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Synthon prevails over Copaxone patent dispute Posted 13/10/2017

On 13 September 2017, the Technical Board of Appeal (TBA) of the European Patent Office (EPO) revoked the patent for Teva Pharmaceutical’s (Teva) synthesis of the active ingredient in Copaxone, a key drug used to treat recurring multiple sclerosis (MS). The case against Israel-based Teva was filed by the Netherlands-based generics and biopharmaceuticals company Synthon BV, who is now clear to market their generic glatiramer acetate in a number of European countries.

Synthon performed a large-scale, multicentre phase III study for glatiramer acetate 20 mg/mL and obtained marketing approval for the generic version in Europe in 2016 [1, 2]. However, in their patent applications, Teva claimed that an improvement made to the glatiramer acetate synthesis process, employing the use of chemical hydrogen bromide (HBr), was unique enough to warrant patent protection. There were three such HBr related patents approved initially and in defence of these, Teva filed injunctions and other legal measures against Synthon in 19 European countries.

With this TBA decision all injunctions against Synthon will be lifted and it will be able to market its generic version of glatiramer acetate across Europe. However, the patent for Copaxone 40 mg/mL (three times a week) does not expire in Europe until 2030 and this will continue to be prescribed to patients. The lower-cost generic version available to patients with recurrent MS will only be available as glatiramer acetate 20 mg/mL.   

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