Don't Go Breakirí My (3d Bioprinted) Heart: Dissecting Patentability and Regulation of 3d Bioprinted Organs

• Publication year: 2020

Don't Go Breakirí My (3D Bioprinted) Heart: Dissecting Patentability and Regulation of 3D Bioprinted Organs

Anna Marie Whitacre
University of Georgia School of Law

Don't Go Breakin' My (3D Bioprinted) Heart: Dissecting Patentability and Regulation of 3D Bioprinted Organs

Cover Page Footnote

J.D. Candidate, 2021, University of Georgia School of Law. I would like to thank Professor Joseph S. Miller and the Editorial Board of the Journal of Intellectual Property Law for their help, as well as Professor Stephen Wolfson for inspiring this Note's Repo Men theme. I would also like to dedicate this Note in loving memory to Ms. Suzanne Coleman, my eighth-grade science teacher. She was instrumental in developing my academic foundation. Ms. Coleman, thank you for giving me the spirit and confidence to push myself and for helping me to discover my love for science.

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DON'T GO BREAKIN' MY (3D BIOPRINTED) HEART: DISSECTING PATENTABILITY AND REGULATION OF 3D BIOPRINTED ORGANS

Anna Marie Whitacre^*

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TABLE OF CONTENTS

I. Introduction............................................................................................359

II. Background..............................................................................................360

A. WHAT ARE 3D BIOPRINTED ORGANS?.........................................................360
B. THE PROMISE OF "ARTIFORGS"......................................................................361
C. PATENTABLE SUBJECT MATTER.....................................................................363

1. Statutory Backbone........................................................................363
2. Controlling and Relevant Case Law............................................364

a. Application of the "Law of Nature" Exception................365

D. CURRENT REGULATION OF HUMAN ORGANS.........................................368

1. The Right to (Not) Sell Your Organs..........................................368

E. CURRENT REGULATION OF MEDICAL DEVICES.....................................371

1. 'Til Death Do Us Part?..................................................................372
2. The Exhaustion Doctrine..............................................................373
3. The Case of the Infringing Medical Implant..............................375

III. Analysis.......................................................................................................375

A. PATENT SUBJECT MATTER ELIGIBILITY.....................................................375
B. REGULATION OF PATENTED 3D BIOPRINTED ORGANS AS MEDICAL DEVICES........................................................................................377

1. Can You Print a Soul?....................................................................378
2. There Cannot Be Altruism Without "You"...............................379
3. Social Inequality..............................................................................380

C. THE FATE OF AN INFRINGING BIOPRINTED ORGAN..........................381

IV. Conclusion ................................................................................................ 382

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I. Introduction

Jude Law fashions a smirk.¹ Maintaining a cool demeanor, he says,

"Mr. Smythe, . . . I'm from the Credit Union."
Smythe stammer[s]. "Wait, I can pay."
"Sorry," [Jude says] "That's not my department." [Jude] raise[s] the taser and [takes] steady aim. "I'm legally bound to ask you if you'd like an ambulance on standby, though you will be unable to secure another artiforg² from the Credit Union in replacement."
"Wait," [Smythe says] again, "don't—"
That's as far as [Smythe] got before [Jude's] taser darts slammed into [Smythe's] chest and released their electricity. He went down twitching . . .³

The ever-handsome Jude Law ties a white apron around himself.⁴ He reaches into his duffel bag and withdraws a scalpel.⁵ He pushes the sharp tip into Smythe's belly.⁶

Now, I am sure we can all use our imaginations to envision what happens next. If not, go see Repo Men.⁷ Nonetheless, I will let a spoiler slip. Jude Law proceeds to thrust his hand into Smythe's open wound and dig out Smythe's artificial liver.⁸ Why? Because Smythe defaulted on his "artiforg" payment.⁹

When Repo Men was released in 2010, those of us who saw it probably thought this type of scenario could never happen; in fact, the absurdity of the plot is likely what attracted us to the theater in the first place. Although the idea of creating

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functioning artificial human organs is astonishing, it is frankly more frightening to think that a third party could legally retrieve one of our body parts without our consent. This fear is partly because artificial organs are not just outlandish ideas from a work of science fiction—they are scientific reality.¹⁰ These artificial organs are not made from huge chunks of metal, as in Repo Men, or from other synthetic or nonliving materials.¹¹ 3D bioprinted organs actually comprise of living cells.¹²

