NEW YORK, Nov. 24, 2008 /PRNewswire-FirstCall/ -- Forest Laboratories, Inc. announced today that the U.S. Patent and Trademark Office ("USPTO") has closed prosecution on the merits of the reexamination proceedings for the patent for Bystolic(R) and confirmed the validity of all of the previously granted claims. As a result, the USPTO has issued a Notice of Intent to Issue Ex Parte Reexamination Certificate for U.S. Patent No. 6,545,040 (the '040 patent) to Janssen Pharmaceutica N.V., the patent holder. The Notice withdraws all of the enumerated rejections and confirms such validity. The '040 patent covers nebivolol, the active ingredient in Bystolic(R), a beta-blocker that is currently approved in the United States for the treatment of hypertension. The '040 patent expires in April 2020. Forest has applied for patent term extension for this patent until December 2021.
(Logo: http://www.newscom.com/cgi-bin/prnh/20001011/FORESTLOGO ) About the Bystolic(R) License
Forest licensed U.S. and Canadian rights to nebivolol from Mylan Laboratories Inc. in January 2006. Forest markets nebivolol under the Bystolic trademark in the U.S. Mylan licensed the U.S. and Canadian rights to nebivolol from Janssen Pharmaceutica N.V. in February 2001, and has obtained Janssen's consent to sub-license nebivolol to Forest Laboratories in those territories.
About Forest Laboratories
Forest Laboratories is a U.S.-based pharmaceutical company with a long track record of building partnerships and developing and marketing products that make a positive difference in people's lives. In addition to its well-established franchises in therapeutic areas of the central nervous and cardiovascular systems, Forest's current pipeline includes product candidates in all stages of development and across a wide range of therapeutic areas. The company is headquartered in New York, NY. To learn more about Forest Laboratories, visit http://www.frx.com/.
Except for the historical information contained herein, this release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. These statements involve a number of risks and uncertainties, including the difficulty of predicting FDA approvals, the acceptance and demand for new pharmaceutical products, the impact of competitive products and pricing, the timely development and launch of new products, and the risk factors listed from time to time in Forest Laboratories' Annual Report on Form 10-K, Quarterly Report on Form 10-Q, and any subsequent SEC filings.
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