Abstract
Synthetic biology holds great promise for a number of application areas, and in particular for human health care. It may help to address the challenge of ever increasing innovation cost that the pharmaceutical industry is currently facing, with the number of new drugs approved per billion US dollar spent on research and development halved every 9 years since 1950. In this book chapter we review the challenges that the pharmaceutical industry is confronted with, present and analyze examples of applications of synthetic biology in this field, and discuss potential changes to the industry’s intellectual property management that the advent of synthetic biology might bring about.
Keywords
Access this chapter
Tax calculation will be finalised at checkout
Purchases are for personal use only
Notes
- 1.
Note that we use the term “synthetic biology” in the broader sense of “the design and fabrication of biological components and systems that do not already exist in the natural world” (http://syntheticbiology.org/FAQ.html). In the narrower sense, synthetic biology means to employ, in such design and construction, a standardized set of parts.
- 2.
- 3.
Assuming an average life expectancy of 68 years WHO (2009) and constant DALY numbers throughout life.
- 4.
The facts about Amyris are based on “Amyris Biotechnologies,” Stanford Graduate School of Business, Case E331, 2009.
- 5.
References
Allarakhia M, Wensley A (2005) Innovation and intellectual property rights in systems biology. Nat Biotechnol 23(12):1485–1488. doi:10.1038/nbt1205-1485
Allen AC, Timothy KL (2012) Synthetic biology: an emerging engineering discipline. Ann Rev Biomed Eng 14:155–178
Cohen WM, Nelson RR, Walsh JP (2000) Protecting their intellectual assets: appropriability conditions and why U.S. manufacturing firms patent (or not). Working Paper 7552 NATIONAL BUREAU OF ECONOMIC RESEARCH, Cambridge, MA 02138, http://www.nber.org/papers/w7552
Dickson M, Gagnon JP (2004) Key factors in the rising cost of new drug discovery and development. Nat Rev Drug Discov 3(5):417–429. doi:10.1038/nrd1382
Dimasi JA, Hansen RW, Grabowski HG (2003) The price of innovation: new estimates of drug development costs. J Health Econ 22(2):151–185. doi:10.1016/S0167-6296(02)00126-1
Erickson B, Singh R, Winters P (2011) Synthetic biology: regulating industry uses of new biotechnologies. Science 333(6047):1254–1256. doi:10.1126/science.1211066
Folcher M, Fussenegger M (2012) Synthetic biology advancing clinical applications. Curr Opin Chem Biol 16:1–10
Heller MA, Eisenberg RS (1998) Can patents deter innovation? The anticommons in biomedical research. Science 280:698–701
Henkel J, Maurer SM (2007) The economics of synthetic biology. Mol Syst Biol 3:117:1–4
Henkel J, Maurer SM (2009) Parts, property and sharing. Nat Biotechnol 27(12):1095–1098
Khalil AS, Collins JJ (2010) Synthetic biology: applications come of age. Nat Rev Genet 11(5):367–379. doi:10.1038/nrg2775
Kockaya G (2010) What are the Top most costly diseases for USA? The alignment of burden of illness with prevention and screening expenditures. Health 02(10):1174–1178. doi:10.4236/health.2010.210172
Medema MH, Breitling R, Bovenberg R, Takano E (2011) Exploiting plug-and-play synthetic biology for drug discovery and production in microorganisms. Nat Rev Micro 9(2):131–137. doi:10.1038/nrmicro2478
Munos B (2009) Lessons from 60 years of pharmaceutical innovation. Nat Rev Drug Discov 8(12):959–968. doi:10.1038/nrd2961
Murray CJL, Lopez AD, Mathers CD, Ezzati M, Jamison DT (2006) Measuring the global burden of disease and risk factors, 1990–2001. In: Lopez AD, Mathers CD, Ezzati M, et al., editors. Global Burden of Disease and Risk Factors. Washington (DC): World Bank; 2006. Chapter 1. Available from: http://www.ncbi.nlm.nih.gov/books/NBK11817/
Pammolli F, Magazzini L, Riccaboni M (2011) The productivity crisis in pharmaceutical R&D. Nat Rev Drug Discov 10(6):428–438. doi:10.1038/nrd3405
Rai A, Boyle J (2007) Synthetic biology: caught between property rights, the public domain, and the commons. PLoS Biol 5(3):e58. doi:10.1371/journal.pbio.0050058
BCC Research (2011) Synthetic biology: emerging global markets. http://www.bccresearch.com/market-research/biotechnology/global-synthetic-biology-markets-bio066b.html
Ruder WC, Lu T, Collins JJ (2011) Synthetic biology moving into the clinic. Science 333(6047):1248–1252. doi:10.1126/science.1206843
