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15 Sep 2020

Mylan and development partner win significant EPO ruling related to Copaxone

Decision clears legal pathway to expand access for patients living with multiple sclerosis in markets across Europe.

The Technical Board of Appeal of the European Patent Office (EPO) has held that Yeda Research and Development Company, Ltd.'s European Patent no. 2 949 335 related to Teva's Copaxone 40 mg/mL three times weekly product is invalid and revoked across Europe.

With the EPO's decision, Mylan has once again overcome Teva's attempts to restrict multiple sclerosis (MS) patients' access to safe and affordable alternatives.

During the last 11 years, Mylan has successfully defeated Teva's four waves of US patent litigation, eight Citizen Petitions, injunction proceedings in India, and more than 15 regulatory challenges, patent litigations or commercial actions across Europe.

The EPO's positive ruling will allow Mylan to immediately return to the market and accelerate commercialization in other markets across Europe.

Mylan CEO Heather Bresch commented: "The decision by the EPO marks a significant step forward for Mylan in several ongoing legal actions around Europe related to this important product, and further increases our confidence in our ability to continue to expand access to a lower-cost, high quality, therapeutically equivalent version of Copaxone to the multiple sclerosis community across even more markets in Europe and beyond."

Indicated for the treatment of patients with relapsing forms of MS, Mylan's lower-cost therapeutically equivalent version of Copaxone will benefit thousands of MS patients across Europe who are living with this very difficult condition and in need of a more affordable treatment option.

Mylan's product is currently marketed under a number of brand names in European markets including Brabio, Clift, Copemyl, Copemyltri and Glatiramyl.

Mentioned Companies
Mylan Laboratories Limited
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