Wyeth Seeks To Consolidate Protonix Patent Cases
This article was originally published in The Pink Sheet Daily
Executive Summary
Teva, Sun Pharmaceutical and Schwarz Pharma targeted in lawsuits involving the proton pump inhibitor.
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Wyeth and German drugmaker Altana plan to consolidate litigation against three generic drug companies in a patent infringement dispute involving the proton pump inhibitor Protonix (pantoprazole), according to an Aug. 9 court filing. Defendants in the cases are Teva, India-based Sun Pharmaceutical and Germany-based Schwarz Pharma and its subsidiary Kudco Ireland. The filing states that Wyeth and Altana will make the consolidation motion Sept. 11. In the cases, filed in New Jersey federal court, Altana and Wyeth allege that the generic companies have infringed on patent no. 4,758,579 through ANDA filings with FDA. According to FDA's "Orange Book," the '579 patent is valid through July 19, 2010. The '579 patent claims "certain compounds useful for inhibiting gastric acid secretion, including pantoprazole sodium, the active ingredient of Protonix," court documents state. Teva's ANDA application was filed in April 2004; Sun's application was filed in March 2005. Sun also filed a second application in June 2005 for an injectable form of pantoprazole, according to court documents. Teva received tentative ANDA approval April 19 for the 20 mg and 40 mg delayed-released tablets of pantoprazole, while Sun received tentative approval for the 20 mg tabs June 22. Schwarz filed its ANDA in July. Another company, Sandoz, also received tentative ANDA approval April 19, but Wyeth told "The Pink Sheet" DAILY that Sandoz's application was based on a Paragraph III certification, meaning the company will wait until the '579 patent expires in 2010. Sandoz is not a party to the case. A stay has been issued on final ANDA approvals until August 2007 or earlier if there is a court ruling, Wyeth said. Although Wyeth filed the original NDA for Protonix, Altana owns the patent, which is licensed to Wyeth in the United States. In Europe, pantoprazole will lose patent exclusivity in 2009. - Jonathan Block |