IN a move that was ostensibly meant to boost the manufacture of a drug to cure hepatitis C, United States pharmaceutical major Gilead signed a licensing agreement with seven Indian generic companies to manufacture and market its hepatitis C drugs sofosbuvir and ledipasvir across 91 developing countries. The company said the agreement would allow technology transfer to Indian companies for developing their manufacturing capabilities and enhancing production. The companies that are party to the agreement are Cadila Healthcare, Cipla, Hetero Labs, Mylan Laboratories, Ranbaxy Laboratories, Sequent Scientific and Strides Arcolab.
However, a number of public health activists and intellectual property rights experts raised concerns about the move and said it was aimed at curbing competition and wider accessibility of hepatitis C medicines. Even as Gilead is about to finalise the agreement with the generic manufacturers, the Indian patent office is yet to take a call on granting a patent for these drugs. A number of treatment groups and generics firms have filed patent oppositions on Gilead’s key patents in India.
The agreement covers only 91 countries. In countries which are excluded from the deal, competition from the generics that are signing a licensing agreement with Gilead will be prohibited. In a statement, Rohit Malpani, Director of Policy and Analysis at Medecins Sans Frontieres Access Campaign, said: “Gilead’s licensing terms fall far short of ensuring widespread affordable access to these new drugs in middle-income countries, where over 70 per cent of people with hepatitis C live today. Gilead’s deal excludes many middle-income countries considered by industry to be profitable emerging markets, even though people living with chronic hepatitis C in these countries often come from poor and marginalised communities with little ability to pay for expensive medicines.”
Swaraj Paul Barooah, editor-in-chief of "Spicy IP", an intellectual property think tank, highlighted other major problems with the agreement.
He said: “Though the Indian generic companies have the freedom to decide the price of the drug, they have to pay 7 per cent royalty to Gilead as per the agreement. This is bound to reflect in the prices passed on to consumers. Also, the hepatitis C drug has not yet received a patent in India and there are several pre-grant oppositions pending. In this situation, open competition from the generics would have been a much better route for bringing down the prices.”
Sagnik Dutta
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