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India’s IPAB rejects Monsanto patent on section 3(d) grounds

India’s Intellectual Property Appellate Board has rejected Monsanto’s application for a method of producing stress-resistant plants, finding that it lacked inventive step and failed to meet the requirements of section 3(d)

Monsanto filed a patent for a method for producing crops that are more resistant to stresses such as heat, salt and draught. After the patent controller rejected the initial application, Monsanto narrowed the application to five claims. One of the claims involved the insertion of DNA which would cause the production of CspA or CspB cold shock proteins, which are known to be more stress resistant.

Anand and Anand represented Monsanto before the IPAB, which rejected the application based on a lack of inventive step as embodied in section 2(1)(ja) of the Patents Act. It also found that the patent was barred by section 3(d).

“The IPAB noted that there were prior art for the expression of this gene to produce cold shock proteins in other kinds of cells, such as yeast and human cells,” explained Meenakshi Khurana of Khurana & Khurana. “The patent controller found, and the IPAB agreed, that it is obvious for a person skilled in the art to then try to introduce this gene into plants.”

The IPAB also looked into whether the patent satisfied the requirements of section 3(d), the provision unique to India’s Patents Act which prohibits the patenting of new uses of a known substance or the use of a known method unless the use of the method creates a new product.

Monsanto argued that the patent claims were not for use of a substance within the meaning of section 3(d), but rather for a method for producing a transgenic plant. It also argued that it complies with section 3(d) because it is a new method that also results in a new product, namely a plant with increased stress tolerance. In support of this argument, Monsanto submitted post-filing data demonstrating the increased stress tolerance over that of wild plants.

The IPAB rejected these arguments. It found that the prior art showed that these specific proteins had been used in other types of cells for increasing stress tolerance, and introducing them in plant cells constituted a new use of a known substance. It also found that any surprising and better results achieved would not satisfy section 3(d), as the patent is still a new use of a known substance.

A new application

India’s patent system has come under heavy criticism after the country granted its first compulsory licence last year as well a string of high-profile patent rejections. One particularly controversial issue is section 3(d), the grounds behind the rejection of Novartis’s Glivec patent. Section 3(d) prevents the patenting of different forms of a known substance unless the applicant can show greater therapeutic efficacy, which Novartis was unable to do before for Glivec.

Khurana pointed out that the application of section 3(d) in the Monsanto case is somewhat unique. “The intention behind section 3(d) was to deal with pharmaceuticals,” she explained. “The main purpose is to prevent evergreening of patents. As far as I know, this is the first time that section 3(d) has been applied to genetically modified crops.”

Despite the somewhat new application, Khurana says that she believes the interpretation of section 3(d) in the case was consistent with the context. Noting that Monsanto has already received patents in other jurisdictions for this technology, she pointed out that it confirms the one thing that both supporters and detractors of India’s patent system are likely to agree on.

“India’s patent system has been stricter than many others, including the US and Europe, in terms of determining what is patentable.”

Monsanto has not announced whether it will appeal the IPAB’s ruling to the Delhi High Court.

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