This is the long back-story to a short order, which disposed of a big ANDA litigation. On June 13, 2011, the Supreme Court vacated the Federal Circuit’s opinion relating to a standing issue in Eisai Co., Ltd., et al. v. Teva Pharmaceuticals USA, Inc. Through Its Gate Pharmaceuticals Division and remanded the case with an instruction to dismiss it as moot. It did this because Teva did not have a right—under the Hatch-Waxman regime—to challenge four patents that protect donepezil, a drug used to treat dementia.

Eisai actually has five patents that protect its product. Teva and Eisai already litigated the first patent, and Teva was enjoined from launching its product until that patent expired in November 2010. Ranbaxy (another generic manufacturer) what the first one to file for FDA approval and name the remaining four patents, which entitled it to a generic manufacturer exclusivity period. Teva wasn’t pleased, because its ANDA application could not be approved during Ranbaxy’s exclusivity period.

Teva filed a suit on the remaining four patents, so that it could trigger Ranbaxy’s exclusivity period. Two of the patents expired with the first patent in 2010, and Teva was granted a covenant not to sue on the others. So it seems that Teva had no standing to sue, right?

That’s what the district court thought, but the Federal Circuit disagreed. It told the district court that it had abused its discretion in not allowing the suit to go forward. The court knew that there was a little gaming of the statutes here, which created a weird blockade against Teva’s entry into the market, and it stretched the statutes a bit to provide Teva relief.

The Supreme Court wasn’t on board with that plan. It considered the petition briefs and dealt with the standing issue on the merits at the petition stage. This is unusual, and demonstrates that appellate advocates need to be thinking about persuading the court on the merits of the case at the petition stage, even though that is not the true purpose of a petition.


File Faster!

We’ve seen a number of requests for the court to expedite the briefing schedule. In this case, the court noted (again) that the appellants could speed up the briefing schedule by filing their briefs early, and that the appellees represented to the court that they would get their opposition brief on file within 30 days of the appellant’s filing. Expedited briefing schedule request denied. Merial Ltd. v. CIPLA Ltd., Nos. 2011-1471, -1472 (Fed. Cir. July 18, 2011).