In re Remeron Direct Purchaser Antitrust Litig.

• Decision Date: 18 February 2005
• Docket Number: No. 03-0085(FSH).,03-0085(FSH).
• Citation: 367 F.Supp.2d 675
• Parties: In re REMERON DIRECT PURCHASER ANTITRUST LITIGATION.
• Court: U.S. District Court — District of New Jersey

367 F.Supp.2d 675

In re REMERON DIRECT PURCHASER ANTITRUST LITIGATION.

No. 03-0085(FSH).

United States District Court, D. New Jersey.

February 18, 2005.

Franklyn C. Steinberg, III, Steinberg Law Offices, Somerville, NJ, for Movant.

Lisa J. Rodriguez, Trujillo Rodriguez & Richards, LLP, Haddonfield, NJ, Rebekah R. Conroy, Cohn Lifland Pearlman Hermann & Knopf LLP, Saddle Brook, NJ, for Plaintiff.

Kevin J. McKenna, Mara E. Zazzali, Gibbons, Del Deo, Dolan, Griffinger & Vecchione, PC, Newark, NJ, for Defendant.

OPINION & ORDER

HOCHBERG, District Judge.

INTRODUCTION

This matter comes before the Court upon the parties' cross motions for summary judgment. Three issues remain in this antitrust case: (a) whether Defendants had monopoly power in a relevant market, (b) whether Defendants used such monopoly power to monopolize the market by delaying the listing of their drug combination in the FDA's Orange Book, and (c) whether Defendants used such monopoly power to monopolize the market through an overall scheme. Defendants have filed a motion for summary judgment on all three issues. Plaintiffs have filed two motions for partial summary judgment — one on the issue of monopoly power and the other on the issue of monopolization by delayed-listing.

This opinion analyzes both parties' respective summary judgment motions with respect to the "direct evidence" approach for determining Defendants' market power, which is the sole basis of Plaintiffs' motion for summary judgment on monopoly power and is one issue of Defendants' motion.¹ The Court reviews the motions on the papers in accordance with Fed.R.Civ.P. 78.

BACKGROUND

Organon, Inc. and Akzo Nobel N.V. ("Defendants" or "Organon") manufacture the antidepressant drug mirtazapine, commercially marketed as Remeron. Mirtazapine was originally claimed in their now-expired United States Patent No. 4,062,848 (the "'848 patent") and introduced in the United States in 1996. Including patent and regulatory exclusivities, Organon's exclusive right to manufacture and sell mirtazapine expired on June 14, 2001.

Mirtazipine is alone in the selective noradrenergic/serotonergic class of antidepressants ("NSSA"). The oldest commonly used antidepressants are those in the selective serotonin reuptake inhibitor class ("SSRI") which includes, among others, brand-names Prozac, Paxil and Zoloft. Other antidepressants recently marketed in the United States include brand name Effexor (alone in the SNRI class), brand name Desyrel (alone in the SARI class), and brand name Wellbutrin (alone in the NDRI class).

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 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 ("FDA") for listing in the APPROVED DRUG PRODUCTS WITH THERAPEUTIC EQUIVALENCE EVALUATIONS ("Orange Book").²

Beginning in February 2001, several generic drug manufacturers ("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) ("Paragraph IV Certifications"), which stated that the '099 patent was invalid or would not be infringed by their generic version of mirtazapine.

Organon thereupon 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 including (1) improperly listing the '099 patent in the Orange Book and (2) baselessly initiating patent infringement actions against the Generics. Organon Inc. v. Mylan Pharms., Inc., 293 F.Supp.2d 453 (D.N.J.2003) ("Organon II"). This Court granted Organon's motion to dismiss both of these claims on December 3, 2003 because (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.³ Organon II, 293 F.Supp.2d at 459, 461. The Generics and Organon settled the Generics' remaining counterclaims in April 2004.⁴

In the action now before the Court, Plaintiffs are the direct purchasers of mirtazapine who allege injury from having paid higher prices as a result of delayed Generic entry. As did the Generics, Plaintiffs allege that Organon improperly delayed listing the '099 patent in the Orange Book for the purpose of extending their monopoly on the mirtazapine market. Had Organon listed the '099 patent within 30 days after its issuance (December 2, 1999) as required by FDA rules, Plaintiffs allege the Generics could have filed Paragraph IV certifications as early as June 15, 2000. However, because the ' 099 patent was not listed in the Orange Book until February 1, 2001, the first ANDAs for generic mirtazapine were not filed until February 28, 2001, and the Hatch-Waxman contesting process and Generic entry were delayed.

