Noven Files Patent Infringement Lawsuit Against Mylan Technologies

-- 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.

About Noven
Noven Pharmaceuticals, Inc. is a specialty pharmaceutical company engaged in the research, development, manufacturing, marketing and sale of prescription pharmaceutical products. Noven’s business and operations are focused in three principal areas – transdermal drug delivery and related manufacturing, the Novogyne joint venture, and Noven Therapeutics, Noven’s specialty pharmaceutical unit. Noven is committed to developing and offering products and technologies that meaningfully benefit patients, its customers and its industry partners. Noven is a stand-alone operating subsidiary of Japan-based Hisamitsu Pharmaceutical Co., Inc., and is positioned to serve as Hisamitsu’s U.S. growth platform in prescription pharmaceuticals. For more information about Noven, visit For information about Hisamitsu, visit

Joseph C. Jones
Vice President – Corporate Affairs
Noven Pharmaceuticals, Inc.