ANDA case

OSI Pharmaceuticals, Inc., Pfizer and Genentech

Our attorneys helped clients OSI Pharmaceuticals, Inc., Pfizer, Inc. and Genentech, Inc. successfully defeat a challenge by generic drug manufacturer, Mylan Pharmaceuticals, Inc. (Mylan), which was seeking FDA approval to market a generic version of Tarceva®. Annual worldwide sales of Tarceva total approximately one billion dollars.

Mylan challenged both the patent covering the compound erlotinib, the active ingredient in Tarceva, as well as a second patent covering the method of using erlotinib to treat non-small-cell lung cancer (NSCLC). After a 5-day bench trial, the US District Court for the District of Delaware ruled that the two patents covering Tarceva and its use are not invalid. The Court rejected Mylan’s assertions that the patent covering the compound erlotinib was obvious and that the second patent covering the method of using erlotinib to treat NSCLC was anticipated by or rendered obvious by prior art. Viewing the record as a whole, the Court found that “Mylan did not meet its burden to demonstrate that the patents are invalid by clear and convincing evidence.”

The case was OSI Pharmaceuticals Inc., Pfizer, Inc. and Genentech Inc. v. Mylan Pharmaceuticals Inc. (Civ. No. 09-185-SLR).

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