US District Court for the District of New Jersey has denied Teva Pharmaceutical and Sun Pharma motion for judgment as a matter of law seeking to reverse the earlier jury verdict in the patent litigation over generic Protonix.
Wyeth and Nycomed's request for FDA to reset the date of Teva's final approval to January 2011, based on the fact that Teva has patent defences remaining at the District Court, including patent misuse, has also been rejected by the court.
Accordingly, Teva and Sun Pharma are not prohibited from making further sales prior to January 2011, the date when the paediatric exclusivity expires.
Other claims of Sun Pharma, including patent misuse and unclean hands, that also concern the validity and enforceability of the patents, remain pending.
Teva and Sun continue to believe the patent is invalid and unenforceable and intends to pursue all available legal remedies including appeals.
Teva's Pantoprazole Sodium DR tablets are the AB-rated generic equivalent of Wyeth's erosive Gerd treatment Protonix DR tablets.
Sun Pharma commercially launched the product on January 30, 2008, after the December 22, 2007 commercial launch by Teva Pharmaceutical 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.