Eisai Sues Teva Over Alzheimer’s Drug Patent

By Dunstan Prial, The Record, Hackensack, N.J.

Dec. 9–Eisai Co. said Thursday that it has filed a patent infringement lawsuit against Teva Pharmaceutical Industries Ltd. in an effort to block Teva from marketing a generic version of Eisai’s lucrative Alzheimer’s treatment Aricept.

Eisai, a leading Japanese drug maker whose U.S. headquarters are in Teaneck, filed suit on Wednesday in federal court in Newark, company spokeswoman Cathy Pollini said.

Teva, of Israel, is the world’s largest manufacturer of generic drugs. Calls to the company’s U.S. headquarters were not returned.

In October, Teva filed an abbreviated new drug application with the U.S. Food and Drug Administration seeking approval to market a generic version of Aricept. There is no generic version of the treatment available.

According to published reports, Aricept is used by an estimated 1 million of the 4.5 million Americans now being treated for Alzheimer’s disease.

Eisai is alleging in its suit that approval of Teva’s application would violate its patent on donepezil hydrochloride, the active ingredient in Aricept.

“We filed this suit to challenge Teva’s abbreviated new drug application to the FDA for donepezil as Eisai believes our patent is valid until its expiration on Nov. 25, 2010. Our intent is to vigorously enforce and defend that patent,” Pollini said.

Pollini said Eisai believes approval of Teva’s application by the FDA would be an infringement of Eisai’s “intellectual property rights.”

Aricept, a neurological treatment used to slow the affects of Alzheimer’s, was first approved for use in the U.S. in 1996.

It was the first drug approved for marketing by Eisai’s U.S. operations and it now generates sales of nearly $1 billion, or about half of the U.S. division’s sales.

In 2003, Eisai filed a similar suit against Teva after Teva sought to market a generic version of Eisai’s other major product, Aciphex, which is used for treating gastrointestinal disorders, including heartburn and stomach ulcers. Dr. Reddy’s Laboratories, an Indian drug company, is also named in the suit.

The case is still pending in federal district court in New York.

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