THE “MEDICAL MILE” GEARING TOWARD 3D-BESPOKE ...

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279

THE “MEDICAL MILE” GEARING TOWARD 3D-BESPOKE HEALTHCARE

A COMPARISON OF UNITED STATES AND EUROPEAN UNION

PATENT REGIMES

Jamil Ammar*

ABSTRACT

New and improved 3D bio-printing technologies combined with an improved

understanding of cell biology and materials science set the stage for the next medical

revolution where the mainstream use of 3D bio-printing of functional biological organs

seems to be within our grasp. The legal structures regulating this technology, therefore,

must strike a careful balance between innovation and accessibility to state-of-the-art

healthcare. Conventional wisdom currently makes two mutually contradictory assertions.

The first assertion is that patent law does not provide adequate protection to 3D bio-

printed inventions; this negatively hinders the development of such inventions. The

second assertion is that patent law unduly expands the scope of patentability, particularly

in the biotechnology field. As it happens, when applied to 3D bio-printing, such a

simplistic dichotomy of patent law as being either ineffective or over-protective is

overstated and positively unhelpful.

To date, much of the discussion regarding 3D bio-printing focuses on whether or not

a 3D printed organ is patent eligible. This article goes further than this by raising a

number of distinct, though interrelated, issues. As an introduction, this article discusses

the current state of patent law regarding the protection of 3D bio-printed inventions,

whether patent law is an enabler or a prohibitor of 3D bio-printed inventions, and

whether the phrase “markedly different,” as coined by the U.S. Supreme Court in

Diamond v. Chakrabarty means similarity or difference, in a trademark kind of way.

Areas of conflict between 3D bio-printing technologies and patent law are discussed.

Patent categorization of an important example technology, that of 3D printing on a

patient’s body, is considered. This leads to the closely related issue of whether technology

provides therapeutic, cosmetic or surgical intervention. Assuming a 3D-printed organ to

be patent eligible, whether a healthcare provider should be held strictly liable for claimed

defects in the “man-made” organ that is printed under its control and used in medical

procedures “within” its premises, is investigated. In an era where the field of bio-printing

is often described as developing a “disruptive technology” and where 3D bio-printing is

developing into machines that are capable of performing sophisticated tasks, it is

important to address not only how such technologies will affect the patent regime, but

also what role, if any, patent law should play in the regulation and use of this emerging

technology.

Keywords: 3D technology; bio-printing; patent law; regenerative medicine

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280 GONZAGA LAW REVIEW Vol. 52:2

TABLE OF DEFINITIONS1

Autologous transplantation: the transplantation to a patient of his/her own cells.

Parthenogenesis: the process of an “ovum developing into a being without

fertilization.”2

Ectopic tissue: a foreign tissue of a type that “forms in a distinct tissue or non-native

location, as a result of the transfer of cellular products.”

Ex vivo: “the manipulation of cells, tissues or organs outside of the body with the

intent to return to a living body.”

In vivo: “occurring within the body.”

In vitro: “occurring outside of the body.”

Non-homologous use: “intended therapeutic use of cells outside their native

physiological context, for example, the transplantation of hematopoietic stem

cells into the heart for repair or regeneration of myocardial tissue.”

Teratoma: “a benign, encapsulated mass of complex differentiated tissues com-

prising elements of all three embryonic germ layers: ectoderm, endoderm, and

mesoderm. Used to assess the pluripotency of stem cells (their capacity to form

all tissues in the body).”

* Visiting Scholar at Rutgers School of Law-Newark. Earlier versions of this article

were presented to Rutgers Faculty Colloquium and Windsor Faculty of Law seminar series.

Special thanks to Talal Mchleh, Reid Kress Weisbord, David Horton, George Thomas, Stuart

Green, Sabrina Safrin, Fares Abu Awwad, Christopher Waters, Anneke Smit, Sara Wharton,

Wissam Aoun and various members of Faculty at Rutgers School of Law-Newark, University

of Windsor and University of Detroit Mercy School of Law for commenting on, providing

feedback or supporting this article. All errors and omissions are my own. For financial support,

the author would like to thank the Institute of International Education (IIE), New York and

Rutgers Law School Chancellor’s Office-Newark.

1. Unless otherwise provided, the source of the definitions is the International Society

for Stem Cell Research, Guideline for the Clinical Translation of Stem Cells. See Guidelines

for the Clinical Translation of Stem Cells, INT’L SOC’Y FOR STEM CELL RES. 19 (December 3,

2008), http://www.isscr.org/docs/default-source/clin-trans-guidelines/isscrglclinicaltrans.pdf.

2. An unfertilized oocyte contains only ‘maternal’ DNA and no ‘paternal’ DNA. As

such, it cannot develop into extra-embryonic cells and thus it is not capable of developing into

a complete human being. See generally Case C-364/13, Int’l Stem Cell Corp. v. Comptroller

Gen. of Patents, Designs and Trademarks, ECLI:EU:C:2014:2451, paras. 29-30.

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2016/17 3D-BESPOKE HEALTHCARE 281

TABLE OF CONTENTS

I. INTRODUCTION .................................................................................... 282

II. INTRODUCING 3D BIOPRINTING ........................................................... 286 A. Design .......................................................................................... 286 B. Methods ........................................................................................ 286 C. Specificity ..................................................................................... 287 D. 3D Printability of Human Organs ............................................... 291

III. PATENT LAW: ENABLER OR PROHIBITOR OF 3D TECHNOLOGY? ......... 294 A. Patentability of 3D Bio-printed Organs: A U.S. Perspective ...... 296 B. Bio-manufacturing of “Living Organisms” ................................. 298 C. USPTO Guidelines on Biotechnology: 3D Test ........................... 301 D. Patent Eligibility of 3D Bio-printed Organs ................................ 303

IV. E.U. LAW ............................................................................................. 305 A. A 3D Test: Article 53(a) of the EPC ............................................ 307 B. 3D Bio-printed Organs: Patentability in Europe......................... 310 C. 3D Bio-printing onto a Body: Treatment, Surgical

or Cosmetic? ................................................................................ 311 D. Product Liability Issues ............................................................... 314

V. FUTURE IMPACT OF 3D TECHNOLOGY ON THE MEDICAL SECTOR ....... 318 A. Size Matters: Medical Devices Under a 3D Lens ........................ 318 B. Collision Course: 3D Medical Device Patents

and Biomedicine .......................................................................... 320 1. 3D “Remaking” of Medical Devices ..................................... 321 2. Stretching the Boundaries of Patentability............................. 321 3. Medical Device Distribution .................................................. 323

VI. CONCLUSION ........................................................................................ 324

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I. INTRODUCTION

Three-dimensional (3D) bio-printing technology is likely to have a far-

reaching impact on consumers, communities, governments and economies

worldwide3, and governments and businesses are already forming strategies to

capitalize on this important and emerging sector. Indeed, in his 2011 “We Can’t

Wait” initiative, President Obama launched the National Additive

Manufacturing Innovation Institute to foster the United States growth

capabilities and strength in 3D printing.4 The U.S. is currently ranked first in the

world in terms of both the number of 3D patents and the physical location of the

inventor.5 Since 1980, more than 30,000 3D patent applications have been

published.6

The medical devices sector has been an important early adopter of 3D

technologies7 where the exploitation of novel 3D technologies has led to a steady

stream of new and improved medical devices.8 Examples include bone vascular

grafts, tracheal splints,9 cartilaginous structures,10 hearing aids, dental, spinal

implants and advanced prosthetics.11 The U.K.’s Royal Academy of Engineering

3. Thierry Rayna & Ludmila Striukova, From Rapid Protoyping to Home

Fabrication: How 3D Printing is Changing Business Model Innovation, 102 TECHNOLOGICAL

FORECASTING & SOC. CHANGE 214, 215–16 (2016).

4. See America Makes: The National Additive Manufacturing Innovation Institute,

MANUFACTURING.GOV, http://www.manufacturing.gov/nnmi-institutes/ (last visited Oct. 17,

2016).

5. 3D Printing a Patent Overview, U.K. INTELL. PROP. OFF. 10 (Nov. 2013),

https://www.gov.uk/government/uploads/system/uploads/attachment_data/file/445232/3D_P

rinting_Report.pdf.

6. Id. at 40.

7. For example, in the U.K., the United Kingdom’s Technology Strategy Board

(TSB) has invested £7 million in key additive manufacturing areas. Jim Banks, Adding Value

in Additive Manufacturing: Researchers in the United Kingdom and Europe Look to 3D

Printing for Customization, IEEE PULSE, Nov.-Dec. 2013, at 22, 25. Of the eighteen successful

fund applications, five were in the medical field. Id.

8. See Thomas Gerling et al., Dynamic DNA Devices and Assemblies Formed by

Shape-Complementary, Non–Base Pairing 3D Components, 347 SCI. 1446, 1446, 1451

(2015) (self-assembling 3D DNA structures); Kandice Tanner and Michael Gottesman,

Beyond 3D Culture Models of Cancer, 7 SCI. TRANSLATIONAL MED. 1, 1 (2015) (discussing

the use of 3D culture models in relation to cancer treatments).

9. A degradable 3D printed splint is cleared through the FDA. Already, two

successful cases have been recorded. Additive Manufacturing of Medical Devices Public

Workshop 10/8/2014, FDA 58 (Oct. 8, 2014), https://www.fda.gov/downloads/MedicalDevic

es/NewsEvents/WorkshopsConferences/UCM425399.pdf (statement of Dr. Scott Hollister).

10. Sean V. Murphy & Anthony Atala, 3D Bioprinting of Tissues and Organs, 32

NATURE BIOTECHNOLOGY 773, 773 (2014).

11. Banks, supra note 7, at 23.

http://www.manufacturing.gov/nnmi-institutes/

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predicts that biomedical implants,12 in situ bio-manufacturing and synthetic

whole body organ, will be in routine clinical use in the foreseeable future.13 This

is crucial to maintaining a state-of-the-art healthcare system. Providing adequate

patent protection to 3D bio-printed organs therefore, is likely to provide a

commercial environment that is conducive to the necessary investments that are

needed to accelerate technological advances, which in turn will drive the

realization of tomorrow’s “personalized healthcare” solutions.

The reproduction of cellular and extracellular components of an organ

requires the harnessing of specific functional components of cells within that

organ. Taking the liver as an example, physiologically accurate biomaterials can

be engineered by mimicking the liver’s lobular structure.14 Understanding the

tissue microenvironment, in particular the hierarchy of functional and supporting

cell types and the ingredients of soluble or insoluble materials, is vital.15 This

requires a significant investment of resources, and patent protection is an

important and key tool in protecting that investment while, at the same time,

allowing the sharing of inventions and supporting information.

An exciting promise of 3D technologies lies in their potential to enable the

development of products that cannot currently be produced by conventional

manufacturing methods.16 Examples of such innovative products include

engineered tissues and synthesized functional organs, all of which require new

and advanced methods of development, production and delivery.17 From an

economic standpoint, the value of a global bio-printing market will be worth

approximately three billion U.S. dollars by 2025.18

12. “Biotechnological inventions” are defined as “inventions which concern a product

consisting of or containing biological material or a process by means of which biological

material is produced, processed or used,” “‘Biological material’ means ‘any material

containing genetic information and capable of reproducing itself or being reproduced in a

biological system.’” The European Patent Convention, THE EUROPEAN PATENT OFF. 330

(June 2016), http://documents.epo.org/projects/babylon/eponet.nsf/0/F9FD0B02F9D1A6B4

C1258003004DF610/$File/EPC_16th_edition_2016_en.pdf.

13. Additive Manufacturing: Opportunities and Constraints, ROYAL ACAD.

ENGINEERING 6 (May 23, 2013), http://www.raeng.org.uk/publications/reports/additive-

manufacturing.

