Organon Inc. v. Mylan Pharmaceuticals, Inc.

• Decision Date: 03 December 2003
• Docket Number: Nos. CIV.A. 01-2171(FSH), CIV.A. 01-3835(FSH), CIV.A. 01-2682(FSH), CIV.A. 01-4246(FSH).,s. CIV.A. 01-2171(FSH), CIV.A. 01-3835(FSH), CIV.A. 01-2682(FSH), CIV.A. 01-4246(FSH).
• Citation: 293 F.Supp.2d 453
• Parties: ORGANON INC. and Akzo Nobel N.V., Plaintiffs, v. MYLAN PHARMACEUTICALS, INC., Defendant. Organon Inc. and Akzo Nobel N.V., Plaintiffs, v. Teva Pharmaceuticals Usa, Inc., Defendant. Organon Inc. and Akzo Nobel N.V., Plaintiffs, v. Alphapharm Pty, Ltd., Defendant.
• Court: U.S. District Court — District of New Jersey

293 F.Supp.2d 453

ORGANON INC. and Akzo Nobel N.V., Plaintiffs, v. MYLAN PHARMACEUTICALS, INC., Defendant.

Organon Inc. and Akzo Nobel N.V., Plaintiffs, v. Teva Pharmaceuticals Usa, Inc., Defendant.

Organon Inc. and Akzo Nobel N.V., Plaintiffs, v. Alphapharm Pty, Ltd., Defendant.

Nos. CIV.A. 01-2171(FSH), CIV.A. 01-3835(FSH), CIV.A. 01-2682(FSH), CIV.A. 01-4246(FSH).

United States District Court, D. New Jersey.

December 3, 2003.

COPYRIGHT MATERIAL OMITTED

Kevin J. McKenna, Gibbons, Del Deo, Dolan, Griffinger & Vecchione, PC, Newark, NJ, for plaintiffs/counter-defendants.

Brian D. Romanowsky, Harwood Lloyd, LLC, Hackensack, NJ, Allyn Zissel Lite, Lite, Depalma, Greenberg and Rivas, LCC, Arnold B. Calmann, Saiber, Schlesinger, Satz & Goldstein, Esqs., Newark, NJ, for defendants/counter-claimants/movant.

OPINION

HOCHBERG, District Judge.

This matter comes before the Court upon Plaintiffs Organon Inc.¹ and Akzo Nobel N.V.'s (together, "Organon") Motion to Dismiss Defendants' counterclaims for antitrust and other state law violations, pursuant to Fed.R.Civ.P. 12(b)(6) for failure to state a claim. Pursuant to Fed. R.Civ.P. 78, this Court has reviewed the submissions of the parties.

BACKGROUND

Organon manufactures the antidepressant drug mirtazapine,² which was originally claimed in its now-expired United States Patent No. 4,062,848 (the "'848 patent"). Organon filed a New Drug Application ("NDA") 20-415, with the Food & Drug Administration (the "FDA") to gain approval for the use of mirtazapine for the treatment of depression, which the FDA approved on June 14, 1996. 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"), such as Prozac. Organon did not submit an NDA to gain FDA approval for the combination use of mirtazapine and an SSRI for the treatment of depression. As such, use of mirtazapine in combination with an SSRI by doctors is considered an "off-label" use. In January 2001, fourteen months after being granted the '099 patent, Organon submitted the '099 patent to the FDA for listing in the Orange Book.³

Beginning in February 2001, several generic drug manufacturers, including the Defendants, filed Abbreviated New Drug Applications ("ANDAs") with the FDA, seeking approval for their generic version of mirtazapine. The Defendants 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. Organon subsequently filed actions against Mylan Pharmaceuticals, Inc. ("Mylan"), Teva Pharmaceuticals USA, Inc. ("Teva"), and Alphapharm Pty Ltd. ("Alphapharm") (collectively, the "Defendants")⁴, as well as other actions against several generic drug manufacturers, alleging claims of inducement to infringe the '099 patent. Organon's actions for inducement to infringe claimed that the Defendants would induce doctors and pharmacists to infringe the '099 patent by encouraging or acquiescing in the substitution of generic mirtazapine for Organon's Remeron in combination use with an SSRI to treat depression.

As Organon sued each of the Defendants within forty-five days of Organon's receipt of the Defendants' Paragraph IV Certifications, FDA approval of the Defendants' 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 Defendants' sale of generic mirtazapine did not induce infringement of the '099 patent. See Organon, Inc. v. Teva Pharmaceuticals, Inc., 244 F.Supp.2d 370 (D.N.J.2002) ("Organon I"). Thus, Organon's stay of the generic drug manufacturers' ANDAs for mirtazapine lasted approximately fourteen to eighteen months.

