General disadvantages of fixed-dose combinations cannot reduce the reasonable expectation of success derivable from the prior art with respect to the formulation of a pharmaceutical composition containing two specific active pharmaceutical ingredients. A synergistic effect is not suitable to establish inventive step of a fixed-dose combination of two active pharmaceutical ingredients, where the synergistic effect was already observed for the simultaneous but separate administration of the same active ingredients.
The full summary of this case has been published on Kluwer IP Law.
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