KEY ISSUES: Synthetic biology

Synthetic biology - also referred to by the media as "extreme engineering," "biotechnology on steroids," "artificial life industry," and "original syn" - represents a shift from seeking to understand biological systems to actually new ones. Much of the effort in the field is currently aimed at developing eco-friendly bio-fuels, bio-medical innovations, and computing technologies. These efforts, however, are geared toward giving rise to new organisms that, in turn, give rise to numerous ethical, legal, and social concerns, including the difficulty and hubris inherent in assessing the "value" of different life forms, questions related to intellectual property rights, and distributive justice. In addition, synthetic biology presents two unique and very significant implications - "bioterror" and "bioerror" (i.e., the accidental release or escape of synthetic organisms into the environment).

Bioterrorism is a palpable risk because: (1) synthetic biology deals with creating and redesigning viruses and bacteria; (2) synthesis of such organisms is inexpensive; and (3) the necessary inputs can be easily obtained. These factors are exacerbated by the fact that some argue for the "open sourcing" of synthetic biology developments, meaning that instructions for creating synthetics would be available via the Internet. Thus, the potential for synthetic biology-enabled bioterrorism is substantial - despite the fact that the Centers for Disease Control and Prevention has identified and regulated production of 80 "select agents," and the guidelines set forth in a variety of conventions, including the 1993 Chemical Weapons Convention, the 1972 Biological and Toxin Weapons Convention, and the 1925 Geneva Protocol, ban the manufacture, storage, and use of microbes for hostile purposes.

In addition to bioterrorism, synthetic biology poses a bioerror threat because the manufactured microorganisms could "escape" into the natural environment. Because scientists do not yet understand how to synthesize organisms with predictable replication and mutation properties, not only is the individual behavior of an escaped organism difficult to forecast, its effect on the natural world is also equally impossible to foretell.

Intellectual property rights are an issue whose specter is felt in many areas of emerging technology, and synthetic biology is not exempt. The 1980 landmark U.S. Supreme Court decision in Diamond v. Chakrabarty¹ has led to the granting of patent rights over biological materials and organisms, and under the patenting protocols that have emerged since Chakrabarty, patent protections would be afforded to many of synthetic biology's basic genetic pathways and building blocks. Furthermore, the current trend of overly broad patents, covering both the basic building blocks of biological life and synthetic systems responsible for creating that life, run the risk of creating monopolies in the industry and giving rise to "patent thickets."²

¹Diamond v. Chakrabarty, 447 U.S. 303 (1980).
² Patent thickets refer to the fact that overly broad patents tend to overlap with one another, and, as a result, an innovator must pay several sources for use of the same material or information, ultimately draining monetary resources and slowing development.

Finally, from a global economics perspective, synthetic biology could alter global trade and production patterns, as well. While production of synthetic biology-created alternatives could decrease overall cost and increase efficiency in various sectors, it could also eliminate the livelihoods of people in developing countries. Synthetics may come to represent the future for production and trade of many basic commodities, including rubber, drugs, and ethanol, thereby dictating global trade leadership based on access to, and implementation of, this new technology, furthering the economic gap between advanced and developing countries.