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Governing Intellectual Property Rights Within Publicly Funded Biobanks

Governing Intellectual Property Rights Within Publicly Funded Biobanks

Author: R. Neethu
Publisher: Kluwer Law International
ISBN: 9789403506210
Published In: June 2019
Format: Hardback
Jurisdiction: International ? Disclaimer:
Countri(es) stated herein are used as reference only

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Description
Contents

Details
Governing Intellectual Property Rights Within Publicly Funded Biobanks addresses the implications that intellectual property rights (IPRs) have in the context of biobanks and how they need to be addressed in the governance of biobank-based research. The boom in biobanks and health databases as research infrastructures have evoked various legal and ethical debates. Since then numerous new developments have emerged such as digitalization, big-data research, and artificial intelligence that have important implications for biobank-based research and collaborations. This paradigm offers new legal challenges for commercial involvement, particularly within a publicly funded setting. In this innovative book, the author shows that securing maximum social benefit out of the knowledge emanating from the use of biobank resources lies in managing IP inputs and outputs effectively in keeping with the values that are core to such research.

What’s in this book:

Focusing on the challenges of involving IPRs particularly in the precompetitive phase of biobank-based research, this book offers an extensive understanding of the role of different IPRs and identifies the gaps in the law and its implications for biobanks. The analysis covers important aspects in relation to biobanks such as:
- digital integration and biomedical data storage;
- ownership of biological samples;
- commercialization and benefit sharing;
- partnership models;
- public sector research;
- disposition of samples;
- consent;
- cross-border exchange;
- trade secrecy;
- privacy;
- regulatory stewardship;
- business strategies;
- ethical considerations over biological resources;
- patenting of inventions relating to personalized medicine;
- ethical parameters within patent law; and
- rights regarding genetic data and databases.
This book includes observations, case studies and interviews conducted by the author. In conclusion, the author offers cogent recommendations for legal interoperability of IP rules and research practices designed to enhance the ability of biobanks to share, access and reuse data.

How this will help you:

This book is the first of its kind to explore the organizational and legislative choices for biobanks particularly while engaging in the protection of research results and technology transfer within a publicly funded setting. It will be of substantial interest to all stakeholders in biobanking, especially policymakers, biobankers and researchers working in the field of health law as well as for legal practitioners, academics and patient interest groups providing insight on how IPRs pose challenges as well as offer the potential for genomic research particularly in the light of big-data-based research.
About the Author

Foreword

Preface

List of Abbreviations

PART I
Definition, Principles and Evolving Models of Governance for Biobanks

CHAPTER 1
The Definition of Biobanks: Finding the Focal Points

CHAPTER 2
Evolving Governance and Structural Frameworks for Biobanks: Regulation, Guidelines and Policy

PART II
Translation Research, Patents and Technology Transfer

CHAPTER 3
Uncertain Legal Status for Use of Biological Materials in Pre-patent Research

PART III
Genetic Databases, Data and Digitalization

CHAPTER 4
Regulating Human Genetic Databases in Europe

CHAPTER 5
Copyrights Within Genetic Database and Biobanks

CHAPTER 6
Protection of ‘Genetic Data’: Trade Secrets Law and Public Research

PART IV
Commercial Collaboration in Biobanks, Guidelines, Practices and Good Governance

CHAPTER 7
Contractual Agreements and IP Policies of Biobanks

CHAPTER 8
Consequences of Involving IPR Within Biobanks

PART V
Conclusion and Way Forward

CHAPTER 9
End of Biobanks and the Role of IPR: From Resources in Common to Utilization for Common

Annex I

Bibliography

Table of Cases

Index