Tuesday, December 13, 2011

Warner-Chilcott v. Mayne on doxycycline hyclate : see the conclusion!

At the beginning of the decision, one has

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, we vacate the preliminary injunction and remand this action for further proceedings.

but go to the end of the decision to see what happened!

The issue was a "stabilizing coat" on the doxycycline hyclate on the product of generic maker Mylan.

On the stabilizing coat:

The majority of the hearing focused on the parties’ respective experts and various tests those experts had performed to show the existence or non-existence of a “stabilizing coat” in Mylan’s ANDA product. In other words, the court’s primary focus was on the question of whether Warner Chilcott was likely to succeed on the merits of its infringement claim, a question which turned on a battle of experts. Warner Chilcott’s expert relied on one test to conclude that Mylan’s product met the “stabilizing coat” limitation, while Mylan’s expert relied on five different tests to reach the opposite conclusion. The district court recognized that determining which tests to credit was “one of the threshold inquiries,” and that there existed “some serious factual disputes between the experts” on this issue.

The district court (of New Jersey) had granted an preliminary injunction against Mylan. The CAFC on preliminary injunctions:

A plaintiff seeking a preliminary injunction must establish that:
(1) “he is likely to succeed on the merits”;
(2) “he is likely to suffer irreparable harm in the absence of preliminary relief”;
(3) “the balance of equities tips in his favor”; and
(4) “an injunction is in the public interest.”
Winter v. Natural Res. Def. Council, Inc., 555 U.S. 7, 20 (2008) (citations omitted). Such an injunction is “an extraordinary remedy never awarded as of right.” Id. (citation omitted). Where, as here, an accused infringer has challenged the validity of a patent in response to a motion for a preliminary injunction, this court has ad- dressed the procedures district courts are to use to analyze the question of validity. See, e.g., Titan Tires Corp. v. Case New Holland, Inc., 566 F.3d 1372, 1378-79 (Fed. Cir. 2009). As it relates to the present appeal, we have ex- plained that “the trial court first must weigh the evidence both for and against validity that is available at this preliminary stage in the proceedings.” Id. at 1379.
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.3 As discussed below, these errors warrant vacating the preliminary injunction.

The need for an evidentiary hearing on disputed issues of fact:

In the Third Circuit, as in other circuits, “a district court cannot issue a preliminary injunction that depends upon the resolution of disputed issues of fact unless the court first holds an evidentiary hearing.” Elliott v. Kiesewetter, 98 F.3d 47, 53 (3d Cir. 1996) (citing Prof’l Plan Examiners of New Jersey, Inc. v. Lefante, 750 F.2d 282, 288 (3d Cir. 1984)); see also Ty, Inc. v. GMA Accessories, Inc., 132 F.3d 1167, 1171 (7th Cir. 1997) (“If genuine issues of material fact are created by the response to a motion for a preliminary injunction, an evidentiary hearing is indeed required.”). In such cases, “[t]he chief ques- tion . . . is whether, in ordering the preliminary injunc- tion, the district court relied upon any facts that were properly disputed.” Williams v. Curtiss-Wright Corp., 681 F.2d 161, 163 (3d Cir. 1982).
Here, it is clear that the district court relied on dis- puted factual issues in granting Warner Chilcott’s motion for a preliminary injunction. Indeed, the court expressly identified those disputed issues when it explained that there were “some serious factual disputes between the experts” and “there’s clearly factual dispute between the two of you.” J.A. 25, 57. Rather than resolving those disputes through an evidentiary hearing, followed by adequate factual findings, as Mylan requested, the court put them aside for a later day. That runs afoul of the Third Circuit case law cited above.

Consequences of no findings of fact:

The district court also failed to make any findings as to Mylan’s invalidity challenge, thus preventing this court from engaging in any meaningful review of that issue. A court “must find the facts specially and state its conclusions of law separately.” Fed. R. Civ. P. 52(a)(1). “It is of the highest importance to a proper review of the action of a court in granting or refusing a preliminary injunction that there should be fair compliance with Rule 52(a) of the Rules of Civil Procedure.” Mayo v. Lakeland High- lands Canning Co., 309 U.S. 310, 316 (1940); Kos Pharms., 369 F.3d at 712 n.10 (quoting Mayo and explain- ing that a district court’s failure to explain each of the likelihood of confusion factors in a trademark infringement analysis “runs afoul of Rule 52(a)”); see also Nutri- tion 21 v. United States, 930 F.2d 867, 869 (Fed. Cir. 1991) (“Sufficient factual findings on the material issues are necessary to allow this court to have a basis for mean- ingful review.”). Absent appropriate findings, the normal course is to vacate the district court’s decision and remand the matter for a proper analysis. See Sabinsa Corp. v. Creative Compounds, LLC, 609 F.3d 175, 183 (3d Cir. 2010) (“Typically, when a district court fails to adequately support its findings, we merely remand for a re-weighing of the applicable factors.”); Pretty Punch Shoppettes, Inc. v. Hauk, 844 F.2d 782, 785 (Fed. Cir. 1988) (same).


Although there is no precise formula district courts must use rendering their findings under Rule 52(a), an utter failure to make any findings contravenes that rule. In addition to violating Rule 52(a), these omissions are also contrary to our case law, which requires district courts to consider both the accused infringer’s validity defense and the patentee’s arguments in support of its patent. See Titan Tire, 566 F.3d at 1379 (“[T]he trial court first must weigh the evidence both for and against validity that is available at this preliminary stage in the proceedings.”). Accordingly, we remand the matter for the district court to make appropriate findings consistent with these authorities.4

BUT, note the conclusion:

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. See Salinger v. Colting, 607 F.3d 68, 84 (2d Cir. 2010). With that in mind, we remand this matter for proceedings consistent with this order.


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