Court rules against Teva on patent dispute

Posted: July 28, 2013

Teva Pharmaceutical Industries Ltd. suffered a setback Friday when the U.S. Court of Appeals for the Federal Circuit in Washington ruled in favor of several generic companies in a patent dispute over Teva's top-selling drug, Copaxone.

Copaxone is injected by patients to treat multiple sclerosis. If the court decision stands and the U.S. Food and Drug Administration approves generic versions, cheaper medicine might be on the market as early as May 25, 2014, instead of 2015. That might help patients, but it will likely hurt Teva's profit.

Teva's stock closed down 53 cents Friday at $40.73.

Copaxone generates about 20 percent of Teva's $20 billion in annual revenue and, according to Teva's 2012 annual report, accounted for "a very significant contribution to our profits."

Based in Israel, Teva's Americas headquarters is in North Wales, Montgomery County. Teva previously said it would cut $1.5 billion to $2 billion from its budget by 2015. It plans to close its plant in Sellersville, Bucks County, in 2017.

Teva said in a statement Friday that it was "disappointed" with the decision and would appeal, perhaps directly to the Supreme Court. Teva said the FDA should require generic versions of complex injectable drugs such as Copaxone to meet the same standards as the orginal.

However, the FDA has been moving the other way, said Bernstein Research analyst Ronny Gal.

"The agency approved most pending complex products," Gal wrote in a recent note to clients. "It has also provided guidance alleviating clinical requirements for several other drugs previously considered 'undoable.' "

Mylan Laboraties Inc., with headquarters in Canonsburg, Pa., was on the winning side of the decision.

"We are very pleased with today's ruling," Mylan chief executive Heather Bresch said in a statement, "and we expect that it will allow Mylan to launch its generic version of Copaxone on May 25, 2014," pending expiration of the patents and FDA approval.


Contact David Sell at 215-854-4506 or dsell@phillynews.com, or follow on Twitter @phillypharma. Read his blog at www.inquirer.com/phillypharma.

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