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Sunday 9 March 2014

Pfizer Xalatan ruling: Consiglio di Stato ruling now available

Last month, in our blog post "Italy: Consiglio di Stato reinstates original Pfizer Xalatan order", here, we hosted a contribution from Gian Paolo Di Santo (Partner NS Head of the I.P./I.T. Department of law firm Pavia e Ansaldo, Milan) on the question of whether Pfizer was in breach of competition law rules in seeking to maximise its protection for latanaprost.

 The decision of the Consiglio di Stato (in Italian) was published in full on 12 February and Gian Paolo has kindly provided us with a copy that you can access here or download here. According to Gian Paolo,
"the decision is rather concise and straightforward, mainly recapping the development of the whole procedure and essentially acknowledging that the Authority decision (which was far more detailed) was not affected by any lack of reasoning and that instead the decision of the TAR Latium (first instance administrative Court) failed to understand the very core of the matter. The problem was that, even if the request for a divisional patent was legitimate, this did not allow Pfizer to use such a divisional patent solely for the purpose of excluding its competitors by means of a SPC + paediatric extension requests. Of course one might have expected some more indications from the Supreme administrative Court, but instead they mainly referred to the decision of the ICA and stated that the investigation that took place could not be considered erroneous".
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2 comments:

  1. Anonymous10 March 2014 at 14:53

    So a divisional patent cannot be validly used solely for the purpose of excluding competitors by means of an SPC and pediatric extesnion requests. Could the parent application be validly used in such a way? Or is it prohibited to seek any IP right purely for an exclusionary purpose?

    Absent a precise explanation of what exactly constituted an abuse in this case, this appears to be no more than a crude landgrab by the Italian competition authorities who feel emboldened by AstraZeneca.

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  2. Anonymous17 March 2014 at 13:35

    The parent application may not have been filed solely for exclusionary purposes. The parent filing provides for the dissemination of valuable information to the public in exchange for exclusion. Although, of course, the PCT or direct EP filing fulfils the public dissemination, so the national phase entry would clearly be anti-competitive.

    I'm sure that when I read the decisions I will find them wholly persuasive, don't you think?

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