Multiple sclerosis drug: US court invalidates Teva's patent; boost for Natco, Mylan

US: The United States Court of Appeals for the Federal Circuit has upheld a judgment that declared Teva Pharma’s Copaxone 40 mg/ml dosing patents as invalid, Natco Pharma said in a regulatory filing on Monday.

The development is bound to boost Natco Pharma and its marketing partner Mylan Pharma, who sell a generic version of the drug used in the treatment of multiple sclerosis in the U.S.

Inter partes reviews

The Federal Circuit has affirmed the District of Delaware’s decision that Teva’s Copaxone 40 mg/ml dosing patents are invalid as obvious. It also affirmed the final written decisions issued by the Patent Trial and Appeal Board in three inter partes reviews filed by Mylan related to the same patents, Natco said. These were the last remaining patent infringement cases Mylan was defending in the U.S. relating to Glatiramer Acetate injection 40mg/ml. Natco and Mylan had launched the generic version in the U.S. in October 2017. “Today’s decisions are important milestones as we continue to focus our efforts on meeting the needs of multiple sclerosis patients in the US,” Natco said. The invalidated patents are owned by Yeda Research & Development Co. Ltd. and licensed to Teva Pharma.

Copaxone is the most prescribed for relapsing forms of MS in the U.S., with brand sales for the 20 mg/ml dose at approximately $527 million and about $2.86 billion for the 40 mg/ml dose for the 12 months ended Aug, the company said citing IQVIA.