This timely book discusses the application of the EU competition rules to pharmaceuticals, covering the prohibitions on anticompetitive agreements and abuse of dominance, and merger control.
The author team comprises academic experts and private practitioners who analyse recent case law at both EU (and UK) and Member State levels – in the context of current issues and future trends, including those related to COVID-19 – and examine the impact of competition law on the behaviour of the pharmaceutical industry. The book carefully considers the balance between competition and innovation, as well as between competition and regulation. It concludes that competition and regulation are not alternatives, but complementary, and that novel ways of taking into account risk and real innovation through competition assessments have been developed.
Integrating an overview of competition law, IP law and pharmaceutical regulation, this book will be an ideal read for scholars and graduate students, as well as private and public practitioners interested in pharmaceutical and European law.
Contents:
Foreword xiv
PART I INTRODUCTION, LEGAL AND
ECONOMIC CONTEXT
1 Introduction 2
Marcel Canoy, Jotte Mulder and Wolf Sauter
2 Excessive pricing doctrine in the pharmaceutical sector:
the space for reform 16
Frederick M Abbott
3 Evergreening exclusive rights in pharmaceutical products:
the case of SPCs, paediatric extensions and orphan drugs 33
Frantzeska Papadopoulou
4 The economics of patents and innovation in pharma 48
Marcel Canoy and Matthijs Versteegh
PART II THE COMPETITION CASES
SECTION IIA PAY FOR DELAY AND PATENT STRATEGIES
5 Settlement agreements acknowledging patent validity in
the United Kingdom 62
Okeoghene Odudu
6 Anticompetitive pharmaceutical patent settlements: the EU
cases on pay-for-delay 79
Jotte Mulder and Wolf Sauter
SECTION IIB EXCESSIVE PRICING
7 The Aspen case of the Italian Competition Authority 98
Claudia Desogus
8 Unfair pricing: policy considerations and recent experience
in the pharmaceutical sector 113
Andrew Groves and Lourenço Ventura
9 Temporary dominance and excessive pharmaceutical
pricing – CD Pharma (Denmark) 124
Behrang Kianzad
10 Excessive pricing for pharmaceuticals in the Netherlands:
the Leadiant case 138
Freek Bruggert and Clara Ceulemans
11 The EU Aspen decision: the European Commission’s first
excessive pricing decision in the pharmaceutical market 151
Harald Mische
SECTION IIC DISPARAGEMENT AND MISLEADING
INFORMATION
12 Disparagement: the European Union and France 175
Adrien Giraud, Juliette Raffaitin and Constance Dobelmann
13 The dissemination of misleading information in the
pharmaceutical market: the Italian experience 199
Margherita Colangelo
SECTION IID MERGERS AND PARALLEL TRADE
14 EU merger control in the pharmaceutical sector: an overview 213
Jan Truijens Martinez
15 Taking stock of the single market imperative in the Court’s
case law on parallel trade in pharmaceuticals: are matters
as settled as they seem? 229
Jotte Mulder
PART III FUTURE DIRECTIONS
16 Towards responsive enforcement of EU antitrust in
pharmaceuticals 248
Wolf Sauter
17 Excessive pricing in pharmaceuticals: perspectives from
EU antitrust and regulation 264
Giorgio Monti and Leigh Hancher
18 Tackling grand challenges with competition law: lessons
from the pandemic 281
Ioannis Lianos, Timo Minssen and Christy Kollmar
Index
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