Competition Law and IP Rights in Pharmaceuticals and Biotechnology

Björn Lundqvist, Timo Minssen, and Justin Pierce

Detailed discussion of case law from the EU and EU Member States, EU legislation, and European Commission notices.
Evaluates EU competition and IP law policy with comparison to corresponding developments in US antitrust and IP law policy.
Timely and up-to-date coverage of emerging issues and recent developments, such as the Pharmaceutical Sector Inquiry and subsequent case law; the Technology Transfer Block Exemption and TT Guidelines; and private action under competition law.
Offers comparison with the ICT sector, where issues such as patent and FRAND ambush have become important.
Includes useful guidance on how to deal with competition issues that arise within the intellectual property framework, such as access to patents granted in Europe under Art. 102 TFEU and in the US under exemptions to intellectual property law.

Competition Law and IP Rights in Pharmaceuticals and Biotechnology

Björn Lundqvist, Timo Minssen, and Justin Pierce

Description

This book provides an analytical overview of the function and application of competition law and intellectual property (IP) law in the pharmaceutical and biotechnology sectors. It offers a general introduction to the foundations and principles of competition law and its interface with intellectual property law, as well as a brief scientific preface, and an overview of the competitive environment and innovation system in which the pharmaceutical industry operates. It presents and discusses practices and conduct that have been identified as allegedly anticompetitive, analysing them from the perspectives of both competition and intellectual property law. The book discusses the issues raised by the 2009 EU (European Union) Pharmaceutical Sector Inquiry in depth, with reference to the case law that has developed since the Inquiry was published. In particular, the book scrutinises the cases and investigations in the European Union and United States regarding 'pay-for-delay' and other settlement agreements, the misuse of the patent systems, the misuse of the courts, and the alleged misuse of the regulatory system by pharmaceutical companies. It considers co-marketing, co-promotion, and co-branding from an antitrust perspective. There is discussion of different patent strategies and whether they violate competition law or patent law. The book also covers the introduction of the unitary patent in Europe, the Unified Patent Court, and their implications for the utilization of competition law.

The book describes and explains developments relating to competition law and intellectual property law in the relevant sectors, putting them into context from both a theoretical and practical perspective. It addresses important competition law issues that arise where IP rights are acquired and utilised in Europe. It also contains useful guidance on how to deal with competition issues that arise within the intellectual property framework, and discusses when competition law is applicable and when exemption under intellectual property law may be applied.

This comprehensive and detailed analysis is invaluable to practitioners, researchers, and students alike.

Competition Law and IP Rights in Pharmaceuticals and Biotechnology

Björn Lundqvist, Timo Minssen, and Justin Pierce

Part I: The Pharma and Biotech Business, Framework and Limitations
1: The Context, Purpose and Limitation of the Book
2: The Pharma Industry and its Business Strategies
3: The Legal Framework, Concepts and Basic Principles and the Parallel Trade Regulation
Part II: The Function of Competition Law
4: Pharma Agreements under Article 101 TFEU
5: Dominance and Abuse
6: Pharma Sector-Specific Abusive Conduct
7: A short comparative analysis of the development under EU Competition law with the US development under the antitrust laws, i.e. Secs. 1 and 2 Sherman Act and Sec. 5 FTC Act.
Part III: Solutions and Reflections
8: Competition within IPRs the solution to the problems now addressed under Competition law? - The way forward: Future developments, emerging issues and conclusions

Competition Law and IP Rights in Pharmaceuticals and Biotechnology

Björn Lundqvist, Timo Minssen, and Justin Pierce

Author Information

Björn Lundqvist, Associate Professor of EU Competition Law, Copenhagen Business School, University of Copenhagen, Timo Minssen, Associate Professor of Intellectual Property & Innovation Law, Centre for Information and Innovation Law (CIIR), University of Copenhagen, and Justin Pierce, Doctoral Student, Department of Law, Lund University

Dr Björn Lundqvist is Associate Professor of EU Competition Law at Copenhagen Business School. He was Head of EU Competition Law at Roschier, Stockholm from 2009 to 2012. He is the author of 'Standardization under EU Competition Rules and US Antitrust Law' (Edward Elgar, 2014); Dr Timo Minssen is a Professor of Biotechnology Law at the University of Copenhagen. He has worked for a Life Science company and for law firms in Sweden and Germany. He has published a number of articles on comparative patent law and EU competition law, including his prize-winning monograph 'Assessing the Inventiveness of Bio-Pharmaceuticals under European and US Patent Law A comparative study with special emphasis on DNA- and protein-related inventions'.; Justin Pierce is a Postdoctoral Researcher at Lund University.