© 2015

Biotechnology and Intellectual Property Rights

Legal and Social Implications


About this book


This book offers a valuable contribution to contemporary legal literature, providing deep insights into the interface between law and genetics, highlighting emerging issues and providing meaningful solutions to current problems. It will be of interest to a broad readership, including academics, lawyers, policy makers and scholars engaged in interdisciplinary research.
In the context of examining and analyzing the legal and social implications arising from the recent conjunction of biotechnology and intellectual property rights, the book particularly focuses on human genes and gene variations. Emphasis is placed on “patent law,” as a considerable percentage of genetic inventions are covered by patents. The book presents a comparative and critical examination of patent laws and practices related to biotechnology patents in the United States, Canada, European Union and India, in order to gather the common issues and the differences between them. The international patent approach regarding biotechnology is also analyzed in light of the constant conflict between differentiation and harmonization of patent laws. The book highlights the potential gaps and uncertainties as to the scope of numerous terms such as invention, microorganisms, microbiological processes, and essential biological processes under TRIPS. Also analyzed are the social and policy implications of patents relating to genetic research tools and genetic testing. The intricacies involved in providing effective intellectual property protection to bioinformatics and genomic databases are also examined. Bearing in mind the collaborative nature of bioinformatics and genomic databases, the book evaluates the pros and cons of open biotechnology and assesses the implications of extending intellectual property rights to human genetic resources, before explaining the ownership puzzle concerning human genetic material used in genetic research.


Bioinformatics Biotechnology Human Genes Human Genetic Resource Intellectual Property Rights (Patents) Open Biotechnology

Authors and affiliations

  1. 1.Amity Law SchoolNoidaIndia

About the authors

Kshitij Kumar Singh is an Assistant Professor at the Amity Law School, Noida, India. He obtained his Ph.D. (Law) from the Banaras Hindu University Varanasi, India. During his doctoral study, he received the Canadian Commonwealth Scholarship Asia-Pacific 2010. The field of gene patenting and biotech law has been of special interest to him. Dr. Singh’s LL.M. dissertation is on the topic “Human Genome and Cloning: Legal and Human Rights Issues”; he has also published many articles on biotechnology law. He gained related experience as a research intern (2009) and a visiting research fellow (2010) under the Canadian Commonwealth Scholarship 2010 at the University of Western Ontario, London, Canada. During this period he examined laws governing or needing biotechnology developments in India and Canada. The term was instrumental in expanding his research interest to the international aspect of the laws governing genetic patents and biotech research.

Bibliographic information


“This comprehensive book provides a valuable reference for those seeking to learn the most recent developments in biotechnology patent law in the United States, European Union, Canada and India. … This book is highly recommended for researchers, practitioners and policy makers. Readers will find the flow and organization of the book accessible.” (Shubha Ghosh, Journal of Intellectual Property Law, Issue 2, February, 2017)