Albany Molecular Research, Inc. and its wholly owned subsidiary, AMR Technology, Inc., announced that a settlement regarding U.S. patent infringement litigation involving ALLEGRA® and ALLEGRA®D-12 has been reached among them, Aventis Pharmaceuticals, Inc., sanofi-aventis U.S. LLC, Teva Pharmaceuticals, USA, Inc. and Barr Laboratories, Inc. The settlement agreement and related licensing arrangements are subject to review by the Federal Trade Commission and U.S. state Attorneys General. As part of the settlement, AMRI has entered into an amendment to its licensing agreement with sanofi-aventis U.S. LLC to allow sanofi-aventis U.S. LLC to sublicense patents related to ALLEGRA® and ALLEGRA®D-12 to Teva Pharmaceuticals, USA, Inc. and Barr Laboratories, Inc. in the United States. AMRI will receive an upfront sublicense fee from sanofi-aventis U.S. LLC of $10 million. Sanofi-aventis U.S. LLC will also provide royalties to AMRI on the sale of products containing fexofenadine hydrochloride (the generic name for the active ingredient in ALLEGRA® ) and products containing fexofenadine hydrochloride and pseudoephedrine hydrochloride (generic ALLEGRA®D-12) by Teva Pharmaceuticals, USA, Inc. and Barr Laboratories, Inc. through 2015, along with additional considerations. AMRI will continue to receive royalties from sanofi-aventis U.S. LLC for the sale of products containing ALLEGRA®, ALLEGRA®D-12 and authorized generics for the remaining term of the patents. Royalties for the sale of products containing ALLEGRA® outside of the United States were not part of this litigation and will continue to be unaffected. “This agreement to settle the patent litigation diversifies the number of products from which AMRI will receive royalty payments, removes uncertainty related to an at-risk launch of a generic version of ALLEGRA®D-12, and affirms the validity of our patents,” said AMRI Chairman, President and CEO Thomas E. D’Ambra. Litigation will continue for patent infringement related to ALLEGRA®, ALLEGRA®D-12, and ALLEGRA®D-24 for other generic drug manufacturers in the United States and other jurisdictions. In March 2004, AMRI joined Aventis Pharmaceuticals, Inc. in filing lawsuits pertaining to AMRI’s fexofenadine-related patents. Aventis Pharmaceuticals, Inc. originally filed patent infringement actions in the United States District Court for the District of New Jersey against several generic pharmaceutical manufacturers in 2001 based on patents relating to sanofi-aventis U.S. LLC’s ALLEGRA® and ALLEGRA®D-12 products.
