(Changes source to court papers, Teva)
By Caroline Humer
May 15 (Reuters) - A U.S. district court dismissed a case by Teva Pharmaceutical Industries Ltd against the U.S. Food and Drug Administration, part of the Israeli company’s broad legal battle aimed at stopping generic versions of its Copaxone drug for multiple sclerosis.
The case, in U.S. District Court in Washington, D.C., was dismissed on Wednesday as being premature because the FDA had not yet approved or rejected the applications for generic forms of the drug, Teva said.
“We are pleased that the judge has requested 24-hour notification of final action from FDA as to the (new drug applications) and continue to evaluate our options,” Teva spokeswoman Denise Bradley said in a statement.
Teva had asked the court to impose clinical trial requirements on companies applying for approval of generic forms of Copaxone. The government said Teva did not have the right to impose conditions on the FDA’s regulatory approval process.
The case is one of many that Teva has filed as it seeks to hold off rival drugmakers from introducing generic forms of Copaxone. Patents for the drug begin expiring later this month.
Last month, the U.S. Supreme Court denied Teva’s request to reverse a ruling from a lower court in favor of two teams of rivals working on generics, Novartis AG’s Sandoz Inc and Momenta Pharmaceuticals Inc, and Mylan Inc and Natco Pharma Ltd. This potentially paves the way for their drugs to go on the market once approved.
The Supreme Court will not hear arguments until its 2014 term begins in October.
U.S. generic drugmaker Mylan, which said it had intervened in the lawsuit in support of the FDA, said it still believed that there was no barrier to the agency in approving its generic version of the MS drug. (Additional reporting by Esha Dey in Bangalore; Editing by Savio D‘Souza and Lisa Von Ahn)