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ARTICLE | Company News

InSite Vision Inc, Merck, Novartis, Pfizer ophthalmic news

October 14, 2013 7:00 AM UTC

The U.S. District Court for the District of New Jersey ruled in favor of Merck, Pfizer and InSite in InSite Vision Inc. et al. vs. Sandoz Inc. et al., a 2011 patent infringement suit against Novartis' Sandoz International GmbH generics unit regarding AzaSite 1% azithromycin ophthalmic solution. The court ruled that U.S. Patents Nos. 6,861,411; 6,239,113; 6,569,443; and 7,056,893, which cover AzaSite, are valid and infringed by Sandoz's ANDA submission for a generic version of AzaSite 1%. The court enjoined Sandoz from marketing its generic version in the U.S. until the latest expiration date of the patents. The '411 patent expires Nov. 25, 2018 and the '113, '433 and '893 patents each expire March 31, 2019. The court also dismissed with prejudice all of Sandoz's counterclaims for non-infringement and invalidity of the patents, which prevents Sandoz from re-filing the claims in court.

In June, Merck, Pfizer and InSite filed a similar suit in the court alleging that an ANDA from Mylan Inc. (NASDAQ:MYL, Canonsburg, Pa.) for a generic AzaSite 1% infringes the patents. The court has not yet scheduled a trial date. ...