By Suresh Pillai --
GeoPharma and Dr. Reddy's Resolve Patent Litigation Related to Claritin® Patents
On January 20, 2009, GeoPharma, based in Largo, FL, announced the settlement of its Clarinex® (Desloratadine) ANDA patent litigation with Schering-Plough (based in Kenilworth, NJ) and Sepracor (based in Marlborough, MA) (see "Court Report," February 24, 2008). On February 20, 2008, Sepracor and Schering filed suit against GeoPharma for infringement of U.S. Patent Nos. 6,100,274, 7,214,683, and 7,214,684. Prior to this filing, GeoPharma had filed a Paragraph IV certification claiming that these patents were either invalid or had not been infringed upon.
The settlement allows GeoPharma to commercially launch its generic Desloratadine drug on July 1, 2012 (or earlier under certain conditions), with a six month marketing exclusivity. Other specific terms and conditions of the settlement agreement have not been disclosed. The agreement itself is subject to review by the United States Federal Trade Commission and the Department of Justice.
The GeoPharma settlement is but the most recent settlement of lawsuits covering the Clarinex® patents. On December 23, 2008, Dr. Reddy's, based in Hyderabad, India, announced a settlement of its own ANDA patent litigation with Schering and Sepracor (see "Court Report," October 27, 2007). This settlement resolves all pending patent infringement actions filed by Schering and Sepracor against Dr. Reddy's in the U.S. District Court for the District of New Jersey. Under the terms of the agreement, Dr. Reddy's is allowed to manufacture and market generic versions of Clarinex-D®-12 Hour and Clarinex-D®-24 Hour products, with six months marketing exclusivity. Dr. Reddy's also will receive marketing co-exclusivity for its generic version of Clarinex® 5 mg tablet for six months following the launch of the first generic version of that product. The 
agreement is subject to the review of the United States Federal Trade Commission and Department of Justice.
Roche Removes Patent from Boniva® Litigation
Last month, Roche announced that it was dropping one of the patents connected with its multi-party infringement suit, first filed in 2007, against companies manufacturing generic versions of the Roche drug Boniva®. Subsequent to its initial lawsuit filings in 2007, the ongoing lawsuits were consolidated into a single case before U.S. District Court for the District of New Jersey. Until this action, patents that were the subject of the lawsuit included U.S. Patent Nos. 6,294,196, 7,192,938, 7,410,957, and 4,927,814.
In this latest action by Roche, it agreed to drop litigation over the '196 patent with all eight of the defendant drug companies, a group that includes GenPharm, a Mylan subsidiary (see "Court Report," October 7, 2007). In addition to dropping the patent from litigation, Roche granted GenPharm a covenant not to sue based on the pharmaceutical products already being manufactured by GenPharm. The covenant does not cover future GenPharm products. Roche continues to litigate the three remaining patents in suits against all eight defendant companies.
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