American Journal of Law & Medicine

Do You Own Your 3D Bioprinted Body? Analyzing Property Issues at the Intersection of Digital Information and Biology

I.  INTRODUCTION II. HISTORY OF BIOPRINTING     A. The Prototyping Breakthrough: Three-Dimensional Printing     B. Regenerative Medicine and Three-Dimensional Printing     C. The Future of Bioprinting III. LEGAL LANDSCAPE     A. The Road to Moore: Henrietta Lacks and the HeLa Cell Line        1. Moore v. Regents of University of California        2. Cases Following Moore and the "Potential for Human Life"        3. The Road to the Myriad: The Bayh-Dole Act        4. The Myriad Decision VII. WHY IS A DIGITAL SCAN OR BIOPRINTED ORGAN VALUABLE?     A. Dichotomy of Goods According to Rivalry and Competitiveness     B. The Patient's Value     C. The Physician's Value     D. The University's Value     E. The Biotechnology Company's Value IV. PROPOSALS     A. Moratorium on Bioprinting Research?     B. Judicial Response V. CONCLUSION 


By the end of 2013, almost 122,000 organ transplant candidates in the United States remained active on the national waiting list. (1) The current number of candidates exceeds 123,000. (2) To address this overwhelming need, researchers have been exploring methods to supplement traditional organ donations. (3) 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. (4) 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 (5) and the recent adaptation of three-dimensional printing for the health care industry. (6) Today, physicians armed with the latest generation of bioprinters and imaging equipment are creating high-resolution airway splints (7) and personalized bone replacements (8) for human use. These techniques have even achieved success with more complicated structures, including human kidneys (9) and livers. (10)

Bioprinting (11) is advancing at a dizzying pace, introducing questions to the legal profession that once sounded like science fiction. (12) First and foremost, bioprinting challenges existing legal constructions of the human body that are tied to human biology. (13) The rise of genomics in the 1990s has blurred the line between biology and digital information, (14) but the relationship was primarily a one-way street from the biological to the digital. (15) Bioprinting provides the missing path by transforming digital information into biological models that mimic actual organs. (16) Second, bioprinting provides physicians with unprecedented access to models of a patient's body, and the patient may be unaware of this access. (17) This information asynchronicity will often carry the potential for abuse, especially when the interests of the physician and patient are misaligned. (18) These issues should make us feel wary about the direction of bioprinting and our control over the digital self.

Structurally, this Note unfolds these issues in four parts. Part II provides the history of bioprinting, the implementation challenges, and insight into the future direction of the technology. Part III addresses the current legal landscape by examining the key cases that provide important policy considerations regarding bioprinting. Part IV analyzes the interests of the players in a hypothetical transplant of a bioprinted organ from an economic perspective. Part V offers a proposal on how to address the issues raised by bioprinting. The Note concludes with a discussion on the significance of bioprinting at the intersection of property and health law.


A. The Prototyping Breakthrough: Three-Dimensional Printing

Rapid prototyping techniques, including three-dimensional printing, blend the low-cost scalability of mass-produced products with the personalized properties of a tailor-made product. (19) In order to accomplish these goals, the techniques take advantage of two design principles. Dispersion, the first principle, recognizes that complicated designs can be reduced into an abstraction of simpler subsystems and components. (20) In the case of a complicated three-dimensional structure, the structure can be reduced into a series of two-dimensional layers, which can be further reduced into lines and points. (21) Additive manufacturing, the second principle, recognizes that a manufacturer can deposit simple materials in a specific arrangement to arrive at the original design. (22) If a droplet can approximate a point, then a specific arrangement of droplets can form lines, which in turn can be used to form two-dimensional layers and eventually the desired structure. (23)

Early rapid prototyping techniques existed in layered manufacturing patents as early as 1892. (24) However, it was the significant technological advances during the 1980s that led to the development of three-dimensional printing, beginning with the rise of computer-aided design ("CAD") software and ultraviolet light-cured resin. (25) While rapid prototyping principles can be practiced with traditional manufacturing techniques, digital environments supported by CAD software are ideally equipped to handle the complicated mathematical calculations used in dispersion. (26) Furthermore, computer-aided manufacturing ("CAM") software can generate a path for reconstructing the desired object in a format that can be understood by automated manufacturing equipment, allowing a manufacturer to potentially realize savings in both man-hours and the overall production time. (27) The development of ultraviolet light-cured resin allowed manufacturers to use known lithography techniques to print the dispersed layers of an object while bonding two adjacent layers together. (28) A laser emitting ultraviolet radiation, guided by the path generated by the digital environment, would selectively scan the surface of a pool of resin in order to create a thin layer of cured resin. (29) After many iterations of curing and incrementally shifting the cured layers away from the pool's surface to expose more resin, the layers bond together and form a three-dimensional model. (30)

