Law

Backgrounder: The Laws Surrounding Monsanto’s Claim to the Bt Cotton Patent

How can a company own a patent over genetically modified seeds in the first place?

On January 8, the Supreme Court of India ruled that Monsanto’s patent over its Bt cotton seed technology was valid in the country and enforceable. The verdict reverses a Delhi high court judgment, which in May 2018 had ruled that the patent was unenforceable in India and that Nuziveedu and Seeds, an Indian company that had sold the specialised seeds, had not infringed on Monsanto’s patent.

How can a company own a patent over genetically modified seeds in the first place?

For an invention to be patentable in India, it must satisfy three conditions:

  1. Novelty
  2. Non-obviousness
  3. Utility

If it does, and a patent is granted, then the inventor has a monopoly right for a fixed period of time in exchange for public disclosure.

These principles extend to agriculture as well – with some exceptions. For one, the Patents Act of 1970 excludes any method of agriculture, and any process for the medicinal, surgical, curative, etc. treatment of human beings, any treatment to render life-forms free of disease, or to increase their economic value or that of their products.

Also read: Plant Breeder Rights on the Table, Farmers’ Rights for the Chair

However, the World Trade Organisation’s TRIPS Agreement required patents to be available for any invention, whether for products or processes, in all fields of technology. And to comply with TRIPS, which came into effect in 1995, India had to amend many of its patent laws.

This tension between what is and isn’t patentable defines the broadest remit of Monsanto versus the Indian seed companies.

The agricultural biotechnology – or agritech – industry in India has developed in leaps and bounds in the last decade or so. It uses techniques like genetic engineering, molecular markers and diagnostics, vaccines, etc. to modify plants, animals and microorganisms. A subset of this is crop biotechnology, which has been engaged in improving yield, pest resistance, drought resistance, etc.

The laws granting the patent-holder complete autonomy differ from one country to another, and several courts around the world hold different opinions on the subject. Some have ruled in the patent-holder’s favour while others have sided with the plant-breeders, such as Nuziveedu and its clients.

Now, Indian patent law prohibits patents on any plant and animals or any process through a genetically modified organism is ‘created’, as long as it was purely biological. The only notable exception was microorganisms. So Article 27.3 of the TRIPS Agreement allowed governments to exclude “essentially biological” objects and processes – but microorganisms, and microbiological and non-biological processes weren’t exempt from patents.

In Monsanto v. Nuziveedu, the Delhi high court overruled its own decision, in an earlier petition filed by the same parties, in May 2018. It said that section 3(j) of the Patents Act shall include within itself genetic modification and parts thereof as ‘non-patentable’ subject matter.

Monsanto had claimed patent rights over its identification of the Cry2Ab gene from the DNA of a naturally occurring bacterium, for synthesising the nucleic acid sequence by copying the gene into a plant cell, and for the method of inserting the nucleic acid sequence into the plant cell. This process yielded a cotton variety resistant to the bollworm pest (Helicoverpa armigera).

Nuziveedu, a Hyderabad-based seed company, had then challenged Monsanto’s patent. Why? Because when a nucleic acid sequence is introduced into any plant cell, the plant cell becomes unpatentable under the Indian law.

Where patenting plant varieties is concerned, India has thus far followed a sui generis model. This led to the Protection of Plant Varieties and Farmers’ Rights (PPVFR) Act, 2001, which promotes farmers’ interests. Specifically, it allows farmers to cross-breed genetically modified plants and so produce new varieties and increase the agricultural yield.

It is similar to Canada’s Plant Breeders Right Act, which provides a form of intellectual property right by which plant-breeders can protect their new varieties the way an inventor protects an invention with a patent.

The PPVFR Act also seeks to provide an effective system to protect plant varieties, the rights of farmers and plant-breeders and to encourage the creation of new varieties. In addition, the act also recognises farmers’ contributions to conserving and improving genetic resources for the development of new plant varieties.

Also read: Explainer – SC Will Not Stay High Court Order in Monsanto v. Nuziveedu Case

Within this framework, Nuziveedu contended that the Patents Act excludes the “mere discovery of a scientific principle, … the formulation of an abstract theory or discovery of any living thing or nonliving substance occurring in nature” from patentability. As a result, Monsanto’s patent would have to be unenforceable in India.

This seems straightforward. Breeding plants and introducing new traits in a variety is an essentially biological process, so Monsanto’s patent wouldn’t fly.

On January 8, the Supreme Court noted otherwise in a few operative sentences read out in court, which suggested that it was disputing the division bench’s order without commenting directly on the validity of Monsanto’s patent. At the time of writing this article, the text of its judgment hadn’t yet been uploaded to its website. Once it is, let’s hope it will throw some much-needed light – not just on this particular case but the many implications it will have for the future of India’s agritech sector.

Kumar Karan is currently pursuing his B.A. L.L.B. from Symbiosis Law School, Noida. Mehak Sachdeva is a final-year L.L.B. student at the Faculty of Law, University of Delhi.

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