Ruling by US Court of Appeals is a major relief to the Indian company
Natco Pharma has won a patent case against Teva in the US. In a major relief to Natco Pharma, the US Court of Appeals has invalidated Teva’s Copaxone patent, which may help generic pharma companies to launch one of the topselling drugs used in the treatment of relapsing remitting multiple sclerosis. On 18 June 2015, the US Federal Circuit Court ruled in favour of Natco by invalidating Teva’s process patent 5,800,808. This means that Natco can launch generic Copaxone 20 mg in the US market, as soon as it receives US FDA approval.
Last year, the US Supreme Court denied Teva’s application for an injunction seeking to prevent the launch of a generic version of Copaxone. The pharma companies involved in the generic forms of Copaxone are Novartis’ Sandoz, Momenta Pharmaceuticals, Mylan and Natco Pharma.
According to available estimates, annual sales of Copaxone are in the region of US$4.3bn worldwide and account for more than half of Teva’s profit. In 2003, Natco began research to develop a generic version of Copaxone to make a cost effective version of the drug available to patients in India. Later, Natco developed a process for producing copolymer-1 and filed patent applications covering its process. A senior Natco official said that the firm has submitted all the information to the US FDA with regard to the generic version of Copaxone.
'The US Court of Appeals for Federal Circuit has again found Teva’s US 808 patent for Copaxone to be invalid as indefinite. The company awaits approval from the US Food and Drug Administration (US FDA) to launch the product,' Natco said in a filing to the exchanges.
In a separate statement, Mylan chief executive officer Heather Bresch said: 'We have stated all along that the ‘808 patent on Copaxone is invalid. We 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.
Sandoz is the only generic company to have received US FDA approval of Copaxone 20mg in April 2015. Sandoz was well prepared and launched the product on 18 June in the US marketplace, at a list price of $63,000 per year – an 18% discount on Teva’s $74,000 per year list price.