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Sanofi-Aventis v. Food and Drug Administration

July 26, 2010


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

Re Document No.: 26, 32, 34



This matter comes before the court on the plaintiffs' motion for summary judgment and the defendants' and the intervenor-defendants' cross-motions for summary judgment. Plaintiff Debiopharm S.A. ("Debiopharm") is a Swiss company that holds the patent for the anti-cancer drug oxaliplatin. Plaintiff Sanofi-Aventis is the pioneer manufacturer of the drug and plaintiff Sanofi-Aventis U.S. LLC (collectively "Sanofi-Aventis") holds the exclusive license for the drug in the United States. Sanofi-Aventis markets and sells oxaliplatin under the brand name Eloxatin(r). The plaintiffs allege that the Food and Drug Administration ("FDA") violated the Administrative Procedures Act ("APA"), 5 U.S.C. §§ 701 et seq., when it approved applications to manufacture generic oxaliplatin. They seek a court order requiring the FDA to rescind all generic oxaliplatin approvals and to refrain from granting any further approvals until the expiration of an automatic thirty-month stay mandated under the Food, Drug, and Cosmetic Act ("FDCA"), 21 U.S.C. § 355. For the reasons stated below, the court denies the plaintiffs' motion for summary judgment and grants the defendants' and intervenor-defendants' cross-motions for summary judgment.


A. Statutory Framework

The FDCA provides that before any new drug can be introduced into the U.S. market, the FDA must determine that it is safe and effective. 21 U.S.C. § 355(a). The first, or "pioneer," applicant for a given drug must submit to the FDA a new drug application ("NDA"), containing, among other things, "full reports of investigations which have been made to show whether or not such drug is safe for use and whether such drug is effective in use . . . a full list of the articles used as components of such drug . . . [and] a full description of the methods used in, and the facilities and controls used for, the manufacture, processing, and packing of such drugs." Id. § 355(b). Once approved, the pioneer drug is referred to as a "listed" drug. Id.

Companies seeking to manufacture new prescription drugs must file new drug applications ("NDAs") with the FDA demonstrating their drugs' safety and effectiveness before they can market them. Id. § 355(b)(1). Recognizing that the NDA process is costly and time-consuming, Congress amended the FDCA in 1984 pursuant to the "Hatch-Waxman Amendments." Serono Labs., Inc. v. Shalala, 158 F.3d 1313, 1316 (D.C. Cir. 1998) (citing H.R. Rep. No. 98-857, pt. 1 at 14 (1984)). In an effort "to make available more low cost drugs," id., the FDCA permits the manufacturer of a generic version of a listed drug to obtain FDA approval through a far simpler, abbreviated new drug application ("ANDA") containing a more limited set of information than that required for an NDA.*fn1 21 U.S.C. § 355(j). The relevant provisions of the approval process for NDAs and ANDAs are identical. See id. §§ 355(c)(3)(C), (j)(5)(B)(iii).

Among other things, the FDCA requires a drug manufacturer seeking approval to produce a generic version of a drug to certify that the patent for the corresponding brand-name version of the drug "is invalid or will not be infringed by the manufacture, use or sale of the new drug for which the application is submitted." Id. §§ 355(b)(2)(A)(iv), (j)(2)(A)(vii)(IV). The patent holder has forty-five days after receiving notification of the certification to bring a patent infringement action against the drug manufacturer that filed the certification. Id. §§ 355(c)(3)(C), (j)(5)(B)(iii). Once such an action is filed, the FDA must withhold approval of the application to produce a generic drug ("generic drug application") for a thirty-month period ("thirty-month stay"). Id. The thirty-month stay may be terminated, however, if "the district court [in which the patent infringement action is brought] decides that the patent is invalid or not infringed," id. §§ 355(c)(3)(C)(i), (j)(5)(B)(iii)(I). If the court renders such a ruling, provided other conditions for approval have been met, the FDA's approval becomes effective on "date on which the court enters judgment reflecting the decision," id. §§ 355(c)(3)(C)(i)(I), (j)(5)(B)(iii)(I)(aa) ("the entry of judgment provisions").

B. Factual & Procedural History

The plaintiffs in this action are the patent holder, manufacturer and licensee of the anti-cancer drug oxaliplatin, marketed under the brand name Eloxatin(r), the name brand for oxaliplatin. Pls.' Statement of Facts ("Pls.' Statement") ¶ 4; Defs.' Statement of Facts ("Defs.' Statement") ¶ 1. In June and July 2007, the plaintiffs commenced a patent infringement suit in the United States District Court for the District of New Jersey against a number of drug manufacturers who sought to produce generic oxaliplatin. Pls.' Statement ¶ 3; Defs.' Statement ¶ 2. On June 30, 2009, the New Jersey district court entered judgment, ruling that the plaintiffs' patent had not been infringed. Pls.' Statement¶ 5; Defs.' Statement ¶ 4. The FDA subsequently approved the generic drug applications of several pharmaceutical manufacturers seeking to produce and market generic oxaliplatin.*fn2 Pls.' Statement ¶ 9; Defs.' Statement ¶ 6. The plaintiffs appealed the judgment of the New Jersey district court, and the Federal Circuit first stayed and then, on September 10, 2009, vacated the judgment entered by the New Jersey district court and remanded the case back to that court. Pls.' Statement ¶ 12; Defs.' Statement ¶¶ 5, 7.

On August 10, 2009, after the Federal Circuit stayed but before it vacated the New Jersey district court's judgment, the plaintiffs filed suit in this court against the FDA and the Department of Health and Human Services, requesting an injunction that would require the FDA to rescind its approval of the generic drug applications and refrain from granting further approvals until the expiration of the thirty-month stay.*fn3 See generally Compl.; Pls.' Mot. for TRO and Prelim. Inj. After hearing oral argument on the motion, the court denied the plaintiffs' motion for a temporary restraining order and preliminary injunction, holding that the Federal Circuit's stay of the New Jersey district court's judgment did not effectively reinstated the thirty-month stay under the FDCA. See generally Mem. Op. (Aug. 18, 2009). The court subsequently granted leave to intervene to Teva Parenteral Medicines, Inc., Teva Pharmaceuticals USA, Inc., Pharmachemie B.V., Barr Laboratories, Inc., and Pliva-Lachema a.s. (collectively, "TEVA") and Hospira Worldwide Pty, Hospira Inc., Hospira Australia Pty Ltd. d/b/a Mayne Pharma Limited and Mayne Pharma (USA) Inc. (collectively, "Hospira"), manufacturers and distributors of generic oxaliplatin. See Minute Order (Aug. 11, 2009); Minute Order (Dec. 24, 2009).

On September 14, 2009, the plaintiffs filed a motion for summary judgment, arguing that the FDA acted unlawfully in granting the generic drug applications. See generally Pls.' Mot. for Summ. J. ("Pls.' Mot."). The defendants and intervenor-defendants filed cross-motions for summary judgment on September 28, 2009. See generally Defs.' Cross-Mot. for Summ. J. ("Defs.' Mot."); Intervenor-Defs.' Cross-Mot. for Summ. J. ("Intervenors' Mot."). The ...

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