Defendants filed counterclaims claiming that a series of actions taken by Organon violated the Sherman Act. See 15 U.S.C. § 1 et seq. . These actions include: (1) fraudulently seeking and obtaining from the Patent and Trademark Office United States Patent No. 5,977,099 ("the '099 patent"); (2) improperly listing the '099 patent in the Orange Book; and (3) baselessly initiating patent infringement actions against the generic drug manufacturers, claiming induced infringement of the '099 patent. In the instant motion, Organon has moved to dismiss Defendants' counterclaims of antitrust violation, arguing that its listing of the '099 patent in the Orange Book and its subsequent patent infringement actions against the generic drug manufacturers are protected activity under the Noerr-Pennington doctrine.⁵

ANALYSIS

I. Motion to Dismiss

In deciding a motion to dismiss a counterclaim under Fed.R.Civ.P. 12(b)(6), all allegations in the counterclaim must be taken as true and viewed in the light most favorable to the counterclaimant. See Warth v. Seldin, 422 U.S. 490, 501, 95 S.Ct. 2197, 45 L.Ed.2d 343 (1975) and Trump Hotels & Casino Resorts, Inc. v. Mirage Resorts Inc., 140 F.3d 478, 483 (3d Cir.1998). A court may consider only the allegations plead in the counterclaim, exhibits attached to the counterclaim, matters of public record, and undisputedly authentic documents if the counterclaims are based upon those documents. See Pension benefit Guar. Corp. v. White Consol. Indus., 998 F.2d 1192, 1196 (3d Cir. 1993). After viewing the allegations in the light most favorable to the counterclaimant, a court shall dismiss a counterclaim for failure to state a claim only if it appears beyond doubt that no relief could be granted "under any set of facts which could prove consistent with the allegations." See Hishon v. King & Spalding, 467 U.S. 69, 73, 104 S.Ct. 2229, 81 L.Ed.2d 59 (1984). This holds true especially in antitrust cases, where "the proof is largely in the hands of the alleged conspirators," and thus, plaintiffs should be given ample opportunity for discovery and dismissals should be granted sparingly. See Hospital Building Co. v. Trustees of Rex Hospital, 425 U.S. 738, 746, 96 S.Ct. 1848, 48 L.Ed.2d 338 (1976). This "liberal approach to the consideration of antitrust complaints is important because inherent in such an action is the fact that all details and specific facts relied upon cannot properly be set forth as part of the pleadings." See Lucas Indus. v. Kendiesel, Inc., No. 93-4480, 1995 WL 350050 at *2 (D.N.J. June 9, 1995). Further, this Court must take "mere conclusions of the pleader" into account when deciding whether a claim for relief is stated. Id. at *2 (quoting United States v. Employing Plasterers' Assn., 347 U.S. 186, 188, 74 S.Ct. 452, 98 L.Ed. 618 (1954)).

II. Antitrust Claims

The Noerr-Pennington doctrine protects activities by parties to influence government policy or legislation from antitrust claims. See Eastern R.R. Presidents Conference v. Noerr Motor Freight, 365 U.S. 127, 81 S.Ct. 523, 5 L.Ed.2d 464 (1961) and United Mine Workers v. Pennington, 381 U.S. 657, 85 S.Ct. 1585, 14 L.Ed.2d 626 (1965). While the doctrine nominally began as a judicially-created limitation on the scope of the Sherman Act with respect to activities by parties to petition the government to take a certain course of action beneficial to them and harmful to their competitors, it has been expanded to include litigation to protect rights such as patents. See Professional Real Estate Investors, et. al. v. Columbia Pictures Indus., Inc., et al., 508 U.S. 49, 60, 113 S.Ct. 1920, 123 L.Ed.2d 611 (1993) ("PRE").⁶

However, the scope of the Noerr-Pennington doctrine is not without limit. First, courts have held that activities in which the government entity merely plays a ministerial role, rather than making an independent determination, should not be afforded Noerr-Pennington immunity. See In re Buspirone Patent Litigation, 185 F.Supp.2d 363 (S.D.N.Y.2002) ("Buspirone"). Second, litigation will not be protected when a court determines that it is "sham" litigation, i.e., instituted for the sole purpose of precluding competition. PRE, 508 U.S. at 60-61, 113 S.Ct. 1920 (quoting Noerr, 365 U.S. at 144, 81 S.Ct. 523).

A. Listing in the Orange Book as Petitioning Activity

Courts have held that Noerr-Pennington immunity will not extend to activities that do not petition the government to make an independent decision on the merits and where the government acts in merely a ministerial fashion. Buspirone at 370 (listing a patent with the FDA is not petitioning activity eligible for Noerr-Pennington immunity because the FDA's listing of the patent in the Orange Book was ministerial and the FDA did not independently confirm that the patent listing was correct). See also Litton Systems, Inc. v. American Telephone & Telegraph Co., 700 F.2d 785 (2d Cir.1983) (telephone company's filing of tariffs requiring customers to connect equipment purchased from its competitors to the telephone system only through the use of a device designed by the company was not a request for governmental action under the Noerr-Pennington doctrine and was immunized from antitrust liability).

In Buspirone, Bristol-Meyers, a pioneer drug manufacturer, argued that its listing should be regarded as petitioning activity because it was a request for the FDA to publish the information in the Orange Book. The district court, in deciding that Bristol-Myers' listing of its patent in the Orange Book was not petitioning activity for Noerr-Pennington purposes, distinguished "between activities in which the government acts or renders a decision only after an independent review of the merits of a petition and activities in which the government acts in a merely ministerial or...