Genetically Modified crops Bt Cotton: A Story of Conflicting Perspectives

India has the world’s fifth largest cultivated area under genetically modified (GM) crops, at 11.4 million hectares (mh) in 2017. But unlike other big growers, its entire GM crop area is under a single crop — cotton. Thus, the story of Bt. Cotton must necessarily begin with a brief primer on GM crops.

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GM crops represent plants whose genes have been modified using genetic engineering methods by introducing new DNA into plant cells that are grown in tissue culture. The seeds produced as a result of this method contain the new ‘modified-DNA’ that results in the development of an entirely new genetically altered variety of the plant. Unlike traditional breeding, wherein new species are more or less created at random, in genetic engineering , specific genes are identified, isolated and copied into another species, to give the recipient species the desired traits., thereby allowing man to exercise better control over the nature of the new species introduced.

India’s grand foray into agricultural biotechnology began, albeit unofficially, back in 1998, with the approval and subsequent adoption of Bt Cotton. By then, India had already made its mark on the world map as far as cotton production was concerned – the country accounted for nearly 20% of the total cultivated area, although it lagged far behind in the production of the crop itself. The credit for this rather unfortunate flaw in an otherwise extremely profitable crop goes to its vulnerability to pests, including the jassids, aphids, thrips and white fly among the sap sucking pests, and the Pink, American and Spotted Bollworm and the Spododeptra among the leaf eating caterpillars. While cotton plants possess an inherent genetic resistance against the former group, it possesses no resistance against the Bollworms, which has been known to significantly drive up yield losses. The increased use of chemicals to drive away the pests did nothing to save the crop, resulting instead in the development of an increased resistance towards the insecticides and left the farmer in a state of perpetually mounting debt. This unfortunate state of affairs tends to almost always culminate in insufferable social and economic hardships, generating an emergent need to circumvent this peculiar conundrum.

It is at this point that seed giant Monsanto and the Department of Biotechnology (DBT) committee – set up by the Government of India to evaluate Monsanto’s application for permission to test Bollgard (Bt Cotton) in India – enter the picture. Monsanto had acquired a patent on a number of components related to Bt cotton. ‘Bt’ refers to Bacillus thuringiensis, a bacteria found in the soil which produces an insect controlling protein Ccry1A(c) that is lethal to Bollworms. When a gene of this bacteria is inserted into the cotton plant cells, the plant continuously produces in its parts, the toxin that controls the bollworms effectively at the nascent stages of crop growth – effectively reducing the need for use of insecticides by farmers, and resulting in environmental as well as economic benefits. The committee rejected the application citing two reasons – first, that the technology fee was exceedingly high, and second, that the strategy of backcrossing an American variety to a local variety was rife with issues associated with its uncertain implications. The committee was in favour of introducing the gene directly into the local variety in order to avoid the fallouts associated with the former strategy.

Thereafter, in 1996, the Maharashtra Hybrid Seed Company (MAHYCO) – the world’s largest producer of hybrid cotton seeds – filed an application with the DBT to import Bollgard cotton seeds from Monsanto and backcross it with the Indian seed and test the efficacy of the variety in India through field trials. The DBT committee granted permission to MAHYCO, despite the apparent identical similarities between the MAHYCO and the Monsanto proposals. Curiously, the factors that led to the committee’s approval remain to date, undisclosed to the public.

Interestingly, in 1996, Monsanto also obtained the government’s permission to acquire 26% stake in MAHYCO, resulting in the formation of a joint -venture between the two, called Mahyco-Monsanto Biotech Limited, and Monsanto, thus, became directly involved in the 500-plus field trials carried out between1998-2001.

However, four years before its official introduction in the market, a scandal erupted in the country when the Bt cotton seeds escaped from MAHYCO-Monsanto’s contained field trials, and somehow landed in Gujarat as cotton variety ‘N-151’, sold by Indian seed company Navbharat. When the news of the variety having withstood a bollworm attack reached Monsanto’s ears, it took samples and found that the variety contained its Bt gene, and promptly pressed charges against the Navbharat for infringement. While the government threatened to pull the entire stock of Navbharat’s Bt-seeds from the market, farmers staged protests pushing for their right to use the seeds that saved their crops from destruction. The battle ended with Navbharat being forced to stop the sale of the ‘N-151’ variety, and Mahyco-Monsanto’s Bollgard being rushed through regulatory mechanisms to quickly introduce the GM crop seeds in Indian markets.¹

In 2002, following the grant of approval by the country’s Genetic Engineering Approval Committee (GEAC) to produce and commercialise the seeds of three cotton hybrids – MECH 12, MECH 162 and MECH 184. Monsanto also began to license the use of its Bt gene in local varieties to seed companies, resulting in the sprouting of several new hybrid cotton varieties that possessed the Bt trait.

