(Changes source to court papers, Teva)
By Caroline Humer
May 15 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)