The US Supreme Court has sent back a patent case between Natco Pharma and Israel's Teva over the multiple-sclerosis treatment drug Copaxone back for review to a federal circuit court.
In a filing to the BSE, Natco said the US Supreme Court remanded the case relating to Teva's 'patent no 5,800,808' back to US Court of Appeals for the Federal Circuit for that court "to review the patent's validity in accordance with a partially modified standard of review".
Natco had entered into an exclusive licensing and supply agreement with Mylan Laboratories for glatiramer acetate, the generic version of Teva's Copaxone in June 2008. It had, however, faced patent litigation from Teva.
In 2011, a New York trial judge upheld the validity of a Teva patent on the drug and prevented generic-drug makers, including Novartis AG's Sandoz unit and Mylan Inc. From entering the market until the patent expired.
This was, however, reversed by the Federal Circuit Court ruling in 2013 stating the patent was invalid and it was challenged by Teva in the US Supreme Court.
"The Supreme Court made no finding as to the validity of the US'808 patent, but instead sent the case back to the Federal Court to consider the matter in view of the modified standard," Natco Pharma said in its filing.
Shares of Natco Pharma plunged by 5.90 per cent on BSE, closing at 1,432.10 per scrip.
Although the current case relates to strength of 20mg/ml, Natco had last year announced that its marketing partner Mylan had filed an Abbreviated New Drug Application (ANDA) for generic Copaxone of 40mg/ml strength and expected 180 days of marketing exclusivity.
On the other hand commenting on the development, Teva President and CEO said: "We are encouraged by the U S Supreme Court's Decision and look forward to the Federal Circuit's review.
"We will continue to explore all available avenues to protect our intellectual property for Copaxone 20mg/mL."
As per reports, Copaxone accounted for USD 3.1 billion out of Teva's total revenue of USD 15.1 billion in the first nine months of last year.
