Mutual Pharmaceutical Co., Inc. v. Pfizer, Inc.

• Decision Date: 24 March 2004
• Docket Number: Civil Action No. 03-1116 (RMU).
• Parties: MUTUAL PHARMACEUTICAL COMPANY, INC., Plaintiff, v. PFIZER, INC., Defendant.
• Court: U.S. District Court — District of Columbia

307 F.Supp.2d 88

MUTUAL PHARMACEUTICAL COMPANY, INC., Plaintiff, v. PFIZER, INC., Defendant.

Civil Action No. 03-1116 (RMU).

United States District Court, District of Columbia.

March 24, 2004.

Jeremy M. Jay, Leydig, Voit & Mayer, Washington, DC, for Plaintiff.

Francis A. Vasquez, Jr., Frank Panopoulos, White & Case, LLP, Washington, DC, for Defendant.

MEMORANDUM OPINION

URBINA, District Judge.

GRANTING THE DEFENDANT'S MOTION TO DISMISS

I. INTRODUCTION

This case comes before the court on the defendant's motion to dismiss pursuant to Federal Rule of Civil Procedure 12(b)(1). Plaintiff Mutual Pharmaceutical Company, a generic drug manufacturer, seeks a declaratory judgment declaring that its product does not infringe the patent of defendant Pfizer, a pioneer drug manufacturer. The defendant alleges that the court does not have subject-matter jurisdiction over the plaintiff's action. Because the plaintiff does not have a reasonable apprehension of an infringement suit, an actual controversy does not exist. Consequently, the court grants the defendant's motion.

II. BACKGROUND

A. Factual Background

1. Statutory and Regulatory Background

The Food and Drug Administration ("FDA") regulates the pharmaceutical industry. The Federal Food, Drug and Cosmetic Act ("FFDCA") is the statute that governs the manufacture and distribution of drugs and medical devices. 21 U.S.C. §§ 301 et seq. Generic drugs are drugs that are sold without a brand name, but contain the same active ingredient as a brand-name pharmaceutical, commonly referred to as the "pioneer" drug. Mova Pharm. Corp. v. Shalala, 140 F.3d 1060, 1063 (D.C.Cir.1998). Ordinarily, a company seeking to market a pioneer drug must complete a New Drug Application ("NDA"). Id. Preparing an NDA consists of conducting studies and gathering data that prove the drug's safety and efficacy. Id. An NDA is also required to contain a list of any patents that cover the pioneer drug, as well as any patents that cover a specific use for the drug. Purepac Pharm. v. Thompson, 354 F.3d 877, 880 (D.C.Cir.2004). The FDA then publishes all patent information that a pharmaceutical company submits regarding a pioneer drug in a publication titled Approved Drug Products with Therapeutic Equivalence Evaluations, commonly referred to as the "Orange Book." 21 U.S.C. § 355(j)(7)(A).

In 1984, Congress enacted the Hatch-Waxman Amendments ("the Amendments") to the FFDCA, which simplified the process for FDA approval of generic drugs. Mova Pharm., 140 F.3d at 1063. Under the Amendments, applicants who wish to market generic versions of pioneer drugs may file an Abbreviated New Drug Application ("ANDA") which relies on the FDA's previous determination that the pioneer drug is safe and effective. Id. Thus, the generic drug manufacturer need not submit new safety and effectiveness studies. Id. One requirement of the ANDA is that for each patent applicable to the pioneer drug, the ANDA applicant must certify whether the generic drug would infringe that patent, and if not, the reasons why it would not. Id. To satisfy this requirement, an ANDA applicant may certify that (I) the required patent information has not been filed, (II) the patent has expired, (III) the patent has not expired, but will expire on a particular date, or (IV) that the patent is invalid or will not be infringed by the drug for which the ANDA applicant seeks approval. 21 U.S.C. § 355(j)(2)(A)(vii). If an ANDA applicant makes a certification under clause IV (commonly referred to as a "paragraph IV certification") and the pioneer patent holder brings suit within 45 days, the FDA must delay its approval of the ANDA until the earlier of 30 months or the date of a court decision finding the patent invalid or not infringed. 21 U.S.C. § 355(j)(5)(B)(iii); Mova Pharm., 140 F.3d at 1064.

The first applicant to file an ANDA containing a paragraph IV certification is known as a "first filer" and is eligible for a 180-day exclusivity period during which the it is entitled to have the sole generic version of the pioneer drug on the market. 21 U.S.C. § 355(j)(5)(B)(iv). This exclusivity period is calculated from the earlier of 1) the date of the first commercial marketing of the generic drug by the first filer, or 2) the date of a court decision declaring the patent at issue invalid or not infringed. 21 U.S.C. § 355(j)(5)(B)(iv). Any subsequent ANDA filer must wait until the expiration of the first filer's 180-day exclusivity period before receiving FDA approval of its ANDA. Id.

2. The Pfizer-Mutual-Teva Interaction

The plaintiff is a generic pharmaceutical manufacturer seeking a declaratory judgment that would establish that its manufacture, use or sale of quinapril hydrochloride tablets will not infringe the defendant's patent, United States Patent Number 4,473,450 ("the '450 patent"). Compl. ¶ 14. The defendant manufacturers and markets Accupril® brand quinapril hydrochloride, a medication currently approved for the treatment of hypertension and congestive heart failure. Compl. ¶ 5; Pl.'s Opp'n. at 2.

