Summary
If the March 20, 2007 rulings of US District Judge Stanley R. Chester withstand further challenges, then JNJ's TOPAMAX(R) sales will not suffer - at least with respect to Mylan Labs.
Analysis
Judge Chester's rulings are sweeping in scope and represent a definitive victory for JNJ, and, from the other perspective, a complete loss for Mylan. A brief summary of these rulings follow.
With respect to the asserted patent, 4513006: (a) Mylan infringed 9 claims; and (b) the patent is both valid and enforceable.
With respect to regulatory actions: (a) Mylan cannot (until the September 26, 2008 expiration date of 4513006) market generic substitutes for TOPAMAX(R); and (b) the FDA cannot establish an effective approval date for the corresponding ANDA filings of Mylan earlier than the noted September 26, 2008 date.
If this permanent injunction withstands further challenges, then at least with respect to Mylan, JNJ's best-selling TOPAMAX (R) migraine drug will enjoy the full benefits of patent protection of 4513006 until the very last day of that patent's term. This result would be against the noticeable trend - at least in comparison to several recent court opinions of the Federal Circuit - which in effect seems to be tipping the innovator/generic patent battles against the NDA holders and towards the generic ANDA filers.
