Aventis announced that the company, along with AMR Technology, Inc. - a wholly owned subsidiary of Albany Molecular Research, Inc. - has filed additional patent infringement lawsuits against five companies currently seeking approval to produce and market generic versions of Allegra (fexofenadine HCl) and Allegra-D (fexofenadine HCl 60 mg/pseudoephedrine HCl 120 mg).
The lawsuits were filed in the United States District Court of New Jersey and are based on United States Patent Nos. 5,581,011 and 5,750,703, which are owned by AMR Technology, Inc. and exclusively licensed to Aventis. These patents, which expire in the late 2013-2015 timeframe, claim fexofenadine intermediates and processes for making fexofenadine.
Aventis previously filed patent infringement lawsuits against the same five companies involved in this latest action on patents claiming methods of using fexofenadine and fexofenadine formulations. Those companies are Barr Laboratories, Inc., Impax Laboratories, Teva Pharmaceuticals, Mylan Pharmaceuticals and Dr. Reddy's Laboratories. These previously-filed lawsuits are also pending in the District Court of New Jersey and Aventis has requested that the newly filed lawsuits involving the process patents be consolidated with the previously-filed lawsuits.
In a conference on March 8, 2004, the District Court of New Jersey set April 15, 2005 as the end date for the discovery phase of these cases. The previously-set trial date of September 2004 is no longer in effect and no new trial date has been scheduled.
Generic or other versions of Allegra that infringe Aventis' intellectual property rights cannot be marketed lawfully until a decision favorable to the other company in any related patent litigation were to occur, or until the automatic 30-month stay of FDA approval has elapsed, whichever comes first.