Patenting genetically modified organisms
Published: Feb 04, 2022
By Prashanth Shivadass & Pallavi Reddy *
INTELLECTUAL Property, irrespective of the sector, is an area of concern for many in the industry. A recent development is the patent of genetically modified living organisms. While parents in general, leads to monopoly, patenting organisms has high risk concerns in the interests of farmers.
This article covers the basic understanding of what is meant by genetically modified organisms, interaction with various laws and what issues continue to prevail.
What are Genetically Modified Organisms?
Genetic modification ('GM' ) is a technique that involves inserting DNA into the genome of an organism. To produce a GM plant, new DNA is transferred into a plant cell. Usually, the cells are grown in tissue culture where they develop into plants. The seeds produced by these plants will inherit the new DNA 1 .By adding a specific stretch of DNA to the plant, the plant is given new characteristics like making the plant immune to certain diseases, increased resistance to herbicides or improved nutritional content.
Genetic modification through genetic engineering can create plants with desired traits and accuracy. For example, plant geneticists can isolate a gene responsible for drought tolerance and insert that gene into a different plant. Not only can genes be transferred from one plant to another, but genes from non-plant organisms can also be used.
How it Started:
In the year 1980, a genetic engineer, Ananda Mohan Chakrabarty (Plaintiff) invented a living, human-made micro-organism which could be used in clearing oil spills effectively. Upon applying for a patent, the US patent office rejected the application on grounds that the micro-organisms are a product of nature and therefore unpatentable. Subsequently, the board of appeal granted the patent which was affirmed by the Supreme Court opening a flood gate of applications on patenting life forms 2.
Legal position in India:
Genetically modified crops in India are regulated under the Environmental Protection Act 1986, (Manufacture, Use, Import, Export and Storage of Hazardous Microorganisms, Genetically Engineered Organisms or Cells Rules, 1989). These Rules are enforced through different regulatory bodies across various jurisdictions at the top of the which lies the Genetic Engineering Appraisal Committee (GEAC) under the Ministry of Environment, Forest, and Climate Change. 3
Another important governing body that runs parallel to the GEAC is the Department of Biotechnology which operates under the Ministry of Science and Technology. While the GEAC has the authority to approve or disapprove GM testing, the role of the Recombinant DNA Advisory Committee (RDAC) (the main executive body of the Department of Biotechnology) is only advisory in nature. 4
A standing parliamentary committee report of the year 2012, titled 'Cultivation of genetically modified food crops - prospects and effects', highlights the shortcomings of the existing regulatory framework. It reports that most of these committees lack statutory authority, and the lack of a central body masks the entire process in ambiguity. By way of a detailed explanation, the standing parliamentary committee explained that GM crops exceed the ability of the ecosystem to replenish over time in a developing nation like India. 5
India is also a signatory to the Cartagena Protocol, which provides for the safe use of living modified organisms using modern technology that may otherwise have adverse effects on biological diversity, considering risks to human health. India, however, has failed to meet its obligations as it could not develop necessary manpower, infrastructure, and scientific expertise to ensure compliance under this treaty.
Interplay with Patents:
Though the provisions of the Indian Patents Act, 1970, previously did not provide much clarity on the patentability of GM. By way of the 2002 amendment, the term 'plant' was removed from the list of non-patentable category with respect to any process adopted for medicinal, surgical, curative, diagnostic, therapeutic purposes to render them disease free or increase their economic value. 6 Further, the same amendment modified Section 3(j) of the Patents Act, which allows patentability of micro-organisms.
The Protection of Plant Variety and Farmers' Rights Act, 2001, was also enacted to protect the creation of new plant varieties. Plant varieties and seeds, including transgenic varieties and GM seeds, stand protected under this Act. Therefore, the laws in India, though vague, provide some form of protection for new plant varieties.
Persisting Issues:
Genetic modification has brought chaos to the ecology including human health and has affected the normal course of agriculture in the country.
One of the major issues faced in India due to GM crops is that the pests that feed on cotton and brinjal are monophagous, i.e., they eat only one kind of food. This has led to the resistance development of the pests to the protein that is toxic for them, forcing farmers to spray lethal pesticides. Due to this reason, there have been over 50 deaths by pesticide poisoning in Vidarbha in 2017. This situation also raises a vital question about the policies followed by the Government. 7
Conclusion:
New inventions are inevitable in any field of technology including biotechnology. Other than granting patenting of life forms on technical grounds, the criteria should extend to considering morality and public order. The government should regulate strict laws and guidelines for proper research and testing of genetic modification in crops and should draw a limitation to the use of Genetically Modified crops while simultaneously encouraging farmers to continue with organic and sustainable methods of farming.
[ The authors are Partner and Associate respectively, with Shivadass & Shivadass (Law Chambers. The views expressed are strictly personal.]
1 https://royalsociety.org/topics-policy/projects/gm-plants/what-is-gm-and-how-is-it-done/#:~:text=GM%20is%20a%20technology%20that,will%20inherit%20the%20new%20DNA.
2 See, Diamond Vs Chakrabarty, 447 U.S. 303 (1980)
3 The Environmental Protection Act, 1986, Rule 4(4) of Manufacture, Use, Import, Export and Storage of Hazardous Microorganisms, Genetically Engineered organisms or Cells Rules, 1989
4 The Environmental Protection Act, 1986, Rule 4(1) of Manufacture, Use, Import, Export and Storage of Hazardous Microorganisms, Genetically Engineered Organisms or Cells Rules, 1989
5https://prsindia.org/files/policy/policy_committee_reports/1349957427_Standing%20Committee%20Report%20Summary-%20GMO%20Final.pdf
6 Patents (Amendment) Act, 2002, S.4(d)(ii), No. 38, Acts of Parliament, 2002.
7 https://www.thehindu.com/opinion/op-ed/serious-concerns-over-bt-brinjal/article28022577.ece
