UNITED STATES DISTRICT COURT
FOR THE DISTRICT OF COLUMBIA
SANOFI-AVENTIS et al., :
:
Plaintiffs, : Civil Action No.: 09-1495 (RMU)
:
v. : Re Document No.: 5
:
FOOD AND DRUG :
ADMINISTRATION et al., :
:
Defendants. :
MEMORANDUM OPINION
DENYING THE PLAINTIFFS’ MOTION FOR A TEMPORARY RESTRAINING ORDER
AND PRELIMINARY INJUNCTION
I. INTRODUCTION
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 “Sanofi-
Aventis”) holds the exclusive license for the drug in the United States. Sanofi-Aventis markets
and sells oxaliplatin under the brand name Eloxatin®. 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.
II. FACTUAL & PROCEDURAL BACKGROUND
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”).
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B. The New Jersey Suit and Subsequent FDA Action1
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”).2 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
1
As explained below, the court held an emergency hearing on the plaintiffs’ motions. The court
denied the motions from the bench, noting that this memorandum opinion would follow. Hr’g
Tr. 19:17-18. Because the defendants did not file a written brief in opposition, and because the
defendants did not dispute the factual and procedural posture of the case as posited by the
plaintiffs, see generally Hr’g Tr., the court accepts the plaintiffs’ account of the facts as set forth
in their motion.
2
The defendants in this action are not parties to the New Jersey suit. See Pls.’ Mot., Exs. C & D.
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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.
III. ANALYSIS
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
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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).
B. The Court Denies the Plaintiffs’ Motions for a TRO and a Preliminary Injunction
1. The Plaintiffs Have Failed to Demonstrate
a Substantial Likelihood of Success on the Merits
The plaintiffs argue that, because the Federal Circuit entered an order staying the New
Jersey district court’s judgment, the thirty-month period was still in effect and the FDA should
not have approved any pending generic applications regarding oxaliplatin. Pls.’ Mot. at 2. The
defendants retort that the FDA was bound by the Hatch-Waxman Act to approve the generic
applications once the New Jersey district court entered its judgment, regardless of the stay
entered by the Federal Circuit. Hr’g Tr. 12:21-13:4. The parties agree that this is a case of first
impression in which this court is called to determine whether a stay entered by an appellate court
overrides the terminating effect that the entry of a district court judgment has on the thirty-month
period under the Hatch-Waxman Act. Hr’g Tr. 11:10-12.
The plaintiffs argue that the Nken v. Holder, 129 S. Ct. 1749 (2009) rationale governs the
issue and outcome. Pls.’ Mot. at 8-9. In Nken, the Supreme Court articulated the differences
between an injunction and a stay. See generally Nken, 129 S. Ct. 1749. The petitioner, an alien
subject to a deportation order from the Board of Immigration Appeals (“BIA”), sought a stay of
the BIA’s order pending his appeal. Id. at 1754-55. The government objected, arguing that the
Illegal Immigration Reform and Immigrant Responsibility Act (“IIRIRA”) prohibited such action
unless the petitioner could show by “clear and convincing evidence that the entry or execution of
such order was prohibited as a matter of law,” as opposed to the more lenient standard applicable
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to motions to stay. Id. at 1756 (quoting 8 U.S.C. § 1252(f)). Holding that a stay and an
injunction “serve different purposes,” the Court noted that an injunction “direct[s] the conduct of
a particular actor [while] a stay operates upon the judicial proceeding.” Nken, 129 S. Ct. at 1757-
58. The plaintiffs here maintain that, because the Nken Court held that a stay divests a district
court’s order of its enforceability, the FDA had no authority to approve the applications filed by
the defendants in the New Jersey suit. Pls.’ Mot. at 9; Hr’g Tr. 6:15-7:1. The defendants, on the
other hand, aver that the statutory language is clear: the FDA must approve the generic
applications based on the date of the entry of a judgment from the district court, not the date on
which that judgment becomes enforceable. Hr’g Tr. 12:24-13:7. The Nken decision does not
address the central issue in the instant case: the difference, if any, between the date of the entry of
judgment and the date of enforceability of that judgment. See generally Nken, 129 S. Ct. 1749.
Although the plaintiffs rely on the Federal Circuit’s ruling in In re Aventis Pharma S.A.,
2008 WL 5691012 (C.A. Fed. (Cal) July 23, 2008), Pls.’ Mot. at 9, the decision, in fact,
undermines the plaintiffs’ position. Aventis dealt with a similar situation in which a
pharmaceutical company appealed a district court’s ruling that its patent was unenforceable.
