USPTO Issues Notice of Final Determination for Patent Term Extension for NAMENDA(R)
Public Company Information:
Forest Laboratories, Inc. (NYSE: FRX) Forest Laboratories Holdings, Ltd., Merz Pharma GmbH & Co. KGaA, and Merz Pharmaceuticals GmbH announced today that the U.S. Patent and Trademark Office has issued a Notice of Final Determination granting the full five years of patent term extension for U.S. Patent No. 5,061,703 (the '703 Patent), which is listed in the U.S. Food and Drug Administration Orange Book for NAMENDA(R) (memantine hydrochloride). Forest has an exclusive license to the '703 patent from the German pharmaceutical company Merz Pharma. Forest and Merz have commenced patent litigation against several generic manufacturers who have filed ANDAs seeking FDA approval to market generic versions of NAMENDA. A trial in this litigation, pending in the U. S. District Court for the District of Delaware, is scheduled for April 2010. After review of the regulatory timeline for approval of NAMENDA(R) the U.S. Patent and Trademark Office determined that the '703 Patent is entitled to the full five years of patent term extension and will expire on April 11, 2015 instead of as originally anticipated on September 13, 2013.
Merz Pharmaceuticals researches, develops, produces and distributes innovative pharmaceutical products in the areas of neurology and psychiatry as well as in aesthetic dermatology and metabolism. In the area of Alzheimer's research, Merz Pharmaceuticals has achieved a leading position with the first active ingredient worldwide for the treatment of moderate to severe Alzheimer's disease. The company is headquartered in Frankfurt am Main, Germany. To learn more about Merz, visit www.merz.com.
About Forest Laboratories
Forest Laboratories (NYSE: FRX) 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 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.