On Oct 25, 2016, Court of appeal, The Hague rejected the appeal and confirmed the nullification of EP2361924 patent for lack of inventive step.
Teva is the proprietor of EP’924 patent for a “process for preparation of mixtures of trifluoroacetyl glatiramer acetate using purified hydrobromic acid”. This patent had been nullified by the District Court of The Hague in proceedings in first instance initiated by Synthon, for lack of inventive step.
Teva lodged an appeal against this decision based on auxiliary requests. In essence, the appeal judgment focussed on the assessment of novelty and inventive step of the claimed process for obtaining glatiramer acetate (GA), which process involved the use of a solution of hydrobromic acid (HBr) in acetic acid which is essentially devoid of free bromine and which comprises less than 100 ppm of metal ion impurities.
With respect to novelty the court found that EP ‘924 novel over public prior use and declaration of Chemada (Teva’s supplier of the HBr/acetic acid solution). But with respect to Inventive step, court found that the insight that the presence of free bromine in the HBr/acetic acid solution should be reduced as much as possible to avoid bromination of tyrosine during the synthesis of GA, was obvious.
Thus Court of Appeal rejected the appeal and confirmed the nullification of EP ‘924 for lack of inventive step.