Earlier this month a counter claim for patent and trademark infringement was filed by Monsanto at Delhi high court against another seed company, Amar Biotech. With this suit 27% of the Indian seed market has been brought under threat of injunction. Monsanto had also invoked arbitration on proceedings against four other companies. Companies are not only one fighting it out with Monsanto, a group of farmers in Maharashtra have asked the Bombay high court to declare that their traditional plant breeding activities and the consequent exchange and sale of Bt cotton seed do not infringe on any patent rights of Monsanto.
With two-third of Indian cotton seed industry as well as farmers questioning the alleged patent right of Monsanto , it is useful to examine the patent issue involved a little more closely.At the center of the entire controversy is claim 25 of Indian patent no. 214436 which reads as follows:
Claim 25: A nucleic acid sequence comprising a promoter operably linked to a first polynucleotide sequence encoding a plastid transit peptide, which is linked in frame to a second polynucleotide sequence encoding a Cry2Ab Bacillus thuringiensis δ-endotoxin protein, wherein expression of said nucleic acid sequence by a plant cell produces a fusion protein comprising an amino-terminal plastid transit peptide covalently linked to said δ-endotoxin protein, and wherein said fusion protein functions to localize said δ-endotoxin protein to a subcellular organelle or compartment.
Most significant issue in patent application: claim 25
The most significant issue in the patent litigation involves determining the true construction of a patent specification and particularly its claim. Claim 25 of Indian patent no. 214436 deals with not merely a nucleic acid sequence, but rather a nucleic acid sequence having a certain effect in a plant cell. This is clarified by the use of the term ‘wherein’ in the claim language. US courts brielfly engaged with the question of whether the ‘wherein’ clause merely states an inherent result, and not a limitation.
In the present claim, it would appear that the correct and true scope of claim 25 is ‘a plant cell’ in which the nucleic acid sequence is to deliver its intended purpose. However, plants, parts of plants, seeds, plant varieties all stand excluded from patent protection by virtue of section 3(j) of the Indian Patent Act, 1970. Thus, if the above interpretation were to be adopted, then the claim would necessarily fail under Section 3(j). Though Monsanto have argued that the true scope of claim 25 is not a plant cell but the nucleic acid sequence, which in turn is not excluded fron plant protection in India. More problematically, it has further contended that any seed produced anywhere in India by seed companies or farmers that has such a nucleic acid sequence would infringe its patent.
There is some difficulty in accepting the argument; by accepting the claim for nucleic acid it would be undermining the requirement of plant variety completely.
True scope and determination of patent
In order to determine the true scope and extent of patents and in particular claim 25, it is necessary to examine the claims of patent application, including the claims that were rejected.
A total of 59 claims were applied for by Monsanto in Indian patent no. 214436. Almost all of these claims were rejected outright by the IPO, and subsequently deleted by Monsanto. These included the following:
- claims 1 to 7 and 10 to 40, which were directed to a plant comprising the said nucleic acid sequence;
- claims 8, 9 and 53, which were directed towards a plant tissue, such as a seed containing the nucleic acid sequence;
- Claims 48 to 52 and 54 to 56, which were directed to a plant cell containing the nucleic acid sequence;
- Claims 41 to 43, which were directed to a conventional breeding method of producing a transgenic plant involving a step of crossing two plants.
A fundamental principle of patent law is the extent and scope of claims granted in a patent must be understood in the light of claim. Although claim 25, was not rejected by IPO, it has been challenged by various parties on grounds that it relates to other claims, that were already rejected. Monsanto is effectively claiming and seeking to enforce patent right on claims that have been rejected by IPO, and withdrawn by them without any demur. In fact, the entire case of Monsanto is based on the claims drawn by them before IPO that are contrary to Indian patent law.
The applicability of plant protection varieties and farmers act, 2001, arguably the more appropriate legislation for this subject matter, is also going to be determined through these cases. The interpretation that the court finally arrive on the patent matter, is also going to be determined through these cases.