Gene Patents and Plant Varieties: NSAI v. Monsanto

In an earlier post, accessible here, I had explained the NSAI’s new IP strategy in the ongoing dispute with Monsanto. To briefly recap, the technology involved is Monsanto’s patent over a certain gene sequence of the Bt. bacteria as inserted into a cotton genome. The NSAI is arguing that while gene patents are recognised under the law, the same cannot be enforced under Indian patent law and that once the Bt. Trait is introduced into cotton genome, it will be dealt with under the PVPFRA – a sui generis legislation to promote and protect innovation in plant varieties and which has some liberal limitations and exceptions.

The point of this post is to examine NSAI’s position vis-à-vis gene patents. As explained in my earlier post, NSAI’s documents makes the following two points in the context of Section 3(j):

“While the biotechnologies required for developing GM traits are patentable under Indian Patent Act, after the transgene gets integrated in the genome and the GM traits express in a plant variety, such transgenic varieties are not patentable.”

At a later point the note also argues that under the Indian Patents Act, “there is no provision to collect a trait value by enforcing patent rights on seeds and plant varieties to recover the investment and efforts put in to develop a new GM trait and to obtain approvals under the Environment Protection Act (EPA) despite having a patent for technologies which have been used for developing the GM trait, as it becomes part of a plant variety”.

I’m not quite convinced with this explanation. Section 3(j) is a provision which prohibits patents for plants, animals, seeds or any part thereof. It is a provision which lays down an important threshold for patentable subject matter – it has no nexus with enforcement. Under Indian patent law once a patent is granted, Section 48 gives the patentee the power to restrain anybody from infringing the patent by making, selling or offering to sell the technology covered by the patent. There is no requirement, as argued by the NSAI, for a provision enabling the patentee to collect royalties once the seed contains the patented gene sequence.

A more viable line of argument for the NSAI, is to challenge the very scope of gene patents in the context of plants and seeds. As far as I’m aware this question has not been litigated before Indian courts and it’s a question well worth arguing. The simple line of argument that would follow is this – if Section 3(j) in effect prohibits the patenting of plants, seeds or any part thereof, should a patentee be allowed to seek a gene patent in conjunction with a certain plant genome? Would such a method of claiming in effect end up claiming a certain type of plant or seed?

It may help to reference Monsanto’s patent no. 232681, which I presume is for its second generation Bt. Cotton that is the subject of its patent infringement lawsuit against Nuziveedu. This patent claims priority from US Patent Appl. No. 60/297,406. The prosecution history for this patent is quite interesting. The set of claims as filed (accessible here – I’m assuming this since the Patent Office doesn’t indicate which claim set as filed and as granted) aped the American patent application despite India specifically prohibiting patents for plants. Claim No. 1 read as follows: “An insect resistant cotton plant, or parts thereof, seed of said cotton plant having been deposited with the American Type Culture Collection under accession number PTA-2516.”

Claim 2 is on similar lines: “2. An insect resistant cotton plant, or parts thereof, wherein DNA having at least one nucleotide sequence selected from the group of SEQ ID NO: 14, SEQ ID NO: 15, SEQ ID NO: 16, SEQ ID NO. 17 and SEQ ID. NO. 18 forms part of the plant’s genome.” The remaining claims are dependent on Claims 1 and Claim 2.

Predictably the Patent Office in its Examination Report (accessible here) objected to these claims. Objection No. 1 was “Claim 1 to 7 attracts 3(j) of the Patents Act, 1970”. This provision of the Patents Act prohibits the patenting of plants, animals, seeds etc. Monsanto then resubmitted a new set of claims. Claim 1 of which reads as follows:

“1. A synthetic DNA molecule, comprising at least fifteen nucleotides of SEQ ID No. 11 or SEQ ID No. 12, and overlapping the junctions of the Cry2Ab insertions in cotton event MON15985 or the junction of the Cry2Ab insertions and the genomic sequence in cotton event MON 15985, or the complement thereof, wherein said cotton event MON15985 occurs in the cotton seed having been deposited with the American Type Culture Collection under accession number PTA-2516”.

(Accessible here – I am presuming these are the final set of claims because the Patent Office website is never clear on which version is the final version.)

I’m not very familiar with either biotechnology or biotech patents but the claim above does seem to be stretching the use of conjunctions beyond the bounds of the English language. From what I can understand of the claim, it seeks to patent a gene sequence of Bt. bacteria – this is most likely permissible under the law because Section 3(j) of the Patent Act specifically excludes micro-organisms from the list of non-patentable subject matter in Section 3 of the Patents Act. Although, I presume one could still raise the issue of whether naturally occurring micro-organisms are patentable – American courts have looked at these issues in detail and it will be interesting to see how an Indian court looks at the issue. The more interesting question in my opinion, is the manner in which this patent claim is worded. Is Monsanto claiming a gene sequence or is it claiming the entire cotton seed which contains the modified gene sequence? Would this fall foul of Section 3(j) of the Patents Act and if so, what would be the correct format to claim gene sequences? Since these issues have never been litigated in India, we have no way of reasonably predicting the outcome of such litigation.

As far as I’m aware, Nuziveedu hasn’t raised these issues in the patent infringement lawsuit filed against it by Monsanto. While Nuziveedu has been a licensee of Monsanto, I’m quite sure that licensee estoppel doesn’t apply under Indian patent law and there is no bar against Nuziveedu raising these issues in the ongoing litigation.