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Tuesday, August 31, 2004

Mylan to fight generic-drug ruling



By Vicki Smith
The Associated Press

MORGANTOWN, W.Va. - Mylan Pharmaceuticals vowed Monday to refile what it says will be a stronger federal complaint against the U.S. Food and Drug Administration over a ruling that has forced the company to compete with so-called "authorized generics."

Mylan sought dismissal of its first complaint without prejudice Monday after oral arguments in court last week revealed grounds for a broader case that will likely raise antitrust issues.

"We have every intention of taking all necessary steps to end this practice," Mylan chairman and CEO Robert J. Coury said.

Mylan had been seeking a preliminary injunction in U.S. District Court to stop Cincinnati's Procter & Gamble from selling an authorized generic version of Macrobid, a drug used to treat urinary tract infections, at a time when Mylan expected to enjoy sole rights to the generic.

Generally, the first generic drug company to successfully challenge a brand-name patent enjoys 180 days of marketing exclusivity, meaning that its product is the only generic sold during that time. Congress created the provision as an incentive for generic companies and to get lower-cost drugs to the consumer more quickly.

Mylan sued the FDA, saying it failed to enforce congressional intent behind the Hatch-Waxman amendments to the Food, Drug and Cosmetics Act. The FDA contends that it lacks the authority to stop a brand-name drug maker from selling its product at generic prices through another company.

Drake Cutini, an attorney with the Justice Department's Office of Consumer Litigation, did not return a telephone message Monday. Charles Miller, a spokesman for the Justice Department's civil division, declined to comment.

A lawyer for P&G did not immediately comment on Mylan's actions Monday.

Since 2003, brand-name makers such as P&G have been introducing authorized generics by renaming their own product and selling it at a cheaper price through a licensed distributor.



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