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Do You Own Your 3D Bioprinted Body?
Analyzing Property Issues at the Intersection of Digital Information and Biology
Published online by Cambridge University Press: 06 January 2021
Extract
By the end of 2013, almost 122,000 organ transplant candidates in the United States remained active on the national waiting list. The current number of candidates exceeds 123,000. To address this overwhelming need, researchers have been exploring methods to supplement traditional organ donations. At the forefront of this research is regenerative medicine, the field of regenerating or replacing tissue and organ function by studying the body’s own healing mechanisms. Regenerative medicine is quickly fulfilling its promise of producing vascularized, functioning organs in vitro by combining two other areas of research: the replication of cell lines in vitro and the recent adaptation of three-dimensional printing for the health care industry. Today, physicians armed with the latest generation of bioprinters and imaging equipment are creating high-resolution airway splints and personalized bone replacements for human use. These techniques have even achieved success with more complicated structures, including human kidneys and livers.
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- Copyright © American Society of Law, Medicine and Ethics and Boston University 2015
References
1 See M. Colvin-Adams et al., OPTN/SRTR 2013 Annual Data Report: Heart, 15 Am. J. Transplantation (Special Issue 2) 1, 9 fig.1.7, 20 fig.6.4 (2015) (3332 adult and 349 pediatric heart transplant candidates); R. Kandaswamy et al., OPTN/SRTR 2013 Annual Data Report: Pancreas, 15 Am. J. Transplantation (Special Issue 2) 1, 7 fig.1.7 (2015) (2932 pancreas transplant candidates); W.R. Kim et al., OPTN/SRTR 2013 Annual Data Report: Liver, 15 Am. J. Transplantation (Special Issue 2) 1, 6 fig.1.7, 20 fig.7.4 (2015) (15,001 adult and 577 pediatric liver transplant candidates); A.J. Matas et al., OPTN/SRTR 2013 Annual Data Report: Kidney, 15 Am. J. Transplantation (Special Issue 2) 1, 9fig.1.9, 25 fig.7.6 (2015) (96,533 adult and 1360 pediatric kidney transplant candidates); J.M. Smith et al., OPTN/SRTR 2013 Annual Data Report: Intestine, 15 Am. J. Transplantation (Special Issue 2) 1, 6 fig.1.5 (2015) (257 intestine transplant candidates); M. Valapour et al., OPTN/SRTR 2013 Annual Data Report: Lung, 15 Am. J. Transplantation 1, 9 fig.1.7, 19 fig.6.4 (2015) (1578 adult and 36 pediatric lung transplant candidates).
2 HHS, Latest Data Report on National Waiting List Candidates, Organ Procurement & Transplantation Network, http://optn.transplant.hrsa.gov/latestData/viewDataReports.asp (follow “National Data” hyperlink; then select “Waiting List” for Step 1 category; then select “Candidates ….” for the counting method; then follow “Overall by Organ” hyperlink) (last visited Mar. 19, 2015). If patients require more than one type of organ transplant, then the calculated number of candidates may be greater than the total number of candidates.
3 See Nat'l Insts. Health, Fact Sheet: Regenerative Medicine 1 (2010), http://report.nih.gov/nihfactsheets/Pdfs/RegenerativeMedicine(NIBIB).pdf (discussing the potential of regenerative medicine to eliminate donor organ shortage).
4 See id. (describing the promise of regenerative medicine to stimulate “previously irreparable organs to heal themselves” and to empower “scientists to grow tissues and organs in the laboratory and safely implant them when the body cannot heal itself”).
5 Hannah Landecker, Between Beneficence and Chattel: The Human Biological in Law and Science, 12 Sci. Context 203, 211 & n.14 (1999) (observing that human tumor cell research in vitro started as early as 1913, but that the isolation and reproduction of the HeLa cell line in 1951 is attributed for the field's historical success).
6 Fedorovich, Natalja E. et al., Organ Printing: The Future of Bone Regeneration?, 29 Trends Biotech. 601, 601 (2011)CrossRefGoogle ScholarPubMed (suggesting that three-dimensional printing can overcome the remaining challenges in regenerative medicine).
7 See, e.g., Zopf, David A. et al., Bioresorbable Airway Splint Created with a Three-Dimensional Printer, 368 New Eng. J. Med. 2043 (2013)CrossRefGoogle ScholarPubMed.
8 See, e.g., Fedorovich et al., supra note 6, at 601.
9 See, e.g., TED, Anthony Atala: Printing a Human Kidney – Anthony Atala, YouTube (Mar. 8, 2011), https://www.youtube.com/watch?v=9RMx31GnNXY.
10 Nupur Jha, World's First 3D Human Liver Printed by Organavo, Sci. World Rep. (Nov. 12, 2013, 8:47 AM), http://www.scienceworldreport.com/articles/10839/20131112/worlds-first-3d-human-liver-printed-organavo.htm.
11 Throughout this Note, I use “bioprinting” to refer to techniques that produce functional human tissues and organs by three-dimensional printing technology in the field of regenerative medicine.
