The Anticompetitive Misuse of Intellectual Property Rights in the European Pharmaceutical Sector

Gallasch, Sven (2014) The Anticompetitive Misuse of Intellectual Property Rights in the European Pharmaceutical Sector. Doctoral thesis, University of East Anglia.

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Abstract

Pharmaceutical antitrust is currently a centre of attention for the European
Commission, with one decision against Lundbeck and Statements of Objections in
investigations against Johnson & Johnson, Novartis, and Les Laboratoires Servier.
This thesis is the first to develop in detail a ‘European approach’ to pay for delay
settlements and early entry agreements – two types of conduct identified by the
European pharmaceutical sector inquiry. Although pay for delay settlements have
received extensive antitrust scrutiny in the United States, one has to be cautious
when drawing from this expertise, as the underlying regulatory regimes are
fundamentally different in Europe and the US. This need for careful comparative
analyses in pharmaceutical antitrust and the fact that similar conduct might have to
be treated differently on both sides of the Atlantic is showcased by a case study of
the General Court’s AstraZeneca judgment. The analysis shows that the General
Court was correct to dismiss AstraZeneca’s claim that its conduct would not have
led to antitrust scrutiny following the US Walker Process Doctrine, which in fact
covers similar conduct. Additionally, the hypothetical application of the market
definition in AstraZeneca to the market of anti-epileptic drugs highlights the
difficulties that the European Commission might encounter in its future
enforcement in the pharmaceutical sector.
Based on the different incentives for the parties of EU pay for delay settlements, a
novel European theory of harm is developed for pay for delay settlements and early
entry agreements, the latter posing significant anticompetitive potential in Europe.
Based on this theory, pay for delay settlements are scrutinised under EU
competition law and a novel “structured effects-based” test is proposed that is
inspired by the recent Actavis judgment of the US Supreme Court. In terms of early
entry agreements, this thesis is the first to apply EU competition law.

Item Type: Thesis (Doctoral)
Faculty \ School: Faculty of Social Sciences > School of Law
Depositing User: Mia Reeves
Date Deposited: 17 Oct 2014 12:13
Last Modified: 17 Oct 2014 12:13
URI: https://ueaeprints.uea.ac.uk/id/eprint/50554
DOI:

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