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Flanagan, Anne; Ghezzi, Federico; Montagnani, Maria Lillà --- "The Search for EU Boundaries: IPR Exercise and Enforcement as ‘Misuse’" [2010] ELECD 657; in Flanagan, Anne; Montagnani, Lillà Maria (eds), "Intellectual Property Law" (Edward Elgar Publishing, 2010)

Book Title: Intellectual Property Law

Editor(s): Flanagan, Anne; Montagnani, Lillà Maria

Publisher: Edward Elgar Publishing

ISBN (hard cover): 9781848446274

Section: Chapter 6

Section Title: The Search for EU Boundaries: IPR Exercise and Enforcement as ‘Misuse’

Author(s): Flanagan, Anne; Ghezzi, Federico; Montagnani, Maria Lillà

Number of pages: 32

Extract:

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 for-
mulation 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, permit-
ted 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


1 AstraZeneca [2006] OJ L 332/24, appealed on 25 August 2005 AstraZeneca/

Commission (Case T-321/05) (2005/C 271/47), OJ of the European ...