Noven Pharmaceuticals, Inc. announced today that it has filed a lawsuit in the U.S. District Court for the Southern District of New York against Mylan Technologies Inc. ("Mylan") claiming infringement of certain Noven patents (the "Patents") by Mylan.
The lawsuit was filed as a result of an Abbreviated New Drug Application (ANDA) submission by Mylan seeking FDA approval to market and sell a generic version of Vivelle-Dot® (estradiol transdermal system) prior to the scheduled expiration of the Patents in 2014. The lawsuit reflects Noven's commitment to vigorously defending its intellectual property rights against infringement.
Under the Hatch-Waxman Act, because Noven filed this patent infringement lawsuit within 45 days of receiving a Paragraph IV notification letter from Mylan, the FDA must refrain from approving Mylan's ANDA for 30 months (until June 2013), or until a district court decision declaring that the Patents are invalid or not infringed, whichever occurs earlier.
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