 1,000-1,500 ppb range, a variety with a 2-AP content as low as 150 ppb would be hard to come by. According to the scientists, for the patent to be defeated it needs to be established that there are documented varieties of basmati, developed over the years, that extend up to the extreme values of the parametric ranges claimed by RiceTec.
Pusa Basmati 1, which was developed by the Directorate of Rice Research (DRR) of the ICAR under the leadership of E.A. Siddiq and released in 1989, marks the high point of scientific achievement in basmati rice research in the country. According to Siddi q, who is currently distinguished scientist at the DRR, Hyderabad, the findings of research carried out over 20 years in evolving Pusa 1, which has a complex pedigree of nearly 12 rice varieties resulting from repeated crossing and selection, and other v arieties are so exhaustive that they would include all the "novel" claims made by RiceTec. Evidently, Pusa 1, and the research findings of ICAR scientists associated with it, will form the centrepiece of the challenge petition. In terms of aroma, Pusa 1 is only about 80 per cent as good as traditional varieties, but in terms of cooking quality it is as good as if not superior to traditional varieties. Moreover, being a photo-insensitive, semi-dwarf variety that matures in 135 days with a high yield of 4 .5 tonnes/ha as compared to traditional varieties with a yield of about three tonnes/ha, Pusa 1 is apparently very popular with farmers. It is estimated that as much as 40 per cent of cultivated basmati today is of the Pusa 1 variety.
AS part of the effort to prepare a 1,500-page technical document that will form the basis of the challenge petition, the Central Food Technology Research Institute (CFTRI) of the CSIR in Mysore will carry out physico-chemical analyses of as many as 45 va rieties of basmati. These varieties, with identified and well-documented geographical and agricultural characteristics, were selected and given for analysis by the DRR and the APEDA. The CFTRI was chosen to carry out the analyses as the institute had eve n in the 1960s pioneered research in the physico-chemical analyses of rice varieties, particularly the amylose content. According to CFTRI Director V. Prakash, the findings show that the varieties tested do cover the parametric ranges included in the pat ent. But what is important, he points out, is to establish in a legally acceptable way the proper linkages between the agricultural aspects and the chemical aspects.
It would, therefore, seem curious that rice exporters and the government itself should downgrade Pusa 1. Last year, the Food Ministry classified Pusa 1 as "Grade A" variety rice and not as basmati. This whipped up a controversy and caused ICAR scientists great concern. Rice of Grade A variety is not exempt from various levies that basmati, a major foreign exchange earner, is. The issue was sorted out after the Commerce Ministry issued a clarification. Despite this clarification, in July 1999 the All Ind ia Rice Exporters Association (AIREA) issued a peculiar circular on "Certification Mark of Basmati" to exporters - under what authority, it is not clear - which likewise sought to downgrade Pusa 1. It sought to give Pusa 1 (and other crossed and hybrid v arieties of basmati) the status of an allowed adulterant to the traditional or "premium" varieties of basmati. Rice labelled as "Premium Basmati" fetches a high price in the international market and enjoys duty concessions in Europe, one of its main expo rt markets, and in particular the United Kingdom.
The AIREA circular said: "For maintaining the uniqueness of basmati, the subject of 'Certification Mark' was deliberated upon many many times amongst our members as well as with the government. A consensus encompassing the views of our members were forme d which were also sent to the Ministry of Commerce for information and consideration." The guidelines (for "certification") it set were that (a) for "Premium Basmati" a "maximum indeterminate admixture" of 20 per cent of any of the crossed varieties was allowed; (b) with 20-30 per cent admixture, it would be termed "Basmati/Indian Basmati"; and, (c) when the admixture is more than 30 per cent it would be called "Long Grain Aromatic Rice". Although there are five notified crossed/hybrid varieties of basm ati, Pusa 1 is the only one that has been released by the ICAR and is widely used in cultivation because of its high quality. These guidelines automatically imply that from the exporters' perspective, cent per cent Pusa 1 will not qualify to be labelled as "Premium or Indian Basmati".
