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Human Practices 1 Overview 2 Metaphors We Live By, Metaphors We Build Life By 3 Outreach 4 Cooperation and Collaboration 5 Does intellectual property work as intended for synthetic biology? 5.1 Introduction 5.2 The Problem 5.3 Alternatives 5.3.1 Status Quo 5.3.2 Abolition of Gene Patents 5.3.3 Sui Generis Framework 5.4 References

Human Practices

Overview

When reflecting on human practices over the course of our iGEM project, several major themes emerged. We considered major policy issues (intellectual property policy, biosecurity, licensing), the extent and nature of public opposition to synthetic biology, research and bioethics, outreach, collaboration, and decision-making in conditions of uncertainty.

Metaphors We Live By, Metaphors We Build Life By

Outreach

- We dramatically increased awareness and visibility of iGEM and synthetic biology on UVA Grounds as part of recruitment over the past year, attending as a group or running informational tables at events related to bioethics, engineering, and synthetic biology.
- We organized and helped lead a Flash Seminar on Ethical Issues in Synthetic Biology with a member of the Presidential Bioethics Commission. Flash Seminars are one-time student-organized “learning flash mobs” open to undergraduate and graduate students, community members, and faculty, during which people from diverse backgrounds can meet and discuss topics of interest (http://www.washingtonpost.com/wp-dyn/content/article/2011/02/20/AR2011022002666.html).

Ethical Issues in Synthetic Biology
Led by Bioethics, Philosophy, and Public Health Professor John Arras
Two years ago, the J. Craig Venter Institute announced that it had created the world's first self-replicating synthetic genome in a bacterial cell of a different species. The discovery prompted many people to consider the benefits and drawbacks of the emerging field of synthetic biology. While new innovations present opportunities for progress in clean energy products, pollution control, affordable food, vaccines and other medicines, they also introduce harmful risks to humans and communities. This seminar will focus on the safety and security issues posed by the new technology and discuss some of the future-oriented concerns involved with human enhancement.

Cooperation and Collaboration

- Solicited and offered skills using NTMU’s Matchmaker: https://2012.igem.org/Team:NTNU_Trondheim/Matchmaker
- Our advisor was able to help Team Groningen: https://2012.igem.org/Team:Groningen/international_cooperation
- Provided feedback to Team Grenoble on their design for a BioBrick Safety Sheet: https://2012.igem.org/Team:NTNU_Trondheim/Matchmaker
- Responded to UBC’s survey on intellectual property: https://2012.igem.org/Team:British_Columbia/Human_Practices/IP_FAQ

Does intellectual property work as intended for synthetic biology?

Introduction

The emerging field of synthetic biology generally aims to make biology easier to engineer by adapting engineering methodologies to biological systems (Endy, 2005). It promises to produce fundamental advancements in fields ranging from biomedicine to energy, but is also rife with concerns regarding ethics, safety, and governance.

Synthetic biology also spotlights issues of intellectual property, sharing, and innovation (Oye & Wellhausen, 2010). Ideally, intellectual property would provide incentives that effectively promote innovation, align those incentives with social utility, and promote socially equitable cost burden and distribution of the products of innovation. in the form of patents

The Problem

Patent protection is unlikely to harness the potential of synthetic biology. When intellectual property was constitutionally established in the United States as a method for “promoting the progress of the useful arts,” the nature of foreseeable innovation was very different from today’s innovative landscape. Whereas inventions were almost exclusively macro-scale mechanical contraptions, the range of contemporary technologies that have been shoehorned into the patent framework now includes innovations ranging from business strategies to software to self-replicating biomolecular machines. Software code, for example, which can be thought of as a machine made of language, is extremely difficult to justify as either copyrightable or patentable and ends up protected under both systems, an outcome scholars widely regard as harmful to innovative outcomes (Rai & Boyle, 2007). Biotechnology is another field whose nature has defied the conceptual limits of legal constructs formulated. It has been noted that synthetic biology represents a “perfect storm” of characteristics of software and biotechnology that will render existing intellectual property frameworks harmfully obsolete (Rai and Boyle, 2007). Some have gone as far as to claim that status quo patenting practices may snuff out synthetic biology altogether (“How to kill synthetic biology,” 2006).

