Synthetic biology takes as its mission the construction, and "reconstruction," of life at the genetic level.1 The scale and ambition of synthetic biology efforts go well beyond traditional recombinant DNA technology. Rather than simply transferring a preexisting gene from one species to another, synthetic biologists aim to make biology a true engineering discipline.2 In the same way that electrical engineers rely on standard circuit components, or computer programmers rely on reusing modular blocks of code, synthetic biologists wish to create an array of standard, modular3 gene "switches" or "parts" that can be readily synthesized and mixed together in different combinations.4 The Massachusetts Institute of Technology (MIT) has a "Registry of Standard Biological Parts [that] supports this goal by recording and indexing biological parts that are currently being built and offering synthesis and assembly services to construct new parts, devices, and systems."5 Systems, devices, parts, and DNA represent descending levels of complexity - systems consist of devices, and devices consist of parts composed of DNA.6
The idea behind the Registry of Standard Biological Parts (Registry) is that these parts can, and should, be recombined in different ways to produce many different types of devices and systems.7 Although the Registry currently contains physical DNA, its developers believe that, as DNA synthesis technology becomes capable of generating ever-longer sequences, the Registry will be composed largely of information and specifications that can readily be fabricated in DNA synthesizers.8 The fabricated, DNA-based functions would then be "executed" in a cell.
Synthetic biology's long-term goals encompass such far-reaching possibilities as constructing an entirely artificial programmable genome from standard parts. Scientists in the closely allied field of synthetic chemistry are working on artificial RNA and proteins with added amino acids, presumably linked through an artificial genetic code.9 More immediately, synthetic biology "systems" - that is, organisms engineered with artificial metabolic pathways composed of a number of different standard parts - have produced important concrete results, including the possibility of unlimited supplies of previously expensive drugs for malaria.10 Proponents hope to use synthetic organisms for economical production of not only medically relevant chemicals but also a large variety of industrial materials.11 The possibility of lowcost production of "green" fuels such as cellulosic ethanol has particularly caught the attention of prominent venture capitalists.12 Even more apparently whimsical applications, such as programming bacteria to take photographs13 or to form visible patterns14 may be useful for detection of environmental pollutants. Similarly, programming cells to implement digital logic could have large numbers of medical and computational applications.15
At the same time, synthetic biology has engendered numerous policy concerns. From its inception, commentators have raised issues ranging from bioethical and environmental worries to fears of bioterrorism. The successful in vitro creation of a complete polio virus genome "using mail-order segments of DNA and a viral genome map that is freely available on the Internet" provided a focal point for these concerns.16 The worry has been sufficiently great that the synthetic biology community recently released a declaration publicly committing itself to improving the software that checks DNA synthesis orders for sequences encoding hazardous biological systems.17
There is, however, one area that has been largely unexplored by legal scholars until this point - the relationship of synthetic biology to intellectual property law. Nonetheless, scientists working in this area are sufficiently concerned about the possible impact of intellectual property that they are actively thinking about the applicability of "open source"-type strategies to parts and devices. …