Following the success of its first planting in 2002, the extent of Bt Cotton’s cultivation increased manifold between 2002 and 2007, as evinced from the table below –

Area under Bt-cotton in India, 2002 to 2007²:

However, this success story was cut short in 2006, when four years after the introduction of Bt Cotton, Monsanto detected that the Pink bollworm had developed resistance against Bollgard-I, resulting in huge loss of harvest to farmers. While that the pests would eventually develop resistance was known, few had expected it to result so early – interestingly, Monsanto on its website states that “factors that may have contributed to pink bollworm resistance are limited refuge planting and the early use of unapproved Bt cotton seed, planted prior to GEAC approval of Bollgard I cotton, which may have had lower protein expression levels”³.

In 2006, Mahyco-Monsanto received the government’s approval for a new and improved form of Bt-Cotton, referred to as Bollgard-II. This successor to Bollgard-I, contained not one but two Bt genes – Cry1Ac gene and Cry2Ab gene – intended to effect better control over all three types of bollworms, as well as the army worm and Spodoptera – resulting in a much higher level of protection against pests than Bollgard-I. However, if reports are to be believed, in a shockingly short span of time since its entry into Indian markets, the Pink Bollworm has developed resistance to Bollgard II in parts of Gujarat⁴, Andhra Pradesh⁵ and Karnataka, creating widespread worry as to the possible devastation of farmers’ harvest. However, it appears that despite this, more than 41 million GM cotton seed packets were sold in 2015, resulting in Monsanto pocketing almost 6.5 billion Indian rupees ($97 million) in royalties⁶ – this, possibly on account of the general understanding that the degree of protection offered by Bollgard II still reigns over Bollgard I (the use of which does not require the payment of royalties since the discovery of its inefficiency against the pink bollworm) and the use of chemical pesticides (which is required to be used multiple times in one season to equate the protection offered by Bollgard II, and still fails to be as effective and cost efficient ).

*Image is for representation purpose only

Does Monsanto have a patent?

This question requires throws up two primal issues :

1. Did Monsanto have a patent on Bollgard I ?

Fourteen years after Bollgard I entered the market, questions arose as to whether Monsanto ever had a patent on Bollgard I in India. Over the last decade and a half, Monsanto has left farmers high and dry by charging exceedingly high royalty rates, pushing them into debt and in many cases, death. However, it has recently come to light that while its US patent expired in 2012, the company never had a patent in India, and the MoEF inhibited the royalty-free production of indigenous varieties at a time when it appears to have been impermissible for it to do so⁷.

2. Validity of Monsanto’s patent on Bollgard II

The issue is whether the significant reduction in the efficacy of Bollgard II on account of the development of significant resistance against it by the Pink bollworm, should result in the revocation of Monsanto’s patent for Bollgard II in India.

Under Section 64(1) of the Patents Act, three sub-sections are relevant-

(1)Subject to the provisions contained in this Act, a patent, whether granted before or after the commencement of this Act, may, on the petition of any person interested or of the Central Government or on a counter-claim in a suit for infringement of the patent, be revoked by the High Court on any of the following grounds, that is to say –

…………….
f.that the invention so far as claimed in any claim of the complete specification is obvious or does not involve any inventive step, having regard to what was publicly known or publicly used in India or what was published in India or elsewhere before the priority date of the claim:Provided that in relation to patents granted under the Indian Patents and Designs Act, 1911, this clause shall have effect as if the words “or elsewhere” had been omitted;

g.that the invention, so far as claimed in any claim of the complete specification, is not useful;

……………………

j.        that the patent was obtained on a false suggestion or representation;

Dr. Vandana Shiva, Indian scholar and environmental activist, suggests that the patent is revocable under subsections (f) and (j), and writes that “The introduction of Bt genes through genetic engineering was known in India both in the Cotton Research Institute of India and in Dharwad Agriculture University. Adding two Bt genes is obvious to anyone skilled in the art of genetic engineering. The so called invention of introducing Bt genes in cotton has proved to be not useful in controlling pests……The patent was obtained under the false suggestion that Bt cotton will control pests, specially the bollworm”⁸.

Additionally, it is worthwhile to consider that if the claim or specification of Monsanto’s Indian patent on Bollgard II claims its efficacy against the Pink Bollworm, then the patent may be revocable on the ground of lack of usefulness.

She also considers whether the patent can be revoked in public interest under Section 66, which states that –

“Where the Central Government is of opinion that a patent or the mode in which it is exercised is mischievous to the State or generally prejudicial to the public, it may, after giving the patentee an opportunity to be heard, make a declaration to that effect in the Official Gazette and thereupon the patent shall be deemed to be revoked.”