14. Murphy & Atala, supra note 10, at 773–74.

15. Id. at 774.

16. 3D Printing and the New Shape of Industrial Manufacturing, PWC 1

(June 2014), http://www.pwc.com/us/en/industrial-products/assets/3d-printing-next_

manufacturing-pwc.pdf.

17. See id. at 14.

18. Applications of 3D Printing 2014-2024: Forecasts, Markets, Players, RES. &

MKTS., http://www.prnewswire.com/news-releases/applications-of-3d-printing-2014-2024-

forecasts-markets-players---total-3d-printing-market-set-to-grow-to-7bn-by-2025-

300206135.html (last visited Mar. 15, 2017).

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As 3D bio-printed organs become a practical possibility, it is important to

investigate the broad fundamental regulatory concerns that will inevitably arise.

While many types of issues are involved, such as, safety, procurement, and

manufacturing, we mainly focus on patenting issues.

In 2009, the American Society for Testing and Materials (ASTM)

Committee F42 on Additive Manufacturing Technologies was founded with the

pivotal task to develop a set of standards for 3D related manufacturing, materials,

products and processes.19 These standards, of which around a dozen have already

been developed,20 will play a potent role in many aspects of additive

manufacturing technologies.21 The use of scaffolds (in this particular context,

scaffold means a structure providing support to 3D bio-printed cells to multiply),

however, still represents a significant challenge to the process of replacing or

regenerating human cells (often referred to as regenerative medicine); while host

intergradation of human tissues 3D bio-printed outside a human body into the

body is achievable, it remains a non-standardized process. Thus, a consistent set

of tools to evaluate 3D printed regenerative medicine designs must be

established.22

Many administrative bodies and areas of law are relevant to the 3D bio-

printing processes, with the U.S. Food and Drug Administration (FDA), product

liability and patent law being notable examples. This article will focus, albeit not

exclusively, on the relevance of patent law to 3D bio-printing processes, and the

diversity of approaches used in the U.S. and Europe will provide contrasting

examples of 3D bio-printing approaches. In Europe, Article 53(a) and (c) of the

European Patent Convention (EPC), and Articles 5-6 of the so-called Biotech

Directive, may restrict the scope of 3D bio-printing on grounds of, among other

things, morality.23 In contrast, U.S. patent law has no statutory basis to deny

patent protection to 3D bio-printed organs under specific grounds.

19. Committee F42 on Additive Manufacturing Technologies, AM. SOC. FOR TESTING

& MATERIALS INT’L, https://www.astm.org/committee/f42.htm (last visited Mar. 15, 2017)

(navigate to “F42 Scope” for information on the purpose of the committee).

20. All standards developed by F42 are published in the Annual Book of ASTM

Standards, Volume 10.04 and can be accessed here: Annual Book of ASTM Standards, AM.

SOC. FOR TESTING & MATERIALS INT’L, https://www.astm.org/bookstore/bos/ (last visited Mar.

15, 2017).

21. See Standard Terminology for Additive Manufacturing - General Principles -

Terminology, Am. Soc. for Testing & Materials Int’l 1 n.1 http://web.mit.edu/2.810/www/

files/readings/AdditiveManufacturingTerminology.pdf (last visited Mar. 15, 2017).

22. Martho O., Wang et al., Evaluating 3D-Printed Biomaterials as Scaffolds for

Vascularized Bone Tissue Engineering, 27 ADVANCED MATERIALS 138, 138 (2015).

23. Directive 98/44, of the European Parliament and of the Council of 6 July 1998 on

the legal protection of biotechnological inventions, 1998 O.J. (L 213) 16.

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To date, much of the discussion concerning the implications of 3D printing

has centered on the patentability of 3D bio-printed organs, the reproduction and

potential counterfeiting of products, and on the characterization of computer-

aided design files (referred to as CAD files or services), which enable physical

objects to be printed.24 This article discusses how patent law should act so that

3D bio-printing technology is able to achieve its full potential in the medical

sector as well as the myriad of novel opportunities and challenges that 3D bio-

printing brings to the medical sector. This article will also investigate whether

patent law is an “enabler” or a “prohibitor” of 3D bio-printing. Typical

patentability requirements, such as novelty and non-obviousness, are not

discussed, nor is the merit of the philosophical debate as to whether human

organisms should be patented at all.

This article is divided into five sections and an introduction. Sections I and

II introduce 3D bio-printing technology and its potential to produce functional

3D printed organs. Sections III and IV investigate the patentability of 3D bio-

printed organs in the U.S. and Europe. Particular attention is given to the law’s

ability or lack thereof to deal with acute legal issues raised by 3D bio-printing

such as printing directly on a patient’s body. Finally, Section V highlights the

tension surrounding the protection of specific types of 3D bio-technology

devices.

The next section will investigate three major issues: (i) design of 3D bio-

printing processes, (ii) bio-printing methods, and (iii) bio-technological

challenges that necessitate the use of a particular type of bio-ink for living cells.

24. Dinusha Mendis et al., A Legal and Empirical Study into the Intellectual Property

Implications of 3D Printing, U.K. INTELL. PROP. OFF. 3 (March 2015), https://www.gov.uk/

government/uploads/system/uploads/attachment_data/file/421222/A_Legal_and_Empirical_

Study_into_the_Intellectual_Property_Implications_of_3D_Printing_-_Exec_Summary_-

_Web.pdf. The latest study commissioned by the U.K.’s IPO investigated the impact of 3D

printing in a number of industrial fields including, two automotive manufacturing Companies,

ASWO-Group domestic appliance aftermarket, 3D scanning and two video gaming

companies. Id; see Daniel H. Brean, Asserting Patents to Combat Infringement Via 3D

Printing: It’s No “Use,” 23 FORDHAM INTELL. PROP. MEDIA & ENT. L.J. 771, 782–83 (2013)

(“Three-dimensional printing presents yet another instance where the patent system may need

to adapt to avoid stifling innovation.”); Lucas S. Osborn, Regulating Three-Dimensional

Printing: The Converging World Of Bits And Atoms, 51 SAN DIEGO L. REV. 553, 584, 586,

618 (2014); Deven R. Desai & Gerard N. Magliocca, Patents, Meet Napster: 3D Printing and

the Digitization of Things, 102 GEO. L.J. 1691, 1711 (2014).

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II. INTRODUCING 3D BIOPRINTING

A. Design

Three major approaches are usually used to 3D bio-print functional living

human constructs: (i) biomimicry, (ii) autonomous self-assembly and (iii) use of

mini-tissue building blocks.25 Biomimicry is used to 3D print materials that

mimic the composition and functionality of the cellular and extracellular

components of a tissue or organ.26 Autonomous self-assembly uses the principles

of embryonic genesis and organogenesis to produce new materials that can

potentially be manipulated to drive embryonic mechanisms in bio-printed tissue,

using embryonic organ development as a guide.27 “Autonomous self-assembly

relies on the cell as the primary driver of histogenesis, directing the composition,

localization, functional and structural properties of the tissue.”28 Finally, mini-

tissue building blocks are based on the fact that complex organs and tissues, such

as kidneys, can be considered to be comprised of a series of functional building

blocks, termed “mini-tissues.” Once fabricated, mini-tissue building blocks can

be assembled into large constructions by rational design, self-assembly, or a

combination of both. Indeed, entire functional structures have been fabricated ex

vivo, so-called “organs-on-a-chip,” which are connected to a microfluidic

network and used in basic research and pre-clinical drug testing.29

B. Methods

Three major 3D bio-printing methods are available: (i) inkjet bio-printing

(sometimes referred to as drop-on-demand), (ii) microextrusion, and (iii) laser-

assisted bio-printing. Inkjet bio-printing, which is the most common method,

layers picoliter sized droplets of biomaterial onto a substrate in order to produce

2D and 3D structures.30 Microextrusion bio-printing, which is an affordable

technology, is based on the concept of producing continuous beads of material

that are deposited in two dimensions; the deposited material serves as foundation

for the subsequent layers that follow.31 Finally, laser-assisted bio-printing

includes a number of techniques, all of which use laser beams to guide living

25. Murphy & Atala, supra note 10, at 773.

26. Id. at 773–74.

27. Id. at 774.

28. Id.

29. Id.

30. Id. at 775.

31. Saif Khalil, & Wie Sun, Bioprinting Endothelial Cells with Alginate for 3D Tissue

Constructs, 131 J. BIOMECHANICAL ENGINEERING 111002-1 through 2-2 (2009).

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cells onto a substrate; this technique is increasingly used to engineer tissues and

human organs.32

C. Specificity

While many advances have enabled 3D bio-printing to produce living tissues

and organs in a variety of sizes, many technical challenges still remain. A major

challenge is to produce complex micro-architecture or extracellular matrix

components and multiple cell types that are of sufficient quality to replicate

biological function.33 Another important challenge is to improve the speed of 3D

bio-printing, and to improve biocompatibility.34

The success of 3D bio-printing, therefore, depends on a number of factors

including, but not limited to, the accurate identification of the major architectural

and compositional elements of the targeted tissue or organ. Using patient-

specific data to engineer a 3D printed tissue or organ that accurately simulates

the geometric complexity of naturally occurring structures is key for the bio-

printing processes. The design process involves a number of vital steps including

a patient’s organ image acquisition, image segmentation, tissue modeling, and

preoperative planning and approval.35 These challenges can be met by using

technology such as BioAssemblyBot, which is a six-axis 3D printer, and Tissue

Structure Information Modeling software (both by Advanced Solutions Inc,

KY).36 The software enables biologists and designers to import and integrate

commonly acquired patient-specific data, such as computed tomography data, to

aid tissue modeling.37 This, in turn, improves the quality of the engineered tissues

and, thus, opens the door for the production of fully functional organs.38

Amongst all the possible challenges in bio-printing, the choice of cell type

is paramount.39 Cell types that are currently used in regenerative medicine

include differentiated cells, pluripotent stem cells and multipotent stem cells.40


33. Ibrahim Ozbolat & and Yin Yu, Bioprinting Toward Organ Fabrication:

Challenges and Future Trends, 60 IEEE TRANSACTIONS ON BIOMEDICAL ENGINEERING 691,

694 (2013).

34. Murphy & Atala, supra note 10, at 777–78, 782.

35. Additive Manufacturing of Medical Devices Public Workshop 10/8/2014, FDA 9,

10 (Oct. 8, 2014), https://www.fda.gov/downloads/MedicalDevices/NewsEvents/Workshops

Conferences/UCM425399.pdf (statement of LCDR Michel Janda).

36. Cindy Glass, 3D-Printed Organs Are a Heartbeat Closer to Reality, REDSHIFT

(June 11, 2015), https://redshift.autodesk.com/3d-printed-organs-bioficial-heart/.

37. Id.

38. Id.


40. Id. at 774, fig.1.

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Organ rejection, which is due to the body’s natural immune response to a foreign

body,41 is a common problem. In the US, roughly seven percent of transplants

fail within the first year, amounting to nearly 3,000 cases, and seventeen percent

fail within three years, amounting to over 6,000 patients suffering transplant

rejection annually.42 Transplant rejection can be avoided by using an autologous

source of cells, which involves transplantation to a patient of their own cells.43

The problem, however, with autologous cells is that their short lifespan makes

them difficult for 3D bio-printing.44 The ability of stem cells to “generate

multiple functional tissue-specific cell[s]” and to “proliferate in an undif-

ferentiated but multipotent state” makes them an ideal candidate for 3D bio-

printing.45 Both embryonic stem cells and induced pluripotent stem cells have

been demonstrated to have an extended lifespan.46

Following is a brief description of the specific biological functions per-

formed by different types of cells used in 3D bio-printing.