These guidelines, coming from the main trade organ, obviously imply that this kind of "admixture" is the accepted norm of exporters. On the face of it, it is inexplicable why any "admixture" should be permitted at all and why the allowed range should be as high as 30 per cent. However, according to ICAR scientists, by consistently downgrading Pusa 1 as not being basmati, wholesalers and traders have been able to procure Pusa 1 by paying less to farmers and keeping the market price of Pusa 1 significantl y low compared to traditional and notified varieties such as Basmati 379, Basmati 386, Type-3, Tarawadi Basmati (Karnal Local or HBC-19), Basmati 217 and Ranbir Basmati IET (11348).
As compared to the wholesale price (as in 1995) of Rs.20,000 a tonne for traditional varieties, Pusa 1 costs Rs.12,000 a tonne. Indeed, despite such efforts at downgrading Pusa 1, its price shot up from Rs.6,000 a tonne to Rs.12,000 a tonne in just over a year. By paying less in sourcing it from the farms and mixing it with traditional varieties, exporters make a killing from the uniform high price for their export consignments. The AIREA's position (on admixture) is an indirect acknowledgement of the h igh quality of Pusa 1 and if that quality can be got by paying less, why not? The complicity of some government departments, ostensibly to protect trade interests, is evident, but that comes only at the cost of scientific progress and its contribution to the country's economy.
AT present, the Indian basmati exporters' market abroad stands threatened with the entry of RiceTec's Texmati and Kasmati, which cash in on the premium and consumer goodwill associated with the label basmati. RiceTec has obtained registration for its tra demarks of Texmati and Kasmati in several countries. RiceTec's patent has strengthened its foothold in the international market. The trade interests of the Indian basmati exporter will be protected if Texmati and Kasmati do not enjoy the status of basmat i rice in the international market but are treated as any other long-grain American aromatic rice. In the Indian exporters' perspective, their interests would be best served if the government pushed for protecting the intellectual property rights (IPRs) on basmati as geographically indicated goods rather than fight RiceTec's patent.
Traditional basmati grows in the foothills of the Himalayas and the Punjab region in India and Pakistan. But since Pusa 1 is photo-insensitive, its region of cultivation is not geographically restricted; the same is true of Texmati and Kasmati. The entry of Texmati and Kasmati in the international market cannot be prevented, irrespective of whether or not the patent is revoked. For if Pusa 1 is termed a pure basmati line, as indeed it is, so will be Texmati and Kasmati. On the other hand, a geographical appellation to basmati a la Scotch whisky and French champagne under Article 22 of the Trade-Related Intellectual Property Rights (TRIPS) would automatically prevent RiceTec from exploiting the name basmati for its products. But if Texmati and Kasmati a re kept out on grounds of geographical appellation, Pusa 1 too would be kept out. From the trade point of view - in the light of its open admission of admixture up to a third with Pusa 1 - this situation would serve their interests eminently.
There are, however, several catches to this approach. A similar appellation within the country would have certainly helped in this regard. But, unfortunately, India did not till recently have a law for geographical indication of goods nor did India regis ter basmati (or any other good) under the Paris Convention, of which India became a member in 1997. (Article 10 of the Convention provides for geographical indication of wines and spirits.) Although the Geographical Indication of Goods (Registration and Protection) Bill, 1999, is now in place as an Act, the machinery for registration and the mechanism for protection have not been worked out. In the context of TRIPS, a joint effort by India and Pakistan would perhaps strengthen the case but no effort in that direction is evident. But most important, a methodology to characterise basmati in quantitative terms and its linkages to geographical regions needs to be evolved.
THE trade's position with regard to Pusa 1 received a shot in the arm in October 1999 when U.K. researchers claimed, on the basis of a genetic analysis of basmati and other long-grain aromatic rice, that Pusa 1, a crossed basmati variety, does not qualif y to be termed as basmati. The study also claimed that Pakistani Basmati 385, also a crossed variety, was in terms of its genetic content closer to traditional varieties than Pusa 1. In fact, it was reported that the U.K. Ministry of Agriculture, Food an d Fisheries (MAFF), under whose directive the research was conducted to evolve a technique to detect and estimate adulteration in basmati, may even denotify Pusa 1 and withdraw the levy concessions allowed for premium basmati. The flip side, however, was that the study also revealed that in genetic terms, Texmati and Kasmati fell closer to the category of long-grain American aromatic rice than traditional basmati varieties, a fact that should please Indian exporters if the MAFF decides to use this techn ique to set basmati standards in the U.K.
