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Teva Rejected by U.S. Justice on Generic Copaxone Delay

Teva Pharmaceutical
Teva Pharmaceutical Industries Ltd. is the world’s largest maker of generic drugs. Photographer: Akos Stiller/Bloomberg

A U.S. Supreme Court justice rejected Teva Pharmaceutical Industries Ltd.’s bid to block generic versions of its Copaxone multiple-sclerosis drug while the court hears the company’s appeal in a patent clash.

The rebuff by Chief Justice John Roberts leaves Teva open to generic competition as soon as next month. Mylan Inc., Momenta Pharmaceuticals Inc. and Novartis AG’s Sandoz are positioned to start selling generic Copaxone in late May, although they would risk having to pay damages if Teva ultimately wins its patent-infringement case. Momenta and Sandoz are working together on a generic version of the drug.

Copaxone brings in $3.2 billion in annual U.S. sales and accounts for more than half of Teva’s profit. A delay would give Teva more time to switch patients from the 20-milligram dose that is the subject of the legal fight to a 40-milligram dose it says is covered by other patents. The company’s American depositary receipts have risen 27 percent this year.

“Teva will continue pursuing its appeal in the Supreme Court and defending its intellectual property for Copaxone,” according to a statement today from the Petach Tikva, Israel-based company.

Teva has the option of asking another justice to intervene. By custom, that application would then go to the full court for consideration.

Relief ‘Unwarranted’

In a one-paragraph opinion yesterday, Roberts said a court-ordered delay was unnecessary because Teva could recover damages for infringement if it wins the case.

“Given the availability of that remedy, the extraordinary relief Teva seeks is unwarranted,” he wrote.

Roberts also said Teva has shown a “fair prospect of success on the merits” of the case. That is one of the requirements Teva had to meet to get a delay order.

“We are pleased with the chief justice’s decision, and we look forward to introducing the first generic Copaxone treatment for multiple sclerosis patients in the U.S. at market formation,” Mylan Chief Executive Officer Heather Bresch said in a statement. “Mylan remains eligible to receive approval from the U.S. Food and Drug Administration on May 25.”

The Teva patent at issue would shield Copaxone from competition until September 2015. A federal appeals court invalidated the patent, saying it didn’t clearly outline what the company claimed was invented.

Generic Versions

The Supreme Court agreed March 31 to hear Teva’s appeal. Teva then asked Roberts to put the appeals court decision on hold and to block generic competition while the case plays out.

Mylan, Momenta and Sandoz said in a court filing this week that an order blocking their versions would last so long that it would in effect “decide this litigation for Teva.”

Copaxone might face new competition starting May 24, when other patents expire. The generic drugmakers are still awaiting FDA approval, which often comes just before a patent expires.

Although Momenta, Sandoz and Mylan haven’t explicitly said they would begin selling at that point, they suggested in court papers that they would do so.

The case is Teva v. Sandoz, 13-854.

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