Abstract
Two examples of research biobanks are discussed. The first is a set of stored blood samples taken from Havasupai Indians by scientists at Arizona State University (ASU). The second is a set of zinc finger proteins (ZFPs) and zinc finger nucleases (ZFNs) assembled by Sangamo BioSciences, Inc. of California. Both examples involve individual and group autonomy, informational asymmetries, and exchange. Both examples are controversial but for different reasons. In the Havasupai case, the Indians claimed that the scientists used the blood samples to analyze a Havasupai predisposition to diabetes, to which they consented, and to extract information about Havasupai inbreeding, schizophrenia, and geographical origins, to which the Indians did not consent. Eventually, ASU returned the blood samples and compensated the tribe and some individual members. Scrutiny shows that the Havasupai complaints were mainly justified. As to ZFPs and ZFNs, some lawyer-scientists contend that Sangamo’s preeminent patent and trade secret position unfairly hinders others from benefiting from Sangamo’s knowledge. Close examination shows no unfairness in the Sangamo case, for two reasons. First, the Zinc Finger Consortium provided an open access alternative to dealing with Sangamo. Second, under standard economic criteria Sangamo did not have a monopoly on zinc finger technology.
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- 1.
A recent achievement of synthetic biology was the transplantation of a synthesised genome into a recipient cell whose genetic material had been removed (Gibson et al. 2010, p. 52).
- 2.
The DNA sequences must have some known function in a cell, such as coding for the protein keratin. Parts consist of at least two functional DNA sequences that produce something in a cell, such as coding for conjugation plasmids. Devices consist of at least two parts that together perform a more complicated function in a cell—for example, a ribosome binding site, a protein coding region, a promoter, and a terminator can form an inverter (repressor), which lowers an intracellular signal in order to reduce the amount of a target protein. The MIT Registry has not yet carefully defined a system, but Jha 2005 suggests that a collection of devices that performs a task would be a system. For instance, three inverters working together could form a system for quantifying gene expression in terms of PoPS (Polymerase Per Second). Part Types, http://partsregistry.org/Part_Types. Accessed 25 October 2010. Parts, Devices, and Systems, http://partsregistry.org/cgi/htdocs/AbstractionHierarchy/index.cgi. Accessed 25 October 2010. Part Types: Measurement Systems, http://partsregistry.org/wiki/index.php/Part_Types:Measurement_Systems. Accessed 25 October 2010.
- 3.
See, e.g., Havasupai Tribe v. Ariz. Bd. of Regents, 204 P.3d 1063 (Ariz. App. Div. 2008) (reversing the Superior Court’s grant of summary judgment in favor of the tribe and its members and remanding for further proceedings).
- 4.
See, e.g., Tiloussi v. Ariz. State Univ., 2005 WL 6199562 (D. Ariz.) (dismissing some claims but allowing others to proceed).
- 5.
Second Amended Complaint, Havasupai Tribe v. Ariz. Bd. of Regents, CV2005-013190 (filed 22 February 2006) (on file with the author).
- 6.
Settlement Agreement and Mutual Release, Exhibit C, Havasupai Tribe v. Ariz. Bd. of Regents, CV2005-013190 (6 March 2010) (on file with the author).
- 7.
Harmon (2010); Tribal Genes and a Fair Settlement, N.Y. Times, 27 April 2010, at A22.
- 8.
- 9.
Faden and Beauchamp (1986), pp. 235–273, draw a useful distinction, which I happily accept, among autonomous persons, autonomous choices and autonomous actions. However, their book was written before the contemporary philosophical discussion of autonomy, self-governance and control rights, which are important to my analysis, had reached its current maturity. Neither do they devote much attention to groups.
- 10.
I take no position on which institutions or means Indian tribes in the United States should use in governing themselves. For the view that they should use principles drawn from their own tribal tradition and culture, see Riley (2007).
- 11.
- 12.
