Mylan Applauds Court's Dismissal of Teva's Suit Against FDA

   By Anna Prior 
 

Mylan Inc. (MYL) on Thursday said a court dismissed rival generic drug maker Teva Pharmaceutical Industries Ltd.'s (TEVA, TEVA.TV) motion to block approval of generic versions of multiple-sclerosis drug Copaxone.

Teva had sued the U.S. Food and Drug Administration, and Mylan intervened in the suit in support of the agency, Mylan said, adding that the ruling by a District of Columbia federal court also dismissed the case for lack of jurisdiction.

"Following the court's decision against Teva, we continue to see no barrier to FDA approval of Mylan's generic Copaxone following patent expiry," Mylan Chief Executive Heather Bresch said.

A Teva spokeswoman said the company will continue to evaluate its options, but noted that it was pleased the judge requested 24-hour notification of final action from the FDA as to the abbreviated new drug applications

Mylan has been pushing to sell generic versions of Copaxone, and Teva has been fighting the company and other generic drug makers for years.

Last year, the U.S. Court of Appeals for the Federal Circuit, a specialized tribunal that hears patent appeals, threw out Teva's patent, clearing a major hurdle for generic manufacturers to begin producing the drug.

U.S. Chief Justice John Roberts last month refused to block a lower-court ruling that invalidated Teva's patent for Copaxone.

Although best known for its own generic products, Teva, based in Petah Tikva, Israel, has several branded medicines as well. Copaxone is one of the company's most important products, accounting for $4.3 billion of the company's $20.3 billion in total revenue last year.

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