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U.S. District Court Rules Against Merck in NASONEX(mometasone furoate monohydrate) Patent Lawsuit

Fri, 06/15/2012 - 3:25pm
Merck

WHITEHOUSE STATION, N.J., June 15, 2012 – Merck (NYSE: MRK), known as MSD outside the United States and Canada, announced today that the U.S. District Court for the District of New Jersey ruled against the company in a patent infringement suit against Apotex Inc. and Apotex Corp.

"While we are pleased with the court's ruling that the patent for NASONEX is valid, we are disappointed the court ruled that this patent would not be infringed by the Apotex product. We believe the patent for NASONEX in the United States is valid and would be infringed by the Apotex product," said Bruce N. Kuhlik, executive vice president and general counsel of Merck. "Today's decision reflects just one step in the lengthy patent litigation process, and we plan to review all of our options, including a likely appeal of the decision."

The patent at issue in this case is U.S. Patent No. 6,127,353 that covers mometasone furoate monohydrate, the active ingredient in NASONEX and which provides exclusivity for this form of mometasone until April 3, 2018.

Apotex is seeking U.S. Food and Drug Administration (FDA) approval to sell a generic version of NASONEX.

Judge Peter G. Sheridan presided over the trial. Merck was represented by the law firms Weil, Gotshal & Manges LLP and Gibbons P.C.

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 www.merck.com and connect with us on Twitter, Facebook and YouTube.

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; 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 2011 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 (www.sec.gov).

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