Patent Law v Competition Law: the Italian highest administrative delivers judgment on the Pfizer Xalatan case in favour of the Italian Competition Authority

By a judgment made on 14 January 2014 the Italian Council of State (CoS) delivers the appeal on the Pfizer Xalatan case (Case n. 116/2014) finding in favour of the appellant, the Italian Competition Authority (ICA). The ICA had previously found Pfizer to have abused its dominant position in the market for glaucoma medicines based on latanaprost when it deliberately misused the patent application procedures with the aim to prolong the patent protection for Xalatan (Case A431). More precisely, Pfizer relied on a patent divisional application to obtain a supplementary protection certificate, thereby extending the length of patent protection for its patented drug. In the ICA view, Pfizer  acted in this way with the intent to foreclose the market entry of generics when the patent term for Xalaton in Italy was due to expire soon. Therefore, the ICA imposed on Pfizer a fine of €10,6 million. The ICA decision was much debated within the competition law community and different views on whether the ICA analysis was correct were aired (see here and here).
Pfizer appealed the ICA decision to the Regional Administrative Court for Latium (TAR), arguing that it  legitimately filed the divisional application to protect its R&D investments. The Tar agreed with Pfizer. It pointed out that the ICA did not consider that the divisional patent had been revoked and took the view that Pfizer was only seeking to protect its invention within the limits of patent law.

The ICA and others challenged this judgment before the CoS that set aside the appealed judgment and reinstated the ICA decision and its findings. Up to date the CoS only published the ruling. The reasoning of the judgment will be available in a few months’ and will be eagerly awaited with the hope that it may shed some light on the turbulent relationship between competition and patent law exposed in the Pfizer Xalatan case.

Comments

Post a Comment

Popular posts from this blog

Aspen: The Italian Competition Authority fines a generic manufacturer of drugs for excessive pricing

By the decision made on 29 September 2016 in Aspen [i] , the Italian Competition Authority (ICA) has imposed a fine of more than EUR 5 million on the Aspen group (Aspen), a South African manufacturer of generic drugs. Aspen violated Article 102 TFEU by imposing excessive prices for the supply of the so-called ‘Cosmos drugs’. These drugs included Leukeran, Alkeran, Purinethol and Tioguanine, which included the active principles of chlorambucil, melphalan, mercaptopurine and tioguanine, respectively. All these drugs were used to treat cancer pathologies and included in a wider package of pharmaceutical products, whose marketing rights had been purchased by Aspen from the originator GlaxoSmithKline (GSK) in 2009. Aspen had a dominant position in the relevant product markets for the commercialization of anti-cancer drugs manufactured using the active principles of alkeran, leukeran, purinethol and tioguanine. It had the only one market authorization for the sale of drugs and potential ...
Read more

Geographical allocation of turnover in aviation mergers: What the European Commission recently hold

The European Merger Control Regulation (ECMR) stipulates that only concentrations with a European dimension fall within the regulatory jurisdiction of the European Commission to review. A concentration is presumed to have such a dimension when it meets the financial threshold in Article 1 of the ECMR. To this end, it is necessary to calculate the turnover generated by the merging parties within the Community or in one or more member states. However, the geographical allocation of the turnover required by Article 1 for the purpose to establish the Commission’s jurisdiction can be a tricky issue in case of mergers between undertakings with a cross-border activity such airliners. In fact, the activities of airlines span several countries as they typically operate flights and sell tickets in many national markets. Recently, the Commission has dealt with the issue at length in the Ryanair/Aer Lingus case. It identified three possible methodologies for geographical allocation of turnover: -...
Read more

The European Commission unconditionally clears the Facebook/WhatsApp merger

By a Phase I decision the Commission unconditionally approved the Facebook $ 19 billion acquisition of WhatsApp ( Case No COMP/M.7217,Facebook/WhatsApp) . The Commission was required by the parties to review the transaction by means of a reasoned submission filed on the basis of Article 4(5) of the EU Merger Regulation. Indeed, the merger was not a concentration with EU dimension within the meaning of Article 1 EUMR falling within the Commission jurisdiction, since the EU turnover of WhatsApp in 2013 failed to met the financial thresholds in that provision. The Commission identified three relevant product markets affected by the concentration. It restrained the first relevant market, the market for consumer communication services, to the communication apps for smartphones, because WhatsApp was available only for this device. Following its approach in Microsoft/Skype (Case M.6281), upheld by the General Court in the case T-79/12, Cisco Systems and Messagenet v Commission, the Com...
Read more