The Court of Justice of the European Union (CJEU)’s much anticipated early Christmas present for generic producers has arrived in the form of its judgment in the AstraZeneca case (Case C-457/10 P AstraZeneca AB and AstraZeneca plc v European Commission, 6 December 2012). The decision upheld that of the General Court and the Opinion of Advocate General Mazák, and suggests that the pharmaceutical industry may soon be faced with emboldened competition authorities.
At issue was the Commission’s finding of abuse of dominance (under Article 102 TFEU) for two abuses of the patent system by AstraZeneca (AZ). Firstly, the Commission found that AZ had made “misleading representations” to national patent offices in several Member States which enabled it to extend patent protection of one of its headline gastrointestinal treatments longer than should have been possible. Secondly, the selective deregistration of an older form of the drug had deprived generic producers of the simplified procedure for obtaining a marketing authorisation for their products under Article 4(3)(8)(a)(iii) of Directive 65/65. Continue reading