Mylan Laboratories, Inc. v. Leavitt

• Decision Date: 29 June 2007
• Docket Number: Civil Action No. 07-579 (RMU).
• Citation: 495 F.Supp.2d 43
• Court: U.S. District Court — District of Columbia
• Parties: MYLAN LABORATORIES, INC. et al.,<SMALL><SUP>1</SUP></SMALL> Plaintiff, v. Michael LEAVITT et al., Defendants, and Teva Pharmaceuticals USA., Apotex, Inc., Mutual Pharmaceuticals Co., Intervenors.

495 F.Supp.2d 43

MYLAN LABORATORIES, INC. et al.,¹ Plaintiff, v. Michael LEAVITT et al., Defendants, and Teva Pharmaceuticals USA., Apotex, Inc., Mutual Pharmaceuticals Co., Intervenors.

Civil Action No. 07-579 (RMU).

United States District Court, District of Columbia.

June 29, 2007.

David James Harth, Heller Ehrman, LLP, Madison, WI; for Plaintiffs.

Drake S. Cutini, Department of Justice Office of Consumer Litigation, Washington, DC, for Defendants.

Jay P. Lefkowitz, Michael D. Shumsky, Kirkland & Ellis LLP, Arthur Y. Tsien, Olsson, Frank and Weeda, PC, John Will Ongman, Axinn Veltrop & Harkrider LLP, Washington, DC, Robert Breisblatt, Welsh & Katz, Limited, Chicago, IL, Steven E. Feldman, San Diego, CA, Chad A. Landmon, Jo Anne M. Kokoski, Axinn, Veltrop & Harkrider, L.L.P., Hartford, CT, for Intervenors.

MEMORANDUM OPINION

DENYING MYLAN'S EMERGENCY MOTION FOR TEMPORARY RESTRAINING ORDER

URBINA, District Judge.

I. INTRODUCTION

This matter comes before the court on the plaintiffs emergency motion for a temporary restraining order. Plaintiff Mylan Laboratories asks the court to order the FDA to relist Pfizer's patent for Norvasc on its patent register. Currently, the plaintiff is one of only two generic drug manufacturers who market their generic version of this drug to the public. A prior ruling from this court recognized that Mylan would enjoy generic market exclusivity as to this drug until such time as the patent expired² or was otherwise removed from the official patent register.

Mylan's generic market exclusivity was set to expire in September of 2007. However, on June 22, 2007, the FDA delisted Pfizer's patent for Norvasc from its register,³ opening a legal freeway for as many as eight other generic manufacturers to enter the market. Facing this large and unexpected potential diminution of its market share for the generic version of Norvase, Mylan asks the court to direct the FDA to relist the patent, thereby restoring the status quo pending appeal. Because the plaintiff fails to demonstrate sufficiently changed circumstances warranting immediate action by this district court, the court denies the plaintiffs motion for immediate injunctive relief.

II. BACKGROUND

These matters last came before the court in earnest on a motion for a preliminary injunction filed by the plaintiff on April 23, 2007. At that time, the plaintiff objected to numerous rulings of the FDA affecting the barriers-to-entry in the generic drug market for amlodipine besylate. Pl.'s Mot. for Prel. Inj. (Apr. 23, 2007) ("Pl.'s Mot. for Inj."). Of relevance here, Mylan challenged the FDA's conclusion that, under the Hatch Waxman Act, Mylan's 180-day period of market exclusivity for amlodipine besylate does not survive the expiration of Pfizer's patent for Norvasc. Pl.'s Mot. for Inj. at 12. On April 30, 2007, the court ruled, inter alia, that the FDA's interpretation regarding Mylan's market exclusivity constituted a reasonable interpretation of the law. Mem. Op. (Apr. 30, 2007) at 19. Objecting to this ruling, the plaintiff sought reconsideration, which the court denied on May 14, 2007. Order (May 14, 2007). Immediately following this court's denial of Mylan's motion for reconsideration, the plaintiff filed a notice of appeal with the D.C. Circuit. Explaining that the plaintiff had "not satisfied the stringent standards required for an injunction pending appeal, the D.C. Circuit denied relief." Order, Mylan v. Leavitt, No. 07-5156 (D.C.Cir. May 23, 2007) at 1. The plaintiff knocked again at the D.C. Circuit's door, this time with an emergency motion for an expedited appeal. The D.C. Circuit refused this request. Order, Mylan v. Leavitt, No. 07-5156 (D.C.Cir. May 29, 2007) at 1. During the course of these procedural maneuvers, Pfizer's pediatric exclusivity privilege (which was set to expire on September 25, 2007) prevented new generic manufacturers from entering the market. This changed on June 22, 2007, when the FDA delisted Pfizer's patent. Pl.'s Mot. for TRO, Ex. A.

Suddenly, the plaintiff was faced with the prospect that numerous generic drug manufacturers would soon enter the market,⁴ thus diluting the plaintiff's almost exclusive market share for the generic version of Norvasc.

