In re Gabapentin Patent Litigation

• Decision Date: 27 August 2009
• Docket Number: Master Civil Action No. 00-2931.,MDL Docket No. 1384.,C.A. No. 00-CV-3522 (FSH).,C.A. No. 00-CV-2931 (FSH).
• Citation: 649 F.Supp.2d 340
• Parties: In re GABAPENTIN PATENT LITIGATION.
• Court: U.S. District Court — District of New Jersey

649 F.Supp.2d 340

In re GABAPENTIN PATENT LITIGATION.

Master Civil Action No. 00-2931.

C.A. No. 00-CV-2931 (FSH).

C.A. No. 00-CV-3522 (FSH).

MDL Docket No. 1384.

United States District Court, D. New Jersey.

August 27, 2009.

COPYRIGHT MATERIAL OMITTED

John J. Francis, Jr., Esq., Michael C. Zogby, Esq., Drinker Biddle & Reath LLP, Florham Park, NJ, Jack. B. Blumenfeld, Esq., Karen Jacobs Louden, Esq., Morris, Nichols, Arsht & Tunnell LLP, Wilmington, DE, Gerald Sobel, Esq., Myron Kirschbaum, Esq., Stephen J. Elliott, Esq., Gerald Wang, Esq., Kaye Scholer LLP, New York, NY, for Plaintiffs, Pfizer Inc., Warner-Lambert Company LLC, Gödecke GmbH, and Pfizer Pharmaceuticals LLC.

Arnold B. Calmann, Esq., Jeffrey Soos, Esq., Katherine A. Escanlar, Esq., Saiber LLC, Newark, NJ, Edgar H. Haug, Esq., Steven M. Amundson, Esq., David A. Zwally, Esq., Sam V. Desai, Esq., Frommer Lawrence & Haug LLP, Michael L. Keeley, Esq., Daniel S. Bitton, Esq., Axinn Veltrop & Harkrider LLP, New York, NY, for Defendants, Purepac Pharmaceuticals Co., Faulding Inc., and Actavis Elizabeth LLC.

OPINION

HOCHBERG, District Judge.

This matter comes before the Court upon Plaintiffs' (collectively, "Warner-Lambert") Motion to Strike Certain Affirmative Defenses and to Dismiss Certain Counterclaims of Purepac Defendants (Docket # 431), pursuant to Fed.R.Civ.P. 12(b) and 12(f).¹ The Court has considered the briefs of the parties, and oral argument held on April 22, 2009.

I. Background And Procedural Posture

A detailed account of the factual and procedural backdrop to this case is set forth in the Opinion issued by this Court today, deciding Plaintiffs' separate, though similar, Motion to Strike Certain Affirmative Defenses of the Teva, IVAX and Eon Defendants (the "Teva Opinion"). Background information concerning Warner-Lambert's gabapentin patents, Neurontin products and related Orange Book listings need not be reiterated in full for purposes of the instant motion, and is incorporated herein by reference.² To the extent that there are facts unique to Purepac and specifically relevant to the resolution of the present motion, they are set forth below.

Purepac was the first generic drug manufacturer to file ANDAs seeking FDA approval to market generic gabapentin products after the expiration of the '544 Patent (and its pediatric extension). Purepac filed two ANDAs: No. 75-370 for gabapentin capsules on March 30, 1998 and No. 75-694 for gabapentin tablets on September 3, 1999. When Purepac initially filed ANDAs, it submitted a Paragraph IV Certification concerning the '476 Patent and a section viii statement concerning the '479 Patent.

Relying on the Paragraph IV Certifications in these ANDAs, Warner-Lambert sued Purepac for infringement of the '476 and '479 Patents.³ Purepac filed counterclaims alleging, in pertinent part, violation of the antitrust laws and unfair competition.⁴ In a motion similar to that now pending before this Court, Warner-Lambert moved to dismiss Purepac's antitrust counterclaims. Warner-Lambert argued that Purepac lacked standing to bring a claim for antitrust injury and that its infringement actions were protected by the Noerr-Pennington doctrine and were therefore immune from antitrust liability. Judge Lifland denied Warner-Lambert's motion on December 22, 2000. Warner-Lambert Co. v. Purepac Pharm. Co., Nos. 98-2749, 99-5948, 00-2053, 2000 WL 34213890 (D.N.J. Dec. 22, 2000) (the "December 22 Opinion").⁵

Judge Lifland ultimately granted summary judgment in Purepac's favor in May 2003. Warner-Lambert Co. v. Purepac Pharm. Co., et al., Nos. 98-2749, 99-5948, 2003 WL 21698310 (D.N.J. May 22, 2003) (the "May 22 Opinion").⁶ As discussed in greater detail below, Purepac now alleges that the Tablet and Capsule Lawsuits were sham litigation pursued by Warner-Lambert purely for anticompetitive purposes.⁷

Once the '482 Patent was issued and listed in the Orange Book, Purepac amended its ANDAs to include Paragraph IV Certifications concerning that patent. This second certification forms the basis for the current patent infringement litigation. Like the Teva, IVAX and Eon Defendants, Purepac launched its gabapentin capsules and tablets despite the pending litigation, first offering its gabapentin capsules for sale in October 2004, and its gabapentin tablets in December 2004.

