Daiichi says appeals court upholds decision against allowing Mylan's generic levofloxacin

By E. Janene Geiss

Philadelphia, Dec. 22 - Daiichi Sankyo Co., Ltd. announced Thursday that the U.S. Court of Appeals for the Federal Circuit affirmed the decision of the U.S. District Court for the Northern District of West Virginia, which held that Daiichi's patent (No. 5,053,407) on its billion-dollar-a-year broad spectrum antibacterial agent levofloxacin is valid and would be infringed by Mylan Laboratories, Inc.'s and Mylan Pharmaceuticals, Inc.'s proposed generic levofloxacin tablets.

As a result, generic drug manufacturer Mylan will not be allowed to enter the U.S. market with a generic version of levofloxacin before the expiration of Daiichi's patent on Dec. 20, 2010, according to a company news release.

Daiichi granted an exclusive license to Johnson & Johnson to make, use and sell pharmaceutical preparations containing levofloxacin in the United States with the right of sublicense.

Ortho-McNeil Pharmaceutical, Inc. is an exclusive sublicensee for levofloxacin tablets in the United States and markets levofloxacin tablets under the trade name Levaquin.

Ortho-McNeil and Johnson & Johnson were co-plaintiffs in this litigation, officials said.

Daiichi is a Tokyo-based pharmaceutical company.

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