41. See id. at 781.

42. Lara E. Tushla, When a Transplant Fails, NAT’L KIDNEY FOUND., https://www.

kidney.org/transplantation/transaction/TC/summer09/TCsm09_TransplantFails (last visited

Mar. 15, 2017).


44. Id.

45. Id.

46. See generally Benjamin E. Reubinoff et al., Embryonic Stem Cell Lines from

Human Blastocysts: Somatic Differentiation In Vitro, 18 NATURE BIOTECHNOLOGY 399

(2000).

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Timeline Type of

Human Cell Functioning Capacity

From ovum the

fertilization of an

ovum until roughly

approx. four days after

fertilization

Totipotent

(zygote)

Each undifferentiated cell has the capacity

to become a complete human being or

separate organism such as a heart, brain or

liver.47

Within five days after

fertilization

Pluripotent

(blastocyst)

Pluripotent cells, however, are incapable of

future development into a human body or a

complete organism. Pluripotent cells can be

obtained without destroying an embryo. As

time goes by, pluripotent cells become more

task-orientated, i.e., differentiated.

Other types of 3D bio-

printable cells include:

1. Multi-potent

stem cells

These cells have the capacity to self-renew

by dividing and to develop into multiple

specialized cell types such as blood cells

(white cells, red cells, platelets), or skin

cells.48

2. Induced

Pluripotent stem

cells (iPSC)49

3. Adult stem

cells

Since each cell type raises a different set of ethical and legal issues, the

choice of cell type is both a biological and a legal issue. Not all types of cells are

47. See generally Case C-364/13, Int’l Stem Cell Corp. v. Comptroller Gen. of

Patents, Designs and Trademarks, ECLI:EU:C:2014:2451, paras. 38–42. Excluding this type

of cell is justified under the grounds that it is considered a stage of human development and

thus not an invention. Another reason behind the bar from patentability is to protect life. See

id.; see also Graeme Laurie, Patenting Stem Cells of Human Origin, 26 EUR. INTELL. PAT.

REV. 59, 59 (2004).

48. See Stem Cell Information, NAT’L INST. HEALTH, https://stemcells.nih.gov/

glossary.htm (last visited Mar. 15, 2017).

49. Use of these cells still faces many technical and safety hurdles. Medical

ramifications include the risk of tumorigenesis. See MARTIN FRIEDLANDER & DAVID R.

HINTON, STEM CELLS AND CELLULAR THERAPY, in RETINA 675 (Stephen J. Ryan ed., 5th ed.

2013).

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patent-eligible. For example, embryos (totipotent cells), despite their suitability

for use in 3D printing due to their ability to produce all cell types and to organize

cells into a coherent body,50 are not patentable. Consequently, it can be seen that

the biological and legal definitions of the term “embryo” are not sufficiently clear

to characterize a 3D bio-printed organ patentable. It should be noted that stem

cells can be either embryonic or non-embryonic. For example, pluripotent or

multipotent stem cells are non-embryonic and they lack the required elements of

totipotency that are provided by the egg, such as proteins, RNA and microRNA.51

The significance of embryonic cells in potentially hindering the patentability of

3D bio-printed organ also arises from the fact that embryos cannot be feasibly

produced by reprogramming,52 a technique used to reprogram an adult cell to

express genes important for maintaining the properties of embryonic stem cells.53

In other words, totipotent cells, which are the most suitable embryonic stem cell

type for 3D bio-printing, are frequently patent ineligible. Other less biologically

capable stem cells are, in principle, patent eligible. Striking an acceptable

balance between legal requirements and technological needs is, therefore, an

important task.

In addition to identifying suitable cell types and developing printable bio-

ink for use in the 3D bio-printing of organs, scaffolds must be developed that are

capable of supporting cellular attachment, proliferation, and function.54 Once all

these technical demands are met, a digital blueprint of the required tissue or

organ is created, usually in the form of a CAD file.55 Using patient’s medical

images, 3D bio-printing and CAD-CAM (computer-aided manufacturing)

technologies open the door for the manufacture of 3D tissues and organs.56

Various technologies, such as computed tomography and magnetic resonance

imaging are used to obtain a 3D anatomical map of a defective tissue or organ.57

CAD-CAM and mathematical modelling techniques that communicate with the

3D printer are then used to 3D bio-print the required organ.

50. Maureen L. Condic, Totipotency: What It Is and What It Is Not, 23 STEM CELLS

AND DEV. 796, 796 (2014).

51. Id. at 803.

52. Id. at 802–04.

53. Stem Cell Basics, U.S DEP’T FOR HEALTH & HUM. SERVS. & NAT’L INST. OF

HEALTH 11, https://stemcells.nih.gov/sites/default/files/SCprimer2009.pdf (last updated

Apr. 8, 2015).

54. See Michael Molitch-Hou, Autodesk Releases Cutting Edge Software for Medical

3D Printing, 3D PRINTING INDUSTRY (Sept. 2, 2015), https://3dprintingindustry.com/news/

autodesk-releases-cutting-edge-software-for-medical-3d-printing-56870/.

55. See id.


57. Id.

https://stemcells.nih.gov/sites/default/files/SCprimer2009.pdf

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D. 3D Printability of Human Organs

3D-printed tissues and organs are used for a variety of purposes. Among

them, preclinical drug testing and serving as a tissue source for repairing or

replacing defective organs are two notable examples. Preclinical drug testing is

conventionally carried out on either living cells or on live animals.58 Animals are

not always suitable for preclinical testing due to differences in the toxicity of the

test drug between laboratory animals and humans.59 It is estimated that 50

percent of drugs that pass preclinical testing could ultimately be toxic for

humans.60 In vitro drug testing on human tissues does not always yield accurate

results due to the different action of the drug in different organs and tissues. For

example, a drug that treats kidney disease may be toxic to liver cells. A project

currently underway at Wake Forest School of Medicine, to create a “body-on-a

chip,” relies on 3D printing technology to engineer very small human organ-like

structures.61 The goal is to create a realistic ground for testing how the human

body might react to given chemical and biological entities, including therapeutic

compounds.62 The project is based on the idea of linking a number of very small

3D printed organ-like structures together in order to enable more accurate testing

of how a chemical or biological entity might affect the human body as a whole,

or at least a number of organs.63 The “body-on-a-chip” technique uniquely

creates both the biochemical and the physical environments that are needed

for cells to multiply.64 By producing miniature kidney-like or liver-like organs

made from human cells, 3D bio-printing provides economical and accurate

testing results.

58. Trisha Gura, Systems for Identifying New Drugs are Often Faulty, 278 SCI. 1041,

1041 (1997).

59. Id. at 1041–42.

60. U.S. to Develop Chip that Tests if a Drug is Toxic, REUTERS (Sept. 16, 2011),

http://www.reuters.com/article/us-drugs-chip-idUSTRE78F5KX20110916.

61. MILITARY APPLICATIONS, WAKE FOREST INST. FOR REGENERATIVE MED., http://

www.wakehealth.edu/Research/WFIRM/Projects/Body-on-a-Chip.htm (last updated Apr. 12,

2016).

62. Id.

63. Id.

64. Until recently, scientists had to use a donor’s organ and had to remove all the

cellular components from the organ to use it as scaffold. Additive Manufacturing of Medical

Devices Public Workshop 10/8/2014, FDA 114, 117 (Oct. 8, 2014), https://www.fda.gov/

downloads/MedicalDevices/NewsEvents/WorkshopsConferences/UCM425399.pdf (stateme

nt of Dr. James Yoo). In this case, “the organ . . . would retain all the ultrastructure structural

architecture” of a living organ. Id. 3D bioprinting technology has solved this issue. It is

possible to 3D print ‘microstructures’ like liver, bladder tissue, heart, testes, and kidney

structures. Id. at 117.

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In 2015, Organovo Inc. reported their printing of the first human kidney

proximal tubular tissue.65 This tissue incorporated multiple cell types patterned

to reproduce the structure of kidney tubular tissue.66 This came after a previous

successful attempt by the same company to print a cellular assay of liver tissue

(exVive3d) for pre-clinical testing purposes.67 The liver performs a number of

vital functions including the synthetization of key proteins and the metabolism

of xenobiotics (foreign chemical substances).68 Failure of any of these key

functions can cause disease and drug-induced toxicity.69 Using a rapid 3D bio-

printing technology combined with tissue engineering, in 2016, a team of

researchers at the University of California reported that they have developed “a

microscale hepatic construct consisting of physiologically relevant hexagonal

units of liver cells . . . .”70 This was a key development in the process of

personalized drug screening as well as in vitro studies of liver pathophysiology.71

Providing more accurate pre-clinical testing results is not the only advantage

offered by 3D technology. Another equally important advantage is cost

reduction. Some experts estimate roughly 40 percent “of the $50 billion spent

annually on developing new drugs goes toward treatments that will never make

it to [the] market.”72 Therefore, the possibility of testing drug candidates in 3D

bio-printed liver tissue in order to investigate their therapeutic effectiveness and

toxicology will offer significant cost savings to the pharmaceutical sector.73

65. Press Release: Organovo Reports First-Quarter Fiscal 2016 Financial Results

and Corporate Highlights, ORGANOVO (Aug. 10, 2015), http://www.prnewswire.com/news-

releases/organovo-reports-first-quarter-fiscal-2016-financial-results-and-corporate-high

lights-300126322.html.

66. Id.

67. Justin B. Robbins et al., Bioprinted Three-Dimensional (3D) Human Liver

Constructs Provide a Model for Interrogating Liver Biology, ORGANOVO, http://organovo.

com/wp-content/uploads/2015/07/12-12-13_ASCB_Poster_Final_JBR_V2.pdf (last visited

Mar. 16, 2017).

68. The Liver: Anatomy and Functions, UNIV. ROCHESTER MED. CTR.,

https://www.urmc.rochester.edu/encyclopedia/content.aspx?ContentTypeID=85&ContentID

=P00676 (last visited Mar. 4, 2017).

69. Neil Kaplowitz, Idiosyncratic Drug Hepatotoxicity, 4 NAT. REV. 489, 489 (2005).

70. Xuanyi Maa et al., Deterministically Patterned Biomimetic Human iPSC-derived

Hepatic Model Via Rapid 3D Bioprinting, 113 PROC. NAT’L ACAD. OF SCI. 2206, 2206 (2016).

71. Id.

72. Joel Anderson, Organovo’s (ONVO) Deal with L’Oreal (LRLCY) Could Indicate

a Range of Options for the Biotech Small Cap, EQUITIES.COM (Apr. 10, 2015), https://www.

equities.com/news/organovo-s-onvo-deal-with-l-oreal-lrlcy-could-indicate-a-range-of-

options-for-the-biotech-small-cap.

73. Id.

https://www.urmc.rochester.edu/encyclopedia/content.aspx?ContentTypeID=85&ContentID=P00676

https://www.urmc.rochester.edu/encyclopedia/content.aspx?ContentTypeID=85&ContentID=P00676

AMMAR 6/6/2017 1:45 PM


To date, just a few successful printing attempts of functional organs have

been reported and the reported “organs” have all been miniature in size.74 Lee

Cronin states that there is still significant work to be done before the use of bio-

printed organs is either “practical or commonplace.”75 A significant technical

challenge is how to achieve biologically realistic tissue thicknesses.76 Once the

thickness of an engineered tissue exceeds 150-200 micrometers, oxygen can no

longer diffuse between host and transplanted tissue.77 A 2012 paper by a team at

the Scripps Research Institute, which was followed by a 2015 paper published

by a team at Wake Forest School of Medicine, demonstrated that 3D technology

can be used to avoid this problem.78 The Wake Forest team 3D-printed an ear,

which they successfully integrated in the body of a mouse; the ear survived for

two months.79 Using an integrated tissue printer, the Wake Forest team in-

corporated microchannels into the ear tissue, thus overcoming the diffusion limit

of 100–200 mm for cell survival in engineered tissues.80 In 2014, a team of

scientists from Nanjing reported their successful attempt to construct a schematic

model of a life-sized eye that simulates the optical performance of the human

eye.81 Naturally occurring collagen and phospholipids were printed to produce

artificial tissues that mimic human corneas.82 This work provides a potential

substitute for the use of human donor corneas.83

The significance of these advances cannot be overstated. According to the

U.S. Department of Health and Human Services, while an average of 80 organ

transplants are carried out daily in the US, 22 people die every day due to

shortages in transplant organs.84 Indeed, according to the American Transplant


75. Id.

76. Cui Xiaofeng et al., Thermal Inkjet Printing in Tissue Engineering and

Regenerative Medicine, U.S. NAT’L INST. HEALTH 2 (2012), published in 6 RECENT PAT. DRUG

DELIVERY FORMULAS 149 (2012).