Purepac filed an Answer to Plaintiffs' Amended Complaint on April 21, 2008. In addition to the affirmative defenses and counterclaims raised by its co-Defendants, Purepac has also requested declarations of unenforceability of the '482 Patent on grounds of patent misuse and unclean hands, and has raised counterclaims asserting (1) monopolization and attempted monopolization in violation of Section 2 of the Sherman Act and (2) common-law unfair competition.⁸ Purepac bases these counterclaims on allegations that Warner-Lambert engaged in an "overall scheme to forestall, preclude, and delay generic competition" for Neurontin. Amended Answer and Amended and Supplemental Counterclaims ¶ 104, In re Gabapentin Patent Litig., No. 00-2931 (D.N.J. Apr. 21, 2008) ("Purepac Answer").

According to Purepac, Warner-Lambert perpetrated this scheme by: (1) intentionally withholding material prior art from the Patent Office during prosecution of the '482 Patent, resulting in a delayed issuance of the patent and ultimately allowing Warner-Lambert to obtain a successive 30-month stay of FDA approval for Purepac's products; (2) abusing FDA regulations by certifying that the '476 and '479 Patents covered the approved compounds in and uses of Neurontin, while knowing that such certifications were false; and (3) filing objectively baseless patent-infringement lawsuits asserting the '476 and '479 Patents against Purepac. Purepac alleges that Warner-Lambert's objective was to obtain more market exclusivity for Neurontin than the patent laws and regulatory system allow.

On June 16, 2008, Warner-Lambert moved to strike Purepac's unclean hands and patent misuse defenses and moved to dismiss Purepac's counterclaims for declaratory relief, monopolization, attempted monopolization and unfair competition, claiming that they are not viable as a matter of law.

II. Standard of Review

Warner-Lambert moves to strike certain of Purepac's affirmative defenses pursuant to Fed.R.Civ.P. 12(f) and moves to dismiss certain of Purepac's counterclaims pursuant to Fed.R.Civ.P. 12(b)(6). As discussed in the Teva Opinion, Fed.R.Civ.P. 12(f), which allows the Court to "strike from a pleading an insufficient defense or any redundant, immaterial, impertinent, or scandalous matter," offers the primary opportunity for plaintiffs to object to affirmative defenses. An affirmative defense is insufficient as a matter of law if it cannot succeed under any circumstances. Eisai Co., Ltd. v. Teva Pharm. USA, Inc., 557 F.Supp.2d 490, 493 (D.N.J.2008) (citing In re Sunrise Sec. Litig., 818 F.Supp. 830, 840 (E.D.Pa.1993)).

As also discussed in the Teva Opinion, striking an affirmative defense "is a drastic remedy, to be resorted to only when required for the purposes of justice." North Penn Transfer, Inc. v. Victaulic Co. of America, 859 F.Supp. 154, 158 (E.D.Pa. 1994). Courts have, however, "recognized that such motions may serve to hasten resolution of cases by eliminating the need for discovery which in turn saves time and litigation expenses." Resolution Trust Corp. v. Moskowitz, No. 93-2080, 1994 WL 229812, at *13 (D.N.J. May 24, 1994). Motions to strike will, therefore, be granted "when a defense is legally insufficient under any set of facts which may be inferred from the allegations of the pleading." Glenside West Corp. v. Exxon Co. U.S.A., 761 F.Supp. 1100, 1115 (D.N.J.1991).

To survive a motion to dismiss filed under Rule 12(b)(6), "[f]actual allegations must be enough to raise a right to relief above the speculative level on the assumption that all of the complaint's allegations are true," even if doubtful in fact. Bell Atlantic Corp. v. Twombly, 550 U.S. 544, 545, 127 S.Ct. 1955, 167 L.Ed.2d 929 (2007) ("Twombly"). According to the Third Circuit, "stating ... a claim requires a complaint with enough factual matter (taken as true) to suggest the required element. This does not impose a probability requirement at the pleading stage, but instead simply calls for enough facts to raise a reasonable expectation that discovery will reveal evidence of the necessary element." Phillips v. County of Allegheny, 515 F.3d 224, 234 (3d Cir.2008) (internal quotations omitted) (citing Twombly, 550 U.S. at 555-56, 127 S.Ct. 1955). The same standards are applied to a court's analysis of the sufficiency of counterclaims. See e.g., Organon Inc. v. Mylan Pharm., 293 F.Supp.2d 453, 456-57 (D.N.J.2003) ("Organon").

Although a court does not need to credit "bald assertions" or "legal conclusions," it must view all of the allegations in the counterclaim as well as all reasonable inferences that can be drawn therefrom in the light most favorable to the counterclaimant. Morse v. Lower Merion Sch. Dist., 132 F.3d 902, 906 (3d Cir.1997) (citing Rocks v. City of Philadelphia, 868 F.2d 644, 645 (3d Cir.1989)); see also In re Burlington Coat Factory Sec. Litig., 114 F.3d 1410, 1429-30 (3d Cir.1997).⁹ The Supreme Court recently held that "once a claim has been stated adequately, it may be supported by showing any set of facts consistent with the allegations in the complaint." Twombly, 550 U.S. at 546, 127 S.Ct. 1955.¹⁰

Antitrust complaints, in particular, are to be liberally construed at this stage of the proceeding. See In re Hypodermic Prods. Antitrust Litig., MDL No. 1730, 2007 WL 1959224, at *5 (D.N.J. June 29, 2007) (citing Commonwealth of Pa. ex rel. Zimmerman v. PepsiCo, Inc., 836 F.2d 173, 179 (3d Cir.1988)). "[I]n antitrust cases, where `the proof is largely in the hands of the alleged conspirators,' dismissals prior to giving the plaintiff ample opportunity for discovery should be granted very sparingly." Hosp. Bldg....