US Court of appeals Affirms Prior Decisions Finding Copaxone111 40 mrfml Patents Invalid- 

A milestone for NATCO and its marketing partner Mylan

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Hyderabad : NATCO Pharma Limited {NSE: NATCOPHARM; BSE: 524816) has 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 partes 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. Today’s decisions are important milestones as we continue to focus our efforts on meeting the needs of multiple sclerosis patients in the U.S. 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 t he 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. Approximately 400,000 individuals in the U.S. have MS and relapsing MS accounts for 85% of initial MS diagnoses.

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