J&J Dismisses Concerta Patent Suit Against Impax
This article was originally published in The Pink Sheet Daily
Executive Summary
"Odd" case against the first-filer ends, but litigation with Andrx continues.
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Johnson & Johnson's dismissal of its Concerta patent suit against Impax represents the end of a "very odd case," the generic firm said, but is not a settlement. The firms "just agreed to stop" arguing, Impax told "The Pink Sheet" DAILY Oct. 3. Impax believes it holds 180-day exclusivity for the attention deficit/hyperactivity disorder therapy, methylphenidate extended release. According to a dismissal order issued by a Delaware federal court, J&J subsidiaries Alza and Ortho-McNeil agreed to drop their claims against Impax, and the generic manufacturer agreed to drop its counterclaim seeking a declaratory judgment. However, another defendant in the case, Andrx, was not part of the order, according to court documents. Prior to the suit's filing on Sept. 1, 2005, Andrx said it expected launch of its ANDA would be delayed by the filer with 180-day exclusivity (1 (Also see "Andrx' Concerta Generic Likely Blocked By Another ANDA Filer's Exclusivity" - Pink Sheet, 29 Jul, 2005.)). J&J declined to comment on the dismissal order. Regardless of the outcome in court, generics still appear to face a regulatory hurdle. A citizen petition filed by McNeil in 2004 remains under FDA review. The petition requests the agency to "apply additional bioequivalence metrics other than the average bioequivalence parameters" to ensure that Concerta generics are "both bioequivalent and clinically relevant to the innovator product" (2 (Also see "Andrx Expects “Near Term” FDA Response To Petition Blocking Concerta Generics" - Pink Sheet, 11 Aug, 2004.)). The suit against the generic firms focused on the product's controlled-release characteristics. J&J alleged that the ANDAs would violate Concerta's two patents, nos. 6,919,373 and 6,930,129. The patents are nearly identical, covering methods and devices for providing prolonged drug therapy. According to FDA's "Orange Book," both the patents expire on Jan. 31, 2018 following a six-month pediatric exclusivity extension. J&J positions Concerta as having advantages over other methylphenidate products due to the proprietary Oros technology, which provides a slow rate of drug delivery, minimizing the risk of abuse. Concerta's annual U.S. sales totaled approximately $842 mil. for the 12 months ending July 2006. - Jonathan M. Block ([email protected]) [Publisher's Note: F-D-C Reports is hosting an audio conference on Oct. 12, 2006, entitled "Patentbusters: The Uncertain Future of Branded and Generic Drugs in the Wake of Plavix and Apotex." For more details please visit: 3 http://www.fdcreports.com/audio/.] |