Nycomed and Wyeth Continue Lawsuit to Defend Patent for Pantoprazole


Nycomed and its licence holder Wyeth Pharmaceuticals, a division of Wyeth (NYSE:WYE), announced today that the United States District Court for the District of New Jersey denied Nycomed’s and Wyeth’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® (pantoprazole sodium) prior to resolution of ongoing patent litigation between the parties. The case will now proceed to trial.

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.

ALTANA Pharma AG, acquired by Nycomed at the beginning of this year, and Wyeth sued Teva and Sun for patent infringement based on Teva’s and Sun’s filing of Abbreviated New Dug Applications (ANDAs) seeking U.S. Food and Drug Administration (FDA) approval to market generic versions of Protonix® before the patent for pantoprazole, the active ingredient in Protonix®, 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, Nycomed and Wyeth filed a motion for preliminary injunction to prevent launch of a generic product pending the resolution of the lawsuit.

About Nycomed

Nycomed is a pharmaceutical company that provides medicines for hospitals, specialists and general practitioners, as well as over-the-counter medicines in selected markets.

The company is active within a range of therapeutic areas, including cardiology, gastroenterology, osteoporosis, respiratory, pain and tissue management. New products are sourced both from own research and from external partners. Operating throughout Europe and in fast-growing markets such as Latin America, Russia/CIS and the Asia-Pacific region Nycomed has a presence in about 50 markets worldwide.

Privately owned, the combined group had annual sales of approximately € 3.4 billion and an EBITDA of € 933.4 million (2006 results).

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