Patentability of micro-organisms

Written By: Disha Gupta

Monsanto Technology LLC and Ors. v. Nuziveedu Seeds Ltd. and Ors[1]

The Patents (Amendment) Act, 2002 brought microorganisms within the purview of the Patents Act, 1970, making microorganisms, which are genetically modified or fit the criteria of being novel, non-obvious and capable of industrial application, patentable as per Section 3(j) of the Act. With a continuing boom in technological advancements all over the world, the law revolving around the patentability of microorganisms has also taken some interesting turns. This case study delves into various aspects relevant to this field, as discussed in the famed case of Monsanto Technology LLC and Ors. v. Nuziveedu Seeds Ltd. and Ors.

The Plaintiffs, Mosanto Technology LLC and Ors, as per their patent rights had enter into a sub-license agreement with the defendants for an underlying time of ten years. Sub-licensing entails granting certain licensed rights on a product to a third party by the licensee. The defendants, Nuziveedu Seeds Ltd and Ors, were allowed to grow “genetically Modified Hybrid Cotton Planting Seeds” with assistance of the Plaintiffs’ innovation. The agreement further provided for the payment of license fee or trait value[2] by the Defendants, for utilization of the Plaintiffs’ protected innovation. On disputes of non-payment of this fee in view of subsequent price control regime introduced by the State, the plaintiff over turned the agreement and filed an injunction application under Order 39, Rule 1 and 2 of the Code of Civil Procedure to stop the defendants from using their registered trademark (“BOLGARD” and “BOLGARD II” brand cotton technology) in violation of the registered patent during the pendency of the suit. In its answer, Nuziveedu filed a counter- claim to test the legitimacy of the patent. This Court held that the innovation was not a patentable topic under Section 3(j) of the Patents Act 1970. The said provision bars from patentability “plants and creatures in entire or any part thereof other than miniature life forms i.e. micro-organisms yet including seeds, assortments and species and basically natural cycles for creation or engendering of plants and creatures”. The Court was of view that the result of Monsanto was all the more appropriately secured under the Protection of Plant Variety and Farmers’ Rights Act, 2001 (PPVFR). The two parties consequently, appealed to the Supreme Court.

The essential issue consequently was whether NAS turns into “a particle of the plant or seed” after inclusion? Following which the issue whether there was patent infringement would be resolved, further contribution to the interpretation of section 3(j) while also determining whether the Division Bench was correct in holding that the invention belongs to a plant variety?

Claims of both the parties with respect to patentability of micro-organisms

Monsanto’s claim was that NAS is a miniature living being, a micro organism and hence can be granted a patent under the patents Act. It contended further that the patent so contested was for NAS and not for the plant. It was undoubtedly a novel i.e. not foreseen by use, distribution or publication, inventive i.e. non-obvious product to an individual skilled in that particular workmanship and was indeed fit for its utility or industrial application. Since NAS wasn’t found naturally, it was a creation of human intervention and not by a basic organic cycle.

The defendant on the other hand asserted that NAS all alone was not fit for its utility in industrial application. It was simply after inclusion into the plant seed that it delivered the ideal outcome. It was further contended that whenever Nucleotide Acid Sequencewas presented, it turned into an essential seed particle and currently there is no innovation which could then seclude it from within the seed. Additionally, the gene likewise got transmitted within the descendants of the plant, it comprised a fundamental organic cycle. It likewise presented that since NAS couldn’t form its duplicate all alone by reproduction, it was just a synthetic creation via some chemicals and not a micro organism. In this manner, it was beyond the domain of patent security on account of Section 3 (j) of thepatents act, 1970.

Novelty, inventiveness, and utility or industrial application are the three essential requirements for any invention to be considered patent eligible[3]. The doctrine of anticipation is the main test of novelty. For the non-obviousness of the inventive step, we have to rely on the expertise of a person skilled in the art. It is a qualitative step. While this is usually easy to establish for mechanical inventions, in the case of innovations in biology, they are subject to interpretation and current understanding of living systems.

