Antitrust and SPCs in Italy

From Micaela Modiano (Modiano & Partners) comes some useful information concerning developments in Italy, where the national antitrust authority seems to have been taking a closer interest in patent extension than most of its counterparts in EU Member States.  She writes:

"You may have heard that there was a recent decision rendered by the Italian Antitrust Authority regarding divisionals and SPCs. The decisions relates to a European divisional patent and an Italian SPC owned by Pfizer.

I attach both the public version of the decision and an English translation of it.

At point 176. of the decision the Antitrust Authority lists the elements of the alleged exclusion strategy enacted by Pfizer. In particular, the following elements are listed:

"i) the application to the EPO of the divisional patent EP 168 in 2002; 

ii) the validation of same only in Italy, [omissis] for the purpose of requesting in some countries the SPC on Xalatan and thus align the duration of the patent protection to that in force in the rest of Europe; 

iii) the intervention with AIFA for the purpose of preventing the issue of the MAs to the generic pharmaceutical manufacturers and subsequently their inclusion in the transparency list; 

iv) the delivery to the manufacturers of the Xalatan generic drugs of warning letters relating to their marketing prior to the patent expiry of July 2011; 

v) the commencement of civil and criminal litigation in order to discourage or render more burdensome the sale of the generic drugs based on latanoprost (including through massive compensation claims) or to prohibit directly the marketing; 

vi) the application for the subsequent patent extension following the pediatric trial, in other words extending the patent protection of Xalatan until January 2012."

The Antitrust Authority decision is quite striking as it lists a number of things fully contemplated by European (EPC and EU) and Italian law -- such as filing a divisional, validating it in the countries of choice, filing an SPC for it, filing a request for paediatric extension -- among the elements of the alleged exclusion activity.

I think it will make fascinating reading for all those interested in the interaction between IP law (and SPCs in particular) and antitrust regulations. 

Thanks so much, Micaela, for sharing this information with us, as well as your insight on it.