A synopsis

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• By reimagining biology from the perspective of engineers, computer programmers, and hackers, synthetic biologists hope to move beyond the strictures imposed on genes,cells, and organisms by eons of evolution by natural selection.

• Within five years of the first deliberate recombination of DNA, ambition for the field had vaulted towards the new era of ‘synthetic biology’ where not only existing genes are described and analyzed but also new gene arrangements can be constructed and evaluated. Synthetic biology has since moved well beyond this early conception of the field as one of rearranging genes. Now the field envisions not just the redesign of existing organisms, but even the de novo design and “programming” of genes and organisms.

• The metaphor most congruent to the goals of synthetic biology is the gene as algorithm. In this conception of the gene, DNA encodes a set of instructions for carrying out functions via biochemistry just as a computer program encodes a set of instructions for carrying out functions via electricity.

• French geneticists François Jacob and Jacques Monod established that some genes encode biochemical products that,in turn, regulate the expression of other genes. They proposed that “the genome contains not only a series of blue-prints, but a co-ordinated program of protein synthesis and the means of controlling its execution.”

• One approach synthetic biology takes to ensure programmability is the deliberate reengineering of biological parts and systems to make them structurally simplified and functionally predictable.

• Nevertheless, as important as this engineering science approach may be, the ethos of open science, and a concomitant distaste for intellectual property, represents what may be an even more significant influence in the development of synthetic biology.

PROPRIETARY SYNTHETIC BIOLOGY:

Synthetic biology promises to challenge fields beyond science and technology. It is sure to unsettle notions of how the intellectual property laws should apply to biotechnological inventions. Three ways in which synthetic biology may force change to legal doctrine are discussed below. First, human designed DNA sequences, systems, cells, and organisms may avoid criticisms about patents claiming “products of nature.” Second, synthetic DNA sequences may qualify for copyright protection as “original works of authorship fixed in a tangible medium of expression.” Third, synthetic biology may create new routes to trademark protection of its resulting products and services by enabling the routine inclusion in DNA sequences (or other engineered biological structures) of distinctive motifs capable of serving as legally effective indications of source.

• After the Diamond v. Chakrabarty decision in 1980,patent applications and issued patents claiming DNA sequences increased rapidly.Today, patenting DNA sequences is routine. The USPTO Utility Examination Guidelines state that “ a patent on a gene covers the isolated and purified gene but does not cover the gene as it occurs in nature.” The phrase “[‘isolated DNA’] or a similar term (e.g., ‘modified DNA’ or ‘purified DNA’) is widely used to distinguish the claimed DNA from its naturally occurring counterpart, i.e., genomic DNA encoding [the same polypeptide].”Such claims are “unquestionably patentable over the corresponding products of nature,” although they must also satisfy criteria of patentability other than being statutory patentable subject matter. Despite the longstanding Parke-Davis ruling, some have argued that DNA sequences should not constitute patentable subject matter because they are derived from natural (“genomic”) DNA sequences.Synthetic biology allows these concerns to be avoided entirely. Genes constructed using synthetic biological techniques will have their origins in human imagination and will, thus, not be products of nature. Even if the courts were to accede to the wishes of those opposing the patent eligibility of genes isolated from natural genomic sources, synthetic genes would remain patentable subject due to their non-natural origins. In fact, opposition to gene patents as products of nature would incentivize preferential investment in research, development, and patenting of synthetic genes.

• Recent tumult regarding the patentability of isolated human genes is likely to raise the prospective value of synthetic genes. On May 12, 2009, the American Civil Liberties Union (ACLU) filed a lawsuit to challenge the eligibility of human genes for patent protection.As the complaint stated, Every person’s body contains human genes, passed down to each individual from his or her parents. These genes determine, in part, the structure and function of every human body. This case challenges the legality and constitutionality of granting patents over this most basic element of every person’s individuality.

• However, synthetic biology can involve the design and construction of new, human designed DNA sequences. Here the synthetic biologist designs the particular DNA sequence, and “writes” it when she synthesizes the sequence.Since there is an author in this case, such DNA sequences should qualify as “original works of authorship.” Furthermore, although DNA sequences lack the explicit statutory recognition as copyrightable subject matter that computer software possesses, synthetic DNA sequences may be eligible for copyright protection under the expansive interpretation of “works of authorship” manifested by Congress in the legislative history of the 1976 amendments to the Copyright Act.

