Roche vs Cipla: Tarceva Patent to be reviewed by Indian Supreme Court

In this article, I am quoted as stating:

“According to a patent law expert, the validity of Roche’s patent was in serious doubt. “In view of the existence of Gefatinib, an earlier known molecule, the court appeared to suggest that Erlotinib, Roche’s patented molecule, may not be inventive,” said Shamnad Basheer, a professor in intellectual property law at the National University of Juridical Sciences, Kolkata. “Secondly, there is a serious doubt about whether or not Cipla infringes the Roche patent at all.”

Unfortunately, this is not my statement or view, but my encapsulation (in an earlier blog post) of what the court suggested in its judgment. I noted then that:

“The appellate court overruled Justice Bhat on this point and held that on the evidence before the court, Roche had failed to establish a prima facie case. Firstly, the validity of Roche’s patent was in serious doubt. In view of the existence of Gefatinib, an earlier known molecule, the court appears to suggest that Erlotinib, Roche’s patented molecule may not be inventive.

Secondly, there is a serious doubt about whether or not Cipla infringes the Roche patent at all.

Since the court ruled that Roche had not even established a prima facie case, it did not have to wade into the other factors, such as the pricing of the drug and the public interest factor, something that the trial judge, Justice Bhat had based his judgement on.”

The Legality of the Delhi High Court Order

My own views on this poorly reasoned appellate court judgment are found in a later blog post, where I note that:

“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…

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 construction 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?”

Betting on the Outcome at the Supreme Court:

So which way is the case likely to go? Since Cipla has been on the market since 2007, it is unlikely that the Supreme Court will now issue an order of injunction against the sales of Cipla’s Erlocip. It is likely to find that the balance of convenience is in favour of Cipla. This tentative conclusion is strengthened by the fact that the main trial in this case is proceeding before the trial court and is likely to conclude by the end of the year. The apex court may therefore direct that the trial itself be speeded up and a final decision on the merits of the case be issued quickly.

However, given the poorly reasoned decision of the Delhi Division Bench, the court is likely to step in and overturn some of their findings. In particular, I’d be very surprised if they sustained the findings on non disclosure and non infringement. As for validity and the lack (or otherwise) of a prima facie case, I find it difficult to wager either way. And the same is the case with “pricing” differentials and whether this factor can be used to deny an injunction.

In any case, this presents an excellent opportunity for the Supreme Court to step in and clarify the law on injunctions in patent cases. How should a court assess the existence or otherwise of a “prima facie” case? Should a court defer to agency (patent office) expertise? And if so, to what extent? Can a court look into pricing and public interest whilst deciding a patent infringement matter? One hopes that there will be more clarity on these and other issues by the end of this year.