The UK High Court of Justice has issued a decision in favour of Mylan and its European partner Synthon, finding all claims of Teva’s patent relating to Copaxone invalid.
It is another vital milestone for Mylan, and further increases the company’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.
Over the course of the last eight 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 across Europe, and now the litigation in the UK, while also obtaining dismissal of Teva’s suit against the FDA seeking to delay approval of the 20 mg/mL product.
In addition, Mylan recently learned of Teva’s latest action concerning the filing of an infringement action against the company’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 one that had just been invalidated and the counterpart to a US 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.
The Copaxone ruling will also help pave the way for Mylan’s future launches of a Glatiramer Acetate Injection in certain European markets.