Attention: News/Business Editors
March 4, 2003
For Immediate Release

Apotex Wins Key Battle Over Generic Paxil®
Court Victory on Hemihydrate Patent Clears Key Hurdle

WESTON, FLORIDA, U.S.A – Apotex Corp. today praised a U.S. federal judge ruling that its generic version of Paxil® (paroxetine hydrochloride) does not infringe a patent held by GlaxoSmithKline. The ruling is a major step forward toward launch of Apotex’s generic version of GSK’s Paxil® as the decision is subject to appeal and other patents remain to be litigated. A generic launch date still cannot be predicted but Apotex is hopeful of being able to launch in the U.S. no later than 2005.

As the first company to submit a Paragraph IV Certification challenging GSK’s patents, Apotex also expects to enjoy the 180-day generic exclusivity period provided by the Hatch-Waxman Amendments.

After a three week trial, where Apotex Corp., Apotex, Inc. and TorPharm, Inc. (“Apotex”) were represented by the law firm of Lord, Bissell & Brook, the Honorable Richard A. Posner, sitting by designation in the United States District Court for the Northern District of Illinois in Chicago, ruled that the patent that GSK was heavily relying upon to prevent generic competition, U.S. Patent No. 4,721,723 (“’723 patent”) for crystalline paroxetine hydrochloride hemihydrate, was not infringed by the paroxetine hydrochloride anhydrous product that Apotex proposes to market pursuant to its ANDA (Abbreviated New Drug Application). The Court further observed that if GSK’s view of the allowable coverage for the ‘723 patent were adopted, the patent would be invalid. The Court also rejected GSK’s request for entry of an injunction against Apotex, finding that to “provide relief in such a case would be to invite a form of extortion,” and would “make no sense” in the context of Hatch-Waxman.

“We are elated with the ruling of Judge Richard Posner and anticipate being able to bring this important drug to market no later than 2005,” said Apotex Chief Executive Officer Dr. Barry Sherman. “This victory is a strong confirmation of what we have been arguing since 1998: our generic version of Paxil® does not infringe any valid patents and therefore should be available to consumers today,” Dr. Sherman added.

Apotex won tentative FDA approval for paroxetine hydrochloride in May of 2001. U.S. sales of the brand drug were approximately $2.2 billion in 2002. Since Apotex filed its ANDA application with the FDA, GSK has filed nine additional patents leading to four additional patent infringement suits against Apotex.

Final FDA approval of Apotex’s product is still blocked by two 30-month stays derived from late-listed patents (U.S. Patent Nos. 6,113,944 and 6,172,233) in FDA’s “Orange Book,” resulting from pending litigation between the parties before Judge R. Barclay Surrick in the United States District Court for the Eastern District of Pennsylvania. Apotex has already secured summary judgment that the ‘944 and ‘233 product claims are invalid, and has asked Judge Surrick to order GSK to de-list these two patents to permit FDA to issue final approval. That motion remains pending.

Also pending is a decision from the United States Court of Appeals for the Federal Circuit relating to the legality of GSK’s late-listing activities.

Paroxetine hydrochloride is the active ingredient in Paxil®.

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 over the last 12 months. For more information visit apotexcorp.com.

Paxil® is a registered trademark of GlaxoSmithKline.

Through its U.S. sales and marketing headquarters located in Weston, Florida; operation centers in Indianapolis, Indiana and research and development facilities in Vernon Hills, 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 of Apotex Inc., a 26 year old privately held company with headquarters in Toronto, Canada. Apotex employs over 5,000 people in research, development, manufacturing and distribution of pharmaceuticals worldwide.

 - 30 - 

For additional information, please contact:

Bob Billings
Manager
Public Affairs
Tel: 800-706-5575 ext. 4226
bbillings@apotex.com

or

Elie Betito 
Director 
Public and Government Affairs
Tel: (416) 749-9300
Cell: (416) 985-1067
ebetito@apotex.com