Cipher PharmaceuticalsInc. today announced a final judgment hasbeen entered in favour of Cipher in relation to pending patent litigation withPurdue Pharma Products L.P. and Napp Pharmaceutical Group Ltd. (together”Purdue”) in the United States District Court for the Eastern District ofVirginia. The patent litigation involves the company’s New DrugApplication, filed with the FDA,for CIP-TRAMADOL ER, an extended-release tramadol product. The Cipher Judgmentterminates any further stay of FDA approval of Cipher’s NDA under theapplicable provisions of the Hatch-Waxman Act. Cipher plans to move forward toobtain FDA final approval as part of its broader CIP-TRAMADOL ERcommercialization strategy. The company continues to conduct ongoingdiscussions with potential commercial partners interested in licensingCIP-TRAMADOL ER. The final judgment in favour of Cipher holds that the patents-in-suit areinvalid for obviousness based on a prior decision of the United StatesDistrict Court for the District of Delaware, dated August 14, 2009,invalidating the Orange Book-listed patents for Ultram(R) ER in litigationfiled by Purdue against Par Pharmaceutical, Inc. That decision in thePar litigation is currently under appeal before the United States Court ofAppeals for the Federal Circuit. Cipher anticipates that Purdue may appeal theCipher Judgment as well, though Purdue has not yet done so. Cipher filed a revised NDA for CIP-TRAMADOL ER in Q2 2008, and receivedtentative FDA approval in February 2009. In Q3 2009, the Company filed aParagraph IV Certification with the FDA, which states that the relevant patentlisted in the FDA’s “Orange Book” for Ultram(R) ER is invalid, unenforceable,and/or will not be infringed by the manufacture or sale of Cipher’s drugproduct. Under the applicable provisions of the Hatch-Waxman Act, this patentchallenge can delay or stay final FDA approval of Cipher’s NDA by 30 months,or until the patent challenge is resolved, whichever occurs first. The CipherJudgment terminates any further stay of Cipher’s NDA under the applicableprovisions of the Hatch-Waxman Act.
