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Apotex Victory in Generic Paxil Confirmed; Federal Circuit Court of Appeals Affirms District Court's Judgment in Favor of Apotex.


Business Editors/Health/Medical Writers

WESTON, Fla.--(BUSINESS WIRE)--April 26, 2004

Apotex Corp. today praised the decision of the U.S. Court of Appeals for the Federal Circuit holding that GSK's U.S. Patent No. 4,721,723, the patent covering Paxil(R) (paroxetine hydrochloride Paroxetine hydrochloride
Paxil; a SSRI that is used to treat mental depression, OCD, and various other disorders.

Mentioned in: Antidepressant Drugs, SSRI

paroxetine hydrochloride

Paxil, Paxil CR, Seroxat (UK)

), is invalid.

"We feel vindicated with this decision," said Apotex Chief Executive Officer Dr. Barry Sherman. "This confirms what we have been arguing since 1998: our generic version of Paxil(R) does not infringe any valid patents and deserves to be on the market," Dr. Sherman added.

"This is further affirmation," continued Dr. Sherman, "that GSK GSK GlaxoSmithKline plc (pharmaceutical company)
GSK Glycogen Synthase Kinase
GSK Gruppentraining Sozialer Kompetenzen (Germany)
GSK Greenland Shark (FAO fish species code) 
 has kept an affordable alternative from consumers for years by asserting patents that they knew, or ought to have known, were either invalid or that our product did not infringe."

Apotex has filed a separate antitrust action with the U.S. District Court in the Eastern District of Pennsylvania regarding GSK's conduct in filing and asserting invalid patents to unlawfully prevent generic competition. "Today's ruling will further support our assertions that we have been unlawfully held off the market and consumers were denied this important product for far too long due to the stall tactics used by GSK," commented Sherman.

Apotex was the first drug manufacturer to challenge the validity of patents covering Paxil(R) and the first to gain FDA FDA
abbr.
Food and Drug Administration


FDA,
n.pr See Food and Drug Administration.

FDA,
n.pr the abbreviation for the Food and Drug Administration.
 approval and bring a low-cost Paxil(R) alternative to consumers. Apotex won tentative FDA approval for paroxetine hydrochloride in May of 2001. Since Apotex filed its ANDA ANDA
abbr.
abbreviated new drug application
 application with the FDA, GSK has filed nine additional patents leading to four additional patent infringement patent infringement n. the manufacture and/or use of an invention or improvement for which someone else owns a patent issued by the government, without obtaining permission of the owner of the patent by contract, license or waiver.  suits against Apotex.

Apotex began selling generic paroxetine paroxetine /par·ox·e·tine/ (pah-rok´se-ten) a selective serotonin uptake inhibitor used as the hydrochloride salt to treat depression and obsessive-compulsive, panic, and social anxiety disorders.  in the U.S. in September of 2003 triggering generic rival Par to launch an authorized generic version of brand-name Paxil(R) under a deal with GSK.

Paroxetine hydrochloride is the active ingredient in Paxil(R).

Paxil(R) is a registered trademark of GlaxoSmithKline.

Apotex' U.S. product line now includes approximately 50 different quality generic pharmaceuticals, used by millions of patients worldwide. Apotex leads the industry in new generic FDA approvals. For more information visit apotexcorp.com.

Through its U.S. sales and marketing headquarters located in Weston, Florida; operation centers in Indianapolis, Indiana and research and development facilities in Lincolnshire, Illinois; Apotex Corp. is committed to being a market leader in research and development and is responding to increasing consumer demand for safe, high quality, affordable alternatives to brand medicines. Apotex Corp. is a wholly owned subsidiary Wholly Owned Subsidiary

A subsidiary whose parent company owns 100% of its common stock.

Notes:
In other words, the parent company owns the company outright and there are no minority owners.
 of Apotex Inc., a 30 year old privately held company privately held company

A firm whose shares are held within a relatively small circle of owners and are not traded publicly.
 with headquarters in Toronto, Canada. Apotex employs over 5,000 people in research, development, manufacturing and distribution of pharmaceuticals worldwide.
COPYRIGHT 2004 Business Wire
No portion of this article can be reproduced without the express written permission from the copyright holder.
Copyright 2004, Gale Group. All rights reserved. Gale Group is a Thomson Corporation Company.

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Publication:Business Wire
Geographic Code:1CANA
Date:Apr 26, 2004
Words:443
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