The opinion of the court was delivered by: RICHARD ROBERTS, District Judge
On January 2, 2004, this Court heard oral arguments of counsel on
Plaintiff TorPharm, Inc.'s ("TorPharm' s") motion for a preliminary
injunction. Having fully considered the submissions of the parties and
arguments of counsel, the Court issued an oral order and final judgment
for the reasons stated on the record on January 2, 2004. This written
order memorializes the oral order and final judgment issued and made
effective on January 2, 2004.
The Court finds that there is no genuine dispute of material fact, and
therefore, under Fed.R.Civ.P. 65(a)(2), TorPharm's preliminary
injunction motion is, without objection from any party, hereby
consolidated with a final decision on the merits.
As to the first claim for relief in TorPharm's Amended Complaint, the
Court enters a judgment for TorPharm declaring that (a) the Food and Drug
Administration's ("PDA's") letter ruling of July 30, 2003 awarding shared
180-day exclusivity to multiple ANDA applicants for generic paroxetine
hydrochloride 10 mg, 20 mg, 30 mg, and 40 mg tablets was contrary to the
plain language of the Federal Food, Drug and Cosmetic Act,
21 U.S.C. § 355(j)(5)(B)(iv), and (b) TorPharm is entitled to sole 180-day
exclusivity for generic paroxetine hydrochloride 10 mg, 20 mg, 30 mg, and
40 mg tablets.
The Court further permanently enjoins and prohibits the FDA, Tommy G.
Thompson (in his official capacity as Secretary of Health and Human
Services), and Mark B. McClellan (in his official capacity as
Commissioner of Food and Drugs), and their agents, servants, employees
and attorneys, and all persons in active concert with them, from issuing
final approval of Alphapharm's ANDA No. 75-716, or the ANDA of any other
applicants for paroxetine hydrochloride 10 mg, 20 mg, 30 mg, and 40 mg
tablets, until the expiration of TorPharm's 180-day exclusivity period
for those products under ANDA No. 75-356.
The Court hereby enters final judgment for TorPharm and against the
Defendants on the first claim for relief in TorPharm's Amended Complaint.
The Court dismisses the second and third claims of TorPharm's Amended
Complaint as moot. This is a final, appealable order.
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