MUMBAI BDR Pharmaceuticals said on Monday it has applied to India's patent office for a compulsory license to sell a generic version of Bristol-Myers Squibb Co's cancer drug dasatinib, after unsuccessfully seeking a voluntary license from Bristol-Myers.
Under a global Trade-Related Aspects of Intellectual Property Rights agreement, countries can issue compulsory licenses for certain drugs that are deemed unaffordable to a large section of their populations.
If approved, a compulsory license for dasatinib, a blood cancer drug, would be another setback for global drugmakers in India. German company Bayer AG lost an appeal earlier this month challenging the first such Indian license, which was granted to Natco Pharma for cancer drug Nexavar.
Dasatinib is sold as Sprycel by U.S.-based Bristol-Myers Squibb and costs about 165,000 rupees ($3,050) for a month's treatment in India.
BDR Pharma filed its application seeking a compulsory license on March 4 and has offered to sell the drug at 8,100 rupees for a month's dose, Aravind Badiger, technical director at BDR, an Indian pharmaceuticals company, said.
"We expect the patent office to respond at the earliest," he said in an email response to a Reuters query.
BDR had unsuccessfully sought a voluntary license from Bristol-Myers to sell a copycat version of the drug, Badiger said.
Bristol-Myers Squibb said in a statement that it does not comment on ongoing proceedings. The company said it "has and will continue to pursue all appropriate avenues to protect its intellectual property rights in India."
It said Sprycel is protected by a composition of matter patent from the Indian Patent Office.
Natco Pharma already sells a generic version of dasatinib in India, which is the subject of a legal battle with Bristol-Myers Squibb.
Generic drugs account for about 90 percent of India's $13 billion drug market. While India holds promise for global drugmakers facing slower growth in developed markets, big pharmaceutical companies have lost several rulings on intellectual property rights in recent years.
Among those setbacks, India revoked patents granted to Pfizer Inc's cancer drug Sutent, Roche Holding AG's hepatitis C drug Pegasys, and Merck & Co's asthma treatment aerosol suspension formulation.
($1 = 54.17 Indian rupees)
(Additional reporting by Caroline Humer in New York; Editing by Tony Munroe, Charlotte Cooper and Leslie Adler)