III. ANALYSIS

A. Legal Standard for Injunctive Relief Pending Appeal

When a party appeals the court's interlocutory or final judgment granting, dissolving, or denying an injunction, the court, in its discretion, "may suspend, modify, restore, or grant an injunction during the pendency of the appeal[.]" FED.R.CIV.P. 62(c). The court analyzes motions for a stay pending appeal under the same factors that it considers for motions for a preliminary injunction. Wash. Metro. Area Transit Comm'n v. Holiday Tours, 559 F.2d 841, 842-43 (D.C.Cir. 1977). Thus, the court may issue a stay pending appeal of an order on interim injunctive relief only when the movant demonstrates:

(1) a substantial likelihood of success on the merits, (2) that it would suffer irreparable injury if the injunction is not granted, (3) that an injunction would not substantially injure other interested parties, and (4) that the public interest would be furthered by the injunction.

Mova Pharm. Corp. v. Shalala, 140 F.3d 1060, 1066 (D.C.Cir.1998) (internal citations omitted). Because the plaintiff seeks a mandatory injunction, rather than to merely maintain the status quo, the plaintiff must demonstrate (beyond the familiar four-part test for injunctive relief) that it is "clearly" entitled to the relief it seeks or "extreme or very serious damage will result."⁵ Farris v. Rice, 453 F.Supp.2d 76, 79 (D.D.C.2006); see also King v. Leavitt, 475 F.Supp.2d 67, 71 (D.D.C.2007) (quoting Mylan Pharm., Inc. v. Shalala, 81 F.Supp.2d 30, 36 (D.D.C.2000)).

The court observes that because it has previously considered the precise legal issue on appeal, the movant's showing of likelihood of success must be impressive. Fullmer v. Mich. Dept. of State Police, 207 F.Supp.2d 663, 664 (E.D.Mich.2002) (noting that the movant must demonstrate a likelihood of reversal on appeal). The law-of-the-case doctrine, which prevents a court from revisiting an issue it has already decided, reinforces this conclusion. LaShawn v. Barry, 87 F.3d 1389, 1393 (D.C.Cir.1996) (declaring that "[t]he same issue presented a second time in the same case in the same court should lead to the same result ... in the absence of extraordinary circumstances such as where the initial decision was `clearly erroneous and would work a manifest injustice") (citations omitted).

To justify a stay pending appeal, a movant need not always establish a high probability of success on the merits, as a particularly strong showing of irreparable injury or some other combination of factors may warrant a stay. Cuomo v. U.S. Nuclear Regulatory Comm'n, 772 F.2d 972, 974 .(D.C.Cir.1985) (per curium); United States v. Philip Morris Inc., 314 F.3d 612, 617 (D.C.Cir.2003).

As for burdens, it is "the movant's obligation to justify the court's exercise of such an extraordinary remedy." Cuomo, 772 F.2d at 978; see also Twelve John Does v. District of Columbia, No. 80-2136, 1988 WL 90106, at *1 (D.D.C. Aug.4, 1988) (cautioning that [a]n indefinite stay pending appeal is an extraordinary remedy, and is to be granted only after careful deliberation has persuaded the Court of the necessity of the relief") (citations omitted); Judicial Watch, Inc. v. Nat'l Energy Policy Dev. Group, 230 F.Supp.2d 12, 14 (D.D.C.2002) (noting that "the applicant must satisfy `stringent standards required for a stay pending appeal'") (citing Summers v. Howard Univ., No. 02-7069, 2002 WL 31269623 (D.C.Cir. Oct.10, 2002)). When a moving party fails to establish a substantial case on the merits, and further fails to "demonstrate that the balance of equities or the public interest strongly favors the granting of a stay," a motion for stay is properly denied. Cuomo, 772 F.2d at 972.

B. The Plaintiff Fails to Demonstrate that a Stay Pending Appeal is Justified

Mylan's current arguments for a stay pending appeal are substantially similar to the arguments it made in its first request for a preliminary injunction. That is, the plaintiff again argues that the FDA's conclusion regarding Mylan's exclusivity is not reasonable, and that Mylan will suffer irreparable harm if other manufacturers enter the market. Compare Pl.'s Mot. for Inj. at 12 (arguing that "nothing in the text or legislative history of the Hatch-Waxman Act indicates that generic exclusivity is forfeited upon patent expiration") with Pl.'s Mot. for TRO (June 26, 2007) at 9 (arguing that "vested 180-day generic exclusivity extends beyond patent expiration"); compare Pl.'s Mot. for Inj. at 15 (asserting that "Moss of such exclusivity would impair its access to customers and diminish its ability to establish and retain market share") with Pl.'s Mot. for TRO at 21 (asserting that "Mylan will irrevocably lose a portion of [anticipated] revenues").

Since the court issued its April 30, 2007 Memorandum Opinion, 484 F.Supp.2d 109, the FDA has delisted Pfizer's patent and, consequently, eight rival generic manufacturers are mobilized to enter the generic market.⁶ Pl.'s Mot. for TRO at 1; Notice (June 28, 2007). The plaintiff argues that this elevates the probability and extent of irreparable injury, as "now eight other generics are poised to flood the market during the pendency of Mylan's appeal." Pl.'s Reply at 9.

The changed circumstances alleged by the plaintiff do not warrant a reexamination of the court's appraisal of the four factors guiding issuance of a preliminary injunction. As to the plaintiffs likelihood of success on the merits (properly cast as its likelihood of obtaining a reversal, Fullmer, 207 F.Supp.2d at 664), the court remains confident in its prior determination that "the FDA's conclusion that Mylan's 180-day exclusivity does not survive patent expiration constitutes a reasonable interpretation of the statute...