Media headlines, especially from business media houses and American media, continue to scream that Monsanto has had a “patent victory” in the Supreme Court of India

Media headlines, especially from business media houses and American media, continue to scream that Monsanto has had a “patent victory” in the Supreme Court of India which will in turn boost biotech investment in India. The news stories claim that Monsanto won a patent-related legal battle and that the Court ruled that Monsanto can claim patents on its GM cotton seeds. This is even after five full days after the judgement has been uploaded onto the Court’s website.

Supreme Court overturns Delhi HC judgement of April 2018, but does not pronounce its own stand on Monsanto’s patent:

Yes, it is true that the Supreme Court on 08/01/2019 overturned an earlier ruling in the Delhi High Court by a Division Bench on 11.04.2018 wherein Justice S Ravindra Bhat and Justice Yogesh Khanna of the Delhi HC recorded one of their conclusions thus – “the subject patent falls within the exclusion spelt out by Section 3 (j) of the Patents Act; the subject patent and the claims covered by it are consequently held to be unpatentable”, speaking about Monsanto’s Patent No. 214436, pertaining to the (Bt Cry2Ab) genetic sequence which is the basis of its Bollgard II Bt cotton business. The Division Bench incidentally upheld the Single Judge’s directions to Monsanto to continue with its obligations which caused Monsanto to appeal against the March 2017 single judge’s orders in the first instance.

To the extent that the Supreme Court overturned the Division Bench judgement which pronounced the patent and its claims unpatentable, the patent of Monsanto can be assumed to be restored. However, it is not correct to say that Supreme Court’s Justices Rohintan Fali Nariman and Navin Sinha pronounced that Monsanto can claim patents on its GM cotton seeds.

Supreme Court points to lacunae in Division Bench’s pronouncement on patentability of a genetic sequence, and asks parties to get the original suit heard by the single judge bench of Delhi HC:

The SC judgement said the following in fact about the Division Bench judgement: “Summary adjudication of a technically complex suit requiring expert evidence also, at the stage of injunction in the manner done, was certainly neither desirable or permissible in the law. The suit involved complicated mixed questions of law and facts with regard to patentability and exclusion of patent which could be examined in the suit on basis of evidence…. There is no gain saying that the issues raised were complicated requiring technological and expert evidence with regard to issues of chemical process, biochemical, biotechnical and micro biological processes and more importantly, whether the nucleic acid sequence trait once inserted could be removed from that variety or not, and whether the patented DNA sequence was a plant or a part of a plant etc., are again all matters which were required to be considered at the final hearing of the suit…. The Division Bench ought to have confined itself to the examination of the validity of the order of injunction granted by the Single Judge….The order of the Division Bench is set aside. The order of the Single Judge dated 28.03.2017 is restored and the suit is remanded to the learned Single Judge for disposal in accordance with law”. Therefore, the Supreme Court merely ordered that the dispute(s) be taken back to the Single Judge bench of the Delhi High Court, while showcasing what it pronounced as procedural/legal lapses by the Division Bench. By no stretch of imagination can it be claimed that the Supreme Court has pronounced its stand on the validity of Monsanto’s patent and even upheld it.

Long standing dispute between Monsanto and Nuziveedu:

The dispute between Monsanto and Nuziveedu goes back a long way. To around 2003 in fact, when Nuziveedu had to face India’s de-facto patent regime in the form of its biosafety regulatory regime under the Ministry of Environment & Forests, which compelled Nuziveedu to get into sub-licensing agreements with Monsanto (Monsanto Mahyco Biotech), to be able to use the Bt technology in its cotton hybrids. That was for Bollgard I technology or Cry1Ac gene which did not even have a patent in India. Trouble has been brewing since then.

The original disputes that brought the parties to the Delhi High Court in 2016 pertained to the fact that Monsanto contends that Nuziveedu is still to pay its dues with regard to trait/license fees, while Nuziveedu contends that Monsanto has illegally terminated their sub-license agreement on 14.11.2015 in an unjustified manner and that it is not bound to pay anything more than the trait value fixed by states and centre. There was also the matter of whether trademarks of Bollgard can be used or not, or even the use of abbreviations like “BGII” by Nuziveedu which denies any infringement.

Single Judge Bench did not delve into the patentability matters:

On 28.03.2017, a Single Judge Bench of Delhi High Court, while adjudicating on an application for injunction, did not actually decide on the patentability question and kept it for examination until after the pleadings were complete. Judge R.K. Gauba only ordered that during the pendency of the suit, the parties shall remain bound by their respective obligations under the sub-license agreement that the parties got into. Monsanto et al preferred an appeal against the injunctive relief provided by the single judge bench.

The Supreme Court now pointed out that even though the single judge bench did not deal with, or consider the counter claim of Nuziveedu Seeds (defendants) with regard to the patentability, the Division Bench’s judgement that the Patent of Monsanto was subject to patent exclusion under Section 3(j) of Indian Patents Act and thereby invalidating the patent, in effect made the defendants counter claim succeed.

Is this merely a mercantile matter as being debated in India’s Courts?

The issue of patentability of nucleic acid sequences came up in the context of whether there is an patent infringement by Nuziveedu.

The entire dispute and legal debate between the two (groups of) parties make it look as though it is a matter of mercantile laws whereas the core of the issue affects farmers and their livelihoods. Going by an affidavit filed by the Union of India in a related case in the Delhi High Court, wherein they state that farm suicides were caused by Bt cotton, high seed prices and losses incurred by farmers, it is a matter of life and death for farmers! At the end of the day, the disputed royalties, license and trait fees etc., are all being shelled out by farmers of this country and not coming from the pockets of Monsanto or Nuziveedu. In the USA and Canada, it is well known that Monsanto had sued, fined and jailed farmers in the name of patent infringement. The recent Supreme Court judgement records Monsanto’s counsel submitting in the Court that the plaintiffs (Monsanto et al) have no intention to sue any Indian farmer for violation of patent. That Monsanto cannot and will not is obvious, without a riot breaking out on the streets of India.

