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Comparative Issues in the Governance of Research Biobanks pp 209–229Cite as

Opening Research Biobanks: An Overview

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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.

Roberto Caso is the author of paragraphs 16.1, 16.2, and 16.6. Rossana Ducato is the author of paragraphs 16.3, 16.4 and 16.5.

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Notes

  1. 1.

    According to Robert Merges, IP law is like Shanghai or other megacities of the developing world, where new constructions and buildings proliferate everywhere without taking into account the urban planning of the old city. The author concludes his metaphor asserting that: “It’s an exciting time, to be sure; but a confusing time too”. Merges (2011).

  2. 2.

    See also Ladas (1929), Plant (1934a, b), Nordhaus (1969), Mazzoleni and Nelson (1998), Menell (1999), and Landes and Posner (2003).

  3. 3.

    Heller and Eisenberg (1998), p. 698.

  4. 4.

    See Heller and Eisenberg (1998), Lessig (2004a, b), and Boyle (2008).

  5. 5.

    Bayh–Dole Act is a watershed from the past patent regimes. First of all, it introduces the possibility of patenting results of publicly funded research. Secondly, it allows university and public laboratories to sell exclusive licences to private companies or to create partnership with them in order to economically exploit the research results and to translate their basic research into marketable products. See Rai and Eisenberg (2003) and Corian and Weinstein (2011).

  6. 6.

    Digital Millennium Copyright Act, 17 U.S. Code. This statute has qualified as a criminally relevant behaviour the circumvention of technological protection measures and the distribution of tools to encompass DRM.

  7. 7.

    Copyright Term Extension Act, 17 U.S. Code, also known as Mickey Mouse Protection Act, extended copyright terms in the U.S.A. as following: duration of copyright protection is raised from 50 to 70 years after the death of the author and it lasts 120 years after creation or 95 years after publication if it is a work of corporate authorship.

  8. 8.

    Council Directive 91/250/EEC of 14 May 1991 on the legal protection of computer programs, in Official Journal L 122 of 17 May 1991.

  9. 9.

    Directive 96/9/EC of the European Parliament and of the Council of 11 March 1996 on the legal protection of databases, in Official Journal L 077 of 27 March 1996.

  10. 10.

    Directive 98/44/EC of the European Parliament and of the Council of 6 July 1998 on the legal protection of biotechnological inventions, in Official Journal L 213 of 30 July1998.

  11. 11.

    Directive 2001/29/EC of the European Parliament and of the Council on the harmonization of certain aspects of copyright and related rights in the information society, in Official Journal L 167 of 22 June 2001. The importance of IP protection is stressed in whereas 4 and 9.

  12. 12.

    Directive 2004/48/EC of the European Parliament and of the Council on the enforcement of intellectual property rights, in Official Journal L 157 of 30 April 2004. See whereas 10: “The objective of this Directive is to approximate legislative systems so as to ensure a high, equivalent and homogeneous level of protection in the internal market”.

  13. 13.

    Taking as an example the case law of the United States, because its parabola serves to illustrate the evolution of the trend towards enclosure, regarding patents we can mention Diamond v. Chakrabarty, 447 U.S. 303 (1980), affirming that, “anything under the sun made by man is patentable”, and introducing the patent protection for micro-organism; State Street Bank and Trust Company v. Signature Financial Group Inc., 149 F. 3d 1368 (1998), establishing the patentability of business methods in the United States; Appeal from the United States District Court for the Southern District of New York in Case No. 09-CV-4515 (Association for Molecular Pathology v. UPO) overruling the revolutionary judgment of the NY District court which had invalidated the Myriad patents on BRCA gene in virtue of the “product of nature” doctrine. The Court of Appeal overruled the decision of the inferior court and confirmed the principle that isolated DNA is a distinct chemical entity with different physical characteristics from natural DNA, so eligible for patent protection under 35 USC §101. Meanwhile, with regard to copyright Eldred v. Ashcroft, 123 S.Ct 769 (2003) is significant, a decision that seems to attribute to Congress the possibility of extending the validity of copyright without apparently any limit (see Samuelson 2003; Lessig 2004a, b; Kranich 2006); more specifically on file sharing, see the famous ruling of A&M Records v. Napster, 239 F.3rd 1004 (9th Cir. 2001); MGM Studios Inc. v. Grokster Ltd, 545 U.S. 913 (2005)

  14. 14.

    Corian and Weinstein (2011).

  15. 15.

    Boyle (2003).

  16. 16.

    Parisi et al. (2005).

  17. 17.

    Hardin (1968).

  18. 18.

    Michelman (1967) and Heller (1998, 1999).

  19. 19.

    http://www.time.com/time/specials/packages/completelist/0,29569,1884779,00.html. Accessed 01.02.2012.

  20. 20.

    Streitz and Bennett (2003), Kinney et al. (2004), and Murray and Stern (2007).

  21. 21.

