by Howard E. Rosenberg, Ph.D.
Last October the Italian Antitrust Authority (“Italy”) commenced a procedure against Pfizer Italia Srl and Pfizer Health AB (“Pfizer Italy”) for abuse of Pfizer Italy’s dominant position with respect to the drug Xalatan® (latanoprost). Pfizer Italia Srl and Pfizer Health AB, are the holders of the Italian marketing authorizations (“MAs”) on the product.
Italy was concerned that Pfizer Italy had pursued strategies to artificially prolong a patent for the purpose of preventing or delaying the entry into the market of generic versions of Xalatan®. This procedure was following a complaint filed by Ratiopharm, which seems understandable in light of the recent Enquiry on the Pharmaceutical Sector concluded in 2009 by the European Commission (“EC”). The procedure should be completed on October 15, 2011.
According to the submitted documentation, Pfizer Italy requested and obtained an extension of its patent, by filing an application for a divisional patent, which was followed by an application for a supplementary protection certificate (‘SPC”) aimed at extending patent protection up to 2011. The divisional patent for which the SPC was granted, however, was recently revoked by the European Patent Office (“EPO”) in Munich.
Italy recently announced that it has extended the investigations to Pfizer Inc. (“Pfizer U.S.”) based on the information it had collected from Pfizer Italy. Apparently, Italy found documentation “showing that the initiatives relating to the application for divisional patent EP ‘168 at the EPO in 2002 and the SPC application at the Italian Patent and Trademark Office in 2009, aimed at realigning the expiry of the rights in Italy with the expiry of the rights in the other European countries (from September 2009 to July 2011), were centrally coordinated and managed by the US company Pfizer Inc., either directly or through other European subsidiaries”. Hence Pfizer U.S. is also now a party to the proceedings and will need to furnish all requested information to Italy and, presumably, will be subject to the decision made by the Italian Antitrust Authority.