The Federal Circuit heard oral argument this past Tuesday in the Plavix case (Appeal No. 06-1613), in which Apotex is appealing a preliminary injunction enjoining Apotex's sales of generic Plavix. An .mp3 audio file of the oral argument may be downloaded from the Federal Circuit's website (link).
On August 31st, Judge Sidney H. Stein of the U.S. District Court for the Southern District of New York granted a preliminary injunction to Sanofi-Synthelabo and Bristol-Myers Squibb in their patent infringement case against Apotex. In a 58-page opinion, Judge Stein found that Apotex was unlikely to prevail at trial in proving invalidity or unenforceability of Sanofi's U.S. Patent No. 4,847,265. In addition, Judge Stein found Apotex's defenses of laches and unclean hands unconvincing.
Judges Bryson, Clevenger, and Lourie heard the oral argument and will decide the appeal. Though many issues were briefed, the arguments from the parties and questions from the panel focused on anticipation and irreparable harm. Apotex argued that the disclosure of a genus of racemic compounds in Sanofi's own prior art U.S. Patent No. 4,529,596 anticipates claim 3 of '265 patent, which is directed to a single enantiomeric compound encompassed in the genus disclosed in the '596 patent. With respect to irreparable harm, Apotex argued that by agreeing to limit damages to 50% of Apotex's sales of generic Plavix, Sanofi and BMS essentially admitted their damages could be calculated and therefore there is an adequate remedy at law, precluding an injunction.
In my view, the Federal Circuit panel hearing the oral argument seemed convinced that Judge Stein correctly decided the "likelihood of success on the merits" prong (in other words, that Apotex would be unable to prove invalidity at trial), and seemed a bit more skeptical that Sanofi and BMS would suffer irreparable harm if the preliminary injunction was vacated. Even on irreparable harm, however, the panel asked tougher questions of counsel for Apotex, and seemed to favor plaintiffs' position. More than once, the panel reminded counsel that Apotex faced "an uphill battle" because of the high standard of review: abuse of discretion.
The Federal Circuit could release an opinion on Apotex's appeal at any time. A trial in the district court is scheduled to begin on January 22, 2007.
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