Appendix 31

• Author: Kenneth Dorsney
• Pages: 737-746

737

A–31

OPE N I N G ME M O R A N D U M OF LA W IN SU P P O R T OF MO T I O N FO R

TEM P O R A R Y RE S T R A I N I N G ORDER AND PR E L IM I N A R Y IN J U N C T I O N

IN THE UNITED STATES DISTRICT COURT

[Name of District]

[DISTRICT COURT CAPTION]

PLAINTIFF’S OPENING MEMORANDUM OF LAW IN

SUPPORT OF ITS MOTION FOR A TEMPORARY

RESTRAINING ORDER AND A PRELIMINARY INJUNCTION

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

motion for an immediate temporary restraining order pursuant to Fed. R. Civ. P. 65(b)

and a subsequent preliminary injunction to prevent Defendant (“Generic”) from

manufacturing, importing, or flooding the market with its generic [type of drug] product

until at least after this Court issues its decision on whether Generic’s product infringes

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

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On [Date], four days after That Other Generic Co. (“TOG”) forfeited its 180-day

first-filer exclusivity period, Generic formally provided “45-days’ notice of its intended

launch of its GenX product, which product is the subject of Generic’s ANDA (“ANDA

Product”) that FDA approved on [Date].” [Cite]. Consequently, Brand has no choice but

to seek immediate relief under Rule 65(b) to halt Generic’s infringing manufacture of

launch quantities of its ANDA Product. Brand further respectfully requests a preliminary

injunction to preserve the status quo until this Court issues its decision on the merits of

whether Generic’s ANDA Product infringes claim 1 of the ‘001 patent.

Plaintiffs have asked Generic not to launch its ANDA Product until this Court can

decide whether Generic infringes the ’001 patent, which Generic concedes is valid and

enforceable. Generic has refused, indicating that it will launch its ANDA Product,

irrespective of whether the Court has adequate time to render its decision. Brand submits

that temporary injunctive relief to prevent Generic’s at-risk launch not only prevents

irreparable harm to Brand and serves important interests of judicial economy, but also

tempers Generic’s zeal that, if left unrestrained, will only make simple matters in this

case unnecessarily complicated—to the considerable detriment of the trial and appellate

courts.

When faced with similar circumstances in In re Cyclobenzaprine Hydrochloride

Extended-Release Capsule Patent Litig., Civ. No. 09-MD-2118, (D. Del. Apr. 8, 2011),

Judge Robinson initially entered an order allowing time for a decision on the merits in an

orderly fashion. Id. After deciding the case on its merits against the patentees, Judge

Robinson subsequently issued another temporary restraining order enjoining an at-risk