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(Reuters) — The U.S. Supreme Court on Tuesday ruled for Teva Pharmaceutical Industries Ltd. in its fight with generic drug manufacturers over patent protections for Copaxone, its top-selling multiple sclerosis drug, by sending the case back to a lower court for further review.
On a 7-2 vote, the justices said that the U.S. Court of Appeals for the Federal Circuit had not used the correct approach in analyzing whether the patent in question, due to expire in September 2015, was valid.
The appeals court had thrown out the patent, a move that would give generic competitors a green light to enter the market if upheld. As litigation continues, the legal confusion is likely to benefit Israel-based Teva.
In the meantime, Teva is switching patients with multiple sclerosis, an often-disabling nervous system disease affecting the brain and spinal cord, over to a new patent-protected formulation of Copaxone.
There are two teams developing cheaper generic forms of Copaxone: one involving Novartis AG's Sandoz Inc. and Momenta Pharmaceuticals Inc. and another involving Mylan Inc. and Natco Pharma Ltd.
The legal question was to what extent the appeals court, which hears all patent appeals, has leeway to second-guess findings made by a District Court judge about patent claim construction, the key issue in the case. Teva had argued that the appeals court should have deferred to a District Court judge, who had ruled in the company's favor.
In an opinion by Justice Stephen Breyer, the court said that the appeals court must defer to the federal district judge unless there is evidence of “clear error.” The appeals court used the wrong legal analysis in making its ruling, he said.
“A District Court judge who has presided over, and listened to, the entirety of a proceeding has a comparatively greater opportunity to gain that familiarity than an appeals court judge,” Justice Breyer added.
Justices Clarence Thomas and Samuel Alito dissented, saying the appeals court took the correct approach.
(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.