Court Affirms Prior Decisions Finding Copaxone® 40 mg/ml Patents Invalid- a milestone for NATCO and its marketing partner Mylan
Deepthi | Myequity news | Date : 15-10-2018 10:50:00 IST
NATCO Pharma Limited today announced that the United States Court of Appeals for the Federal Circuit has affirmed the District of Delaware's decision that Teva's Copaxone® 40 mg/ml dosing patents are invalid as obvious. The Federal Circuit also affirmed today the final written decisions issued by the Patent Trial and Appeal Board (PTAB) in three inter parties reviews filed by Natco's marketing partner, Mylan, related to the same patents.
These were the last remaining patent infringement cases Mylan was defending in the U.S. relating to Glatiramer Acetate Injection 40mg/ml. The invalidated patents are U.S. Patent Numbers 8,232,250; 8,399,413; 8,969,302; and 9,155,776, which are owned by Veda Research & Development Co., Ltd and licensed to Teva Pharmaceuticals Industries, Ltd.
Copaxone® is the most prescribed MS treatment for relapsing forms of MS in the U.S. with brand sales for the 20 mg/ml dose of approximately $527 million and for the 40 mg/ml dose of approximately $2.86 billion for the 12 months ending Aug. 31, 2018, according to IQVIA.
About Natco Pharma Limited:
Natco Pharma Limited is a vertically integrated and R&D focused pharmaceutical company engaged in developing, manufacturing and marketing of finished dosage formulations (“FDF”) and active pharmaceutical ingredients (“APIs”). It markets and distribute its products in over 40 countries.