U.S. District Court Rules Against Merck in TEMODAR® (temozolomide) Patent Lawsuit
The company will appeal the decision
WHITEHOUSE STATION, N.J., Jan. 26, 2010 - Merck & Co., Inc. announced today that the U.S. District Court for the District of Delaware ruled against the company in a patent infringement suit against Teva Pharmaceuticals USA Inc.
"We are very disappointed with the court's ruling, and we continue to believe the patent for TEMODAR in the U.S. is valid and enforceable," said Bruce N. Kuhlik, executive vice president and general counsel at Merck. "Today's decision reflects a step in the lengthy patent litigation process, and we plan to appeal this decision."
Teva is seeking FDA approval to sell a generic version of the 5, 20, 100, 140, 180 and 250 mg capsules of TEMODAR, a chemotherapeutic agent approved for the treatment of adult patients with newly diagnosed glioblastoma multiforme and for refractory anaplastic astrocytoma, two forms of brain cancer.
In her decision, Judge Sue L. Robinson ruled that Merck's patent on TEMODAR was unenforceable due to prosecution latches and/or inequitable conduct.
Today's Merck is working to help the world be well. Through our medicines, vaccines, biologic therapies, and consumer and animal products, we work with customers and operate in more than 140 countries to deliver innovative health solutions. We also demonstrate our commitment to increasing access to health care through far-reaching programs that donate and deliver our products to the people who need them. Merck. Be Well. For more information, visit www.merck.com.
Forward Looking Statement
This news release includes "forward-looking statements" within the meaning of the safe harbor provisions of the United States Private Securities Litigation Reform Act of 1995. Such statements may include, but are not limited to, statements about the benefits of the merger between Merck and Schering-Plough, including future financial and operating results, the combined company's plans, objectives, expectations and intentions and other statements that are not historical facts. Such statements are based upon the current beliefs and expectations of Merck's management and are subject to significant risks and uncertainties. Actual results may differ from those set forth in the forward-looking statements.
The following factors, among others, could cause actual results to differ from those set forth in the forward-looking statements: the possibility that the expected synergies from the merger of Merck and Schering-Plough will not be realized, or will not be realized within the expected time period, due to, among other things, the impact of pharmaceutical industry regulation and pending legislation that could affect the pharmaceutical industry; the risk that the businesses will not be integrated successfully; disruption from the merger making it more difficult to maintain business and operational relationships; Merck's ability to accurately predict future market conditions; dependence on the effectiveness of Merck's patents and other protections for innovative products; the risk of new and changing regulation and health policies in the U.S. and internationally and the exposure to litigation and/or regulatory actions.
Merck undertakes no obligation to publicly update any forward-looking statement, whether as a result of new information, future events or otherwise. Additional factors that could cause results to differ materially from those described in the forward-looking statements can be found in Merck's 2008 Annual Report on Form 10-K, Schering-Plough's Quarterly Report on Form 10-Q for the quarterly period ended September 30, 2009, the proxy statement filed by Merck on June 25, 2009 and each company's other filings with the Securities and Exchange Commission (SEC) available at the SEC's Internet site: www.sec.gov.