12 See Michael Crichton, Next 251-52, 357-59, 372-77, 393-95 (2006) (discussing the fictional consequences of granting property rights over cell lines, such as the use of eminent domain to retrieve additional samples from the source or from descendants); Obasogie, Osagie K. & Theung, Helen, Moore Is Less: Why the Development of Induced Pluripotent Stem Cells Might Lead Us to Rethink Differential Property Interests in Excised Human Cells, 16 Stan. Tech. L. Rev. 51, 69 (2012)Google Scholar (noting that advances in induced pluripotent stem cell research, a critical development for bioprinting, “raises important questions for property law that have not even been articulated yet alone addressed”).
13 See, e.g., Norton, Aaron T. & Zehner, Ozzie, Which Half Is Mommy? Tetragametic Chimerism and Trans-Subjectivity, 36 Women's Stud. Q. 106, 122 (2008)Google Scholar (“A challenge to professionals and lay individuals is (and will continue to be) to imagine alternative legal and medical frameworks that open more space to valuing lived experience over genetic codes…. These legal precedents will not only directly challenge deterministic genetic assumptions but will also become reflexively involved with our evolving conceptualizations of bodies and their interrelations.”).
14 Eugene Thacker, The Global Genome: Biotechnology, Politics, and Culture 29 (2005) (“Genome databases, biological ‘libraries' of cell lines, patient databases at hospitals and clinics, prescription databases, insurance databases, online medical services, and a host of other innovations are transforming the understanding of ‘life itself' into an understanding of informatics.”).
15 The relationship was asymmetric in the sense that it was easier to translate biology into digital information than the reverse – creating a biological form by means of a digital blueprint. See id. (“In rarer cases, cell therapies, in vitro fertilization, genetic screening, and tissue engineering are literal instances of this biopolitical condition, in which data is made flesh.” (emphasis added)); TED, Craig Venter Unveils “Synthetic Life,” YouTube (May 21, 2010), https://www.youtube.com/watch?v=QHIocNOHd7A (unveiling “the first synthetic cell, a cell made by starting with the digital code in the computer” after fifteen years of effort).
16 See TED, supra note 9 (“So we go layer by layer through the organ, analyzing each layer as we go through the organ, and we then are able to send that information, as you see here, through the computer and actually design the organ for the patient.”).
17 See TED, Nina Tandon: Could Tissue Engineering Mean Personalized Medicine?, YouTube (Dec. 6, 2012), https://www.youtube.com/watch?v=r6nSmSTKHGc (“[T]issue engineering is actually poised to help revolutionize drug screening at every single step of the path: disease models making for better drug formulations, massively parallel human tissue models helping to revolutionize lab testing, reduce animal testing and human testing in clinical trials, and individualized therapies that disrupt what we even consider to be a market at all.”).
18 See, e.g., Landecker, supra note 5, at 219 (suggesting that the attending physician manipulated Moore, the patient, into scheduling follow-up visits since it “was vital to Golde’s patent application that Moore’s blood not enter the public domain.”).
19 Melchels, Ferry P.W. et al., Additive Manufacturing of Tissues and Organs, 37 Progress Polymer Sci. 1079, 1081-82 (2012)CrossRefGoogle Scholar.
20 Yongnian, Yan et al., Rapid Prototyping and Manufacturing Technology: Principle, Representative Technics, Applications, and Development Trends, 14 Tsinghua Sci. & Tech. (Supp. 1) 1, 2 (2009)Google Scholar.
21 Id.
22 Id. at 2-3. In some complicated systems, the abstract component could be realized as a “droplet, or a cell, or even a protein molecule.” Id.
23 See id. (noting that the process is conceptually the reverse of the dispersion process).
24 Id. at 2. Some scholars suggest that the pyramids in Egypt represent an earlier form of rapid prototyping, reducing a pyramid structure into layers of simple bricks. Id. While the pyramids may embody some of the fundamental principles of rapid prototyping, the construction techniques of the pyramids were far from rapid. Moreover, the patent in 1892 is an early example of an arbitrary three-dimensional shape. Manufacture of Contour Relief-Maps, U.S. Patent No. 473,901 (filed Apr. 24, 1890).
25 Yongnian, supra note 20, at 2; see also Apparatus for Prod. of 3D Objects by Stereolithography, U.S. Patent No. 4,575,330 (filed Aug. 8, 1984).
26 See Yongnian, supra note 20, at 3.
27 See id.
28 See '330 Patent col. 4 ll. 34-42 (noting that lithography techniques have also been used in other industries, including electronics and ink for high-speed printing).
29 See Yongnian, supra note 20, at 4.
30 See '330 Patent col. 5 ll. 55-59 (“[A]s the fluid medium cures and solid material forms to define one lamina, that lamina is moved away from the working surface of the fluid medium and the next lamina is formed in the new liquid which replaces the previously formed lamina …”).
