PETAH TIKVA (dpa-AFX) - Teva Pharmaceutical Industries Ltd. (TEVA) announced the U.S. Supreme Court's decision in Teva Pharmaceuticals USA Inc. et al. Petitioners v. Sandoz Inc. et al. that reversed the Federal Circuit Court's judgment of invalidity of Teva's '808 patent for COPAXONE (glatiramer acetate injection) 20 mg/mL.
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 U.S. Supreme Court's Decision and look forward to the Federal Circuit's review,' said Erez Vigodman, President and CEO of Teva. '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 U.S. 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 U.S. 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 U.S. 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 around the world; Teva launched a less frequent dosing formulation, 40 mg/mL three-times-a-week, in the US in Jan 2014.
COPAXONE (glatiramer acetate injection) is indicated for the treatment of patients with relapsing forms of multiple sclerosis.
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