Economic and Social Justice Perspectives
Edited by Anne Flanagan and Maria Lillà Montagnani
Chapter 6: The Search for EU Boundaries: IPR Exercise and Enforcement as ‘Misuse’
Anne Flanagan, Federico Ghezzi and Maria Lillà Montagnani 1. INTRODUCTION In 2006, the EU Commission fined pharmaceutical company AstraZeneca (AZ) €60 million, finding that AZ had violated Article 82 of the EC Treaty via its misuse of pharmaceutical marketing authorization procedures and patent systems in seven Member States, in order to prevent or delay entry by generic drug manufacturers.1 Specifically, AZ misled certain national patent offices about the inception of its product marketing in order to obtain longer supplementary protection certificates (SPCs). This SPC strategy was intended to stretch AZ’s patent duration for its leading medicinal product far beyond the term provided under patent law. At the same time, AZ, as part of a post-patent-strategy, changed its product formulation in countries where the patent/SCP was close to expiring, thereby preventing generic manufacturers that were ready to produce and market the original formulation and parallel importers from entering the market until they could manufacture and produce the new formulation. These behaviors, sometimes called the ‘evergreening’ of patents, permitted AZ to control the market access for both generic producers and for parallel traders by exploiting its patent far beyond its term of duration and, to a certain extent, beyond its scope. The full implication of AZ’s AstraZeneca  OJ L 332/24, appealed on 25 August 2005 AstraZeneca/ Commission (Case T-321/05) (2005/C 271/47), OJ of the European Union 29 October 2005. The Lisbon Treaty, 2007 OJ C 306/01 (17 December 2007) amended the EC Treaty to rename it the Treaty on the Functioning...
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