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.
