Abstract
Is the development of synthetic biology threatened by sharing and ownership issues? What measures are synthetic biologists taking to address intellectual property and commons issues that may threaten development of the field? Part I presents a conceptual framework for the analysis of ownership and sharing in emerging technologies, organized around two dimensions – a private ownership vs commons axis and a clarity vs ambiguity axis. It then uses the framework to assess the fit between conventions governing intellectual property and elements of synthetic biology. Part II describes internal positions on ownership and sharing within the community of synthetic biologists, highlighting areas of agreement on common ownership of registries of parts for basic research and education, standards for performance and interoperability, and design and testing methods; and agreement on private ownership of designs of devices ripe for commercialization. Part II also discusses the varied views of synthetic biologists on precisely where to draw the line on public vs private ownership of biological parts and design principles. The conclusions examine domestic and international forces that may shape the evolution of formal legal conventions and informal practices in synthetic biology.
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Notes
- 1.
Scientific American Editors, “How to Kill Synthetic Biology,” Scientific American, June 2006
- 2.
Heller and Eisenberg argue that research rights on patents set biomedical technologies apart from information technologies which tends to be characterized by other forms of property rights, including copyright, and “work-around” solutions (1998).
- 3.
Note that the number of players involved in ambiguous public ownership world could be one (the national government) or many (public universities, government agencies, and others). The number of players in an ambiguous private ownership situation could be one (IBM in the 1980s, which owned hundreds of key information technology patents) or many (small biotech firms each banking on a small intellectual property ownership portfolio). Though costs and types of transactions in each situation differ, ambiguity leads to suboptimal results in all.
- 4.
The US Supreme Court ruling in KSR vs Teleflex, 550 U.S. 398 (2007) and the US Court of Appeals for the Federal Circuit ruling in Bilski 2007-1130 (Serial No. 08/833,892) may reduce the likelihood that broad patents that combine obvious elements of prior art will be granted in the future.
- 5.
The Peer to Patent Project http://dotank.nyls.edu/communitypatent/accessed October 2008.
- 6.
Assembled by the authors from statutes and news articles, Information on OECD countries from [3] and [9].
- 7.
Van Overwalle, van Zimmeren (2006) suggest that compulsory licensing for public health, allowed under the WTO TRIPS Agreement, has given rise to more debate than the research exemption.
- 8.
The US has relatively clear statutes allowing firms submitting generic drugs to the FDA to benefit from the already proven quality of branded drugs protected under patents. This exemption for regulatory approval is meant to facilitate the quicker diffusion of generic drugs following the expiration of the branded patent.
- 9.
Roche Products Inc vs Bolar Pharmaceutical Co 733 F 2d 858 (Fed. Cir. 1984)
- 10.
Madey vs Duke University 307 F 3d 1351, 1362 (Fed. Cir. 2002)
- 11.
National Research Council (2004) as quoted in Dent et al. (2006)
- 12.
This figure was created by searching US and European patent databases for selected keyword phrases common to synthetic biology. Current research aims at creating a more comprehensive database of keyword phrases in synthetic biology that will be able to provide a more complete picture of the existing “patent landscape”. In addition to the MIT SynBERC group’s work on this patent landscape, a consortium of social scientists present at Synthetic Biology 3.0 as well as other European groups are doing complementary work.
- 13.
Thanks to Hanna Breetz and Matthew Silver for the research and assembly of this data as of 2007. Note that this map should be taken only as indicative of research in the field as a whole. Research teams at Lancaster University, the Technical University of Munich, and elsewhere are constructing more authoritative patent landscapes.
- 14.
The USPTO (1999) notes “invention must have specific and substantial utility…Exclude throw-away, insubstantial, non-specific utility.” These directives are consistent with case law, including: Brenner vs Manson 86 S.Ct. 1033, 383 U.S. 519, 16 L.Ed.2d 69, 148 U.S.P.Q. 689 U.S.Cust. & Pat.App., March 21, 1966.
- 15.
Registry of Standard Biological Parts (http://partsregistry.org/Main_Page) accessed November 2008.
- 16.
Openwetware, http://www.openwetware.org accessed October 2008.
- 17.
BioBricks Foundation http://bbf.openwetware.org/ accessed December 2008.
- 18.
There remains a legal restriction that the IP must not “diminish or detract from” the specific federally funded research goals or, if wholly tangential to the purpose of federal funding, it must be “without interference with or cost to the government-funded project.” But interference or diminishment is difficult to prove, and thus these limitations are largely unenforced Mowrey et al. (2004).
- 19.
Discussion with Adam Arkin, SB 2.0, Berkeley, California, 20 May, 2006.
- 20.
See Barton (2007) and WIPRO (2008) for moderate analyses on this issue. Intense concern over access to second generation biofuel patents were raised by China, India, Brazil and Korea delegates after the AWG-LCA Workshop on Research and Development of Technology, UN Climate Change Conference, Poznan, December 6, 2008.
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Acknowledgments
The authors acknowledge with gratitude members of the MIT Program on Emerging Technologies working group on intellectual commons and property, including Hanna Breetz, Lawrence McCray, Scott Mohr, Matthew Silver Gautam Mukunda, Neelima Yeddanapudi and Larry McCray; Arti Rai and James Boyle of Duke University Law School; participants at SB2.0, SB3.0 and SB4.0 including Rick Johnson of Arnold and Porter LLP, Stephen Maurer and Paul Rabinow of the University of California, Anne Marie Mazza of the National Research Council, Clara Sattler of Yale University Law School and the Max-Planck-Institut für Geistiges Eigentum; and participants in the 2007 Atlanta Conference on Science, Technology and Innovation Policy. Finally, the auth ors owe a special debt to members of the Synthetic Biology Engineering Research Center (SynBERC) who are creating the objects of sharing and ownership that this paper examines, including Adam Arkin, George Church, Drew Endy, Jay Keasling, Jason Kelly, Natalie Kuldell, Tom Knight, Kristala Prather, Randy Rettberg, and Reshma Shetty. This work was supported by the NSF Integrated Graduate Education Research and Traineeship Program and NSF SynBERC. All errors and omissions are our own. This work has some rights reserved under the Creative Commons Attribution-Share Alike 3.0 United States License.
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Oye, K.A., Wellhausen, R. (2009). The Intellectual Commons and Property in Synthetic Biology. In: Schmidt, M., Kelle, A., Ganguli-Mitra, A., Vriend, H. (eds) Synthetic Biology. Springer, Dordrecht. https://doi.org/10.1007/978-90-481-2678-1_8
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