SpicyIP Tidbit: Cipla wins round one in its battle against Roche

The much awaited judgment of the Delhi High Court on the issue of temporary injunction in the Roche-Cipla case is finally out. Cipla’s risky strategy has paid off with the Delhi High Court allowing it to continue the manufacture of Erlotinib till a final ruling on the case. The only caveat that the Court attached was that Cipla maintain ‘fair accounts’ of the drugs sold so that it may adequately compensate Roche in case of an adverse final ruling. SpicyIP will carry a more detailed analysis of this judgment later. As of now we’ll just point out the ‘spicy’ bits. From what has been reported in the Mint and the Business Standard the Court seems to have declined granting a temporary injunction against Cipla on the grounds of public interest or as the Mint put it – ‘irreversible damage to the patients’ since the cost of Cipla’s generic version is one-third that of Roche’s patented drug. As SpicyIP has commented before: Indian law, unlike American law, does not explicitly recognize public interest as one of the grounds for granting temporary injunction. Having said that we have to point out that ‘public interest’ seems to be one of the deciding factors in pharmaceutical patent case. Even in the Glivec case when Novartis was trying to enforce its EMR one of the main arguments used by generic manufacturers was that public interest would be injured because of the high price of Novartis’ drug. However the only reason that both the single judge and the appeals court ruled in favour of Novartis in the EMR case was because it gave an undertaking to the Court that it would ensure that all patients earning below Rs 3,36,000 a month (yes a month!) would be given the drug for free. Clearly pharmaceutical manufacturers have to argue the ‘public interest’ issue more convincingly if they want to enforce their patents.
It will also be interesting to see the effect of this judgment in the Compulsory Licensing case involving Roche/Pfizer and NATCO. Tarceva is one of the drugs in question that NATCO wants to export to Nepal. NATCO had actually challenged Roche’s patent over Tarceva in a pre-grant opposition and had lost that time.