On January 15, 1999, Teva Pharmaceuticals USA, Inc. ("Teva") filed an ANDA seeking approval to market generic quinapril hydrochloride tablets. Def.'s Mot. at 6; Pl.'s Opp'n at 8. Teva's ANDA contained a paragraph IV certification, asserting that the '450 patent was invalid. Id. In response, Warner-Lambert Company, the defendant's predecessor-in-interest, filed suit in the United States District Court for the District of New Jersey on March 2, 1999, which was within 45 days of Teva's paragraph IV certification. Id. That case is still pending. Id. As the first filer, Teva is entitled to the 180-day exclusivity period, which will commence on the date it first commercially markets its generic quinapril hydrochloride or the date on which a court declares the '450 patent invalid. 21 U.S.C. § 355(j)(5)(B)(iv); Def.'s Mot. at 6. To date, neither event has occurred.

On January 30, 2003, the plaintiff submitted an ANDA to the FDA seeking approval to market its own generic quinapril hydrochloride tablets. Compl. ¶ 6. As part of its ANDA, the plaintiff also made a paragraph IV certification asserting that its ANDA would not infringe the '450 patent. Id. ¶ 7. The defendant has not filed suit against the plaintiff for infringement of the ' 450 patent within 45 days of the paragraph IV certification. Id. ¶ 11.

Because Teva has not begun commercial marketing of its generic quinapril hydrochloride tablets and the New Jersey district court has not yet declared the '450 patent invalid or not infringed, the 180-day exclusivity period has not begun to run. If the plaintiff prevails in this case, and the court declares the '450 patent invalid or not infringed, the 180-day clock will start running on Teva's exclusivity period, clearing the way for the plaintiff to begin marketing its drug at the expiration of that 180-day period. Pl.'s Opp'n at 7-8 (noting that filing the instant action for declaratory judgment was the "only step it could [take] to clear the way for the FDA to give final approval to Mutual's ANDA").¹

3. Procedural History

On May 23, 2003, the plaintiff filed its complaint. On July 8, 2003, the defendant filed a motion to dismiss pursuant to Federal Rule of Civil Procedure 12(b)(1) for lack of subject-matter jurisdiction. The court now turns to that motion.

III. ANALYSIS

A. Legal Standard for a 12(b)(1) Motion to Dismiss

Federal courts are courts of limited jurisdiction and the law presumes that "a cause lies outside this limited jurisdiction." Kokkonen v. Guardian Life Ins. Co. of Am., 511 U.S. 375, 377, 114 S.Ct. 1673, 128 L.Ed.2d 391 (1994); St. Paul Mercury Indem. Co. v. Red Cab Co., 303 U.S. 283, 288-89, 58 S.Ct. 586, 82 L.Ed. 845 (1938). Because "subject-matter jurisdiction is an `Art. III as well as a statutory requirement[,] no action of the parties can confer subject-matter jurisdiction upon a federal court.'" Akinseye v. District of Columbia, 339 F.3d 970, 971 (D.C.Cir.2003) (quoting Ins. Corp. of Ir., Ltd. v. Compagnie des Bauxites de Guinee, 456 U.S. 694, 702, 102 S.Ct. 2099, 72 L.Ed.2d 492 (1982)). On a motion to dismiss for lack of subject-matter jurisdiction pursuant to Rule 12(b)(1), the plaintiff bears the burden of establishing that the court has subject-matter jurisdiction. Evans v. B.F. Perkins Co., 166 F.3d 642, 647 (4th Cir.1999); Rasul v. Bush, 215 F.Supp.2d 55, 61 (D.D.C.2002) (citing McNutt v. Gen. Motors Acceptance Corp., 298 U.S. 178, 182-83, 56 S.Ct. 780, 80 L.Ed. 1135 (1936)). The court may dismiss a complaint for lack of subject-matter jurisdiction only if "`it appears beyond doubt that the plaintiff can prove no set of facts in support of his claim which would entitle him to relief.'" Empagran S.A. v. F. Hoffman-LaRoche, Ltd., 315 F.3d 338, 343 (D.C.Cir.2003) (quoting Conley v. Gibson, 355 U.S. 41, 45-46, 78 S.Ct. 99, 2 L.Ed.2d 80 (1957)).

Because subject-matter jurisdiction focuses on the court's power to hear the claim, however, the court must give the plaintiff's factual allegations closer scrutiny when resolving a Rule 12(b)(1) motion than would be required for a Rule 12(b)(6) motion for failure to state a claim. Macharia v. United States, 334 F.3d 61, 64, 69 (D.C.Cir.2003); Grand Lodge of Fraternal Order of Police v. Ashcroft, 185 F.Supp.2d 9, 13 (D.D.C.2001). Moreover, the court is not limited to the allegations contained in the complaint. Hohri v. United States, 782 F.2d 227, 241 (D.C.Cir.1986), vacated on other grounds, 482 U.S. 64, 107 S.Ct. 2246, 96 L.Ed.2d 51 (1987). Instead, to determine whether it has jurisdiction over the claim, the court may consider materials outside the pleadings. Herbert v. Nat'l Acad. of Sciences, 974 F.2d 192, 197 (D.C.Cir.1992).

B. Legal Standard for the Declaratory Judgment Act

Under the Declaratory Judgment Act, a court may declare the rights and other legal relations of any interested party where there exists an "actual controversy," defined as "a controversy of...