3(d)-ed by IPAB, Monsanto denied patent on method of producing climate-resistant plants

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On July 5, 2013, the IPAB upheld the decision of the Controller against grant of patent to Monsanto Inc. for a method of producing plants which can withstand harsh environmental conditions. Monsanto filed the application in India (2407/DELNP/2006) on May 1, 2006 (priority date of Sept. 29, 2003) for a ‘recombinant DNA molecule for enhancing stress tolerance in plants, recombinant plants and methods thereof’. As is evident from the title, the application initially claimed (a) recombinant DNA (rDNA) molecule encoding a specific cold shock protein (CSP) (b) steps for inserting the rDNA into plant cells and (c) transgenic plants expressing CSP. Later, Monsanto restricted the scope of the application to ‘a method of producing a transgenic plant with increased heat tolerance, salt tolerance, or drug tolerance’. The claims on proteins of the ‘cold shock domain’ responsible for the cold tolerant properties and the resultant stress resistant plants were excluded. 

Nonetheless, the Controller refused registration for lack of inventive step and that the subject matter is ineligible in terms of Sections 3(d) and 3(j). The IPAB concurred with the Controller’s findings on all counts except Section 3(j). 

Summary of the IPAB Order

Although, Monsanto’s claims were limited to the method of producing stress-resistant plants, the IPAB held that the true construct of the application seeks to cover the ‘use’ of cold shock protein for expression of heat, salt and drug tolerant traits. Since the cold tolerant properties of CSPs is known from the prior art, the Board concluded that the patent lacked the inventive step and was ineligible in terms of Section 3(d). Below is the gist of IPAB’s findings: 

(i) Lack of inventive step: The Controller held that the structure and function of cold shock protein responsible for climate resistant is a ‘known’ and hence rejected the claim as obvious. Monsanto argued that that the application of single bacterial gene (i.e. CSP) in developing climate resistant variety was unclear and results were ‘unpredictable’ at the time of the filing (i.e. prior art). Furthermore, the prior art suggested that environmental tolerance ‘is a quantitative trait under the control of many genes’ and hence the invention claimed ‘teaches away’ from the existing science.

The IPAB, however, refused Monsanto’s arguments relying on prior art which demonstrated reasonable degree of predictability in employing CSPs in developing stress-resistant varieties. The Board reaffirmed the Controller findings that: 

the claimed invention is related to production of transgenic plant by transformation with admittedly known cold shock protein. Claims do not define any invention under section 2(1)(ja) of the Patents Act, 1970 as structure and function of cold shock protein was already known in cited prior art and it is obvious to person skilled in plant to make transgenic plant.

(ii) Section 3(d): Monsanto argued that the invention does not claim any ‘new’ use of known substance (i.e. CSP) instead, it submitted that the invention relates to a ‘method’ of producing a ‘new product’ (i.e. stress resistant plants). Further, it adduced post filing data which demonstrate ‘superiority’ of transgenic plants produced using the claimed method vis-à-vis wild plants. 

The Board again rejected the arguments reiterating that the cold tolerant properties of CSPs are already known. The Board rightly concluded that the application in essence claims ‘new use’ of specific proteins from ‘cold shock domain’ for producing desired traits and therefore ineligible under Section 3(d). 

(iii) Section 3(j): Monsanto argued that the production of transgenic variety involves ‘substantial human intervention’ in inserting the rDNA molecule into the plant cell and transforming the cell into climate resistant plant. The Controller, however, rejected the claim on the ground that the invention relates to essential biological process of regeneration and selection and hence ineligible as per Section 3(j). The IPAB agreed with Monsanto’s submission that the plant cell is transformed as a result human intervention in the manner claimed in the application. To this extent, the Controller’s findings were set aside. 

Exaggerated political overtones

Expectedly, the decision attracted reactions from environmental activists who viewed the decision as an end to Monsanto’s monopoly on climate resistant varieties. Some were quick to draw parallels with the Novartis decision of the Supreme Court applauding the IPAB for ‘standing up to corporate greed and domination of the world food supply’. Dr. Vandana Shiva of Navadanya stated that ‘what the Novartis case is to Right to Health, the Monsanto case is to the Right to Food and Farmers Rights to Seed and Livelihoods’. These views in my opinion are a tad bit far-fetched and misleading. 

The IPAB decision on Section 3(d) relies on same reasons that found lack of inventive step. This again raises the issue of whether Section 3(d) is a patentability or patent-eligibility standard, a question which the Supreme Court dodged to provide a categorical answer in the Novartis decision. Be that as it maybe, the IPAB did not look into the patentability of genetically modified organisms (GMOs) that demonstrate improved climatic resistance. Hence, drawing huge conclusions on India's patent regime based on the decision with little clarity on Section 3(d) is far-fetched. Therefore, Monsanto could still obtain a patent on such plant varieties.

Furthermore, the Protection of Plant Varieties and Farmers’ Rights Act, 2001 (PPV&FR Act) could offer an alternative to patent protection in this regard. The legislation provides for a sui generis model of protection for ‘extant’ varieties among others. Unlike new and farmer varieties, protection of extant verities need not fulfill the criteria of ‘novelty’ [Sec. 15(1)]. Under the Act, the right holder obtains exclusivity to sell, market, distribute, import and export the registered variety for a limited period.

[Jul. 31, 2013: An error in the earlier draft has been corrected based on Mrinalini Kochupillai's comment. Relevant portion appears as struck-out]