In the recent years, biotechnology has emerged as a major contributor to the growth of Indian economy. With the fast-growing global developments in biotechnology, the Indian Patent Office has eased its conservations towards patenting genes in India, while still upholding the benefits for Indian farmers as its main priority. The balancing act of allowing new technology to thrive without affecting the existing market players, has been well accomplished by the Indian Patent Office through various guidelines introduced via Indian Biotechnology Guidelines, 2013 and The Manual of Patent Office Practice and Procedure, 2005.
Gene patenting refers to patenting a process of manipulating DNA and chemical substance related therewith, gene sequences and fragments of gene that are not present in their natural state in nature.
In India, the Section 3(C) of the patent Act, 1970, does not allow "discovery of any living thing or non-living substance occurring in nature" as patentable subject matter. Further, section 3 (j) of the Indian Patent Act, 1970 includes objection 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 to be patentable.
However, over the past few years, patenting in India has been evolving considerably. To cater to the global developments in biotechnology and its corresponding growth in the Indian economy, the India patent Office released the Indian Biotechnology Guidelines, 2013 and Manual of Patent Office Practice and Procedure, 2005.
The Manual of Patent Office Practice and Procedure, 2005 emphasises that recombinant DNA, plasmids and processes of manufacturing thereof are patentable provided they are produced by substantive human intervention. The Manual includes the following conditions to be satisfied for granting a patent for any gene:
- The genetically modified gene sequence/amino acid sequence must be novel, involve inventive step and also have industrial applicability;
- The method of expressing the genetically modified gene sequence/amino acid sequence is novel;
- an antibody against that protein/sequence that is genetically modified can be claimed to be protected; or
- a kit made from the antibody/sequence can be claimed to be protected.
The criterion to be met for patenting the recombinant DNA and is that "novelty owing to substantial human intervention", as stated in the Manual.
Further, according to Indian Biotechnology guidelines, 2013, a gene that is recombinant and has inventive step and industrial application is said to be patent eligible. However, it may be noted that the guidelines do not require to satisfy the condition of substantive human intervention that was stated earlier in the Manual. It may be noted that once a gene patent is granted in India, the holder is entitled to reap the commercial benefits of the gene patent.
India being a vibrant agricultural economy with a vast majority of its population involved in farming industry, a strong legal protection for genetic engineering in plants may have its drawbacks for India. The farmers and local community in India have significantly contributed to the creation, conservation, exchange and using of the genetic diversity through their traditional practices. However, since gene patenting is allowed in other countries, this legal regime may provide advantages to the agro – biotech companies outside India, that have obtained several patents on genetic inventions relating to plants. The developed nations have free access to the biological resources and associated knowledge of the developing countries which gives rise to "bio-piracy" and "cultural piracy".
Therefore, in order to address this issue of "bio-piracy" and "cultural piracy", India has taken various measures under the Indian Patent Act, 1970, The Protection of Plant Variety and Farmers Right (PPVFR) Act, 2001 and Biological Diversity Act, 2002. The PPVFR act includes the following essentials:
- Disclosure Requirement that requires the applicant to disclose the all details of the origin of the parent variety of the gene as well as a declaration that the genetic material has been lawfully acquired.
- Benefit Sharing, wherein the citizens of India or group thereof may have an opportunity to claim a share of the benefits based on the extent and nature of use of the genetic material in developing the variety, commercial utility of the variety and demand in the market of the variety.
- Critical Analysis of the benefit sharing provisions so that the objective of the PPFVR Act reaches the local people and peasants in a huge country like India through the traditional societies in the various states.
Similarly, the Biological Diversity Act, 2002 also includes benefit sharing by establishing a separate biodiversity management committee to monitor the conservation of genetic resources and Traditional Knowledge (TK) related therewith. Therefore, the Biological Diversity Act reasserts the sovereign rights of India over its genetic resources.
In the recent years, India has granted patents for cDNA used in various innovations that satisfy the Acts' criteria mentioned above. For example, the Genetically Stable JEV cDNA, which was based on Japanese Encephalitis Virus (Patent No: 243799) referred to a recombinant viral construct that aimed at expressing an exogenous polypeptide in a cell. The Indian Patent office considered that the genetically modified and stable gene JEV cDNA, which was based on Japanese Encephalitis Virus was novel, involved inventive step and had industrial applicability and hence granted the patent. Also, in another instance, the Supreme Court of India set aside the order of the Division Bench and restored the order of the Single Judge dated 28.03.2017 in the Monsanto Technology LLC v Nuziveedu Seeds Ltd case, dated January 8, 2019. Further, the suit was remanded to the Single Judge for disposal in accordance with law. This decision by the Supreme Court of India, has established BT crops as important innovations that can be protected under patents. This decision not only reassures the companies to continue such innovations and seek protection under Patents Act, 1970 but also solves issues in Patent law related to biotechnological inventions including DNA, RNA, rDNA and further research in the area of biotechnology.
Gene Patenting has its own advantages as well as disadvantages. The genetic modifications are advantageous for advances in development of medicines and fulfils the need for food security in India. However, the law governing the plant biotechnology is under the obligation to safeguard the interests of the local farmers in India who comprise a vast majority of the Indian population. Here, the benefit claimers (mainly peasants and farmers who carry the traditional knowledge of seeds) have no voice in determination and bargaining of benefit sharing. A considerable number of changes are required at the legislative level to strengthen the rules and regulations that bind gene patenting in India, while providing reasonable benefit to the owners of traditional knowledge that is passed over thousands of years in India.
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