Noven Pharmaceuticals, Inc. announced today that it has filed a lawsuit in the U.S. District Court of New Jersey against Watson Pharmaceuticals ("Watson") for infringement of certain Noven patents (the "Patents") by Watson.
The lawsuit was filed as a result of an Abbreviated New Drug Application (ANDA) submission by Watson seeking FDA approval to market and sell a generic version of Daytrana® (methylphenidate transdermal system) prior to the scheduled expiration of the Patents in 2018. 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 Watson, the FDA cannot approve Watson's ANDA for 30 months (until March 2014), unless the district court finds the Patents invalid or not infringed before the 30 months pass.
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