In the recent judgement in the High Court of Delhi in Monsanto Technology LLC and Ors. v. Nuziveedu Seeds Limited and Ors, the Delhi High Court has single-handedly devastated the Biotechnology (Bt.) industry in India. Its judgement will have far-reaching consequences on multiple sectors such as genetic modification and biotechnology, pharmaceuticals and the agriculture industry.
Brief Facts and Monsanto’s Patent Claims
Through a Government notice from the Department of Agriculture, the trait fees, or the fees charged for seeds with genetic coding for a specific characteristic (such as pest resistance, or higher yield), were revised for certain seeds including Bollgard and Bollgard II of Monsanto, a Fortune 500 global conglomerate.
Subsequently, Monsanto terminated a contract with Nuziveedu, a seed distributor working in India, for the licensing of the seeds after Nuziveedu challenged the trait fee charged by Monsanto and demanded damages alleging breach. Nuziveedu in response challenged Monsanto’s patent claims on the ground that plants and essentially biological methods of making them may not be patented.
Of the several claims, which largely involved the multiple processes in creating the particular plant varieties, claims 25-27 are relevant as per the judgement.
Essentially, Monsanto’s claim was that of a patent over the specific gene sequences that enable the cotton variety to produce its resistance as vigorously as it does through the use of a toxin which it produces. Monsanto has applied for a patent over the genetic sequence, or the recipe, created to produce the toxin as well as a promoter, which is needed to induce the process of making the toxin. This creates a trait that enables cotton plants to produce a substance that is toxic to pests, such as bollworms. The plant with this trait is then crossbred with local varieties for creating a variety that inherits the characteristics that local species developed to thrive in the given area.
The High Court decided that Monsanto could not patent Bt. Technology under the Indian Patents Act 2001 (Patents Act). However, Monsanto was granted protection for the plant varieties it claims a patent over under the Plant Variety Protection and Farmer’s Right Act 2002 (Plant Variety Act). It also decided that Monsanto had illegally terminated the contract, as mentioned earlier.
To elaborate, the court held that the patent granted was only for the identification of the event as opposed to the method of creating the seed. This implies that the patent extends to inventing the proper gene sequence and creating a cell with the same sequence. It does not extend to the cell creating a plant. Essentially, the Court has separated the creation of the modified cell and the creation of the modified plant as two separate events. The method of creating the seed involves what the court considers “essentially biological processes” as per Section 3(j) of the Patents Act. The phrase has not been defined in statutes, but in this context, it refers to reproduction and cell division.
Once we replace essentially biological processes with cell division and reproduction, it becomes much easier to understand the court’s fallacy. “Essentially Biological Processes” are those processes that naturally occur in organisms. Section 3(j) implies that patenting the production or creation of something is prohibited when those means are “essentially biological processes.”
Therefore, the Court has denied Monsanto its patent claim over the processes and products involved in creating the plant and has given them patent only over the event. The holding essentially means that Monsanto only has rights over a narrower construction than they claim of patent over both the identification of the event and the creation of the seed. In cross-breeding the Bt. Cotton variety with a local variety, the product is no longer a microorganism and cannot benefit from the exemption in 3(j) of the Patents Act. The significant part of the analysis was to show that plants could not be patented and that their product was at the end of the day, a plant, as it was created using essential biological processes such as reproduction.
Essential Biological processes and Genetic Modification: Is there a Difference?
I find that the general narrative, in the cases relied upon, involved protecting essential biological processes, for example, selective breeding to create a more robust variety. Such processes may occur naturally. However, the entire strain of seeds sown could not have been created without human intervention. While there was cross-breeding with local varieties, should such cross-breeding vitiate the entire right over property that was created by Monsanto? Such reasoning is fallacious because what may apply to one part of this process need not apply to the entire process. The process may have involved crossbreeding to make the product better suited to Indian conditions, that does not mean the entire process is a result of this single step. Faking an accent does not make one British or change one’s personality. Similarly using crossbreeding does not make the entire method an essentially biological process. It cannot be reduced to one single step.
Further, the court has drawn analogies between our laws and foreign decrees after disregarding relevant differences. Many of the cases do not specifically note the difference between crossbreeding and genetic modification. When the court asserts that Monsanto tried to patent what is an “essentially biological process”, it implies that such a hybrid can be created naturally through reproduction and cell division alone (cross-breeding between plants). However, looking at the progress in the field, it is astronomically unlikely that crossbreeding will result in bacterial genes expression in plants. Even if the claims of patents over the plant itself are invalid, the method of their development cannot be reduced to essentially biological.
Are There Adequate Protections Under the Plant Variety Act?
The High Court also suggests that protection under the Patents Act and protection under the Plant Variety Act are mutually exclusive and suggest the latter for protecting interests in transgenic plant species. Arguing that the Parliament enacted the latter shortly after adding s. 3(j) with the knowledge of both, there was legislative intent to make them mutually exclusive. However, the protections available under this act are not adequate. Simply because such a change would permit several groups to create their variety with such a trait, out of the transgenic crops, the biotechnology industry in India will see severe repercussions. Such products are quickly outdated; bollworms are reportedly becoming resistant to Bt crops. There is no longer an incentive to develop/sell such seed in India. Companies will respond by exiting the Indian market, taking away the option of using Bt. crops from farmers.
While an urge to protect or assist farmers who cannot afford such exorbitant pricing is noble, if indeed this was one of the motivating factors behind the decision, demolishing protections available to biotechnology and transgenic crops does nothing to ease their plight.
The Supreme Court has declined to stay the High Court’s Order in the previous listing in May; the case is likely to be listed again in mid-July. Whether or not there is a change in the court’s approach remains to be seen.