U.S. court ruling to benefit Natco

Hyderabad-based generic pharmaceutical manufacturer Natco Pharma could benefit from US Supreme Court’s quashing pharmaceutical major Teva Pharmaceutical interim injunction to revive its patent on Copaxone (Glatiramer Acetate), a generic multiple sclerosis drug.

The U.S. Supreme Court denied a request by Teva to stay a lower-court ruling in a patent case that sided with generic manufacturers of Teva’s multiple sclerosis drug.

The decision could help generic companies like Natco launch the drug in U.S. “The Supreme Court of U.S. has denied Teva’s request for an injunction relating to generic Copaxone, clearing legal hurdle for Mylan and Natco to launch the same in that market,”

Natco said in a filing to the Bombay Stock Exchange (BSE), adding that this is the second time the chief justice had denied Teva’s request for such an injunction.

Copaxone registered sales of U $805 million in the U.S. in the December quarter and the U.S. market for it is about $3 billion.

Natco has in place an agreement with U.S.-based Mylan to market the generic version of Teva’s Copaxone.

Teva’s Copaxone patents, expiring in September 2015 were held invalid by a US lower court in July 2013, making generic entry possible after May 24 this year when remaining patents expire.

This would allow generic players to launch the product ‘at risk’ in the U.S. market.

“At risk launch option is before the Supreme court’s verdict which could come in Teva’s favour,” Siddhant Khandekar, Chief Manager – Research, ICICI Securities told this correspondent.

“The court will hear arguments and rule during its 2014-15 term, which starts in October and runs through the following June.”

Meanwhile, Natco said it would await `concurrence’ from its partner Mylan as also other regulatory approvals in the US, including approval from the US Food & Drug Administration (US FDA) before deciding on the launch.

Shares surge

On the Bombay Stock Exchange, Natco Pharma stock surged 13 per cent intra-day trade before reacting to close up 7.5 per cent at Rs. 769.35.