In a well-reasoned judgment
issued recently, the Delhi High Court (“Court”) adjudicated upon a suit for patent infringement comprising three patents over insecticides and herbicides.
The three patents owned by the plaintiff relate to a herbicidal composition. The distinctive attribute of the composition developed by the plaintiff is this: it is an amalgam of 2 compounds each of which combats different kinds of weeds. More specifically, the composition consists of a compound called Metsulfuron, which controls grassy weeds and a compound called Sulfosulfuron which controls broad leaf weeds. As a result, the composition, according to the plaintiff, is the only one which effectively tackles grassy as well as broad leaf weeds together.
The composition is in the shape of wettable granules. Around 10% of the composition consists of Metsulfuron and around 70% consists of Sulfosulfuron. The gravamen of the Plaintiff’s case was that it found out from market sources and field executives that the defendant participated in a tender for the supply of a composition consisting of these two compounds roughly in the same proportion in which they are present in the plaintiff’s composition. This being the case, it sued for patent infringement.
Defendant’s arguments:
To repel the plaintiff’s contentions, the defendant advanced three main arguments.
First, the defendant argued that both compounds comprising the plaintiff’s composition have been well known for a considerable amount of time – metsulfuron methyl since 1986 and sulfosulfuron since the 90s. Many compositions consisting of these compounds have existed for a long time, so the plaintiff’s argument that it invented this composition is lacking in merit. In particular, the defendant relied on a paper published by one Dr. C. P. Singh, at the G.P. Pant College of Agriculture, who dealt with the consequences of a potential combination of these two compounds and patent US 301 which, the defendant argued, relates to a composition containing these two compounds.
Second, the defendant argued that there exist several pertinent differences between the plaintiff’s patent and the defendant’s composition. More specifically, it focused on how, in the defendant’s composition, a stabilizer and the absence of the use of tallow soap as defoamer are missing. Further, the quantity of wetting agents, dispersing agents and suspending agent are significantly higher in the defendant’s composition.
Third, in support of the second argument, the defendant referred to a finding of the Registration Committee of the Central Government Insecticides Board (“Committee”) to the effect that the registration obtained by the defendant for its composition was not covered by the plaintiff’s process patent. In light of the fact that all the three patents of the plaintiff revolve around the same process, the defendant argued, the clear finding that the plaintiff’s process and the defendant’s composition were dissimilar returned by the Committee firmly supported its stance.
Reasoning of Court:
The Court arrived at the conclusion that the defendant’s conduct constituted patent infringement. In the Court’s view, this conclusion was dictated by four key reasons.
First, the Court outlined five key similarities between the plaintiff’s patent and the defendant’s composition. These similarities were in the shape of such things as similar percentage of metsulfuron methyl and Sulfosulfuron in the composition; existence of silicon defoarmer in both compositions; and absence of fatty acid ester.
Second, the Court held that the parties were ad idem on the point that the only difference between their compositions was this: the defendant’s composition did not include a stabilizer which was present in the plaintiff’s composition. The mere existence of a stabilizer of 0.1 to 10% in the plaintiff’s composition, held the Court, was not a sufficient basis to distinguish the two compositions.
Third, none of the materials cited by the defendant as prior art, the Court held, envisaged the composition developed by the plaintiff. In explicating this point, the Court specifically relied on US 301 and a paper written by CP Singh.
As regards US 301, the Court held that it did not constitute prior art as that composition was not just confined to sulfosulfuron and metsulfuron but in fact included other compounds and the percentage in which sulfosulfuron and metsulfuron were present was different. As regards Dr. C.P. Singh’s paper, the Court held that Dr. Singh was of the view that a combination of sulfosulfuron and metsulfuron would not be effective and that the two must be used in a sequential fashion for maximum effect. This being the case, Dr. Singh’s conclusion was directly at odds with the plaintiff’s composition, thereby indicating that the paper did not envisage the plaintiff’s composition.
Finally, relying on the Kerala High Court’s judgment in the case of Shogun Organics Ltd., Vs. Union of India, the Court held that a finding of the Committee does not have any bearing on the validity of a patent. In support of its conclusion, the Court drew sustenance from the fact that a pre-grant opposition against the plaintiff’s patent had been dismissed, coupled with the fact that another dispute involving the plaintiff’s patents was settled in its favour.
