Kaye Scholer Wins Victory for Patent Holders of Cancer Drug Tarceva in ANDA Case
May 1, 2012
Kaye Scholer helped its 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.”
Kaye Scholer IP Partner Ben Hsing led the team representing the plaintiffs, along with IP Counsel Sapna Palla, and Associates Daniel Forchheimer and Hanna Cohen. Former Kaye Scholer Partner Leora Ben-Ami also advised on the matter. The case was OSI Pharmaceuticals Inc., Pfizer, Inc., and Genentech Inc. v Mylan Pharmaceuticals Inc. (Civ. No. 09-185-SLR).
In August 2011, Kaye Scholer successfully helped Pfizer turn back a challenge by Teva Pharmaceuticals when Pfizer defeated Teva’s attempt to bring a generic version of Viagra® to the market in 2012. That victory preserved through 2019 Pfizer’s patent exclusivity for its blockbuster drug.