Healthcare Industry News: Protonix
News Release - December 24, 2007
Wyeth Will Pursue Claim for Damages Resulting From Teva Pharmaceuticals' Launch of Generic Pantoprazole in Violation of PROTONIX PatentCOLLEGEVILLE, Pa., Dec. 24 (HSMN NewsFeed) -- Wyeth Pharmaceuticals, a division of Wyeth (NYSE: WYE ), today announced it will pursue a patent infringement claim for lost profits and other damages against Teva Pharmaceuticals USA, Inc. resulting from Teva's launch of a pantoprazole tablet -- a generic version of Wyeth's 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," says 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. That 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 pediatric use of the product.
Sales of Protonix for the first nine months of 2007 totaled approximately $1.4 billion.
Wyeth will hold a conference call with research analysts at 8 a.m. on December 24, 2007 to discuss its plans going forward. Interested investors and others may listen to the call live or on a delayed basis through the Internet web cast, which may be accessed by visiting the Company's website at www.wyeth.com and clicking on the "Investor Relations" hyperlink.
About Wyeth Pharmaceuticals
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, hemophilia, oncology, vaccines and nutritional products.
Wyeth is one of the world's largest research-driven pharmaceutical and health care products companies. It is a leader in the discovery, development, manufacturing and marketing of pharmaceuticals, vaccines, biotechnology products and non-prescription medicines that improve the quality of life for people worldwide. The Company's major divisions include Wyeth Pharmaceuticals, Wyeth Consumer Healthcare and Fort Dodge Animal Health.
The statements in this press release and on the related conference call that are not historical facts are forward-looking statements based on current expectations of future events and are subject to risks and uncertainties that could cause actual results to differ materially from those expressed or implied by such statements. In particular, we note that the impact of the launch of generic pantoprazole tablets on sales of Protonix cannot be predicted with certainty and will depend upon market and competitive conditions, the outcome of future proceedings in this litigation and other factors, many of which are beyond our control. We and Nycomed may not be able to uphold the validity of the Protonix patent, recover our lost profits and other damages resulting from infringing sales and/or obtain a permanent injunction against further sales of generic pantoprazole. Other risks and uncertainties include the inherent uncertainty of the timing and success of, and expense associated with, research, development, regulatory approval and commercialization of our products, including with respect to our pipeline products; government cost-containment initiatives; restrictions on third-party payments for our products; substantial competition in our industry, including from branded and generic products; data generated on our products; the importance of strong performance from our principal products and our anticipated new product introductions; the highly regulated nature of our business; product liability, intellectual property and other litigation risks and environmental liabilities; uncertainty regarding our intellectual property rights and those of others; difficulties associated with, and regulatory compliance with respect to, manufacturing of our products; risks associated with our strategic relationships; economic conditions including interest and currency exchange rate fluctuations; changes in generally accepted accounting principles; trade buying patterns; the impact of legislation and regulatory compliance; risks and uncertainties associated with global operations and sales; and other risks and uncertainties, including those detailed from time to time in our periodic reports filed with the Securities and Exchange Commission, including our current reports on Form 8-K, quarterly reports on Form 10-Q and annual report on Form 10-K, particularly the discussion under the caption "Item 1A, Risk Factors." The forward-looking statements in this press release and on the related conference call are qualified by these risk factors. We assume no obligation to publicly update any forward-looking statements, whether as a result of new information, future developments or otherwise.
Source: Wyeth Pharmaceuticals
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