Teva's ($TEVA) been waiting a long time to get its Copaxone patent appeal before the Supreme Court. And now that the court has heard oral arguments, it seems to be divided on the issue.
Key to note is that SCOTUS isn't discussing Teva's multiple sclerosis star specifically; rather, the Israeli company is arguing that the appeals court that nixed its patent should have deferred to the district court--which upheld it--on issues of fact. On that matter, justices appeared unsure as to how much leeway the appeals court should have to second-guess district court judges' findings when it comes to patent claim construction, Reuters reports.
Some justices--including Chief Justice John Roberts and Justice Samuel Alito--questioned altering the status quo, which gives the appeals court the freedom to rethink lower court findings. "Why don't we defer, as has been done now forever, to the Federal Circuit?" Justice Sonia Sotomayor asked, as quoted by the news service.
|Supreme Court Justice Stephen Breyer|
But others noted that federal district judges, unlike appeals court judges, can preside over longer hearings and examine all the evidence firsthand before handing down decisions--a "powerful reason for saying in a technical case, 'Don't overturn the judge's factual findings,'" Justice Stephen Breyer said.
While experts say Teva has a decent shot to walk away with a SCOTUS win, it likely won't be the end of the legal battle for the Petah Tivka-based drugmaker. A probable scenario involves the case being remanded back to the appeals court--and that court could very well uphold its earlier decision to invalidate Copaxone's key IP shield.
But either way, hope is not lost for Teva when it comes to Copaxone's market share, ISI Group analyst Umer Raffat told FiercePharma. In that respect, the timing for generic launches from teams of Mylan ($MYL) and India's Natco Pharma, and Novartis' ($NVS) Sandoz and Momenta Pharmaceuticals ($MNTA)--both of which have ANDAs pending with the FDA--is more important than SCOTUS' decision.
And even if generics do roll out before Teva has a final answer, the company already has a large percentage of patients switched over to its patent-protected, long lasting 40 mg dose of the drug--a population that's not likely to want to switch back, according to Raffat. "The fact that they've switched over about 60%--it's an uphill task now for generics makers," he said.
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