Sep. 17, 2009 (Business Wire) -- 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.”
Background
In February 2008, OSI filed with the U.S. Patent and Trademark Office an application to reissue its composition of matter patent for Tarceva 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 Tarceva
Tarceva is a once-a-day pill that targets the EGFR pathway. Tarceva is designed to inhibit the tyrosine kinase activity of the EGFR signaling pathway inside the cell, one of the critical growth factors in NSCLC and pancreatic cancers. Tarceva is indicated as a monotherapy for patients with locally advanced or metastatic NSCLC whose disease has progressed after one or more courses of chemotherapy. Results from two multicenter, placebo-controlled, randomized Phase III trials conducted in first-line patients with locally advanced or metastatic NSCLC showed no clinical benefit with the concurrent administration of Tarceva with platinum-based chemotherapy (carboplatin and paclitaxel or gemcitabine and cisplatin) and its use is not recommended in that setting.
