Sun Pharmaceutical Industries said the US District Court for New Jersey had denied its appeal to reverse an earlier jury verdict in the patent litigation over the generic version of Wyeth’s heartburn medicine, Protonix.
With this, Sun Pharma is facing the possibility of paying damages for launching the drug ‘at risk’, if the final verdict goes against it.
“The claims of Sun Pharma show it will further pursue the case and will continue to sell the drug. If it loses the case, it may have to face damage claims which may be two-three times of the earnings, i.e. around $80-$100 million,” said Ranjit Kapadia, vice-president, institutional research, with HDFC Securities.
However, another research company said the damages, if Sun Pharma had to pay, might amount up to $400 million.
Sun Pharma said the detailed opinion of the court supporting the order had not been issued. The company continues to believe the patent is invalid and unenforceable, and will pursue all available legal remedies, including appeals, according to a statement issued on Saturday. The court had not prohibited it from selling the product prior to January 20, 2011, the first day after the end of pediatric exclusivity, claimed Sun Pharma.
“Other claims of Sun Pharma, including patent misuse and unclean hands, that also concern the validity and enforceability of the patents remain pending. In view of this, the court denied Wyeth and Nycomed’s motion seeking a court order to set the effective approval date for the ANDA (abbreviated new drug application) to January 20, 2011, the first day after the end of pediatric exclusivity,” the company said.
Sun Pharma is fighting with Wyeth and Nycomed over the patent validity of this drug. Now, Wyeth is owned by the largest drug maker, Pfizer.
Sun Pharma and Israel-based Teva Pharmaceutical Industries were the first to challenge the validity of the drug’s patent. Protonix, Wyeth’s third best-selling drug, had sales of $2.5 billion for the 12 months ended June 30, 2007.
Sun Pharma had commercially launched the product on January 30, 2008, a month after Teva launched it. Prasco Laboratories had launched another product, an authorised generic version by Wyeth, a day before Teva’s launch. Wyeth had tried to get an injunction to stop the launch of generics soon after Teva’s launch, but failed to get one.
Sun Pharma’s shares today closed at Rs 1,721.15, down 1.07 per cent, on the Bombay Stock Exchange.