Plaintiffs also allege "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 not found to violate antitrust laws.⁵ Necessary to finding for Plaintiffs on either of these issues is an initial determination that Organon had monopoly power in a relevant market.

SUMMARY JUDGMENT STANDARD

Pursuant to Fed.R.Civ.P. 56(c), a motion for summary judgment will be granted if the pleadings, depositions, answers to interrogatories, and admissions on file, together with the affidavits, if any, show that there is no genuine issue as to any material fact and that the moving party is entitled to judgment as a matter of law. See Anderson v. Liberty Lobby, Inc., 477 U.S. 242, 247, 106 S.Ct. 2505, 91 L.Ed.2d 202 (1986); Celotex Corp. v. Catrett, 477 U.S. 317, 322, 106 S.Ct. 2548, 91 L.Ed.2d 265 (1986). In other words, "summary judgment may be granted only if there exists no genuine issue of material fact that would permit a reasonable jury to find for the nonmoving party." Miller v. Indiana Hosp., 843 F.2d 139, 143 (3d Cir.1988). All facts and inferences must be construed in the light most favorable to the non-moving party. Peters v. Delaware River Port Auth., 16 F.3d 1346, 1349 (3d Cir.1994). The judge's function is not to weigh the evidence and determine the truth of the matter, but to determine whether there is a genuine issue for trial. See Anderson, 477 U.S. at 249, 106 S.Ct. 2505. "Consequently, the court must ask whether, on the summary judgment record, reasonable jurors could find facts that demonstrate, by a preponderance of the evidence, that the nonmoving party is entitled to a verdict." In re Paoli R.R. Yard PCB Litigation, 916 F.2d 829, 860 (3d Cir.1990).

The party seeking summary judgment always bears the initial burden of production. Celotex Corp., 477 U.S. at 323, 106 S.Ct. 2548. This burden requires the moving party to establish either that there is no genuine issue of material fact and that the moving party must prevail as a matter of law, or to demonstrate that the nonmoving party has not shown the requisite facts relating to an essential element of an issue on which it bears the burden. See id. at 322-23, 106 S.Ct. 2548. Once the party seeking summary judgment has carried this initial burden, the burden shifts to the nonmoving party.

To avoid summary judgment, the nonmoving party must then demonstrate facts supporting each element for which it bears the burden, and it must establish the existence of a "genuine issue of material fact" justifying trial. Miller, 843 F.2d at 143; see also Celotex Corp., 477 U.S. at 324, 106 S.Ct. 2548. The nonmoving party "must do more than simply show that there is some metaphysical doubt as to material facts." Matsushita Elec. Indus. Co. v. Zenith Radio Corp., 475 U.S. 574, 586, 106 S.Ct. 1348, 89 L.Ed.2d 538 (1986). "Where the record taken as a whole could not lead a rational trier of fact to find for the nonmoving party, there is no `genuine issue for trial.'" Id. at 587, 106 S.Ct. 1348 quoting First National Bank of Arizona v. Cities Serv. Co., 391 U.S. 253, 289, 88 S.Ct. 1575, 20 L.Ed.2d 569 (1968). Further, summary judgment may be granted if the nonmoving party's "evidence is merely colorable or is not significantly probative." Anderson, 477 U.S. at 249-50, 106 S.Ct. 2505.

DISCUSSION

Section 2 of the Sherman Act "sanctions those `who shall monopolize, or attempt to monopolize ... any part of the trade or commerce among the several states.'" Queen City Pizza, Inc. v. Domino's Pizza, Inc., 124 F.3d 430 (3d Cir.1997) quoting 15 U.S.C. § 2. "The offense of monopoly under § 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." Aspen Skiing Co. v. Aspen Highlands Skiing Corp., 472 U.S. 585, 596 n. 19, 105 S.Ct. 2847, 86 L.Ed.2d 467 (1985) quoting United States v. Grinnell Corp., 384 U.S. 563, 570-71, 86 S.Ct. 1698, 16 L.Ed.2d 778 (1966); Queen City Pizza, Inc. v. Domino's Pizza, Inc....