Miami-based generic drug maker Ivax challenges patents of Forest

Long Island Business News, Aug 15, 2003 by Claude Solnik

A Miami-based maker of generic drugs is challenging the patents of blockbuster anti-depressant drug Lexapro made by Forest Laboratories, a Manhattan company with significant Long Island operations.

Ivax Corp. filed the challenge recently as it sought approval with the Food and Drug Administration to market escitalopram oxalate, the generic form of Lexapro.

Lexapro's patent is slated to expire in 2009 with a two-year extension that could give it until 2011, although Ivax hopes to bring its own drug to market as early as 2007 if its challenge is upheld.

We believe we have valid patents and we're going to defend them, said Charles Triano, a spokesman for Forest. The firm employs hundreds of people in Commack, Farmingdale and Hauppauge who help package and distribute Lexapro.

In 2000, Ivax won a kind of David-versus-Goliath challenge of the patent for Taxol, a chemotherapy drug made by Bristol-Myers Squibb.

There's tremendous expenditure of time and money, David Malina, a spokesman for Ivax, said of the challenge. We just don't do it with the idea of losing.

Forest has 45 days to respond and would automatically receive a 30- month stay before litigation takes place.

Together, Lexapro and Celexa, another anti-depressant, account for 75 percent of Forest's business.

Forest reported $2.2 billion in fiscal 2003 sales. Lexapro racked up $190 million in sales in the most recent quarter, up from $142 million a year ago, while the more well-established anti-depressant Celexa recorded $284 million in sales. But Lexapro is expected to supplant Celexa.

For the three months ended June 30, Ivax reported $343 million in revenues.

Increasingly, you see generic drug manufacturers becoming more and more aggressive, said David Lickrish, an analyst at Punk, Ziegel & Co. in Manhattan. The patents that protect Lexapro are composition of matter and they're typically thought of as the strongest and most enforceable patents.