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

I. INTRODUCTIONBy 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 vitro5 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 splints7 and personalized bone replacements8 for human use. These techniques have even achieved success with more complicated structures, including human kidneys9 and livers.10Bioprinting11 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.II. HISTORY OF BIOPRINTINGA. THE PROTOTYPING BREAKTHROUGH: THREE-DIMENSIONAL PRINTINGRapid 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.23Early 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. …