US drugmaker OSI Pharmaceuticals has filed two law suits in the US District Court in Delaware against Israeli-owned Teva Pharmaceuticals USA and Mylan Pharmaceuticals for infringement of US patent nos 5,747,498, 6,900,221 and 7,087,613, all of which are associated with the firm's targeted lung cancer drug Tarceva (erlotinib).
The law suits are based on Abbreviated New Drug Applications filed by Teva and Mylan seeking permission to manufacture and market a generic version of the drug before the expiration of the three patents. The filing of these restricts the Food and Drug Administration from approving these ANDAs until May 18, 2012 (the statutory stay period), unless an adverse court ruling occurs prior to such time. OSI says it "plans to vigorously protect and enforce the intellectual property rights of Tarceva."
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