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Apotex, Inc. v. U.S. Food and Drug Administration

September 17, 2007


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

Document No. 3




The plaintiff, Apotex, Inc., has marketed a generic version of the drug Prilosec for over three years pursuant to the approval of defendant*fn1 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's*fn2 ("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.


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 plaintiff's request for injunctive relief.


A. Legal Standard for Injunctive Relief

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

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