77. Id.

78. See generally id. at 2–3; Hyun-Wook Kang et al., A 3D Bioprinting System to

Produce Human-Scale Tissue Constructs with Structural Integrity, 34 NATURE BIO-

TECHNOLOGY 312, 318 (2016).

79. Id. at 315.

80. Id. at 318.

81. Ping Xie et al., Application of 3-Dimensional Printing Technology to Construct an

Eye Model for Fundus Viewing Study, PLOS ONE, Nov. 2014, at 1.

82. Id. at 2.

83. M. Mirazul Islam et al., Functional Fabrication of Recombinant Human Collagen-

Phosphorylcholine Hydrogels for Regenerative Medicine Applications,12 ACTA BIO-

MATERIALIA 70, 79 (2015).

84. See generally, Organ Donation Statistics, ORGANDONOR.GOV, http://www.organ

donor.gov/about/data.html (last visited Mar. 4, 2017).

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Foundation, 120,000 people are currently waiting for an organ transplant, with

another patient added to the waiting list every 12 minutes.85 Enabling 3D

biotechnology to achieve its full potential requires, among many other things,

innovation-friendly regulations.

III. PATENT LAW: ENABLER OR PROHIBITOR OF 3D TECHNOLOGY?

The response of patent law to matters that depend directly on the maturity of

a rapidly developing scientific field, such as 3D bio-printing, is inevitably

complex. Inventions in the medical sector have “extremely high upfront

investment [costs]” in order for a product to reach the market.86 Thus, significant

economic interests are at stake. Once disclosed, many inventions “are easily

duplicated at relatively low cost . . . .”87 This makes patent protection of

paramount importance to regenerative medicine in general, and to medical device

manufacturers in particular. Patent protection acts as a barrier to market entry,

enabling inventors to recoup their upfront expenses.88 Inventors are granted

exclusive rights in their inventions and creations as a way to advance public

welfare through disclosure of information.89 With open-source 3D technology

becoming mainstream (an open source software can be freely used, changed, and

shared by anyone),90 the combination of advanced 3D mapping and 3D printing

is likely to disturb the long standing balance of the patent system. Information

can be easily “consumed” without depletion. Absent patent protection, it is

difficult to prevent individuals who would not pay for the information from

85. See generally Facts: Did You Know?, AM. TRANSPLANT FOUND., http://www.

americantransplantfoundation.org/about-transplant/facts-and-myths/ (last visited Apr. 16,

2016). In the United States alone, more than 120,000 people need a lifesaving organ transplant.

Id. In the U.K. alone, more than 6,000 people need a transplant. Organ Donation and

Transplantation Activity Data: United Kingdom, NHSBT-ORGAN DONATION HOME (Jan.

2017), http://www.organdonation.nhs.uk/. Of those, three a day will die waiting as there are

not enough organs available. Emily Dugan, Tragedy of Britain’s Organ Transplant Patients,

INDEP., http://www.independent.co.uk/life-style/health-and-families/health-news/tragedy-of-

britains-organ-transplant-patients-8488397.html (last visited Mar. 4, 2017).

86. Adam Lewin, Medical Device Innovation in America: Tensions Between Food and

Drug Law and Patent Law, 26 HARV. J.L. & TECH. 403, 413 (2012).

87. Id.

88. Eric P. Raciti & James D. Clements, A Trap for the Wary: How Compliance with

FDA Medical Device Regulations Can Jeopardize Patent Rights, 46 IDEA: INTELL. PROP. L.

REV. 371, 371–72 (2006).

89. Id. at 372.

90. See generally OPEN SOURCE INITIATIVE, https://opensource.org/ (last visited Oct.

16, 2016) (“Open source software is software that can be freely used, changed, and

shared. . . .”).

http://www.organdonation.nhs.uk/;

http://www.independent.co.uk/life-style/health-and-families/health-news/tragedy-of-britains-organ-transplant-patients-8488397.html

http://www.independent.co.uk/life-style/health-and-families/health-news/tragedy-of-britains-organ-transplant-patients-8488397.html

https://opensource.org/

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getting it in the first place.91 Left unchecked, losses of intellectual property rights

are likely to hinder the optimal adoption of 3D printing. Therefore, the legal

structures regulating 3D technology must strike a careful balance between

promoting the technological development of the healthcare system and ensuring

the effectiveness and accessibility of medical products available on the market.

A recent study suggests 3D technology is likely to significantly challenge

current businesses models in that companies will seek security with respect to

IP, particularly regarding licensing, rights to 3D printing, and liabilities.92 When

responding to the potential supply chain (on-demand delivery), IP threats are a

major concern. Such concerns are not unfounded; digital crime and IP theft

currently globally cost $375-575 billion per year.93 According to a similar survey

conducted by PricewaterhouseCoopers (PWC), 27.8 percent of the surveyed

manufacturers believe threats to IP will be one of the most significant disruptions

to emerge from the widespread adoption of 3D printing.94 The concluding

remarks of the PWC survey state IP protection “is a major issue surrounding the

growth of 3D printing that has not yet been solved.”95

A lack of adequate IP protection, therefore, is one of the pressing limitations

that hinder the widespread adoption of 3D technology. This concern is better

understood in the context that, currently, more than 30,000 new digital designs

are shared monthly,96 such that many scholars expect advances in 3D printing

technology will bring IP law to “its knees.”97

91. Kenneth J. Arrow, Economic Welfare and the Allocation of Resources for

Invention, in THE RATE AND DIRECTION OF INVENTIVE ACTIVITY: ECONOMIC AND SOCIAL

FACTORS 609, 615 (Universities-National Bureau Committee for Economic Research,

Committee on Economic Growth of the Social Science Research Council ed., 1962).

92. See Industrial Manufacturing: Megatrends Research, KPMG 23 (2014),

https://assets.kpmg.com/content/dam/kpmg/pdf/2014/01/megatrends-research-2014-kpmg-

en.pdf.

93. Net Losses: Estimating the Global Cost of Cybercrime, CTR. FOR STRATEGIC &

INT’L STUD. & MCAFEE 2 (June 2014), http://www.mcafee.com/us/resources/reports/rp-

economic-impact-cybercrime2.pdf.

94. 3D Printing and the New Shape of Industrial Manufacturing, supra note 16, at 10.

95. Id. at 14.

96. Paul Brody & Veena Pureswaran, The New Software-Defined Supply Chain:

Preparing for the Disruptive Transformation of Electronics Design and Manufacturing, IBM

GLOBAL BUS. SERVS. 7 (2013), https://www-01.ibm.com/common/ssi/cgi-bin/ssialias?sub

type=XB&infotype=PM&appname=GBSE_GB_TI_USEN&htmlfid=GBE03571USEN&.

97. HOD LIPSON & MELBA KURMAN, FABRICATED: THE NEW WORLD OF 3D PRINTING 7

(2013).

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If 3D printing is as disruptive as KPMG, PWC, and Lipson and Kurman

claim in their studies,98 then the way(s) in which this technology does or will

disrupt patent law must be investigated. The next section examines how patent

law in both the U.S. and Europe performs against the issues raised above.

A. Patentability of 3D Bio-printed Organs: A U.S. Perspective

Section 101 of the Leahy-Smith America Invents Act (AIA) sets the standard

for patent eligibility.99 It reads: “[w]hoever invents or discovers any new and

useful process, machine, manufacture, or composition of matter, or any new and

useful improvement thereof, may obtain a patent thereof, subject to the

conditions and requirements of this title.”100 A typical patentable subject matter

must satisfy four conditions: (i) fall within the scope of Section 101, (ii) be

novel101, (iii) be useful102 and (iv) be non-obvious.103 A particular impediment to

the patentability of 3D printed inventions is the use of living organisms. Section

33(a) of the AIA prohibits the patentability of “a claim directed to or

encompassing a human organism.”104 Section 33(a) is potentially problematic

since a key advantage of the 3D revolution is that living human tissues (naturally

occurring cells) are used in order to minimize the risk of foreign body

rejection.105 The use of human cells to print organs is, thus, very likely to be a

vigorously contested point because it blurs the boundary between patentable

inventions and unpatentable inventions that involve “human organisms.”106 A

printed invention must therefore clear, among others, two notable hurdles: it must

demonstrate that the invention both (i) novel and falls outside of the excluded

categories set forth by the U.S. Supreme Court107 and (ii) falls outside of the

excluded subject matter under Section 33 (a). The patenting of bio-printed

98. See generally INDUSTRIAL MANUFACTURING: MEGATRENDS RESEARCH, supra note

92, at 23; 3D Printing and the New Shape of Industrial Manufacturing, supra note 16, at 14;

LIPSON & KURMAN, supra note 97, at 7.

99. 35 U.S.C. § 101 (2015).

100. Id.

101. Id. § 102.

102. Id. at § 101.

103. Id. at § 103.

104. Leahy-Smith America Invents Act, Pub. L. No. 112-29, 125 Stat. 284 (2011)

(codified at 35 U.S.C. § 33(a) (2012)).

105. Cf. Cui, supra note 76, at 2 (discussing the use of living human tissues in creating

functional 3D organs).

106. 35 U.S.C. § 101 note (a) (2012).

107. See Mayo Collaborative Serv. v. Prometheus Labs., Inc., 132 S. Ct. 1289, 1293

(2012) (“‘[L]aws of nature, natural phenomena, and abstract ideas’ are not patentable.” (citing

Diamond v. Diehr, 450 U.S. 175 (1981)).

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inventions is likely to stir the controversy that the current patent regime expands,

that is, not only the scope of protection, but also the subject matter that can be

protected under patent law.108 This issue is further complicated by the fact that

current advances in genetic engineering have enabled scientists to replicate, by

using 3D printing, a significant number of naturally occurring substances.109

The question of whether a 3D bio-printed invention is patentable depends on

whether the invention is treated as product of a law of nature, a natural

phenomenon or, equally significantly, whether it falls under Section 33(a) of the

AIA. If it can be demonstrated that an invention that incorporates a “living

organism” is non-naturally occurring, that is, it is a man-made living organism,

it may still be patentable. Thus, the fact that a 3D bio-printed invention

incorporates a biologically active organism does not, in and of itself, negate its

patentability, providing of course that all other patenting conditions are met.110

Here, one must consider whether the method of producing a 3D-printed

organ falls within the definition of “manufacturing” under Section 101 of the

AIA.111 In order to do this, one must consider the interpretation of two

interrelated terms: “living organisms” under Section 33(a), and

“manufactur[ing].”112 The phrase “living organisms” is not defined by the

statute.113 According to the ninth edition of the Manual of Patent Examining

Procedure (MPEP) released in 2015, human organisms are not patent-eligible

108. For example, the Nobel Prize laureate for economics, Joseph Stiglitz points out the

problem of the inefficiency of the current patent and innovation system under neoliberalism.