She justifies this by arguing that – “Hundreds of thousands of Indian farmers being driven to suicide because of high costs of seed, and false promises is enough ground for the government to revoke Monsanto’s Bt cotton. Why are farmers being made to pay such a high price for a failed technology ? And why are lobby groups defining Monsanto imposing a failed technology  as “innovation”?…. It is built into the technology of Bt cotton that the plant will become vulnerable to non target insects, and bollworm- the target pest – will evolve resistance.”⁹

Obviously, the contentions of Dr. Shiva boils down to see whether Monsanto’s patent on Bollgard II can be challenged on these (or other) grounds.

Of course, the same was challenged by the Hyderabad based Nuziveedu Seeds before Delhi High Court. The division bench of Delhi High Court in, the matter of Nuziveedu Seeds Ltd. & Others vs. Monsanto Technology LLC & Others, order dated April 11, 2018 held that the Patent held by Monsanto (through its Indian arm MAHYCO-MONSANTO BIOTECH LTD (MMBL) on Bollgard-II technology is not enforceable in India. In the court, Monsanto claimed that the patent is a biotech invention containing the infusion of Bt gene into the cotton genome. The Bt. bacterium eradicates pests afflicting the cotton plant. Monsanto states that the patent does not cover plants per se, but does cover components that can be termed microbiological processes and microorganisms, thus patentable under the Indian Patents Act, 1970.

The Division bench of Delhi High Court while rejecting the contentions of Monsanto held that – Monsanto can apply for registration under the Plant Varity Act (within three months of this judgment). The Delhi High Court noted that “the denial of a positive order” would result in violation of provisions of the Essential Commodities Act and would deprive the farmers the right to access to seeds that were hitherto available to them.

However, in the sensational turn of the events and as expected, Monsanto approached the Supreme Court of India. The Supreme Court on January 08, 2019 overturned the Division Bench judgement of the Delhi High Court which pronounced the patent and its claims unpatentable. As on today, the Supreme Court remanded the suit back to Single bench of the Delhi High Court and asked the learned Single Judge for disposal in accordance with law. And the legal battle continues…

1 Bt Cotton – The facts behind the hype, GRAIN in January 2017 at https://www.grain.org/es/article/entries/582-bt-cotton-the-facts-behind-the-hype

2 Dr. TM Manjunath, Bt-Cotton in India: Remarkable Adoption and Benefits, FBAE at http://fbae.org/2009/FBAE/website/our-position-bt-cotton.html

3 Pink Bollworm Resistance to GM Cotton in India , MONSANTO on April 11, 2017 at https://monsanto.com/company/media/statements/pink-bollworm-resistance/

4 Girish Pattanashetti, After Raichur, pink bollworm attacks cotton fields in Haveri, THE HINDU on August 1, 2016 at http://www.thehindu.com/news/national/karnataka/After-Raichur-pink-bollworm-attacks-cotton-fields-in-Haveri/article14580646.ece

5 PT, Govmt working on solution to control pink bollworm cotton pest, THE ECONOMIC TIMES on Jan 5, 2016 at http://economictimes.indiatimes.com/industry/cons-products/garments-/-textiles/govt-working-on-solution-to-control-pink-bollworm-cotton-pest/articleshow/50454647.cms

6 Mayank Bhardwaj, Exclusive: Monsanto pulls new GM cotton seed from India in protest, Reuters on August 25, 2016 at http://www.reuters.com/article/us-india-monsanto-idUSKCN10Z1OX

7 Shishir Arya & Snehlata Shrivastav , Seeds of doubt: Monsanto never had Bt cotton patent, TIMES OF INDIA on January 8, 2015 at http://timesofindia.indiatimes.com/india/Seeds-of-doubt-Monsanto-never-had-Bt-cotton-patent/articleshow/47578304.cms (“The Central Institute of Cotton Research (CICR), in an RTI reply to farm activist Vijay Jawandhia, emphatically stated that Monsanto’s ‘cry1ac Mon 531’ gene was never patented in India. However, the ministry of environment and forests (MoEF) wrote to him that the Bt seed developed by University of Agriculture Sciences (Dharwad), which was found to contain the Mon 531 strain, “cannot be launched in the market” due to a “patent violation”. It did not specify who held the patent.”)

8 See Vandana Shiva, Monsanto vs Indian Farmers on April 27, 2016 at http://vandanashiva.com/?p=402

Disclaimer: The views expressed here are the personal views of the author and do not necessarily represent or reflect the views of his professional engagements in any capacity.

The author acknowledges the valuable inputs received from Advocate Kiran M G, Dr. Vandana Shiva and Advocate Deepak K Singh.