Mylan says Teva ends litigation over generic

Mylan N.V. said Teva has dismissed its pending district court litigation against Mylan regarding Mylan’s Glatiramer Acetate Injection 40 mg/mL, the first generic version of Copaxone 40 mg/mL.

Copaxone is Teva’s blockbuster multiple sclerosis treatment.

“The litigation involved two non-Orange Book listed patents, U.S. Patent Nos. 9,155,775 and 9,763,993, relating to the final sterile filtration step in the manufacturing process for glatiramer acetate products,” said Mylan.

“Teva dropped litigation on these patents after the U.S. District Court for the District of Delaware issued a decision adopting Mylan’s interpretation of the patents’ claims.

“In addition, Teva has agreed to withdraw the Irish equivalent to these patents from the recently filed proceeding in Ireland.

“After the dismissals, Teva’s only remaining patent challenges in the U.S. and Ireland against Mylan’s Glatiramer Acetate Injection 40mg/mL relate to the three-times-a-week dosing regimen, which Mylan has already successfully invalidated at the U.S. District Court for Delaware, the U.S. Patent Trial and Appeal Board and the United Kingdom’s High Court of Justice.

“Teva is appealing these decisions.”