Teva asks US Supreme Court to stay ruling in Copaxone case

Teva has filed an application with the US Supreme Court to stay a ruling by the US Court of Appeals for the Federal Circuit that allowed generic drug makers to enter the market before the expiry of Teva’s patents covering its $4.3 billion-a-year multiple sclerosis drug Copaxone (glatiramer acetate).

The application comes a week after the Supreme Court agreed to hear Teva’s appeal against the Federal Circuit decision in its case against two generic pharmaceutical company teams seeking to launch their own versions of Copaxone: Sandoz and Momenta, and Mylan and Natco.

In July last year, the Federal Circuit invalidated a patent covering Copaxone, allowing generic drug makers to enter the market on May 24, 2014, the day the remaining Copaxone patents expire.

The invalidated patent was due to expire on September 1, 2015.

In its application to stay the appeals court’s ruling, Teva said the Supreme Court’s intervention was needed before the May date “to ensure that its decision on the merits next term will not come effectively too late to prevent irreparable harm to Teva”.

The case is due to be heard by the Supreme Court when the next term begins in October. A decision on the case may not be handed down until early 2015, by which time competitors’ products could have been on the market for nearly a year.

Teva’s prior requests to stay the ruling had been denied, although it argued that now “there is at least a fair prospect—if not a strong probability—of reversal” of the appeals court’s decision.

It added: “Accordingly, Teva should not now be left without the injunction that the District Court granted to protect Teva against irreparable harm.”

Teva told LSIPR that it has no further comment related to the litigation.