    Moore v. Regents of University of California, 51 Cal.3d 120, Supreme Court of California, 9 July 1990.

  22. 22.

    Landecker (1999), O’Brien (2001), Lucey et al. (2009), Javitt (2010), and Skloot (2010).

  23. 23.

    The Moore affair gave rise to a long and famous lawsuit: John Moore, after discovering the business built from his cell by Dr. Golde and Dr. Quan, his two physicians at UCLA, tried to sue them for breach of fiduciary duty in the doctor–patient relationship (both had acted without his informed consent), but above all for the recognition of property rights on the patented cell line (he claimed for conversion). About this case, see Annas (1988), Paganelli (1989), Hipkens (1992), Burrow (1997), and Campbell (2006).

  24. 24.

    Johns (2009).

  25. 25.

    Heller and Eisenberg (1998), Mowery (1998), and Granieri (2010).

  26. 26.

    Nelson (2001). Some authors downsized the importance of Bayh–Dole Act in the university patent process. See, for example, Mowery et al. (2004) and Mowery and Sampat (2005).

  27. 27.

    Such as for example, Dialog System. See Summit (2002).

  28. 28.

    Guedon (2004), Suber (2004a, b), Kranich (2006), and Caso (2009).

  29. 29.

    Rai and Eisenberg (2003).

  30. 30.

    This recent trend towards the appropriation of data is posing serious obstacles to full and open access to data for scientific purposes. ICSU (2004).

  31. 31.

    Booth and Zemmel (2004), Cuatrecasas (2006), and Weigelt (2009).

  32. 32.

    Translational medicine is based on pre-clinical bio-molecular analysis of a critical mass of human biological samples in order to obtain results immediately usable in the clinical context. This allows the identification of biomarkers, i.e. those molecules that can predict the risk of cancer, the presence of a neoplasia and the possibility of identifying the most appropriate and effective drug or treatment for a particular patient. See FitzGerald (2005).

  33. 33.

    Streitz and Bennett (2003), Ku (2007), Rodriguez (2008), Lei et al. (2009), and Noonan (2009). Specifically on the problems related to MTA and possible solutions offered by Science Commons, see Margoni (2012).

  34. 34.

    Hess and Ostrom (2007), Hope (2008), Edwards et al. (2009), Weigelt (2009), Lei et al. (2009), and De Robbio and Corradi (2010).

  35. 35.

    Kitch (1977) and Gallini and Scotchmer (2002).

  36. 36.

    The Italian virologist identified the genetic sequence of the avian flu virus and decided to make it available to the worldwide scientific community by uploading it to GenBank, disregarding the invitation of the WHO to file it in a limited-access database. See Enserink (2006).

  37. 37.

    Strauss (2010).

  38. 38.

    The following classifications were also illustrated by Prof. Richard Gold during the seminar “Models for Sharing Data” within the Biobank Lab, held at the University of Trento in May 2010.

  39. 39.

    In 1983, he announced the GNU project, an operative system compatible with Unix, the proprietary software more widespread in research laboratories in American universities. Stallman’s novel idea consisted in the creation of a licence (copyleft, “all rights reversed”) giving much more power to the user than to the owner. About the origins of free software, see Stallman (2002).

  40. 40.

    Raymond (2000).

  41. 41.

    A way to overcome this problem is a particular technique called reverse engineering, where the reverser analyses the programs and tries to understand how they work without having the source code. See Lessig (1999) and Nichols and Twidale (2003).

  42. 42.

    Stallman (2002).

  43. 43.

    Gitter (2012).

  44. 44.

    Dasgupta and David (1987).

  45. 45.

    Boettinger and Burk (2004).

  46. 46.

    Ibid., p. 225.

  47. 47.

    See BIOS concordance.

  48. 48.

    About the adoption of the open source model in the biotech field, Hope ( 2008).

  49. 49.

    http://www.bios.net/daisy/bios/home.html. Accessed 01.02.2012.

  50. 50.

    Internation HapMap Project, http://hapmap.ncbi.nlm.nih.gov/. Accessed 01.02.2012. See also The International HapMap Project (2003).

  51. 51.

    See http://hapmap.ncbi.nlm.nih.gov/datareleasepolicy.html. It is not well specified how quick the release into the public domain has to be.

  52. 52.

    According to Daniel de Beer a “patent parasite” is a patent developed from the original material “to which just a tiny change has been made”. De Beer (2005), p. 366.

  53. 53.

    HapMap Project, Data Release Policies.

  54. 54.

    von Hippel and von Krogh (2003).

  55. 55.

    Hope (2008), Chakravarty et al. (2007).

  56. 56.

    As pointed out by Gold (2010).

  57. 57.

    Lerner and Tirole (2005).

  58. 58.

    de Beer (2005).

  59. 59.

    Gold and Nicol (2012).

  60. 60.

    Suber (2004a, b).

  61. 61.

    Guedon (2004).

  62. 62.

