Synthesizing Law for Synthetic Biology
37 Pages Posted: 25 Jun 2010
In his Nobel Prize acceptance speech more than half a century ago, Edward L. Tatum suggested an ambitious new goal for biology: "not only to avoid structural and metabolic errors in the developing organism, but also to produce better organisms." Synthetic biology aims to effect such a paradigm shift in the biological sciences by marrying approaches from engineering and computer science to an expanding array of standardized biological parts and sophisticated biological methods. By importing engineering principles, such as standardization, decoupling, and abstraction, into the biological sciences, synthetic biology may transform biology into a field in which it is routine to design and construct genes, gene combinations, genomes, proteins, metabolic pathways, cells, viruses, and whole organisms rapidly, inexpensively, and easily. Already, a number of institutions have helped synthetic biology achieve considerable success, both in terms of science and public awareness. The BioBricks Foundation (BBF) and the Registry of Standard Biological Parts have successfully built a collection of thousands of standard DNA parts (BioBricks), which can be combined in a manner analogous to Lego® bricks, or even modified into new BioBricks, and the International Genetically Modified Machine (iGEM) competition has attracted participation from thousands of contestants and hundreds of teams from dozens of countries. While the ethos of openness that pervades synthetic biology promises a democratization of biology, significant challenges to its openness still exist. The proprietary restrictions imposed by “closed” intellectual property - chiefly patents - create legal risk and uncertainty. Ironically, synthetic DNA sequences are likely more easily patentable and copyrightable than are DNA sequences derived from natural sources, thus creating the possibility that synthetic biology may increase, rather than decrease, the potential for intellectual property restrictions. Furthermore, concerns about bioethics, biosafety, and biosecurity may be exacerbated by democratized and open innovation of, and access to, the products and methods of synthetic biology. To this end, the BBF has developed a licensing framework, the BioBrick Agreement, that might govern legal relationships between the BBF, BioBricks contributors, and BioBricks users. An agreement like the BioBrick Agreement has the potential to be more than a mere license. In fact, like a constitution, it could help define some of the foundational values and principles that synthetic biology might espouse to ensure that its societal contributions prove beneficial to a degree commensurate with its scientific potential.
Keywords: synthetic biology, biological engineering, gene, DNA, patent, copyright, intellectual property, trademark, gene patent, gene copyright, gene trademark, biotechnology, genetic engineering, bioethics, biosafety, biosecurity, open source biology, biobrick, user innovation, open innovation
JEL Classification: I10,I12,I18,K10,K11,K19,K20,K21,K23,K29,K30,K32,K39,L12,L41,L43,L65,O14,O30,O31,O32,O33,O34,O38,O39
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