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
(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.
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 ...