In a move which is sure to kick off a fresh controversy in the regulatory framework over patent issues, Hyderabad-based Natco Pharma has launched Bristol Myers Squibb’s (BMS) cancer drug Dasatinib, under the brand name of Sprycel. Natco has received the marketing licence from the Uttarakhand government to sell the drug. Prior to this, the company had approached Drug Controller General of India (DCGI) to sell the drug.
Natco is selling the drug at a discount of 94 per cent at Rs 9,000 for 60, 50 mg tablets as against BMS’ price of Rs 1,60,000. Earlier, Natco had applied for an export licence for Dasatinib with the DCGI. Natco and Hetero Pharma are locked in a patent infringement battle with BMS over the same drug at the Delhi High Court since 2009.
While Bristol-Myers Squibb does not comment on ongoing litigation, they clarified that Sprycel (Dasatinib) is protected by a patent granted by Indian Patent Office, Mumbai (India) in 2000 and indicated that the company will pursue all appropriate legal avenues to protect its intellectual property rights in India.
Natco’s launch comes at a time when BMS’ injunction suit against Natco is pending hearing at the Delhi High Court. This move by Natco has irked multinational drug firms, with many again calling for a patent-linkage system for drug marketing approvals in order to protect patent rights and recover investments in R&D.
EP News Bureau – Mumbai
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