The facts, known to most of you are briefly as below:
Roche sued Cipla before the Delhi High Court claiming that “Erlocip”, a generic product by Cipla corresponding to Roche’s originator drug, “Tarceva” violates Roche’s Indian patent (IN196774)–hereafter ‘774 patent. Both drugs are based on a compound that goes by the name of “Erlotinib Hydrocloride”.
Trial Court Ruling
The single judge, Justice Ravindra Bhat declined a temporary injunction on the ground of “public interest” i.e. the lower priced generic version of Cipla would enable “more access” to this life saving drug in India. Although Cipla challenged the validity of Roche’s patent in this suit and even claimed non infringement, the trial judge found that Roche had established a “prima facie” case of infringement. However, the judge curiously noted that Cipla had raised a “credible challenge” to the patent. For our earlier posts on this case, see here.
At the appellate court, Cipla focussed less on the “public interest” part and more on the “non infringement” aspect, as discussed below:
The judge held that since Roche had not established infringement of its ‘774 patent, there was no “prima facie” case in favour of Roche. And therefore the application for interim injunction was dismissed.
Since this was really the “ratio” of the case, I plan to focus just on this “non infringement” aspect in this post.
The other parts of the judges’ ruling (that the patent in issue faced a credible challenge of invalidity and was therefore vulnerable + that public interest dictated that no injunction ought to be granted) is really “obiter” and will be taken up in a future post.
To appreciate Cipla’s “non infringement” argument, it may help to take a look at the patents that have been implicated in this case.
1. The Suit Patent (774)
Application Number: 537/DEL/1996
Granted patent: IN196774 (‘774)
Grant Date: 23 Feb 2007 or 6 July 2007 (we’re not sure, since the patent office appears to have found the patent to be in order for grant and then sat on it extensively before issuing a certificate–during which time an opposition was filed by Natco and decided in favour of Roche.
This case again demonstrates the value of PH Kurian’s order that no patent certificates shall be kept pending and shall be issued immediatley after the application is placed in order for grant.
Corresponding US patent: US 5747498 (‘498). This was granted in the US in 1998.
2. The Future Patent Application (‘507)
A later patent application claiming a specific polymorph B of Erlotinib hydrochloride was filed in India (IN/PCT/2002/00507/DEL) (hereafter the ‘507 application). This corresponds with US patent 6900221 (the ‘221 patent). This was filed in India in 2002 and rejected in December 2008 after an opposition filed by Cipla on the grounds of section 3(d) primarily.
Cipla’s argument runs thus: The ‘774 patent only disclosed Erltonib Hydrochloride, existing as Polymorphs A+B. Whereas the ‘507 application claims Polymorph B alone. The Tarceva tablet corresponds to polymorph B alone, since this polymorph is much more stable and capable of being made into tablet form (solid form oral dosage).
The judge found in favour of Cipla, holding that Tarceva really corresponded to Polymorph B, which was the subject matter of ‘507, an application that was ultimately rejected. Therefore there was no infringement of the ‘774 patent. The judge then holds that Roche ought to have disclosed the ‘507 application to the patent office whilst prosecuting the ‘774 patent. Had this been disclosed, the judge opines that ‘774 patent may not have been likely to be granted at all! And then goes on to impose costs on Roche in this regard for non disclosure/suppression of material facts.
Concerns with Appellate Ruling
My concerns with the above line of judicial reasoning are as below:
i) The first claim of the ‘774 patent reads as:
“A novel [6,7-bis(2-methoxyethoxy)quinazolin-4-yl]-(3-ethynylphenyl) amine hydrochloride compound of the formula A.”
To me, this appears to be a claim covering the compound: “Erlotinib Hydrochloride”. This compound may exist in several polymorphic forms, but any such forms are likely to be subsumed within this patent.
Therefore assuming Cipla’s drug relies on only one particular polymorphic form of the Erlotinib Hydrochloride compound (Form B), it will still infringe the main patent. For Cipla cannot get to such polymorphic form wihtout in some way implicating the patent covering Erlotinib Hydrocholride.
