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Opening Research Biobanks: An Overview

  • Roberto CasoEmail author
  • Rossana Ducato
Chapter

Abstract

In biomedical research and translational medicine, the ancient war between the exclusive right (private control over information) and public access to information is struggling on a new battlefield: research biobanks. The latter are becoming increasingly important (one of the ten ideas changing the world, according to Time magazine) because they collect, store and distribute in a secure and professional way a critical mass of human biological samples for research purposes. Tissues and related data are fundamental for the development of biomedical research and the emerging field of translational medicine, because they represent the “raw material” for every kind of biomedical study. For this reason it is crucial to understand the boundaries of IP in this prickly context. After an overview of the complex interactions among the different stakeholders involved in the process of the production of knowledge, in this paper we will thin out some blurring of language concerning concepts often mixed up, such as “open source”, “open access”, and their precipitates. Then, the aim is to understand if we can use the concepts in the biomedical context, and which are the open models proposed in literature specifically for research biobanks in order to avoid the tragedy of anticommons.

Keywords

Intellectual Property Open Source HapMap Project Material Transfer Agreement Research Biobanks 
These keywords were added by machine and not by the authors. This process is experimental and the keywords may be updated as the learning algorithm improves.

References

  1. Alpa G, Bessone M (1997) Il contratto standard nel diritto interno e comunitario. Giappichelli TorinoGoogle Scholar
  2. Annas GJ (1988) Whose waste is it anyway? The case of John Moore. Hastings Center Rep 18:37–39CrossRefGoogle Scholar
  3. Boettinger S, Burk DL (2004) Open source patenting. J Int Biotechnol Law 1:221–231Google Scholar
  4. Boggiano A (1991) International standard contracts: the price of fairness. Grham & Trotman, DordrechtGoogle Scholar
  5. Booth B, Zemmel R (2004) Prospects for productivity. Nat Rev Drug Discov 3:451–457CrossRefGoogle Scholar
  6. Boyle J (1997) Shamans, software and spleens: law and construction of the information society. Harvard University Press, HarvardGoogle Scholar
  7. Boyle J (2003) The second enclosure movement and the construction of the public domain. Law Contemp Probl 66:33–74Google Scholar
  8. Boyle J (2008) The public domain: enclosing the commons of the mind. Yale University Press, LondonGoogle Scholar
  9. Burrow B (1997) Second thoughts about U.S. Patent #4,438,032, Bull Med Ethics 124:11–14Google Scholar
  10. Cambon-Thomsen A (2003) Assessing the impact of biobanks. Nat Genet 34:25–26CrossRefGoogle Scholar
  11. Campbell EP (2006) Patent rights in biological material. Biobusiness legal affairs. http://www.genengnews.com/articles/chitem.aspx?aid=1880. Accessed 1 Feb 2012
  12. Caso R (2009) L’open access alle pubblicazioni scientifiche: una nuova speranza. In: Caso R (ed) Pubblicazioni scientifiche, diritto d’autore e open access. Università degli Studi di Trento, Trento, pp 7–45Google Scholar
  13. Chakravarty S, Haruvy E, Wu F (2007) The link between incentives and product performance in open source development: an empirical investigation. Global Bus Econ Rev 9:151–169CrossRefGoogle Scholar
  14. Chesbrough HW (2003) Open innovation: the new imperative for creating and profiting from technology. Harvard Business Press, BostonGoogle Scholar
  15. Corian B, Weinstein O (2011) Patent regimes, firms and the commodification of knowledge. Socio Econ Rev 10:1–26. doi: 10.1093/ser/mwr019 Google Scholar
