Glatiramer acetate – USA

Glatiramer acetate – USA

On Jan 30, 2017, Judge Gregory M. Sleet of the U.S. District Court for the District of Delaware declared that four of Teva’s 2030 method-of-use patents are invalid due to “obviousness.” Teva continues to pursue patent infringement litigation against the ANDA filers based on a fifth 2030 method-of-use patent, as well as a 2035 manufacturing process patent.
Teva is involved in patent infringement litigation against competitors that have filed ANDAs with Paragraph IV certifications seeking FDA approval for generic versions of Copaxone (glatiramer acetate) 40 mg/mL pre-filled syringes. There are five patents listed in the Orange Book for Copaxone 40 mg/mL: U.S. Patent Nos. 8,232,250; 8,399,413; 8,969,302; 9,155,776; and 9,402,874 (all set to expire on August 19, 2030). Sandoz, Amneal, Dr. Reddy’s, Mylan (in partnership with Natco), and Synthon submitted ANDAs with Paragraph IV certifications challenging the OB patents.
Judge Sleet issued a decision in favor of the ANDA filers. More specifically, Judge Sleet agreed with the ANDA filers that the ’250, ’413, ’302, and ’776 patents are invalid due to obviousness. In an opinion explaining his decision, Judge Sleet was not impressed by Teva’s patents: “The court sees the ’250, ’413, ’302, and ’776 patents as nothing more than ‘life-cycle management’–an attempt to continue to monopolize a multi-billion dollar market for a blockbuster drug.”
Teva may appeal this decision to the U.S. Court of Appeals for the Federal Circuit.
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