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Biovail Corp. v. U.S. Food and Drug Administration

March 22, 2007

BIOVAIL CORPORATION ET AL., PLAINTIFFS,
v.
U.S. FOOD AND DRUG ADMINISTRATION ET AL., DEFENDANTS, AND ANCHEN PHARMACEUTICALS, INC., TEVA PHARMACEUTICALS USA, INC., IMPAX LABORATORIES, INC., INTERVENOR-DEFENDANTS.



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

Document No. 14

MEMORANDUM OPINION DENYING THE PLAINTIFFS'MOTION FOR INJUNCTIVE RELIEF*fn1

I. INTRODUCTION

The plaintiffs, Biovail Corporation and Biovail Laboratories International SRL (collectively, "the plaintiff" or "Biovail") manufacture the drug Wellbutrin XL. On August 23, 2006, the plaintiff brought suit and filed a motion for a temporary restraining order ("TRO") against the defendants Food and Drug Administration and Andrew C. Von Eschenbach*fn2 (collectively "the defendant" or "FDA") challenging the FDA's consideration of generic versions of Wellbutrin XL for approval. On August 25, 2006, the court denied the plaintiff's motion for a TRO because the plaintiff failed to demonstrate a substantial likelihood of success on the merits and irreparable injury.

This case now comes before the court on the plaintiff's second motion for injunctive relief. The plaintiff's newest motion emerges from the defendant's approval of intervenor-defendant Anchen's Abbreviated New Drug Application ("ANDA"),*fn3 clearing Anchen's generic drug for entry into the marketplace. In the instant suit, the plaintiff once again argues that the defendant violated the Administrative Procedures Act ("APA"), 5 U.S.C. § 706, and the Food, Drug and Cosmetic Act ("FDCA"), 21 U.S.C. § 301 et seq., by not applying proper standards in ruling on the bioequivalence of Anchen's product and by not requiring generic products to carry proper labeling. Because the plaintiff has failed to demonstrate a substantial likelihood of success on the merits of its claims and irreparable injury, the court denies the plaintiff's second motion for a temporary restraining order.

II. BACKGROUND*fn4

Intervenor-defendant Anchen Pharmaceuticals, Inc. ("Anchen") manufactures a generic version of Wellbutrin XL. Intervenor-Def. Anchen's Opp'n to Pl.'s Mot. ("Anchen's Opp'n") at 5. In September 2004, Anchen filed an ANDA with the FDA, seeking approval of its generic drug for entry into the marketplace. Id. Anchen's ANDA lists Wellbutrin XL as the reference listed drug ("RLD"),*fn5 or brand-name drug, for Anchen's generic drug. Pl.'s Second Mot. for a TRO and Prelim. Inj. ("Pl.'s Mot.") at 3-4 (referring to Wellbutrin XL as the innovator drug for Anchen's ANDA); Def. FDA's Opp'n to Pl.'s Mot. ("FDA's Opp'n") at 13; Anchen's Opp'n at 16; Intervenor-Defs. Teva & Impax's Joint Opp'n to Pl.'s Mot. ("Teva & Impax's Joint Opp'n") at 1.

Prior to approving brand-name Wellbutrin XL, the FDA required the plaintiff to demonstrate that Wellbutrin XL was the bioequivalent*fn6 of two previously-approved versions of Wellbutrin -- Wellbutrin IR (immediate release) and Wellbutrin SR (sustained release). Pl.'s Mot. at 8. Because the plaintiff made that showing, Wellbutrin XL's labeling correctly states that it is the bioequivalent of both of these versions. Id. at 8-9. On December 14, 2006, the FDA approved Anchen's ANDA for a generic formulation of Wellbutrin XL, pursuant to the FDCA. Id. at 1. It concurrently denied the plaintiff's citizen petition which urged the FDA to apply certain standards in approving ANDAs for generic Wellbutrin XL, including a suggestion that the FDA require Anchen to demonstrate that its drug is the bioequivalent to the two previous versions of Wellbutrin. Id.

On December 18, 2006, in response to the FDA's approval of Anchen's ANDA and its concurrent denial of the plaintiff's citizen petition, the plaintiff filed a motion to amend its complaint and a second motion for a TRO. The plaintiff contends that the FDA's failure to require the additional bioequivalence studies has resulted in false and misleading labeling on Anchen's drug. Id. at 2-4. The plaintiff asks the court to stay the effectiveness of both the FDA's approval of generic drugs as well as its response to the plaintiff's citizen petition, and, thereby, to prevent the distribution of generic versions of Wellbutrin XL. Id. at 4.

On January 2, 2007, the court granted a joint motion to intervene brought by Impax Laboratories, Inc., a manufacturer of a generic version of Wellbutrin XL, and Teva Pharmaceuticals USA, Inc., the exclusive United States distributor for Impax's product. Min. Or. granting Teva Pharm. USA, Inc. and Impax Lab., Inc.'s Joint Mot. to Intervene (Jan. 2, 2007). The court now turns to the plaintiff's motion for injunctive relief.

III. ANALYSIS

A. Legal Standard for Injunctive Relief

This court may issue 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) (quoting CityFed Fin. Corp. v. Office of Thrift Supervision, 58 F.3d 738, 746 (D.C. Cir. 1995)); see also World Duty Free Americas, Inc. v. Summers, 94 F. Supp. 2d 61, 64 (D.D.C. 2000). It is particularly important for the movant to demonstrate a substantial likelihood of success on the merits. Cf. Benten v. Kessler, 505 U.S. 1084, 1085 (1992) (per curiam). Indeed, absent a "substantial indication" of likely success on the merits, "there would be no justification for the court's intrusion into the ordinary processes of administration and judicial review." Am. Bankers Ass'n v. Nat'l Credit Union Admin., 38 F. Supp. 2d 114, 140 (D.D.C. 1999) (internal quotation omitted).

The four factors should be balanced on a sliding scale, and a party can compensate for a lesser showing on one factor by making a very strong showing on another factor. CSX Transp., Inc. v. Williams, 406 F.3d 667 (D.C. Cir. 2005) (citing CityFed Fin. Corp., 58 F.3d at 747). "An injunction may be justified, for example, where there is a particularly strong likelihood of success on the merits even if there is a relatively slight showing of irreparable injury." CityFed Fin. Moreover, the other salient factor in the injunctive-relief analysis is irreparable injury. A movant must "demonstrate at least 'some injury'" to warrant the granting of an injunction. CityFed Fin. Corp., 58 F.3d at 747 (quotation omitted). Indeed, if a party makes no showing of irreparable injury, the court may deny the motion for injunctive relief without considering the other factors. Id.

Because interim injunctive relief is an extraordinary form of judicial relief, courts should grant such relief sparingly. Mazurek v. Armstrong, 520 U.S. 968, 972 (1997). As the Supreme Court has said, "[i]t frequently is observed that a preliminary injunction is an extraordinary and drastic remedy, one that should not be granted unless the movant, by a clear showing, carries the burden of persuasion." Id. (citation omitted). Therefore, although the trial court has the discretion to issue or deny a preliminary injunction, it is not a form of relief granted lightly.In addition, any injunction that the court issues must be ...


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