Searching over 5,500,000 cases.


searching
Buy This Entire Record For $7.95

Download the entire decision to receive the complete text, official citation,
docket number, dissents and concurrences, and footnotes for this case.

Learn more about what you receive with purchase of this case.

In re Remeron Antitrust Litigation

September 8, 2004

IN RE REMERON ANTITRUST LITIGATION
IN RE REMERON DIRECT PURCHASER ANTITRUST LITIGATION WALGREEN CO., ET AL., PLAINTIFFS,
v.
ORGANON, INC. AND AKZO NOBEL N.V., DEFENDANTS.
CVS MERIDIAN, INC. AND RITE AID CORP., PLAINTIFFS,
v.
ORGANON, INC. AND AKZO NOBEL N.V., DEFENDANTS.



The opinion of the court was delivered by: Hochberg, District Judge.

OPINION

INTRODUCTION

This matter comes before the Court upon Defendants Organon USA Inc. and Akzo Nobel N.V.'s (collectively "Organon") consolidated motion to dismiss Plaintiffs' antitrust claims pursuant to Fed.R.Civ.P. 12(b)(6). The Court has considered the written submissions of the parties pursuant to Fed.R.Civ.P. 78.

BACKGROUND

Organon manufactures the antidepressant drug mirtazapine, commercially marketed as Remeron, which was originally claimed in its now-expired United States Patent No. 4,062,848 (the " '848 patent"). Adding its patent and regulatory exclusivities, Organon's exclusive right to manufacture and sell mirtazapine expired on June 14, 2001.

On November 2, 1999, Organon was granted United States Patent No. 5,977,099 (the " '099 patent") for a method of treating depression using a combination of mirtazapine and a selective serotonin reuptake inhibitor ("SSRI"). In January 2001, fourteen months after being granted the '099 patent, Organon submitted the '099 patent to the United States Food and Drug Administration (the "FDA") for listing in the APPROVED DRUG PRODUCTS WITH THERAPEUTIC EQUIVALENCE EVALUATIONS (the "Orange Book").*fn1

Beginning in February 2001, several generic drug manufacturers (the "Generics") filed Abbreviated New Drug Applications ("ANDAs") with the FDA, seeking approval for their generic version of mirtazapine. The Generics each filed a certification, under 21 U.S.C. § 355(j)(2)(A)(vii)(IV) (the "Paragraph IV Certifications"), which stated that the '099 patent was invalid or would not be infringed by their generic version of mirtazapine.

Subsequently, Organon sued the Generics for inducement to infringe the '099 patent. Because Organon sued each of the Generics within forty-five days of receipt of the Paragraph IV Certifications, FDA approval of the generic ANDAs was automatically stayed by operation of the Hatch-Waxman Act and would remain stayed until the earlier of thirty months or a judicial determination that the '099 patent was invalid or not infringed. See 21 U.S.C. § 355(j)(5)(B)(iii). On December 18, 2002, this Court ruled that the Generics' sale of mirtazapine did not induce infringement of the '099 patent. See Organon Inc. v. Teva Pharms., Inc., 244 F.Supp.2d 370 (D.N.J.2002) ( "Organon I ").

The Generics filed counterclaims against Organon for antitrust violations under the Sherman Act. Organon Inc. v. Mylan Pharms., Inc., 293 F.Supp.2d 453 (D.N.J.2003) ("Organon II "). These claims include: 1) improperly listing the '099 patent in the Orange Book; and 2) baselessly initiating patent infringement actions against the Generics.*fn2 On December 3, 2003, this Court granted Organon's motion to dismiss the Generics' antitrust claims based on the grounds that: 1) the language of 21 U.S.C. §§ 355(b)(1), (c)(2) and 21 C.F.R. § 314.53(b) "gave Organon a reasonable basis for listing in the Orange Book"; and 2) Organon had an objective basis to believe it could assert a claim of patent infringement with a reasonable calculation of a favorable outcome.*fn3 Organon II, 293 F.Supp.2d at 459, 461. This Court made clear, however, that it had not ruled on whether a late listing claim could survive a motion to dismiss. In April of 2004, the Generics settled their counterclaims against Organon.

In the instant action, Plaintiffs, the direct purchasers of mirtazapine, filed amended antitrust complaints against Organon alleging "an overall scheme" to monopolize the relevant market, claiming that when taken together, the allegations against Organon constitute an antitrust violation, even if the individual allegations are found to not violate antitrust laws. Their complaints alleged also that: 1) Organon obtained the '099 patent through fraud on the PTO; 2) Organon improperly listed the '099 patent in the Orange Book; 3) Organon baselessly initiated patent infringement actions in Organon I;*fn4 and 4) Organon improperly delayed listing the '099 patent in the Orange Book for the purpose of extending their monopoly on the mirtazapine market.*fn5 This fourth claim is premised on the allegation that, had Organon listed the '099 patent within 30 days after its issuance (December 2, 1999) as is required by FDA rules, the Generics could have filed Paragraph IV certifications as early as June 15, 2000. Because the '099 patent was not listed in the Orange Book until February 1, 2001, however, the first ANDAs for generic mirtazapine were not filed until February 28, 2001, and the Hatch-Waxman contesting process was delayed. As a result, Organon gained an extended period of market exclusivity. This "late listing" claim is among Plaintiffs' antitrust allegations in the instant case.

STANDARD

A. Motion to Dismiss

A motion to dismiss under Fed.R.Civ.P. 12(b)(6) should be granted "if it appears to a certainty that no relief could be granted under any set of facts which could be proved." Morse v. Lower Merion Sch. Dist., 132 F.3d 902, 906 (3d Cir.1997). While a court need not credit a complaint's "bald assertions" or "legal conclusions," it is required to accept as true all of the allegations in the complaint and all reasonable inferences that can be drawn therefrom, and view them in the light most favorable to the plaintiff. Id. (citing Rocks v. City of Philadelphia, 868 F.2d 644, 645 (3d Cir.1989)); In re Burlington Coat Factory Sec. Litig., 114 F.3d 1410, 1429-30 (3d Cir.1997).

B. Antitrust Claims

The Supreme Court has dictated that an antitrust injury is a type of injury the antitrust laws were intended to prevent and also one that is a result of a defendant's unlawful conduct. Brunswick Corp. v. Pueblo Bowl-O-Mat, Inc., 429 U.S. 477, 489, 97 S.Ct. 690, 50 L.Ed.2d 701 (1977). The purpose of the Sherman Act is "to protect the public from the failure of the market." 15 U.S.C.A. § 2 n. 4, quoting Spectrum Sports, Inc. v. McQuillan, 506 U.S. 447, 113 S.Ct. 884, 892, 122 L.Ed.2d 247 (1993).

The offense of monopolization under Section 2 of the Sherman Act has two elements: 1) the possession of monopoly power in the relevant market; and 2) the willful acquisition or maintenance of that power, as distinguished from growth or development as a consequence of a superior product, business acumen or historic accident. United States v. Grinnell Corp., 384 U.S. 563, 570-71, 86 S.Ct. 1698, 16 L.Ed.2d 778 (1966). A specific intent to monopolize is not required for a court to find a Section 2 violation. The "completed offense of monopolization ... demands only a general intent to do the act, for 'no monopolist monopolizes unconscious of what he is doing.' " Times-Picayune Publ'g Co. v. United States, 345 U.S. 594, ...


Buy This Entire Record For $7.95

Download the entire decision to receive the complete text, official citation,
docket number, dissents and concurrences, and footnotes for this case.

Learn more about what you receive with purchase of this case.