Date : December 17, 2019
A recent shift in the sphere of what was a term first widely applied to the molecular and cellular technologies that began to emerge in the 1960s and ’70s, biotechnology has instigated interesting advancements in the field of Agrobiotechnology and plant genomics.
This paradigm shift has metamorphosed the way biotechnology is perceived from being merely regarded as a field that taps the biological processes of microorganismsto one that is making more attempts to actualise and develop more sustainable varieties of crops, therapeutic proteins and other drugs and commodities through genetic engineering. An unsubtle increase in the number of patent applications filed to that effect, therefore, stands testimony to a somewhat re-engineered perception on how we imagine and comprehend the agrobiotechnology industry and its many branches.
Given the vast number of patent applications filed, however, it would be remiss to ignore the many constrains and issues that may inadvertently hinder most enforcement mechanisms once patent protection comes into play vide patent grants. It is also not unreasonable to believe that the fact that these many innovations in plant biotechnology are happening at rapid rates, the grant of a patent in tandem with the provisions of the Patents Act, 1970 is rendered far more difficult owing to the a poor understanding of the many innovations and innovative processes as well as the industry itself. This has in turn led to a plethora of patent infringement cases flooding the halls of the courts to seemingly incorrigible degrees.
A recent dispute involving an American multinational agrochemical and agricultural biotechnology corporation, called Monsanto, and an Indian agribusiness company, known as Nuziveeduserves as a perfect example that illustrates the arguments made herein quite nicely.
The judgement being discussed presently is a Division Bench, Delhi High Court judgement that was pronounced in lieu of cross appeals filed by Monsanto and Nuziveedu against the order of a single judge of the Delhi High Court. To surmise, The Division Bench of the Delhi High Court declared Monsanto’s patent for Bt. Technology invalidby invoking the provisions under Section 3 of the Patents Act, 1970, which provides for what would not be considered as “inventions” within the meaning of the Patents Act; and more specifically, Section 3(j) which states, “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 animal”.
Interestingly, Section 3(j) makes apparent its exception of microorganisms, which is understandable owing to both India’s commitments to the TRIPS and the revolutionary Diamond v/s Chakrabarthy (1980)U.S. Supreme Courtruling. However, what was particularly contentious and, frankly, disturbing about the rationale (or a lack thereof) of the Division Bench’s ruling was a complete disregard for the assessment mechanisms for a constructed claim, specifically, one that included deciding on the validity of a claim by first studying, assessing and interpreting the claimed product or process in tandem with Section 2(1) (j) of the Patents Act, 1970 which reads,“invention" means a new product or process involving an inventive step and capable of industrial application”,as well as, Article 27(1) of the TRIPS agreements which elucidates that Patents shall be available for any inventions, whether products or processes, in all fields of technology, provided that they are new, involve an inventive step and are capable of industrial application.
In the present case, however, the Division Bench failed in appropriately assessing the claims in accordance with the prescribed standards. They concluded that “the moment the DNA containing the nucleotide sequence (subject patent) is hybridized to produce the transgenic seeds/plants; the seeds/plants fall within the purview of the PV Act, and, above, the process of creation of such seeds/plants are also excluded from patentability as they squarely fall within the meaning of an “essentially biological process” that is exempted from patentability within the meaning of section 3(j), as well. For these reasons, it is held that the subject matter, the concerned nucleotide sequence over which Monsanto has patent rights and the process is unpatentable by reason of Section 3 (j) of the Patents Act.”This may be noted to be incorrect as reagrds their opinion that the entirety of the Monsanto’s product is a result of an “essentially biological process” which is barred under Section 3(j). The conclusion is incorrect because while it is true that transfer of genes from one species to another species can take place naturally, in the case of Monsanto’s patent, the introduction of specific Bt. bacteria genes into the cotton genome was purely a result of human intervention and action, andwas not a natural process thereby not covered under the “essentially biological process” bar.
Additionally, one may also make an “efficacy” argument to refute the Bench’s conclusion, in that, while it is indeed possibly to naturally undertake the aforementioned gene modification, the process is a morbidly slow one that spans generations.
Moreover, in Dimminaco AG v. Controller of Patents & Designs (2002), it was held that on satisfying the ‘vendability test’ which states that the product should be a commercial entity, there was no statutory bar in the patent statute to accept a manner of manufacture as patentable even if the end product contained a living organism.
It may therefore be noted that the Division Bench of the Delhi High Court committed major judicial fallacies in deciding the present case vis-à-vis not just by not adhering to prescribed laws and precedents, but also by completely disregarding any and all assessment of “evidence” while deciding the case. Fortunately, Indian Intellectual Property jurisprudence came out the victor when the Supreme Court ruled in favour of Monsanto on appeal.
The Patents Act, 1970
447 U.S. 303 (Diamond vs. Chakrabarty)
Article 27(1) TRIPS
FAO (OS) (COMM) 86/2017, C.M. APPL.14331, 14335, 15669, 17064/2017 (Nuziveedu vs. Monsanto; Division Bench Delhi High Court)
(2002) I.P.L.R. 255 (Cal) (Dimminaco A.G. vs. Controller of Patents Designs)