Wednesday, June 19, 2013

Teva, Sun Settle Suit over Pantoprazole Patent

Case Filed: Sep 13, 2007

Case Closed: Jul 16, 2013

Judge: Jose L. Linares

Court: New Jersey District Court

Case Summary:
A patent infringement suit was filed by Atlanta Pharma and Wyeth against Teva and Sun as a result of filing an Abbreviated New Drug Application (ANDA) no. 77-056 and 77-058 (respectively) with the FDA concerning its intent to market 20 mg and 40 mg generic Protonix® (pantoprazole sodium) tablets. 

The patent involved in this suit was US4758579, entitled Fluoroalkoxy substituted benzimidazoles useful as gastric acid secretion inhibitors issued on Jul 19, 1988 and expired[*] on Jul 19, 2005. The patent was last assigned[†] to Nycomed (subsidiary of Pfizer) (source: MaxVal’s Assignment Database). As per the complaint, Atlanta owns the patent and Wyeth (owned by Pfizer) is the exclusive licensee of the ‘579 patent.

Wyeth/Pfizer is the current holder of the NDA no. 20-987 for which the FDA granted approval for 20 and 40 mg delayed-release tablets with active ingredient pantoprazole sodium that are sold under the trade name Protonix. It is used to treat erosive esophagitis (damage to the esophagus from stomach acid), and other conditions involving excess stomach acid such as Zollinger-Ellison syndrome.

The case is concluded as Teva, Sun, Wyeth/Pfizer and Altana/Nycomed (subsidiary of Pfizer) announced that they have entered into a settlement agreement to resolve the patent dispute. As part of the settlement, Teva and Sun agreed to pay $2.15 billion to Wyeth/Pfizer and a partner to settle the litigation over unauthorized sales of the heartburn drug with pantoprazole sodium as active ingredient. Pursuant to the settlement, Court ordered all claims and counterclaims be dismissed with prejudice. 

See 2:04-cv-02355 for more details. To get alerts on cases filed/closed, subscribe to our Litigation Alerts.

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[*] Expected expiration date. Patent Term Estimator is a free web-based tool that automatically calculates patent terms and expiration dates for U.S. utility patents.
[†] MaxVal offers Patent Assignment Alert service where subscribers receive email alerts when assignments relating to target applications, patents or entities of interest are recorded.

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