India's Natco Pharma has big plans for a Pfizer HIV drug--provided the world's largest drugmaker plays along. Natco has taken the first step toward a compulsory license on Selzentry (maraviroc), by notifying drug giant that it wants to make its own generic version and sell it at one-fifth of the Pfizer price.
Indian patients can't afford the current price of 65,000 rupees ($1,430) for a monthly supply, Natco says. More patients could get treatment if it were allowed to market the copycat form for 15,000 rupees ($330), it adds. If Pfizer doesn't issue Natco a license, the Indian company can turn to the government for a compulsory license.
Indian patent law allows drugmakers to apply for "compulsory licenses"--permissions to market generic drugs for public health reasons--beginning three years after a drug is patented. Theoretically, Natco could sell its version if the government determines that the branded version isn't available to Indian citizens at an affordable price, Dow Jones reports. But some aspects of the law are murky, so obtaining that license isn't a cut-and-dried process, the news service notes.
Compulsory licenses are controversial, of course, because branded drugmakers want control of their own intellectual property. Some pharma companies have granted licenses to generics makers to help supply the developing world with lifesaving drugs. But patient advocates want more cheap versions of lifesaving meds, and some countries have forced drugmakers to comply. Thailand, for instance, got worldwide attention in 2008 when it imposed compulsory licenses on four costly cancer drugs made by Novartis, Sanofi-Aventis and Roche.
But Natco's move also illustrates the vagaries--some would say weaknesses--of Indian patent law. Just a few days ago, India refused to give Abbott Laboratories patent coverage on a combination AIDS drug, a move that thrilled low-cost generics makers and patient groups, but worried branded drugmakers.