He contends that the American IP regime is designed to maximize rent seeking rather than

innovation, and that the current IP regime stifles innovation. LAW AND ECONOMICS WITH

CHINESE CHARACTERISTICS: INSTITUTIONS FOR PROMOTING DEVELOPMENT IN THE TWENTY-

FIRST CENTURY 254 (David Kennedy & Joseph E. Stiglitz eds., 1st ed. 2013); see also Joseph

E. Stiglitz & Arjun Jayadev, India’s Patently Wise Decision, PROJECT SYNDICATE 3 (Apr. 8,

2013), https://www.project-syndicate.org/commentary/the-impact-of-the-indian-supreme-

court-s-patent-decision-by-joseph-e—stiglitz-and-arjun-jayadev. Similar remarks were raised

by the Nuffield Council on Bioethics raising concerns regarding biotechnology

governance. Emerging Biotechnologies: Technology, Choice and the Public Good, NUFFIELD

COUNCIL ON BIOETHICS 152, 158, 167 (Dec. 2012), http://nuffieldbioethics.org/wp-content

/uploads/2014/07/Emerging_biotechnologies_full_report_web_0.pdf; see Sabrina Safrin,

Hyperownership in a Time of Biotechnological Promise: The International Conflict to Control

the Building Blocks of Life, 98 AM. J. INT’L L. 641, 641 (2004).

109. Cf. Cui, supra note 76, at 3 (discussing the use of 3D printing in replicating DNA

cells and mammalian cells).

110. See generally Diamond v. Chakrabarty, 447 U.S. 303, 313 (1980) (“Congress thus

recognized the relevant distinction . . . between products of nature, whether living or not, and

human-made inventions.”).

111. 35 U.S.C. § 101 (2015).

112. Id.

113. Id.

https://www.project-syndicate.org/commentary/the-impact-of-the-indian-supreme-court-s-patent-decision-by-joseph-e--stiglitz-and-arjun-jayadev

https://www.project-syndicate.org/commentary/the-impact-of-the-indian-supreme-court-s-patent-decision-by-joseph-e--stiglitz-and-arjun-jayadev

AMMAR 6/6/2017 1:45 PM


subject matter.114 “If the broadest reasonable interpretation of the claimed

invention as a whole encompasses a human being, then a rejection under 35

U.S.C. 101 must be made indicating that the claimed invention is directed to non-

statutory subject matter.”115

Investigating the patentability of a functional 3D-printed organ requires a

detailed examination of not only how the term “manufacturing” is interpreted by

the U.S. Supreme Court but, more importantly, how it ought to be interpreted.

B. Bio-manufacturing of “Living Organisms”

Despite the limitations imposed under Section 33(a), since Diamond v.

Chakrabarty, there has been a clear expansion of the scope of patentable subject

matter.116 Section 100(a) of the AIA defines “invention” as “invention or

discovery.”117 The discovery of new processes or products, as opposed to

creating them, is therefore, in principle, patent eligible.118 In the 3D bio-printing

context, an inventor may invent a process, a product, or both. The term “process”

is defined as “art or method, and includes a new use of a known process, machine,

manufacture, composition of matter, or material.”119 As such, a process could be

a method for “making something,” such as a method for 3D printing a cell or an

organ; a “method for using something,” such as a method for enabling oxygen

and nutrients to flow into a 3D-printed tissue or organ by using a specific

biodegradable material. In some cases, 3D patentable processes may produce a

product, such as a living organ, that may or may not be patent eligible. Unlike

“human organisms,” which are excluded from the scope of patentable subject

matter, the processes of bioprinting living organs themselves are patent eligible.

The U.S. Supreme Court has interpreted the term “manufacture” as being

“the production of articles for use from raw or prepared materials by giving to

these materials new forms, qualities, properties, or combinations, whether by

hand-labor or by machinery.”120 The term “composition of matter” is also

construed very broadly. It includes:

114. MPEP § 2105 (9th ed. 2015 Rev. 7, Nov. 2015); U.S. Pat. & Trademark Off.,

Report to Congress: Study and Report on the Implementation of the Leahy-Smith America

Invents Act 21–22 (2015).

115. U.S. Pat. & Trademark Off., Memorandum on Claims Directed to or

Encompassing a Human Organism (Sept. 20, 2011).

116. Jeffrey M. Kuhn, Patentable Subject Matter Matters: New Uses for an Old

Doctrine, 22 BERKELEY TECH. L.J. 89, 89 (2007).

117. 35 U.S.C. § 100 (2015).

118. Id. at § 100(a).

119. Id. § 100(b).

120. Diamond v. Chakrabarty, 447 U.S. 303, 308 (1980).

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All compositions of two or more substances and . . . all composite articles, whether they be the results of chemical union, or of mechanical mixture, or whether they be gases, fluids, powders or solids.121

Defining the terms “manufacturing” and “composition of matter” in such a

broad way could potentially be very significant for the patentability of 3D bio-

printed living organs. Case law of the U.S. Supreme Court indicates that some

forms of “human organisms” are patent eligible. Diamond v. Chakrabarty

addressed the patentability of a man-made genetically engineered bacterium

capable of breaking down crude oil under 35 U.S.C. § 101.122 In this case, three

types of claims were at stake: process claims, that is, methods of producing the

bacterium; claims for carrier materials, such as straw and new bacteria; and

claims to the bacterium itself.123 The court ruled that man-made microorganisms

are patent-eligible.124 Chakrabarty’s microorganism constitutes a “manufacture”

or “composition of matter” within the statute.125 The newly produced bacterium

has “markedly different characteristics from any found in nature and one having

the potential for significant utility.”126 Ultimately, claims that were directed to

the processes of production and use of the bacterial organisms were allowed

under 35 U.S.C. § 10l.127 In other words, possessing biological activity does not

necessarily negate the patentability of man-made microorganisms.128 However,

the Supreme Court made clear that “the laws of nature, physical phenomena, and

abstract ideas” are not patent eligible.129

Chakrabarty was the high-water mark in the patentability of biotech

inventions. Some of the Supreme Court’s recent rulings curtail the patentability

of biotechnology inventions. In Mayo v. Prometheus Laboratories, the Court

advanced a two-pronged test under which the determination of the patent

eligibility of an invention rests on two interrelated questions. 130 The first

question is whether the claims are directed to a patent-ineligible subject matter

(i.e., laws of nature, natural phenomena or abstract ideas).131 If so, a second

121. Id. at 308 (quoting Shell Development Co. v. Watson, 149 F. Supp. 279, 280

(D.D.C. 1957)).

122. Id. at 305.

123. Id. at 305–06.

124. Id. at 313.

125. Id. at 309–10.

126. Id. at 310.

127. Id. at 309.

128. Id. at 309–10.

129. Id. at 309.

130. See generally Mayo Collaborative Servs. v. Prometheus Labs., Inc., 132 S. Ct.

1289, 1297–99 (2012).

131. Id. at 1293.

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question is what “else is there in the claims before us?”132 In other words, courts

should consider the extent to which aspects of the claim(s), individually or

cumulatively, transform the nature of the claim(s) into a patentable subject

matter.

In Myriad, the Supreme Court held that a claim directed to a product of

nature adds nothing new and is, therefore, not patent eligible.133 As such, “a

naturally occurring DNA segment is a product of nature and not patent eligible

merely because it has been isolated, but that cDNA [used to express certain

protein in a cell that does not normally express such a protein] is patent eligible

because it is not naturally occurring.”134

The rule against patents on naturally occurring things is not without limits, however, for “all inventions at some level embody, use, reflect, rest upon, or apply laws of nature, natural phenomena, or abstract ideas,” and “too broad an interpretation of this exclusionary principle could eviscerate patent law.135

The Supreme Court later reasoned that these three categories are patent

ineligible because “they are the basic tools of scientific and technological

work.”136 The patenting of which may stifle innovation rather than promote it,

thereby thwarting the goals of patent law.137 Under Alice’s two-pronged test, the

court should first determine whether the claims are directed to one of the three

excluded subject matters.138 If so, the court should then examine the extent to

which the additional elements “transform the nature of the claim” into a

patentable subject matter.139 The Supreme Court has described the second step

of this analysis as a search for an “‘inventive concept’ – i.e., an element or

combination of elements that is ‘sufficient to ensure that the patent in practice

amounts to significantly more than a patent upon the [ineligible concept]

itself.’”140

132. Id. at 1297.

133. Ass’n. for Molecular Pathology v. Myriad Genetics, Inc., 133 S. Ct. 2107, 2111

(2013).

134. Id.

135. Id. at 2116.

136. Id.

137. Alice Corp. v. CLS Bank Int’l, 134 S. Ct. 2347, 2354 (2014) (citation omitted).

138. Id. at 2355.

139. Id.

140. Id.

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Ariosa Diagnostics, Inc. v. Sequenom is the most recent biotechnology case

related to our present discussion.141 The claims were directed to “methods for

detecting paternally-inherited fetal DNA in maternal blood samples, and

performing a prenatal diagnosis based on such DNA.”142 This invention makes

it possible to diagnose potential birth defects without using highly intrusive

means.143 By comparison with DNA taken from the father of an unborn child, it

is possible to distinguish cell-free fetal DNA in the blood plasma of a mother

from the mother’s DNA.144 Based on the Mayo/Alice framework, the Court of

Appeals for the Federal Circuit concluded that Claims 1 and 21 of this case are

patent ineligible because they are directed to “detecting the presence of a

naturally occurring thing or a natural phenomenon, cffDNA in maternal plasma

or serum . . . [T]he claimed method begins and ends with a naturally occurring

phenomenon.”145 The Court reasoned that, as Alice subsequently confirmed, the

two-step framework articulated in Mayo applies to distinguish patents that claim

“laws of nature, natural phenomena, and abstract ideas from those that claim

patent-eligible applications of those concepts.”146 Significantly, the Court of

Appeals stressed that, unless narrowly tailored to the particular application of the

law that has been developed, claims for a newly discovered law of nature should

be invalid “as they too broadly preempt the use of the underlying idea.”147

C. USPTO Guidelines on Biotechnology: 3D Test

The United States Patent and Trademark Office (USPTO) guideline on

biotechnology sheds some light on the interpretation of the term

“manufacturing,”148 which could be helpful in explaining the point at which a 3D

bio-invention may be considered “manufactured” and, thus form patentable

subject matter. According to the guideline, the patentability of a stem cell-related

application rests, among other issues, on whether the claimed invention does

“recite additional elements that amount to significantly more than the judicial

141. See generally Ariosa Diagnostics, Inc. v. Sequenom, Inc., 788 F.3d 1371 (Fed. Cir.

2015).

142. Id. at 1374.

143. Id. at 1373–74.

144. Id. at 1373.

145. Id. at 1373–74, 1376.

146. Id. at 1375.

147. Id. at 1380 (Linn, J., concurring).

148. Nature-Based Products, U.S. PAT. & TRADEMARK OFF. 14–15, http://www.uspto.

gov/patents/law/exam/mdc_examples_nature-based_products.pdf (last visited Mar. 16, 2017).

AMMAR 6/6/2017 1:45 PM


exception.”149 As such, an “isolated man-made human pacemaker cell” (a heart

cell) is not patent eligible because the invention is a nature-based product and,

thus, does not have markedly different characteristics from any naturally

occurring counterpart(s) in their natural state.150 In order to consider how this

applies to 3D bio-printed inventions, it is necessary to investigate one of the

examples cited by the guideline.

