India recommends compulsory licence for anti-cancer drug
The Health Ministry in India has recommended that a compulsory licence (CL) is issued for the manufacture of Bristol-Myers Squibb’s (BMS) anti-cancer drug Sprycel (dasatinib), potentially opening the door to the sale of cheaper imitations.
The department of industrial policy and promotion (DIPP), which outlines policies in relation to patents, has the authority to approve the licence.
If approved, it will be India’s second CL following the decision in March 2012 to issue a licence to Natco Pharma for the manufacture of Bayer AG’s anti-cancer drug Nexavar.
Dasatinib was approved for first line use in patients with chronic myelogenous leukaemia and Philadelphia chromosome-positive acute lymphoblastic leukaemia.
It is also being evaluated for use in other forms of cancer, including advanced prostate cancer.
According to Ashwani Balayan, partner at ALG India Law Offices in New Delhi, local media reports have indicated that the DIPP is likely to accept the recommendations.
Compulsory licences have previously been recommended in India for two more anti-cancer drugs, Roche Holding AG’s Herceptin and BMs’s lxabepilone, but a final decision has not been made on these.
Balayan indicated this was a trend that was likely to increase, with further considerations understood to be taking place for anti-diabetes and hepatitis drugs.
“The grant of such compulsory licences will hopefully not act to discourage patentees from filing patent applications,” Balayan told LSIPR.
“The decrease in prices may, in fact, be combatted by the increase in volumes. Thus, the gain to the public in terms of reduced drug prices due to compulsory licences may not always translate into an equivalent loss to the patentees.”
The TRIPS Agreement, administered by the World Trade Organization, allows a country to issue a compulsory licence without the consent of the innovator if it is in the public interest.
The decision to recommend the licence for dasatinib centred on its price, which the government says is too high. It currently costs more than Rs.100,000 (US $1,540) for a one month dosage.
“Although the TRIPS Agreement does not specifically list out the reasons that might be used to justify the grant of compulsory licensing, the Doha Declaration on TRIPS and Public Health confirms that countries are free to determine the grounds for granting compulsory licences,” Balayan said.
“Section 92 of the Indian Patents Act enables three grounds/situations in which this can be done: in circumstances of national emergency, in circumstances of extreme urgency or in the case of public non-commercial use.”
