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TORPHARM, INC. v. FOOD AND DRUG ADMINISTRATION

United States District Court for the District of Columbia


January 8, 2004.

TORPHARM, INC. Plaintiff,
v.
FOOD AND DRUG ADMINISTRATION, TOMMY G. THOMPSON, Secretary of Health and Human Services, and MARK B. McCLELLAN, Commissioner, Food and Drug Administration, Defendants and ALPHAPHARM PTY., LTD., Intervenor-Defendant

The opinion of the court was delivered by: RICHARD ROBERTS, District Judge

FINAL ORDER

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. Page 2

  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. ยง 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.

20040108

© 1992-2004 VersusLaw Inc.



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