Warner Chilcott Labs. v. Mylan Pharms. Inc., No. 2011-1611 (Fed. Cir.)
An interesting development in ANDA litigation this year has been the increasing frequency with which district courts have granted preliminary injunctions or temporary restraining orders against ANDA filers--even, in some cases, after the district court has found after a full trial that the patents in suit are invalid. In a decision Monday, the Federal Circuit vacated a preliminary injunction against Mylan because the district court "relied on disputed facts in granting the preliminary injunction without holding an evidentiary hearing, and failed to make any findings as to Mylan's invalidity defense."
In this case, involving Mylan's ANDA for a generic version of DORYX (doxycycline hyclate), Warner Chilcott sued Mylan for infringement of U.S. Patent No. 6,958,161, directed to a tablet formulation of doxycycline. In August 2011, just one month before the 30-month stay would expire, Warner Chilcott filed a motion for a temporary restraining order and preliminary injunction against Mylan. The district court heard arguments from counsel, but did not conduct an evidentiary hearing and did not hear live testimony from any of the witnesses. The district court granted the preliminary injunction, but "did not address Mylan's arguments that the '161 Patent is invalid because of anticipation or obviousness, though it did acknowledge that those claims had been asserted." The Federal Circuit granted Mylan's request for expedited briefing and heard oral arguments on November 22, 2011.
At the outset of its analysis, the Federal Circuit cited the four well-known requirements for a preliminary injunction, as established by the Supreme Court, and noted that a preliminary injunction "is an extraordinary remedy never awarded as of right." The court then cited its own precedent as establishing that when an accused infringer has challenged the validity of a patent in response to a motion for a preliminary injunction, "the trial court first must weigh the evidence both for and against validity that is available at this preliminary stage in the proceedings." The Federal Circuit found:
In this case, the district court abused its discretion in two ways. The court: (1) failed to hold an evidentiary hearing despite acknowledging that the decision turned on disputed factual issues; and (2) did not weigh the evidence or make any findings as to Mylan's invalidity challenge.
Interestingly, while the Federal Circuit vacated the preliminary injunction, it suggested that a temporary restraining order might be appropriate:
Although the district court's entry of the preliminary injunction in this case is contrary to controlling authority, we are mindful of the court's demanding schedule and desire to avoid duplicating its efforts with a soon-to-be-scheduled bench trial in this case. If doing so serves judicial efficiency, the district court may consider entering a temporary restraining order after this court's mandate issues, then consolidating the preliminary injunction hearing with the bench trial on the merits, assuming that can occur within the timeframes mandated by the Federal Rules of Civil Procedure.
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