A worker picks cotton on a farm during a harvest in India. (Photographer: Prashanth Vishwanathan/Bloomberg)

Monsanto Case Judge Must Test These Five Legal And Three Policy Questions 

BloombergQuintOpinion

Recently, the Supreme Court remanded a case originally filed by Monsanto against Nuziveedu Seeds. It sent the case back to the trial court on the grounds that the Division Bench of the Delhi High Court exceeded its scope on appeal and added that the patent invalidity question should be considered on remand. This article is a discussion of the big questions that the case gives rise to.

Patent Validity Question

The most impactful broad question relates to an Indian patent owned by Monsanto entitled “Process for transforming plants to express Bacillus Thuringiensis deltaendotoxin”. Nuziveedu’s assertion is that Section 3(j) of the Patents Act, 1970, excludes patent protection for plants and plant varieties and hence, Monsanto’s patent is invalid. Indeed, Section 3(j) excludes protection for “plants and animals in whole, or any part, thereof, other than microorganisms, but including seeds, varieties and species and essentially biological processes for production or propagation of plants and animals.”

Monsanto agrees that Section 3(j) does not provide patent protection for plants. Instead, Monsanto asserts that its patent does not claim a plant or plant variety but that the claim is towards a process for the introduction of a nucleic acid sequence (NAS) into the plant genome.

That is, Monsanto has claimed that the patent is a biotechnological process containing the introduction of Bt gene into the cotton plant genome.

Cotton plants grow in a Monsanto facility in Missouri, U.S. (Photographer: Daniel Acker/Bloomberg)
Cotton plants grow in a Monsanto facility in Missouri, U.S. (Photographer: Daniel Acker/Bloomberg)

First, patent protection is statutorily given to what is claimed. In this case, the analysis of the claims, as seen below, show that Monsanto has claimed the plant and not just the process of introducing the NAS. Claims 22 to 24 of Monsanto’s patent as published in the Indian patent office states the following:

22. The method of claim 1 or 2, wherein said plant is a dicotyledonous plant.

And, claim 1 states the following:

1. A method for producing a transgenic plant comprising incorporating into its genome a nucleic acid sequence.

Reading the above, it is clear that Monsanto’s method patent covers the transgenic plant. In other words, if a competitor were to figure out a different method of introducing the NAS into the cotton plant, Monsanto will still claim infringement of the patent. Further, the genome becomes a part of the seed. Protection for seeds is also categorically excluded under Section 3(j). Additionally, Monsanto’s title for the patent is for a “Method of Transforming Plants” and there is no express exclusion for the plants in the published document.

Monsanto’s argument is that the patent is limited to the method of introducing the genetic sequence into a plant genome, and not on the final plant.

If that is the case, Monsanto should not be preventing farmers from using seeds from the transgenic plant.

Thus, Monsanto’s patent covers the transgenic plant.

Second, the question in India has related to Bt cotton. But, if the patent is considered valid, Monsanto has claimed rights over not just cotton, but the entire group of plants/seeds being , soybean, tomato, potato, citrus, tobacco, canola, and strawberry provided it is created by using the method of introducing the NAS genes into the plant genome as seen below.

Claim 23 of the Monsanto patent states the following:

23. The method of claim 22, wherein the plant is a dicotyledonous plant selected from the group consisting of cotton, soybean, tomato, potato, citrus, tobacco, canola, and strawberry.

Third, Monsanto has claimed that the patent should be valid because the genetic method claimed by Monsanto is man-made and does not exist in nature. In dealing with the question, the Supreme Court also noted that “Claims 1-24 are not excluded under Section 3(j) being essentially biological processes as there exists significant human intervention.”

There is nothing in the statute to state that human genetic intervention in plants makes it anything else other on a plant nor, does it take it away from the purview of Section 3(j) exclusion.

Plus, the invention is not for the method of introducing NAS but for a method to produce a transgenic plant by introducing the NAS, and hence, the patent falls within the ambit of the exclusion under Section 3(j).

Fourth, Monsanto has also argued that because the NAS can be removed from the plant, the NAS alone and not the plant should be considered as the patented invention. It is true that the human intervention of introducing the NAS may be per se patentable. But, that question has no bearing here since the patent is clearly for a “transgenic plant.”

In any case, if the pest resistance trait introduced from the NAS can be automatically replicated without change into the seeds of the next generation, it is arguable that the process is biological.

