Momenta, Mylan, Natco Pharma Ltd., Novartis, Teva autoimmune news

Teva filed a motion to add three undisclosed patents to its 2008 complaint against Momenta and Novartis' Sandoz International GmbH generics unit regarding Teva's Copaxone glatiramer acetate. The amendment was filed "under seal." The original suit, filed in August 2008 in the U.S. District Court of the Southern District of New York, alleges that Momenta and Sandoz, which submitted an ANDA for generic Copaxone, are infringing U.S. Patents Nos. 7,199,098; 6,939,539; 6,054,430; 6,620,847; 5,981,589; 6,342,476; and 6,362,161, which expire in 2014. Teva said the additional undisclosed patents expire after 2014 (see BioCentury, Sept. 8, 2008).

Separately, Teva sued Mylan and Natco in the same court, alleging that Mylan's September ANDA for generic Copaxone infringes all seven disclosed patents. Mylan's ANDA contains a Paragraph IV claim that the patents are invalid, unenforceable or not infringed. Teva seeks to prevent Mylan from selling its generic until the patents expire. Mylan has a deal with Natco to manufacture generic Copaxone. ...