31 See Mironov, Vladimir et al., Organ Printing: From Bioprinter to Organ Biofabrication Line, 22 Current Opinion Biotech. 667, 669 (2011)CrossRefGoogle ScholarPubMed.
32 Michael Weinberg, It Will Be Awesome If They Don't Screw It Up: 3D Printing, Intellectual Property, and the Fight over the Next Great Disruptive Technology 3 (2010), http://publicknowledge.org/files/docs/3DPrintingPaperPublicKnowledge.pdf. The brevity of my description here does not imply that this step is simple. On the contrary, at least one leader in this field has suggested that the creation of a digital blueprint is an important barrier in the adoption of three-dimensional printing. TED, Lisa Harouni: A Primer on 3D Printing, YouTube (Jan. 23, 2012), https://www.youtube.com/watch?v=OhYvDS7q_V8 (“[W]hy don’t we all have one in our home? Because, simply, most of us here today don’t know how to create the data that a 3D printer reads…. But there are more and more technologies, software and processes today that are breaking down those barriers.”).
33 Weinberg, supra note 32, at 3.
34 Id. To simplify the technique employed by CAM software, assume that the software divides the digital rendering into stackable layers that can be printed one at a time. For example, if the intended object is an apple, the CAM software acts as a knife to thinly slice the apple. Then, the CAM software translates each layer into a set of instructions for the printer tool to follow, ensuring that the layers are filled properly. Three-dimensional printers today may employ a variety of techniques to hold the final object together, including a modified version of the ultraviolet light-cured resin process or a laser sintering process that fuses the deposited material. See Yongnian, supra note 20, at 4-6.
35 See Yongnian, supra note 20, at 4-6. For example, stereolithography, the technique involving a laser described in notes 28-30 and accompanying text, requires the formation of removable structures in order to support more complicated designs. See id. at 4. Another technique uses an ink-jet printing nozzle to deposit a small droplet of a liquid binding agent onto a powdered surface. See id. at 6. Once all of the droplets have been deposited for a single layer, a new thin layer of powder is spread over the previous surface. See id. Since the binder only causes adjacent material to solidify, the undisturbed powder provides support during formation but can be dusted off the final structure. See id. This process may use less material and follow a different tool path because no support structures are necessary. See id.
36 See TED, supra note 9.
37 Id.
38 See id.
39 See Melchels et al., supra note 19, at 1086.
40 Id. at 1087. Cell seeding is the spreading of viable cells onto a porous or mesh structure in a manner that encourages uniform cell distribution and penetration. See Villalona, Gustavo A. et al., Cell-Seeding Techniques in Vascular Tissue Engineering, 16 Tissue Engineering: Part B 341, 342 (2010)Google ScholarPubMed. A variety of cell seeding techniques have been developed, including gravity seeding, rotational seeding, and vacuum seeding. See id. at 342-43.
41 See Melchels et al., supra note 19, at 1086.
42 Id. at 1087.
43 See id.
44 Id.
45 Miller, Jordan S. et al., Rapid Casting of Patterned Vascular Networks for Perfusable Engineered Three-Dimensional Tissues, 11 Nature Materials 768, 768 (2012)CrossRefGoogle ScholarPubMed.
46 Melchels et al., supra note 19, at 1088.
47 See Miller et al., supra note 45, at 768.
48 Id. Sacrificial molding refers to techniques where one material is cast into a bulk material with the intention of “sacrificing” the first material in order to reveal an intricate architecture within the bulk material. See id.
49 Id. (identifying carbohydrate glass as a material that had sufficient mechanical strength, dissolvability, and biocompatibility in the presence of living cells). In one embodiment, the carbohydrate glass was reinforced with dextrans, which also improved temperature stability. Id.
50 For a detailed explanation of the encapsulation method, see id. at 773.
51 Id. at 770 fig.2.
52 Id. at 768 (noting that prior to using a type of sugar called carbohydrate glass, the organic solvents used were toxic to living cells and the process used to remove the lattice structure were harmful to living cells).
53 See id. at 770.
54 See TED, supra note 9 (remarking that the ability to grow different kinds of cells was a challenge to bioprinting).
55 See Obasogie & Theung, supra note 12, at 67 (noting the ethical controversy surrounding the destruction of human embryos that was necessary to further embryonic stem cell research).
56 Id. (“[T]he 2007 discovery of iPSCs was heralded as a new technology that might resolve this ethical and political problem.”).
57 Id. at 66-67.
58 See id. at 68 (describing the success of inducing a pluripotent state in the skin cells of mice); TED, supra note 17 (“We induce cells, okay, say, skin cells, by adding a few genes to them, culturing them, and then harvesting them. So they’re skin cells that can be tricked, kind of like cellular amnesia, into an embryonic state…. [Y]ou can grow any type of tissue out of them: brain, heart, liver, you get the picture, but out of your cells.”).
