F Hoffman-La Roche Ltd v Cipla Ltd Expert Analysis


The long awaited Hoffman-La Roche v. Cipla judgement was finally passed last week marking the end of the first phase of a key battle between Big Pharma and the Indian generic industry. Although there are pending suits before the Delhi High Court which have been filed by Roche against several other generics, most prominently NATCO, Glenmark and Dr. Reddy’s, it is expected that the finding of non-infringement against Cipla will pre-determine the fate of those lawsuits as well. Shwetasree Majumder dissects the 275 page judgement and analyses the various issues argued and the court’s ruling.
By Shwetasree Majumder
Opening Remarks

The Hoffman La Roche/Cipla case was played out in far greater detail in the public domain than in the courts, right from the start. With all the attention it garnered (mostly unsavoury), particularly on the alleged Indian judicial climate turning anti-innovator, it won’t be an exaggeration if I say that thousands across the globe were waiting to see which way the wind blows with this crucial decision. And that is probably where this decision scores the highest. It panders to none, sticks to the facts and the applicable law and comes as a breath of fresh air in steering clear of access-pricing-patent linkages which have been known to dangerously dilute core patent law principles in the past.
In fact Justice Manmohan Singh’s judgement of 07.09.2012 exonerating Cipla’s generic version (Erlocip) of Roche’s cancer drug Tarceva from patent infringement while upholding the validity of Roche’s cancer drug patent (IN ‘774) can claim several firsts. Perhaps the most prominent of these, is that it can legitimately claim to be India’s first post-trial judicial application of mind in this specific field to a case of such magnitude. The speedy conclusion of the trial in this case is also worthy of mention – four years since the day it was filed (including the time taken for the hearing and decision on an intervening appeal from the interim order), several volumes of evidence and dozens of hearings later, we have this 275 page judgement – no mean feat!
The plot and premise of the dispute is straightforward – Roche was granted Indian Patent No. IN ‘774 in February 2007, under which per Claim 1, they had patent rights over the Erlotinib Hydrochloride (EH) molecule which has demonstrated breakthrough capabilities as an Epidermal Growth Factor Receptor (EGFR) inhibitor which spiked survival benefit in non-small cell lung cancer (NSLC) patients.