Advances in synthetic biology result in more people engineering more biological systems using more genetically encoded functions (i.e., parts). Today, uses of genetically encoded functions are typically protected and shared via a patent-based property rights framework. However, many examples now exist for which advancing synthetic biology tools exacerbate tensions within the existing patent-based framework. For example, DNA synthesis companies may unknowingly risk patent infringement liability by constructing DNA sequences that may be covered by third party property rights for their customers. Such liability risks also impact the availability of services provided by other groups. For example, companies that have created automated strain-engineering platforms for their own in-house use are reluctant to make these platforms available to others in the research community, in part due to patent infringement liability risks. Thus, how property rights are applied to support or hinder the scaling of uses of genetically encoded functions becomes a strategic economic and legal topic to consider in service of best enabling innovation. We are therefore investigating and developing options that others can consider regarding how intellectual property rights can be adapted and applied to best support ownership, access, sharing, and innovation in synthetic biology and biotechnology, more broadly.
The first component of this work aims to establish an initial set of technologies considered enabling for the field of synthetic biology so that we and others might systematically investigate the intellectual property rights coupled to these technologies. The second component then looks to develop a portfolio of options for promoting innovation in synthetic biology. It explores legislative options as well as policy and community options to more effectively work within the existing patent-based legal framework. We anticipate these options will not present a complete solution for all the property rights issues encountered in the emerging field of synthetic biology, but instead will serve to inform and contribute to broader discussions about how property rights can best be applied and adapted to promote innovation in synthetic biology and biotechnology, more broadly.
Survey of Enabling Technologies in Synthetic Biology
Linda Kahl and Drew Endy have co-authored a manuscript entitled “A Survey of Enabling Technologies in Synthetic Biology” which presents the results of a first-ever survey conducted among a community of practitioners engaged in synthetic biology research. By tapping the experiences and perspectives of synthetic biology researchers, they aimed to construct an initial set of technologies that support the engineering of biological systems so that we and others could begin to investigate the property rights and regulatory policies covering those technologies. The results of this first study offer a snapshot view of the technologies used by synthetic biology researchers, and give a sense of the many and varied technologies that support work in this field.. Many of these technologies are widely accessible for use, either by virtue of being in the public domain or through legal mechanisms such as non-exclusive licensing. Access to some patent protected technologies is less clear and the use of such tools may be subject to restrictions imposed by material transfer agreements or other contract or licensing terms. The survey found that most synthetic biology researchers in both commercial and non-commercial settings used and contributed biological parts to publicly available registries. Also, synthetic biology researchers with previous iGEM experience were more likely to use and contribute parts to publicly available registries, regardless of whether they worked in academia or industry.
Synthetic Biology Ownership, Sharing & Innovation Systems (OASIS) Workshop
In January 2012, the Synthetic Biology Ownership, Sharing & Innovation Symposium was held as a means to jump-start the process of investigating and developing options for adapting and applying property rights to best support ownership, sharing, and innovation in synthetic biology. Organized between the Department of Bioengineering and the School of Law at Stanford, the symposium included a diverse set of ~24 policy makers, funders, industrial synthetic biologists, and practicing and academic lawyers. Participants considered real world case studies that exemplify the stresses placed on the existing legal framework as a result of advances in synthetic biology. They compared scenarios and began drafting proposals for applying and adapting existing legal frameworks to best support innovation in synthetic biology. Linda Kahl and Drew Endy have sustained and presented this work through a number of important venues, discussed below.
Since this symposium, Linda Kahl and Drew Endy have drafted a written report presenting the portfolio of options for promoting innovation in synthetic biology. The portfolio includes options for public policy and legislation, options for investors and organizations that fund synthetic biology research, and options for individuals and groups within the synthetic biology research community. They found that no single option provides a “silver bullet” that meets all of the specified performance goals and implementation criteria for promoting innovation in synthetic biology. Rather, multiple options that can be pursued by individuals and institutions working at all levels – policy and legislation, investors and funding agencies, practitioners and community – are needed to create the optimal environment for innovation in synthetic biology, and biotechnology more broadly. They plan to publish this portfolio of options in one or more articles designed to reach the synthetic biology research community as well as policy makers, the legal community, and other stakeholders interested in promoting innovation in synthetic biology.
Kahl L.J. and D. Endy. A Survey of Enabling Technologies in Synthetic Biology. 2012. Submitted.
Stanford Law School Conference on Intellectual Property Law and the Biosciences
In April 2012 Drew Endy presented the keynote speech at the Stanford Law School Conference on Intellectual Property Law and the Biosciences. This conference brought together judges, top legal scholars and experienced practitioners from across the country to examine some of the key legal and policy issues raised by the biosciences industry.
Six Academies Symposium
In June 2012 the National Academy of Sciences hosted the third in a series of three international symposia on Synthetic Biology. Drew Endy and Linda Kahl participanted in a panel discussion focueds on opportunities and challenges in intellectual property for innovations in synthetic biology alongside Arti Rai (Duke Law), Dan Kevles (Yale University), Mark Lemley (Stanford Law) and Nita Farahany (Duke Law). Linda Kahl presented a conceptual framework illustrating how the pace and scale of innovation in synthetic biology is exacerbating tensions within the existing patent-based legal system, and panelists presented some of the options for new legislation considered at the Stanford symposium. A written summary will be published as a National Research Council report.
National Academies Committee on Science, Technology, and Law
In October 2012, Drew Endy, Linda Kahl and Berthold Rutz (European Patent Office) presented on Intellectual Property, Ownership and Sharing Arrangements for Synthetic Biology at the National Academies Committee on Science, Technology, and Law Annual Meeting.
International Workshop on Synthetic Biology Intellectual Property
In January 2013, Drew Endy, Linda Kahl, Arti Rai and others participated in a meeting at Imperial College London to assess the demand for international discussion on ownership and sharing issues that may impede research and prospects for commercialisation in synthetic biology. The two-day meeting was held under the auspices of the US NAS CSTL and was a joint activity of the Royal Society and the Royal Academy of Engineering. The consensus reached was that further international discussions on intellectual property and synthetic biology are warranted. A broader international workshop to be convened at Imperial College London is being planned for July 2013.
Review of Synthetic Biology Standards and Intellectual Property
Linda Kahl and Andrew Torrance (University of Kansas Law School) have co-authored a review of current work on standards setting efforts by institutions, firms, governments, and individuals within the field of synthetic biology. This work, commissioned by the National Academies’ Board on Science, Technology, and Economic Policy (STEP), was presented at the Symposium on Management of Intellectual Property in Standards-Setting Processes held on October 3-4, 2012 in Washington, DC.
Torrance A.W. and Kahl L.J. 2012. Synthetic Biology Standards and Intellectual Property, a report prepared for The National Academies’ Board on Science, Technology, and Economic Policy, October 2012.