BioCentury
ARTICLE | Company News

InSite, Merck, Novartis, Pfizer ophthalmic news

November 18, 2013 8:00 AM UTC

Novartis' Sandoz Inc. generics unit filed an appeal asking the U.S. Court of Appeals for the Federal Circuit to rehear a 2011 patent infringement suit regarding AzaSite 1% azithromycin ophthalmic solution. In October, the U.S. District Court for the District of New Jersey ruled in favor of Merck, Pfizer and InSite in the case, InSite Vision Inc. et al. vs. Sandoz Inc. et al. The lower 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 are 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 (see BioCentury, Oct. 14).

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. ...