Italian u-turn on latanoprost abuse of dominant position dispute

The SPC Blog is very pleased to thank Micaela Modiano (Modiano & Partners) and Anna Maria Stein (Franzosi Dal Negro Setti),for the following item of news from Italy:

"Recently we reported  he decision of the Italian Antitrust Authority in the latanoprost case. In that decision, the Authority found that Pfizer abused its dominant position as a result of a combination of activities including filing a divisional, validating it only in a part of the designated states, filing an SPC and a paediatric extension based on it and Pfizer's involvement in related litigation in Italy.

Pfizer filed an appeal against this decision. On 3 September 2012 the Italian administrative court competent for this appeal issued its decision on Pfizer's appeal. The appeal decision is very interesting because, while the Italian Antitrust Authority had held that Pfizer's behaviour represented an abuse of dominant position, the Italian administrative court has now decided that this finding is entirely incorrect. In particular, the most noteworthy points of the administrative court decision are -- as regards the issue of abuse of dominant position -- that:

* Pfizer's divisional does not amount to an abusively excluding activity, since it was filed several years before the anticipated market entry of generic companies (i.e. not simultaneously with it), 

* the filing of Pfizer's divisional does not amount to an abusively excluding activity just because it took place when Pfizer realized the more limited protection conferred by the parent patent, 

* contrary to what happened in the AstraZeneca case, Pfizer did not provide the EPO with elusive information when pursuing its divisional, 

* Pfizer's litigation activity was not an abusively excluding activity, given that in most of the relevant litigation Pfizer was actually the defendant rather than the plaintiff, 

* Pfizer's warning letters sent prior to the litigation were not an abusively excluding activity, given that they were sent on the basis of Pfizer objectively having obtained an SPC for Italy; 

* the Antitrust Authority finding is altogether flawed as it appears to be based on the fact that, at the time of the Authority's decision, the divisional patent had been revoked by the EPO Opposition Division, while ignoring that the revocation could be (and was indeed) appealed. That is to say, it was not final at the time, and was indeed overturned by the EPO Board of Appeal.

Thus, while the Italian Antitrust Authority had held that a number of activities which are based on the provisions of the EPC and of the EC SPC and paediatric extension regulations allegedly represented, taken together and in the way in which Pfizer had carried them out, constituted an abuse of Pfizer's dominant position, the Italian administrative court has now held that Pfizer legitimately and non-abusively relied on such provisions simply to obtain the IP rights to which it was entitled.

The new Italian administrative court decision is therefore important as it appears to take away some of the very negative light shed in a blanket-like manner by the Italian Antitrust Authority on divisionals, SPCs and paediatric extensions. The new decision does not necessarily say that one can always and under any circumstance file a divisional, SPC or paediatric extension or sending warning letters or be involved in litigation without ever incurring in anticompetitive behaviour, but it surely says that in this particular case Pfizer merely relied on the available legal provisions to obtain certain rights it was entitled to.

We now wait to discover whether the administrative court decision will now be appealed by the Antitrust Authority"..

For those readers who are actually Italian or read Italian, the original decision is here.  Micaela and Anna Maria are seeing what they can do to get us all an English translation. Thanks!