Monsanto’s Patent on Method of Producing Transgenic Plants refused by IPAB

9th July, 2013 - 11:48 am Categories: News & Updates Pharma/Biotech Patent Litigations 0 Comments

Monsanto’s Indian patent application 2407/DEL/NP/2006 on transgenic plants with heat/salt/draught tolerant plants is rejected by IPAB.  The subject patent application is directed to a method of producing a draught/stress/heat/salt/drug tolerant transgenic plants by inserting a recombinant DNA molecule that expresses a cold shock protein CspA or CspB. The subject patent application was rejected by the Controller of Patents on lack of inventive step under 2(1)(ja) in view of three prior art references and under section 3d.

The final set of amended claims contain four claims, the independent claim is as follows:

1.  A method of producing a transgenic plant comprising the steps of:

 (a) inserting into the genome of plant cells a recombinant DNA molecule comprising a DNA encoding a cold shock protein, wherein said DNA encoding said cold shock protein is operably linked to a promoter and operably linked to a 3′ transcription termination DNA polynucleotide;

(b) obtaining transformed plant cell containing said recombinant DNA;

(c) regenerating plants from said plant cells; and

(d) selecting a plant for increased heat tolerance, salt tolerance, or drought tolerance.

In the IPAB decision, it was held that the cited prior art discloses structure and function of cold shock protein CspA and CspB and thus would be obvious to a person skilled in the art to make transgenic plants using the same. Further, under section 3(d), it was held that the subject patent’s invention is just a new application of the already known cold shock protein in producing stress/draught/heat/salt tolerant transgenic plant.

It was held that it was already known in the prior art  to use cold shock protein for expression in E.coli, yeast cell, vertebrate cells, human cell Hela, Rat cell BLAB/c 3T3,NIH 3T3 and Rat embryo fiberblasts. It is also further disclosed in prior art: “additional vectors and sources ………….including …….yeast cloning vectors , plant vectors …………[page 23 and 24 ]”

It was thus held that there is sufficient suggestion in cited prior art documents that the method would work for plants with reasonable success, hence rendering the subject patent obvious.

“When the 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 which is heat or drought tolerance by inserting the recombinant DNA molecule in its genome.”

Similarly under section 3d objection, it was held that: “Mere use of admittedly known substance is not permitted under section 3(d).The argument of surprising result will not change the position as it will be still be a new use of known even if it produces better results.” It was already known to use CspA, CspB protein of the ‘cold shock domain’ for expression of cold shock protein in E.coli, yeast cell, vertebrate cells, human cell Hela, Rat cell BLAB/c 3T3,NIH 3T3 and Rat embryo fiberblasts. But it was not previously used to achieve that specific results in plants. The selection of specific proteins from ‘cold shock domain’ to achieve better result in plants contributes merely to a new use of such substance.

It was thus finally concluded that the subject patent claim is a new use of known cold shock protein for expression in plants to produce heat/salt/drought tolerant plants and is merely a discovery of new property of known substance and not an invention.

Implications

The refusal of grant of this Monsanto’s patent will definitely by applauded by farmers community throughout India as they will be free to develop and reproduce such draught/salt/heat tolerant plants without infringement of any third party’s patent on the same. Had this patent been granted, Monsanto would have controlled the production and sale of their patented climate resilient plants/seeds and kept the much higher prices causing much plight to the farmers in India. In calamities like the recent Uttarakhand floods, such salt tolerant crop varieties are needed in large amounts by the farmers of such areas who otherwise cannot produce crops because of sea salt deposition on their farms in such conditions. If this patent would have been granted, the farmers would have to buy such plants/seeds from Monsanto or undergo licensing agreements to use the patented method, which now they will be able to use and produce themselves freely.

Also, after this decision came out, Navdanya** publishes as below:

“We applaud the decision of the Patent Office and Appellate Board and will disseminate it world wide the so other countries can use it to protect farmers, biodiversity and seed sovereignty. We will also be ready to intervene in case Monsanto brings the case to the Supreme Court.”

On another hand, such decision will be condemned by such seed and plant innovators like Monsanto in the developed markets like US and EP, especially when this patent has been successfully granted in US and EP. According to them, refusal of patent protections diminishes motivation for further innovation and that the rewards for innovation should be paid so that more innovative products and processes keep arriving in the markets. For pharmaceutical inventions too India is already on the priority watch list of US for refusing/ revoking patents u/s 3d which have been successfully granted in other countries.

** Navdanya is a network of seed keepers and organic producers spread across 16 states in India. It has its 54 seed banks across the country and organic farm spread over an area of 20 acres in Uttranchal, north India.

About the Author: Ms. Meenakshi Khurana, Patent Attorney at Khurana & Khurana and can be reached at: Meenakshi@khuranaandkhurana.com

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