  16. Cuatrecasas P (2006) Drug discovery in jeopardy. J Clin Invest 116:2837–2843. doi: 10.1172/JCI29999 CrossRefGoogle Scholar
  17. Dasgupta P, David P (1987) Information disclosure and the economics of science and technology. In: Feiwel G (ed) Arrow and the ascent of modern economic theory. New York University Press, New York, pp 519–542Google Scholar
  18. De Beer D (2005) Is open-sourced biotechnology possible? In: Wynants M, Cornelis J (eds) How open is the future? economic, social & cultural scenarios inspired by free & open-source software. VUB Brussels University Press, Brussels, pp 357–372Google Scholar
  19. De Robbio A (2010) Biobanche e proprietà intellettuale: commons o caveau?. http://didattica.spbo.unibo.it/bibliotime/num-xiii-3/derobbio.htm. Accessed 1 Feb 2012
  20. De Robbio A, Corradi A (2010) Biobanche in bilico tra proprietà privata e beni comuni: brevetti o open data sharing? JLIS it 1:305–329. doi: 10.4401/jlis-4537 Google Scholar
  21. Derry J, Mangravite L, Suver C, Furia M, Henderson D, Schildwachter X, Izant J, Sieberts S, Kellen M, Friend S (2011) Developing predictive molecular maps of human disease through community-based modeling. http://dx.doi.org/10.1038/npre.2011.5883.1. Accessed 1 Feb 2012Google Scholar
  22. Edwards AM, Bountra C, Kerr DJ, Willson TM (2009) Open access chemical and clinical probes to support drug discovery. Nat Chem Biol 5(7):436CrossRefGoogle Scholar
  23. Enserink M (2006) Italy’s influenza diva. Science 314:918–919CrossRefGoogle Scholar
  24. FitzGerald GA (2005) Anticipating change in drug development: the emerging era of translational medicine and therapeutics. Nat Rev Drug Discov 4:815–818. doi: 10.1038/nrd1849 CrossRefGoogle Scholar
  25. Gallini N, Scotchmer S (2002) Optimal design: the case of cumulative innovation. http://socrates.berkley.edu/Xscotch/ip.htm. Accessed 1 Feb 2012
  26. Gitter DM (2012) The challenges of achieving open source sharing of biobank data. In: Pascuzzi G (ed) Comparative issues in the governance of research biobanks. Property, privacy, intellectual property, and the role of technology. Springer, Heidelberg (this volume)Google Scholar
  27. Gold RE (2010) Models for sharing data. Seminar at the Department of Law, University of TrentoGoogle Scholar
  28. Gold ER, Nicol D (2012) Beyond Open Source: Patents, Biobanks and Sharing. In: Pascuzzi G (ed) Comparative issues in the governance of research biobanks. Property, privacy, intellectual property, and the role of technology. Springer, Heidelberg (this volume)Google Scholar
  29. Granieri M (2010) La gestione della proprietà intellettuale nella ricerca universitaria. Invenzioni accademiche e trasferimento tecnologico. Il Mulino, BolognaGoogle Scholar
  30. Guedon JC (2004) The “green” and “gold” roads to open access: the case for mixing and matching. http://eprints.rclis.org/archive/00003039/01/science.pdf. Accessed 2 Feb 2012
  31. Hardin G (1968) The tragedy of the commons. Science 162:1243–1248CrossRefGoogle Scholar
  32. Heller MA (1998) The tragedy of the anticommons: property in the transition from Marx to markets. Harv Law Rev 111:621–688CrossRefGoogle Scholar
  33. Heller MA (1999) The boundaries of private property. Yale Law Rev 108:1163–1223CrossRefGoogle Scholar
  34. Heller MA, Eisenberg RS (1998) Can patents deter innovation? The anticommons in biomedical research. Science 280:698–701CrossRefGoogle Scholar
  35. Hess C, Ostrom E (2007) Understanding knowledge as a commons. MIT University Press, CambridgeGoogle Scholar
  36. Hipkens HL (1992) Failed search for the perfect analogy: more reflections on the unusual case of John Moore. Ky Law J 80:337–352Google Scholar
  37. Hope J (2008) Biobazaar: the open source revolution and biotechnology. Harvard University Press, CambridgeGoogle Scholar
  38. ICSU (2004) Report of the CSPR assessment panel on scientific data and information. http://www.science-softcon.de/cspr.pdf. Accessed 1 Feb 2012
