U.S. Court Invalidates Teva's Copaxone Patent

The 2-1 decision by the U.S. Court of Appeals for the Federal Circuit is a blow to the Israeli drug giant in its seven-year fight over patent protections for Copaxone.

Andrew Chung
An employee collects newly manufactured pills at the tablet production plant at Teva Pharmaceutical headquarters in Jerusalem in 2011.
An employee collects newly manufactured pills at Teva's headquarters in Jerusalem.Credit: Adam Reynolds/Bloomberg
Andrew Chung

REUTERS - A U.S. appeals court on Thursday once again invalidated a patent held by Teva Pharmaceutical Industries Ltd on its top-selling multiple sclerosis drug Copaxone, clearing the way for the launch of a cheaper, generic version.

The 2-1 decision by the U.S. Court of Appeals for the Federal Circuit, the nation's top patent tribunal, was a blow to Israel's Teva in its seven-year fight against two generic drugmakers over the patent protections for Copaxone.

It is the second time the appeals court has reviewed Teva's patent. In January, the U.S. Supreme Court said the appeals court took the wrong approach in its original decision to cancel the patent.

The extended litigation has benefited Teva, which has been able to continue to sell Copaxone without competition from other manufacturers that would offer steep discounts for their generic versions.

A Teva spokeswoman said the company is "committed to pursuing all legal pathways, including seeking further appellate review."

Two teams have been developing generic forms of Copaxone: one involving Novartis AG's Sandoz unit and Momenta Pharmaceuticals Inc and another involving Mylan Inc and Natco Pharma Ltd.

Momenta President and Chief Executive Officer Craig Wheeler said in a statement that the company was pleased with the decision. "We look forward to providing patients with a more affordable generic alternative for the treatment of multiple sclerosis," he said.

Teva's patent covered a method of manufacturing the drug. The Federal Circuit said on Thursday that under the high court's latest standards for determining when a patent is too vague to deserve legal protection, the Teva patent is indefinite.

Teva "has failed to inform with reasonable certainty those skilled in the art about the scope of the invention," the court said.

Teva had sued Sandoz and Mylan in 2008 and 2009 in federal court in New York for patent infringement over their Copaxone copycat versions.

Central to the case was how the district judge interpreted a specific term in a key patent for the drug. The appeals court did not accept that interpretation and invalidated the patent.

The Supreme Court said the Federal Circuit should have deferred to the district judge unless there is evidence of "clear error," sending the case back down.

Teva's Copaxone

But, the appeals court on Thursday found the patent is still indefinite.

Shares of Teva were nearly unchanged on the New York Stock Exchange at midday.

The case is Teva Pharmaceutials USA, Inc et al v. Sandoz, Inc, et al, in the U.S. Court of Appeals for the Federal Circuit, No. 12-1567.

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