Consiglio di Stato gives judgment in the Pfizer case

By Claire Davies and Osman Zafar

Earlier this year, the Consiglio di Stato (Italy’s highest administrative court) ruled that Pfizer’s use of patents and supplementary protection certificates (SPCs) relating to Xalatan/latanoprost in Italy constituted an abuse of its dominant position. This in effect reinstated the Italian Competition Authority’s (ICA’s) original decision and fine of €10.7m (£8.8m).

Pfizer had a European patent for Xalatan, which contains the active ingredient latanoprost and is used to treat glaucoma. This patent expired in September 2009 and although Pfizer had filed SPCs and paediatric extensions in several EU countries, it had not done so in Italy. Pfizer, having applied for a divisional patent covering latanoprost in 2002, obtained SPC protection in Italy based on the divisional patent rather than the parent patent. It also requested a paediatric extension.

The ICA held that these steps, together with others, formed part of a ‘complex strategy’ used by Pfizer to delay the entry of generic drugs into the Italian market — Pfizer had therefore abused its dominant position. On first appeal, the Regional Administrative Court of Lazio disagreed with this assessment, holding that Pfizer had simply used legal means to protect its intellectual property rights and that the ‘quid pluris’ (something more) required to prove abuse had not been demonstrated…

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