Showing papers by "Andrew W. Torrance published in 2010"

Synthesizing Law for Synthetic Biology

Abstract: 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.

Synthesizing Law for Synthetic Biology

Abstract: In his influential 2005 article Foundations for Engineering Biology, Drew Endy, a professor in the Department of Bioengineering at Stanford University and “one of synthetic biology’s foremost visionaries,”1 described the considerable promise and limitations of synthetic biology.2 On the optimistic side of the ledger, it had already “been used to manipulate information, construct materials, process chemicals, produce energy, provide food, and help maintain or enhance human health and our environment.”3 However, he also lamented that “our ability to quickly and reliably engineer biological systems that behave as expected remains quite limited.”4 In the ensuing five years, synthetic biology has begun to realize its scientific potential and has reached the public consciousness. In November 2010, the seventh annual International Genetically Engineered Machine (iGEM) competition will be

Patent Law, HIPPO, and the Biodiversity Crisis

Abstract: Planet earth is host to a dazzling variety of living organisms. This diversity of life, or – biodiversity, is vital to the survival and prosperity of humanity, supplying such vital amenities as food, clothing, shelter, natural biochemicals useful in medicine, industry, and agriculture, and even irreplaceable ecosystem services, such as clean air and water. Despite the prodigious amount of biodiversity on earth, human activities have been depleting it at an accelerating rate that has now reached the level of a mass extinction event. The five greatest threats to biodiversity can be summarized by the – HIPPO acronym: (1) Habitat loss, (2) Invasives, (3) Pollution, (4) Population, and (5) Overexploitation. Together, these five factors describe the phenomena largely responsible for the current mass extinction event, and patent law offers valuable assistance in combating each one. Though it cannot offer a complete solution to the biodiversity crisis, the patent system can offer powerful tools to help save biodiversity. On first inspection, patent law might appear an unlikely ally for conserving biodiversity for at least two reasons. First, beyond bioprospecting, patents would seem only tangentially relevant to biodiversity loss. Second, as a tool for promoting economic growth, the patent system might be viewed as contributing to biodiversity loss by those who assume that economic growth and environmental protection are mutually antithetical. However, patents can indeed benefit biodiversity. This article illustrates how patents can combat each of the major threats to biodiversity that constitute the HIPPO acronym. By creating an extinction bar to patentability, patents create incentives for bioprospectors, biopharmaceutical firms, and countries that host abundant biodiversity to prevent habitat destruction. Sovereign immunity provides the federal and state governments with the right to make use of patented inventions useful for countering invasives. Existing compulsory licensing schemes provide models for how patented pollution abatement technologies could be widely disseminated to combat pollution. The incentives created by the patent system can help to create more efficient new technologies capable of counteracting the damage inflicted on biodiversity by human population growth. Finally, the patent system has already proved itself adept at spurring the creation of ingenious inventions capable of alleviating overexploitation of biodiversity. Though far from a panacea, the patent system does have important roles to play in ameliorating the biodiversity crisis.

Gene Concepts, Gene Talk, and Gene Patents

Abstract: Since the existence of a discrete unit of heredity was first proposed by Gregor Mendel, scientific concepts of the “gene” have undergone rapid evolution. Beyond obvious epistemic and operational importance to the scientific community, changing gene concepts have exerted strong effects on institutions such as medicine, the biotechnology industry, politics, and the law. A particularly rich example of this is the interplay between gene concepts and patent law. Over the last century, biology has elaborated gene concepts that variously emphasized genes as discretely material, genes as information, and genes as extremely complex. By contrast, patent law has steadily adhered to a simpler, more stable concept of the gene since the advent of gene patents in the late 1970s. In fact, while the biology community has increasingly engaged in vigorous internal debate regarding the gene’s complexity and uncertainty, it has tended simultaneously to emphasize the simplicity and certainty of the gene to constituencies outside the biology community, most notably the United States Patent and Trademark Office (USPTO) and the Federal courts. Rather than allow gene concepts to become contested by constituencies outside biology, the biology community appears to have used its authority to maintain a portrayal of the gene that facilitates the appropriation of rents from genes through the patent system. This use of “gene talk” has undergirded the growth of biotechnology into a powerful industry that has economically rewarded investors, academic institutions, and biologists. Not only may gene talk have facilitated the patenting of genes, but the prominence of gene patents describing a relatively simpler gene concept may have fed back into biological science to promote a simpler, and more patentable, concept of the gene even among members of the biology community.

Gene Concepts, Gene Talk, and Gene Patents

Abstract: Since the existence of a discrete unit of heredity was first proposed by Gregor Mendel, scientific concepts of the “gene” have undergone rapid evolution. Beyond obvious epistemic and operational importance to the scientific community, changing gene concepts have exerted strong effects on institutions such as medicine, the biotechnology industry, politics, and the law. A particularly rich example of this is the interplay between gene concepts and patent law. Over the last century, biology has elaborated gene concepts that variously emphasized genes as discretely material, genes as information, and genes as extremely complex. By contrast, patent law has steadily adhered to a simpler, more stable concept of the gene since the advent of gene patents in the late 1970s. In fact, while the biology community has increasingly engaged in vigorous internal debate regarding the gene’s complexity and uncertainty, it has tended simultaneously to emphasize the simplicity and certainty of the gene to constituencies outside the biology community, most notably the United States Patent and Trademark Office (USPTO) and the Federal courts. Rather than allow gene concepts to become contested by constituencies outside biology, the biology community appears to have used its authority to maintain a portrayal of the gene that facilitates the appropriation of rents from genes through the patent system. This use of “gene talk” has undergirded the growth of biotechnology into a powerful industry that has economically rewarded investors, academic institutions, and biologists. Not only may gene talk have facilitated the patenting of genes, but the prominence of gene patents describing a relatively simpler gene concept may have fed back into biological science to promote a simpler, and more patentable, concept of the gene even among members of the biology community.

Family Law and the Genomic Revolution

Abstract: The Genomic Revolution, gene patent law, and genetic alternation will have profound effects on the family and family law. Increasingly, the possibility exists of precisely genotyping offspring (or even gametes). The effects of this may be benign or they may be destructively negative. Either way, this technology has already begun to arrive, thereby stirring controversy. The availability or unavailability of human gene patents (and related patents, such as those claiming methods of medical diagnosis or treatment) could help determine whether the rate of genetic discovery and development increases or decreases. Finally, the potential to “repair,” or even enhance, the genetic complement of human beings at early stages of their lives could lead to parents hoping to cure their children or to a runaway genomic arms races wherein parents attempt to provide their children with affirmative advantages over their peers. Rapid advances in genetic technologies, such as the $1000 genome, gene diagnostic tests, personalized genomics, and gene therapy, coupled with the flux in the law of gene patents (and patents on related inventions), will ensure the substantial transformation of the legal milieu in which parents make reproductive choices. Family law will be transformed.