U.S. Patent and Trademark Office Grants Reissued Patent Replacing OSI Pharmaceuticals’ Tarceva® Composition of Matter Patent
30 December 2009 - 2:01AM
Business Wire
OSI Pharmaceuticals, Inc. (NASDAQ: OSIP) today announced that
the U.S. Patent & Trademark Office (PTO) has granted reissue
patent RE41,065, replacing Tarceva’s® (erlotinib) composition of
matter patent (formerly No.5,747,498). The Company had applied for
the reissue patent in February 2008, and on September 17, 2009 the
Company had announced that the PTO had issued a “Notice of
Allowance” accepting the Company’s application to correct certain
errors relating to the claiming of compounds, other than Tarceva,
which had fallen outside of the scope of the main claim of the
patent. The reissue patent will have the same November 18, 2018
expiration date (excluding any potential six-month pediatric
exclusivity period) as the original ‘498 patent.
“We believe the reissue of the Tarceva patent, which now
includes a claim that solely identifies Tarceva, is a highly
successful outcome,” stated Colin Goddard, Ph.D., Chief Executive
Officer of OSI Pharmaceuticals. “In addition, we view this reissue
grant as a positive step in managing generic challenges to the
Tarceva patent estate.”
About OSI
Pharmaceuticals
OSI Pharmaceuticals is committed to "shaping medicine and
changing lives" by discovering, developing and commercializing
high-quality, novel and differentiated targeted 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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