Pfizer Inc. v. Apotex Inc., Case Nos. 08-cv-7231

• Court: United States District Courts. 7th Circuit. United States District Court (Northern District of Illinois)
• Writing for the Court: ROBERT M. DOW
• Citation: 731 F.Supp.2d 741
• Parties: PFIZER INC., Pfizer Ireland Pharmaceuticals, Warner-Lambert Company, and Warner-Lambert Company LLC, Plaintiffs, v. APOTEX INC. and Apotex Corp., Defendants.
• Decision Date: 30 June 2010
• Docket Number: Case Nos. 09-cv-6053,Case Nos. 08-cv-7231

731 F.Supp.2d 741

PFIZER INC., Pfizer Ireland Pharmaceuticals, Warner-Lambert Company, and Warner-Lambert Company LLC, Plaintiffs,
v.
APOTEX INC. and Apotex Corp., Defendants.

Case Nos. 08-cv-7231, 09-cv-6053.

United States District Court,
N.D. Illinois,
Eastern Division.

June 30, 2010.

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Rudolf E. Hutz, Daniel C. Mulveny, Jeffrey B. Bove, Mary W. Bourke, William E. McShane, Connolly Bove Lodge & Hutz LLP, Wilmington, DE, Jeffrey Mark Drake, John S. Mortimer, Wood, Phillips, Katz, Clark & Mortimer, Chicago, IL, for Plaintiffs.

William Andrew Rakoczy, Andrew M. Alul, Deanne M. Mazzochi, Paul J. Molino, Rakoczy Molino Mazzochi Siwik LLP, Chicago, IL, for Defendants.

MEMORANDUM OPINION AND ORDER

ROBERT M. DOW, JR., District Judge.

Plaintiffs Pfizer Inc., Pfizer Ireland Pharmaceuticals, Warner-Lambert Company, Warner-Lambert Company LLC (collectively "Pfizer") filed this patent infringement action against Defendants Apotex Inc. and Apotex Corp. (collectively "Apotex") for infringement of United States Patent No. 5,273,995 ("the '995 patent"). The suit was prompted by Apotex's filing of an Abbreviated New Drug Application ("ANDA"), in which it seeks permission from the Food and Drug Administration ("FDA") to market a generic version of Pfizer's pharmaceutical product, Lipitor®. Currently before the Court is Apotex's motion to dismiss [34, docket no. 09-6053] Pfizer's claim for infringement of the '995 patent for lack of subject matter jurisdiction and for failure to state a claim pursuant to Federal Rules of Civil Procedure 12(b)(1) and 12(b)(6). For the reasons stated below Apotex's motion is denied.¹

I. Background

A. Procedure Background

On November 4, 2008, Apotex notified Pfizer that it had filed an Abbreviated New Drug Application ("ANDA") with the FDA to market a generic version of Pfizer's cholesterol-lowering drug Lipitor®. Under the Hatch-Waxman Act of 1984, Pfizer was required to file suit against Apotex within 45 days of receiving that notice in order to obtain a statutorily mandated 30-month stay of FDA approval of Apotex's ANDA. See 21 U.S.C. § 355(j)(5)(B)(iii). On December 17, 2008, Pfizer filed suit against Apotex in Delaware District Court alleging that Apotex's ANDA infringed the '995 patent. Because

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Pfizer anticipated (correctly) that Apotex would challenge personal jurisdiction in Delaware, Pfizer also filed an identical patent infringement suit in this Court just hours after filing the Delaware action. Pfizer's action against Apotex in this Court was assigned case number 08-cv-7231.

On March 16, 2009, Pfizer moved to stay the proceedings in this case pending the outcome of the jurisdictional dispute in Delaware [43]. This Court granted Pfizer's motion to stay in an order dated June 12, 2009, 640 F.Supp.2d 1006 (N.D.Ill.2009). See [92]. On August 13, 2009, the Delaware court granted Apotex's § 1404(a) transfer motion and ordered the Delaware action transferred to this Court. In light of the Delaware court's transfer order, this Court vacated the stay of case number 08-cv7231 on August 18, 2009. See [98]. The Delaware action was transferred to this Court on September 28, 2009, was assigned case number 09-cv-6053, and was consolidated with case number 08-cv-7231. See [108].

On March 17, 2009-after the filing of both the Delaware and Illinois actions-the United States Patent and Trademark Office ("PTO") issued U.S. Patent No. RE40,667 ("the '667 patent"). The '667 patent is a reissue patent, which the PTO issued on the basis of the first of two reissue applications filed by Pfizer based on the '995 patent. Following the issuance of the '667 patent, Pfizer filed a first amended complaint [25, docket no. 09-cv-6053] in the Delaware action asserting both the '995 and ' 667 patents. Pfizer filed a motion for leave to file a first amended complaint in this Court. See [59]. However, this Court did not rule on that motion prior to staying the case. Following the consolidation of the two actions, this Court deemed the amended complaint that was filed in Delaware to be the operative complaint in the consolidated action. See [109].

Prior to the Delaware court's transfer of the action, Apotex had filed a motion to dismiss the first amended complaint. See [34, 35, 40, 47 docket no. 09-6053]. In the interest of efficiency and economy, this Court decided to consider the previously filed Delaware briefs on the motion to dismiss the amended complaint. See [109]. The Court allowed the parties to raise any relevant factual and/or legal developments that had arisen since the prior briefs were filed in a series of short supplemental briefs. See [115, 124, 125, 126]. All of the briefs on this pending motion are oversized, which is appropriate in view of the complexity of the issue raised.