Patent-driven innovative outcomes synthetic biology can expect can be observed in other contexts. When tested empirically over the past 150 years, stronger patent protection was actually associated with lower rates of patenting (Lerner, 2002, cited in Torrance, 2010). When tested using interactive computer simulations, not only is a patent system significantly worse at promoting innovation than a pure commons in terms of innovation rate, productivity, and social utility, but a commons coexisting with a patent system is statistically no better than a pure patent system (Torrance & Tomlinson, 2009). Psychological insights into the process of innovation are also becoming increasingly messy, indicating that many seemingly irrelevant factors ranging from the height of the ceiling to environmental stimuli influencing dream incubation have strong effects on innovative output (e.g. Kraft, 2005; Anthes, 2009). Biomedical and biological sciences may be particularly susceptible to the so-called “tragedy of the anticommons:” excessive fragmentation of knowledge too far upstream by intellectual property enclosure strongly inhibits follow-on research (Heller and Eisenberg, 1998). An especially strong ethos of open innovation exists within a large segment of the synthetic biology research community in part due to a justified fear of the effects of excessive patenting in the field (Torrance, 2010).

The application of synthetic biology to biomedicine in particular deserves special attention, as it represents an extremely active field of synthetic biology research, many theoretical successes, and astounding promise for the near future (Weber & Fussenegger, 2012).

Although often heralded as the single resounding success of patent policy, pharmaceutical research more broadly is dramatically skewed toward low-importance, high- profit drugs at excessive consumer cost (Love & Hubbard, 2007). Overall, roughly $50 billion per year in private medical R&D spending is incentivized by the social cost of $400-480 billion per year in additional royalty costs due to patent monopoly pricing (Love & Hubbard, 2007) . Status quo legal configurations can be expected to produce similar outcomes in medical applications of synthetic biology.

Alternatives

Alternative policy futures for intellectual property in synthetic biology are diverse and unpredictable, but include the status quo, abolishing gene patents, and the formulation of a sui generis legal framework for synthetic biology innovation. Criteria for evaluation include political feasibility, effectiveness of increasing innovation rate, alignment between incentives and social utility, and distributive justice measured in terms of consumer cost and fairness in distribution.

Status Quo

The existing policy configuration remains the subject of intense criticism from a variety of perspectives. Gene patents are opposed on principle by a variety of groups that view them as commodifying life (Andrews & Paradise, 2005), scientists and researchers believe that the current patent landscape harms openness of research (“Who owns science?” 2009), and the courts have recently challenged prevailing notions of gene-patentability . Since these and other principled concerns are highly unlikely to dissipate in the foreseeable future, we can anticipate a continuing degree of legal uncertainty about the largely court-defined patentability of synthetic biology gene products. As explained above, the status quo will likely inhibit research, skew research toward highly profitable domains that do not necessarily represent social need, and dramatically inflate consumer costs. Although patents also provide an unambiguous method of leveraging “copyleft” licenses, as demonstrated by the BioBricks Foundation (Rai & Boyle, 2007), there is reason to conclude that coexistence of such a commons with the rest of the patent system will not produce substantially better innovation outcomes (Torrance & Tomlinson, 2009).

Abolition of Gene Patents

Recent polls indicate abolishing gene patents is probably the most generally popular alternative, representing a near-majority of the public and about twice the number in favor of keeping the current system as it is (Genetic Engineering and Biotechnology News, 2012). Industry intensely claims, however, that patents are necessary to their innovation. Although it might appease opposition groups, making gene sequences unpatentable subject matter without also providing an alternative system would likely promote a spillover from patents to other forms of intellectual property protection, since genetic material in synthetic biology is formally susceptible not only to patent enclosure, but also to copyright and trademark (Torrance, 2010). Especially in biomedical applications, some form of financial incentive is necessary to overcome the extremely expensive process of clinical trials and regulatory approval, which complicates simplistic analogy to innovation patterns in open source software development (Rai & Boyle, 2007).

Sui Generis Framework

Drafting sui generis (custom, one-of-a-kind) legislation for synthetic biology or biotechnology more broadly may thus be justified. A strong argument can be made that patents simply are conceptually inadequate structures for genetic information (Calvert, 2008), and that this is a key internal link to effectively promoting socially useful research without exorbitant. The BioBricks Foundation constitution, which emphasizes standardization, openness, and social responsibility, provides a model on which to build such a framework (Torrance, 2010). A framework based on this model would ideally provide tailor-made solutions to synthetic biology’s unique challenges of potentially costly regulatory hurdles to translation, ecological risk, and interactional complexity while acknowledging its unique research requirements. However, the process of drafting such legislation is likely to be long, difficult, and uncertain (Rai & Boyle, 2007).

References