Minor delays on Thursday preceded the start of proceedings: Senior Counsel Arvind Nigam, who was leading Natco’s arguments, was busy with another case. Natco tried to adjourn the matter, but Senior Counsel CS Vaidyanathan, leading Roche’s case, was allowed to continue with his arguments, from where he had left off. (see earlier post)
Natco’s counter-claim annulled by res judicata?
A key argument put forward by Roche was that Natco could not seek the defence of a counter-claim in the present infringement allegations for reasons of constructive res judicata.
Towards this, Roche outlined Natco’s “behaviour” in connection with this matter — pre-grant opposition; being given an express opportunity (in the order) for a post-grant opposition, but then opting to apply for a compulsory license. Mr Vaidyanathan argued that this would, on the face of it, lead to estoppel and waiver of rights at Natco’s end, especially to introduce any question of the validity of Roche’s patent. They had already had an opportunity to do so, but chose instead to pursue their rights for a compulsory license (thereby tangentially accepting the validity of the patent).
In essence, Roche argued that where two parties have contended issues before administrative authorities or quasi-judicial bodies like the Controller of Patents, the parties are subject to the decision that has attained finality, and the same points cannot be raised again in a subsequent proceeding. To buffer this, Roche drew the court’s attention to, interestingly enough, the Division Bench order (of the Delhi HC) in Roche vs Cipla itself, which you can read here, and its para 65, which I quote in part below:
“[A] patent which survives the pre-grant and post-grant challenges can still be made vulnerable on grounds different from the ones raised at those stages. The fact that the challenge is on grounds not urged at those stages, would lend credibility to the challenge. If the challenge is on the same grounds considered and rejected by the Controller of Patents, then of course, the burden on the defendant to demonstrate credibility of the challenge would be considerably higher degree.”
But what about drug pricing and public interest?
While the Court seemed fairly open to Roche’s arguments, it kept returning to that devil of an issue — drug pricing and public interest. There was a brief parley in one of our earlier posts on this issue on the sore lack of definition and clarity on “public interest” in Indian law. This seems to be becoming the standard “back-up” plan for the so-called generic companies in patent cases, but could do with a little more material substantiation.
Roche seemed to have come prepared for this, since the Court had, even in the previous hearings, raised this issue. Mr Vaidyanathan took the court through the Patents Act, and its legislative intent, on both Thursday and Friday — viz., the host of safeguards contained in the Act in re granting opportunities to an opponent of a patent, pre-grant opposition, writ, post grant, appeal, revocation before IPAB (from which a writ would lie), revocation as a defense (from which an appeal would lie).
Roche then did a explanatory exposition of the licensing provisions of the Patents Act, whether voluntary or compulsory, and reiterated that a key reason for Natco’s failed/aborted compulsory license application was because of mala fide behaviour on Natco’s part which came to the court’s attention, i.e., Natco appeared to have started production of the infringing product before the grant of the license.
How’s Roche-Natco different from Roche-Cipla?
The court, after hearing all of this, returned to the public interest issue, and asked Mr Vaidyanathan to distinguish the original Single Judge Bench decision in the Roche-Cipla matter, from the present case. That 2008 order had refused to grant an interim injunction on grounds of public interest (this was appealed against later; read this post for current status on that case).
Here, Mr Vaidyanathan highlighted an interesting factoid — that the public interest aspect had in fact never been brought to light before the Single Judge. Particularly, he argued that the while for each proposition, the Judge had recorded submissions of the parties’ for public interest, the lack of the same was conspicuous.
Predictably, the court on Friday also contemplated that it might be bound by the Division Bench judgement in the Roche-Cipla case, while deciding on the injunction in the present case. (Recall that the DB had refused the injunction). Roche disagreed, and contended that that order was interim, and could not have any influence or binding value even in the Roche v. CIPLA trial itself.
That’s all for now. We will hopefully be updating you on this after today’s proceedings, when Roche is likely to conclude its arguments, and Natco is likely to commence.
sc,
Many thanks for the detailed update.
Importantly, as I recall, at least 1 company – possible Cipla has also filed its post grant revocation at the IPAB for Erlotinib compound patent – in suit here.
Freq. Anon.
Indeed, the “public interest” is one of the most important questions in patent law today — especially in regard to generics. Strange that the term has yet to be adequately defined, because many cases would appear to hinge on just such a definition. I’m anxious to see how this issue will play out in the courts — in this case and in others.