Mumbai: Hyderabad-based Natco Pharma Ltd’s stock on Monday lost 5.97% after a US court ruled against one of the company’s generic drug applications at US Food and Drug Administration. Natco, which was granted India’s first compulsory license to make an affordable generic version of German drug maker Bayer Healthcare AG’s cancer drug Nexavar in February, had sought approval for a generic version of a multiple sclerosis drug --Copaxone, which is already patented by global generic giant Teva Pharmaceutical Industries Ltd. Natco’s shares closed at Rs 350.6 a unit on Bombay Stock Exchange on Monday.
The US court had on Friday ruled in case filed by Teva Pharmaceuticals against Natco’s drug application that the Indian company infringed the petitioner’s patent claims on the drug. The case was going on in the US court since Natco sought approval for its version of this drug in the US market with its partner Mylan Inc in June 2008.
“Natco is disappointed in the court’s decision. While the company has not yet had the opportunity to review the court’s opinion, it will fully investigate all available options for appeal once the court’s full opinion becomes available,” said a statement from Natco on Monday.
On the unfavourable ruling from the US court, Natco’s partner Mylan Inc that it intends to fully evaluate its options to appeal against the ruling.
“Although Mylan is disappointed in the court’s decision, and while we have not yet had the opportunity to review the court’s opinion, we fully intend to evaluate our options for an appeal once the court’s full opinion becomes available,” said Mylan’s chief executive Heather Bresch.
Natco and Mylan had sought the approval of this drug, which is currently patented by Teva in the US, under the so-called para 4 provision that allows generic companies to enter the market with a cheaper generic drug before the expiry of the original patent by challenging the discovery claims of the patent holder.
A Mylan statement on Monday added that “As previously stated, Mylan’s earnings guidance for 2012 and earnings targets for 2013 are not reliant on the launch of a generic Copaxone, and therefore our expectations for these periods are unchanged.”