On 14th October 2015, Teva Pharmaceutical Industries’ European Patent EP 2 177 528 was revoked.
The patent was one of a family of patents covering Copaxone® (glatiramer acetate injection), its intermediates and processes for its production. Global Copaxone® franchise sales were $4.2 billion in 2014.
The opposition was filed by Mylan, Synthon BV, and an unidentified third party. The patent was maintained in amended form at the first instance opposition hearing in 2014. In response to a request for accelerated prosecution of the ensuing appeal, the EPO heard the case after the patent received a mixed reception in national litigation proceedings. Earlier this year the UK High court maintained the patent, while the Dutch court revoked it. The central revocation in the EPO will bring to an end any further European national litigation relating to this patent.
Arnie Clarke, representing the first appellant in this case, led the attack against the patent. A hard fought two day hearing at the EPO resulted in the board of appeal giving its opinion that, inter alia, the patent lacked an inventive step.
This is the second patent in this family to have been revoked. In February 2015, Teva withdrew its approval of the text for European Patent EP 1 799 703 in EPO appeal proceedings, leaving the EPO with no option but to revoke the patent. It is likely that Teva took this procedural step in order to avoid the potentially negative decision of the EPO’s board of appeal impacting on related national litigation.
The concentration of the parties will now turn to the remaining European patent in this family, which is also under opposition in the EPO.