U.S. Agency Rejects Teva Bid to Extend Patent on Copaxone

Four of Teva's patents on flagship multiple sclerosis drug set to expire next month.

A worker at a Teva factory in Kfar Sava shows the Teva drug Copaxone.
Ofer Vaknin

The U.S. Patent Office on Friday rejected a request by Teva Pharmaceutical Industries to extend one of several patents on its flagship multiple sclerosis drug, Copaxone.

Sales of the drug in the United States alone were $3.2 billion last year. On a global basis, Copaxone generated 63% of the company’s operating profits in the fourth quarter of 2013.

Teva shares declined 1.96% on the New York Stock Exchange Friday, in comparison to a 1.01% decline in the NYSE Arca Pharmaeutical Index.Four of Teva’s patents on Copaxone are set to expire next month.

Teva said it has the right to appeal the most recent Patent Office decision and is weighing its next step.

Last Monday the U.S. Supreme Court agreed to hear an appeal by Teva in a related patent fight.

Teva hopes to delay the introduction by competitors of cheaper, generic versions of Copaxone. By agreeing to hear the case, the Supreme Court cast into doubt a July 2013 ruling by the U.S. Court of Appeals for the Federal Circuit in favor of two teams developing cheaper generic forms of Copaxone: one involving Novartis’ Sandoz and Momenta Pharaceuticals divisions and another involving Mylan and Natco.

Friday’s U.S. Patent Office decision, however, undermines the Israeli drug company’s legal case. As a result, if Mylan and Natco get approval from the U.S. Food and Drug Administration for their generic version of Copaxone, it would pave the way for generic competition for a drug that has been the major cash cow of Teva.

In its forecast for 2014, Teva projected that every month that it manages to delay the sale of generic competition for Copaxone would result in $78 million in higher profits for the company. Teva is also pinning its hopes on a new, larger-dose version of the drug.

With reporting from Reuters.