Allergan and Alcon have reached an agreement to settle two patent infringement lawsuits initiated by Allergan. Under the terms of agreement, Allergan will dismiss both patent suits with prejudice, and also grant Alcon a co-exclusive license with Allergan for brimonidine tartrate 0.15% ophthalmic solution. The settlement grants Alcon the right to introduce its brimonidine 0.15% product on September 30, 2009 or earlier if certain market conditions occur, the primary condition being a trigger based generally on the extent to which prescriptions of Alphagan P 0.15% have been converted to other brimonidine-containing products marketed by Allergan. In return, Alcon will pay royalties to Allergan on sales of the product once it has been launched.
Allergan filed the first lawsuit in the U.S District Court for the District of Delaware contending that Alcon’s proposed brimonidine 0.15% product infringes Allergan’s orange book listed US Patent Nos. 6,673,337 and 6,641,834. Both ‘337 and ‘834 patent are valid up to July 2021 and January 2022 (with pediatric exclusivity). The lawsuit was in response to a New Drug Application (NDA) filed by Alcon under section 505(b) (2) of the Federal Food, Drug and Cosmetic Act seeking approval for marketing generic brimonidine tartrate ophthalmic solution 0.15% product in the United States. Alcon’s product received tentative Food and Drug Administration (FDA) approval on 28th February 2005, but final approval was withheld pending resolution of the litigation.
The second lawsuit was filed in the U.S. District Court for the District of California alleging infringement of U.S Patent Nos. 6,166,012 and 6,492,361 directed to self-preserved antibiotic products. Alcon believes this lawsuit was intended to target its leading ophthalmic ocular antibiotic Vigamox (0.5% moxifloxacin HCl ophthalmic solution).
Allergan filed the first lawsuit in the U.S District Court for the District of Delaware contending that Alcon’s proposed brimonidine 0.15% product infringes Allergan’s orange book listed US Patent Nos. 6,673,337 and 6,641,834. Both ‘337 and ‘834 patent are valid up to July 2021 and January 2022 (with pediatric exclusivity). The lawsuit was in response to a New Drug Application (NDA) filed by Alcon under section 505(b) (2) of the Federal Food, Drug and Cosmetic Act seeking approval for marketing generic brimonidine tartrate ophthalmic solution 0.15% product in the United States. Alcon’s product received tentative Food and Drug Administration (FDA) approval on 28th February 2005, but final approval was withheld pending resolution of the litigation.
The second lawsuit was filed in the U.S. District Court for the District of California alleging infringement of U.S Patent Nos. 6,166,012 and 6,492,361 directed to self-preserved antibiotic products. Alcon believes this lawsuit was intended to target its leading ophthalmic ocular antibiotic Vigamox (0.5% moxifloxacin HCl ophthalmic solution).
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