Analysis on the Judgement

The order of the Division Bench to invalidate the patent under Section 3(j) is not convincing in our view. The court appears to
have arrived at the judgement without adequate claim construction and expert witness. The claim construction is the
primary requirement in deciding the validity of a patent, which in the present case, appears to have been inadequate. The
misinterpretation of Section 3(j) to invalidate the patent is a major setback to innovation in the field of plant biotechnology.
According to Section 3(j), following inventions are not patentable:
“(j) plants and animals in whole or any part thereof other than micro organisms but including seeds, varieties and
species and essentially biological processes for production or propagation of plants and animals”
According to Section 3(j), plants and animals per se or any part thereof are not patentable. Moreover, ‘essentially biological
processes’ to produce plants and animals are also not patentable. Though the definition of ‘essentially biological processes’
was not defined in the Patents Act, Rule 26(5) of the EPC states that “a process for the production of plants or animals is
essentially biological if it consists entirely of natural phenomenon such as crossing or selection”.
In the present case, the court made an observation that:
“The conclusion that the court draws therefore, is that transgenic plants with the integrated Bt. Trait, produced by
hybridization (that qualifies as an “essentially biological process” as concluded above) are excluded from
patentability within the purview of section 3(j), and Monsanto cannot assert patent rights over the gene that has thus
been integrated into the generations of transgenic plants.”
It is to be observed that, Monsanto got a patent for the introgression of specific Bt. bacteria genes into the cotton
genome with human intervention. This cannot be considered as an essentially biological processes. So, the court’s
observations in considering the claims of the Monsanto’s patent as essentially biological processes appears to be
inappropriate.
Monsanto had alleged infringement of Claim 25 of the patent; claim 25 is recited below:
“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 8-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 5- endotoxin protein, and
wherein said fusion protein functions to localize said 5-endotoxin protein to a subcellular organelle or compartment.”
The claim deals with the extraction of a specific nucleic acid sequence from Bacillus thuringiensis (Bt bacterium) and
inserted into a plant cell. The modified nucleic acid sequence produces toxins that are resistant to boll-worm attacks.
Better claim construction and expert witness would have helped the court to prevent the misinterpretation of Section 3(j).
Monsanto has appealed before the Supreme Court and challenged the decision of Division Bench. We wish the apex court
pronounces a judgement with reasoning, such that companies can continue to innovate and seek protection within the
framework of the Patents Act and international obligations, which India has agreed to by way of TRIPS, and the like.