Bacillus thuringiensis

In Maharashtra, 12 Farmers Arrested For Sowing GM Cotton Seeds

Two FIRs were registered at Hiwarkhed and Akot police stations on the complaints lodged by the agriculture department.

Akola: In a first in Maharashtra, at least 12 farmers from Akola district have been booked for allegedly sowing banned herbicide-tolerant Bt (HTBT) cotton seeds, police said Wednesday.

The farmers had allegedly planted the seeds in their farms in Adgaon and Akoli Jahangir villages as part of a protest organised by Shetkari Sanghatna against the Union government’s ban on the use of genetically modified Bt (bacillus thuringiensis) cotton and brinjal seeds.

On June 10, several hundred farmers had sowed the GM cotton and brinjal seeds in the east Maharashtra district.

The Sanghatana has been opposing the ban on GM crops claiming that they gave higher yields at lower costs and brought benefits to cultivators.

Also read: Why Do Visions of Farming’s Future Never Involve Farmers?

Two FIRs were registered at Hiwarkhed and Akot police stations on the complaints lodged by the Agriculture department, a Hiwarkhed police station officer said Wednesday.

Among those booked by police included Sanghatna spokesperson Lalit Bahale.

“The farmers have been booked under various sections of the Indian Penal Code (IPC) and Environment Protection Act and the Seeds Act,” said Hiwarkhed police station inspector Somnath Pawar.

The use of GM crops in the country is tightly regulated as per “Rules for the Manufacture/Use/Import/Export and Storage of Hazardous Microorganisms, Genetically Engineered Organisms or Cells, 1989” under the Environment (Protection) Act, 1986.

As per the Ministry of Agriculture and Farmers Welfare, the evaluation of each application of GM crop is done on a case-to-case basis after a thorough examination of health, environment, food and feed safety assessment studies.

(PTI)

Supreme Court’s Monsanto Ruling Overlooks Need to Protect Farmers’ Rights

By allowing Monsanto its patent under the Patents Act 1970, we could be en route to monopolising private interest over the public.

Biotechnology has revolutionised agriculture by helping farmers produce a greater variety of crops in larger quantities. Against this backdrop, the Monsanto v. Nuziveedu case – centred on the enforceability of Monsanto’s Bt cotton patent – carries great weight.

If Monsanto eventually triumphs, it’d mean that genetically modified plant varieties are patentable in India. If Nuziveedu, a Hyderabad-based seeds company, wins, then it will bolster the rights of farmers to cross-breed plant varieties.

On January 8, the Supreme Court set aside an order of a division bench of the Delhi high court on the case, and restored the earlier order of the single bench. In effect, Nuziveedu had been directed to continue paying royalties to Monsanto for using the latter’s Bt cotton tech.

But irrespective of how the case turns out, farmers’ rights should be prioritised in an agrarian country like India. We already have the Protection of Plant Varieties and Farmers Right (PPVFR) Act 2001. It protects plant varieties as well and the rights of farmers and breeders to develop them. It also complies with the TRIPS Agreement, which asks that plant varieties be patentable, protectable through a sui generis system or a combination of the two.

Also read: Supreme Court Saves Monsanto From Its Own ‘Incomprehensible’ Legal Strategy

What often goes unsaid is that the PPVFR Act also protects the rights of researchers. And on January 8, the Supreme Court disregarded this aspect when it held that Monsanto’s technique to develop Bt cotton is outside the PPVFR Act’s purview.

In remanding the matter back to the single bench of the Delhi High Court, the apex court said that such a complex matter can’t be adjudicated summarily without considering the evidence and cross-examination of witnesses. And overall, the ruling overlooked the broader objectives of the PPVFR Act.

The consequences can be far-reaching. By allowing Monsanto its patent under the Patents Act 1970, and keeping the technology’s benefits from being shared more equally, we could be en route to monopolising private interest over the public.

For starters, TRIPS allows a nation to develop its own sui generis model through which to protect the rights of the producer of a genetically modified plant varieties/species. So the PPVFR Act protects the farmers’ rights through the Plant Varieties and Farmers’ Rights Authority, responsible for registering new varieties and ensuring farmers can avail them. If a breeder prevents farmers from accessing a variety specified in the PPVFR Act, the authority can force him to license it and comply.

In this endeavour, the act has some support from the Patents Act. Its section 3(j) specifies that plants and animals – or their parts – can’t be patented as inventions.

However, processes involving microorganisms could still be patented, and herein lay the rub. Bt cotton is a cotton plant that contains genes from a bacterium called Bacillus thuringiensis. These genes allow the plant – like they allow the bacterium – to produce toxins in their tissues that are harmful to the bollworm. In other words, Bt cotton is a cotton variety resistant to bollworms.

