Motion to Extend the Stay of FDA Approval

• Author: Kenneth L. Dorsney
• Pages: 869-869

Motion to Extend the Stay of FDA Approval

IN THE UNITED STATES DISTRICT COURT

[Name of District]

[DISTRICT COURT CAPTION]

Pursuant to 21 U.S.C. § 355(j)(5)(B)(iii), Plaintiff Brand, Inc. (“Brand”) hereby

moves the Court to extend the stay of FDA approval of Defendant Generic, Inc.

(“Generic”)’s Abbreviated New Drug Application No. 00-001 through trial of this case.

A court can grant a motion to extend the stay of FDA approval upon the finding

that either party “fails to reasonably cooperate in expediting the action.”

, 557 F.3d 1346, 1348 (Fed. Cir. 2009). Here, as set forth in

Plaintiff’s Opening Brief submitted herewith, the stay should be extended because

Generic failed to reasonably cooperate to expedite the trial of Brand’s patent

infringement action.

DATED: [Date of Signature]

[Name of Counsel for Plaintiff]

[Name of Attorney for Plaintiff]

[Address of Counsel for Plaintiff]

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