India is among the top 12 biotechnology destinations in the world, and has the third-biggest biotechnology industry in the Asia-Pacific. While bio-pharma constitutes the major part of the bio-tech industry, in FY16-17, the bio-agri segment accounted for 14 per cent of the industry.
Ensuring the growth of the bio-technology industry requires that an inventor’s rights be adequately protected. Inability to do so will invariably lead to dwindling motivation and investments in this industry.
Invalidating patents on gene (nucleotide) sequences generated by sufficient human interference, that are considered patentable subject matter in India as well as most of other countries, sets a precedence with far-reaching consequences.
First and foremost, it raises the question on the validity of 162 granted and 780 filed patents; secondly, it authorises the Protection of Plant Variety and Farmers Right Act, 2001 (PVFRA) in perpetuity to interfere and fix the technology fee between agri-biotech inventors and their clients. Finally, it undermines the fundamentals of a well-balanced legal framework that protects plant varieties under PPVFRA and bio-tech innovation patents under the Patents (Amendment) Act 2005.
The Indian Patent Act, 1970, as modified in 1999, 2002 and finally in 2005, governs patent legislation. The Patent Amendments Act in 2002 included “biochemical, biotechnological and microbiological processes” within the definition of “potentially patentable chemical processes”, whereas it excluded patenting of plants per se under section 3(j) of the Act in 2005.
At the same time, a sui generis system for protection for plant varieties was introduced under the PPVFRA to protect the rights of farmers and plant breeders, which also prevents unauthorised use of plant varieties registered under the PPVFRA.
The PPVFRA covers all categories of plants, but does not cover micro-organisms, or DNA or RNA or protein sequences. Most patent offices, including the US patent office and Indian Patent office hold natively occurring genetic sequences as they occur in nature as unpatentable. But genetic sequences with sufficient modifications done by human intervention, with commercial applications, are considered patentable subject matter.
A major legal dispute is currently going on between Monsanto, the developer of the Bt cotton, and Nuziveedu Seeds, which had licensed the patent claiming the Bt gene from Monsanto to develop insect-resistant varieties.
The patented gene sequence as claimed by Monsanto in its granted patent 214436, causes the plant to produce a protein that is toxic for insects of the Lepidoptera order, which comprises bollworms, one of the major insect pest for cotton. On April 11, 2018, a division bench of the Delhi High court pronounced the Monsanto patent claiming the “Bt gene” to be invalid, even though it does not claim any plants or plant parts, making all scientists engaged in bio-tech research in India ponder over the consequences of this judgment, which could set a precedent for invalidating all patents with claims around genetic sequences.
Would this judgment entail that any nucleic acid that could potentially ever be introgressed into plants be considered unpatentable in India? The repercussions of this judgment on the budding Indian bio-tech sector also has to be watched closely.
The Delhi High Court judgment, which came as a result of a long running commercial dispute between Monsanto and Nuziveedu Seeds, concluded that the concerned gene sequences over which Monsanto has patent rights are unpatentable by reason of Section 3 (j) of the Patents Act.
The court ruled that these genes, once integrated into the seeds and plant varieties used by breeders, would come under the purview of Section 3(j); thus the patent rights of the gene sequences cease to exist.
Many Indian patents on novel genetic sequences filed by the public and private sector have been reviewed and granted by the Indian patent office and are also protected in other countries under the Patent Cooperation Treaty (PCT).
The dilemma that has emerged is: whether seeds and plant varieties with or without patented technology have any implication for farmers’ rights to save and exchange plants, seeds and other farm produce.
Agri-biotech sector worried
Obviously, holding all genetic sequences, even if they are made by human intervention and that could potentially be introgressed into plants, as unpatentable subject matter would set a dangerous precedent that could irrevocably harm the Indian agri-biotech sector in the long run.
This precedent could, by extension, become a standard practice for the patentability of gene sequences that are the core of the vaccine and pharma sector too. Thus, it is paramount for the government of India to set the record straight on protection of naturally occurring plant varieties and man-made gene sequences in the court of law.
Puneeta Arora is a founding partner at AvidInvent. Bhagirath Choudhary works for South Asia Biotechnology Centre, New Delhi. The views are personal.