Aventis, 314 Fed. Appx. at 292. There is, however, a crucial distinction between Aventis and the
instant case: the Federal Circuit in Aventis did not simply stay the district court’s order, but
instead “order[ed] the district court to temporarily defer entry of judgment, pending . . .
resolution of the mandamus petition.” Id. (emphasis added). Thus, the district court was
expressly ordered not to enter judgment, the entry of judgment provision by its terms could not
apply. Here, in contrast, the New Jersey court did enter a judgment, Pls.’ Mot. at 7, and that
judgment was stayed, id., Ex. D. The plain language of the entry of judgment provision of the
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Hatch-Waxman Act is clear that the FDA’s approval of a generic application “shall be made
effective on the [] date on which the court enters judgment.” 21 U.S.C. § 355(c)(3)(C)(i)(I)
(emphasis added). Because the New Jersey court actually entered judgment, triggering the entry
of judgment provision in the Hatch-Waxman Act requiring the FDA to approve the pending
applications, the plaintiffs have failed to demonstrate a likelihood of success on the merits of
their claim. Although the foregoing alone provides a sufficient basis for denying the plaintiffs
the relief they seek, Am. Bankers Ass’n, 38 F. Supp. 2d at 140, there are other factors that
militate against injunctive relief, which the court touches upon briefly.
2. The Plaintiffs Have Failed to Demonstrate Irreparable Harm
and that the Public Interest Favors Injunctive Relief3
[REDACTED]4 The defendants counter that, if the plaintiffs prevail in the New Jersey
suit they will be able to obtain damages to compensate for any financial injury caused by the
generic drug manufacturers’ violation of the Federal Circuit’s order. Hr’g Tr. 14:7-11.
In the D.C. Circuit, “economic loss does not, in and of itself, constitute irreparable harm.”
Wis. Gas Co. v. Fed. Energy Regulatory Comm’n, 758 F.2d 669, 674 (D.C. Cir. 1985) (stating
that “[m]ere injuries, however substantial, in terms of money, time and energy . . . are not
enough. The possibility that adequate compensatory or other corrective relief will be available at
a later date, in the ordinary course of litigation weighs heavily against a claim of irreparable
3
The defendants do not address the balance of equities factor, see Hr’g Tr. 16:13-16, and the court
acknowledges that this factor favors the plaintiffs.
4
Pursuant to the court’s sealing order, Order (Aug. 10, 2009) and the subsequent order un-sealing
the case but maintaining certain documents under seal, Order (Aug. 14, 2009), certain
information contained in this memorandum opinion is protected from public disclosure and is
only available to the parties at this time.
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harm”). Nevertheless, a TRO may be the appropriate equitable remedy “where the loss threatens
the very existence of the movant’s business.” Wash. Metro. Area Transit Comm’n v. Holiday
Tours, Inc., 559 F.2d 841, 843 n.2 (D.C. Cir. 1977).
In this case, however, the plaintiffs do not need the “extraordinary and drastic remedy” of
injunctive relief to protect them from the prospect of economic harm. Mazurek, 520 U.S. at 972.
Rather, the plaintiffs can protect their economic interests by seeking enforcement of the Federal
Circuit’s order staying the New Jersey suit and potentially collect damages from any
manufacturer who violates that order.
With respect to the public interest involved in this case, the plaintiffs allege that the
public is served by adherence to the applicable law – the Hatch-Waxman Act, Pls.’ Mot. at 15-
16; Hr’g Tr. 9:8-17. For the same reasons that the court determined that the plaintiffs are
unlikely to succeed on the merits of their claim, the court rejects this argument. The defendants
submit that the public interest lies in access to generic drugs that have been FDA approved, Hr’g
Tr. 16:16-25. Because the plaintiffs have not demonstrated that they are substantially likely to
succeed on the merits of their claim, keeping generic oxaliplatin products off the market will not
benefit the public interest. See Serono Laboratories, Inc. v. Shalala, 158 F.3d 1313, 1326 (D.C.
Cir. 1998) (explaining that “if . . . [the movant] is not likely to establish that [the generic drug
applications were] wrongly approved, then the public interest considerations weigh against an
injunction”), Bristol-Myers Squibb Co. v. Shalala, 923 F. Supp. 212, 222 (D.D.C. 1996)
(holding that the “public will . . . benefit from increased competition . . . . A delay in the
approval [of the generic drug application], without a showing of a substantial likelihood on the
merits[,] would not further the public interest”).
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IV. CONCLUSION
For the foregoing reasons, the court denies the plaintiffs’ motion for a TRO and
preliminary injunction. An Order consistent with this Memorandum Opinion was issued on
August 11, 2009.
RICARDO M. URBINA
United States District Judge
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