As expected, the judgment of the Division Bench (DB) of the Delhi High Court in the Monsanto v. Nuziveedu litigation was admitted by the Supreme Court last week and the case is now slated for a hearing in July sometime. The bench of two judges hearing the matter refused to grant a stay on the operation of the DB’s judgment. While I don’t (yet) have access to the pleadings, I’m told that Monsanto’s legal team is now disputing the extent to which they waived their right to trial and are claiming that the High Court erred in assuming that they had waived their right to trial even on the issue of patent validity.
As I mentioned earlier, it seemed rather exceptional for Monsanto to waive its right to a trial in such a complicated case. The fact that they are contesting the judgment on this issue of waiver of trial clearly indicates some confusion before the Division Bench. Since Indian courts do not maintain verbatim transcripts or video recordings of the proceedings, Monsanto is going to be drawn into a ‘he-said, she said’ situation and judges tend to believe other judges. It is highly unlikely that the SC will set aside the decision on these grounds.
So how then is the appeal going to proceed before the Supreme Court?
Ideally an appeal of this nature should be confined to the appellate court examining whether there has been any abuse of discretion by the lower courts i.e. correcting errors made by the lower court if any. However, in high-profile cases like this, the Supreme Court very often ends up hearing the entire case de novo i.e. from scratch. This is what happened in the Glivec case – the Supreme Court’s judgment bears little semblance to the IPAB’s judgment.
If the court is going to hear the appeal de novo it will have a chance to finally lay down the law on some basic principles of patent law. The success of the court in this endeavour depends largely on its ability to cut through the clutter and zero into the core legal issues.
Claim construction – what is the subject matter of Claim 25 and is it hit by Section 3(j)?
The first and foremost issue, in my opinion, is the manner in which the patent claims are to be interpreted by the court. The patent claims are the most crucial aspect of any patent litigation because these claims identify the nature and scope of the invention being protected.
There are several techniques to interpret claims and the basic debate on claim interpretation is quite similar to the debate on statutory interpretation. Judges have a choice of sticking to a literal interpretation of the words contained in the claim or going for a purposive interpretation by looking at the history of the patent prosecution etc. etc. I suspect Indian judges will tilt towards the latter but whatever the conclusion the Supreme Court comes to it is important for the Court to lay down the substantive law on the issue. Common law depends on case by case evolution and this case can be an important milestone in how the Patent Office understands claim construction.
Other issues for the court to consider are whether claim interpretation is purely a question of law or fact and whether the parties are expected to lead evidence on the issue and whether a trial court should be conducting a separate claim construction hearing.
Based on the claim construction principles laid down by the Supreme Court, it will be interesting to see how it interprets Claim 25 of the disputed patent. The claim is as follow:
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.
In my opinion, the Division Bench of the High Court does a very poor job of interpreting this claim because it gives three different interpretations to the same patent claim.
At one point it states the invention is not a product or a process but for an “event”. In the court’s words, “in the opinion of the court…. what was granted was not a patent over the product, or even the method, but of identification of the “event” i.e. the place in the genetic sequence of the DNA where the CryAB2 protein, in the plant cell.”
At a later stage, the court states that “it is held that the subject matter, the concerned nucleotide sequence over which Monsanto has patent rights and the process is unpatentable by reason of Section 3(j) of the Patents Act”. Here the court appears to reach this conclusion on the grounds that Monsanto’s patent is for an “essentially biological process” which is specifically prohibited by Section 3(j).
Then while discussing the issue of overlaps between the Patents Act and the Plant Variety Protection & Farmers Right Act (PVPFRA) the court states that “a transgenic variety can be a “new variety” and, therefore registrable under Section 15(1) …..Therefore, there is not merit in Monsanto’s argument that its products cannot ipso facto be registered and secure protection under the PV Act”. So here, the Court characterises Monsanto’s invention as a plant variety which again is unpatentable under Section 3(j).
So, is Monsanto’s patent, for an “event”, “an essentially biological process” or a “plant variety”? The court appears to be saying that the invention is all three – that in my opinion is a category error and highlights the importance of claim construction because only when the nature of invention is correctly identified can the court go ahead and determine whether the said invention falls foul of the criteria in Section 3 of the Patents Act before assessing the patent on other factors such as inventiveness etc.
Each set of interpretations offered by the Division Bench has different implications. If the claim is interpreted to mean an “essentially biological process” (read Eashan Ghosh’s excellent post over here for the High Court’s understanding of “essentially biological”) or “microbiological process” (read my post here) or a “plant variety” then Monsanto will have a tough time swinging the case in its favour because it will be hit by Section 3(j).
If the invention is identified as selected genes of a micro-organism and the placement of said genes at a particular location in a plant genome then I don’t see Section 3(j) tripping the patent. The analysis then will have to shift to the question of whether the said invention was novel and inventive. To determine that question, the Supreme Court will have to remand the matter to the trial court to determine the evidence.
The challenge thus for the Supreme Court is to ensure that it does not err on the issue of claim construction.