Only Approval Needed for Generic Copaxone After Judge Denies Injunction

Mylan and Sandoz need only FDA approval to launch their generic versions of Teva’s blockbuster MS drug Copaxone, after a federal judge refused Teva’s request to block generic entry.

No ruling can be made on blocking generic Copaxone (glatiramer acetate) until the Supreme Court’s Jan. 20 decision sending the case back to a lower court is finalized, the judge in the Southern District of New York ruled. Once that occurs, jurisdiction will immediately revert to the Federal Circuit, where he has no authority.

The Federal Circuit is due to take up Teva’s patent infringement case against the generics makers sometime soon, when  the Supreme Court’s January decision striking down an earlier finding invalidating the drug’s last patent becomes final.

Teva’s request to block generic entry until the last of Copaxone’s patents, the ‘808, expires Sept. 1, came during what the judge called a “peculiar procedural lacuna.”

Until Teva can ask the Federal Circuit for a blocking order, there’s nothing stopping Mylan and Sandoz from launching — except a greenlight from the FDA, one legal expert says.

All of the remaining blocking patents protecting Copaxone — which enjoyed $1.4 billion in sales in the third quarter of last year — expired in May. The Israeli brand and generics maker has combined its so-far successful legal appeal of a finding of patent invalidity with efforts to switch patients to a newer formulation of Copaxone that is patent-protected until 2030. So far, more than half of Copaxone patients have made the switch.

Teva said that it was disappointed in the ruling and looks forward to the Federal Circuit review. — Bryan Koenig