Patent Settlements in the Pharmaceutical Industry under US Antitrust and EU Competition Law.

Patent Settlements in the Pharmaceutical Industry under US Antitrust and EU Competition Law.

Book

xxxi, 479 pages ; 25 cm.

9789403501130

Patent Settlements in the Pharmaceutical Industry under US Antitrust and EU Competition Law examines patent settlements between originators and generic pharmaceutical manufacturers under United States (US) antitrust and European Union (EU) competition law. The major focus is on patent settlements involving reverse payments, commonly known as “pay-for-delay” settlements. Reverse payment settlements or “pay-for-delay agreements” create heated debates regarding the balance between competition and intellectual property law. These settlements touch upon sensitive issues such as timely generic entry and access to affordable pharmaceuticals on the one hand and the need to preserve innovation incentives for originators and to strengthen the pipeline of life-saving pharmaceuticals on the other hand. This book is one of the first to analyse critically and comparatively how such patent settlements and various other strategies employed by the pharmaceutical industry are scrutinised by US and European courts as well as enforcement authorities, focusing on the applicable legal tests and the main criteria used by courts and enforcement authorities when applying antitrust scrutiny.

Includes bibliographical references (pages 391-425) and index.

[Alphen aan den Rijn, Netherlands] : Kluwer Law International, 2018.

Anglais