Teva drug approval at risk after court validates Eisai patent

The court ruling has reduced the chances of an imminent launch of a generic version of Eisai’s ulcer drug.

Eisai Co., Ltd. (Tokyo Stock Exchange/Osaka Securities Exchange: 4523), Japan’s fourth largest drug company received a boost yesterday after a US court ruled that a substance patent on its ulcer drug Aciphex was valid. The patent will expire in 2003.

The ruling has reduced the chances of generic manufacturers launching their own versions of the drug. “Reuters” reported that Aciphex is Eisai’s major product in the US market, accounting for about 45% , or $1.1 billion, of its overall US drug sales of in the last business year.

The latest ruling is not final since the court will still hear arguments from the generic makers, including Teva Pharmaceutical Industries Ltd. (Nasdaq: TEVA; TASE: TEVA), which claim there were flaws in Eisai's patent procedure.

Teva said in February this year it had been granted tentative US Food and Drug Administration (FDA) approval for its generic version of Aciphex.

Nomura analyst Ryoichi Urushihara told “Reuters”, “If the courts rule in favor of this claim, a generic could still go on sale before the expiration of the substance patent. However, the validity of the patent itself has been recognized, which we consider a major step forward in allowing Eisai to exercise its patent rights on Aciphex.”

Published by Globes [online], Israel business news - www.globes.co.il - on October 10, 2006

© Copyright of Globes Publisher Itonut (1983) Ltd. 2006

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