US Supreme Court Rules in Favor of Teva in Copaxone Patent Case
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Teva Pharmaceutical Industries Ltd. reports that the US Supreme Court's decision in Teva Pharmaceuticals USA, Inc. et al. Petitioners v. Sandoz Inc. et al. has reversed a federal circuit court's judgment of invalidity of Teva's ‘808 patent for Copaxone (glatiramer acetate injection) 20 mg/mL, Teva’s drug for treating relapsing forms of multiple sclerosis (MS). The Supreme Court remanded the case to the Federal Circuit for further review in light of the applicable standard the Supreme Court laid out for appellate review of claim construction.

“We are encouraged by the US.Supreme Court's Decision and look forward to the Federal Circuit's review,” said Erez Vigodman, president and CEO of Teva, in a company statement. “We will continue to explore all available avenues to protect our intellectual property for Copaxone 20mg/mL. Copaxone will remain a proprietary, global market leading product for the reduction in the frequency of relapses in patients with relapsing forms of MS over the product's lifecycle.”

The US Supreme Court heard oral arguments in Teva Pharmaceuticals USA, Inc. et al. Petitioners v. Sandoz Inc. et al. on October 15, 2014 to determine if claim construction rulings in patent cases are entitled to deference when the district court makes factual findings in the process. A ruling last year by the US Court of Appeals for the Federal Circuit upheld four Teva patents that expired in May 2014 while invalidating another patent (the ‘808 patent) that is set to expire on September 1, 2015. Prior to the appellate court's decision, in July 2012, the US District Court for the Southern District of New York ruled in favor of Teva and upheld the ‘808 patent for Copaxone 20 mg/mL.

Copaxone is available in 20 mg/mL globally; Teva launched a less frequent dosing formulation, 40 mg/mL three-times-a-week, in the US in January 2014. Copaxone is Teva’s top-selling drug; in 2013, it had revenues of $4.328 billion. The US Orange Book patents covering Copaxone (20 mg) expired in May 2014. To combat generic-drug incursion for Copaxone, Teva developed a new formulation, Copaxone 40 mg/mL, which is administered three times a week. The new formulation, which was approved by the US Food and Drug Administration in January 2014, allows for a less frequent dosing regimen administered subcutaneously for patients with relapsing forms of MS.  

In a statement, Mylan CEO Heather Bresch said: “We continue to believe that the ‘808 patent is invalid as indefinite and we will address that issue with the Federal Circuit Court of Appeals. Nevertheless, Mylan’s global platform has consistently demonstrated that our success is not about any one product. With that said, we look forward to bringing our generic version of Copaxone® to market.”

Source: Teva Pharmaceutical and Mylan

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