  39. Javitt G (2010) Why not take all of me? Reflections on the immortal life of Henrietta Lacks and the status of participants in research using human specimens. Minn J Law Sci Technol 11:713–754Google Scholar
  40. Johns A (2009) Piracy: the intellectual property wars from Gutenberg to Gates. University of Chicago Press, ChicagoGoogle Scholar
  41. Kinney AJ, Krebbers E, Vollmer SJ (2004) Publications from industry. Personal and corporate incentives. Plant Physiol 134:11–15CrossRefGoogle Scholar
  42. Kitch E (1977) The nature and the function of the patent system. J Law Econ 20:265–290CrossRefGoogle Scholar
  43. Kranich N (2006) Countering enclosure: reclaiming the knowledge commons. In: Hess C, Ostrom E (eds) Understanding knowledge as a commons. MIT Press, Cambridge, pp 85–122Google Scholar
  44. Ku K (2007) Point: MTAs are the bane of our existence! Nat Biotechnol 25:721–722Google Scholar
  45. Ladas S (1929) The efforts for international protection of scientific property. Am J Int Law 23:555–559CrossRefGoogle Scholar
  46. Landecker H (1999) Between beneficence and chattel: the human biological in law and science. Sci Context 12:203–225CrossRefGoogle Scholar
  47. Landes WM, Posner RA (2003) The economic structure of intellectual property law. Harvard University Press, CambridgeGoogle Scholar
  48. Lei Z, Juneja R, Wright BD (2009) Patents versus patenting: implications of intellectual property protection for biological research. Nat Biotechnol 27(3):6–40Google Scholar
  49. Lerner J, Tirole J (2005) The economics of technology sharing. Open source and beyond. J Econ Perspect 19:99–120CrossRefGoogle Scholar
  50. Lessig L (1999) The limit in open code: regulatory standards and the future of the net. Berkley Technol Law J 14:759–769Google Scholar
  51. Lessig L (2004a) Free culture: the nature and future of creativity. Penguin, New YorkGoogle Scholar
  52. Lessig L (2004b) How I lost the big one. http://www.legalaffairs.org/issues/March-April-2004/story_lessig_marapr04.msp. Accessed 1 Feb 2012
  53. Lucey BP, Nelson-Rees WA, Hutchins GM (2009) Henrietta Lacks, HeLa cells, and cell culture contamination. Arch Pathol Lab Med 133:1463–1467Google Scholar
  54. Margoni T (2012) The roles of material transfer agreements in genetics databases and biobanks. In: Pascuzzi G (ed) Comparative issues in the governance of research biobanks. Property, privacy, intellectual property, and the role of technology. Springer, Heidelberg (this volume)Google Scholar
  55. Mazzoleni R, Nelson RR (1998) The benefits and costs of strong patent protection: a contribution to the current debate. Res Policy, Elsevier 27:273–284CrossRefGoogle Scholar
  56. Menell PS (1999) Intellectual property: general theories. In: Bouckaert B, De Geest G (eds) Encyclopedia of law and economics. Edward Elgar, Cheltenham, pp 129–188Google Scholar
  57. Merges RP (2011) Justifying intellectual property. Harvard University Press, CambridgeCrossRefGoogle Scholar
  58. Michelman FI (1967) Property, utility and fairness: comments on the ethical foundations of just compensation law. Harv Law Rev 80:1165–1258CrossRefGoogle Scholar
  59. Mowery DC (1998) Collaborative R&D: how effective is it? Issues in science and technology. http://www.issues.org/15.1/mowery.htm. Accessed 1 Feb 2012
  60. Mowery DC, Sampat BN (2005) The Bayh-Dole Act of 1980 and university industry technology transfer: a model for other OECD governments? J Technol Transfer 30:115–127CrossRefGoogle Scholar
  61. Mowery DC, Nelson RR, Sampat BN, Ziedonis AA (2004) Ivory tower and industrial innovation. University-industry technology transfer before and after the Bayh-Dole Act. Standford University Press, Palo AltoGoogle Scholar
  62. Murray F, Stern S (2007) Do formal intellectual property rights hinder the free flow of scientific knowledge? An empirical test of the anti-commons hypothesis. J Econ Behav Organ 63:648–687CrossRefGoogle Scholar