Heart pacemaker cells generate electrical impulses that control heart-rate and

when they become damaged they must be repaired.151 Suppose that a bio-claim

discloses the use of differentiated stem cells as pacemaker cells, for use in

regenerating damaged heart tissue. Man-made pacemaker cells have been

developed that are genetically and phenotypically identical to naturally occurring

pacemaker cells. These cells are characterized by expressing a protein called

marker P. Other man-made pacemaker cells, however, exhibit a different

phenotype to that of naturally occurring cells; these cells are expressed by marker

Z. Suppose that the man-made marker Z cell type increases efficiency of oxygen

utilization compared to naturally occurring pacemaker cells. This added

efficiency is significant for patients that have suffered a heart attack. Among

others, the applicant drafted the following claim: “A composition comprising a

population of isolated man-made human pacemaker cells in a biocompatible

three-dimensional scaffold.”152 According to the USPTO’s guideline, this claim

is patent eligible for reasons that will be discussed in the next paragraph.

This claim concerns a nature-based product because the latter is a

combination of cells and a scaffold. However, one should question how the

combination has markedly different characteristics from any naturally occurring

counterpart(s) in their natural state. Recall that isolated man-made cells do not

have markedly different characteristics from their naturally occurring

counterparts due to their isolation from a tissue suspension or man-made

manufacture.153 By the same token, placing the cells into a biocompatible 3D

scaffold does not “result in the cells or the scaffold having any characteristics

(structural, functional or otherwise) that are different from the naturally

occurring cells or the scaffold in its natural state.”154 However, once the claim as

a “whole” is analyzed to determine whether any element, or combination of

elements, is markedly different from what occurs in nature, a different, more

149. 2014 Interim Eligibility Guidance Quick Reference Sheet, U.S. PAT. &

TRADEMARK OFF. 3 (2014), https://www.uspto.gov/patents/law/exam/2014_eligibility_

qrs.pdf.

150. Nature-Based Products, supra note 148, at 14.

151. Id. at 13.

152. Id. at 14.

153. Id. at 15.

154. Id.

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favorable, conclusion can be reached. On the one hand, the recitation of the

biocompatible 3D scaffold in combination with the pacemaker cells is not

required for growing or using the cells. This is because the cells can be grown or

used in other containers, and is not recited at a high level of generality. On the

other hand, the addition of the pacemaker cells to the scaffold confines the claim

to a specific useful application of the scaffold, in this case, repair of cardiac

tissue. This is because the pacemaker cells are not routinely required for all

practical uses of the scaffold. As such, the combination of these elements does

improve the technology of regenerative medicine by facilitating faster tissue

regeneration than when pacemaker cells are implanted. For these reasons, the

claim cited above amounts to “significantly more” than what occurs in nature

and, therefore, qualifies as eligible subject matter.155

D. Patent Eligibility of 3D Bio-printed Organs

Under Chakrabarty’s standard, a patentable 3D microorganism must meet,

among others, three interrelated conditions: it must: (i) be man-made, (ii) have

“markedly different characteristics from any found in nature” and (iii) be

potentially useful.156 Unlike laws of nature, physical phenomena, and abstract

ideas, a 3D man-made microorganism that is markedly different from any similar

organism in nature is patent eligible.

The patent eligibility of a fully functional 3D printed organ depends on

several issues. Claims are likely to be patent eligible if they are directed to one

or more of the (i) processes, (ii) methods or (iii) substances that are used in the

bio-printing processes. It is less clear if the printed organ itself is patent eligible.

On one hand, a strict interpretation of Section 33(a) of the AIA, which prohibits

the patentability of “a claim directed to or encompassing a human organism”157

opens the door for a 3D printed organ to be characterized as a “living invention”

whose printing relies on, among other factors, “living organisms” and thus falls

foul of Section 33. On the other hand, it is difficult to characterize the 3D printed

organ as a “human organism” simply because the printing processes involve the

use of “living cells.” Under Chakrabarty’s standard for human-made micro-

organisms, having some biological activities, does not necessarily negate

patentability. The printed organ is not capable of developing into a complete

human being nor does it form a critical stage in the development and formation

of a human being as embryonic stem cells, such as totipotent cells, do. What is

more, the 3D-printed organ is a man-made invention that is markedly different

155. Id. at 15–16.

156. Diamond v. Chakrabarty, 447 U.S. 303, 310 (1980).

157. Leahy-Smith America Invents Act, Pub. L. No. 112-29, § 33, 125 Stat. 284, 340

(2011).

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from any similar organism in nature and has enormous utility potential. In the

context of the USPTO guideline discussed above, the phrase “markedly

different,” as coined by the Supreme Court in Chakrabarty, should not be

understood in a trademark similarity-difference manner158 While it is possible

for a 3D-printed organ to look similar, or even identical, to another organism in

nature, it can still be “markedly different” in terms of its characteristics, quality

or functionality;159 thus meeting the requirements of both Section 33 and novelty

(newness) under 35 U.S. Code § 102.

Under the framework of Mayo/Alice, 3D bio-printing processes, which

clearly rely on naturally occurring cell growth, are likely to be patent eligible.

The Supreme Court determined that the claimed process that set forth laws of

nature must add something “that in terms of patent law’s objectives” has

significance to the laws of nature.160 This newly added thing is supposed to

transform the process into an “inventive application of the formula.”161 The

aforementioned patent claim cited by the USPTO, that is, human pacemaker cells

in a biocompatible 3D scaffold, is a good example. The use of man-made

scaffolding or bio-ink, for example, requires a significant number of

transformative steps. These steps are likely to satisfy Mayo’s and Myriad’s two-

pronged test that the invention is not a mere isolation or 3D printing of a natural

substance.162 Put differently, it would appear 3D-printed substances that occur in

nature, and even organs, are patentable subject matter providing they have

structural, functional or other characteristics that are different from those of the

respective natural products. Such 3D processing of the natural substance renders

it a new product for the purpose of Sections 101 and 102. For example, as long

as it has any structural, functional or other characteristics that are different from

158. When deciding a trademark infringement and the likelihood of consumer

confusion test in Europe, courts pay special attention to the aural, visual and conceptual

similarities of the marks in question, in particular, their distinctive and dominant components.

Case C-251/95, Sabel v. Puma, 1997 ECR 1-6191, para. 23. In the U.S., whether a claim of

trademark infringement brought under 15 U.S. Code § 1114 (1)- infringement for registered

mark- or 15 U.S.C. Code §1125(a)- infringement of rights in a mark acquired by use- the test

of the likelihood of consumer confusion varies across the circuits. See for example Interpace

Corp. v. Lapp, Inc., 721 F. 2d 460, 463 (3d Cir. 1983) (establishing the 10 Lapp factors);

Polaroid Corp. v. Polarad Elec. Corp., 287 F.2d 492, 495 (2d Cir. 1961) (establishing an eight-

factor test); and Squirtco v. Seven-Up Co.; 628 F.2d 1086, 1091 (8th Cir. 1980) (establishing

a six-factor test).

159. Nature-Based Products, supra note 148, at 15.

160. Mayo Collaborative Servs. v. Prometheus Labs., Inc., 132 S. Ct. 1289, 1299

(2012).

161. See id. at 1299.

162. See 2014 Interim Eligibility Guidance Quick Reference Sheet, U.S. PAT. &

TRADEMARK OFF. 1 (2014), https://www.uspto.gov/patents/law/exam/2014_eligibility_

qrs.pdf.

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the respective naturally occurring organ, a 3D-printed liver made from living

tissue may, in principle, qualify as a new product and, thus, be patent eligible.163

With the above in mind, one may seriously question the advantages of

patenting the bio-printed product itself, especially, a bio-printed human organ.

After all, the organ is not a typical product; it is usually tailor-made to the needs

of a specific patient and, in many cases, the organ will be based on the patient’s

own cells in order to minimize the risk of rejection.164 This is exactly the novelty

and strength of regenerative, or personal, medicine. The printed organ is unlikely

to be sold to the mass market, or to be modified. From this perspective, the

patentability of the 3D bioprocesses and bio-ink is more significant than the

patentability of the end product itself. So far, this issue has captured the attention

of many patent law experts.165

IV. E.U. LAW

Unlike patent law in the U.S.,166 the EPC contains a statutory basis for the

courts to deny patent protection of morally controversial biotechnology

163. Id. at 3.

164. See Jacques P. Guyette et al., Bioengineering Human Myocardium on Native

Extracellular Matrix, 118 CIRCULATION RES.: J. AM. HEART ASS’N 56, 56 (2016).

165. E.g., Julie L. Langdon, Potential Patenting Challenges for 3D Printed Organs: A

Review of Recent Court Decisions Provides Insight into Patent Eligibility of 3D Organs,

GENETIC ENGINEERING & BIOTECHNOLOGY NEWS (Dec. 17, 2015), http://www.genengnews.

com/print/40108.

166. A number of attempts were made to play the ‘morality’ card in the U.S. and most

were fruitless. In one notable example, the Federal Circuit rejected the application of the

concept of a ‘moral’ utility requirement under patent law. The Court noted: “it has been stated

that inventions that are injurious to the well-being, good policy, or sound morals of society are

unpatentable. . . . but the principle that inventions are invalid if they are principally designed

to serve immoral or illegal purposes has not been applied broadly in recent years. . . . Congress

never intended that the patent laws should displace the police powers of the States, meaning

by that term those powers by which the health, good order, peace and general welfare of the

community are promoted. Of course, Congress is free to declare particular types of inventions

unpatentable for a variety of reasons, including deceptiveness. . . . Until such time as Congress

does so, however, we find no basis in section 101 to hold that inventions can be ruled

unpatentable for lack of utility simply because they have the capacity to fool some members

of the public.” Juicy Whip, Inc. v. Orange Bang, Inc., 185 F.3d 1364, 1366–68 (Fed. Cir. 1999)

(internal quotation marks omitted). However, the USPTO rejected a patent application directed

to a human/non-human chimera (No 08/993,563) arguing that ‘‘inventions directed to

human/non-human chimera could, under certain circumstances, not be patentable because,

among other things, they would fail to meet the public policy and morality aspects of the utility

requirement.” U.S. Pat. & Trademark Off., Facts on Patenting Life Forms Having a

Relationship to Humans, Media Advisory No. 98-6 (April 1, 1998), https://www.uspto.gov

/about-us/news-updates/facts-patenting-life-forms-having-relationship-humans. A similar re-

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inventions.167 Two notable examples are (i) Article 53(a), Rule 28(c),168 the

morality test of the EPC and (ii) Article 6(2), Rule 28(d) of the European

Directive on the Legal Protection of Biotechnological Inventions. The latter

explicitly denounces the commercialization of a number of technologies that are

considered immoral and, thus, patent ineligible.169 The human body, during the

various stages of its formation, as well as the mere discovery of one of its

elements, “including the sequence or partial sequence of a gene,” are considered

to be patent ineligible.170 The European Patent Office (EPO) Technical Board of

Appeal has made it clear that the commercial exploitation of inventions that

offend morality standards are not to be endorsed.171 According to the EPO’s

Technical Board of Appeal, inventions whose exploitation is not in conformity

with the conventionally accepted standards of conduct pertaining to the culture

inherent in European society are to be excluded from patentability.172

Despite these moral impediments and in stark contrast with U.S. patent law,

“an element isolated from the human body or otherwise produced by means of a

technical process, including the sequence or partial sequence of a gene, may

constitute a patentable invention, even if the structure of that element is identical

sult was reached in Tol-O-Matic Inc. where the USPTO concluded the utility requirement of

35 U.S.C. §101 precludes inventions “injurious to the well-being, good policy, or good morals

of society.” Tol-O-Matic, Inc. v. Proma Product-und Marketing Gesellschaft M.b.H ., 945

F.2d 1546, 1552–53 (Fed. Cir. 1991) (citing In re Nelson, 280 F.2d 172, 178–79 (C.C.P.A.

1960)).

