Apotex Inc. v. U.S. Food and Drug Admin.

• Decision Date: 17 September 2007
• Docket Number: Civil Action No. 07-1194(RMU).
• Citation: 508 F.Supp.2d 78
• Parties: APOTEX INC., Plaintiff, v. U.S. FOOD AND DRUG ADMINISTRATION et al., Defendants, and Astrazeneca LP, Intervenor-defendant.
• Court: U.S. District Court — District of Columbia

508 F.Supp.2d 78

APOTEX INC., Plaintiff, v. U.S. FOOD AND DRUG ADMINISTRATION et al., Defendants, and Astrazeneca LP, Intervenor-defendant.

Civil Action No. 07-1194(RMU).

United States District Court, District of Columbia.

September 17, 2007.

Arthur Y. Tsien, Olsson, Frank and Weeda, PC, Washington, DC, William A. Rakoczy, Amy D. Brody, Rakoczy Molino Mazzochi Siwik, LLP, Chicago, IL, for Plaintiff.

Andrew E. Clark, U.S. Department of Justice, Washington, DC, for Defendants.

Carolyn Frances Corwin, Joshua D. Wolson, Covington & Burling, Washington, DC, for Intervenor-defendant.

MEMORANDUM OPINION

DENYING THE PLAINTIFF'S MOTION FOR INJUNCTIVE RELIEF

URBINA, District Judge.

I. INTRODUCTION

The plaintiff, Apotex, Inc., has marketed a generic version of the drug Prilosec for over three years pursuant to the approval of defendant¹ U.S. Food and Drug Administration ("FDA"). On June 28, 2007, subsequent to a court order concluding that the plaintiff's actions violated two of intervenor-defendant Astrazeneca's² 2 ("Astra") patents for brand-name Prilosec, the FDA revoked the plaintiff's approval to continue marketing its generic drug. The revocation of the plaintiff's final approval forced the plaintiff to immediately cease distribution of its generic drug. The plaintiff brought the instant suit and a motion for a temporary restraining order ("TRO") and preliminary injunction ("PI"), claiming that the FDA's action violates the Administrative Procedure Act, 5 U.S.C. § 702 ("APA"). The plaintiff asks the court to set aside the FDA's decision and to reinstate the plaintiff's final approval to distribute its generic drug. Alternatively, should the court deny the plaintiff's motion, the plaintiff requests that the court grant it interim relief pending appeal. Because the court concludes that the plaintiff has not shown a likelihood of success on the merits or irreparable injury sufficient to warrant a TRO or PI, the court denies the plaintiff's motion. For the same reason, the court denies the plaintiff's request for interim relief pending appeal.

II. BACKGROUND

a. The Hatch Waxman Amendments & Pediatric Exclusivity

The 1984 Hatch Waxman Amendments amended the Federal Food, Drug, and Cosmetic Act ("FFDCA" or "the Act") and patent laws, altering the drug approval procedure to facilitate generic drugs' entry into the marketplace. In re Barr Labs., 930 F.2d 72, 76 (D.C.Cir.1991). Significantly, the amendments eliminated the requirement that an application for a generic version of a brand-name drug contain independent clinical research data, so long as it certifies that the generic drug is the bioequivalent to an approved, brand-name drug. Mylan Labs., Inc. v. Thompson, 389 F.3d 1272, 1275 (D.C.Cir.2004). Briefly, the procedure for drug approval is as follows: A brand-name drug manufacturer seeking FDA approval must submit a New Drug Application ("NDA") which includes, inter alia, technical data on the composition of the drug, the means for manufacturing it, clinical trial results establishing its safety and effectiveness, and labeling describing the use for which approval is requested. 21 U.S.C. 355(b); see also Mylan Labs., Inc. v. Leavitt, 484 F.Supp.2d 109, 113 (D.D.C.2007). Once the FDA approves a brand-name drug's NDA, a generic drug manufacturer seeking FDA approval may submit an Abbreviated New Drug Application ("ANDA"), meaning that it can "piggyback" on the safety and effectiveness findings of the NDA. Purepac Pharm. Co. v. Thompson, 354 F.3d 877, 879 (D.C.Cir.2004). This allows ANDA applicants. "to proceed more quickly to the marketplace." Teva Pharms. USA, Inc. v. FDA, 182 F.3d 1003, 1004 (D.C.Cir.1999).

