US Court Dismisses Teva Case to Block Generic Copaxone

16.05.2014 -

Shortly before expiration of the patent on the multiple sclerosis treatment Copaxone, a US district court has dismissed a case by Teva Pharmaceutical Industries, subsidiary of the Israeli drugmaker, to block approval of a generic form of the drug.

The case, part of the Israeli company's broad legal battle aimed at stopping generic versions, was dismissed by the Washington, DC district court. The court said the suit was being premature because the US Food and Drug Administration (FDA) had not yet approved or rejected the applications for generic forms of the drug.

Teva had also asked the court to impose clinical trial requirements on companies applying for approval of generic versions.

In March, the US Supreme Court agreed to hear the Isreali company's appeal of a July 2013 ruling by a US court of appeals that favored two teams developing cheaper generic forms of Copaxone.

The appeals court had upheld some of the nine patents related to the drug, or portions of them, but declared several invalid, so that patent protections were set to expire in May 2014 instead of September 2015.

Oral arguments in the case will begin in the Supreme Court at its 2014 term beginning in October of this year.

US generic drugmaker Mylan said it had intervened in the lawsuit in support of the FDA.