Pharmaceutical Innovation, Competition and Patent Law

Pharmaceutical Innovation, Competition and Patent Law

A Trilateral Perspective

Edited by Josef Drexl and Nari Lee

Considering the arguments from the perspectives of innovation, competition law and patent law, this book explores the difficult question of balancing protection with access, highlighting the difficulties in harmonization and coordination. The contributors to this book, including academics, judges and practitioners from Europe, the US and Japan, explore to what extent patent strategies and life-cycle management practices take advantage of patent laws and health-care regulation and disrupt the necessary balance between incentives for innovation and access to affordable medicine and health care.

Chapter 11: AstraZeneca and the EU sector inquiry: when do patent filings violate competition law?

Josef Drexl

Subjects: law - academic, biotechnology and pharmaceutical law, competition and antitrust law, intellectual property law


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).

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