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.