Complaint for Declaratory Judgment

• Author: Kenneth L. Dorsney
• Pages: 699-708

Complaint for Declaratory Judgment

IN THE UNITED STATES DISTRICT COURT

[Name of District]

[DISTRICT COURT CAPTION]

COMPLAINT FOR DECLARATORY JUDGMENT

Plaintiff, [Name of Plaintiff] (“Plaintiff”), by its attorneys, for its Complaint

against [Name of Defendant] (collectively, “Defendant”) alleges as follows:

INTRODUCTION

1. Plaintiff brings, and is entitled by statute to maintain, this action for

declaratory judgment of patent noninfringement under, inter alia, the Federal Declaratory

Judgment Act, 28 U.S.C. §§ 2201 and 2202, and 21 U.S.C. § 355(j)(5)(C)(i), which is part

of the Hatch-Waxman Amendments to the Federal Food, Drug, and Cosmetic Act

(“FFDCA”), as amended by Title XI of the Medicare Prescription Drug, Improvement,

and Modernization Act of 2003, Pub. L. No. 108-173, 117 Stat. 2066 (2003) (“MMA”).

2. This action arises out of, inter alia, Plaintiff’s submission of an

Abbreviated New Drug Application (“ANDA”) to the U.S. Food and Drug Administration

(“FDA”) seeking approval to market a generic version of Defendant’s brand-name anti-

depression medication BrandX, known generically as GenX.

3. Defendant purports to own U.S. Patent Nos. 1 (“the ’001 patent”) and 2

(“the ’002 patent”). Upon submission by Defendant, the ’001 and ’002 patents were listed

in FDA’s compilation of approved drugs and their respective patents entitled “Approved

Drug Products With Therapeutic Equivalence Evaluations,” commonly referred to as the

“Orange Book.” As a consequence of such Orange Book listing, Defendant maintains, and

has affirmatively represented to the world, that the ’001 and ’002 patents claim the

approved drug BrandX, or a method of using that drug, and that a claim for patent

infringement could reasonably be asserted against any generic ANDA applicant, including

Plaintiff, attempting to market a generic GenX product before expiration of the ’001 and

’002 patents.

4. Plaintiff seeks to market a generic GenX product before the expiration of

the ’001 and ’002 patents. Therefore, as required by the FFDCA, Plaintiff has certified to

the FDA that its ANDA products will not infringe any valid or enforceable claims of the

’001 and ’002 patents and has further notified Defendant of the legal and factual bases for

those certifications. Plaintiff’s submission of the so-called paragraph IV certifications to

the ’001 and ’002 patents constitutes an artificial act of patent infringement putting

Plaintiff at considerable risk of being sued by Defendant both before and after market

entry.

5. This regulatory submission creates the necessary case or controversy and

subject matter jurisdiction for Defendant to sue Plaintiff—and for Plaintiff to obtain

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