The U.S. patent laws allow a patent owner to “reissue” an issued patent to fix certain mistakes in the way an invention was claimed. Until recently, however, branded pharmaceutical companies considering reissue to add narrow claims to a patent covering a U.S. Food and Drug Administration-approved drug faced a Catch-22. This arose because a patent owner was generally unable to add such claims by reissue without first admitting that the originally issued claims were invalid as being too broad.
Following such an admission, the branded pharmaceutical company faced a dilemma: maintain the patent listing in the FDA’s Orange Book and risk possible accusations of improper listing, or delist and potentially cause the first generic challenger of the patent to forfeit its 180-day marketing exclusivity, which could expose the brand owner to greater competition. Recent decisions by the U.S. Court of Appeals for the Federal Circuit and the D.C. Circuit — In re Tanaka and Teva Pharmaceuticals USA Inc. v. Sebelius — have eliminated this Catch-22, opening the path to a possible increase in reissue applications by branded pharmaceutical companies. In re Tanaka, 640 F.3d 1246 (Fed. Cir. 2011); Teva Pharmaceuticals USA Inc. v. Sebelius, 595 F.3d 1303 (D.C. Cir. 2010).
