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Research Handbook on Intellectual Property and the Life Sciences
Intellectual property (IP) is a key component of the life sciences, one of the most dynamic and innovative fields of technology today. At the same time, the relationship between IP and the life sciences raises new public policy dilemmas. The Research Handbook on Intellectual Property and the Life Sciences comprises contributions by leading experts from academia and industry to provide in-depth analyses of key topics including pharmaceuticals, diagnostics and genes, plant innovations, stem cells, the role of competition law and access to medicines. The Research Handbook focuses on the relationship between IP and the life sciences in Europe and the United States, complemented by country-specific case studies on Australia, Brazil, China, India, Japan, Kenya, South Africa and Thailand to provide a truly international perspective.
More Information
Critical Acclaim
Contributors
Contents
More Information
Intellectual property (IP) is a key component of the life sciences, which is becoming one of the most dynamic and innovative fields of technology today. At the same time, the relationship between IP and the life sciences is raising new public policy dilemmas. The Research Handbook on Intellectual Property and the Life Sciences comprises contributions by leading experts from academia and industry that confront current debates and controversies at the intersection of IP and the life sciences through in-depth analyses of key topics including pharmaceuticals, diagnostics and genes, plant innovations, stem cells, the role of competition law and access to medicines.
The first section of this book highlights the importance of IP for medicines and pharmaceuticals, discussing topics including gene patents, and the second section deals with agricultural sector issues such as plant innovations. The third section of the book covers areas of research and development in the life sciences, such as stem cell research, and raises questions about incorporating ethical considerations into patent law. While the primary focus of the book is on Europe and the United States, the fourth section includes country-specific case studies on Australia, Brazil, China, India, Japan, Kenya, South Africa and Thailand to provide a truly international perspective.
This Research Handbook is written in an accessible style that will appeal to intellectual property law scholars, practitioners and experts in the life sciences who are interested in the legal implications of IP for the life sciences.
The first section of this book highlights the importance of IP for medicines and pharmaceuticals, discussing topics including gene patents, and the second section deals with agricultural sector issues such as plant innovations. The third section of the book covers areas of research and development in the life sciences, such as stem cell research, and raises questions about incorporating ethical considerations into patent law. While the primary focus of the book is on Europe and the United States, the fourth section includes country-specific case studies on Australia, Brazil, China, India, Japan, Kenya, South Africa and Thailand to provide a truly international perspective.
This Research Handbook is written in an accessible style that will appeal to intellectual property law scholars, practitioners and experts in the life sciences who are interested in the legal implications of IP for the life sciences.
Critical Acclaim
‘In this topical and accessible book Duncan Matthews and Herbert Zech have brought together scholarly work of the highest quality, written by leading experts in the field. Each chapter addresses current issues at the interface of intellectual property and the life sciences in a detailed and comprehensive manner. It is a cogent and thorough volume, written with great clarity and compiled deftly. The book is highly recommended to academic scholars and practitioners alike.’
– Maximilian Haedicke, University of Freiburg, Germany
‘This exciting volume offers fresh perspectives on the role of IP in areas of high importance, including traditional pharmaceutical industries, biologic drugs and biotechnology, and agriculture. The book also features analyses of IP in national and regional approaches to research and development, and fresh case studies of country experiences. With the participation of authors from a wide range of countries, the volume provides new insights on the law and politics of IP in the life sciences with a truly global perspective. This book will serve as a valuable reference for scholars, students, and practioners.’
– Ken Shadlen, London School of Economics and Political Science
– Maximilian Haedicke, University of Freiburg, Germany
‘This exciting volume offers fresh perspectives on the role of IP in areas of high importance, including traditional pharmaceutical industries, biologic drugs and biotechnology, and agriculture. The book also features analyses of IP in national and regional approaches to research and development, and fresh case studies of country experiences. With the participation of authors from a wide range of countries, the volume provides new insights on the law and politics of IP in the life sciences with a truly global perspective. This book will serve as a valuable reference for scholars, students, and practioners.’
