Vacate That Injunction

Warner Chilcott Laboratories Ireland Ltd. v. Mylan Pharmaceuticals Inc., No. 2011–1611 (Fed. Cir. Dec. 12, 2011) (Chief Judge Rader, Circuit Judges Dyk and O’Malley) (nonprecedential)

While the Federal Circuit takes some heat for taking a long time to issue decisions, it can really move when it wants to. This case went from the District Court’s order issuing a preliminary injunction to the Federal Circuit’s decision vacating that injunction in less than 3 months:

CAFC Decision - Vacate That Injunction


What’s the Rush?

Like any good fast-paced action thriller, there’s drugs involved. Specifically, the antibiotic doxycycline, which Warner Chilcott sells under the brand name Doryx®. Mylan filed an Abbreviated New Drug Application (ANDA) to make a generic version, and Warner Chilcott sued Mylan for patent infringement.

That suit triggered an automatic 30-month stay (that is, a delay) of the FDA’s approval process for Mylan’s ANDA. The stay expired this fall. So, to keep Mylan’s generic drug off the market, Warner Chilcott asked the District Court for a preliminary injunction to block Mylan from selling their drug until this patent suit is resolved.

The District Court held a hearing in September and issued an order the next day for a preliminary injunction. Mylan quickly appealed to the Federal Circuit.

Sorry, No Shortcuts

The Federal Circuit had some problems with how the District Court handled this. One problem was that the lower court didn’t really address Mylan’s invalidity defense—it only briefly mentioned the defense in the opinion—and that’s a big no-no. A court has to consider an invalidity defense and make some sort of factual findings relating to that invalidity position if it’s going to issue a preliminary injunction that will block the party accused of infringing the patent.

The other problem was that the trial court didn’t have an evidentiary hearing, even though it said that it needed more testimony to be able to decide the infringement issue. It seems that the lower court’s calendar was full, and there was no time to have a hearing before trial.

The Federal Circuit was sympathetic to the trial court’s workload, but concluded that the court couldn’t grant the preliminary injunction without an evidentiary hearing, because there were disputed factual issues. (This opinion was written by Judge O’Malley, a former District Court judge.) The court vacated the injunction and sent the case back to the trial court.

Was what the District Court did OK? Or was the Federal Circuit right to say that you can’t rush through the process?

You can read the opinion at the Federal Circuit’s web site.