59 While computerized genome sequencing is not available today, it may be possible in the future. Cf. Presidential Comm'n for the Study of Bioethical Issues, New Directions: The Ethics of Synthetic Biology and Emerging Technologies 3 (2010), available at http://permanent.access.gpo.gov/gpo9019/PCSBI-Synthetic-Biology-Report-12.16.10.pdf (“The technical feat of synthesizing a genome from its chemical parts so that it becomes self-replicating, when inserted into a bacterial cell of another species, while a significant accomplishment, does not represent the creation of life from inorganic chemicals alone…. The feat therefore does not constitute the creation of life, the likelihood of which still remains remote for the foreseeable future.”).
60 See TED, supra note 15.
61 See Mironov et al., supra note 31, at 667.
62 Id. at 668.
63 See id. at 668-69.
64 See id. at 667.
65 See id. at 670 (explaining that use of a bioreactor provides a critical step in bioprinting because it accelerates tissue maturation).
66 Id. at 669.
67 Id. at 671.
68 Id. at 671-72.
69 Id. at 668.
70 See supra text accompanying note 15.
71 Moore v. Regents of the Univ. of Cal., 793 P.2d 479 (Cal. 1990).
72 Ass'n for Molecular Pathology v. Myriad Genetics, Inc., 133 S. Ct. 2107 (2013).
73 Landecker, supra note 5, at 212.
74 Id.
75 Id.
76 Id. HeLa is the oldest human cell line that is widely used in scientific research. Id. While I do not discuss the issue in depth here, it is worth noting that the original HeLa cells were taken from Lacks without her knowledge or consent. For more information about the complicated ethical issues raised by Lacks' own lack of property rights in her cells, see, generally, Rebecca Skloot, The Immortal Life of Henrietta Lacks (2010).
77 Id.
78 Id.
79 B.J.C., HeLa (for Henrietta Lacks), 184 Sci. 1268, 1268 (1974).CrossRefGoogle Scholar Early attributions were actually made to a pseudonym of Henrietta Lacks, Helen Lane, but the personhood argument for the immortality of Lacks still carried the same force. See id.
80 Landecker, supra note 5, at 214 (noting that “the information gleaned from cells is useless unless it eventually relates back to the biology and then the pathology of the patient”).
81 See id. (“The continuity between person and cell line was the rationale for using ‘cells in place of the whole patient.’”).
82 Id. at 215.
83 Id.
84 See id. at 216 (noting that research institutions expended “real capital” in order to obtain potentially lucrative results, so the institution should gain the benefit of their expenditure).
85 See id. at 215 n.17 (characterizing the views as the “Lockean paradigm of radical individualism assuming a dualism between the body as commodity and the person as transactor and an older paradigm in which ownership of the self is understood in terms of the ability to defend one’s inalienable corporeal integrity against oppression and abuse”).
86 Id. at 215 (internal quotation marks omitted).
87 Moore, 793 P.2d 479.
88 Id. at 480.
89 Id. at 481.
90 Id. at 480, 482. While Moore signed a general consent form regarding his splenectomy, the court noted that “neither Golde nor Quan informed Moore of their plans to conduct this research or requested his permission.” See id. at 481.
91 Landecker, supra note 5, at 219 (noting that “this anticipation also structured Golde’s manipulation of his human patient” and that Moore's blood could “not enter the public domain”).
92 Moore, 793 P.2d at 487.
93 Id. at 488-89.
94 Id. at 489 n.20.
95 Id. at 489-91 (refusing to equate privacy rights with the property rights necessary for a conversion claim).
96 Id. at 491-92 (concluding that the “practical effect” of the statutory scheme was the limitation of a property interest).
97 Id. at 492-93 (concluding that the issued patent is an authoritative determination that the cell line and its derivative products were a product of invention, both “factually and legally distinct” from the cells taken from Moore).
98 Id. at 497.
99 Id. at 496 (concluding that “[l]egislative interest is demonstrated by the extensive study recently commissioned by the United States Congress”). The study referenced by the Court, the “OTA Report,” expressed that “companies are unlikely to heavily invest in developing, manufacturing, or marketing a product when uncertainty about clear title exists.” Id. at 494 (citing Office of Tech. Assessment, U.S. Congress, New Developments in Biotechnology: Ownership of Human Tissues and Cells (Chris Elfring ed., 1987)).
100 Id. at 493-97 (noting that a patient still has the protection of tort liability when a physician violates a duty of disclosure).
101 Id.
102 See supra text accompanying notes 1-2.
103 See Moore, 793 P.2d at 496.
104 Emanuel D. Thorne, The Economics of Organ Transplantation, in 2 Handbook of the Economics of Giving, Altruism and Reciprocity 1335, 1336 (Serge-Christophe Kolm & Jean Mercier Ythier eds., 2006).
105 42 U.S.C. § 274e(a) (2012) (“It shall be unlawful for any person to knowingly acquire, receive, or otherwise transfer any human organ for valuable consideration for use in human transplantation if the transfer affects interstate commerce.”).
106 See Moore, 793 P.2d at 493-97.
107 See id. at 493-94. In a Tennessee case, the disposition of cryogenically-preserved embryos turned on a balancing test involving the autonomy argument. Davis v. Davis, 842 S.W.2d 588 (Tenn. 1992).
