India's Cipla got a big boost yesterday as the World Health Organization affirmed its generic version of Roche's antiviral drug Tamiflu. The UN agency said Cipla's Antiflu is as effective as the Roche drug. And with a recent win in a patent fight against Gilead, which owns the patents on Tamiflu in India, Cipla is all clear to manufacture its version.
Meanwhile, the company announced that it had agreed to sell Antiflu to Mexico, where the current outbreak of H1N1 first became apparent. According to Reuters, Mexico will need to issue a compulsory license to waive the patent on Tamiflu so that it can buy Antiflu under existing international trade rules. Cipla's managing director said it would sell Antiflu to Mexico and other countries only if they indemnified the company against any patent litigation.
Obviously, compulsory licensing is a controversial subject in pharma; the few times countries have opted to waive patent protection, there's been a brouhaha of drugmaker protest. Indeed, on the heels of Cipla's announcement of its Mexico deal, Roche said that it's still negotiating with Mexico itself, and that it "sees no rationale for compulsory licensing." And with Cipla in negotiation with other Latin American countries as well, Roche is likely to be taking those negotiations on the road.
- read the Financial Times story