Losartan in Italy

The SPC Blog has recently heard from Micaela Modiano of Modiano and Partners that the Italian PTO also granted the pediatric extension for losartan in Italy, see excerpt here from the Italian PTO online IP rights database.

Micaela comments -

"It is also interesting that in Italy the regulatory agency (AIFA) issued an official communication, here, published in the Italian OJ, indicating not only that it had accepted the variation determined by the addition of the pediatric indication, but also that "Therefore, the patent owner or SPC owner has the right to a 6-month extension of the period provided for." (see highlighted sentence in the official communication)

As far as we know, this is the first time that the Italian regulatory agency has officially commented on something that would then be taken up by the Italian PTO (usually, it's the other way round, i.e. the Italian regulatory agency uses the Italian PTO sources for determining when SPCs expire and in turn determining when a generic MA request can be submitted, according to a certain interpretation of the Italian IP code made by the Italian regulatory agency the correctness of which is currently unclear).

We were told by the Italian PTO that they welcomed the Italian regulatory agency communication as the PTO examiners feel that they are unable to determine when the studies made by the SPC owner justify the pediatric extension and when they don't. It remains to be seen whether an official communication by the Italian regulatory agency as made in the losartan case will thus become the standard practice in case of pediatric studies."