In 2004, Monsanto had sub-licensed Nuziveedu to sell Bt cotton seeds and pay royalties to Monsanto. Nuziveedu improved on Monsanto’s product to develop and market seed varieties suitable for the Indian agricultural market.

In 2015, Nuziveedu denied Monsanto any further royalties after the government introduced a price-control regime. So Monsanto filed a suit in the Delhi high court claiming Nuziveedu had violated its patent and that Nuziveedu would have to cough up the royalty amount.

In March 2017, a single-judge bench of the Delhi high court directed Nuziveedu to continue paying Monsanto the royalty amount. Nuziveedu appealed, and a division bench of the court ruled in its favour instead, denying patent rights to Monsanto. The bench also asked Monsanto to have its variety registered under PPVFR Act. If Monsanto had done so, it would have lost its patent rights altogether.

Monsanto then approached the Supreme Court, which denied the stay application against the order of the division bench. Monsanto had argued that section 3(j) of the Patent Act allowed microorganisms to be patented, so the company held valid patent rights over the product as well as the process. Monsanto also submitted that its patent was over the altered gene, and not the plant as a whole.

On the other hand, Nuziveedu argued that Monsanto couldn’t claim Bt cotton as its own variety because section 3(j) of the Patents Act said plants couldn’t be patented. This is only fair because a seed containing the altered DNA constitutes a necessary part of the plant and therefore is a part of the plant itself.

Nuziveedu also contended that the process of developing Bt cotton was essentially biological because the gene’s advantages are manifested only when the plant grows. This is a biological phenomenon that requires no human intervention.

Also read: What the Supreme Court Said in Its Bt Cotton Judgment

But the Supreme Court preferred not to answer the patentability question, or even whether the patent complied with various international agreements India has ratified. Instead, it simply said that the matter shouldn’t have been decided as summarily as it was by the division bench.

However, the issue of patentability had not been raised before the single bench and therefore it couldn’t be raised before the division bench. In sum, the appeal had been dismissed merely as a matter of procedural non-compliance.

The Supreme Court has effectively set aside an opportunity it had to answer the many important questions Monsanto v. Nuziveedu raises vis-à-vis India’s agritech sector. Given the country’s needs and its sociopolitical circumstances, the courts could have settled the matter in the farmer’s favour – as they have before. The Supreme Courts of various other countries have already done so. This could only mean India has to wait longer to assert that it is on the side of the people as well.

Kumar Karan is currently pursuing his B.A. L.L.B. from Symbiosis Law School, Noida. Mehak Sachdeva is a final-year L.L.B. student at the Faculty of Law, University of Delhi.

Backgrounder: The Laws Surrounding Monsanto’s Claim to the Bt Cotton Patent

How can a company own a patent over genetically modified seeds in the first place?

On January 8, the Supreme Court of India ruled that Monsanto’s patent over its Bt cotton seed technology was valid in the country and enforceable. The verdict reverses a Delhi high court judgment, which in May 2018 had ruled that the patent was unenforceable in India and that Nuziveedu and Seeds, an Indian company that had sold the specialised seeds, had not infringed on Monsanto’s patent.

How can a company own a patent over genetically modified seeds in the first place?

For an invention to be patentable in India, it must satisfy three conditions:

Novelty
Non-obviousness
Utility

If it does, and a patent is granted, then the inventor has a monopoly right for a fixed period of time in exchange for public disclosure.

These principles extend to agriculture as well – with some exceptions. For one, the Patents Act of 1970 excludes any method of agriculture, and any process for the medicinal, surgical, curative, etc. treatment of human beings, any treatment to render life-forms free of disease, or to increase their economic value or that of their products.

Also read: Plant Breeder Rights on the Table, Farmers’ Rights for the Chair

However, the World Trade Organisation’s TRIPS Agreement required patents to be available for any invention, whether for products or processes, in all fields of technology. And to comply with TRIPS, which came into effect in 1995, India had to amend many of its patent laws.

This tension between what is and isn’t patentable defines the broadest remit of Monsanto versus the Indian seed companies.

The agricultural biotechnology – or agritech – industry in India has developed in leaps and bounds in the last decade or so. It uses techniques like genetic engineering, molecular markers and diagnostics, vaccines, etc. to modify plants, animals and microorganisms. A subset of this is crop biotechnology, which has been engaged in improving yield, pest resistance, drought resistance, etc.

The laws granting the patent-holder complete autonomy differ from one country to another, and several courts around the world hold different opinions on the subject. Some have ruled in the patent-holder’s favour while others have sided with the plant-breeders, such as Nuziveedu and its clients.