Therefore, it ought not to matter that the drug “Tarceva” (and Cipola’s generic version) was primarily based on the Polymorph B version (as elucidated in the later ‘507 application). Making the drug will necessarily infringe the parent ‘774 patent.
ii) Not only did the court appear to have missed the above chain of logic, it went out of its way to hold that Roche suppressed material information by not bringing the existence of the ‘507 application to the notice of the court or the patent office (during the course of prosecution of the ‘774 patent). The court insinuated that by withholding this information, Roche was in some way culpable of fraud.
Firstly, if the ‘774 patent is broad enough to subsume all polymorphs, is there a need for Roche to disclose any other accompanying patent application to the court? Of coure, there could be a section 8 issue here, but that is a matter for the patent office and the corresponding oppositions filed. Section 8 requires that all information relating to corresponding patent applications/grants in foreign countries be brought to the notice of the patent office. For an interesting discussion on the contours of this provision, see this post by Sai Deepak.
Secondly, I don’t necessarily see an inconsistency in Roche’s statements at the patent office with respect to the ‘507 application: i.e. that although ‘774 patent subsumes the polymorph, it still does not disclose it adequately enough, meriting another patent application (‘507) that is of the “selection” variety. As to whether this second application is meritorious enough to warrant a separate patent is another issue–and the patent office held (in its December 2008 oppn decision) that it wasn’t meritorious enough.
Does the strength or otherwise of this later patent application that was ultimately rejected by the patent office affect the strength of Roche’s infringement case that was plainly limited to the ‘774 patent?
At best, whether or not Roche committed fraud by withholding pertinent information appears a contentious issue to me? And not a conclusive one or a strong enough one to merit the awarding of “costs” of Rs 5 lakhs. Imposing such costs on them when they were attempting to legitimately fight on the basis of what they thought to be validly granted patent rights appears a bit extreme to me.
In what can only be termed as the worst kind of a double whammy, Roche lost out on both patents (‘774 and ‘507).
Conclusion 1: Whither the Claim?
The most surprising part of the division bench decision is that they do not refer to the claims of the ‘774 patent even once. The key question ought to have been:
What exactly does the ‘774 patent claim? Does it cover Erlotinib Hydrochloride? As I’ve argued earlier, from my tentative understanding of claim construcition and chemistry, the claim covers Erltoinib Hydrochloride. As to whether or not this is a valid claim is a different issue. But assuming it is valid, does not Cipla’s use of a specific form or version of this compound infringe?
Conclusion 2: Deconstructing the Reasoning of the Judges
If my tentative reading of the claim is correct, how did the judges miss it? And why did they go out of their way to impose costs on Roche? I offer three potential reasons and welcome your thoughts on this.
(i) The judges were clearly biased against Roche: In my opinion, this is very very unlikely (not least because I run the risk of contempt here)
(ii) Our judges are still coming to grips with patent law and cannot be expected to master patent nuances on day one. Consequently, there will be mistakes at this stage. However, this would then mean that our courts must, as far as possible, defer to the patent office on issues of claim validity and the like? At least to the extent that such issues of validity, turn not on issues of law but issues of fact, such as determining the scope of the prior art and determining whether something is obvious or not to a person skilled in the art. And particularly when such patent has already been subjected to an opposition. I will come back to this point in a later post.
(iii) Roche’s counsel and strategy were no match for that deployed by Cipla.
I personally think the decision came out the way it did owing to reasons number (ii) and (iii) (with reason number (iii) being the predominant reason). I had already suggested this in a number of earlier posts. I also happen to have sat in court during some of the hearings and must say that the combination of Pratibha Singh and Arun Jaitley was simply terrific.
However, notwithstandind the relative deficiences in choice of counsel and in terms of legal strategy, my own view is that Roche has a perfectly appealable case (on merits) to the Supreme Court. If not for anything else, it must get that little black mark of “suppressing material facts” expunged.
As to whether it will be able to obtain a temporary restraining order from the Supreme Court is unclear. Given that two lower courts denied the injunction and Cipla has been selling the drug since December 2007, the apex court is unlikely to grant an injunction. However, there is a good chance that it may just get its claim construction and chemistry right. What do our readers think?