– Ken Shadlen, London School of Economics and Political Science
Contributors
Contributors: J. Allred, T. Avafia, C. Chiarolla, D.B. Degen, J.M. Golden, M. Graf, J. Harrington, A. Heinemann, M.D. Janis, M.A. Kock, X. Lin, C.R. McManis, A. Metzger, T. Minssen, C. Mund, P. Paranaguá, A. Plomer, S. Ragavan, M. Rimmer, C. Seitz, T. Takenaka, G. Van Overwalle, D. Wächter, G. Würtenberger, Z. Xinfeng, B. Yagi, B. Yao
Contents
Contents:
Preface
Part I - Medicine and Pharmaceutics
1. Patenting Biosimilars
Claudia Mund
2. Patenting Diagnostics
Dieter Wächter
3. Patenting Human Genes in Europe- And how it compares to the US and Australia
Timo Minssen
4. Patenting Human Genes in the United States
Samantak Gosh
5. An Exorbitant Monopoly: The High Court of Australia, Myriad Genetics, and Gene Patents
Matthew Rimmer
6. Exclusivity for Biologics
Duncan Matthews
Part II - Agricultural Sector (Crop Sciences)
7. Protection of Plant Innovations
Gert Würtenberger
8. Patenting Non Transgenic Plants in the EU
Michael A. Kock
9. Non-Obvious Plants
Mark D. Janis
10. Transgenic Plants
James Allred
11. Convention on Biological Diversity and Regulatory Law as Plant Protection
Claudio Chiarolla
12. Patents on Native Traits: What Scope of Protection?
Axel Metzger
Part III - Research and Development
13. The European Union’s IP Policy and Funding of Stem Cell Research
Aurora Plomer
14. Stem Cell Patents in the United States
John M. Golden
15. Early Stage Patenting, the US Bayh-Dole Act, and the Anti-Commons Hypothesis
Charles R. McManis and Brian Yagi
16. IP in Research and Development Agreements
Melanie Graf and Herbert Zech
17. Patent pools and clearinghouses in the life sciences: back to the future
Geertrui Van Overwalle
Part IV - Country Case Studies in IP and the Life Sciences
18. Understanding the Brazilian Patent Reform
Pedro Paranaguá
19. IP protection in the life sciences in China
Lin Xiuqin and Zhang Xinfeng
20. Diverse Harmonization: Indian Example
Srividhya Ragavan
21. Life Science Research and Patents in Japan: A Comparative Study of Life Science Invention Patentability between the Japanese and US Patent Acts
Toshiko Takenaka
22. Intellectual Property and the Life Sciences in Kenya: Enforcement and Access to Medicines
John Harrington
23. IP and Life Sciences: A Case Study of South Africa
Tenu Avafia
24. Thailand’s Compulsory Licenses and the Increase of Investment Arbitration
David B. Degen
Part V - Boundaries of IP and the Life Sciences
25. Parallel Imports within the European Union
Gert Würtenberger
26. Pay for Delay Agreements
Claudia Seitz
27. Abusive Filing of IP Rights
Andreas Heinemann
Index
Preface
Part I - Medicine and Pharmaceutics
1. Patenting Biosimilars
Claudia Mund
2. Patenting Diagnostics
Dieter Wächter
3. Patenting Human Genes in Europe- And how it compares to the US and Australia
Timo Minssen
4. Patenting Human Genes in the United States
Samantak Gosh
5. An Exorbitant Monopoly: The High Court of Australia, Myriad Genetics, and Gene Patents
Matthew Rimmer
6. Exclusivity for Biologics
Duncan Matthews
Part II - Agricultural Sector (Crop Sciences)
7. Protection of Plant Innovations
Gert Würtenberger
8. Patenting Non Transgenic Plants in the EU
Michael A. Kock
9. Non-Obvious Plants
Mark D. Janis
10. Transgenic Plants
James Allred
11. Convention on Biological Diversity and Regulatory Law as Plant Protection
Claudio Chiarolla
12. Patents on Native Traits: What Scope of Protection?
Axel Metzger
Part III - Research and Development
13. The European Union’s IP Policy and Funding of Stem Cell Research
Aurora Plomer
14. Stem Cell Patents in the United States
John M. Golden
15. Early Stage Patenting, the US Bayh-Dole Act, and the Anti-Commons Hypothesis
Charles R. McManis and Brian Yagi
16. IP in Research and Development Agreements
Melanie Graf and Herbert Zech
17. Patent pools and clearinghouses in the life sciences: back to the future
Geertrui Van Overwalle
Part IV - Country Case Studies in IP and the Life Sciences
18. Understanding the Brazilian Patent Reform
Pedro Paranaguá
19. IP protection in the life sciences in China
Lin Xiuqin and Zhang Xinfeng
20. Diverse Harmonization: Indian Example
Srividhya Ragavan
21. Life Science Research and Patents in Japan: A Comparative Study of Life Science Invention Patentability between the Japanese and US Patent Acts
Toshiko Takenaka
22. Intellectual Property and the Life Sciences in Kenya: Enforcement and Access to Medicines
John Harrington
23. IP and Life Sciences: A Case Study of South Africa
Tenu Avafia
24. Thailand’s Compulsory Licenses and the Increase of Investment Arbitration
David B. Degen
Part V - Boundaries of IP and the Life Sciences
25. Parallel Imports within the European Union
Gert Würtenberger
26. Pay for Delay Agreements
Claudia Seitz
27. Abusive Filing of IP Rights
Andreas Heinemann
Index
