Notice of Allowance issued by PTO for OSI's EGFR drug

Sep 18 2009

OSI Pharmaceuticals, Inc. (NASDAQ: OSIP) announced today that the U.S. Patent & Trademark Office has issued a “Notice of Allowance” in OSI’s reissue application for U.S. Patent No.5,747,498 (the ‘498) composition of matter patent for Tarceva^® (erlotinib). The reissued patent will replace the original ‘498 patent and have the same November 2018 expiration date.

“This decision by the PTO is encouraging as OSI, along with the biopharmaceutical industry, recognizes that patent rights are an important asset in protecting the extensive R&D investment necessary to bring new drugs and therapeutics to patients. Today’s action by the PTO is significant as we view this reissue grant as a positive step in managing generic challenges to the Tarceva patent estate,” stated Colin Goddard, Ph.D., Chief Executive Officer of OSI Pharmaceuticals. “With a potential approval on the horizon based on the SATURN data in the first-line maintenance setting for non-small cell lung cancer; additional ongoing Phase III studies in NSCLC for first-line EGFR mutation patients and in the stage I-IIIa adjuvant setting; and, further Phase III studies in ovarian cancer and hepatocellular carcinoma, we believe Tarceva will remain a growing, anchoring asset for the Company over the next decade.”