Natco stirs patent battle with generic version of Sprycel

The pharma sector may soon be embroiled in another bloody patent battle. This time it's over US drug maker Bristol Myer Squibb's (BMS) USD 800-million blood-cancer drug Sprycel, reports CNBC-TV18's Archana Shukla.

Natco Pharma has exploited a loophole in the Indian drug regulatory laws and US drug-maker BMS is not amused.

Natco has gone ahead and launched a generic version of BMS' patented Sprycel at a whopping 94% discount at Rs 9,000 for 60, 50 mg tablets as against BMS' price of Rs 1,60,000 on grounds that it has approval from the Uttarakhand state drug regulator.

Now while BMS had won a patent battle on Sprycel against Hetero Drugs, which was seeking a central regulator nod, in 2009, Natco's launch has been made possible only because the Drugs and Cosmetics Act empowers state regulators to approve new drug versions after four years of the grant of the first licence.

Interestingly, even the government's Parliamentary Standing Committee report on the Central Drugs Standard Control Organisation (CDSCO) had pointed out the difference between the state and central regulators.

What is worse for BMS is that Natco's launch comes even as 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. Clearly, Natco has stirred up a hornet's nest.