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Merck Wins TEMODAR Patent Infringement Lawsuit on Appeal

Wednesday, November 10, 2010

Whitehouse Station, NJ -- Merck & Co., Inc. said today that a federal appellate court ruled in its favor in a TEMODAR patent infringement suit against Barr Laboratories, an affiliate of Teva Pharmaceuticals.

By a 2-1 vote, the appellate court rejected Barr's arguments and reversed a lower court ruling that the U.S. patent was unenforceable.

"The court appropriately ruled that the patent for TEMODAR in the U.S. is enforceable," said Bruce N. Kuhlik, executive vice president and general counsel of Merck. "We invest heavily in R&D to discover innovative medicines like TEMODAR, and we will vigorously defend our intellectual property rights."

Teva had been seeking FDA approval to sell a generic version of the 5, 20, 100, 140, 180 and 250 mg capsules of TEMODAR. In connection with Teva's prior agreement not to launch during the appeal, Merck agreed that it will not object to Teva's launch of a generic version of TEMODAR in August 2013. The U.S. patent and exclusivity periods otherwise will expire on February 2014.

Schering Corporation filed the patent infringement lawsuit against Barr in July 2007. A trial was held in U.S. District Court for the District of Delaware in October 2009.

About Merck

Today's Merck is a global healthcare leader working to help the world be well. Merck is known as MSD outside the United States and Canada. Through our prescription medicines, vaccines, biologic therapies, and consumer care and animal health 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 healthcare through far-reaching policies, programs and partnerships. For more information, visit

Forward Looking Statement

This statement 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; the impact of pharmaceutical industry regulation and health care legislation; 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 2009 Annual Report on Form 10-K and the company’s other filings with the Securities and Exchange Commission (SEC) available at the SEC’s Internet site (

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