The US Patent & Trademark Office (PTO) has issued a “Notice of Allowance” in OSI Pharmaceuticals’ (OSI) reissue application for US Patent No 5747498 (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.
Colin Goddard, CEO of OSI, said: “This decision by the PTO is encouraging as OSI, along with the biopharmaceutical industry, recognises 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.
“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.”