Sun Pharma announced that the US District Court for the District of New Jersey denied its motion for judgement as a matter of law seeking to reverse the earlier jury verdict in the patent litigation over generic Protonix. The detailed opinion of the Court supporting this order has not yet been issued. Sun Pharma continues to believe that the patent is invalid and unenforceable and will pursue all available legal remedies including appeals.
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 to January 20, 2011, the first day after the end of paediatric exclusivity. As a result, Sun Pharma is not prohibited from further selling the product prior to January 20, 2011.
Pantoprazole Sodium DR Tablets are the AB-rated generic equivalent of Wyeth's Protonix DR Tablets. Sun Pharma had announced a commercial launch of the product on January 30, 2008, after the December 22, 2007 commercial launch by Teva Pharmaceutical Industries Ltd. of generic Pantoprazole Sodium tablet products, and after the January 29, 2008 commercial launch by Wyeth of generic Pantoprazole Sodium tablets product through its designated distributor.
Protonix is a registered trademark of Wyeth Pharmaceuticals, Inc.