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26 Oct 2017

Mylan wins UK court ruling related to Copaxone 40 mg/mL patent

Court finds all claims of Teva's patent relating to Copaxone invalid based on obviousness.

The UK's High Court of Justice has issued a decision in favour of Mylan and its European partner Synthon, finding all claims of Teva's patent EP (UK) 2 949 335 (EP 335) relating to Copaxone 40 mg/mL invalid based on obviousness.

This victory is yet another important milestone for Mylan, and this UK court decision only further increases Mylan's confidence in its ability to bring high quality, lower-cost generic versions of Copaxone to the multiple sclerosis community and patients around the world.

During the course of the last 8 years, Mylan has successfully overcome Teva's four waves of US patent litigation, eight Citizen Petitions, injunction proceedings in India, more than 15 regulatory challenges, patent litigations or commercial actions across Europe, and now the litigation in the UK, in addition to obtaining dismissal of Teva's suit against the FDA seeking to delay approval of the 20 mg/mL product. This positive ruling in the UK will further help pave the way for Mylan's future launches of Glatiramer Acetate Injection 40 mg/mL in certain European markets.

In addition, Mylan recently learned of Teva's latest action with the filing of an infringement action against Mylan's Irish subsidiary Mylan Teoranta in the High Court of Ireland alleging that Mylan's Glatiramer Acetate 40 mg/mL injection infringes two European patents. In fact, one of those patents is the same patent that was just invalidated today by the UK High Court of Justice and the counterpart to a U.S. patent that was previously held invalid by both the United States District Court for the District of Delaware and the Patent Trial and Appeal Board.

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