On September 3, 2012, an Italian administrative court has rendered a very important decision in a matter relating to the abuse of dominant position connected with the grant of certain IP rights (a European divisional patent as well as the supplementary protection certificate (SPC) and paediatric extension based thereon) and the use of such IP rights as the basis for warning letters and litigation.
In particular, earlier this year the Italian Antitrust Authority had assessed a situation in which a pharmaceutical company, Pfizer, had obtained a divisional patent, an SPC and a paediatric extension in Italy, with resulting warning letters and litigation by third parties. The Antitrust Authority had found that Pfizer had abused its dominant position by having obtained and used such IP rights. More specifically, the Antitrust Authority had alleged that Pfizer had obtained such IP rights on the basis of elusive information provided to the competent administrative authorities (particularly the EPO which had granted the divisional patent).
After issuance of the Antitrust Authority decision, Pfizer had filed an appeal against this decision. On 3 September, the Italian administrative court competent for this appeal issued its decision on Pfizer’s appeal. The appeal decision is very interesting because the Italian administrative court has now decided that the finding of the Antitrust Authority 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:
(a) Pfizer’s divisional does not amount to an abusively excluding activity, since it was filed several years before the anticipated market entry of competing (generic) products (in other words, the divisional was filed simultaneously with such market entry),
(b) 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,
(c) contrary to what happened in the AstraZeneca case now pending before the EU judicial authorities, Pfizer did not provide the EPO with elusive information when pursuing its divisional,
(d) 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,
(e) 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 the relevant IP rights in Italy;
(f) the fact that the divisional had been revoked by the EPO Opposition Division was not proof that the granted of the patent had been achieved by providing elusive information of the EPO;
(g) the finding of the Antitrust Authority 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, the revocation 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 European SPC and paediatric extension regulations allegedly represented, taken together and in the way in which Pfizer had carried them out, 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 and thus defend its legitimate interests.
The Italian administrative court decision of September 3 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 decision does not necessarily say that one can always and under any circumstance file a divisional, SPC or paediatric extension, send warning letters or be involved in litigation without ever incurring in anticompetitive behaviour; however, it surely says that in this particular case Pfizer merely relied on the available legal provisions to obtain certain rights it was entitled to and defend its legitimate interests.
The decision can now further be appealed. If an appeal is indeed filed, it will surely be an interesting case to watch given that in any case the whole situation is assessed on the basis of the same legal principles and case law which also applies to antitrust issues at the EU level.

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