Tuesday, July 16, 2013

Copaxone Litigation - District Court rules in favor of Natco / Mylan

Mylan Inc. (Nasdaq: MYL) today announced that Judge Katherine Forrest of the U.S. District Court for the Southern District of New York has dismissed Teva's lawsuit alleging that Mylan's Abbreviated New Drug Application ("ANDA") for its generic version of Copaxone® (glatiramer acetate) would infringe four patents held by Teva (U.S. Patent Nos. 66,514,938, 7,074,580, 7,163,802, and 7,615,359).


Implications

We believe this lower court decision does not change the timing of likely generic entry from a patent standpoint, as the process patent which is still under appeal in the federal circuit still needs to be invalidated. The process patent expires in 2015, while the patent (related to markers of glatiramer acetate) which have been recently dismissed by the lower court expires in 2019/2020.   The federal circuit decision on the process patent is due in 3rd or 4th quarter this year. In case the generic players are able to invalidate the process patent, that would allow generic entry in 2014 ( subject to USFDA approval). 


Mylan is appealing to the Federal Circuit a separate decision involving other Teva patents (U.S. Patent Nos. 5,800,808, 5,981,589, 6,048,898, 6,054,430, 6,342,476, 6,362,161, 6, 620,847, 6,939,539 and 7,199,098), which were upheld by retired Judge Barbara Jones of the Southern District of New York. Oral argument on Mylan's appeal was held on May 7, 2013.


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