After reviewing the facts of the ruling and the relevant law, the author comments:
"This much-awaited decision is welcomed for the clear and, in principle, correct answer given to an important point of law. It is crystal clear, from now on, that an SPC for a medicinal product will be valid only if the first marketing authorization in the EU is in line with Europe-wide regulatory rules.
However, on a more practical level, the ECJ's decision raises inevitable concerns on a possibly significant number of similar cases that could be soon brought before national courts in order to verify the validity of any SPC in question. Furthermore, this situation could also affect additional research and investment for medicinal products that will soon be under scrutiny in respect of their SPC".