Wyeth and Nycomed Announce Court Denial of Preliminary ...( MADISON N.J. Sept. 6 /- Wyeth (NY...),Health

MADISON, N.J., Sept. 6 /PRNewswire-FirstCall/ -- Wyeth (NYSE: WYE), and its business partner Nycomed GmbH, announced today that the United States District Court for the District of New Jersey denied Wyeth's and Nycomed's motion for a preliminary injunction against Teva Pharmaceuticals USA, Inc. and Sun Pharmaceuticals Inc. seeking to prevent the launch of a generic version of PROTONIX(R) (pantoprazole sodium) prior to resolution of ongoing patent litigation between the parties. The Court determined that Teva had raised sufficient questions about the validity of the patent to preclude issuance of the extraordinary remedy of a preliminary injunction. The Court did not conclude that the patent was invalid and emphasized that its findings were preliminary.

The case will now proceed to trial, and the Court stated that the generic companies would need to meet a higher burden of proof, clear and convincing evidence.

Wyeth and Nycomed continue to believe that the PROTONIX patent is valid and enforceable, and will continue to pursue the litigation.

Wyeth and Altana Pharma AG (recently acquired by Nycomed) sued Teva and Sun for patent infringement based on Teva's and Sun's filing of Abbreviated New Drug Applications (ANDAs) seeking U.S. Food and Drug Administration (FDA) approval to market generic versions of PROTONIX before the patent expires on July 19, 2010. Under the Hatch-Waxman Act, the filing of the lawsuit stayed final FDA approval of Teva's ANDA until August 2, 2007, and Sun's ANDA until September 8, 2007. In anticipation of the end of those stays, Wyeth and Nycomed filed a motion for preliminary injunction to prevent launch of a generic product pending the resolution of the lawsuit.

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