Teva Pharmaceutical Industries Ltd. recently made a major announcement on the U.S. Supreme Court‘s ruling on the matter of “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.” According to Teva’s report, the Supreme Court has returned the case to the Federal Circuit for supplementary review in light of the applicable standard the Supreme Court laid out for designation 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.”
It was last October 15, 2014 when the Supreme Court was presented with oral arguments on the Teva Pharmaceuticals USA, Inc. et al. Petitioners v. Sandoz Inc. et al. case, meant to decide on whether or not claim construction rulings in patent cases are qualified for deference in the event a local court makes factual findings in the process.
Last year, the Court of Appeals for the Federal Circuit endorsed 4 Teva patents that had expired May 2014, while nullifying a separate ‘808 patent due to expire come September 1, 2015. Before the appellate court passed its ruling, in July 2012 the US District Court for the Southern District of New York supported the Company, and the ‘808 patent for multiple sclerosis drug, Copaxone® 20mg/mL — a glatiramer acetate injection for the disease’s relapsing-remitting form.
“There is currently no FDA-approved follow-on version of Teva’s COPAXONE®,” said Rob Koremans, MD, the President and Chief Executive Officer 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.”
COPAXONE® is available internationally in its original 20 mg/mL formulation. On January 2014, the Company launched a 40 mg/mL thrice weekly dose in the U.S. Now, the novel MS drug is approved in over 50 countries including the United States, Russia, Canada, Mexico, Australia, Israel, and in all European countries.