Section 355a of the Act provides an incentive for a drug patent holder to conduct studies of a drug which the FDA believes may have beneficial pediatric use. Mylan, Inc. v. Thompson, 389 F.3d at 1276. If the FDA requests that the drug patent holder conduct studies of a drug's applicability to the pediatric population and the patent holder satisfactorily completes the studies, the patent holder is eligible to receive a six-month period of market exclusivity for the drug beyond the patent expiration date. Id. (citing 21 U.S.C. § 355a). This is known as a "pediatric exclusivity" period.

b. Factual & Procedural Background

Intervenor-defendant Astra manufactures the brand-name drug Prilosec. Pl.'s Mot. for TRO and/or Prelim. Inj. ("Pl.'s Mot.") at 1. On December 5, 2002, the plaintiff filed an ANDA for permission to market a generic version of Prilosec ("generic omeprazole" or "the plaintiff's product"). Id. at 7. In response to the plaintiff's filing its ANDA, Astra sued the plaintiff in the United States District Court for the Southern District of New York ("the New York court") for the alleged infringement of Astra's patents. Id. On October 6, 2003, the FDA granted final approval of the plaintiff's ANDA, and the plaintiff has marketed generic omeprazole since that time. Id. On April 20, 2007, Astra's patents for Prilosec naturally expired. Id. at 2.

On June 14, 2007, the New York court ruled that the plaintiff's generic products infringed certain claims of Astra's patents, despite the fact that Astra's patents had expired. Id. at 8; Ex. B. That court also concluded that a period of pediatric exclusivity applied, and therefore, the effective date of approval for the plaintiff's product and other generic products, "shall be no earlier than October 20, 2007," or the date on which the exclusivity period ends. Id. at 8. The plaintiff appealed this decision and requested a stay in the portion of the court's judgment that reset the effective date of Apotex's approval. Id. The Federal Circuit denied that motion. Id. The plaintiff filed an emergency motion to reconsider, and the. Federal Circuit denied that motion on July 10, 2007. Def. FDA's Not. of Filing, Ex. 1 (July 10, 2007).

In response to the New York court's decision, the FDA revoked final approval of the plaintiff's ANDA until at least October 20, 2007. Pl.'s Mot. at 8. The plaintiff opposed this action, but on June 28, 2007, the FDA issued a two-page letter decision revoking Apotex's final approval for generic omeprazole and converting it to tentative approval until the expiration of the exclusivity period imposed by the New York court. Id. at 8-9. The plaintiff now brings the instant suit and a motion for a TRO and/or PI, asking the court to set aside the FDA's decision as "arbitrary, capricious, an abuse of discretion or otherwise contrary to law." Id. at 12. The plaintiff also requests, should the court deny its motions, that the court stay the effects of the FDA's decision pending appeal. Pl.'s Mot. at 1. The court now turns to the plaintiffs request 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, 112 S.Ct. 2929, 120 L.Ed.2d 926 (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. Corp., 58 F.3d at 747.

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. Id. (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, 117 S.Ct. 1865, 138 L.Ed.2d 162 (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 carefully circumscribed and tailored to remedy the harm shown. Nat'l Treasury Employees Union v. Yeutter, 918 F.2d 968, 977 (D.C.Cir.1990) (citation omitted).

B. The Court Denies the Plaintiff's Motion for Injunctive Relief

1. The Plaintiff Fails to Demonstrate a Substantial Likelihood of Success on the Merits

The plaintiff alleges that the FDA abrogated its statutory duty and violated the APA by converting the approval status of its ANDA "solely on the basis" of the New York court's order which imposed a...