Savile CK, Janey JM, Mundorff EC, Moore JC, Tam S, Jarvis WR, Colbeck JC, Krebber A, Fleitz FJ, Brands J, Devine PN, Huisman GW, Hughes GJ (2010) Biocatalytic asymmetric synthesis of chiral amines from ketones applied to sitagliptin manufacture. Science 329(5989):305–309. doi:10.1126/science.1188934
Scannell JW, Blanckley A, Boldon H, Warrington B (2012) Diagnosing the decline in pharmaceutical R&D efficiency. Nat Rev Drug Discov 11:191–200
Singh R (2011a) Facts, growth, and opportunities in industrial biotechnology. Org Process Res Dev 15(1):175–179. doi:10.1021/op100312a
Singh R (2011b) Better living through science: biotech, food and the future. http://www.germaninnovation.org/shared/content/documents/Presentation_Singh.pdf
Synthetic Biology Project (2012) Inventory of synthetic biology products – existing and possible. Draft. http://www.synbioproject.org/process/assets/files/6631/_draft/synbio_applications_wwics.pdf .Accessed 01 Jan 2013
Synthetic Biology Project Maps Inventory (2012) Mapping the emerging synthetic biology landscape. http://www.synbioproject.org/library/inventories/map/. Accessed 01 Jan 2013
Transparency Market Research.com (2012) Synthetic biology market. Global industry analysis, size, growth, share and forecast, 2012–2018. http://www.transparencymarketresearch.com/synthetic-biology-market.html
United Nations (1997) Demographic yearbook – historical supplement. Expectation of life at specified ages for each sex: 1948–1997 (Table 9b), United Nations DYB-CD, Sales No.: E/F.99.XIII.12, United Nations Publications New York, Geneva http://unstats.un.org/unsd/demographic/products/dyb/dybhist.htm. Accessed 01 Jan 2013
United Nations (2012) 2011 Demographic yearbook. Department of Economic and Social Affairs, United Nations, New York. https://unstats.un.org/unsd/demographic/products/dyb/dybsets/2011.pdf. Accessed 01 Jan 2013
U.S. Environmental Protection Agency (2010) Greener reaction conditions award. http://www.epa.gov/greenchemistry/pubs/pgcc/winners/grca10.html. Accessed 01 Jan 2013
Van Zimmeren E (2009) Clearinghouse mechanisms in genetic diagnostics: conceptual framework. In: Van Overwalle G (ed) Gene patents and collaborative licensing models. Cambridge University Press, Cambridge, pp 63–119
Verbeure B (2009) Patent pooling for gene-based diagnostic testing: conceptual framework. In: Van Overwalle G (ed) Gene patents and collaborative licensing models. Cambridge University Press, Cambridge, pp 3–32
Weber W, Fussenegger M (2009) The impact of synthetic biology on drug discovery. Drug Discov Today 14(19–20):956–963. doi:10.1016/j.drudis.2009.06.010
Weber W, Fussenegger M (2011) Emerging biomedical applications of synthetic biology. Nat Rev Genet. doi:10.1038/nrg3094
WHO (1946) Preamble to the Constitution of the World Health Organization as adopted by the International Health Conference, p. 16. Official Records of the World Health Organization No. 2, Summary Report on Proceedings Minutes and Final Acts of the International Health Conference held in New York from 19 June to 22 July 1946. http://whqlibdoc.who.int/hist/official_records/2e.pdf. Accessed 16 Jun 2014
WHO (2008) The global burden of disease: 2004 update. GBD 2004 summary tables. http://www.who.int/healthinfo/global_burden_disease/DALY10%25202004.xls. Accessed 02 Jan 2013
WHO (2009) Global health observatory. Life expectancy at birth. http://www.who.int/gho/mortality_burden_disease/life_tables/situation_trends_text/en/index.html
Zoler ML (2011) Neuropsychiatric disorders dominate disease burden in Europe. From the annual congress of the European College of Neuropsycho-Pharmacology. http://www.internalmedicinenews.com/specialty-focus/mental-health/single-article-page/neuropsychiatric-disorders-dominate-disease-burden-in-europe.html. Accessed 31 Dec 2012
Author information
Authors and Affiliations
Corresponding author
Editor information
Editors and Affiliations
Rights and permissions
Copyright information
© 2014 Springer Science+Business Media Dordrecht
About this chapter
Cite this chapter
Henkel, J., Lüttke, R. (2014). Synthetic Biology: Solving the Pharmaceutical Industry’s Innovation Problems?. In: de Miguel Beriain, I., Romeo Casabona, C. (eds) Synbio and Human Health. Springer, Dordrecht. https://doi.org/10.1007/978-94-017-9196-0_2
Download citation
DOI: https://doi.org/10.1007/978-94-017-9196-0_2
Published:
Publisher Name: Springer, Dordrecht
Print ISBN: 978-94-017-9195-3
Online ISBN: 978-94-017-9196-0
eBook Packages: Biomedical and Life SciencesBiomedical and Life Sciences (R0)