Technology has permeated into every sector in today’s digital age. Innovations and newer, better techniques have enabled far more advances and development in the various sectors of the Indian economy. One such sector is the agriculture sector.
Agriculture is India’s primary occupation, with over fifty-eight percent of the population practicing agriculture and dependent on it as a primary occupation. Technological development and growth have introduced several new practices within this sector, each having their own benefits. This mix of agriculture and technology is often referred to as “Agri Tech”. Several startups are now coming forth in this sector, exploring and developing new techniques to enhance agricultural practices and products.
One such development is genetic engineering. Genetic Engineering is a bio-technical process which is used in developing superior plant breeds. Desirable traits in plants (for example, insect resistance) are introduced into the plant DNA through artificial methods.[1] These genes result in development of superior plant varieties with genetically enhanced qualities. Such plants/crops are called Genetically Modified Plants (GM Plants) or Genetically Modified Crops (GM Crops). Similarly, specific fruits and seeds produced via genetic engineering are termed Genetically Modified Fruits (GM Fruits) and Genetically Modified Seeds (GM Seeds).
This article focuses on GM seeds in India as well as the IP and regulatory framework surrounding them.
GM Seeds: The pros and cons
As stated above, GM Seeds are genetically enhanced seeds which develop into resistant and superior breeds of plants. The purpose behind use of GM seeds is to increase profit and yield of a specific type of crop. In India, the only approved GM Crop is Bt Cotton. Like all other innovations, GM seeds too have their own set of pros and cons.
GM Seeds are developed with a specific objective in mind, such as increased yield. Hence, even though they may cost more than regular seeds, GM seeds will produce a significantly higher yield than regular seeds, which increases the chance of profit.[2] Further, the biggest advantage of GM seeds is that they are not hindered by the usual factors that affect regular seeds. On the contrary, they open new alternatives. For instance, a drought resistant variety of seeds maybe used to grow crops in an area with less water; an insect resistant variety will automatically be able to fight off the pests.[3] This will dramatically reduce farmers’ costs on pesticides and herbicides. Therefore, GM seeds can be used to counter any adverse condition and ensure that there is no loss of livelihood and hunger.
On the other hand, GM Seeds are sold only by a select few companies. This almost-monopoly in terms of availability results in a perpetually high purchase cost for such seeds.[4] Further, such varieties of seeds are patented, and can only be used with the original creator’s express permission. In addition to issues with availability and cost, GM seeds are designed such that they do not create viable seed offspring. Hence, such seeds cannot be replanted. Every time a farmer wishes to grow a new batch, he must go back to the company and buy the seeds.[5] This is profitable for the company; but leaves the farmer highly dependent on such companies. GM seeds (and resulting plants) can also prove harmful consumption wise, since the genetic modification introduced may react with the human body in a harmful manner.[6]
Regulatory Framework on GM seeds in India
GM seeds are synonymous to GM crops when it comes to regulatory regime. In India, the only approved GM Crop is Bt Cotton. Bt Cotton is a variety of Cotton plant that contains a gene extract of the bacterium bacillus thuringiensis. This extract (Bt) helps the plant develop a plant protein that is toxic to the common pink bollworm, the pest that interferes with cotton cultivation. The Genetic Engineering Appraisal Committee (GEAC) approved commercial cultivation of Bt Cotton in India in 2002. Followed by BT Cotton, Bt Brinjal and HT Mustard were also approved by the GEAC in 2007 and 2017 respectively. However, Bt Brinjal was blocked in 2010[7] and the Supreme Court stayed release of HT Mustard in 2017, asking for a public opinion.[8]
GM Crops are governed under several existing legislations, such as the Environment Protection Act, 1986 and the Rules for the Manufacture, Use, Import, Export, and Storage of Hazardous Micro-Organisms/ Genetically Engineered Micro-Organisms or Cells, 1989 (“the Rules, 1989”) notified under the Act. These legislations cover the large-scale applications of GM Crops. The Environment Protection Act further lays down the competent authorities and their compositions for handling different aspects of the Rules.
The Competent Authorities under the Act include:
The Recombinant DNA Advisory Committee (RDAC)[9]: Advisory limb of the Department of Biotechnology, Ministry of Science and Technology. The RDAC is tasked with policy review of biotechnology at national and international levels.
Review Committee on Genetic Manipulation (RCGM)[10]: Executive limb of Department of Biotechnology, Ministry of Science and Technology. The RCGM monitors the safety and protocol. It also provides the guidelines for GMOs. The implementation of these guidelines is further done by bodies like Institutional Biosafety Committees (IBSC).
