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Date Posted: 09:15:49 08/21/04 Sat GMT
Author: Lynn
Subject: N.Ireland's Warner-Chilcott gets court-ruled patent (Indianapolic Star and News)

 
Court upholds patent for Prozac-related PMS drug

By Charles Wilson
Associated Press Writer
August 16, 2004 2:40 PM
 
INDIANAPOLIS -- A federal judge has ruled that the patent for Sarafem was valid, blocking a company's plans to develop a generic version of the Prozac-related drug used to treat premenstrual dysphoric disorder.
The decision leaves Warner-Chilcott Inc. with exclusive rights to market the drug, which the Northern Ireland-based female health specialist expects to bring in about $65 million in annual sales. Warner-Chilcott acquired the rights to Sarafem from Indianapolis-based Eli Lilly and Co. in 2002.
Teva Pharmaceutical Industries' U.S. arm had sought government approval for a generic version of Sarafem, claiming that Lilly's patent was invalid.
Teva said that using the antidepressant fluoxetine _ the main ingredient in Prozac _ to treat severe premenstrual symptoms was obvious and that its own developers had come up with the idea independently at about the same time as had doctors working with Lilly.
In her July 29 ruling, however, U.S. District Judge Sarah Evans Barker, described Teva's arguments as "unconvincing" and noted that there had been no published research advocating the use of fluoxetine to treat PMS or related disorders before Lilly applied for the patent in 1990.
Premenstrual dysphoric disorder is a disabling form of PMS whose symptoms can include severe depression, anxiety, mood swings, headaches, muscle pain and other physical complaints.
A telephone message seeking comment was left Monday for a Teva official.
David Kelly, Warner-Chilcott's senior vice president for finance and planning, said the Sarafem patent would remain valid until 2008. Kelly said he expected Sarafem to account for between 10 percent and 15 percent of the company's revenues in 2005.
The company paid $295 million for the rights to Sarafem, which Lilly brought to market in 2000. Sarafem generated about $85 million in sales for Lilly in 2001.
Kelly said the drug likely will bring in about $65 million next year for Warner-Chilcott, which in June changed its name from Galen Holdings PLC.
Warner-Chilcott, based in Northern Ireland, markets drugs for female health matters, including contraceptives and hormone therapy. Its U.S. headquarters is in Rockaway, N.J.
Israel-based Teva's U.S. subsidiary is based in North Wales, Pa.

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