Analysis:
On the whole, the judgment comes across as being tightly reasoned and founded upon a correct application of well settled legal principles to the factual matrix obtaining in the case at hand. Since the Court returns clear findings to the effect that the plaintiff’s invention was not covered by the prior art, coupled with the fact that the plaintiff’s and defendant’s compositions were almost identical, a ruling in the plaintiff’s favour flows as a natural consequence of these findings.
In his lucid analysis
of this judgment, Eashan Ghosh, a friend of this Blog, outlines what he views as the infirmities in the Court’s analysis. While I am of the view that the infirmities that he adverts to would not have impacted the outcome in any way, I think one criticism of the judgment which he voices merits deeper scrutiny.
Eashan argues that the Court could not have lightly brushed aside a finding from the Committee to the effect that the defendant’s composition was different from the Plaintiff’s patent, in light of the fact that the Committee possesses subject expertise in this domain.
While it is a settled principle that the Committee is not empowered to rule on claims of patent infringement, I think the Court’s analysis would have been bolstered by an engagement with the findings of the Committee. Indeed, the plaintiff’ consciously chose to withhold the findings of the Committee from the Court. It stands to reason that this decision constitutes a tacit recognition of the importance of the Committee’s findings. This being the case, if the Court had clearly explained why the findings of the Committee do not detract from the findings returned by it, its analysis would have rested on a firmer footing.
Dear Rahul:
Respectfully, I beg to differ.
I think the judge’s analysis in para 19 is completely off the chart.
As I have been taught patent infringement, if a patentee has included any component in his ‘independent claim’, then regardless of what volume/ percentage it is in, the defendant will be held guilty ONLY if he too has that component.
Here, the stabilizer is a compulsory component (not optional).
So, exclusion of stabiliser by defedant clearly took the defendant’s product out of ‘literal infringement’.
Next comes doctrine of infringement under equivalence principle – here the plaintiff has to show that the defendant substituted another product for ‘stabiliser’ that pretty much does the same thing- which analysis clearly, the Judge’s order does not have.
Coming to what the Judge may be doing – but has not put on paper – is the theory of infringement under the ‘pith and marrow’ doctrine – here the ‘substance’ of claimed invention is to be assessed by the Judge and infringement check done thereafter. The Judge seems to be moving on this track but unfortunately, has not completed her analysis of such doctrine in the order.
I believe that based on the position in para 19- this is not correct position of law.
Regards,
Thank you for your comment. While the judge does not explicitly advert to the pith and marrow doctrine in arriving at her conclusion, I think her conclusion is dictated by the application of that doctrine. More specifically, in light of the fact that she outlines five key similarities between the two compositions, it is clear that that she returns a finding that there is real and substantial similarity between the compositions. Also, I think the doctrine of immaterial variance would apply here.
That said, I agree with you that her analysis would have been more robust if she had made an explicit reference to these doctrines. But I don’t think that would have changed the outcome in any way.
Dear Rahul;
I think the Order has its shortcomings even on this count. For a pith and marrow type of decision, the Order still has to discuss that the component which was present as a mandatory component in independent claim and now excluded by the defendant is of very little significance. Unfortunately that can’t be said for a component like stabiliser especially here since the two drugs were earlier not known to available in a single formulation.
If you compare this situation to the US pharmaceutical domain, the generic successfully got a non-infringing position (literal) against an innovator patent and should be eligible for exclusivity however the trial judge held infringement because the Judge felt that FDA approval for generic means that the product is same- here the regulatory body approval for sameness / similarity cannot be seen as a surrogate for skipping the discussion on stabiliser or why patented had it in first place.
“Third, in support of the second argument, the defendant referred to a finding of the Registration Committee of the Central Government Insecticides Board (“Committee”) to the effect that the registration obtained by the defendant for its composition was not covered by the plaintiff’s process patent. In light of the fact that all the three patents of the plaintiff revolve around the same process, the defendant argued, the clear finding that the plaintiff’s process and the defendant’s composition were dissimilar returned by the Committee firmly supported its stance.”
Would this not be an non-infringement argument?
“Finally, relying on the Kerala High Court’s judgment in the case of Shogun Organics Ltd., Vs. Union of India, the Court held that a finding of the Committee does not have any bearing on the validity of a patent. In support of its conclusion, the Court drew sustenance from the fact that a pre-grant opposition against the plaintiff’s patent had been dismissed, coupled with the fact that another dispute involving the plaintiff’s patents was settled in its favour.”
