Abstract

Since the completion of the Human Genome Project, biologists have shifted their efforts from understanding biology to modifying it. Synthetic biology is a rapidly growing interdisciplinary field that includes developing and manufacturing synthetic nucleotide sequences, systems, genomes, and medical devices. Gaining patent protection represents an imperative and significant tool for business development in synthetic biology. Without IP protection, investors most likely will not commit necessary resources for progress. While there have been many important breakthroughs in biotechnology, recent case law rulings and legislative statutes have created obstacles for inventors to gain patent protection of novel synthetic biology inventions. These issues cause hesitation in license agreements and postpone creation of synthetic biology start-up companies. Nevertheless, inventors still can gain patent protection in many branches of synthetic biology. This chapter examines the issues, controversies, and problems associated with patent protection in synthetic biology. It then gives solutions, recommendations, and future directions for the field.

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