Appendix 7

• Author: Kenneth Dorsney
• Pages: 585-593

585

A–7

MOT IO N TO DI SM IS S PURSUANT TO FE D. R . CI V. P . 1 2( b )( 1) AND (6 )

IN THE UNITED STATES DISTRICT COURT

[Name of District]

[DISTRICT COURT CAPTION]

DEFENDANT’S OPENING BRIEF IN SUPPORT OF ITS MOTION TO DISMISS

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)

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[Insert Table of Authorities for Brief]

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Plaintiff [Name of Plaintiff] filed an Amended Complaint (“Complaint”) on

[Date], against [Name of Defendant] (“Defendant”), alleging, as the only cause of action,

patent infringement under 35 U.S.C. § 271(e)(2), i.e., the Hatch-Waxman Act. [Cite].1

Plaintiff’s theory for infringement is that Defendant’s filing of Abbreviated New Drug

Application (“ANDA”) No. 00-001, which seeks FDA approval to market generic

rosuvastatin tablets, infringes one or more claims of U.S. Patent Nos. 1 (“the ‘001

patent”) and 2 (“the ‘002 patent”) (collectively “the patents-in-suit”). [Cite].

Defendant’s answer or responsive pleading is due on [Date] [Cite], and in view of

the jurisdictional deficiencies in the Complaint, Defendant brings this instant Motion to

Dismiss for lack of subject matter jurisdiction under FED. R. CIV. P. 12(b)(1), and for

failure to state a claim upon which relief can be granted under FED. R. CIV. P. 12(b)(6)

(“Motion”).

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For at least the following three reasons, the Court should grant Defendant’s

Motion:

First, the Complaint fails to establish subject matter jurisdiction on its face, and

should, therefore, be dismissed pursuant to FED. R. CIV. P. 12(b)(1). Although the

Complaint suggests that subject matter jurisdiction is proper under 28 U.S.C. §§ 1331 and

1338(a), these statutes only indicate that district courts have original jurisdiction over

civil actions arising under federal laws, such as Title 35 of the Patent Act. The only Title

35 basis alleged for patent infringement here is under 35 U.S.C. § 271(e)(2). However,

because Defendant did not submit a paragraph IV certification as to the patents-in-suit

(i.e., explaining why the patents are not-infringed and/or invalid), legal precedence has

1 An earlier complaint was filed on [Date of Complaint] [Cite], but was superseded by

the [Date of Amended Complaint] Amended Complaint, because, inter alia, the initial

complaint did not include [Name], an assignee to one of the patents-in-suit.