US court rejects Teva’s Copaxone patent plea

HYDERABAD: In a major booster for city-based Natco Pharma, the US Court of Appeals for the Federal Circuit has again struck down Israeli pharma giant Teva Pharmaceutical Industries Ltd’s Copaxone patent, paving the way for Natco Pharma to manufacture the copycat version of the drug subject to the United States Food And Drug Administration (USFDA) nod.
Copaxone is Teva’s blockbuster drug that is used in the treatment of multiple sclerosis and clocked sales over $3 billion in the US last year.
“The US Court of Appeals for Federal Circuit again has found Teva's US patent ‘808 for Copaxone to be invalid as indefinite. The company awaits USFDA approval to launch the product,” Natco told the bourses on Friday.
Teva said the company is committed to pursuing all legal pathways, including seeking further appellate review.
Earlier in July 2013, the US Court of Appeals for the Federal Circuit had ruled in Natco’s favour by allowing it to launch a copycat version of Copaxone through its marketing partner Mylan Inc. But in January 2015, the US Supreme Court asked the US Court of Appeals for the Federal Circuit to review its decision, following which it again ruled that the patent is invalid.