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Mylan Laboratories, Inc. v. Leavitt

June 29, 2007


The opinion of the court was delivered by: Ricardo M. Urbina United States District Judge

Document No. 79



This matter comes before the court on the plaintiff's 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 expired*fn2 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,*fn3 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 Norvasc, 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 plaintiff's motion for immediate injunctive relief.


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,*fn4 thus diluting the plaintiff's almost exclusive market share for the generic version of Norvasc.


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" ...

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