Nuziveedu v. Monsanto – Patentability of Gene Sequences in India (Case Brief and Comments)
Citation: Nuziveedu Seeds Ltd. and Ors. Vs. Monsanto Technology LLC and Ors., MANU/DE/1388/2018.
Monsanto (Monsanto Technology LLC.) holds an Indian Patent (Patent No. 214436, hereinafter referred to as “BT Patent”) with respect to gene sequences and methods for inserting such gene sequences into plant cells to express Bacillus thuringiensis (BT) Delta-endotoxin to provide Bollworm resistance in plants. The final granted patent had two sets of claims: one set claiming the isolated, purified and modified gene sequences, and the second set claiming methods of inserting the gene sequences into plant cells. Claims with respect to transgenic plants, hybrid varieties and seeds that formed part of the patent application were rejected during prosecution by the Indian Patent Office.
Nuziveedu (Nuziveedu Seeds Ltd.), a licensee of Monsanto’s BT Patent, initially challenged the ‘trait fee’ charged by Monsanto, and later challenged the license validity based on claims of patent invalidity. Nuziveedu contended that Monsanto’s BT Patent is not valid because the subject matter of the invention falls within the scope of excluded inventions under Section 3(j) of the Patents Act.
Section 3(j) excludes plants and their parts, seeds and essential biological processes from the scope of patentable inventions. Microorganisms are expressly exempted from the scope of the exclusion. Section 3(j)) reads as follows:
“3. The following are not inventions:
(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”
BT Patent Claims
Independent claims of BT Patent read as follows:
“1. A method of producing a transgenic plant comprising incorporating into its genome a nucleic acid sequence comprising a plant functional promoter sequence 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 d- endotoxin protein, within said plastid transmit peptide functions to localize said d- endotoxin protein to a subcellular organelle or compartment.”
“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 d- 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 d- endotoxin protein, and wherein said fusion protein functions to localize said d- endotoxin protein to a subcellular organelle or compartment.”
Issue: Are gene sequences that form part of claims in the BT Patent excluded from patentability under Section 3(j)?
Holding: Yes, the gene sequences are inventions excluded from patentability under Section 3(j)) of the Patents Act.
Analysis and Comments
The Court started its analysis of patentability by constructing Section 3(j) of the Patents Act. It stated that the mechanism adopted by Parliament was to spell out what was not patentable i.e., plants, seeds, plant varieties, – whole or part and then exclude micro-organisms, but clarify that the exclusion would not apply to “seeds, varieties and species and essentially biological processes for production or propagation of plants and animals”.
In the Court’s words, “the expression ‘includes’ is used as a legislative device to enlarge the meaning of words or phrases “occurring in the body of the statute; and, when it is so used, these words or phrases must be construed as comprehending, not only such things as they signify according to their natural import, but also those things which the interpretation clause declares that they shall include (Ref. Dilworth v. Stamps Commissioners (1899) A.C. 99) which the Supreme Court of India consistently followed.”
Based on the aforestated, the Court looked at dictionary definitions to define the meaning of the term “microorganism” as the term was not defined in the Patents Act or any other related statute. Citing meanings from Cambridge, Oxford and Black’s Law dictionaries, the Court stated that gene sequences in the BT Patent are not microorganisms because they have no existence of their own, and that they are useful only after their introgression at a particular place, and because seed materials must undergo hybridization to suit local conditions. While arriving at the conclusion, the Court did not explain how the aforestated reasons excluded gene sequences that are present in Bacillus thuringiensis, a microorganism, from the scope of patentability, and how the meaning in dictionaries was relevant for this analysis. Neither did the Court feel the need to elaborate why parts of microorganisms are not patentable while microorganisms are patentable. Instead, it went on to point out that Monsanto failed to deposit the biological material and that it did not disclose the source and geographical origin of the material, which is not only irrelevant with respect to the subject matter of the invention, and is also not required if the invention can be described without the deposit.
Inexplicably, the Court then went on to elaborate the meaning of the phrase “essentially biological process” in Section 3(j) by citing the European Patent Convention, EU Directive, and several European decisions to conclude the well known fact that creating hybrid plants through breeding amounts to an essentially biological process despite the human intervention. It discounted and did not address the fact that introducing a gene through genetic engineering through human intervention makes the process not essentially biological. The Court then went on to conclude that transgenic plants are not patentable in India, and therefore, gene sequences that form part of transgenic plants are also not patentable because the gene sequences can be propagated through breeding, which is an essentially biological process. The reasoning may make some sense from the infringement perspective, but the relevance of patentability of transgenic plants and the process of breeding for determining gene sequence patentability is legally and scientifically absurd because they are independent, unconnected subjects for purposes of patent analysis.
Thereafter, the Court went on to point out that gene sequences are inert and inanimate, and that they are relevant only as parts of seeds and plants. Once a gene sequence is introduced into seeds and/or plants, what follows is an essentially biological process, which, according to the Court, makes the gene sequences and processes of introducing them unpatentable under Section 3(j). In other words, the Court stated that because plants, seeds and breeding processes are not patentable, gene sequences and processes related to them are also not patentable. Here, the Court has wrongfully combined different inventions to analyze patentability of one based on patentability of another.
A student of patent law learns in his first class that he/she must first identify all inventions in a given inventive concept, and then he/she must analyze each of them independently for assessing patentability. Patentability of one invention will not have bearing on the other. In this case, there are several inventions under the inventive concept: BT gene sequences coding for pest resistance, process of inserting the gene sequences, transgenic plant cell, transgenic seeds, transgenic plants, and transgenic hybrids. Only claims with respect to gene sequences and processes have finally been allowed by the Indian Patent Office and only they must be analyzed for invalidity. Other claims have been rejected based primarily on Section 3(j) and grounds of their rejection cannot form grounds for invalidating the claims in question.
Contrary to reason, the Court finally concluded that gene sequences are not patentable because plant variety protection and patent protection are mutually exclusive and not complementary. By that logic, gene sequences must be patentable because plant variety protection statute does not protect gene sequences. the Court then went ahead and gave an opportunity to Monsanto to acquire plant variety protection if it so desires by claiming the priority of the patent filing. Leaving aside the question of whether the Court can grant such a permission, there may not be any term left for plant variety protection to subsist from the patent priority date unless the Court wishes to grant protection from the plant variety filing date.
Overall, the Judgment of the Court falls short on various counts and will hopefully be set aside by the Supreme Court.
An analytical post from BananaIP’s attorneys will follow this case brief.
The author wishes to thank Arjun Kansal for his assistance.
Image source / attribution – Public domain