108 See Obasogie & Theung, supra note 12, at 61.
109 Davis, 842 S.W.2d 588.
110 See id. at 597.
111 Id. at 604.
112 Wendy H. Schacht, Cong. Research Serv., RL32076, The Bayh-Dole Act: Selected Issues in Patent Policy and the Commercialization of Technology 2 (2012).
113 Id.
114 Id. (internal quotation marks omitted).
115 See id. at 14.
116 See id. at 20-21.
117 Id. at 22.
118 Nat'l Research Council, Reaping the Benefits of Genomic and Proteomic Research: Intellectual Property Rights, Innovation, and Public Health 101 (2006) (noting that from 1971 to 2006, approximately 33,000 patents were issued). However, no more than 100 DNA-related patents were being issued per year until 1980. The annual rate peaked in 2001 at 4,500 issued DNA-related patents per year. Id. at 101-03.
119 See Markel, Howard, Patents, Profits, and the American People—The Bayh–Dole Act of 1980, 369 New Eng. J. Med. 794, 794 (2013)CrossRefGoogle ScholarPubMed.
120 Myriad, 133 S. Ct. at 2112; see also Ass'n for Molecular Pathology v. USPTO, 689 F.3d 1303, 1314 (Fed. Cir. 2012) (“Relying on a large set of DNA samples from families with inherited breast and ovarian cancers, the inventors correlated the occurrence of cancer in individual family members with the inheritance of certain marker DNA sequences.”).
121 Myriad, 133 S. Ct. at 2112 (observing that an average American woman has a twelve to thirteen percent risk of developing breast cancer).
122 Id. at 2112-13.
123 Id. at 2113. The Federal Circuit described the relevant technology, including cDNA, in the following manner:
Sequences of DNA nucleotides contain the information necessary to create strings of amino acids, which in turn are used in the body to build proteins. Only some DNA nucleotides, however, code for amino acids; these nucleotides are known as “exons.” Nucleotides that do not code for amino acids, in contrast, are known as “introns.”
Creation of proteins from DNA involves two principal steps, known as transcription and translation. In transcription, the bonds between DNA nucleotides separate, and the DNA helix unwinds into two single strands. A single strand is used as a template to create a complementary ribonucleic acid (RNA) strand … known as pre-RNA, whose nucleotides form an inverse image of the DNA strand from which it was created. Pre–RNA still contains nucleotides corresponding to both the exons and introns in the DNA molecule. The pre-RNA is then naturally “spliced” by the physical removal of the introns. The resulting product is a strand of RNA that contains nucleotides corresponding only to the exons from the original DNA strand. The exons-only strand is known as messenger RNA (mRNA), which creates amino acids through translation. In translation, cellular structures known as ribosomes read each set of three nucleotides, known as codons, in the mRNA. Each codon either tells the ribosomes which of the 20 possible amino acids to synthesize or provides a stop signal ….
DNA's informational sequences and the processes that create mRNA, amino acids, and proteins occur naturally within cells…. It is … possible to create DNA synthetically through processes similarly well known in the field of genetics. One such method begins with an mRNA molecule and uses the natural bonding properties of nucleotides to create a new, synthetic DNA molecule. The result is the inverse of the mRNA's inverse image of the original DNA, with one important distinction: Because the natural creation of mRNA involves splicing that removes introns, the synthetic DNA created from mRNA also contains only the exon sequences. This synthetic DNA created in the laboratory from mRNA is known as complementary DNA (cDNA).
Ass'n for Molecular Pathology, 689 F.3d at 1311-12.
124 Myriad, 133 S. Ct. at 2114.
125 Id.
126 Id. at 2109. Section 101 defines the subject matter categories that are eligible for patent protection—“process, machine, manufacture, or composition of matter.” Alice Corp. Pty. v. CLS Bank Int’l, 134 S. Ct. 2347, 2354 (2014). Section 101 provides a basis for a claim of patent invalidity. Myriad, 133 S. Ct. at 2109.
127 Id. at 2116, 2117. Interestingly, the decision was issued the same year as the Bayh-Dole Act was passed.
128 Diamond v. Chakrabarty, 447 U.S. 303, 305 (1980).
129 Id. at 309-10.
130 Id.
131 Id. at 313 (“Congress thus recognized that the relevant distinction was not between living and inanimate things, but between products of nature, whether living or not, and human-made inventions.”).
132 Myriad, 133 S. Ct. at 2117 (citing Chakrabarty, 447 U.S. at 310) (internal quotation marks omitted).
133 See id. at 2118 (“Myriad’s claims are simply not expressed in terms of chemical composition, nor do they rely in any way on the chemical changes that result from the isolation of a particular section of DNA. Instead, the claims understandably focus on the genetic information encoded in the BRCA1 and BRCA2 genes.”).
