MUMBAI (Reuters) - BDR Pharmaceuticals 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, a BDR executive said on Monday.
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Under a global Trade-Related Aspects of Intellectual Property Rights (TRIPS) agreement, countries can issue compulsory licenses for certain drugs that are deemed unaffordable to a large section of their populations.
If approved, the compulsory license would be another setback for global drugmakers in India. German firm Bayer AG lost an appeal earlier this month challenging the first such Indian license, which was granted to Natco Pharma on cancer drug Nexavar.
Dasatinib is a blood cancer drug sold as Sprycel by Bristol-Myers Squibb and costs about 165,000 rupees ($3,050) for a month's treatment in India.
India's BDR Pharmaceuticals had unsuccessfully sought a voluntary license from Bristol-Myers Squibb to sell a copycat version, Aravind Badiger, technical director at the Indian firm, said in an emailed response to a Reuters' query.
Officials at U.S.-based Bristol-Myers Squibb could not immediately be reached by Reuters for comment.
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, Badiger said.
"We expect the patent office to respond at the earliest," he said in the email.
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 firms 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)
(Editing by Tony Munroe and Charlotte Cooper)
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