The Intellectual Property Appellate Board (IPAB) on 5th July 2013, dismissed Monsanto Technology’s appeal regarding the invention titled, ‘A method of producing a transgenic plant with increased heat tolerance, salt tolerance, or drug tolerance’ thereby upholding the Controller’s decision to refuse the patent application.
Monsanto Technology LLC (‘Monsanto’) filed an application for a patent (2407/DELNP/2006) in India on 1st May 2006, deriving priority from an application dated, 29th September 2003, with 29th September 2004 being the PCT application filing date. The subject matter of the application related to a method for producing a transgenic plant comprising the steps of inserting a recombinant DNA molecule into the genome of plant cells that would render the plant tolerant to extreme environmental conditions such as excessive heat, salt and draught.
As the application progressed to prosecution, the patentability of the invention was objected to by the examiner. The examiner contended that the subject matter of the invention lacked an inventive step in view of the prior art documents: Willimsky Gerald et al "Characterization of cspB, a Bacillus subtilis...low temperatures", Journal of Bacteriology (D1), WO199009447 (D2) and US 5470971 (D3). It was further observed that as the structure and function of the cold shock protein, an essential feature of Monsanto’s invention, was known, its mere application in preparing a cold stress tolerant plant fell under the provisions of Section 2(1) (ja) and 3(d) of the Indian Patents Act, 1970. The examiner was of the opinion that the subject matter also fell under the reservations of Section 3(j) of the Indian Patents Act, 1970 as it claimed essential biological processes of regeneration and selection that included growing of a plant in specific stress conditions.
The subject matter of the application number 2407/DELNP/2006 was initially proposed to be guarded by a set of 20 claims that talked about a recombinant DNA molecule, a recombinant stress tolerant transgenic plant expressing a cold shock protein, a method of producing such a plant and a protein of said subject matter. The claims further included recombinant progeny, propagule, seed and the like. During prosecution, 3 more sets of claims were proposed, out of which the last one containing 5 claims spoke of a method for producing a transgenic plant comprising the steps of inserting an rDNA molecule encoding a cold shock protein into a plant cell, obtaining a transformed plant cell, regenerating plants and selecting plants with increased heat, salt or draught tolerance. Monsanto gave up on some of the initial claims such as rDNA, plant cell, progeny, plant, crop plant, propagule, seed, transgenic plant, isolated protein and a field crop. Monsanto also submitted post-filing data that demonstrated an increased tolerance of the transgenic plants to heat and drought as compared to the non-transgenic controls. The IPAB, like the Controller, based its decision on the following key aspects:
In response to the Controller’s contention regarding the lack of inventive step, the IPAB held that D1 and D2 held enough proof to indicate that the claimed method would work for plants and that a person of ordinary skill would find a reasonable degree of predictability in the idea of incorporating cold shock genes in a plant. The IPAB also took regard of D3 which stated that, better tolerance is expected in the results after undergoing recombination treatment. Therefore, the post-filing findings submitted by Monsanto were not considered sufficient for preventing the application from getting refused. The IPAB, thus, stated that as the structure and function of cold shock protein was already known in cited prior art and its use in a plant would be obvious to a person skilled in the art, the claims do not define any invention under section 2(1)(ja) of the Patents Act, 1970.
Monsanto submitted that the subject matter of the invention of their patent application was not ‘new use’ of known substance, as the subject matter related to ‘a method’ for preparation (transgenic plants with heat, salt and draught tolerance) and ‘a new product’ (the transgenic plants). However, the IPAB with the help of the matter contained in D2, established that use of the proteins employed in Monsanto’s invention is known for expressing cold shock proteins in E. coli, yeast cells and the like. Therefore, the use of the same proteins in plants qualifies under ‘new use’, even if it produces better results.
Claim 1 of Monsanto’s invention encompasses a method for the preparation of transgenic plants with heat, salt and draught tolerance. The IPAB contended that this method required significant human intervention and therefore, refuted the Controller’s objection of the subject matter falling under Section 3(j). However, the IPAB clarified that the involvement of significant human intervention would not make the subject matter patentable, as it lacks an inventive step.
Instead of going for patent protection, had Monsanto filed an application for registration under the Protection of Plant Varieties and Farmer’s Rights Act (PPVFR) 2001, the probability of getting protection for their invention would have increased significantly. Under the PPVFR, various plant varieties, after scrutiny, are given protection for a time period which lasts for about 15-18 years, depending on the type of the plant. The rights offered by this Act allow the breeders to prevent any other person from selling, importing, exporting or producing the breeder’s registered variety or a variety which is similar to such a registered variety thereby offering similar protection as the patent rights.
To conclude, varied legislations to protect different types of intellectual property are available to innovators today. Identifying the right legislation for protecting your IP is the key.