134 See id. at 2117-18.
135 See id.
136 Id.
137 Id. at 2119.
138 Id. at 2111.
139 Id. at 2119 (“That may be so, but the lab technician unquestionably creates something new when cDNA is made.”).
140 Id.
141 Id.
142 Id. at 2117.
143 Id. at 2118.
144 Id. at 2117 (“Myriad found the location of the BRCA1 and BRCA2 genes, but that discovery, by itself, does not render the BRCA genes ‘new … composition[s] of matter,' that are patent eligible.” (internal citation omitted)).
145 See Melchels et al., supra note 19, at 1090 (“Using this method, one can generate porous models that have the overall shape of the scanned tissue and/or organ, built up from fully connected straight struts to ensure manufacturability and optimal mechanical stability.”). While it is not a scanned and printed scaffold, patents have been granted for a scaffold created by decellularizing a donor organ. See, e.g., Culturing Different Cell Populations on a Decellularized Natural Biostructure for Organ Reconstruction, U.S. Patent No. 6,479,064 (filed Dec. 29, 1999).
146 Compare Judith L. Toffenetti & Atabak R. Royaee, Patentability of 3D-Printed Organs, Genetic Engineering & Biotech. News (May 15, 2014), http://www.genengnews.com/insight-and-intelligence/patentability-of-3d-printed-organs/77900129 (“Although the individual cells of a bioprinted organ are naturally occurring, their assembly into a functional organ is not.”), with Craig C. Martin & Sara Tonnies Horton, Patent Eligibility of 3D Printed Organs Will Soon Be an Issue, Today's Gen. Couns., June/July 2014, at 36, 38, available at http://digital.todaysgeneralcounsel.com/Vizion5/viewer.aspx?issueID=25&pageID=39 (“Because bioprinted organs seek to replicate human organs, and even use human cells as building blocks, opponents may likewise argue that bioprinted organs are not markedly different from what occurs in nature ….”).
147 See Melchels, supra note 19, at 1086.
148 See Martin & Horton, supra note 146 (“Patentability will likely rest on what the applicant seeks to patent ….”).
149 See 35 U.S.C. § 102(a) (2012).
150 See id. § 102(b).
151 See id. § 112.
152 See Landecker, supra note 5, at 205 (“Because patient, doctor, university, and biotechnology company each laid claim differently to the cell line, around it an intricate network of symbolic, material, legal, and monetary relations was rendered visible.”).
153 Inge Kaul & Ronald U. Mendoza, Advancing the Concept of Public Goods, in Providing Global Public Goods: Managing Globalization 78, 79 (Inge Kaul et al. eds., 2003).
154 Id.
155 Id.
156 See David H. Holtzman, Privacy Lost: How Technology Is Endangering Your Privacy 170 (2006) (asserting that “it takes only a second to copy [digital information] to another machine”).
157 Id. at 173 (asserting that the only reasonable protective measure is to isolate sensitive data from computers).
158 Kaul & Mendoza, supra note 153, at 87.
159 Id. at 84 (noting the specific example of a chemical formula as a nonrivalrous good due to its ease of being spread through email).
160 Id. (“In the form in which society often likes to see them, they fall into … the private domain, as nonrival but exclusive goods…. Judged on its natural properties, such knowledge is probably more of a nonrival, nonexclusive good ….”).
161 John Rennie, Immortal's Enzyme, Sci. Am., July 1994, at 14, 14.
162 See id. at 14, 16; Rando, Thomas A., Stem Cells, Ageing and the Quest for Immortality, 441 Nature 1080 (2006)CrossRefGoogle ScholarPubMed (discussing the possibility of stem cell use in regenerative medicine).
163 See Rando, supra note 162, at 1082 (“The accumulation of mutations in nuclear and mitochondrial DNA, despite the range of repair mechanisms for preventing such accumulation, sits at the pinnacle of the hierarchy, representing the most fundamental and irreversible changes from which many others follow.”).
164 See Landecker, supra note 5, at 213 (suggesting that the HeLa cells were so active that they overtook other samples, and that the uncertainty of sample integrity cast “doubt … on past work”).
165 See Rando, supra note 162, at 1082.
166 See Kaul & Mendoza, supra note 153, at 81.
167 See Landecker, supra note 5, at 212-13 (describing the early efforts to mass-produce the cells that eventually lead to a “threat to scientists’ sense of control over what had been heralded for years as a scientific success story”).
168 See Kaul & Mendoza, supra note 153, at 92.
169 See Landecker, supra note 5, at 219 (suggesting that Moore had follow-up visits because the cultured cell line was not “fundamentally discontinuous and different from the cells in Moore’s body”).
170 See id. (suggesting that the attending physician manipulated Moore, since it “was vital to Golde’s patent application that Moore’s blood not enter the public domain”). Parts 0 and 0 describe the incentives of the patient and doctor, suggesting that it is likely such collusion will take place in practice.
171 See Kaul & Mendoza, supra note 153, at 80 (“Public goods are defined as … being non-rival in consumption and having nonexcludable benefits. The market cannot price these goods efficiently.”).