167. The European Patent Convention, supra note 12, at 110.

168. Id. Article 53(a)- exceptions to patentability- reads as follows:

European patents shall not be granted in respect of:

(a) inventions the commercial exploitation of which would be contrary to “ordre

public” or morality; such exploitation shall not be deemed to be so contrary

merely because it is prohibited by law or regulation in some or all of the

Contracting States;

(b) plant or animal varieties or essentially biological processes for the production

of plants or animals; this provision shall not apply to microbiological processes

or the products thereof;

(c) methods for treatment of the human or animal body by surgery or therapy and

diagnostic methods practised on the human or animal body; this provision shall

not apply to products, in particular substances or compositions, for use in any

of these methods’.

Id.

169. Council Directive 98/44, art. 6(2), 1998 O.J. (L 213) (EC); European Patent

Convention, supra note 12, at 334.

170. Id. art. 5(1), at 336.

171. EUROPEAN PAT. OFF., CASE LAW OF THE BOARDS OF APPEAL OF THE EUROPEAN

PATENT OFFICE 37 (8th ed. 2016).

172. Plant Genetic Systems v. Greenpeace, Decision T 0356/93-3.3.4, 1995 O.J. Eur.

Pat. Off. 1, 16.

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to that of a natural element” (emphasis added).173 This flexible approach is likely

to have a significant impact on the patentability of 3D bio-inventions. Before

discussing this issue in more detail, we must more thoroughly investigate the

interaction between 3D bioprinting and the morality test.

A. A 3D Test: Article 53(a) of the EPC

There are two different types of morality provision in Europe. The first is

found in Article 53(a) of the EPC and Article 6(1) of the Biotech Directive.

Article 53(a) provides that patents should not be granted for immoral

inventions.174 Despite the contention that patent law is an inappropriate vehicle

for dealing with moral concerns,175 this article is becoming increasingly

significant as a result of current advances in biotechnology and related attempts

to patent bio-inventions. Patent examiners are poorly qualified to deal with moral

questions. Furthermore, it is often unclear what an invention may be ultimately

used for at the early stage of patent application. Indeed, patents cannot dictate

how a given invention is exploited.176 In contrast to the EPC, Article 6(1) of the

Biotech Directive adopts a more lenient approach and provides that inventions

are unpatentable only if “their commercial exploitation [is] . . . contrary to ordre

public or morality.177

The second provision for morality in the E.U. can be found in Rule 28(a-d)

of the EPC (equivalent to Article 6(2) of the Biotech Directive).178 Rule 28 reads:

Under Article 53(a), European patents shall not be granted in respect of biotechnological inventions which, in particular, concern the following: (a) processes for cloning human beings; (b) processes for modifying the germ line genetic identity of human beings; (c) uses of human embryos for industrial or commercial purposes; (d) processes for modifying the genetic identity of animals which are likely to cause them suffering

173. Council Directive 98/44, art. 5(2), Recital 20, 1998 O.J. (L 213) (EC) Recital 20

of the Bio Directive reads: “therefore, it should be made clear that an invention based on an

element isolated from the human body or otherwise produced by means of a technical process,

which is susceptible of industrial application, is not excluded from patentability, even where

the structure of that element is identical to that of a natural element, given that the rights

conferred by the patent do not extend to the human body and its elements in their natural

environment”. Id.

174. European Patent Convention, supra note 12, at 110.

175. Adam Inch, Comment, The European Patent Convention: A Moral Roadblock to

Biotechnological Innovation in Europe, 30 HOUS. J. INT’L L. 203, 240–41 (2007).

176. L. BENTLY & B. SHERMAN, INTELLECTUAL PROPERTY LAW 516 (4th ed. 2014).

177. Council Directive 98/44, art. 6, 1998 O.J. (L 213) (EC).


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without any substantial medical benefit to man or animal, and also animals resulting from such processes.179

An application that falls under any of the excluded categories of invention is

denied patentability under Article 28 without the need to consider the patent

application under Article 53(a).180 If the application falls outside the remit of the

four types of excluded invention within Rule 28, however, the application must

still be examined under Article 53(a).181

The case of the Harvard Oncomouse was the EPO’s first decision to apply

the limitation of Article 53(a). The invention at issue involved the result of a

germ cell manipulation that contained human cancer-causing genes.182 The case

examined the patentability of the invention, which was a “transgenic” mouse,

where DNA from a different mouse had been artificially introduced into the

mouse genome.183 The creation of this mouse raised a pertinent issue of whether

patents should be granted for animals and animal varieties, including higher-

order animals such as mammals.184 The EPO noted that:

Inventions which are made in connection with a new technology and which are to be patented under the EPC have to satisfy the requirements of Article 53 (a) EPC. This means that for each individual invention the question of morality has to be examined and possible detrimental effects and risks have to be weighed and balanced against the merits and advantages aimed at.185

The EPO identifies the following three types of interests: (i) to remedy

human disease, (ii) to protect the environment from the spread of unwanted

genes, and (iii) to avoid cruelty to animals.186 In Wisconsin Alumni Research

Foundation/ Stem Cells, the EPO rejected the patentability of an invention that

involved the destruction of embryos, even though the method of production was

not claimed for protection.187 The term “embryo” was defined in Brüstle v

Greenpeace by the European Court of Justice (CJEU) as something that is

“capable of commencing the process of developing into a human being.”188 This

179. Id. at 110.

180. EUROPEAN PAT. OFF., supra note 171, at 40.

181. Id.

182. Harvard/Onco-mouse, Decision T 19/90, 1990 O.J. Eur. Pat. Off. 1, 1.

183. Id. at 5.

184. Id. at 2.

185. Id. at 21.

186. Id. at 21.

187. Use of embryos/WARF, Decision G 0002/06, 2008 O.J. EUR. PAT. OFF. 1, 30.

188. Case C-34/10, Oliver Brüstle v Greenpeace, 2011 E.C.R. I-9849, para. 37.

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includes “any human ovum after fertilization, any non-fertilized human ovum

into which the cell nucleus from a mature human cell has been transplanted and

any non-fertilized human ovum whose division and further development have

been stimulated by parthenogenesis.”189 As such, unlike totipotent cells,

pluripotent cells are, in principle, patentable subject matter since they cannot give

rise to a complete human body or a complete organ.190

In December 2014, the CJEU rendered its judgement in International Stem

Cell Corporation v. Comptroller General of Patents Designs and Trademarks,

narrowly interpreting the patent exclusion of human embryos for commercial or

industrial purposes.191 The CJEU made clear that, within the meaning of

Article 6(2)(c) of the Biotech Directive, a “non-fertilized human ovum must

necessarily have the inherent capacity of developing into a human being” in order

to be classified as a “human embryo” and thus to be patent ineligible.192 When a

non-fertilized human ovum does not fulfill that condition, “the mere fact that that

organism commences a process of development is not sufficient for it to be

regarded as a human embryo, within the meaning and for the purposes of the

application of Directive 98/44.”193 As such, it would appear that, while the

CJEU’s ruling permits the patentability of pluripotent cells, it does not apply to

non-viable organisms or non-totipotent human embryonic stem cells that are

produced via cloning methods such as somatic cell nuclear transfer.194

Introducing the criterion of “inherent capacity” into a human being, however,

seems to indicate that any organism unable to develop beyond a certain stage due

to a disability or impairment, whether incidental or engineered, may not be

considered an embryo and thus, at least in principle, constitutes patentable

subject matter.195 In the case of human ova subjected to somatic cell nuclear

transfer, it would appear this ovum type may be excluded from patentability only

189. Id. para. 38.

190. Id. para. 12. Recital 42 of the Biotech Directive provides that the exclusion of

human embryos for industrial or commercial purposes from patentability does not “affect

inventions for therapeutic or diagnostic purposes which are applied to the human embryo and

are useful to it.” Council Directive 98/44, Recital 42, 1998 O.J. (L 213) (EC).

191. Case C-364/13, Int’l Stem Cell Corp. v. Comptroller Gen. of Patents, Designs and

Trademarks, ECLI:EU:C:2014:2451, para. 38.

192. Id. para. 27.

193. Id. para. 29.

194. See id. para. 39.

195. See Ana Nordberg & Timo Minssen, A “Ray of Hope” for European Stem Cell

Patents or “Out of the Smog into the Fog”? An Analysis of Recent European Case Law and

How it Compares to the US, 47 INT’L REV. OF INTELL. PROP. & COMPETITION L. 138, 153

(2016).

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if it is a fertilized ovum and is inherently capable of developing into a human

being.196

B. 3D Bio-printed Organs: Patentability in Europe

In stark contrast with the U.S. Supreme Court’s ruling in Chakrabarty,197 a

3D bio-printed organ may be patentable in Europe so long as it is isolated from

the human body or produced by means of a technical process, even if the

structure of the 3D bio-printed organ is not “markedly” different from any found

in nature.198 Recall that Article 5(2) of the Biotech Directive does not exclude

from patentability elements that are “isolated from the human body or otherwise

produced by means of a technical process . . . even if the structure of that element

is identical to that of a naturally occurring element.”199 The wording of Recital

20 of the Biotech Directive leaves no doubt that, at least in principle, and subject

to other conditions, a 3D-printed organ is patentable subject matter under the

EPC.200 Recital 20 reads:

. . . it should be made clear that an invention based on an element isolated from the human body or otherwise produced by means of a technical process, which is susceptible of industrial application, is not excluded from patentability, even where the structure of that element is identical to that of a natural element, given that the rights conferred by the patent do not extend to the human body and its elements in their natural environment.201

Recital 21 of the Biotech Directive further explains that these elements are

produced outside the human body, and are techniques which “human beings

alone are capable of putting into practice and which nature is incapable of

accomplishing by itself.”202

In light of the above, a living human tissue or cell isolated from the human

body or otherwise produced for the purposes of 3D bio-printing or a 3D-printed

organ are not excluded from patentability. This is because 3D bio-printing

processes intend to reproduce the tissue, the organ, or a portion of them, outside

the human body, thus being a technique which nature is incapable of

accomplishing by itself.

196. Id. at 155.

197. Diamond v. Chakrabarty, 447 U.S. 303, 309–10, (1980).

198. Council Directive 98/44, art. 5(2), 1998 O.J. (L 213) (EC).

199. Id.

200. See id. Recital 20.

201. Id.

202. Id. Recital 21.

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To summarize, in the E.U., the patenting of 3D-printed organs (“living

organisms”) is permissible provided that the printed invention is either isolated

from the human body or produced by means of a technical process, and it cannot

be manufactured outside of the human body by natural processes alone.

Regarding the choice of stem cells for 3D bio-printing, following from

International Stem Cell Corporation v. Comptroller, it seems that partheno-

genesis stem cell-based inventions, pluripotent stem cells-based claims for 3D

bio-printed tissues and organs, and the use of both induced stem cells and adult

stem cells are all patent eligible.203

In addition to these requirements, 3D bio-printed inventions are only

patentable in Europe if they satisfy Article 53(c), which excludes methods for

diagnosis and treatment.204 As the next section will discuss, this is likely to be

the most difficult legal challenge for many 3D bio-printed inventions.

C. 3D Bio-printing onto a Body: Treatment, Surgical or Cosmetic?

Article 53(c) requires that patents should not be granted in respect of

“methods for treatment of the human or animal body by surgery . . . and

diagnostic methods practiced on the human . . . this provision shall not apply to

products, in particular substances or compositions, for use in any of these

methods.”205 Given the level of technical sophistication and, thus, the complexity

of medical treatments that could be conducted using 3D bio-printing, Article

53(c) is likely to be a major legal impediment for many 3D bio-inventions. It is

helpful, at this point, to explore this issue through a practical example.

