Cadence Pharmaceuticals Comments on USPTO's Non-Final, Initial Office Action on Reexamination of Patent, Says Patents On OFIRMEV Are Valid Until Final Ruling

Cadence Pharmaceuticals, Inc.

today announced that the United States Patent and Trademark Office (USPTO), has issued a non-final, initial office action in the Ex Parte Reexamination of US Patent No. 6,028,222, or the '222 patent, one of the two licensed patents covering OFIRMEV® (acetaminophen) injection. Although the USPTO made an initial determination to reject certain claims, all of the claims of the '222 patent remain valid and in force until the USPTO issues a final action in this reexamination. "This initial office action by the USPTO is not a final decision, rather, it's just one step in the reexamination process, which can take many years to complete. It's very common for the USPTO to reject some or all of the claims of a patent in an initial office action, however, claims that are initially rejected may be subsequently allowed. Importantly, we don't expect this action to have an adverse impact on the pending litigation against Exela," said Ted Schroeder, President and CEO of Cadence. "We strongly believe that the scope and validity of the patent claims in the '222 patent are appropriate and that the USPTO's prior issuance of the patent was correct." The '222 patent covers the formulation of OFIRMEV, and expires in August 2017, and US Patent No. 6,992,218, covers the process used to manufacture OFIRMEV, and expires in June 2021. Upon completion of the company's ongoing pediatric clinical trial of OFIRMEV, both patents will be eligible for an additional six months of marketing exclusivity. In September 2012, a third party filed with the USPTO a Request for Ex Parte Reexamination of the '222 patent, and in December 2012, Cadence received notice that the USPTO had granted the Request for Reexamination. The reexamination process requires the USPTO to consider the scope and validity of the patent based on substantial new questions of patentability raised by a third party or the USPTO. Cadence intends to continue with the reexamination of all of the rejected claims of the '222 patent and the company is confident in its ability to make a strong case for the patentability of the rejected claims as the process continues. Additionally, as permitted under USPTO rules, Cadence plans to file additional claims under the '222 patent. From this point forward, third parties are barred from providing additional information in this reexamination. About OFIRMEV® (Acetaminophen) Injection OFIRMEV (acetaminophen) injection (1000 mg / 100 mL, 10 mg / mL; for intravenous use only), Cadence Pharmaceuticals' proprietary intravenous formulation of acetaminophen, is indicated for the management of mild to moderate pain, the management of moderate to severe pain with adjunctive opioid analgesics, and the reduction of fever. The FDA approval of OFIRMEV was based on data from clinical trials in approximately 1,020 adult and 355 pediatric patients. These trials included two studies evaluating the safety and effectiveness of OFIRMEV in the treatment of pain, and one study evaluating OFIRMEV in the treatment of fever. The effectiveness of OFIRMEV for the treatment of acute pain and fever has not been studied in pediatric patients less than 2 years of age.