Teva drops Copaxone generic suit against Mylan

Teva has dropped its litigation over two US patents against Mylan, after a district court adopted Mylan’s interpretation of the patents.

Yesterday, December 11, Mylan announced that the dispute over its glatiramer acetate injection, a generic version of Teva’s Copaxone, had been dismissed by Teva.

Copaxone, a treatment for patients with relapsing-remitting forms of multiple sclerosis (MS), is a blockbuster drug sold by Teva.

The litigation involved US patent numbers 9,155,775 and 9,763,993, which relate to the final sterile filtration step in the manufacturing process for glatiramer acetate products.

Teva also agreed to withdraw the Irish equivalent of these patents from a recently filed proceeding in Ireland.

The only remaining patent challenges in the US and Ireland concern the dosing regimen that is issued three-times-a-week.

Mylan said it had already successfully invalidated this patent at the Delaware court, the Patent Trial and Appeal Board and the English High Court.

In October, Mr Justice Arnold of the English High Court invalidated two patent claims of a European patent protecting Copaxone.

A fourth wave of litigation will start between the parties in April next year, this time focusing on an improved process for preparing glatiramer acetate.

Mylan received Food and Drug Administration approval and launched its glatiramer acetate injection 40 mg/mL for three-times-a-week injection.

“The ruling and case dismissal give us even greater confidence in our ability to continue providing this important product to thousands of MS patients nationwide who are living with this very difficult disease and in need of a more affordable treatment option,” said a spokesperson for Mylan.

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