Intellectual Property Protection for Synthetic Biology, Including Bioinformatics and Computational Intelligence

Intellectual Property Protection for Synthetic Biology, Including Bioinformatics and Computational Intelligence

Matthew K. Knabel (Fernandez & Associates, LLP, USA), Katherine Doering (Fernandez & Associates, LLP, USA & JD Candidate, University of Nebraska, USA) and Dennis S. Fernandez (Fernandez & Associates, LLP, USA)
Copyright: © 2015 |Pages: 12
DOI: 10.4018/978-1-4666-6611-5.ch016


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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Synthetic biology is a unique way to study life that combines the arts of life science, engineering, and computer science to promote human health and preserve the environment. Since the completion of the Human Genome Project in 2001, the scientific field has learned the function of many gene products. These advances have led to assembly of biological parts, such as DNA, plasmids, promoters, and translational units, into registries. Most notably, the International Genetically Engineered Machine (iGEM) Foundation ( For a period of 20 years (depending on the type of patent), an inventor and/or assignee has a monopoly over making, using, licensing, or selling the invented property in exchange for full disclosure of the invention. This process promotes economic growth and progress by disclosing knowledge to both individuals skilled in that particular field and laypersons who are interested in the process or invention. Patent protection in synthetic biology has increased rapidly in the past 25 years. In 1990, only 13 patents associated with technologies in synthetic biology were filed. Since then, there has been a 600% increase worldwide in the number of filed patents (van Doren, 2013). Activity in the United States is the most dynamic, as the number of patents filed has increased by over 400%.

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