Abstract
Realizing positive network effects inherent in the engineering of biology requires an infrastructure that enables researchers to share and access information and materials that reside outside the boundaries of any one organization. Empirical studies are needed to document the actual practices of synthetic biology researchers in disseminating data, materials, methods, and practices across institutional and international boundaries. Such studies could provide insight into how the infrastructure for sharing and accessing information and materials influences technology choices, and could clarify the role of open access and proprietary models in technology development. By informing the decisions of practitioners, funding agencies, investors, and policy-makers, social science research could help advance both innovation and social impact in the field of synthetic biology.
The emerging field of synthetic biology holds great promise for generating biological solutions to address many of society's most pressing needs. Advances in DNA synthesis and assembly technologies, innovations in computer-aided design, and the creation of automated strain engineering platforms and associated technical standards are improving efficiencies in the design, construction and testing of biological systems. As such, the tools of synthetic biology can help address unmet challenges in health, energy, environment, and agriculture.
Realizing positive network effects inherent in the engineering of biology requires an infrastructure that enables researchers to share and access information and materials that reside outside the boundaries of any one organization. The landscape for synthetic biology research is diverse, comprising organizations that are large and small, academic and commercial, and from higher income and lower income countries.Footnote1 Within this diverse landscape, high transaction costs for sharing information and materials impair the ability of researchers to collaborate with one another and discourages cooperation between organizations. As a specific example, synthetic biology researchers in both academia and industry often are unable to freely share the biological parts they develop.Footnote2 When sharing biological parts with others outside their own laboratories, most academics need to have a manuscript submitted or accepted for publication, while most industry researchers need to have an agreement in place. On the other end, when requesting biological parts created by others, researchers or their institutions often are asked to sign material transfer, licensing, or non-disclosure agreements. Importantly, researchers do not always receive the parts they request. When requesting parts as tangible materials, 26% of academics and 57% of industry researchers report having been denied access due to concerns about property rights. Property rights are not the only barrier to access; 32% of academics and 50% of industry researchers reported having been denied access due to other concerns (e.g. competition, failure to fill requests, inability to clear customs).
Although many synthetic biologists use public registries to distribute materials (typically DNA contained within plasmids), the use of these materials often is highly restricted by the terms of material transfer agreements (). For example, Addgene was among the public registries most used by SB6 survey participants. In distributing DNA in plasmid form, Addgene uses an electronic version of the Uniform Biological Material Transfer Agreement (UBMTA), which limits transfer to only academic or non-profit institutions for non-commercial use. As such, researchers from for-profit institutions or those desiring to develop commercial applications would not be able to access biological parts under Addgene's contract terms.Footnote3 The iGEM Registry of Standardized Biological Parts, by contrast, does not restrict distribution and use via material transfer agreements. However, the iGEM Registry serves a specific educational purpose that is not necessarily aligned with the needs of those developing commercial applications of synthetic biology.
Table 1. Synthetic biology researchers use private and public registries to distribute tangible materials and information about biological parts.
Public registries such as those of the BIOFAB: International Open Facility Advancing Biotechnology (BIOFAB), the Synthetic Biology Engineering Resource Center (Synberc), and the Joint BioEnergy Institute Public Registry (JBEI-ICE Public) do not distribute materials and instead provide information, including DNA sequences, from which parts can be synthesized. In theory, de novo synthesis has the potential to broaden access to biological parts for synthetic biology research and commercial development. As one survey respondent commented ‘I can simply make any parts I have been denied access due to whatever reasons.’ In practice, de novo synthesis is not a realistic option for many synthetic biology researchers, and those who require DNA parts as tangible materials must either rely on public registries or negotiate an agreement with the providing institution.
As the field of synthetic biology continues to evolve, reliance on registries of biological parts may change as researchers adopt new platforms and alternate ways of working. Empirical studies are needed to document the actual practices of synthetic biology researchers and the mechanisms used for disseminating data, materials, methods, and practices across institutional and international boundaries. Such research could provide insight into how the infrastructure for sharing and disseminating information and materials influences technology choices. Social science research also is needed to better understand the role of open access and proprietary models in the selection and dissemination of technologies in synthetic biology. For example, research into how patents are used by and affect start-up and early-stage synthetic biology companies would shed light on the effectiveness of patenting as compared to other methods of capturing competitive advantage (e.g. first mover advantage, trade secrecy, etc.) in the commercial development of synthetic biology products and applications. By informing the decisions of practitioners, funding agencies, investors, and policy-makers, social science research can help positive network effects be realized for advancing both innovation and social impact in the field of synthetic biology.
Funding
This work was supported by the U.S. National Science Foundation [grant number EEC-0540879, subaward 00008432].
Notes on contributor
Linda J. Kahl is a patent attorney admitted to practice in California and before the U.S. Patent and Trademark Office. She directs the BioBricks Foundation's legal program and also leads the Ownership, Access, Sharing, and Innovation Systems (OASIS) project for Synberc, a multi-university Synthetic Biology Engineering Research Center funded by the U.S. National Science Foundation.
Notes
1. The interactive map produced by the Synthetic Biology Project at the Woodrow Wilson International Center for Scholars shows nearly 700 companies, universities, research institutions, and other entities working on synthetic biology across the globe, available at http://www.synbioproject.org/sbmap/.
2. Data from the SB6 State-of-the-Art survey of 141 self-identified synthetic biology researchers from the USA (n = 71) and 26 other countries (n = 70). Responses were received from synthetic biology researchers in both academia and industry, including 87 from academia (72 universities, 6 government labs, 9 research institutes), 46 from industry (14 with less than 50 employees, 9 with 51–1000 employees, and 23 with >1000 employees), and 8 affiliated with both academic and commercial organizations.
3. Addgene offers a limited number of plasmids to for-profit companies through an Industry Material Transfer Agreement, though use is still restricted to research only.