Forest Laboratories has sued several companies including Teva Pharmaceuticals USA, Barr Laboratories Inc. and Lupin Ltd., to protect the lucrative market for the Alzheimer's drug Namenda from generic competition.
Forest and Merz Pharma GmbH & Co. KgaA filed two patent suits on Thursday in the U.S. District Court for the District of Delaware. One of the complaints names defendants including Teva, Lupin, Cobalt Laboratories Inc., Orchid Pharmaceuticals Inc., Upsher-Smith Laboratories Inc. and Wockhardt Limited. The other suit is against Barr Laboratories Inc. and Barr Pharmaceuticals Inc.
Barr has confirmed the lawsuit against him.
Namenda has a sales of $738 million for the 12 months leading up to Sept. 30, 2007, a Forest spokesman said Friday.
Patent at Issue:
US 5,061,703—entitled “Adamantane Derivatives in the Prevention and Treatment of Cerebral Ischemia” and issued in 1991, expiring in 2010, but Forest has applied for an extension that would extend the patent's life through September 2013, according to Forest.
Frankfurt, Germany-based Merz is the '703 patent's sole assignee, while Forest is the patent's exclusive licensee.
The suits were triggered by the defendants filing ANDA seeking the U.S. Food and Drug Administration's approval to market generic versions of Namenda.
All of the defendants' ANDAs included allegations that the '703 patent is invalid, unenforceable and/or not infringed by the commercial manufacture, use or sale of the proposed generics, according to Forest's complaints.
Both complaints ask the court for judgments that the defendants have infringed the '703 patent and that the effective date of any approval of the ANDAs at issue can't come before the expiration of the '703 patent. Forest also wants injunctive relief barring the defendants from making, using, selling or importing any of the proposed generics before the patent expires, and an award covering the attorneys' fees and costs incurred in the suits.
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