Mylan, Synthon Win European Patent Office Ruling Related To Copaxone 40 Mg/ML

(RTTNews) - Mylan N.V. (MYL) said Tuesday that the company and development partner Synthon has won a significant European Patent Office ruling related to Copaxone 40 mg/mL.

According to Mylan, the European Patent Office or EPO's Technical Board of Appeal has held that Yeda Research and Development Co. 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.

Mylan's lower-cost therapeutically equivalent version of Copaxone is indicated for the treatment of patients with relapsing forms of MS, a chronic inflammatory disease of the central nervous system.

Mylan noted that the EPO's decision has once again enabled it to overcome Teva's attempts to restrict multiple sclerosis or MS patients' access to safe and affordable alternatives. The ruling will allow Mylan to immediately return to the market and accelerate commercialization in other markets across Europe.

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

"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," said Mylan CEO Heather Bresch.

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