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Sanofi-Aventis v. Food and Drug Administration

August 21, 2009


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

Re Document No. 5



This case is before the court on the plaintiffs' motion for a temporary restraining order ("TRO") and preliminary injunction. 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 "SanofiAventis") 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 ask the court to order the Food and Drug Administration ("FDA") to rescind approval it has given to third-party drug manufacturers to manufacture and market generic versions of oxaliplatin. Because the plaintiffs have failed to demonstrate that they are substantially likely to succeed on the merits of their case, the court denies their request for a TRO and preliminary injunction.


A. The Hatch-Waxman Act

The relevant portions of the Hatch-Waxman Act, 21 U.S.C. § 355 ("the Hatch-Waxman Act") amended the Food, Drug and Cosmetic Act, 21 U.S.C. § 351 et seq., and dictate the process by which generic drugs are approved by the FDA and marketed by the drug companies. Among other things, the Hatch-Waxman Act requires a drug manufacturer seeking approval to produce a generic version of a drug to certify that the patent for the corresponding brand-named drug "is invalid or will not be infringed by the manufacture, use or sale of the new drug for which the application is submitted." 21 U.S.C. § 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. 21 U.S.C. § 355(c)(3)(C), (j)(5)(B)(iii). Once such an action is filed, the FDA must withhold approval of the drug manufacturer's application to produce a generic drug ("generic application") for a thirty-month period ("thirty-month stay"). Id. The thirty-month stay may be shortened, however, if "the district court [in which the patent infringement action is brought] decides that the patent is invalid or not infringed," 21 U.S.C. § 355(c)(3)(C)(i), at which point the FDA's approval shall be effective the "date on which the court enters judgment," 21 U.S.C. § 355(c)(3)(C)(i)(I) ("the entry of judgment provision").

B. The New Jersey Suit and Subsequent FDA Action*fn1

The plaintiffs in this action are the patent holder, manufacturer and licensee of Eloxatin, the name brand for oxaliplatin. Compl. ¶ 2. After a number of drug manufacturers seeking to produce generic versions of oxaliplatin filed the required patent certification, the plaintiffs brought a patent infringement suit against them in the United States District Court for the District of New Jersey ("the New Jersey suit").*fn2 Pls.' Mot. at 7. On June 18, 2009, the New Jersey court ruled that the plaintiffs' patent had not been infringed and, on June 30, 2009, that court entered judgment. Id. The plaintiffs filed an emergency motion to stay the district court's judgment pending appeal with the Federal Circuit, which the court granted on July 1, 2009. Id., Ex. C. On July 10, 2009 the Federal Circuit extended the stay to include the entire period up to the disposition of the appeal. Id., Ex. D. The Federal Circuit has yet to rule on the merits of the appeal.

On August 7, 2009, the FDA approved the application of Teva Parenteral Medicines, Inc. ("Teva") to produce a generic version of oxaliplatin. Id. at 1. On August 10, 2009, the plaintiffs filed a complaint with this court, seeking a TRO and preliminary injunction that would require the FDA to rescind its approval of Teva's application. See generally Compl.; Pls.' Mot. At an emergency hearing held that same day the court denied the plaintiffs' motions from the bench for the reasons set forth below.


A. Legal Standard for Injunctive Relief

This court may issue interim injunctive relief only when the movant demonstrates "[1] that he is likely to succeed on the merits, [2] that he is likely to suffer irreparable harm in the absence of preliminary relief, [3] that the balance of equities tips in his favor, and [4] that an injunction is in the public interest." Winter v. Natural Res. Def. Council, Inc., 129 S.Ct. 365, 374 (2008) (citing Munaf v. Geren, 128 S.Ct. 2207, 2218-19 (2008)). It is particularly important for the movant to demonstrate a 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).

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). The Supreme Court has 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. 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 ...

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