An adjuvant is not an ‘active ingredient’ within the meaning of Article 1(b) of Regulation No 469/2009
14-01-2014 Print this page
Adjuvant does not fall within the definition of ‘active ingredient’ within the meaning of the provision, and adjuvant which has no therapeutic effect on its own does not fall within the definition of ‘combination of active ingredients’
"45. In the light of all the foregoing considerations, the answer to the questions referred is that Article 1(b) of Regulation No 469/2009 must be interpreted as meaning that, just as an adjuvant does not fall within the definition of ‘active ingredient’ within the meaning of that provision, so a combination of two substances, namely an active ingredient having therapeutic effects on its own, and an adjuvant which, while enhancing those therapeutic effects, has no therapeutic effect on its own, does not fall within the definition of ‘combination of active ingredients’ within the meaning of that provision."
IPPT20131114, CJEU, GSK v Patent Office
C‑210/13 - ECLI:EU:C:2013:762
