OSI Pharmaceuticals Files Patent Infringement Lawsuits Against Teva Pharmaceuticals USA and Mylan Pharmaceuticals
20 March 2009 - 12:34PM
Business Wire
OSI Pharmaceuticals, Inc. (NASDAQ: OSIP) announced today that
the Company has filed two lawsuits in U.S. District Court in
Delaware against Teva Pharmaceuticals USA, Inc. (�Teva�) and Mylan
Pharmaceuticals, Inc. (�Mylan�) for infringement of US Patent No.
5,747,498, US Patent No. 6,900,221 and US Patent No. 7,087,613. All
three patents are associated with Tarceva� (erlotinib).
The lawsuits are based on Abbreviated New Drug Applications
(ANDAs) filed by Teva and Mylan seeking permission to manufacture
and market a generic version of Tarceva before the expiration of
the three patents. The filing of these lawsuits restricts the FDA
from approving Teva and Mylan�s ANDAs until May 18, 2012 (the
statutory stay period), unless an adverse court ruling occurs prior
to such time.
OSI plans to vigorously protect and enforce the intellectual
property rights of Tarceva.
About OSI
Pharmaceuticals
OSI Pharmaceuticals is committed to "shaping medicine and
changing lives" by discovering, developing and commercializing
high-quality, novel and differentiated personalized medicines
designed to extend life and improve the quality of life for
patients with cancer and diabetes/obesity. For additional
information about OSI, please visit http://www.osip.com.
This news release contains forward-looking statements. These
statements are subject to known and unknown risks and uncertainties
that may cause actual future experience and results to differ
materially from the statements made. Factors that might cause such
a difference include, among others, OSI's and its collaborators'
abilities to effectively market and sell Tarceva and to expand the
approved indications for Tarceva, OSI�s ability to protect its
intellectual property rights, safety concerns regarding Tarceva,
competition to Tarceva and OSI�s drug candidates from other
biotechnology and pharmaceutical companies, the completion of
clinical trials, the effects of FDA and other governmental
regulation, including pricing controls, OSI's ability to
successfully develop and commercialize drug candidates, and other
factors described in OSI Pharmaceuticals' filings with the
Securities and Exchange Commission.
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