Appeal from the United States District Court for the District of New Jersey in case no. 09-CV-2073, Judge William J. Martini.
The opinion of the court was delivered by: O'malley, Circuit Judge.
NOTE: This disposition is nonprecedential.
Before RADER, Chief Judge, DYK and O'MALLEY, Circuit Judges.
This is a Hatch-Waxman Act case in which Mylan Pharmaceuticals Inc. and Mylan Inc. (collectively, "Mylan") appeal the district court's entry of a preliminary injunction prohibiting Mylan from launching the generic version of 150 mg Doryx, which is the branded name for the doxycycline hyclate delayed-release tablets sold by Plaintiffs-Appellees. 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.
Plaintiff-Appellee Mayne Pharma International Pty. Ltd. ("Mayne") is the holder of New Drug Application No. 50-795 relating to delayed release tablets containing 75 mg base, 100 mg base, and 150 mg base of doxycycline hyclate. Mayne also owns U.S. Patent No. 6,958,161 ("the '161 Patent"), entitled "Modified Release Coated Drug Preparation," which covers the branded drug Doryx.
Mayne licenses the '161 Patent to Plaintiffs-Appellees Warner Chilcott*fn1 and has partnered with Warner Chilcott to market Doryx in the United States.
On December 5, 2008, Mylan filed an Abbreviated New Drug Application ("ANDA") to sell a generic version of 150 mg Doryx. Mylan included with its ANDA a certification under 21 U.S.C. § 355(j)(2)(A)(vii)(IV) asserting that the '161 Patent is invalid, unenforceable, and/or will not be infringed by the manufacture, use, or sale of Mylan's proposed generic drug. Following Mylan's ANDA, on May 1, 2009, Warner Chilcott filed an infringement suit against Mylan in district court, triggering the thirty-month statutory stay of approval of Mylan's ANDA product by the U.S. Food and Drug Administration ("FDA"). The district court consolidated Warner Chilcott's suit against Mylan for discovery purposes with several other suits Warner Chilcott filed against other companies that, like Mylan, are seeking to sell generic versions of Doryx.
The only claim at issue for purposes of this appeal is claim 21 of the '161 Patent, which recites:
A tablet for oral administration, the tablet being a modified release preparation having one or more coated core elements, each core element comprising an active ingredient comprising an acid salt of doxycycline and having a modified release coating, wherein a stabilising coat is provided between each core element and its modified release coating so that, upon in vitro dissolution testing, the amount of active ingredient released at any time on a post-storage dissolution profile is within 40 percentage points of the amount of active ingredient released at any time on a pre-storage dissolution profile.
'161 Patent col. 14 ll.20-23 (emphasis added).
In this case, Warner Chilcott's infringement argument turns on whether Mylan's ANDA product has the claimed "stabilizing coat." On July 20, 2011, following the parties' submissions and a hearing pursuant to Markman v. Westview Instruments, Inc., 52 F.3d 967 (Fed. Cir. 1995) (en banc), the district court construed the emphasized language above, which includes "stabilizing coat," to mean "a layer of material(s) between each core element and its modified release coating, which keeps the migration of core materials to a minimum such that the interaction of core materials with coating materials is reduced or prevented." Warner Chilcott Labs. Ireland v. Impax Labs., Inc., 2011 WL 2971155, at *7 (D.N.J. Jul. 20, 2011).
On August 24, 2011, just over one month before the end of the FDA's thirty-month stay on September 27, 2011, Warner Chilcott filed a motion for a temporary restraining order and preliminary injunction against Mylan, seeking to prohibit Mylan from launching its generic 150 mg product once it received final approval from the FDA.*fn2 The parties briefed Warner Chilcott's motions and submitted witness declarations, including declarations from their respective experts. The district court heard arguments from counsel regarding both motions on September 21, 2011. The court did not conduct an evidentiary hearing and did not hear live testimony from any of the witnesses. The hearing lasted just over an hour.
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. Joint Appendix ("J.A.") A25; see also J.A. 57 ("[T]here's clearly factual ...