- Alert: Court of Appeal upholds finding that Teva's patent relating to MS treatment is not obvious (Synthon v Teva)
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IP & IT analysis: This judgment concerned an appeal by Synthon B.V. (Synthon) against the dismissal of its action to revoke a patent held by Teva Pharmaceutical Industries Ltd (Teva) relating to the levels of free bromine and metal ion impurities present in the manufacturing of and final product Copaxone, which is sold as a treatment for multiple sclerosis (MS). Synthon’s appeal concerned challenges to findings that certain claims of the patent were not obvious, whilst Teva cross-appealed findings that other claims of the patent disclosed added matter. The court held that it had not been established at trial that a hydrobromic acid (HBr) and glacial acetic acid (AcOH) solution would have less than 500 ppm metal ion impurities provided only that it was kept in glass vessels. Therefore, the claim to keep the HBr and AcOH solution away from metal surfaces at all times was not obvious. On the second ground, the court held, among other things, that the judge had been entitled to treat as unreliable expert evidence as to the level of bromine which would cause discolouration. On the third ground, the court rejected the argument that all the patent was doing was imposing a measuring step on the prior art process. Accordingly, Synthon’s appeal was dismissed. The court also dismissed Teva’s cross-appeal on the basis that it was not inevitable that glatiramer acetate made from trifluoroacetyl (TFA) polypeptides containing less than 1000 ppm metal ion impurities would have a corresponding quantity of metal ions and, accordingly, the relevant corresponding limit for the finished product had not been disclosed in the application.
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