Opening Memorandum of Law in Support of Motion to Extend the Stay of FDA Approval

• Author: Kenneth L. Dorsney
• Pages: 871-876

Opening Memorandum of Law in Support of Motion to

Extend the Stay of FDA Approval

IN THE UNITED STATES DISTRICT COURT

[Name of District]

[DISTRICT COURT CAPTION]

[Insert Table of Contents]

[Insert Table of Authorities]

This is Plaintiff’s (also referred to herein as “Brand”) memorandum supporting its

motion to extend the stay of FDA approval of Defendant’s (“Generic”) ANDA No. 00-

001 through the end of trial to determine whether Generic’s [type of drug] product

infringes claim 1 of U.S. Patent No. 1 (“the ’001 patent”).

I.

Brand brought this patent infringement action after Generic filed Abbreviated

New Drug Application (“ANDA”) No. 00-001 with the U.S. Food and Drug

Administration (“FDA”) to market generic versions of BrandX (“ANDA Product”). 21

U.S.C. § 355(j)(5)(B)(iii) prevents the FDA from approving the ANDA for 30 months so

that Brand can pursue its infringement claims up to judgment before Generic can

“failed to reasonably cooperate in expediting the action,” such as by causing a delay in

the trial by making late changes to its ANDA. ,

Trial was originally set for [Date]. On [Date], months after fact discovery closed

and after Brand served its expert reports showing that the contents of Generic’s ANDA

evidenced that Generic’s ANDA Product would infringe claim 1 of the ’001 patent,

Generic amended its ANDA. Facing a looming loss at trial based on the factual and

expert evidence that Brand had developed in the first two years of this case, Generic

opted to jump ship. Generic first abandoned each and every one of the invalidity

contentions it had advanced during discovery, and substituted a new theory of invalidity

Generic does not and cannot dispute that its belated tactics were designed to

bolster its defense against Brand’s infringement contentions. But Generic’s strategy of

pressing the re-start button after the close of fact discovery was not without adverse and

with fact discovery and expert reports directed to the original ANDA that no longer

871

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