The draft decree on liberalization and consumer protection, discussed in these days by the Italian Governemnt, contains a provision (Art. 27) according to which the Italian Medicines Agency (AIFA) "does not have the power to assess the existence of patent or industrial protection" within the proceeding for the granting of a marketing authorization to a generic medicine.
While the case law on this specific issue was not clear cut, it was instead clear that IP issues must be dealt with before the civil courts, namely the IP specialized courts. The "clarification" risks therefore to introduce a further element of uncertainity.
We will revert to this matter as soon as the final text of the decree will be published; meanwhile you can contact me, Gualtiero Dragotti (gualtiero.dragotti@dlapiper.com) for any additional information.