OSI Pharmaceuticals Response to Initial Non-Final Office Action by U.S. Patent and Trademark Office
February 27 2009 - 6:32AM
Business Wire
OSI Pharmaceuticals, Inc. (NASDAQ: OSIP) announced that the
Company received notification from the U.S. Patent and Trademark
Office (PTO) that an initial office action has been issued
regarding OSI�s application for a reissue of the Company�s
composition of matter patent for Tarceva� (erlotinib), U.S. Patent
No. 5,747,498 (the �498 patent). The office action includes an
indication of allowability to composition of matter claims,
including a claim specifically directed to Tarceva, while initially
rejecting certain other claims. A rejection of some claims in an
initial office action is not unusual in a patent reissue
application proceeding.
�We are pleased with the indication of allowability of
Tarceva-specific composition of matter claims and intend to respond
to the rejection of the remaining claims,� stated Colin Goddard,
Ph.D., Chief Executive Officer of OSI Pharmaceuticals. �We are
encouraged by the PTO�s response and are optimistic that this first
step will allow us to have the reissue process substantially
completed by the end of 2009.�
The �498 patent is one of three OSI patents covering Tarceva�
(erlotinib). All three Tarceva patents, the �498 patent, US Patent
No. 6,900,221 and the US Patent No. 7,087,613, remain listed in the
Orange Book with the FDA and are enforceable against any
infringer.
Background
In February 2008, OSI filed with the U.S. Patent and Trademark
Office an application to reissue U.S. Patent No. 5,747,498 in order
to correct certain errors relating to the claiming of compounds,
other than Tarceva, which fall outside of the scope of the main
claim in the patent. OSI�s reissue application looked to correct
these errors by deleting surplus compounds from the claims. Like
most composition of matter patents, the �498 patent claims many
compounds in addition to Tarceva. Tarceva itself is accurately
described in the �498 patent.
About OSI
Pharmaceuticals
OSI Pharmaceuticals is committed to "shaping medicine and
changing lives" by discovering, developing and commercializing
high-quality and novel pharmaceutical products designed to extend
life and/or improve the quality of life for patients with cancer
and diabetes/obesity. The Company�s oncology programs are focused
on developing molecular targeted therapies designed to change the
paradigm of cancer care. OSI�s diabetes/obesity efforts are
committed to the generation of novel, targeted therapies for the
treatment of type 2 diabetes and obesity. OSI's flagship product,
Tarceva� (erlotinib), is the first drug discovered and developed by
OSI to obtain FDA approval and the only EGFR inhibitor to have
demonstrated the ability to improve survival in both non-small cell
lung cancer and pancreatic cancer patients in certain settings. OSI
markets Tarceva through partnerships with Genentech, Inc. in the
United States and with Roche throughout the rest of the world. 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, a rejection of the reissue application, challenges to OSI�s
intellectual property, any adverse litigation decisions ,
competition from other pharmaceutical companies, the ability to
effectively market products, OSI's and its collaborators' abilities
to successfully develop and commercialize drug candidates, the
completion of clinical trials, the FDA review process and other
governmental regulation, and other factors described in OSI
Pharmaceuticals' filings with the Securities and Exchange
Commission.
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