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Merck sues Teva in dispute over anti-osteoporosis Fosamax patents

Teva claims Merck's patents are invalid and unenforceable

WILMINGTON - Merck & Co. (NYSE:MRK) has sued the U.S. unit of Teva Pharmaceuticals (Nasdaq:TEVA) in a fresh move to block the sale in the United States of generic versions of Merck's anti-osteoporosis drug, Fosamax.

In papers filed on Tuesday in the U.S. District Court in Delaware, Merck alleged that the Israel-based generic drug company infringed nine Merck patents related to Fosamax when it sought fast-track approval (ANDA) for a 35-milligram tablet of alendronate sodium, the generic name of Fosamax.

Merck, the world's No. 3 drugmaker, said that the ANDA (abbreviated new drug application) filed with the Food and Drug Administration allegedly constituted infringement of nine Merck patents expiring between 2007 and 2018.

In its FDA filing, Teva said there was no infringement, claiming the Merck patents were invalid and unenforceable, court papers show.

Last month Merck sued Teva for alleged Fosamax patent infringement, and in August it sued Barr Laboratories (NYSE:BRL) to block its generic version of Fosamax.

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Osteoporosis is a disease, primarily of older patients, in which the loss of bone matter causes bones to become porous and brittle. The disease affects 28 million Americans, 80% of them women.

The market for osteoporosis treatment, excluding hormone replacement therapy, was $2.4 billion in the 12 months ending June 2001, according to IMS Health Inc.

Annual sales of Fosamax total $762.7 million, according to Barr, making it the No.1 osteoporosis drug in terms of sales and prescriptions.

Merck has asked the court to block Teva's further alleged infringement. It hopes to obtain an order that will delay the effective date of Teva's ANDA until after 2018, the last expiration date in the suite of Fosamax patents cited in the lawsuit.

Merck also seeks unspecified damages, tripled for alleged "willful" infringement.