172 Id.
173 Id. at 84 (“Yet many knowledge elements are made exclusive and private through property rights…. An example is manufacturing procedures protected by process patents.”).
174 Id. at 89 (“A more active, policy-driven approach to identifying public goods opens the door for an equivalent expansion of other aspects of public goods theory and research.”).
175 The Moore case, discussed at length in Part 0, did not involve bioprinting or an organ transplant. However, the case may provide a useful illustration, as these actors are general to most cases involving intellectual property rights in the health care industry. Moore's issue started after presenting symptoms of hairy-cell leukemia. Moore, 793 P.2d at 480.
176 See B.J.C., supra note 79, at 1268; Crichton, supra note 12, at 393 (“Even though [the cells] are removed from his body, he will rightly feel that they are still his. This is a natural and common human feeling.”).
177 Radin, Margaret Jane, Property and Personhood, 34 Stan. L. Rev. 957, 986 (1982)CrossRefGoogle Scholar.
178 Id. at 978.
179 Id. at 959.
180 See supra Part III.a.
181 Ward Farnsworth, The Legal Analyst: A Toolkit for Thinking About the Law 218 (2007) (“[T]he mind searches for a satisfying story to account for the ending. Once it is found, it makes the ending seem inevitable.”).
182 See id. at 111 (noting that one method of assigning value in a public goods problem is through contract law).
183 This is a distinct measure of value that courts recognize in the calculation of expectation damages. See, e.g., Hawkins v. McGee, 146 A. 641, 644 (N.H. 1929) (holding that the correct measure of damages for the breach of warranty was the difference between “the value of the hand which the defendant promised and the one which resulted from the operation.” (emphasis added)).
184 See Crichton, supra note 12, at 394 (“[P]eople will not donate their tissues for research. They will sell them to corporations instead…. Patients are not naïve and neither are their attorneys”); Farnsworth, supra note 181, at 154 (noting that the competitive price to contract with a party should form a sense of loyalty in certain market conditions).
185 While Henrietta Lacks did not live long enough to benefit from Dr. Jonas Salk's polio vaccine, another patient may receive the benefit of drug trials based on the sampled cell line or a medical device based on the digital blueprint. See Landecker, supra note 5, at 212.
186 See Moore, 793 P.2d at 480-82.
187 See, e.g., 35 U.S.C. § 154(a)(1) (2012) (“Every patent shall contain a short title of the invention and a grant to the patentee, his heirs or assigns, of the right to exclude others from making, using, offering for sale, or selling the invention throughout the United States or importing the invention into the United States, and, if the invention is a process, of the right to exclude others from using, offering for sale or selling throughout the United States, or importing into the United States, products made by that process, referring to the specification for the particulars thereof.” (emphasis added)).
188 See Landecker, supra note 5, at 215.
189 See id.
190 TJ McCue, About a Boy: 3D Printed Heart Model Saves Young Life, Forbes (Feb. 26, 2014, 9:33 AM), http://www.forbes.com/sites/tjmccue/2014/02/26/about-a-boy-3d-printed-heart-model-saves-young-life.
191 Maanvi Singh, Novice Neurosurgeons Train on Brains Printed in 3-D, NPR (Dec. 16, 2013, 3:40 PM), http://www.npr.org/blogs/health/2013/12/12/250577798/novice-neurosurgeons-train-on-brains-printed-in-3-d.
192 See, e.g., Moore, 793 P.2d at 482.
193 Id.
194 Moore sought treatment at the University of California at Los Angles Medical Center, and his attending physician likely had obligations that resulted in the Regents of the University of California as the assignee of the patent. See id.
195 See, e.g., id.
196 See Bd. of Trs. of the Leland Stanford Junior Univ. v. Roche Molecular Sys., Inc., 131 S. Ct. 2188, 2192 (2011).
197 See Landecker, supra note 5, at 215.
198 See Roche, 131 S. Ct. at 2199 (noting that “universities typically enter into agreements with their employees requiring the assignment to the university of rights in inventions,” doing “so without violence to the basic principle of patent law that inventors own their inventions”).
199 See Schacht, supra note 112, at 9.
200 Id. at 10. This estimate concerns university license agreements based on product sales, suggesting that other licensing opportunities may increase this number.
201 Id. at 9.
202 Id. at 10.
203 Id.
204 Id. at 12.
205 Kenney, Martin & Patton, Donald, Does Inventor Ownership Encourage University Research-Derived Entrepreneurship? A Six University Comparison, 40 Res. Pol'y 1100, 1101 (2011)Google Scholar.
206 See id.
207 Id.
208 The Regents of the University of California and the attending physician negotiated agreements with Genetics Institute for cell line product development and commercial distribution. Moore, 793 P.2d at 482.
209 See Schacht, supra note 112, at 9-12; Kenney & Patton, supra note 205, at 1101.
210 See Moore, 793 P.2d at 482 (noting that the Regents of the University of California and Golde accepted at least $440,000 in funding and salary in addition to 75,000 shares of common stock).
