Sun and Teva losing battle over generic Protonix

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Sun and Teva losing battle over generic Protonix

Generics/News | Posted 13/08/2010 0 Post your comment

On 19 July 2010, it was announced that a US court had denied a motion by India’s Sun Pharmaceutical Industries and Israel-based Teva Pharmaceutical Industries to reverse the earlier verdict of patent infringement on Pfizer/Nycomed’s gastrointestinal drug Protonix (pantoprazole).

The district court in New Jersey upheld a ruling made in April 2010 which found the patent on Protonix held by Pfizer’s Wyeth unit to be valid. The court has not yet issued its reasoning for the decision and both Sun and Teva have stated that they “continue to believe the patent is invalid and unenforceable”, adding that they “intend to pursue all available legal remedies including appeals”.

Pantoprazole is a proton pump inhibitor used to reduce or prevent the production of gastric acid.

Sun and Teva's Pantoprazole Sodium DR tablets are the generic equivalent of Wyeth's acid reflux treatment Protonix DR tablets. Teva began commercially shipping the product in December 2007 and Sun in February 2008.

Both generic manufacturers stated that they have not been prohibited from selling generic versions of Protonix before the expiry of Pfizer's marketing exclusivity in January 2011, as other claims concerning the validity of the patents, including patent misuse, are still pending.

Nycomed’s Chief Executive, Mr Hakan Bjorklund, said, “we are very pleased that the court recognised and acknowledged that our patent is valid”, adding that patents “represent the foundation of pharmaceutical innovation”. The Swiss firm went on to say it “will continue to vigorously pursue its damage claims”, noting that in 2007, before Teva and Sun started their at-risk launches of generic Protonix, sales of the drug reached US$1.9 billion, “and have since then decreased considerably”.

Nycomed and Wyeth filed their patent infringement lawsuit against Sun and Teva in May 2004, which if won could mean large damage claims against the generic companies.

References:

Nycomed Press Release. Nycomed’s U.S. patent for Protonix (pantoprazole) valid. 19 July 2010

Sun Pharmaceutical Industries Press Release. Sun Pharma: An update on generic Protonix litigation. 19 July 2010

Teva Press Release. Teva Provides Update on Generic Protonix Litigation. 19 July 2010