Note that Section 3(j) also excludes essentially biological processes. Further, if the patent is only for the method, then, it will be difficult for Monsanto to justify the licenses over the seeds from the Bt plant as valid. As a biological by-product, the seeds will not cover any intellectual property protected technology.

But, considering that Monsanto defines its patent as a “transgenic plant,” human intervention notwithstanding, it is arguable that the material is statutorily barred as being unpatentable under Section 3(j).

Fifth, considering that the patent covers a transgenic plant, it implicates the Protection of Plant Varieties and Farmer’s Rights Act (PPVFRA). The preamble of the PPVFRA states that the enactment seeks to “encourage the development of new varieties of plants.”

In saying this, PPVFRA does not exclude genetically modified plant. Section 2(za) defines a "variety" as “a plant grouping except microorganism within a single botanical tax on of the lowest known rank.”

Contrary to what Monsanto claims, Section 2(za) of the PPVFRA does not help its case.

Indeed, it does not say that plants with genetically modified nucleic acids are not a variety. Thus, Section 2(za) does implicate Monsanto’s product as a plant variety.

Boxes of Monsanto’s products at a manufacturing and packaging facility. (Photographer: Jasper Juinen/Bloomberg)
Boxes of Monsanto’s products at a manufacturing and packaging facility. (Photographer: Jasper Juinen/Bloomberg)

The Trade And TRIPS Questions

India should carefully consider the implications for the following reasons:

  • India’s position on plant protection is supported by Article 27.3 of the TRIPS Agreement.

TRIPS provides member countries the flexibility to protect plant variety either by patents or by a sui generis method or, by a combination thereof. There is no need to provide more protection such as utility patents which goes beyond the sui generis protection outlined in PPVFRA.

  • Monsanto’s utility patent is exactly the kind that India initially sought to exclude under Section 3(j).

If Monsanto’s application is considered patentable under the Patents Act, then, then the judgment will essentially create a loophole to circumvent Section 3(j) by allowing claims that assert the insertion of any chemical or DNA into plants, to get indirect patent protection for plants which is currently statutorily barred in India.

  • If Monsanto’s patent is considered valid, plant-based innovation will start benefitting from two different types of protections in India.

That is, such transgenic plants may get utility patent protection under the Patents Act as well as plant variety protection under the PPVFRA, which is a different protection regime altogether. Facilitating two layers of protection implies larger agricultural policy considerations for India and deserves careful consideration.

For instance, in the United States, in the 1930s the Plant Patent Act protected asexually reproducible plants. In 2000, the Plant Variety Protection Act (PVPA) introduced sui generis protection for sexually reproducible plant varieties. In 2001, the US Supreme Court specifically allowed utility patent protection and held that patent protection can exist in addition to plant patents (for asexually reproducible plants) and the sui generis form of PVPA certificate. The over-lapping protection regime resulted in many plant innovations being protected simultaneously by utility patents, plant patents or PVP certificate.

It resulted in a huge shift, causing the privatisation of agriculture which, in turn, resulted in what Professor Kieth Aoki then termed as the “Seed Wars.”

That era significantly shifted research from the public to the private sector.

At the time of the WTO negotiations, developing countries such as India wanted to prevent over-lapping protection systems. That is the main reason for India’s initial resistance to utility patent protection for plants during the WTO negotiations, preferring instead to adopt a sui generis form of protection. Awarding utility patent protection for plants, in general, would now create a two-tiered system in India wherein a company can hold a utility patent on a “genome” and then benefit from a separate layer of protection under the PPVFRA, where applicable.

The disadvantage to such layered protection is that where the PPVFRA fails, the utility patents can be asserted and vice-versa. Companies can also stagger the patent and PPVFRA protection to extend the period of overall protection beyond 20 years, in a manner comparable to ever-greening in the case of pharmaceuticals.

It is up to the learned single judge of the Delhi High Court to make or break the market for India’s farmers in a country that already sees a high rate of suicide by its farmers on account of changes from the trade regime. But, this dispute also takes India into the next generation of complexities of patents and its intersection with trade.

Srividhya Ragavan is an expert in intellectual property and trade laws and a Professor of Law at Texas A&M University School of Law.

The views expressed here are those of the author and do not necessarily represent the views of BloombergQuint or its editorial team.