CAFC Reverses USPTO Anti-Patentee Reissue Policy In Re Tanaka

Falls Church, VA & San Diego, CA – April 18, 2011 – Birch, Stewart, Kolasch & Birch, LLP (BSKB) announced today that the U.S. Court of Appeals for the Federal Circuit (CAFC) reversed the decision of the United States Patent and Trademark Office (USPTO) In Re Tanaka, Appeal No. 2010-1262, April 15, 2011.

This outcome restores the right of patentees to seek reissue of a patent and strengthens the validity of many patents already reissued. In December 2009, the USPTO Board of Patent Appeals and Interferences issued a decision in the matter of Ex Parte Tanaka. Tanaka sought to add a dependent claim to a patent but did not cancel or modify the original independent claim. The reissue application was rejected on the basis that the error was not one that could be corrected under Section 251.

Charles Gorenstein, a Partner at BSKB, represented Tanaka before the CAFC. He observed that the Court substantially adopted the arguments and reasoning presented on behalf of Appellant, Tanaka, in reversing the U.S. Patent and Trademark Office decision. “The Court acknowledged that, in earlier cases, it had considered substantially identical scenarios, and concluded that the addition of narrower claims to a patent by reissue, without any other changes to the original patent, was proper under 35 U.S.C. §251 because, in the absence of those claims, the patent could be wholly or partly inoperative to protect what the patentee regards as his invention. The majority of the Court rejected the U.S. Patent and Trademark Office view that the decisions in those earlier cases were mere dicta, or not in any way controlling, simply because those cases rose to appeal for reasons that differed from the present case.”

This case has important implications for pharmaceutical companies. It is common for patents for new pharmaceutical drugs to disclose and claim a large number of drugs. Because pharmaceutical companies often invest millions of dollars developing a specific drug and obtaining FDA approval, it is typical to include claims to the specific drug under development. If a mistake is made during the original prosecution of the patent and, as a result appropriate claims for protecting the invention are not included in the original patent, an inability to reissue the patent to include appropriate claims could adversely affect the likelihood of effectively protecting the invention. The present decision protects a patentee’s right to properly reissue to protect the invention. In the Tanaka case, both Merck and Teva filed opposing amicus briefs on the issues being considered by the CAFC, Merck in support of Tanaka and Teva in support of the USPTO.

The decision In Re Tanaka raises technical and legal issues that are highly complex. BSKB is one of a handful of firms in the U.S. equipped to handle such a case, due to its specialized legal expertise as well as a practice group specifically dedicated to patent reexaminations and reissues.