Natco Pharma, a city-based drug maker, on Friday said the US Court of Appeals for Federal Court has again found one of the patents of Teva’s Copaxone as invalid.
Natco, along with its partner Mylan, is awaiting the approval from the US Food and Drug Administration to launch the product in the U.S. market.
“Natco Pharma Limited announced today that US Court of Appeals for Federal Circuit again has found Teva’s US patent 808 for Copaxone to be invalid as definite. The company awaits USFDA approval to launch the product,” Natco said in a statement.
Last year, the United States Supreme Court has denied Teva’s application for an injunction seeking to prevent launch of a generic version of Copaxone involving Natco Pharma.
The drug makers involved in the generic forms of Copaxone are Novartis AG’s Sandoz and Momenta Pharmaceuticals, Mylan and Natco Pharma.
A senior official of Natco told PTI that they have submitted all the information to FDA with regard to the generic version of Copaxone (Glatiramer Acetate) which is used in the treatment of relapsing-remitting multiple sclerosis.
“We have done everything from our side. Once approval comes, we are ready to launch the product. We manufacture the drug and Mylan will market it,” the official said.
The Natco stock was trading at Rs 2,187.05, up 5.33 per cent, on BSE at 1513 hours.
Mylan CEO Heather Bresch, in a separate statement, said: “We have stated all along that the ‘808 patent on Copaxone is invalid... We continue to remain very confident and look forward to bringing our product to market upon approval from the US Food and Drug Administration.”
Bresch further said the ruling underscores concerns of Teva’s ongoing financial prospects as the Copaxone franchise has historically been its largest and most significant revenue driver.
According to Teva’s 2014 annual report, Copaxone is responsible for $4.2 billion, or 21 per cent, of the total revenues.
