US Court Clears Way for Natco's Copaxone Launch

This is the second time Teva’s request was denied by the court for an injunction paving way for generic drug makers Mylan Inc and Natco to launch the top selling drug

Published: 22nd April 2014 06:00 AM  |   Last Updated: 22nd April 2014 01:57 AM   |  A+A-

Natco Pharma Ltd may soon launch generic version of multiple sclerosis drug Copaxone with the US Supreme Court rejecting Teva’s application for an injunction seeking to prevent its launch.

This is the second time Teva’s request was denied for such an injunction and paves way for generic drug makers Mylan Inc and Natco to launch the top selling drug, which registered $4.2 billion revenue in the US in 2013.

Though Teva has the option of filing one more injunction with another justice, such requests are rarely granted, say industry experts.

“The Supreme Court of US 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 disclosure with the bourses.

It may be noted that in July 2013, the US Court of Appeals for the Federal Circuit had first ruled in favour of two teams - one comprising Novartis AG’s Sandoz Inc and Momenta Pharmaceuticals Inc., and the other involving Mylan Inc and Natco -- developing cheaper generic forms of Copaxone

The appeals court upheld about 9 patents involved in Copaxone, or portions of them, but declared several invalid. It means, patent protections were set to expire in May 2014 instead of September 2015.

Teva had sought to prevent the lower court ruling from going into effect, as the Supreme Court will not hear oral arguments until its 2014 term begins in October. Effectively, a ruling could come as late as June 2015, which is why Teva sought to stay the lower court’s decision.

In his decision, the US Supreme Court chief justice John Roberts, said he was not convinced Teva had shown the likelihood of irreparable harm if the application was denied, because if Teva wins the SC case it can seek damages from the generic companies for past infringement on its patents.

Shares of Natco surged as much as 13 per cent after the US court denied Teva’s request. Natco’s scrip closed 7.5 per cent higher at ` 769.35 in BSE on Monday.


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