Natco in a statement maintained that the US Supreme Court made no finding as to the validity of the patent, but instead remanded the case back to the US Court of Appeals for the Federal Circuit to consider the matter in view of the modified standard of review. However, the markets responded on the basis of the obvious effect of the court ruling.
According to reports, the US Supreme Court on Tuesday ruled that the US pharmaceutical company could still benefit from patent protection for the top selling multiple sclerosis drug.
Whereas the patent on Copaxone was to expire by May end in 2014, Teva Pharmaceuticals sought its extension until September 1, 2015, while launching a longer acting Copaxone in addition to the existing version of the drug.
The lower court , which had pronounced the patent as invalid earlier, might have to take a fresh look at its conclusions in view of the Supreme Court’s action, analysts said. In any case, this would result in further delays in the possible launch of generic versions of the drug intended by several players.
Over five years ago, Natco had filed an application with the US Food and Drug Administration (US FDA) for the launch of the generic version of Copaxone, which had been the biggest contributor to Teva’s top line in recent times. The other generic filers include Momenta Pharmaceuticals Inc and Sandoz, Inc. The application is still pending before the US drug regulator.
Last week, the Delhi High Court reserved the orders on a petition filed afresh in 2012 by Teva seeking injunction orders against Natco Pharma from exporting the drug to the US. Natco, which had hit the headlines by securing the first-ever compulsory licence in India for cancer drug Sorafenib Tosylate or Nexavar owned by Bayer Corporation, was hoping to gain a big upside from the launch of the generic multiple sclerosis drug along with its partner Mylan.
The company is fighting patent lawsuits pertaining to another three-four drugs , including for a swine flu, in US courts, according to the people in the know.
Natco scrip on Wednesday fell 5.90 per cent or Rs 89.75 to close at Rs 1,432.10 on the BSE.
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