  63. Nelson RR (2001) Observations on the post-Bahy-Dole rise of patenting at American universities. J Technol Transfer 26:13–19. doi: 10.1023/A:1007875910066 CrossRefGoogle Scholar
  64. Nichols D, Twidale M (2003) The usability of open source software. http://frodo.lib.uic.edu/ojsjournals/index.php/fm/article/view/1018/939. Accessed 1 Feb 2012
  65. Noonan K (2009) Conflating MTAs and patents. Nat Biotechnol 27:504–505CrossRefGoogle Scholar
  66. Nordhaus WD (1969) Invention, growth and welfare: a theoretical treatment of technological change. MIT Press, CambridgeGoogle Scholar
  67. O’Brien SJ (2001) Cell culture forensics. PNAS 14:7656–7658. doi: 10.073/pnas.141237598 CrossRefGoogle Scholar
  68. Paganelli M (1989) Alla volta di Frankestein: biotecnologie e proprietà (di parti) del corpo. Foro it IV: 417–441Google Scholar
  69. Parisi F, Schulz N, Depoorter B (2005) Duality in property: commons and anticommons. Int Rev Law Econ 25:578–591CrossRefGoogle Scholar
  70. Plant A (1934a) The economic aspects of copyright in books. Econ New Series 1:167–195CrossRefGoogle Scholar
  71. Plant A (1934b) The economic theory concerning patents for Inventions. Econ New Series 1:30–51CrossRefGoogle Scholar
  72. Rai A, Eisenberg R (2003) Bayh-Dole reform and the progress of biomedicine. Law Contemp Probl 66:289–314Google Scholar
  73. Raymond ES (2000) The cathedral and the bazaar. http://www.catb.org/~esr/writings/homesteading/cathedral-bazaar/. Accessed 1 Feb 2012
  74. Rodriguez V (2008) Governance of material transfer agreements. Technol Soc 30:122–128CrossRefGoogle Scholar
  75. Roppo E (1975) Contratti standard: autonomia e controlli nella disciplina delle attività negoziali di impresa. Milano, GiuffrèGoogle Scholar
  76. Samuelson P (2003) The constitutional law of intellectual property after Eldred v. Ashcroft. http://people.ischool.berkeley.edu/~pam/papers/post-Eldred.pdf. Accessed 1 Feb 2012
  77. Skloot R (2010) The immortal life of Henrietta Lacks. Crown Publishers, New YorkGoogle Scholar
  78. Stallman R (2002) Free software, free society. http://www.gnu.org/doc/fsfs-ii-2.pdf. Accessed 1 Feb 2012
  79. Strauss S (2010) Pharma embraces open source models. Nat Biotechnol 28:631–634CrossRefGoogle Scholar
  80. Streitz WD, Bennett AB (2003) Material transfer agreements: a university perspective. Plant Physiol 133:10–13CrossRefGoogle Scholar
  81. Suber P (2004a) Creating an intellectual commons through open access. http://nrs.harvard.edu/urn-3:HUL.InstRepos:4552055. Accessed 1 Feb 2012
  82. Suber P (2004b) Open access overview: focusing on open access to peer-reviewed research articles and their preprints. http://www.earlham.edu/~peters/fos/overview.htm. Accessed 1 Feb 2012
  83. Summit R (2002) Reflections on the beginnings of dialog: the birth of online information access. http://support.dialog.com/publications/chronolog/200206/jun2002.pdf. Accessed 1 Feb 2012
  84. The International HapMap Project (2003) The International HapMap Consortium. Nature 426: 789–796Google Scholar
  85. von Hippel E (2005) Democratizing innovation. MIT Press, CambridgeGoogle Scholar
  86. von Hippel E, von Krogh G (2003) Open source software and the ‘private-collective’ innovation model: issues for organization science. Organ Sci 14:209–223CrossRefGoogle Scholar
  87. Weigelt J (2009) The case for open-access chemical biology. EMBO Rep 10:941–945CrossRefGoogle Scholar

Copyright information

© Springer-Verlag Berlin Heidelberg 2013

Authors and Affiliations

  1. 1.Law and Technology Research Group, Department of Legal SciencesUniversity of TrentoTrentoItaly
  2. 2.Law and Technology Research Group, Department of Legal SciencesUniversity of TrentoTrentoItaly

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