But that is not the only black and white way to look at patents on ostensible “nucleic acid sequences which are chemical compounds” as though they have no bearing on seeds, seed monopolies and exorbitantly high prices of such seeds, which have a direct bearing on farmers’ net returns and livelihoods. Elsewhere, it is well documented that farmers have limited choices with regard to seeds and planting material due to patent enforcement and resulting monopolies. In the end, seed companies benefit enormously at the expense of farmers – it is reported that Monsanto would have realised trait value of around US$ 240 millions between 2010-2015 and it is obvious that this came from poor Indian farmers’ pockets. It would therefore be useful for Indian courts to keep this in mind and not look at it as a mere mercantile matter.

Is the genetic sequence patented under Patent No. 214436 merely a chemical compound?

Patent No. 214436 vis-à-vis the Indian Patents Act…

A look at the entire patent filing episode by Monsanto shows very clearly that the claims were manipulated opportunistically between process and product claims, so that it somehow fits into the Indian patent laws prevalent at a particular point of time.

While looking at Monsanto’s claim that its Patent No. 214436 is essentially about a “nucleic acid sequence” which is a chemical created in a laboratory, the Court has to remember that if that is the case, this chemical compound would be regulated within the pesticides regulatory regime in India, not the GMOs regime. It is after all this genetic sequence which makes ordinary cotton varieties into Bt cotton, which consequently get regulated as living organisms, under the EPA 1986 and not as a pesticide.

The nucleic acid sequence is indeed heritable when embedded into a plant cell, and heritability is a trait connected with a living organism. However, it is not capable of reproducing itself and therefore, is not a micro-organism which is specified as a patentable matter in the Indian law.

The Indian Patents Act had a sub-section (2) added under Section 5 in 2002, which gave an explanation for “chemical processes” allowing for patenting of chemical processes which was significantly deleted when the Parliament amended the Act in 2005. The legislative intent of the Indian Parliament is clear – it denied protection under Patents Act for such genes and genetic materials, and brought such seeds under the Protection of Plant Varieties and Farmers Rights Act of 2001, and is reflected also in the National Seeds Policy of 2002. This is consistent with India’s international stand too, which however the Indian Patent Office did not always uphold since it began granting several patents on genetic materials.

Claims with regard to the disputed patent show that it is both about a DNA sequence as well as its linking to other sequences (process) and placement in a plant cell (process). Claim 25 in this patent is not merely describing a product but is about a process for making a product of certain functions. The said nucleic acid sequence can be functional only after becoming a part of the plant cell.

Amongst the many parties that intervened and are on the defendants’ side in the case, the argument is that the patented product is an inherent, intrinsic and integral part of a plant as it exists at the sub-cellular level (and a part of a plant is excluded from patentability), and that the claim is not about a chemical sequence in a vial but about having a plant produce a high level of expression of an endotoxin protein etc.

Can there be a patent without fulfilling the “industrial application” criterion?

For any invention to be patented, an essential criterion to be fulfilled is that of industrial application. Monsanto’s NAS (nucleic acid sequence), described by it as a chemical product, is not capable of industrial application until it is first integrated into a plant cell where it can express itself through essentially biological processes of transcription, translation and replication; until it stabilises into the plant through repeated back-crossing processes which are also essentially biological processes and until the NAS is heritable to the next generation of seeds which are sold as F1 hybrids, which happens through essentially biological processes. There is no industrial application of a mere NAS by itself without essentially biological processes, which then make the NAS unpatentable under Indian law.

Precedence of citing public interest and revocation of patents exists

It is clear that there is no reason for grant of patents which have even an indirect bearing on plants, because the Indian law has explicitly kept them out of patentability. Giving patents on genes and nucleic acid sequences will have such an indirect bearing and should therefore not be allowed.

Incidentally, Sec. 66, which allows for revocation of a patent in public interest, has indeed been used in the past in the case of revocation of Indian Patent No. 168950 granted initially to Agracetus Inc. for a “method of producing transformed cotton cells by tissue culture”. The then ICAR DG argued that the patent was incontrovertibly detrimental to our farmers and our people at large, and the Law Ministry concurred. One of the grounds was on safety of such genetically engineered cotton. The revocation was not on technical grounds of process vs product or non patentable subject matter etc., but on the simple fact that certain patents are generally prejudicial to the public. The same approach should be applied to Monsanto’s disputed patent as well as all other such patents in India, and such patent grants be revoked.

Inventions that are prejudicial to public interest are not patentable

This approach is reinforced by Section 3(b) which also specifies ‘inventions not patentable’ – Sec. 3(b) states, “an invention the primary or intended use or commercial exploitation of which could be contrary to public order or morality or which causes serious prejudice to human, animal or plant life or health or to the environment”. Given the Government of India’s own admission in a court of law on the lack of efficacy of Monsanto’s proprietary technology (which is the patent subject matter), that farmers were being forced to commit suicides, and given that Bt cotton farmers (90-95% of India‟s Bt cotton is planted to this “event” of Monsanto) are incurring large scale losses due to uncontrollable pest attacks, this ‘invention’ is a fit case to be declared as “not patentable”.

REFUNDING THE COLLECTIONS MADE SO FAR TO INDIAN FARMERS

It is not just a revocation of the patent that is called for, but a refund of the amounts collected from Indian farmers as part of seed prices from the seed companies involved in the sub-licenses. The only way justice can be meted out to them is by getting the Appellants and Respondents in this case to collectively pay back what they have collected from our farmers, as fund to be returned to them.

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