B. Factual Background ²

On December 28, 1993, the PTO issued the '995 patent, which is identified pursuant to 21 U.S.C. § 355(b)(1) by the United States Food and Drug Administration ("FDA") as covering Pfizer's Lipitor® product. FAC ¶¶ 2, 13. Lipitor® is the brand name for Pfizer's atorvastatin calcium medication, which is presently indicated for the prevention of cardiovascular disease and high cholesterol levels in the bloodstream.

In 2006, the United States Court of Appeals for the Federal Circuit held that claim 6 of the '995 patent is invalid as a result of a technical problem in the drafting of the claim, which resulted in a violation of 35 U.S.C. § 112, ¶ 4. See id. ¶ 44; Pfizer, Inc. v. Ranbaxy Laboratories Ltd., 457 F.3d 1284, 1291 (Fed.Cir.2006). Specifically, the court found that claim 6 was an improper dependent claim under § 112, ¶ 4 because it recited subject matter outside

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the scope of the claim on which it depended. Pfizer, 457 F.3d at 1291. Pfizer concedes that the technical defect in claim 6 of the ' 995 patent also is contained in other claims in the '995 patent.

In an effort to correct the invalidating drafting errors, Pfizer filed two reissue applications based on the '995 patent. Pfizer filed the first reissue application on January 16, 2007 as U.S. Pat.App. No. 11/653,830 ("the '830 reissue application"); it included a corrected claim 6 of the ' 995 patent and two new claims (claims 13 and 14). Pfizer filed the second reissue application-U.S. Pat.App. No. 11/973,897 ("the '897 continuation reissue application")-on October 10, 2007, while the '830 reissue application was still pending. The second reissue application is a continuation reissue application of the '830 reissue application; it includes all of the claims of the '995 patent except for claim 6, as well as one new claim. According to Pfizer, the '830 reissue application was limited to corrected claim 6 (and the two new claims) in order to expedite its reissue.

On March 17, 2009, the PTO issued the '830 reissue application as the '667 reissue patent. FAC ¶¶ 3-4. Like the '995 patent, the '667 patent covers Pfizer's Lipitor® product. Claim 6 of the '667 patent is identical in scope to claim 6 of the '995 patent, but is an independent claim. Id. ¶ 45. As far as the Court is aware, the '897 continuation reissue application remains pending before the PTO; no party has advised the Court to the contrary.

By letter dated November 4, 2008, Apotex notified Pfizer that it had filed an ANDA seeking approval from the FDA to engage in the commercial manufacture, use, and sale of a generic version of atorvastatin (the drug Pfizer markets as Lipitor®) prior to the expiration of the '995 patent. Id. ¶¶ 18, 47. The letter asserted that the '995 patent was invalid, unenforceable and/or not infringed by Apotex's proposed ANDA product. Id. ¶ 21. In the claim for infringement of the '995 patent, of which Apotex seeks dismissal, Pfizer alleges that Apotex infringed the '995 patent under 35 U.S.C. § 271(e)(2) by filing its ANDA seeking approval from the FDA to engage in the commercial manufacture, use, or sale of a product containing atorvastatin calcium prior to the expiration of the '995 patent. Id. ¶ 50.

II. Legal Standards

Apotex has moved to dismiss Pfizer's claim for infringement of the '995 patent for lack of subject matter jurisdiction under Federal Rule of Civil Procedure 12(b)(1), and for failure to state a claim under Rule 12(b)(6). The purpose of a motion to dismiss is not to decide the merits of the case. A Rule 12(b)(6) motion tests the sufficiency of the complaint, Gibson v. City of Chicago, 910 F.2d 1510, 1520 (7th Cir.1990), while a Rule 12(b)(1) motion tests whether the Court has subject matter jurisdiction. Long v. Shorebank Development Corp., 182 F.3d 548, 554 (7th Cir.1999). In reviewing a motion to dismiss under either rule, the Court takes as true all factual allegations in Pfizer's complaint and draws all reasonable inferences in its favor. Killingsworth, 507 F.3d at 618; Long, 182 F.3d at 554.

To survive a Rule 12(b)(6) motion to dismiss, the complaint first must comply with Rule 8(a) by providing "a short and plain statement of the claim showing that the pleader is entitled to relief" (Fed.R.Civ.P. 8(a)(2)), such that the defendant is given "fair notice of what the * * * claim is and the grounds upon which it rests." Bell Atlantic Corp. v. Twombly, 550 U.S. 544, 555, 127 S.Ct. 1955, 167 L.Ed.2d 929 (2007) (quoting Conley v. Gibson, 355 U.S. 41, 47, 78 S.Ct. 99, 2 L.Ed.2d 80 (1957)). Second, the factual allegations in the complaint must be sufficient to raise

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the possibility of relief above the "speculative level," assuming that all of the allegations in the complaint are true. E.E.O.C. v. Concentra Health Servs., Inc., 496 F.3d 773, 776 (7th Cir.2007) (quoting Twombly, 550 U.S. at 555, 127 S.Ct. 1955). "Detailed factual allegations" are not required, but the plaintiff must allege facts that, when "accepted as true, * * * 'state a claim to relief that is plausible on its face.' " Ashcroft v. Iqbal, ---U.S. ----, 129 S.Ct. 1937, 1949, 173 L.Ed.2d 868 (2009) (quoting Twombly, 550 U.S. at...