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June 9, 2004.


The opinion of the court was delivered by: DENISE COTE, District Judge


This Opinion addresses the justiciability of a declaratory judgment claim that a generic drug applicant is preparing to induce the infringement of method of use patents. The method of use patents protect the use of the drug pioglitazone in combination with other drug therapies. The defendant is currently seeking approval from the FDA to market its generic pharmaceutical for use alone, or in what is called monotherapy. For the reasons described below, the declaratory judgment claim presents a sufficiently concrete controversy to be adjudicated, and motion to dismiss is denied.

  Plaintiffs Takeda Chemical Industries, Ltd. and Takeda Pharmaceuticals North America, Inc. (collectively, "Takeda") bring this patent action pursuant to the Food Drug and Cosmetic Act, 21 U.S.C. § 301-99, and the Drug Price Competition and Patent Term Restoration Act of 1984, Pub. L. No. 98-417, 98 Stat. 1585 (1984) (codified in scattered sections of titles 21, 35, and 42 U.S.C.) (the "Hatch-Waxman Act"), and under the patent laws of the United States, alleging that defendants Watson Pharmaceuticals, Inc., Watson Laboratories, Inc., Watson Pharma, Inc., and Danbury Pharmacal, Inc. (collectively, "Watson") have infringed and will induce infringement of Takeda's patents protecting its product Actos, a drug used to treat Type II diabetes. Watson now moves to dismiss the third through eleventh causes of action ("Claims III-XI") for lack of subject matter jurisdiction under Fed.R.Civ.P. 12(b)(1), and for failure to state a claim under Fed.R.Civ.P. 12(b)(6).


  All of the facts recited below are undisputed or taken from the complaint. To resolve this motion, it is also necessary to understand the federal statutory framework governing approval of new and generic drugs. This Opinion assumes familiarity with the description of that framework contained in Allergan, Inc. v. Alcon Labs., Inc., 324 F.3d 1322, 1325-27 (Fed. Cir. 2003) (per curiam) (affirming summary judgment). Only a brief summary of the procedures most relevant to this motion is included here.

  I. The Hatch-Waxman Act: The Regulatory Framework

  In order to market a drug for a particular use, a manufacturer must obtain approval from the Federal Drug Administration ("FDA") through the submission of a new drug application ("NDA"), which must include extensive safety and efficacy information. 21 U.S.C. § 355(b). The NDA applicant must also file information about patents that have claims which cover the drug or that cover a method of using the drug. Id. The FDA lists patents that claim an approved or pending use of a new drug in the FDA publication known generally as the "Orange Book". Id. at § 355(j)(7)(A)(i). If the application for an NBA is approved, the manufacturer is granted an automatic five-year period of exclusivity to market the drug. Id. at § 355(c) (3)(D) (ii). A separate, non-patent exclusivity period of five years is available if the drug is deemed a pioneering drug that qualifies as a new chemical entity ("NCE"). See 21 C.F.R. § 314.108 (b) (II).

  A manufacturer seeking approval of a generic version of an FBA-approved drug may file an Abbreviated New Brug Application ("ANDA") at the end of the fourth year of the NCE exclusivity period. 21 U.S.C. § 355(j)(2)(A), 355(j)(5)(D)(ii). The ANDA permits the generic manufacturer to avoid the costly and time-consuming safety and efficacy studies required of the brand name drug manufacturer so long as the generic drug is a bioequivalent of an FDA-approved drug. See Warner-Lambert Co. v. Apotex Corp., 316 F.3d 1348, 1357 (Fed. Cir. 2003) (affirming summary judgment).

  In its ANDA, the generic drug manufacturer must address all patents listed in the Orange Book that are related to the NDA-approved drug. It may do so through certifying one of the following:
(i) no patent information has been filed;
(ii) the approved drug's patent has expired;
(iii) the ANDA applicant does not seek final approval prior to the date the approved drug's patent will expire; or
(iv) the approved drug's patent "`is invalid or will not be infringed by the manufacture, use, or sale' of the generic drug for which the ANDA is being submitted. (a `Paragraph IV certification.')"
Allergan, 324 F.3d at 1326 (citing 21 U.S.C. § 355(j)(2)(A)(vii)).*fn1 If the generic drug manufacturer files a Paragraph IV certification, it is immune from patent infringement suits so long as its infringing acts are related to compliance with the FDA's regulatory approval process. 35 U.S.C. § 271(e)(1). As a matter of law, however, the act of filing an ANDA is deemed an act of infringement if the purpose of such filing is to obtain approval to engage in the commercial manufacture, use, or sale of a drug that is claimed in a patent before the expiration of the patent. Id. at § 271(e)(2). Thus, a generic drug manufacturer is permitted to "file an ANDA before a patent expires and, in so doing, allege non-infringement and invalidity of the patent," while a brand name drug manufacturer is allowed to challenge the ANDA application in court. Allergan, 324 F.3d at 1326.

  Paragraph IV certifications are not the only way for ANDA applicants to satisfy their obligation to address all relevant patents. If a method of using the approved drug is patented and is listed in the Orange Book, but the applicant is not seeking approval for the patented use — that is, it is not filing a Paragraph IV certification — the manufacturer must state in the ANDA that the method of use patent does not claim the use for which the manufacturer is seeking approval. 21 U.S.C. § 355 (j)(2)(A) (viii) ("Section viii Statement").*fn2 In other words, by filing a Section viii Statement, an ANDA applicant indicates that a patent poses no bar to approval of its ANDA because it seeks to market the drug for a use other than the one encompassed by the patent.*fn3 See Warner-Lambert, 316 F.3d at 1359-62.

  II. Actos

  On July 15, 1999, the FDA approved Takeda's NDA for pioglitazone hydrochloride ("pioglitazone"), which is marketed under the brand name Actos. Recognizing Actos as a pioneering drug, the FDA granted five years of NCE exclusivity to Takeda. Takeda currently markets Actos for use as an adjunct to diet and exercise to improve glycemic control in patients with Type 2 diabetes.*fn4 Actos is approved by the FDA for use in monotherapy (i.e., administration alone and not in combination with another drug), as well in combination therapy where pioglitazone alone does not result in adequate glycemic control.

  Takeda has acquired several patents relating to pioglitazone that claim, inter alia, the chemical compound pioglitazone, pharmaceutical compositions of pioglitazone in combination with other active ingredients, and methods of treating diabetes using pioglitazone in combination with other drugs. Eleven of these patents are listed in the Orange Book. None of the patents currently held by Takeda covers the use of pioglitazone in monotherapy.

  U.S. Patent 4,687,777 (the "`777" patent) is directed to the pioglitazone molecule itself. The remaining Orange Book patents relate to the administration of pioglitazone in combination therapy. U.S. Patent 5,965,584 (the "`584" patent) and U.S. Patent 6,329,404 (the "404" patent) contain product claims covering pioglitazone in combination with other active ingredients, as well as methods of using pioglitazone in combination with a second agent. The remaining Orange Book patents include claims directed to methods of using pioglitazone in combination therapies. The method of use claims of the `584 patent and the `404 patent, and the remaining methods ...

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