3. November 2009 00:57
Cipher Pharmaceuticals Inc. (TSX: DND) ("Cipher" or the "Company") today announced that Purdue Pharma Products L.P. and Napp Pharmaceutical Group Ltd. have filed a complaint against Cipher in the United States District Court for the Eastern District of Virginia, for alleged infringement of two U.S. patents. The action relates to Cipher's New Drug Application ("NDA") filed with the U.S. Food and Drug Administration ("FDA") for CIP TRAMADOL ER, the Company's extended-release tramadol product.
Cipher filed a revised NDA for CIP-TRAMADOL ER in Q2 2008, and received tentative FDA approval in February 2009. In Q3 2009, the Company filed a so-called "Paragraph IV Certification" with the FDA, which states that the relevant patent listed 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 drug product. Under the applicable provisions of the Hatch-Waxman Act, this patent challenge can delay final FDA approval of Cipher's NDA by 30 months, or until the patent challenge is resolved, whichever occurs first.
Cipher management believes that this type of litigation is common and considers it to be within the ordinary course of business. Cipher intends to vigorously defend itself against the suit and is confident in the strength of its application.
On August 14, 2009, the United States District Court for the District of Delaware issued a decision and final judgment invalidating certain claims of the Orange Book-listed patents for Ultram(R) ER in litigation filed against Par Pharmaceutical, Inc. That judgment in the Par litigation is currently on appeal before the United States Court of Appeals for the Federal Circuit.
Source: CIPHER PHARMACEUTICALS INC.
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