Wyeth (WYE) Files Preliminary Injunction Against Teva Pharma (TEVA) and Sun Pharmaceutical

June 25, 2007 9:04 AM EDT

In Today\'s 8-K Filing From Wyeth (NYSE: WYE): In May 2004, Altana Pharma AG (Altana) (which was recently acquired by Nycomed) and Wyeth filed suit against Teva Pharmaceuticals USA, Inc. and Teva Pharmaceutical Industries, Ltd. (Nasdaq: TEVA) in the United States District Court for the District of New Jersey alleging that Teva\'s filing of an Abbreviated New Drug Application (ANDA) seeking U.S. Food and Drug Administration (FDA) approval to market generic pantoprazole sodium tablets infringed U.S. Patent No. 4,758,579, which expires in July 2010. Pantoprazole sodium is the active ingredient in Protonix. As a result of the filing of that suit, final FDA approval of Teva\'s ANDA was automatically stayed until August 2, 2007. In April 2005, Altana and Wyeth filed suit against Sun Pharmaceutical Advanced Research Centre Ltd. and Sun Pharmaceutical Industries Ltd. (Sun) in the United States District Court for the District of New Jersey alleging that Sun\'s filing of an ANDA seeking FDA approval to market generic pantoprazole sodium tablets infringed that same patent. As a result of that suit, final FDA approval of Sun\'s ANDA was automatically stayed until September 8, 2007. These cases have been consolidated into a single proceeding pending before the United States District Court for the District of New Jersey. No trial date has yet been set.

Teva\'s and Sun\'s ANDAs have each been tentatively approved by the FDA. The FDA may finally approve Teva\'s and Sun\'s ANDAs for pantoprazole sodium tablets on August 2, 2007 and September 8, 2007, respectively.

In anticipation of potential final approval of these ANDAs, on June 22, 2007, Wyeth filed a motion with the Court seeking a preliminary injunction against both Teva and Sun that would prevent them from launching generic versions of Protonix until the Court enters a final decision in the litigation.

Wyeth believes that the patent will withstand the challenges by Teva and Sun and intends to vigorously enforce its patent rights. Wyeth also believes that it has a strong basis for seeking a preliminary injunction to prevent an early generic launch. However, the course and outcome of future proceedings in any litigation cannot be predicted with certainty. It is possible that Wyeth will not be able to prevent Teva and/or Sun from launching generic products following their receipt of final FDA approval, which likely would negatively impact sales of Protonix significantly.

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