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U.S. Supreme Court justices divided over Teva patent battle


(Reuters) — The U.S. Supreme Court on Wednesday appeared closely divided as it weighed Teva Pharmaceutical Industries Ltd.’s high-profile fight with generic drug manufacturers over patent protections for Copaxone, its top-selling multiple sclerosis drug.

Teva is battling to protect a key patent for the drug that is due to expire in September 2015. The $4-billion-a-year drug accounts for 50% of Teva profits, and the patent fight is one of the most important business cases of the current term for the nine Supreme Court justices.

There are two teams developing cheaper generic forms of Copaxone: one involving Novartis A.G.’s Sandoz Inc. and Momenta Pharmaceuticals Inc. and another involving Mylan Inc. and Natco Pharma Ltd.

The justices appeared unsure over to what extent the U.S. Court of Appeals for the Federal Circuit, which hears all patent appeals, should have leeway to second-guess findings made by a District Court judges about patent claim construction, the key issue in the case.

The appeals court ruled in favor of the generics, overturning a lower court ruling that went Teva’s way.

Several justices, including Chief Justice John Roberts and Justice Samuel Alito, appeared to be reluctant to tinker with the existing system.

“Is it worthwhile as a practical matter?” Judge Alito asked.

Other justices seemed more concerned about the appeals court exerting too much power over lower court judges.

Justice Stephen Breyer, citing other areas of the law in which lower court judges have discretion, said that the fact district judges weigh all the evidence first hand before issuing decisions is a “powerful reason” why their appeals courts should defer to them.

In July 2013, the U.S. Court of Appeals for the Federal Circuit ruled the patent was invalid, prompting Teva to seek Supreme Court review. The Supreme Court declined to stay the appeals court ruling pending appeal, meaning Copaxone currently has no patent protection.

With the fate of the patent uncertain, Mylan has said it plans to launch as soon as it has government approval, which could be before the end of 2014. Sandoz and Momenta declined to comment on when they expect their product to be available.

In the meantime, Teva is switching multiple sclerosis patients who use the drug over to a new patent-protected formulation of Copaxone.

A ruling is due by the end of June.

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