Drexl, Josef --- "AstraZeneca and the EU sector inquiry: when do patent filings violate competition law?" [2013] ELECD 855; in Drexl, Josef; Lee, Nari (eds), "Pharmaceutical Innovation, Competition and Patent Law" (Edward Elgar Publishing, 2013) 290

Book Title: Pharmaceutical Innovation, Competition and Patent Law

Editor(s): Drexl, Josef; Lee, Nari

Publisher: Edward Elgar Publishing

ISBN (hard cover): 9780857932457

Section: Chapter 11

Section Title: AstraZeneca and the EU sector inquiry: when do patent filings violate competition law?

Author(s): Drexl, Josef

Number of pages: 33

Abstract/Description:

The European Commission’s decision in AstraZeneca, and the subse- quent judgments of the General Court (GC) and the Court of Justice of the European Union (CJEU) quite rightly attract a great amount of attention for a number of reasons. For the first time, a pharmaceutical company was fined for an abuse of market dominance. For the first time, European institutions had to assess the relevant markets in the field of pharmaceuticals outside the area of merger control; and for the first time, the question arose of whether strategic use of procedures before patent offices could be considered a violation of competition law. Especially because of the latter two questions, both the competition and patent law community were eagerly awaiting the final decision of the CJEU of 6 December 2012. However, as far as the facts of the case are concerned, the decisions in AstraZeneca seem to address issues of a purely transitory nature that will not come up again in practice. In substance, the company was accused of having misused both the patent system and the procedures for obtaining marketing authorization for drugs with the objective of delaying the market entry of generics. More concretely, the Commission held that AstraZeneca had violated ex-Article 82 EC (now Article 102 TFEU) by misinforming national patent offices about the dates of the first marketing authorization for its blockbuster anti-ulcer drug Losec in the framework of its applications for national supplementary protection certificates (SPCs) under the EU SPC Regulation (first abuse).