It's coming! Natco Pharma in India likely will file soon the first request for a compulsory license to sell a generic form of Pfizer's maraviroc HIV pill. This will be the first attempt by an Indian drug compay to initiate the compulsory licensing process. Uh-oh PhRMA members!
India's goverment (and specifically DIPP) has been rattling sabers all summer about the possibility of compulsory licensing provisions being activated. This is response to its fears that India's pharma industry is increasingly being taken over by foreign multi-nationals and that these companies will start to price their products beyond the reach of many Indian consumers. PhRMA took this issue seriously enough to send a delegation to India in October to discuss the policy implications. Big Pharma generally has said that compulsory licensing robs them of any incentive to produce innovative medicines.
Natco for its part first sought a voluntary license but expects to be turned down. Compulsory licesning is the next step. Natco has already informed Pfizer that the price it is charging for the brand-name version of maraviroc is too expensive for the Indian consumer. Natco proposes to reduce Pfizer's price by 77% to better serve India's 2.3 million HIV patients. Indian patent law allows a challenge to occur within 3 years after a patent is awarded - the 3 years was up in January 2010. Pfizer has until May to respond to Natco's voluntary request.
This decision could have sweeping implications for other generic and brand drug sellers in India. It may also call for the creation of new pricing strategies by Big Phama in India or other developing markets. And, it may cause some re-thinking on how one would evaluate the lucrativeness of an so-called emerging market like India. Will Big Pharma be able to bet that expansion into these countries will make up for their patent cliff/poor pipeline issues afterall?
Posted by Bruce Lehr Jan 6th 2011.