OSI seeks to re-issue key Tarceva patent in US

OSI Pharmaceuticals announced today that it has filed with the U.S. Patent and Trademark Office an application to reissue its composition of matter patent for Tarceva® (erlotinib), U.S. Patent No. 5,747,498 (the '498 patent), 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 seeks 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. While the reissue application is pending, the '498 patent remains listed in the Orange Book with the FDA and enforceable against any infringer.

"The generic industry is employing increasingly aggressive tactics toward innovator intellectual property rights, with challenges to IP around the world becoming increasingly common," stated Colin Goddard, Ph.D., Chief Executive Officer of OSI Pharmaceuticals. "We view eliminating these errors as soon as possible as the best approach to defending against any challenge to our Tarceva intellectual property position and have settled on a strategy to reissue the core '498 patent. We remain confident in the ultimate core composition of matter protection of Tarceva and view the reissue filing as a prudent step, given the current environment, in order to manage any prospective generic challenge to the patent estate and to address concerns associated with any possible future litigation."

Source:  Welt Online:


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