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In re Remeron Direct Purchaser Antitrust Litigation

February 18, 2005

IN RE REMERON DIRECT PURCHASER ANTITRUST LITIGATION.


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

OPINION & ORDER

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.*fn1 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").*fn2

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. Sections 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. Sections 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. Sections 355(b)(1), (c)(2) and 21 C.F.R. Sections 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.*fn3 Organon II, 293 F.Supp.2d at 459, 461. The Generics and Organon settled the Generics' remaining counterclaims in April 2004.*fn4

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.*fn5

Necessary to finding for Plaintiffs on either of these issues is an initial determination that Organon had ...


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