• In a measured version of this conception, Endy has suggested that “synthetic biology provides an opportunity to test the hypothesis that the genomes encoding natural biological systems can be ‘rewritten,’ producing engineered surrogates that might usefully supplant some natural biological systems.”

• Given that one of the primary goals of synthetic biology is to engineer cells and genes to become ever more like computers and computer software, as synthetic biology succeeds in making DNA appear more similar to computer software, DNA sequences will likely move towards copyrightability by analogy to computer software. Alternatively, if cells and organisms are already computers and genes are already software, then DNA sequences are already eligible for copyright protection.

• A specific pattern or motif spliced into a synthetic DNA sequence could serve a trademark function if it identified the source of that DNA. To avoid the restrictions of the functionality doctrine, such a DNA trademark would best be placed outside of the coding (or functional) portion of the DNA sequence. As the field of synthetic biology becomes more commercially important, DNA trademarks are likely to play increasingly important roles as indicators of source. • Von Hippel has warned that, “with a few exceptions, innovators do not think that patents are very useful either for excluding imitators or for capturing royalties in most industries,”and that “the characteristics of present-day intellectual property regimes as actually experienced by innovators are far from the beneficial expectations of theorists and policy makers.” He notes a growing realization “that intellectual property rights are bad for innovation too in many cases.”

• An increasing body of empirical research supports the hypothesis that intellectual property protection may harm, rather than spur, technological innovation. More than two decades ago, von Hippel reported that “empirical data seem to suggest that the patent grant has little value to innovators in most fields.”

• Open biology and open synthetic biology represent non-proprietary modes of biotechnological innovation.

• Moser has presented historical evidence showing that, at least during the nineteenth century, countries with patent systems did not experience significantly greater rates of technological innovation than countries without patent systems.

• Yochai and Benkler have instead proposed that “commons-based strategies” may spur rates of innovation in fields such as software, agriculture, and drug development more than proprietary systems.145 Open biology and open synthetic biology represent non-proprietary modes of biotechnological innovation.

The International HapMap Project (IMHP) is a “partnership of scientists and funding agencies from Canada, China, Japan, Nigeria, the United Kingdom, and the United States to develop a public resource that will help researchers find genes associated with human disease and response to pharmaceuticals.”The HapMap (or map of haplotypes) “is a catalog of common genetic variants that occur in human beings.”The IHMP is attempting to create a public domain database of haplotypes by encouraging researchers not to patent their research, but, instead, to contribute their haplotype data freely to the IHMP genetic database. By “making this information freely available, the [IHMP] will help biomedical researchers find genes involved in disease and responses to therapeutic drugs.” Researchers do not require licenses to gain access to the IHMP database, where data “can be downloaded with minimal constraints.”Although one of the goals of the IHMP is to minimize hindrances on genetic research caused by patents, it does not oppose patents claiming haplotypes “as long as this action does not prevent others from obtaining access to data from the [IHMP].

• The first sentence in the Preface of both the Contributor and User Agreements begins with a broad statement of BBF’s mission and values: [The BBF] was established to foster and advance innovation,research, standardization, and education in synthetic biology through the open design, construction, distribution, understanding, and use of BioBrick™ compatible parts, namely standardized genetic materials and associated functional information,in ways that benefit the world.

• Nightmare scenarios include “the malicious use of DNA sequences posted on the Internet to engineer a new virus or more devastating biological weapons.”The preface signals that only beneficial uses should be made of synthetic biology, though the very need to state this positive value indicates an awareness of its opposite.

• Section Two of the Contributor Agreement requires contributors to agree to let the BBF insert a “BioBrick™ Identification Tag” into the DNA sequence of any contributed BioBrick. Users must make related promises in Section Three of the User Agreement, agreeing not to remove any “BioBrick™ Identification Tag” from a BioBrick and to ensure that the BioBrick Agreement logo is displayed prominently whenever a BioBrick, or modification thereof, is made available, commercialized, or distributed; Section Five of the Contributor Agreement informs contributors of this user obligation. This trademark policing is intended to ensure that BioBricks remain both standardized, compatible, and accessible. Finally, the BioBrick Agreement provides for attribution. Section Five of the Contributor Agreement allows contributors to request that users attribute BioBricks to their contributors when those users describe those BioBricks. Section Three of the User Agreement requires that users promise to make such attributions to contributors.