Executive Summary

The U.S. Patent and Trademark Office dismisses AstraZeneca's application to extend a key product patent for the OTC proton pump inhibitor it licenses to Procter & Gamble. The agency explains in a Dec. 16 letter that Prilosec OTC is ineligible for a patent term extension because it was not the first instance of commercial marketing for the underlying active ingredient and because its application was submitted in an untimely fashion. The Prilosec OTC patent expires Oct. 6, 2015, according to FDA's Orange Book of approved drug products. An AstraZeneca spokesman says the firm is "disappointed" in PTO's denial, but "we remain confident in our intellectual property." Attorney Kurt R. Karst of Hyman, Phelps & McNamara, writes in the FDA Law Blog Jan. 4 that AstraZeneca will likely contest PTO's decision in court. He adds in a Jan. 7 interview that the denial "could mean earlier generics" in the PPI market "but we don't know at this point." Private-label OTC PPIs emerged in 2008 after Prilosec OTC lost market exclusivity (1"The Tan Sheet" Aug. 11, 2008, p. 3)