For this situation, the creation is the NAS and the objective of the innovation is its utilization in a plant cell. The property of the NAS is the thing that makes the plant deliver and confine the toxin protein in a particular area in the plant cell. Depending on the analysis by “Marker-Assisted Recurrent Backcrossing in Cultivar Development” by Guoyouet. al, it was concluded that a NAS gene once embedded into a plant, was removable and didn’t turn out to be important for the plant genome, to lose its patentable attributes. Hence, such invention does not fall under section 3(j) of the Patents Act, 1980. These were matters to be considered in the suit on premise of experts’ opinion. The protected NAS isn’t the result of any natural cycle.NAS was a man-made DNA development that didn’t exist in nature and didn’t in any case appear as an inherent portion of a plant existing in nature. The DNA build was embedded into a plant which presents the characteristic of insect resistance to the plant. It contains three unique parts. Firstly, a promoter, secondly, a gene for the production of Cry2Ab 5-endotoxin and thirdly, a component for the production of a transit peptide. Of these three, Cry2Ab 5-endotoxin is human-made gene. This NAS is then embedded into the cell of the plant at a specific area bringing about the creation of “a combination protein” which contains the Cry2Ab 5-endotoxin 7 reinforced with transit peptide. The creation of a combination protein is basic in this regard for the innovation to be affected in plants. The bacillus thuringiensis strain doesn’t deliver such a combination protein. It is the Plaintiffs’ technology that permits a cotton plant to deliver the Cry2Ab 8-endotoxin.

The Division Bench was wrong in holding that the invention belongs to a plant variety. Only the plant varieties and seeds are covered by the PPVFR Act. The Patent Act and the PPVFR Act are mutually exclusively.

The Supreme Court stated that it will not define ‘essentially biological product’ as stated in the paragraph 19[4] of the judgement. Section 64 of the Patent Act, 1970 allows revocation of the patent dependent on a counterclaim in a suit. It assumes a legitimate consideration of the case claims in the suit as well as the counterclaim as per the law and not summary adjudication. This provision is accessible as a safeguard against an infringement activity. The Civil Procedure Code gives an itemized method with respect to the way in which a suit filed under Section 9, including a counterclaim, must be thought of and settled. The apex court was contended with the facts and conditions of the case that the idea of the injunction granted by the Single Judge of Delhi High court was all together in order and merits no impedance while the suit is pending. The Supreme Court also added that the Division Bench ought to have limited itself to the assessment of the legitimacy of the injunction order so granted by the learned Single Judge. The Division Bench’s order was put aside by the apex court. The order by the Single Judge given on March 28th, 2017 was re-established and the suit was remanded to the Single Judge for dismissal as per the law. On 8th January 2019, the SC remanded the issue to the division bench holding that the Delhi HC wasn’t right in choosing the legitimacy of the patent simply based on prima facie assessment. It held that the topic of legitimacy of a patent is to be concerned with the fact and law in question and in this manner proof and an expert’s opinion is required.


The suit filed by the plaintiff was for injunction and not for testing the patentability of the NAS. But the case did bring with it a lot of details with respect to the patentability aspect and incorporated the defendant’s question which was more likely to create a deviation from the main question of patent infringement and payment of the required license fee. Any innovation that involves a biological system to be considered valid patentability, it needs to be established as an invention and not a discovery. In the United States, since the award of a patent for a modified microorganism in the Diamond v. Chakrabarty case (1980), it is accepted that “anything under the sun that is made by man” is eligible for patents, and that it is “living” is not significant. Pure products of nature would be a discovery but if human endeavour is able to impart a new form, new quality, or at least one new property to the original product existing in nature, it would be patentable. In patent law, it is important to rely on the legal fiction called “person skilled in the art”. As such person would be able to help the court in knowing whether there is disclosure and if such disclosure is enabling in nature. Hence, it can be seen that the Supreme Court did not decide on the patentability issue and instead considered it to be based on the expert’s opinion.

[1]AIR 2019 SC 559

[2]Trait fee/value is the amount paid by manufacturers to a company that holds the patent over a product for the use of their technology.

[3]Nambisan P, “Patenting of Life Forms” (science directJune 23, 2017)

[4]“we do not consider it necessary to deal with the same at this stage, and leave open all questions of facts and law to be urged for consideration in appropriate proceedings.”

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