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

September 6, 2006

BIOVAIL CORPORATION ET AL., PLAINTIFFS,
v.
U.S. FOOD AND DRUG ADMINISTRATION ET AL., DEFENDANTS, AND ANCHEN PHARMACEUTICALS, INC., INTERVENOR.



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

Document No. 3

MEMORANDUM OPINION

DENYING THE PLAINTIFFS'MOTION FOR A TEMPORARY RESTRAINING ORDER

I. INTRODUCTION

The plaintiffs, Biovail Corporation and Biovail Laboratories International SRL (collectively, "the plaintiff" or "Biovail") manufacture the drug Wellbutrin XL. Defendant-Intervenor Anchen Pharmaceuticals, Inc. ("Anchen") is awaiting defendant Food & Drug Administration's ("FDA")*fn1 approval of its generic version of Wellbutrin XL. In December 2005, Biovail filed a citizen petition*fn2 with the defendant to raise Biovail's concerns regarding the defendant's evaluation of generic versions of Wellbutrin XL. Specifically, the plaintiff's petition sought to ensure that the defendant applied the proper standards in determining whether the generic drugs pending FDA approval are the bioequivalents*fn3 of Wellbutrin XL. The plaintiff asserts that some versions of generic Wellbutrin XL may contain dangerous versions of a chemical known to cause grand mal seizures, and, as a result, the introduction of these generic drugs into the market threatens public safety and damage to Wellbutrin XL's reputation. The plaintiff alleges that the defendant routinely withholds ruling on citizen petitions until after approving a generic drug and, consequently, eliminates any opportunity for meaningful judicial review of its decision.

The plaintiff now brings this motion for a temporary restraining order ("TRO") alleging that the defendant violated the Administrative Procedures Act, 5 U.S.C. § 706 ("APA"), and the plaintiff's right to constitutional due process, U.S. Const. Amend. V, by failing to respond substantively to the plaintiff's citizen petition within 180 days. The plaintiff asks the court to compel the defendant to rule on the plaintiff's citizen petition one week prior to approving the generic drugs. The plaintiff also asks the court to enjoin the defendant from ruling on citizen petitions concurrent to approving Abbreviated New Drug Applications ("ANDA"). The defendant and Anchen oppose the plaintiff's motion, arguing that the defendant acted properly by issuing a tentative response within 180 days. Moreover, they assert that the defendant is not required to rule on a citizen petition prior to approving a generic drug. Because the plaintiff has not demonstrated a substantial likelihood of success on the merits of its claims or irreparable injury, the court denies the plaintiff's motion for a temporary restraining order.

II. BACKGROUND

A. Factual History

The plaintiff manufactures and sells the prescription drug Wellbutrin XL. Compl. ¶¶ 7-8, 11. Wellbutrin XL is an FDA-approved "innovator"*fn4 prescription drug used to treat depression. Id. ¶ 10. Wellbutrin XL contains the active ingredient bupropion hydrochloride in extended-release tablets for use in once-daily doses. Id. ¶ 13.

The Federal Food, Drug, and Cosmetic Act, 21 U.S.C. §§ 321 et seq., allows parties seeking approval for generic forms of FDA-approved drugs to file ANDAs. Compl. ¶ 14. If an ANDA for a generic drug "relies upon the findings and safety effectiveness for the innovator drug," the FDA may approve the generic version of the innovator drug. Id. ¶ 14. The FDA may not approve an ANDA unless the generic drug is the "bioequivalent" of the innovator drug. Id. ¶ 15.

Although no generic version of Wellbutrin XL is currently on the market, on November 14, 2005, the FDA granted "tentative approval" to an ANDA filed by Anchen. Id. ¶ 17.

Concerned that improper doses of bupropion can cause grand mal seizures, the plaintiff filed a citizen petition on December 20, 2005. Compl. ¶ 18. In its petition, the plaintiff requested that the FDA apply specific criteria in the approval process to determine the bioequivalence of any generic version of Wellbutrin XL prior to granting approval for that generic drug. Id. ¶ 18. On June 7, 2006, the defendant informed the plaintiff that it would be unable to decide the plaintiff's citizen petition within the 180-day period "because it raised complex issues requiring extensive review and analysis by Agency officials." Id. ¶ 19. On June 29, 2006, the plaintiff sent a letter to the defendant requesting that it take immediate action on its citizen petition. Id. ¶ 21. The plaintiff claims that the defendant has failed to respond to the letter. Id.

B. Procedural History

On August 23, 2006, the plaintiff filed a motion for a TRO, requesting that the court compel the defendant to rule on the plaintiff's citizen petition. Pl.'s Mot. at 1. In addition, the plaintiff asks the court to require the defendant to rule on the plaintiff's petition at least one calendar week prior to granting any application for a generic Wellbutrin XL product, thereby affording the plaintiff "a meaningful opportunity to seek judicial review" if the FDA denies its petition. Id. at 1.

Because of the time-sensitive nature of the plaintiff's motion, the court ordered expedited briefing. On August 24, 2006, the defendant and Anchen opposed the plaintiff's motion by arguing that it cannot succeed on the merits of its claim because the defendant issued a tentative response regarding the plaintiff's citizen petition within 180 days. Def. FDA's Opp'n to Pl.'s Mot. ("FDA's Opp'n") at 6. Moreover, the defendant argues that the law does not require it to respond to a citizen petition prior to ruling on an ANDA. Id. at 2. The defendant and Anchen also assert that the plaintiff demonstrates little more than speculative economic harm, which is an insufficient showing to warrant a TRO. FDA's Opp'n at 8-11; Anchen's Opp'n to Pl's Mot. (Anchen's Opp'n) at 13-16. The court now turns to the plaintiff's motion.

III. ANALYSIS

A. Legal Standard for Injunctive Relief

This court may issue interim injunctive relief only when the ...


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