On 3 September 2012, the Italian Administrative Tribunal for Lazio ("Tribunale Amministrativo di Lazio", the "Tribunal") annulled an earlier decision of the Italian Competition Authority ("Autorità Garante della Concorrenza e del Mercato", the "Authority") which had fined pharmaceutical group Pfizer € 10.6 million for abuse of dominance in the market for medicines based on the active substance latanoprost for the treatment of glaucoma (see VBB on Competition Law, Volume 2012, No. 1, available at www.vbb.com). Pfizer holds a 60% market share in that market through the sales of its Xalatan® pharmaceutical product.
The Authority's initial decision had found that Pfizer had engaged in anti-competitive practices by artificially extending the patent protection of its Xalatan® product and simultaneously threatening to sue various generic medicine producers likely to enter the market. According to the Authority, Pfizer's Xalatan® Italian patent expired in September 2009, but the company effectively extended its protection to July 2011 and later to January 2012, with the intention of keeping rivals out of the market. Commitments were offered by Pfizer, but the Authority rejected these for failing to address the competition concerns.
For its part, the Tribunal overturned the Authority's decision, finding that Pfizer's behaviour was legitimate. Much emphasis was placed on the Authority's refusal to accept the commitments proposed by Pfizer during the proceedings. In the Tribunal's view, that refusal was "logically and procedurally" incorrect. On the contrary, the Tribunal considered that the proposed commitments had an "objective substantive consistency" and were "likely to diminish the legal uncertainty created by Pfizer's strategy".
In addition, the Authority was also criticised for adopting a too wide interpretation of the AstraZeneca precedent, in which the European Commission – whose decision was subsequently upheld by the EU General Court - had fined AstraZeneca € 60 million for allegedly abusing Article 102 TFEU through a misuse of the patent system with a view to blocking or delaying market entry for generic versions of its ulcer medicine Losec® (active substance: omeprazole) and preventing parallel imports of Losec® (see VBB on Competition Law, Volume 2005, No. 6 & Volume 2010, No. 7 available at www.vbb.com). According to the Tribunal, the Authority failed to establish sufficient evidence of such behaviour by Pfizer.
With regard to the Authority's findings of abuse of dominance and its theory of harm, the Tribunal stated that Pfizer had done nothing more than defend its legitimate interests. In particular, anti-competitive behaviour needed to be supported by evidence of "clear exclusionary intent and an additional anti-competitive element" which went beyond legitimate business practices. In the present case, the Authority had failed to demonstrate that Pfizer effectively acted with the intention of excluding generic producers from the market. For all the above reasons, therefore, the Tribunal decided to annul the Authority's decision imposing a fine on Pfizer.
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