Includes bibliographical references and index.

Acknowledgements v -
Introduction 1 -
I. The Different Faces of Pharmaceutical Markets 1 -
II. Purpose and Scope of the Analysis 3 -
III. Methodology 7 -
IV. Structure of the Book 9 -
PART I -
1. Regulating Entry 15 -
I. The Main Features of Pharmaceutical Markets: The Supply Side and the Demand Side 15 -
II. The Product Life Cycle and the Costs of Innovation 20 -
III. The Access to the Market: Regulatory Approaches 23 -
A. The European Regulatory Framework 23 -
B. The US Regulatory Framework 27 -
IV. Concluding Remarks 33 -
2. Regulating Exclusivity 34 -
I. The Interplay between Regulatory Exclusivities and Intellectual Property Rights 34 -
II. Intellectual Property Rights in the Pharmaceutical Industry: An Overview on the Role of Patents 35 -
III. EU Supplementary Protection Certificate and US Patent Term Restoration 41 -
IV. Regulatory Exclusivity 48 -
V. Research and Bolar Exemptions 52 -
VI. Exhaustion Doctrine and Parallel Trade 59 -
VII. Concluding Remarks 63 -
3. Regulating Prices 64 -
I. Pharmaceutical Pricing and Reimbursement Systems in Europe 64 -
II. The US System 70 -
III. Concluding Remarks 76 -
viii Contents -
PART II -
4. Competition Law Enforcement in Pharmaceutical Markets: An Introduction 79 -
I. EU and US Antitrust Rules: An Essential Overview 79 -
II. Antitrust Enforcement in the Pharmaceutical Sector 87 -
III. Market Definition 95 -
IV. Concluding Remarks 100 -
5. Reverse Payment Patent Settlements 102 -
I. The Recurrence of Reverse Payment Patent Settlements in Pharmaceutical Markets 102 -
II. Reverse Payment Patent Settlements in the United States 105 -
A. Earlier Case Law and the Actavis Ruling 105 -
B. Critical Issues after Actavis 109 -
C. Further Developments 113 -
III. EU Case Law on Reverse Payment Patent Settlements 119 -
A. Lundbeck 120 -
B. Generics 123 -
IV. Comparative Analysis 127 -
A. Legal Frameworks 127 -
B. The Antitrust Assessment 129 -
V. Concluding Remarks 134 -
6. Product Hopping 136 -
I. Pharmaceutical Product Reformulations 136 -
II. Product Hopping before US Courts 140 -
III. The EU Experience 146 -
IV. The Antitrust Assessment of Product Reformulation 151 -
V. Concluding Remarks 155 -
7. Excessive Drug Pricing 157 -
I. The Resurgence of Excessive Pricing Cases in the Pharmaceutical Sector 157 -
II. Excessive Pricing under EU Competition Law 161 -
A. Aspen 165 -
III. The US Approach 169 -
IV. The Role of Antitrust Enforcement on Excessive Drug Prices 176 -
V. Concluding Remarks 178 -
Contents ix -
PART III -
8. Further Interactions: Pharmaceutical Markets, Intellectual Property and Human Rights 183 -
I. The Right to Health and Access to Medicines and the Relationship with Intellectual Property Rights: An Overview 183 -
II. Compulsory Licensing 191 -
III. Concluding Remarks 196 -
9. Public Health and Public Interest in Competition Law 198 -
I. Public Health and Competition Law 198 -
II. Competition Law and Non-competition Interests 203 -
III. Concluding Remarks 208 -
Conclusion 209 -
Bibliography 213 -
Index 233.

"This book explores the fundamental and inextricable relationship between regulation, intellectual property, competition law, and public health in pharmaceutical markets, examining their interconnections and the delicate balance between the various interests and policy goals at stake. The study is enhanced by the adoption of a comparative perspective, tracing convergence and divergence between EU and US systems through the analysis of relevant applicable rules, significant cases, and policy choices"--Publisher's description.