The cost of three-dimensional printing has decreased through innovation and a shift from institutional to consumer-driven demand, (31) but the fundamental process of developing a printed object has not changed significantly. The process begins with a digital blueprint of the object, usually created from a three-dimensional scan of a real object or modeled with the assistance of CAD software. (32) This blueprint exists in a digital format that can be transferred anywhere over the Internet, giving rise to large online repositories of three-dimensional models that any Internet user can access. (33) Then, CAM software translates this digital blueprint into a path that a machine will follow to assemble a real object from a variety of materials. (34) The translation may vary by implementation, which primarily falls under two categories: techniques that rely on a laser or electron beam and techniques that rely on extrusion or droplets. (35)


Regenerative medicine has been studied since the early-to-mid twentieth century. (36) Yet, the 1990s and early 2000s held the critical developments in biomaterials, cell growth, and vascular networks necessary for growing organs in vitro. (37)

Biomaterials are materials that can be successfully transplanted in a patient without rejection, (38) including biodegradable polymers, ceramics, hydrogels, and combinations of the materials. (39) Two common materials used in the three-dimensional printing industry--polymers and ceramics--are compatible with most printing techniques and have properties that offer a high degree of control, but the techniques are either too toxic or too extreme for live cells to be seeded during the printing process. (40) These materials are best suited for "scaffolds," the base structures that are separately seeded with cells before a transplant. (41)

Hydrogels, which are polymer chains that retain their three-dimensional shapes after absorbing water, have been successfully employed during the three-dimensional printing process to provide structure and deliver cells. (42) The main interest in using hydrogels is that a cell can be suspended in a droplet of hydrogel, providing both a three-dimensional structure and an environment mimicking the properties of natural tissue. (43) One challenge with hydrogels is creating a process that forms the droplets and links droplets of the hydrogel together without harming the suspended cells. (44) The current solutions limit the available printing techniques available for hydrogels, significantly impacting resolution and speed. (45) Another challenge is balancing the need for high-density hydrogel structures to increase strength and stability with the need for low-density hydrogel structures to promote cell migration and formation of vascular networks. (46)

Sugar is also a promising material to use with hydrogels where intricate vascular networks require external assistance. (47) Researchers are using sugar in a three-part sacrificial molding technique, rather than as a stand-alone biomaterial. (48) In order to accomplish this, the vascular network is printed as a lattice of thin filaments in a type of sugar called carbohydrate glass, which is a mixture of sucrose and glucose developed for the food industry. (49) Channels are then formed by casting the lattice network in a suspension of cells and hydrogel. (50) Finally, the lattice network is dissolved, allowing the sugar to How out of the structure through the formed channels. (51) Like polymer and ceramic, sugar is compatible with some of the available high-resolution printing techniques; and, unlike polymer and ceramic, sugar has the additional advantage of dissolving easily in the presence of living cells. (52) The current disadvantage of using sugar is that the suspension of cells and hydrogel is not printed alongside the sugar; the suspension is cast around the sugar in a separate step. (53)

In order to generate the cells used with these techniques, researchers have had to develop techniques for growing cell cultures that can differentiate into the specialized cells of an organ. (54) In the past, embryonic stem cells showed promise for such a task, but the techniques used to extract these cells raised ethical objections. (55) Current research efforts have yielded an exciting and less controversial method to achieve the same result: induced pluripotent stem cells (IPSCs). (56) IPSCs are the ideal solution for bioprinting in three regards: (1) they continue to divide for a long time in vitro; (2) they can be recruited as specialized cells, which perform the individual functions required by organs; (57) and (3) a patient sample can be as unobtrusive as a skin scraping. (58)


Do researchers need IPSCs in order to make bioprinting feasible? One day, computerized genome sequencing may allow doctors to create a bioprinted organ without a sample of the patient's cells. (59) The technology to make this a reality is lacking today, but the path has been charted with the development of the synthetic, self-replicating cell. (60)

Researchers are also investigating the viability of organ fabrication as a commercial substitute for traditional organ donations. (61) Three factors are critical for its success: automation, integration, and quality control. (62) The development of three-dimensional printer technology holds the promise to address automation issues, especially as robotic control to deposit hydrogels and cellular spheroids continues to improve speed and resolution. (63) By depositing the cells directly, the fabricator avoids the manual steps involved in scaffolding and lattice networks. (64) Integration is currently being explored by combining a bioreactor--an environment that promotes the growth of a vascular network in the bioprinted organ--and the bioprinter. (65) Additionally, the fabrication stage for the cellular spheroids and hydrogel droplets is being developed for the bioprinter, but storage and premature fusion of the cells must be overcome to make integration feasible. (66) Finally, quality control is important, as product failures may have great consequences in lifesaving organ transplants. (67) In order to automate quality control, sensors will need to be developed to monitor progress at each stage and allow the system to respond in real-time. (68) The planning phases ahead of the creation of an organ are equally important for reducing failures and obtaining regulatory approval. (69)


If bioprinting is beginning to bridge the gap between human biology and data, (70) then a two-pronged approach is appropriate for analyzing the policy arguments that relate to bioprinting. With respect to the biology side of the argument, the Moore case and its progeny provide the background for analyzing property interests in organs and tissue outside the human body. (71) The second prong relates to the Myriad case, in which the Supreme Court addressed potential property interests in genetic information. …

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