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Regulation of Synthetic Biology

BioBricks, Biopunks and Bioentrepreneurs

Alison McLennan

This book explores the interplay between regulation and emerging technologies in the context of synthetic biology, a developing field that promises great benefits, and has already yielded fuels and medicines made with designer micro-organisms. For all its promise, however, it also poses various risks. Investigating the distinctiveness of synthetic biology and the regulatory issues that arise, Alison McLennan questions whether synthetic biology can be regulated within existing structures or whether new mechanisms are needed.
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Chapter 8: How will patents affect synthetic biology?

Alison McLennan


Chapter 8 investigates the interaction between patent law and synthetic biology, in the context of longstanding debate over patenting and the life sciences. It evaluates the likelihood of patents having an unintended negative impact on synthetic biology innovation. It also explores the application of case law on patentable subject matter, including the Myriad cases. This case law is unlikely to preclude patenting of various tools and processes within synthetic biology. Chapter 8 further argues that promoting synthetic biology innovation requires regulation to be directed to encouraging sharing and open access within synthetic biology research, and promoting patent quality. The chapter explores the patent examining practices of the United States Patent and Trademark Office in relation to several families of patent applications filed by scientists of the J Craig Venter Institute. The case study shows that patent law principles and examining practices have worked well in relation to these applications.

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