On September 06, 2006 the U.S. Court of Appeals for the Federal Circuit upheld the District Court decision that Mylan’s unique delivery system did not infringed the U.S. Patent No. 6,124,355 (the ‘355 patent) assigned to ALZA Corporation (now Johnson & Johnson subsidiary) and declared the ‘355 patent invalid on the grounds of anticipation and obviousness. This judgment would now trigger Mylan’s exclusive supply deal with Ortho-McNeil Pharmaceutical and ALZA Corporation, and allow Mylan to launch its generic Ditropan XL with 180-day marketing exclusivity for 5mg and 10mg strengths in the U.S. Ditropan XL market worth around US $ 440 million (2005). The CAFC also upheld a similar lower court decision for Impax Laboratories which holds 180-day marketing exclusivity for 15mg strength.
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