Supreme Court ruling protects Teva's Copaxone patent

JERUSALEM — Teva Pharmaceutical on Tuesday announced the U.S. Supreme Court’s decision in Teva Pharmaceuticals USA vs. Sandoz 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,” stated 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.”

 

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 Sept. 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.

 

“There is currently no FDA-approved follow-on version of Teva’s Copaxone,” added Rob Koremans, president and CEO of Global Specialty Medicines at Teva. “We are encouraged by the FDA’s willingness to date to have dialogue regarding the complexities of Copaxone 20 mg/mL and the potential limitations and other unknowns of purported follow-on versions.”