However, according to agriculture geneticists, the technique itself is suspect. The genetic analysis of the U.K. researchers uses randomly selected molecular markers identified and isolated from several traditional pure basmati rice lines, and estimates, qualitatively and quantitatively, the content of the particular genes that the markers can attach to in the varieties studied, which is revealed as certain visual bands (like spectral bands) in the genetic map. The position of the band reflects the rela tive content of the genes amplified by the marker and the intensity of the bands indicates the amount of the genes present (which is important for detecting levels of adulteration). The U.K. researchers used two different techniques in their analysis - o ne called SSLP, which used 29 markers, and another called AFLP, which used only eight of the 29 markers.
Researchers regard SSLP to be an inherently more sensitive technique than AFLP; besides, it used more markers and thus increased the probability of capturing the key characteristics of basmati rice in the genetic profile. Significantly, SSLP showed that the variability of genes in Pusa 1 as compared to the traditional varieties was far less than the variability evident in the AFLP analysis. Significantly, in the former the variability of the marker-detected genes in Texmati and Kasmati was far more than in Pusa 1 and these tended to bunch together with the long-grain American aromatic rice varieties.
Agriculture geneticists, however, say that the genetic marker technique is not foolproof. According to rice geneticist and breeder Dr. A.K. Singh of the IARI, these methods are still evolving and are far from perfect; more importantly, what is important for a rice variety to qualify as premium basmati are its physico-chemical characteristics such as aroma, L/B ratio, grain elongation on cooking, amylose content, 2-AP content and gelatisation temperature. Unless one can unambiguously identify (through qu antitative trait foci) all the genes that control these traits which set apart basmati from the rest and develop corresponding markers, the method will not capture the true basmati characteristic of a rice variety.
Although scientists at the ICAR and the IARI have identified genes for some of the traits - the gene 'fgr' on chromosome-8 for aroma, for example - the entire set of genes controlling the typical basmati characteristics have not yet been identified. The shortcoming of the marker analysis, particularly the AFLP technique, is immediately apparent: the results of the U.K. research bunched a rice variety called Tericot with traditional basmati varieties while Pusa 1 was found displaced significantly. Terico t, a long-grain rice, is not basmati at all and does not have any of the other typical characteristics of basmati, points out Dr. A.K. Singh. Any scientific conclusion or trade-related regulation based on this method must be challenged, he says.
PUSA 1, being the result of crossing a semi-dwarf non-basmati rice line and a basmati line, is bound to have a different genetic profile in a random marker analysis. Indeed, given that only 10 per cent of the genome of any organism accounts for traits an d characteristics, a random marker set in all likelihood captures more genes than the trait foci, points out Dr. A.K. Singh. From that perspective, the genetic profile of Pusa 1 will display variability from the traditional varieties because, after all, it is a cross between a traditional basmati variety and a non-basmati semi-dwarf line and the shift only reflects the latter's genes, he says.
Ultimately, however, the proof of the pudding is in the eating. In that aspect, Pusa 1 is as good as the traditional varieties; seen from the farmers' perspective it is even better because of its higher yield and on account of its non-lodging and photo-i nsensitive nature. It is this view, reinforced by the Technical Committee, that has led to the government's assurance to fight the RiceTec patent. A researcher is not overly concerned about whether Pusa 1 is called basmati or not. What matters is that th e research should result in better crop varieties and economic good and that is indeed what Pusa 1 has achieved, points out Siddiq. Failure to recognise and reward this contribution of research is tantamount to denying scientific and technological progre ss. Fighting the RiceTec patent will contribute immensely to defending and recognising that achievement of Indian agriculture scientists.