Gene systems and organisms constructed using synthetic biological techniques will have their origins in the human mind and imagination, and as such, will not be the products of nature. Though isolated and purified sequences are patentable, with recent controversies noted, they must satisfy the patentability criteria in addition to satisfying the usual statutory subject matter requirement. Should controversy over the patentability of isolated human genes persist, the value of synthetic genes to scientists will markedly rise. But even then there exist legal gaps, and with their more recently proposed solutions, the suggestion is to develop new legal constructs to adapt the law to newer modes of doing new things in biology. For instance, the implications for copyright’s threefold requirement of original authorship, of enabling expression in a fixed medium, and of the work being capable of reproduction (so far narrowly understood), make it an attractive intellectual property right to consider though there are others that might also apply as scientists develop more capable “biological software”. Trademarks and trade secrets are other potentially lucrative options that might be balanced by more open synthetic biology modes of production, which essentially take a non-proprietary approach to innovation in biotechnology. This presentation will include a discussion of syn-agriculture and of third-to-fourth-generation biofuels in order to help draw a map of the contours of the legal certainties, as well as to identify the perceived gaps and their current conceptual boundaries. It is hoped that evaluating the extent to which the proposed solutions address these uncertainties will help identify opportunities for the effective regulation and management of synthetic biology as a tool with the potential to improve food resources and energy production for the foreseeable bio-future.
37th Congress of IUPS (Birmingham, UK) (2013) Proc 37th IUPS, SA219
Research Symposium: Legal knowledge gaps and constructs in synthetic biology – a comparative review of the state of the art
D. Milius1,2
1. Department of Human Genetics, Faculty of Medicine, McGill University, Montreal, Quebec, Canada. 2. Department of Commercial Law, Faculty of Law, University of Cape Town, Cape Town, Western Cape, South Africa.
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Where applicable, experiments conform with Society ethical requirements.