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RESEARCH PRODUCT

Responsibility and intellectual property in synthetic biology: A proposal for using Responsible Research and Innovation as a basic framework for intellectual property decisions in synthetic biology

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Synthetic biology (SynBio) is an engineering view of biotechnology that has the potential to increase the number and industrial utility of biotechnological applications by implementing engineering principles such as standardization and modularity. The boundaries between SynBio, biotechnology, and metabolic engineering are not always clear, but assessing SynBio in a wider sense—that of modeling‐based biotechnology and/or “sophisticated” metabolic engineering—we find that a significant number of applications and research articles have been generated in the past few years [1]. One of the best‐known examples is that of a synthetic pathway for producing artemisinic acid, a precursor to the antimalarial drug artemisinin, which has been engineered in yeast to produce commercially relevant concentrations of artemisinic acid. This impressive accomplishment can be easily adapted for the development of biofuels, biomaterials, new drugs, or fine chemicals [1]. > The concept of RRI has gained increasing relevance for policy in the EU and has become a cross‐cutting leitmotiv in the Horizon 2020 strategy Two of the authors of this essay (PD and MP) attended the so‐called Giant Jamboree of the international Genetically Engineered Machine (iGEM) competition in Boston, as members of the Valencia Biocampus team, and presented a project, supported by the EU‐funded SYNENERGENE initiative (http://www.synenergene.eu), on Intellectual Property (IP) in SynBio (http://2014.igem.org/Team:Valencia_Biocampus/). The project included an attempt to develop a common language for practitioners, from lawyers to scientists and engineers. Moreover, the team developed an attempt to quantify IP issues by including a “patentability index” (PI), with values ranging from 0 to 10 based on parameters including novelty, inventive step, and industrial application. An additional parameter, “responsibility” (R), was introduced in such a way that the PI can only be greater than zero when R is not zero. In other words, lack of “responsibility” could lead an otherwise‐patentable SynBio invention to fail the …