Now, Indian patent law prohibits patents on any plant and animals or any process through a genetically modified organism is ‘created’, as long as it was purely biological. The only notable exception was microorganisms. So Article 27.3 of the TRIPS Agreement allowed governments to exclude “essentially biological” objects and processes – but microorganisms, and microbiological and non-biological processes weren’t exempt from patents.

In Monsanto v. Nuziveedu, the Delhi high court overruled its own decision, in an earlier petition filed by the same parties, in May 2018. It said that section 3(j) of the Patents Act shall include within itself genetic modification and parts thereof as ‘non-patentable’ subject matter.

Monsanto had claimed patent rights over its identification of the Cry2Ab gene from the DNA of a naturally occurring bacterium, for synthesising the nucleic acid sequence by copying the gene into a plant cell, and for the method of inserting the nucleic acid sequence into the plant cell. This process yielded a cotton variety resistant to the bollworm pest (Helicoverpa armigera).

Nuziveedu, a Hyderabad-based seed company, had then challenged Monsanto’s patent. Why? Because when a nucleic acid sequence is introduced into any plant cell, the plant cell becomes unpatentable under the Indian law.

Where patenting plant varieties is concerned, India has thus far followed a sui generis model. This led to the Protection of Plant Varieties and Farmers’ Rights (PPVFR) Act, 2001, which promotes farmers’ interests. Specifically, it allows farmers to cross-breed genetically modified plants and so produce new varieties and increase the agricultural yield.

It is similar to Canada’s Plant Breeders Right Act, which provides a form of intellectual property right by which plant-breeders can protect their new varieties the way an inventor protects an invention with a patent.

The PPVFR Act also seeks to provide an effective system to protect plant varieties, the rights of farmers and plant-breeders and to encourage the creation of new varieties. In addition, the act also recognises farmers’ contributions to conserving and improving genetic resources for the development of new plant varieties.

Also read: Explainer – SC Will Not Stay High Court Order in Monsanto v. Nuziveedu Case

Within this framework, Nuziveedu contended that the Patents Act excludes the “mere discovery of a scientific principle, … the formulation of an abstract theory or discovery of any living thing or nonliving substance occurring in nature” from patentability. As a result, Monsanto’s patent would have to be unenforceable in India.

This seems straightforward. Breeding plants and introducing new traits in a variety is an essentially biological process, so Monsanto’s patent wouldn’t fly.

On January 8, the Supreme Court noted otherwise in a few operative sentences read out in court, which suggested that it was disputing the division bench’s order without commenting directly on the validity of Monsanto’s patent. At the time of writing this article, the text of its judgment hadn’t yet been uploaded to its website. Once it is, let’s hope it will throw some much-needed light – not just on this particular case but the many implications it will have for the future of India’s agritech sector.

Kumar Karan is currently pursuing his B.A. L.L.B. from Symbiosis Law School, Noida. Mehak Sachdeva is a final-year L.L.B. student at the Faculty of Law, University of Delhi.

Explainer: SC Will Not Stay High Court Order in Monsanto v. Nuziveedu Case

If the patent on Bt cotton were removed and were it to be registered under the PPVFR Act, farmers will be able to use it for further breeding.

The Supreme Court of India has declined to stay a high court order that invalidated Monsanto’s patent for its genetically modified cotton seed. Its decision was voiced in the preamble to a case between Monsanto and Hyderabad-based agricultural seeds company Nuziveedu and its subsidiaries, to be heard in July.

The case brings the spotlight back to the dispute over the interpretation of intellectual property rights (IPR) in the case of genetically modified (GM) plants.

Monsanto was granted patent #214436, titled ‘Methods for transforming plants to express bacillus thuringiensis deltaendotoxins’. The submission covered a range of novel claims, including ‘claim 25’, which dealt with the specific gene sequence from the bacterium Bacillus thurigensis (Bt). When inserted into cotton plants, Bt provided resistance to the American bollworm pest Helicoverpa armigera.

In technical parlance, claim 25 says:

A nucleic acid sequence comprising a promoter operably linked to a first polynucleotide sequence encoding a plastid transit peptide, which is linked in frame to a second polynucleotide sequence encoding a Cry2Ab Bacillus thuringiensis 8-endotoxin protein, wherein expression of said nucleic acid sequence by a plant cell produces a fusion protein comprising an amino-terminal plastid transit peptide covalently linked to said 5- endotoxin protein, and wherein said fusion protein functions to localise said 5-endotoxin protein to a subcellular organelle or compartment.