No researcher can predict all possible uses of blood samples many years down the road. Austin and Lemmens (2009) call this “the problem of the unknown future”. They wisely distinguish between consent to participate in a biobank and consent to participate in specific research projects of the biobank. They argue plausibly that if a biobank satisfies certain conditions, then we can relax strict requirements for informed consent despite the problem of the unknown future. Among these conditions are (1) the biobank has a governance structure that provides consistent information practices across all projects, (2) the biobank uncouples health information from individuals’ identities, and (3) the biobank’s governance structure protects individual privacy interests (Austin and Lemmens 2009, pp. 111, 112–113, 118–121). This possible solution may work less well for informed consent by groups, which they do not address.
- 13.
Defendant Arizona Board of Regents’ Answer to the Havasupai Tribe’s Second Amended Complaint, Tiloussi v. Ariz. Bd. of Regents, CV2005-013190 (30 October 2006) (on file with the author).
- 14.
Horvatta et al. (1999), p. 1114. There are many varieties and subtypes of schizophrenia. Am. Psychiatric Ass’n, Diagnostic and Statistical Manual of Mental Disorders 297–323 [4th ed. Text Revision (2000)].
- 15.
Harmon (2010), supra note 7.
- 16.
Id.
- 17.
Id.
- 18.
Rohter (2007) recounts the giving of blood samples by the Amazonian Karitiania Indians in return for promises of medicine, even though they never received any medicine, and cell lines and DNA from their blood were distributed to scientists world-wide at $85 per sample by Coriell Cell Repositories of Camden, New Jersey, USA.
- 19.
Ishi (c. 1860–1916), the last of the Yana people of California to live most of his life outside European–American culture, spent almost all of his final years in the University of California at Berkeley Museum of Anthropology. For further information, see Kroeber (1961, 2002).
- 20.
One can see a related phenomenon in scientists’ treatment of African Americans in the Tuskegee Syphilis Experiment (1932–1972). Office of the Sec’y (1979), also known as the Belmont Report, summarizes ethical principles for the treatment of human research subjects in the wake of the Tuskegee Experiment, which let blacks with syphilis go untreated. Thomas and Quinn (1991), p. 1498.
- 21.
Lightfoot-Klein (1989).
- 22.
Id. at 38–39.
- 23.
Parfit (1984), pp. 351–379, formulates the non-identity problem and discusses whether the fact of non-identity makes a moral difference.
- 24.
The BioBricks Foundation, http://openwetware.org/wiki/The_BioBricks_Foundation. Accessed 25 October 2010. BBF links to the MIT Registry are informal. However, both organizations support openness in synthetic biology and technical standards for DNA parts.
- 25.
Anderson et al. (2010); The BioBricks Foundation, http://biobricks.org. Accessed 25 October 2010.
- 26.
Comments on Draft Version 1a, dated January 2010, may be sent to Drew Endy or David Grewal. The BioBricks Public Agreement, http://www.biobricks.org. Accessed 25 October 2010.
- 27.
Heller (1998), p. 621.
- 28.
- 29.
Kumar and Rai (2007), p. 1751.
- 30.
Cahoy and Glenna (2009), p. 426.
- 31.
- 32.
Here I would include registered patent agents along with patent lawyers.
- 33.
Solomon v. Kimberly-Clark Corp., 216F.3d 1372, 1382 (Fed. Cir. 2000).
- 34.
For a good summary of the structures and functions of ZFPs, see Klug (2010).
- 35.
US patent no. 7,705,139 (filed 19 October 2006) (issued 27 April 2010).
- 36.
Krishna et al. (2003), p. 532.
- 37.
Kumar and Rai (2007), supra note 29, at 1755 (using their definition from 1751 quoted at text accompanying note 29 supra).
- 38.
Id. at 1756. For critical but appreciative discussion of their article, see Munzer (2009), supra note 29, at 290–297.
- 39.
Chandrasekharan et al. (2009), p. 140. Their article is by far the ablest short account of the patent/trade-secret/open-source landscape of zinc finger technology.
- 40.
Id. at 141.
- 41.
Id. US patent no. 7,177, 766 (filed 2 April 1001) (issued 13 February 2007) (incorrectly numbered in Chandrasekharan et al. 2009, supra note 39, at 141); US patent no. 6,785,613 (filed 28 March 2002) (issued 31 August 2004); US patent no. 6,453,242 (filed 19 January 1999) (issued 17 September 2002).