211 See id.
212 See Schacht, supra note 112, at 9.
213 See Roche, 131 S. Ct. at 2198.
214 See Schacht, supra note 112, at 17.
215 See id. at 4.
216 See id. at 4, 19 (suggesting that universities generally do not look to patents and licenses as a profit mechanism, as “most university license offices barely break even”).
217 See id. at 4 (“Universities, however, generally do not have the means of production necessary to take the results of research and generate marketable products. Such activities are carried out by industry.”).
218 See id. at 3 (acknowledging that the use of licensing to exploit other markets encourages industry concentration).
219 See id.
220 Id.
221 See Presidential Comm'n for the Study of Bioethical Issues, supra note 59, at 17 (noting the increased risks of synthetic biology when paired with commercial activity).
222 See TED, supra note 17 (“Wouldn’t you rather test to see if those cancer drugs you’re going to take are going to work on your cancer? This is an example from Karen Burg’s lab, where they’re using inkjet technologies to print breast cancer cells and study its progressions and treatments.”).
223 See supra text accompanying notes 1-2.
224 See supra note 18 and accompanying text.
225 Presidential Comm'n for the Study of Bioethical Issues, supra note 59, at 7.
226 Presidential Comm'n for the Study of Bioethical Issues, Privacy and Progress in Whole Genome Sequencing 10 (2012), available at http://bioethics.gov/sites/default/files/PrivacyProgress508_1.pdf.
227 For example, one related policy issue is the support of new research fields with great promise. Presidential Comm'n for the Study of Bioethical Issues, supra note 59, at 7. Another related policy is the encouragement of research fields that could revolutionize vaccine and medicine development. See id. at 64 (“Improved production of drugs and vaccines, advanced mechanisms for personalized medicine, and novel, programmable drugs and devices for prevention and healing are among a few of the expected achievements.”); see also TED, supra note 17.
228 See Obasogie & Theung, supra note 12, at 69.
229 See supra notes 201, 218, 222 and accompanying text.
230 See Moore, 793 P.2d at 495-97.
231 Id. at 496 n.42.
232 See Davis, 842 S.W.2d at 597 (“We conclude that preembryos are not, strictly speaking, either ‘persons' or ‘property,' but occupy an interim category that entitles them to special respect because of their potential for human life.”); Obasogie & Theung, supra note 12, at 53.
233 See Obasogie & Theung, supra note 12, at 54 (“[T]he proverbial spleen cells from John Moore and any other ordinary cells removed during medical procedures would potentially be just a few steps away from being turned into gametes that could then be used for reproductive purposes.”).
234 Contra Presidential Comm'n for the Study of Bioethical Issues, supra note 59, at 3 (“The feat therefore does not constitute the creation of life, the likelihood of which still remains remote for the foreseeable future.”).
235 See Obasogie & Theung, supra note 12, at 54-55.
236 See id. at 76 (“We argue that courts should distinguish Moore to clearly identify a property interest in excised somatic cells that are reprogrammed and differentiated into reproductive cells through the processes of induced pluripotency.”). However, the property interest should be limited, not absolute, in order to address concerns about the unprecedented access afforded by bioprinted organs and scans. See infra notes 239-241 and accompanying text.
237 See Moore, 793 P.2d at 482 (noting that the Regents of the University of California acquired a patent).
238 See Schacht, supra note 112, at 9 (noting the benefits to universities of licensing and acquiring patents).
239 This limit is in addition to the traditional limitations of the property regime, such as federal patent law. U.S. Const. art. I, § 8 (“To promote the progress of science and useful arts, by securing for limited times to authors and inventors the exclusive right to their respective writings and discoveries.”).
240 Such a construction may even reconcile Davis with Moore in a manner that avoids the “potential for human life” standard. The Moore court noted in dicta that personal autonomy may be an overriding policy concern. See Moore, 793 P.2d at 493-94. However, I am suggesting that personal autonomy should be recognized as an absolute right, not a factor to be balanced against the interests of other parties. Contra id.(“Liability based upon existing disclosure obligations, rather than an unprecedented extension of the conversion theory, protects patients’ rights of privacy and autonomy without unnecessarily hindering research.”).
241 In Davis, the court said that such a result “would rob [the husband] twice—his procreational autonomy would be defeated and his relationship with his offspring would be prohibited.” Davis, 842 S.W.2d at 604.
242 See, e.g., Munzer, Stephen R., Risk and Reward in Stem Cell Products: A New Model for Stem Cell Product Liability, 18 B.U. J. Sci. & Tech. L 102, 126 (2012)Google Scholar (“The transaction costs will exceed the increase in value from rearranging the legal outcome, which means that the transaction will not be entered into …”).
243 Cf. Moore, 793 P.2d at 482 (unsuccessfully asserting a claim of conversion).
244 See Landecker, supra note 5, at 204.
245 See id. at 215 (“Why does an artificial composition of matter that happens to replicate through biochemical activity still bear the adjective ‘human' at all?”).
246 See supra notes 101-102 and accompanying text.
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