Teva to lose grip on Copaxone next year

The US Supreme Court has refused a request from Teva to stay an appeals court order, meaning the pharmaceutical company will lose exclusivity on Copaxone in May next year, rather than in 2015.

Copaxone is an injectable drug used to treat multiple sclerosis. It made $4 billion in global sales last year and accounted for 20 percent of Teva’s total revenue.

The Supreme Court decision is a boon for a group of generic makers looking to launch their own versions of the drug, including Novartis’s generic arm Sandoz, as well as Momenta Pharmaceuticals, Mylan Laboratories and Natco Pharma.

In 2012, Teva successfully sued the group for infringing patents covering Copaxone at the US District Court for the Southern District of New York.

However, in July of this year, the US Court of Appeals for the Federal Circuit reversed this decision in part, finding that one of Teva’s Copaxone patents, due to expire in 2015, was invalid.

The remaining patents expire in May next year.

At the time of the Federal Circuit ruling Indian pharma company Natco announced it would launch its generic Copaxone in the US market through marketing partner Mylan, in May 2014, subject to approval from the US Food and Drug Administration.

Jeremy Oczek, partner at Bond Schoeneck & King PLLC in Buffalo, said that following the Supreme Court’s decision refusing to stay the appeals court order, Teva is out of options.

“On the heels of the Federal Circuit decision in July, Teva had two avenues,” he said.

“One was to ask the Federal Circuit to rehear the case en banc, so that all of the judges on the circuit could have heard it … the other option was to appeal to the Supreme Court.”

Oczek said it was a curious decision for Teva to ask to stay the Federal Circuit decision pending the filing of a petition to Supreme Court, which he likened to “putting the cart before the horse”.

He added that the likelihood of Teva being granted the stay was low in any event.

Natco could not be reached for comment, while Teva and Mylan did not respond to requests for comment.