Teva ($TEVA) finally has the Supreme Court Copaxone patent battle victory it's been waiting for--but that doesn't mean its legal journey is over.
SCOTUS ruled in the Israeli drugmaker's favor Tuesday, determining by a 7-2 vote that the U.S. Court of Appeals for the Federal Circuit--which nixed a key patent on the multiple sclerosis drug and lopped off 16 months of patent exclusivity--hadn't used the correct approach in analyzing whether that patent was valid, Reuters reports.
But now, it's back to the lower court for reconsideration and that court could very well uphold its earlier patent decision. ISI Group analyst Umer Raffat predicts it "will also rule in Teva's favor now" based on the wording of the decision, he wrote in a Tuesday investor note. "Supreme Court's characterization of appeals court ruling on Copaxone specifically as being 'wrong' is perhaps ahead of expectations," he said.
In the meantime, though, the FDA has yet to approve either of the Copaxone generics it's reviewing, one from Novartis' ($NVS) Sandoz and Momenta Pharmaceuticals ($MNTA) and one from Mylan ($MYL) and India's Natco Pharma. And in terms of preserving MS leader Copaxone's market share--and a vast portion of Teva's profits--that's more important than the SCOTUS win, Raffat told FiercePharma last October.
The FDA's deliberation period has brought the Petah Tikva-based pharma time to switch patients over to a new, long-lasting version of the drug, which it's done at a rate that's both surprised and impressed analysts since the therapy rolled out early last year. "The fact that they've switched over about 60%--it's an uphill task now for generics makers," Raffat said before the SCOTUS appeal began.
Of course, the Teva's SCOTUS victory may help deter generics makers even if they do get the FDA's green light. If they launch before the appeals court reaches its conclusion, they risk paying hefty damages if it ultimately sides with Teva.
Those at-risk launches look "highly unlikely now," Raffat wrote Tuesday.
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