    Creative Commons (CC) is a charitable corporation that promotes the sharing and circulation of knowledge in compliance with copyright law. Although it offers standardised models, its modular licenses (attribution, noncommercial, no derivative works, share alike) and their combinations can provide flexibility in setting the interests of parties. Source: http://creativecommons.org/.

  63. 63.

    Caso (2009).

  64. 64.

    De Robbio (2010).

  65. 65.

    Boyle (1997).

  66. 66.

    Suber (2004a, b).

  67. 67.

    http://www.openwetware.org/. Accessed 01.02.2012.

  68. 68.

    http://www.plos.org/. Accessed 01.02.2012.

  69. 69.

    http://www.openarchives.org/. Accessed 01.02.2012.

  70. 70.

    http://sciencecommons.org/projects/publishing/open-access-data-protocol/. Accessed 01.02.2012.

  71. 71.

    At first, Science Commons encouraged database licensing under the CC licences or the GNU Free Documentation Licence. The initial approach was abandoned for three main reasons (category errors, false expectations, attribution staking) and now the scope is to converge on public domain. http://sciencecommons.org/projects/publishing/open-access-data-protocol/. Accessed 01.02.2012.

  72. 72.

    Ibidem.

  73. 73.

    Kranich (2006).

  74. 74.

    http://www.thesgc.org/. Accessed 01.02.2012. SGC is a non-profit organisation founded in 2004 with the aim of promoting the development of new drugs, investing in basic research and releasing to the public every type of information (from reagents to know-how) The SGC’s primary goal is to determine the three-dimensional structure of proteins, in order to understand the molecular mechanisms of their biological function. Then, the data obtained are deposited in the Protein Data Bank (PDB), a freely accessible archive, which since 1971 collects information about 3D structures of large molecules, including proteins and nucleic acids (http://www.pdb.org/pdb/home/home.do).

  75. 75.

    http://sagebase.org/. Accessed 01.02.2012.

  76. 76.

    http://www.ebi.ac.uk/. Accessed 01.02.2012.

  77. 77.

    http://c-path.org/pstc.cfm. Accessed 01.02.2012.

  78. 78.

    http://www.iuphar.org/. Accessed 01.02.2012.

  79. 79.

    http://www.pistoiaalliance.org/. Accessed 01.02.2012.

  80. 80.

    http://www.imi.europa.eu/. Accessed 01.02.2012.

  81. 81.

    Chesbrough (2003).

  82. 82.

    Weigelt (2009) and Edwards et al. (2009).

  83. 83.

    Ibidem.

  84. 84.

    Derry et al. (2011).

  85. 85.

    http://sagebase.org/downloads/SageBio_Governance.pdf. Accessed 01.02.2012.

  86. 86.

    von Hippel (2005).

  87. 87.

    De Robbio (2010).

  88. 88.

    The contractual component is the ideal solution in order to settle the parties’ interests, but in the biobank context MTA is more the problem than the cure. Collaborative initiatives such as Science Commons have offered contractual models to make the transfer of research materials easier, thanks to a flexible, modular, web-based and user-friendly tool. However, this MTA has the usual disadvantages of standard agreement and its modularity partially alleviates the problem by providing a limited space for autonomy. On the one hand, standardisation helps to reduce transaction costs and to facilitate circulation, but on the other hand, it creates difficulties in the field of open licences. Furthermore, a standard contract is always deficient in participatory aspects, because the contents of the agreement do not result from a negotiation, but it is unilaterally imposed. On the problems related to the standardisation of contracts, see Roppo (1975), Boggiano (1991), and Alpa and Bessone (1997).

  89. 89.

    Cambon-Thomsen (2003).

  90. 90.

    http://www.basquebiobank.com/. Accessed 01.02.2012.

  91. 91.

    NIH Public Access Policies, http://publicaccess.nih.gov/. Accessed 01.02.2012.

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Authors and Affiliations

  1. Law and Technology Research Group, Department of Legal Sciences, University of Trento, Via Rosmini 27, II Floor, Room 8, Trento, Italy

    Roberto Caso

  2. Law and Technology Research Group, Department of Legal Sciences, University of Trento, Via Verdi 53, Trento, Italy

    Rossana Ducato

Authors
  1. Roberto Caso
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  2. Rossana Ducato
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Correspondence to Roberto Caso .

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Editors and Affiliations

  1. University of Trento, via Verdi 73, Trento, 38122, Italy

    Giovanni Pascuzzi

  2. , Faculty of Law, University of Trento, Via Verdi 53, Trento, 38122, Italy

    Umberto Izzo

  3. University of Trento, Via Verdi 53, Trento, 38122, Italy

    Matteo Macilotti

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Caso, R., Ducato, R. (2013). Opening Research Biobanks: An Overview. In: Pascuzzi, G., Izzo, U., Macilotti, M. (eds) Comparative Issues in the Governance of Research Biobanks. Springer, Berlin, Heidelberg. https://doi.org/10.1007/978-3-642-33116-9_12

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