Is this not an invalidity question?
Does this not by itself make the decision flawed and susceptible to being set aside on appeal – where the judge conflates a non-infringement argument with an invalidity argument.
Also for purpose of learning and education – will a pith and marrow analysis supersede a literal claim scope interpretation?
Dear anonymous,
1. I am not sure I agree with your point on insignificance – the judge returns a clear finding that a stabilizer formed a minuscule fraction of the plaintiff’s composition. This being the case, it was not a significant component of the composition. I would submit that the percentage of the component concerned in the composition can be a valid barometer in most circumstances to arrive at a finding of insignificance.
2. I don’t fully follow your reference to the American situation. I don’t think the judge uses the finding of the Insecticide Board as a basis to circumvent the discussion on stabilizer. In fact, the findings of that Committee clearly militate against the conclusion arrived at by the judge, inasmuch as the Committee held that the two compositions are different whereas the judge regards them as being similar.
Hi Arunav,
I don’t think the judge conflates a non-infringing argument with an invalidity argument. The defendant used the findings of the Committee to argue that that its composition was different from the plaintiff’s and, ergo, its composition did not infringe the plaintiff’s patent. The judge returns a finding that the findings of the Committee are irrelevant for purposes of the present proceedings, inasmuch as the Committee’s findings do not have any bearing on a claim of patent infringement.
The fact of the matter, to my mind, is that the Committee’s findings have no weight in the current proceeding. That is the finding of the judge to my mind. I am not sure how the nature of the enquiry undertaken by the Committee in arriving at that finding would matter here. Please correct me if my understanding is wrong.
Dear Rahul:
Coming from the industry side of business, let me clarify on thing for you- a stabiliser is NOT an insignificant item. In fact, that is the reason I think the Judge too is wrong. If you have time, look at the old US litigations pertaining to Atorvastatin where the formulation patent related to a component that prevented degradation.
AS for you not getting the reference to US generic scenario, well, then we have to sit across and I have to explain why I bought that analogous situation. For readers from the pharma domain, it would be clear on how I am comparing the 2 situations.
Regards,
Dear Mr. Bajaj
A reading of the original patent documents, the claims, and the patentees responses to the examination reports may help. They all clearly emphasise that the stabiliser is critical as is seen by the fact that the preamble of the claims itself says “chemically stable”. In this light to say that the use of a different stabiliser in different amounts from what is covered in the patent is an infringement shows insufficient reading. Also the series of orders on this case are quite interesting. It would appear that Plaintiff tried to amend the plaint to change the claim language as reproduced and with specific reference to the stabiliser.
At prima facie stage – would this all not lead to a conclusion that he stabiliser that is referred to in claims being different from that in the composition in practice is a critical different leading to non-infringement finding at least prima facie
Arunav
Hi,
1. This may be a function of my limited domain expertise, but I got the sense that the judge was of the view that the presence of the stabilizer is not critical for the composition to be stable, as it was nobody’s case that the defendant’s composition is not stable.
For instance, the judge says the following at para 19:
“It is not the case of the plaintiff and the defendant that the composition is not a stable compound…”
So Arunav, from what I gather, the question is not if the plaintiff’s claim is chemically stable, as the preamble indicates, but if the stabilizer is an ingredient whose presence is necessary for the composition to be stable. She thinks that the two compositions are stable regardless of the stabilizer. I follow your objection against this.
2. I think the critical difference between the judge’s line of reasoning and the position that the two of you are taking is this: the judge thinks that the absence of the stabilizer is no big deal, as the defendant’s composition is materially the same. In other words, the addition of the stabilizer to the defendant’s composition would not have materially changed it in any way. This is evident from the following extract: “an addition of .1 to 10% weight of the stabilizer being added further would not make the compound as a different compound not infringing the patent of the
plaintiff, as all the essential ingredients with their requisite composition and percentage are the same.”
On the other hand, your argument is this: even under a pith and marrow analysis, which would be the plaintiff’s best case, all material elements in the plaintiff’s composition must be present in the defendant’s composition. In this view of the matter, the question is not if the presence of the stabilizer would make the defendant’s composition different; the question is if the absence of the stabilizer means that the two compositions are not the same in pith and marrow.