- 42.
US patent no. 6,794,136 (filed 20 November 2000) (issued 21 September 2004).
- 43.
Chandrasekharan et al. (2009), supra note 39, at 140.
- 44.
Id.
- 45.
Id. at 141.
- 46.
Id. at 143.
- 47.
Id. at 142 (Fig. 2).
- 48.
For help I am most grateful to Jamie L. Summers and UCLA reference librarian Stephanie Plotin. The Appendix lists these patents.
- 49.
The methodology used to obtain the new data was almost exactly the same as that employed by Chandrasekharan et al. (2009), supra note 39, at 141 (Fig. 1). For the details, see the end of the Appendix. There is a counterpart to Appendix 1 in the online supplementary materials to Chandrasekharan et al. (2009), supra, which are available at http://www.nature.com/nbt/journal/v27/n2/extref/nbt0209-140-S1.pdf. Accessed 25 October 2010.
- 50.
Sangamo (SGMO) trades on Nasdaq and closed at US$4.01 on 21 October 2010, with a 52-week range of US$2.81–6.82. The stock pays no dividend and showed earnings per share of negative US$0.34. See http://finance.yahoo.com/q?s=sgmo. Accessed 25 October 2010.
- 51.
Chandrasekharan et al. (2009), supra note 39, at 142.
- 52.
Id.
- 53.
Id.; The Zinc Finger Consortium, http://www.zincfingers.org. Accessed 25 October 2010. Sander et al. (2007). The Consortium also archives plasmids that code for zinc finger modules, which Addgene distributes to academic scientists. Addgene, http://www.addgene.org. Accessed 25 October 2010.
- 54.
Genetic Testing Facilities and Cost, 19 March 2009, http://www.breastcancer.org/symptoms/testing/genetic/facility_cost.jsp. Accessed 25 October 2010.
- 55.
Ass’n for Molecular Pathology v. U.S. Pat. & Trademark Office, 702F. Supp. 2d 181 (S.D.N.Y. 2010) (holding that Myriad’s method and composition of matter claims are invalid under 25 U.S.C. §101). The case is on appeal to the Federal Circuit.
- 56.
Foundation for Taxpayer & Consumer Rights v. Patent of Wisc. Alumni Res. Found., 2010 WL 1734377 (Bd. Pat. App. & Interf.) (reversing the Examiner’s decision to withdraw the rejection of claims 1–3 of US patent no. 7,029, 913 under 35 U.S.C. §103(a) as obvious and anticipated by prior art); PRN Newswire, Patent on Human Embryonic Stem Cells Rejected After Consumer Groups’ Appeal, 3 May 2010, available at http://www.prnewswire.com/news-releases/patent-on-human-embryonic-stem-cells-rejected-after-consumer-groups-appeal-92668229.html (last visited 25 October 2010) (reporting that “two consumer groups … praised [the decision] as a victory for open scientific inquiry”). WARF is appealing. The decision does not affect WARF US patents nos. 5,843,780 and 6,200,806, which also cover embryonic stem cells.
- 57.
- 58.
Brown (1984), p. 359.
- 59.
Miller et al. (1985), p. 1609.
- 60.
Klug (2005), p. 213.
- 61.
A good review of the development of synthetic biology and the state of the art may be found in Special Issue: Synthetic Biology (2010) BioEssays 32:265–363.
- 62.
- 63.
702 F. Supp. 2d 181 (S.D.N.Y. 2010).
- 64.
Chandrasekharan et al. (2009), supra note 39, at 141.
- 65.
Id. at 142, citing Farrell and Weiser (2003), p. 85.
- 66.
The authors cite Merges and Nelson (1990), p. 839.
- 67.
Chandrasekharan et al. (2009), supra note 39, at 142.
- 68.
Id. (“Sangamo … appears to be highly selective in its choice of collaborators”).
- 69.
Id. at 143.
- 70.
Id.
- 71.
Id.
- 72.
Id.
- 73.
Noveck (2006), p. 123; Ctr. for Patent Innovations, N.Y. Law Sch., Peer to Patent: Second Anniversary Report (June 2009), http://dotank.nyls.edu/communitypatent/CPI_P2P_lo.pdf. Accessed 25 October 2010.
