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Mutual Pharmaceutical Co., Inc. v. Pfizer

March 24, 2004


The opinion of the court was delivered by: Ricardo M. Urbina, United States District Judge.

Document No. 10




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.


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 ...

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