Oberster Gerichtshof, Austria, 22 April 2015, Case No. 4 Ob 20/15t
In C-631/13 (Forsgren), the ECJ already ruled: Article 3(b) of Regulation No 469/2009 must be interpreted as precluding the grant of a supplementary protection certificate for an active ingredient whose effect does not fall within the therapeutic indications covered by the wording of the marketing authorisation.
Article 1(b) of Regulation No 469/2009 must be interpreted as meaning that a carrier protein conjugated with a polysaccharide antigen by means of a covalent binding may be categorised as an ‘active ingredient’ within the meaning of that provision only if it is established that it produces a pharmacological, immunological or metabolic action of its own which is covered by the therapeutic indications of the marketing authorisation.
Now, the Austrian Supreme court shed further light on the SPC-regulation when applying the ECJ’s judgement (Austrian Supreme Court, 4Ob20/15t).