Wyeth to sue Teva over generic version of Protonix

The patent dispute over Protonix rewed up when Wyeth Pharmaceuticals said it would pursue a patent infringement claim for lost profits and other damages against Teva Pharmaceuticals USA, Inc after Teva launched the generic version of Wyeth's top-selling heart burn drug Protonix.

"Teva has not disputed that its product infringes the United States Protonix compound patent exclusively licensed to Wyeth by Altana, recently acquired by Nycomed," said Lawrence V. Stein, senior vice president and general counsel, Wyeth. "We believe our patent is valid and enforceable and that Teva will be required to compensate Wyeth for the substantial damages caused by Teva's violation of our patent rights."

On September 6, 2007 the United States District Court for the District of New Jersey denied Wyeth and Altana's motion for a preliminary injunction against the launch of a generic pantoprazole tablet by Teva and Sun Pharmaceuticals prior to resolution of a pending patent infringement proceeding. Although Teva and Sun did not dispute that such a launch would infringe the Protonix patent, the court found that the defendants had raised sufficient questions about the validity of the patent to preclude the 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 court stated that at trial, the generic companies would face the higher burden of demonstrating by clear and convincing evidence that the patent is not valid. At trial, Wyeth will seek to recover its lost profits and other damages resulting from Teva's infringing sales and a permanent injunction against future sales of generic pantoprazole prior to expiration of the Protonix patent.

The patent will expire in July 2010, but Wyeth's marketing exclusivity may be extended until January 2011 as a result of clinical research undertaken by the company regarding the paediatric use of the product.

Sales of Protonix for the first nine months of 2007 totalled approximately $1.4 billion.

Wyeth Pharmaceuticals, a division of Wyeth, has leading products in the areas of women's health care, infectious disease, gastrointestinal health, central nervous system, inflammation, transplantation, haemophilia, oncology, vaccines and nutritional products.