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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