Genetic Engineering Appraisal Committee (GEAC)[11]: Constituted under the Environment Ministry, this is the statutory body that regulates and approves large scale use of GMOs for research and commercial purpose, particularly from the environmental safety perspective.
In addition to the Environment Protection Act, 1986, India is also signatory to the Convention on Biological Diversity. The Parties to this Convention adopted a supplementary agreement to the Convention in 2003, known as the Cartagena Protocol on Biosafety[12], which sought to protect the biological diversity from potential risks through use of genetically modified organisms. To comply with this requirement, India enacted the National Biological Diversity Act, 2002. This Act constitutes a separate body called National Biodiversity Authority (NBA).[13] The NBA performs both advisory and regulatory functions.
GM Seeds and IP Rights
The Patents Act, 1970 governs patent law in India. Section 3(j) of this Act is the most relevant provision when it comes to GM seeds.
As per Section 3(j), plants in whole or part thereof, seeds, plant varieties and essentially biological processes for production and propagation of plants are categorically excluded from patentability.[14] This provision was introduced as part of the 2002 amendment of the Patents Act to meet India’s obligations under Art. 27 of the TRIPS Agreement. Art. 27.3(b) allows for exclusion of plants, animals, varieties, and essential biological processes, but mandates that micro-organisms, nonbiological and microbiological processes have to be eligible for patents.[15] Comparing Art 27.3(b) and Section 3(j), India has made two additions – the first is to add further limitation by stating “plants and animals in whole or any part thereof” and the second is to specifically include seeds in the category to be excluded. Hence, as per the law in India all types of seeds and varieties will be excluded from patentability. Both natural and GM seeds are excluded from patent protection. Therefore, GM seeds are not directly patentable.
The Patent Act does not cover patentability of genes and genomic sequences. But the restriction in section 3(j) covers any part without limitation. Therefore, natural genes, natural cells, tissues and nucleic acids will still be excluded. But a gene can be patentable if it is “recombinant and having inventive step and industrial application” along with “substantial human intervention.” [16]Therefore, an isolated sequence inserted into a vector and then placed into a host cell to express desired characteristic/trait would be a patentable gene. As per the Mashelkar Committee Report, these recombinant genes are considered “chemical compositions” and such “incremental innovations” ought to be encouraged.[17]
Hence, the grey area that this creates is what happens when recombinant genes are introduced into parts of plants such as cells, tissues and processes. Plant patents are not directly permissible in India, but by patenting the recombinant gene which causes development of such a plant, patent holder can indirectly claim patent rights on the plant itself. This is how Bt Cotton was granted patent in India.
Another factor to consider when considering the role of patents in the economy is that of the companies that sell such recombinant seeds. There are two areas where a company may make use of patents to benefit its business. The first is where the hybrid technology is licensed by a company. If a seed company chooses to license its technology to local companies, then by virtue of licensing contract, it can collect royalties from the local companies.[18] On the other hand, patents can be used during sale of seeds directly. But with most GM seeds, technological barriers exist. GM seeds cannot be propagated and are not viable. Hence, for every new season, the farmer would need to go back to the seed company to buy seeds. Hence, when it comes to local seed companies selling GM seeds, the technological barriers placed are enough to cause their customers to return. Patents don’t play much of a role here.[19]
Another legislation that protects plant varieties is the Protection of Plant Variety and Farmer’s Rights Act, 2001 (“PPVFR Act, 2001”). This Act defines variety to include its propagating material (i.e., seed) and this includes transgenic varieties.[20] Hence, the exclusions under Patents Act are covered under PPVFR Act. Further, the Act also provides for ‘researcher’s rights’ which allow a breeder to license their variety to a local source as an initial source to create new varieties without any authorization.[21] The researcher company has rights only on the transgenic seed. Once the transgenic seed is sold to the local companies as an initial source for producing further hybrid varieties, the company does not patent rights on the subsequent varieties.[22] Under the PPVFR Act, such companies have rights of benefit sharing. The company is allowed to have a share in the benefit accruing to the breeder from such varieties.[23]
In conclusion, it can be said that India has a well-balanced framework when it comes to regulation and determination of IP rights for GM seeds. India has developed provisions more stringent than those compared to the TRIPS Agreement when it comes to protecting IP, and there is a strong regulatory framework in place as well. But the grey area, that is, whether a plant variety can be patented on account being developed by a patented gene, is yet to be addressed properly. Consequently, how this extension of patent rights affects the other elements such as farmers, local companies, etc., can be understood clearly. In the meantime, until such position is clarified, the PPVFR Act adequately covers the loophole.