I present this scene from Repo Men because it generates several important questions. First, was Smythe's organ really his? Well, it was his in the sense that the artificial organ was inside of him and functioned as a natural liver would (at least, we can hope it did). Yet, at the end of the day, we learn that Smythe did not have complete control and dominion over his liver because the "Credit Union" claimed superior title. The issue of title and ownership seems problematic in light of existing federal laws and regulatory schemes. Should 3D bioprinted organs be regulated as natural organs or as medical devices? "What happens if 3D bioprinted organs are patentable? Is there ever a possibility that a recipient of a 3D bioprinted organ could face a Repo Men fate? In light of the growing reality of 3D bioprinted organs, legal issues arising from these concerns can easily bleed into our society. This bleeding therefore demands exploration.

The beginning of this Note dissects the scientific underpinnings of 3D bi-oprinted organs. Part II explores statutory authority and controlling, or otherwise persuasive, case law that pertains to subject matter patentability. Current rights associated with medical devices and one's own natural organs are also identified. Part III analyzes how 3D bioprinted organs should be regulated and how the patentability of 3D bioprinted organs squares with potential regulatory frameworks. Ultimately, this Note reaches the conclusion that 3D bioprinted organs are patentable subject matter and that, in general, 3D bioprinted organs should be regulated as medical devices. In the patentability wrinkle, this Note also observes how the anti-commodification of patented 3D bioprinted organs would be a legal contradiction under current federal law.

II. Background

A. WHAT ARE 3D BIOPRINTED ORGANS?

3D bioprinting is a "manufacturing technique used to fabricate artificial implants or complex tissue constructs through a layer-by-layer building process for

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patient-specific therapy."¹³ Unlike traditional 2D printing, 3D bioprinting is "a comprehensive process requiring various design considerations, including imaging, modeling, printer choice, bioink selection, [cell] culture condition, and 3D construct development."¹⁴

There are two forms of 3D bioprinting that may be implemented to create a 3D bioprinted organ: cellular bioprinting and acellular bioprinting.¹⁵ Cellular bioprinting involves "directly deposit[ing] bioinks with viable cells to form a 3D living structure."¹⁶ Conversely, acellular bioprinting uses nonliving materials such as "ceramics, metals, polymers and their composites" to form a 3D nonliving structure.¹⁷ This 3D nonliving structure is then integrated with cells, outside of the printing process, to form a 3D bioprinted organ.¹⁸ Acellular, compared to cellular, 3D bioprinting "provides more extensive choices for material selection and manufacturing method."¹⁹ Nevertheless, both cellular and acellular printing techniques may be employed to create a 3D bioprinted organ.²⁰

B. THE PROMISE OF "ARTIFORGS"

Repo Men got one thing right: artificial organs would herald an era where recipients could extend or improve their quality of life.²¹ 3D bioprinted organs can potentially revolutionize the medical world by "offer[ing] a pathway for scalable and reproducible mass production of engineered living organs" that "mimic their natural counterparts."²² Given the high demand for donor organs, the United States' organ transplant system is notorious for its lengthy waiting list and

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sluggish waiting time.²³ As of July 2019, over 113,000 men, women, and children were on the national transplant waiting list.²⁴ This number grows each day, and in fact, another person is added to the waiting list every 10 minutes.²⁵ To make matters worse, each day, 20 people die waiting for a transplant.²⁶ These numbers illustrate how 3D bioprinted organs may help to relieve the organ supply shortage by providing an additional supply source.²⁷

While organ bioprinting has "shown great promise in current research," the challenge remains in formulating bioprinted organs that are suitable for implan-tation.²⁸ So, while we are not quite in a Repo Men-type world just yet, an implantable 3D bioprinted human organ future is in sight.²⁹ Conceivably, in just a few years, "industrial, scalable, biofabrication of patient-specific functional 3D living human organs suitable for clinical implantation" will occupy the marketplace.³⁰

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C. PATENTABLE SUBJECT MATTER

The intent behind limiting patentable subject matter is rooted in the underlying sentiment that patents are tools for promoting progress.³¹ In exchange for disclosing useful, novel, and nonobvious inventions to the public, inventors' "sweat of brow" is rewarded with patent protection of their invention.³² The legal reward of a patent arms owners with "the right to exclude others from making, using, offering for sale, or selling...