- 74.
See Munzer (2009), supra note 28, at 276–280.
- 75.
Chandrasekharan et al. (2009), supra note 39, at 140.
- 76.
The authors’ Supplementary Table 1, which is available online (see note 48 supra), lists a total of 68 patents, and my Appendix lists an additional 35 patents.
- 77.
Id. at 143.
- 78.
A university might have a rule that students may not enroll in more than six courses per semester. Understood distributively, this statement is true, for each student may take no more than six courses per semester. Understood collectively, this statement is false, for all of the university’s students taken together may enroll in hundreds if not thousands of different courses each semester. Copi (1972), p. 96.
- 79.
Sangamo Biosciences, Inc., 2009 Form 10-K (5 March 2010), at 27–41, available at http://files.shareholder.com/downloads/SGMO/1025588598x0x358508/F33603B8-8846-4AB7-9429DEAA74-B57B76/65269_002_SANGAMO_BIOSCIENCES_INC_BMK.pdf. Accessed 25 October 2010.
- 80.
Scott (2005), p. 915, claims that Sangamo has a “monopoly” on ZFNs and a “stranglehold” on ZF technologies. His antitrust analysis in support of these claims is pretty much nonexistent. Whether he would make the same claims in 2010 like he did in 2005, I do not know.
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Acknowledgements
Stephen R. Munzer thanks go to Douglas Fretty, Doug Lichtman, Nory Loeung, Jon Michaels, Hiroshi Motomura, Jennifer Mnookin, Neil Netanel, Frances Olsen, Stephanie Plotin, Angela R. Riley, Seana Shiffrin, and Eric Zolt. I am grateful for the short-term research assistance of Jenifer Morrissey and Matthew Schroeder and especially for the exceptional long-term research assistance of Mark Metzke and Jamie L. Summers.
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Appendix
Appendix
To determine the ZF patent landscape from 1 January 2008 through 1 June 2010, UCLA School of Law reference librarian Stephanie Plotin searched the USPTO patent database. Using Dialog®, she searched with the same algorithm used by Chandrasekharan and her colleagues.: (((ZFP) <in> (TITLE,ABSTRACT,CLAIMS)) OR ((ZFP) <in> (TITLE,ABSTRACT,CLAIMS)) OR ((Zinc finger) <in> (TITLE,ABSTRACT,CLAIMS)) OR ((zinc finger binding protein) <in> TITLE,ABSTRACT,CLAIMS)). Although Chandrasekharan et al. used Delphion analysis tools for their search, I believe that Delphion and Dialog would have turned up exactly the same patents. Dr. Mark Metzke and Ms. Jamie L. Summers read and categorised the patents independently. They made appropriate judgments in regard to noise and ZF category. In the case of initial differences of opinion, they discussed the patents in question until they reached consensus. One cannot be certain that the Metzke-Summers team classified the patents issued between 1 January 2008 and 1 June 2010, exactly as the Chandrasekharan-Valley team would have done. The initial categories used were the same as those in Chandasekharan et al.: (1) design or selection of ZFPs, (2) angiogenesis (including methods or applications affecting Vascular Endothelial Growth Factor gene expression using ZFPs and “anti-angiogenesis” applications), (3) modify/affect gene expression (use of engineered fusion ZFPs and/or ZFP transcription factors to alter or regulate gene expression in different cell types), (4) screen for molecular targets using ZFPs (e.g., methods of screening for drug/protein/nucleic acid interactions, or screening for target interaction with drug compounds or ligands), and (5) gene modification (use of an engineered ZFP or ZFN to alter DNA content and make targeted changes in genes). As a result of Metzke’s and Summers’ discussions, they concluded that an additional category was needed: (6) ZFP for non-gene uses (for ZFPs that are used as metal scavengers or other uses not involving nucleotides). Munzer cross-read the patents but did not depart from the Metzke-Summers conclusions, which this Appendix displays (Table 2.1).
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Munzer, S.R. (2013). Research Biobanks Meet Synthetic Biology: Autonomy and Ownership. 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_2
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