Monsanto had claimed a patent right over the entire plant that had the Bt gene sequence inserted into it. The Delhi high court had ruled that this patent was not valid, as under Section 3(j) of the Indian Patents Act 1970, the patenting of plants (rather biological material in general) is not allowed. Should the Supreme Court echo the Delhi court’s verdict, Monsanto will have patent rights only over the gene sequence.

Section 3(j) of the Indian Patents Act 1970 states:

Grant of patents is prohibited to … plants and animals in whole or any part thereof other than micro-organisms but including seeds, varieties and species and essentially biological processes for production or propagation of plants and animals.

The PPVFR Act

Under licensing agreements signed in 2004, Monsanto had sold 50 Bt cotton seeds for Rs 50 lakh to Nuziveedu and its subsidiaries, a deal renewed through a new agreement in 2015. Nuziveedu and its subsidiaries had used those donor seeds in their breeding programme to develop more varieties.

Nuziveedu later contended that the Bt cotton developed by it and its subsidiaries has its own and distinct characteristics separate from the Bt trait. Thus, according to the company, the new varieties they had developed were not the same as the donor seeds patented by Monsanto. Nuziveedu and its subsidiaries have applied for IPR protection for their cotton varieties under the Protection of Plant Varieties and Farmers’ Rights (PPVFR) Act 2001. Nuziveedu has also argued that Monsanto did not transfer the specific method of transformation, that only the seeds of the transgenic variety were given.

The division bench of the Delhi high court, in its ruling, took into consideration how Monsanto negotiated its patent. The court observed the following:

Subsequent correspondence between the Patent office and Monsanto resulted in exclusion of plants, plant cells, tissues and progeny plant containing the nucleic acid sequence as well as plants created through an essentially biological process (excluded on account of Section 3(j)). This narrowing of the patent claims, in the opinion of the court, is relevant, because ultimately what was granted was not a patent over the product, or even the method, but of identification of the ‘event’ i.e. the place in the genetic sequence of the DNA where the CryAB2 protein, in the plant cell.

The court also said that “the moment the DNA containing the nucleotide sequence is hybridised to produce the transgenic seeds/plants, the seeds/plants fall within the purview of the [PPVFR] Act.”

Lack of participation

While many scientists and researchers have said that GM plants can be beneficial for farmers, their arguments have not percolated through to debates that continue to happen on the ground, especially their nuances. For example, Devang Mehta, a synthetic biologist at ETH Zurich, told The Wire, “Resistance to Bt or attacks by other insects do not negate the evidence that shows that Bt cotton has improved the lives of Indian farmers.”

The Bt gene confers resistance to bollworm and, as a linked effect, improves yields. Several studies have documented economic gains to farmers after using Bt cotton.

On the other hand, there have also been many academic reports on bollworms developing resistance to the original Bt gene, and of increased attacks by other insect pests not targeted by Bt, negating the benefits of the Bt gene.

A 2013 paper by P. Ramasundaram, of the National Centre for Agricultural Economics and Policy Research, and S. Vennila, of the National Centre for Integrated Pest Management (both in New Delhi), pointed out that for the (Bt) gene to have its maximum effect, the host cotton plant into which it is inserted – selected from the existing stock of hybrids in India – should also have robust yield potential.

They write, “Most of the socio-economic impact studies on Bt cotton attribute the benefits accrued solely to the new technology, ignoring the effects of the hybrids whose area itself has increased from less than 40% to more than 90% since the introduction of the technology.”

Experts have also been divided over the issue of royalties that farmers need to pay for buying and using Bt cotton seeds. According to Nuziveedu’s submission to the Delhi high court, the donor seeds of the transgenic variety supplied by Monsanto could not be used by farmers. Instead, the Nuziveedu companies had to use the donor seeds to breed new varieties with more or additional traits, produce their seeds and supply those seeds to farmers.

Bt or no Bt, Rajeswari Raina, a science policy expert who specialises on the impact of agricultural research, pointed out that India follows an industrial agriculture model that focuses on increasing yields through supply of inputs in a centrally controlled manner. As a result, this model has been partly responsible for “the historical lack of participation and transparency in decision-making on GM crops”, according to her, as well as for India’s science and technology leaders being unable to find sustainable solutions that are not input-intensive. She is a professor at Shiv Nadar University and former principal scientist at the National Institute of Science, Technology and Development Studies, New Delhi.

However, if Bt cotton were to be registered under the PPVFR Act, farmers will be able to use it for further breeding.

The Supreme Court’s decision on the IPR issue of Bt cotton will not have a bearing on India’s long-delayed decision on whether to allow the commercial cultivation of GM mustard, developed by Deepak Pental and co. at Delhi University.

T.V. Padma is a freelance science journalist.