EPO revokes Copaxone patent, clears path for Mylan
The European Patent Office (EPO) has invalidated and revoked a patent related to Teva’s multiple sclerosis drug Copaxone (glatiramer acetate injection), in a win for Mylan.
In an announcement shared yesterday, September 15, Mylan said that the decision to invalidate European patent number 2,949,335 clears a legal pathway to expand access for patients living with multiple sclerosis in markets across Europe.
The EPO’s Technical Board of Appeal revoked the patent, which was held by Yeda Research and Development Company (the commercial arm of Israel-based Weizmann Institute of Science) and covers a thrice-weekly dosage regimen of 40mg. Teva is the exclusive licensee of the patent.
“With the EPO's decision, Mylan has once again overcome Teva's attempts to restrict MS patients' access to safe and affordable alternatives,” said Mylan.
It claimed that, over the course of 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.
Mylan CEO Heather Bresch added: “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.”
A spokesperson for Teva said the company was “disappointed” with the decision.
“We continue to believe in the value of Copaxone, a treatment that has been studied extensively for more than 20 years and which has provided so far already 2.5 million years of patient experience. We remain strongly committed to reducing patient suffering in the field of multiple sclerosis,” said the spokesperson.
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