Atala suggests that, in principle, it is possible to use a 3D imaging method

to determine the geometry of a wound and the type of cells required to treat that

wound. 206 Once the required data is obtained, it is possible to print the cells that

are required for the treatment directly onto the patient’s body.207 Therefore, one

should now consider whether such a method of printing onto a patient’s body

falls within the scope of Article 53(c). Put differently, one should consider

whether the method of 3D printing directly on the patient’s body can be

203. Case C-364/13, Int’l Stem Cell Corp. v. Comptroller Gen. of Patents, Designs and

Trademarks, ECLI:EU:C:2014:2451, paras. 20–21, 28–29, 38.

204. Patents on Biotechnology: Biotechnology, at the Heart of Many Advances in Life

Sciences, EUR. PAT. OFF., https://web-beta.archive.org/web/20160627125929/https://www.

epo.org/news-issues/issues/biotechnology.html (last visited Oct. 16, 2016).


206. Anthony Atala, Printing a Human Kidney, TED.COM (March 2011),

https://www.ted.com/talks/anthony_atala_printing_a_human_kidney?language=en(Professor

Atala is a leading scientist and the director of the Wake Forest Institute for Regenerative

Medicine in North Carolina).

207. Id.

https://www.ted.com/talks/anthony_atala_printing_a_human_kidney?language=en

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characterized as an invasive step that represents a substantial physical inter-

vention on the body.208 If so, then this 3D printing method is, in principle, patent

ineligible.

Methods of surgical or therapeutic treatments of a human or animal body,209

as well as diagnostic methods practiced on a human or animal body, are excluded

under Article 53(c) of the EPC.210 Products, substances or compositions for use

in any of these methods are, however, patent eligible.211 One aim of Article 53(c)

is to ensure that “actual use, by practitioners, of methods of medical treatment

when treating patients should not be subject to restriction or restraint by patent

monopolies.” The difficulty is to decide whether the restraint concerns a “method

of treatment as opposed to that which is available for treatment.”212 It is pivotal

to keep in mind that only patent claims related to “therapy” and “surgery” are

excluded per se.213 Other types of methods are patent eligible. As such, the

therapeutic/surgical nature of a 3D bio-printed invention is an important

determinant in deciding whether the related claims fall foul of Article 53(c).

In light of Flow measurement/SIEMENS, it would seem that if the 3D bio-

printing method described by Atala can be performed by someone who does not

have the specialized professional skills then, the method of 3D bio-printing on a

patient’s body is likely to be patentable.214 By the same token, if the bio-printing

process on the patient’s body requires oversight from a professional, such as a

surgeon, then the 3D bio-printing method will fall within the exclusion of Article

53(c).215 Thus, irrespective of who performs the described method, a 3D non-

therapeutic, nonsurgical, claim is patent eligible.216


209. The term “therapy” is defined as “any treatment which is designed to cure,

alleviate, remove, or lessen the symptoms of, or prevent or reduce the possibility of contracting

any disorder or malfunction of the animal body.” Thompson/Cornea, Decision T 0024/91-

3.2.02, 1994 O.J. Eur. Pat. Off. para. 2.7.


211. Id.

212. Bristol Myers Squibb Co. v. Baker Norton Pharmaceuticals Inc. [2001] RPC 1 at

¶ 62 (Eng.).

213. See id. at 12.

214. See Flow measurement/Siemens, Decision T 0245/87-3.4.01, 1990 O.J. Eur. Pat.

Off., para. 3.1.

215. Thompson/Cornea, Decision T 0024/91-3.2.02, 1994 O.J. Eur. Pat. Off., para. 2.5.

216. See Contraceptive Method/British Technology Group, Decision T 0074/93-3.3.1,

1994 O.J. Eur. Pat. Off. 1, 7; see generally, Composition for contraception/BAYER

SCHERING PHARMA AG, Decision T 1635/09-3.3.02, 2010 O.J. Eur. Pat. Off. 542, 562-

62. In this case, the European Patent Office Technical Board of Appeal pointed out that

contraceptive use is not therapeutic because “pregnancy is not an illness.” Id. at 562. However,

the Board made clear that the inherent feature of the principle claim to reduce common side

effects of contraceptive use through reduced-dose hormones was therapeutic. Id. at 564.

AMMAR 6/6/2017 1:45 PM


What if a 3D method, such as that described by Atala, is directed at both

therapeutic and non-therapeutic purposes, such as cosmetic? In this case, based

on L’Oréal/Protection against UV, the result depends on whether or not the

therapeutic and non-therapeutic purposes can be separated.217 If they cannot be

separated, the invention is not patentable.218 At this point it is useful to consider

whether Atala’s 3D printing method that is used to treat conditions such as skin

burns should be considered as a therapeutic, cosmetic or surgical application.219

Generally speaking, a method is considered to be surgical if it requires an

advanced level of skill in its execution, even when performed by a nurse (rather

than a surgeon).220 As such, in order to be patentable, a 3D bio-printing method

must be neither therapeutic nor surgical nor diagnostic. Given its potential, 3D

printing enables the safe manipulation of a human body and, in many cases,

without the need for advanced medical skills. In this context, the fate of 3D bio-

printing inventions rests on the definitions of particular terms, such as “surgery”

or “therapy” and, at the same time, it depends on the skills required to use the

invention. If using a 3D bio-printed invention, such as the example of Atala, does

not require the use of advanced skills, then the invention is patentable, unless it

can be categorized as being surgical. In this particular context, therefore, the

current legal landscape is unclear; this lack of clarity leads to uncertainty and

maintains the potential to foster 3D bio-printing-related litigation.

With the above in mind and given that U.S. patent law does not provide a

clear list of unpatentable subject matter, instead of leaving the decision on the

patentability of inventions, such as methods of 3D bio-printing on a patient’s

body, to the discretion of the courts and the USTPO, it is necessary to consider

whether the aforementioned 3D bio-printing invention method would be patent

eligible in the US. Until recently, methods of medical treatment enjoyed a

comfortable scope of protection in the US; this changed, however, following

Mayo v Prometheus.221 One of the claims in this case was directed at a process

that helps doctors determine the medication dosage needed to treat a particular

217. See Protection Against UV Radiation/L’Oreal, Decision T 1077/93, 1996.

218. Drugs are treated differently: “The fact that a [drug] . . . has both a cosmetic and a

therapeutic effect . . . does not render the cosmetic treatment unpatentable.” See Hair Removal

Method/ The General Hospital Corp., Decision T 0383/03-3.2.2, 2004 O.J. Eur. Pat. Off. 1, 4.

219. The term “surgery” is defined as a process to “maintain the life or health of the

human or animal” body on which it is performed. See Pericardial Access/ Georgetown

University, Decision T 0035/99-3.2.2, 1999 O.J. Eur. Pat. Off. 1, 7.

220. See Manual of Patent Practice: Section 4A: Methods of Treatment or

Diagnosis, U.K. INTELL. PAT. OFF. (June 1, 2016), https://www.gov.uk/guidance/manual-of-

patent-practice-mopp/-section-4a-methods-of-treatment-or-diagnosis#ref4A-09 (stating, in

Section 4A.09, that “surgery is defined by the nature of the method, and in particular the level

of skill required and risk incurred”).

221. See Mayo Collaborative Servs. v. Prometheus Labs., 132 S. Ct. 1289,1297 (2012).

AMMAR 6/6/2017 1:45 PM


group of autoimmune diseases.222 Among many others, the American College of

Medical Genetics and Genomics, the American Hospital Association and the

Association for Molecular Pathology support the opinion that if “claims to

exclusive rights over the body’s natural responses to illness and medical

treatment are permitted to stand, the result will be a vast thicket of exclusive

rights over the use of critical scientific data that must remain widely available if

physicians are to provide sound medical care.”223 Ultimately, the Court of

Appeal’s decision was, in part, reversed by the Supreme Court.224 Still, it seems

the aforementioned 3D bio-printing method is patent eligible in the U.S.

D. Product Liability Issues

The USPTO guidelines on biotechnology make it abundantly clear that, from

a patentability standpoint, a man-made cell or organ is not markedly different

from what occurs in nature simply because it has been 3D-printed.225 From a

product liability standpoint, however, the fact that a human organ is 3D-printed

raises a number of interrelated and novel legal issues. A conventional transplant

procedure, where a donor donates an organ to a recipient, carries inherent risks,

including infections and implant malfunction, which may require additional

surgery to repair or replace the implant. The field of organ and tissue donation

and transplantation is heavily regulated, with state and federal legislations

ensuring a safe and system.226 The “quality” of the donated organ (the product)

however is not often contested by the recipient.

In contrast to a natural organ, a 3D bio-printed organ is man-made using a

complicated set of technical and biomedical skills and technologies, as well as a

wide range of living cells and other materials, such as synthetic and/or natural

polymers. From a product liability standpoint, the use of these biomedical skills,

technologies and materials does not raise novel legal issues and, thus, can be

cleared via traditional drug and device approval pathways. Indeed, the FDA, for

instance, has issued draft guidance for industry and FDA staff titled “Technical

Considerations for Additive Manufactured Devices”, which addresses some of

222. Id. at 1294.

223. Id. at 1305.

224. Id.

225. 2014 Interim Guidance on Patent Subject Matter Eligibility, 79 Fed. Reg. 74,618,

74,623 (Dec. 16, 2014).

226. Examples include, Guidance for Industry: Investigating and Reporting Adverse

Reactions Related to Human Cells, Tissues, and Cellular and Tissue-Based Products

(HCT/Ps) Regulated Solely under Section 361 of the Public Health Service Act and 21 CFR

Part 1271, U.S. DEP’T HEALTH & HUM. SERVICES 110-413 (March 2016), https://www.fda.

gov/downloads/Guidances/Tissue/UCM434834.pdf; 42 U.S.C. § 274i(b) (2012); 42 U.S.C. at

§ 274e; Uniform Anatomical Gift Act of 2006 § 16(a).

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these issues.227 However, the FDA makes clear that the guidance does not

address the use or “incorporation of biological, cellular, or tissue-based products

in AM [additive manufacturing].”228 Some novel legal challenges therefore are

still noteworthy. In particular, whether a 3D printed organ should be qualified as

“goods” under the Uniform Commercial Code.229 If so, and given a 3D-printed

organ is man-made, one should consider whether a clinic or hospital, contrary to

conventional wisdom, should be strictly liable for claimed defects in 3D-printed

organs that are made under its control and used in medical procedures within its

premises. In other words, should clinics and hospitals qualify as manufacturers,

distributors, or intermediate sellers of 3D-printed tissues or organs?

An entity “engaged in the business of selling or otherwise distributing . . . a

defective product is subject to liability for harm to persons and

properties . . . .”230 Section 121.15(1) of the Sale of Goods Act provides that:

Where the buyer, expressly or by implication, makes known to the seller the particular purpose for which the goods are required, and it appears that the buyer relies on the seller’s skills judgment . . . there is an implied warranty that the goods shall be reasonably fit for such purpose.231

Limited jurisprudence permits assertion of implied warranty against

healthcare services whenever there is a sale of a “good” under the UCC.232 Due

to the peculiar nature of medical practice, however, the overwhelming majority

of courts are reluctant to abandon the malpractice concept and, thus, are

unwilling to extend the principle of strict liability to health-service providers

under the ground that:

227. Technical Considerations for Additive Manufactured Devices: Draft Guidance for

Industry and Food and Drug Administration Staff, U.S. DEP’T HEALTH & HUM. SERVICES

(May 10,2016), http://www.fda.gov/downloads/medicaldevices/deviceregulationandguidanc

e/guidancedocuments/ucm499809.pdf.

228. Id. at 2.

229. See U.C.C. § 2-105 (AM. LAW INST. & UNIF. LAW COMM’N 2015). In this regard,

the so-called blood shield statutes, which make warranty or strict liability inapplicable

to blood transfusions, could be a difficult legal hurdle. In the same vein, the Restatement of

Torts stresses the idea that human tissue is not a “product” and thus not subject to products

liability claims. The Restatement (Third) of Torts states: “Human blood and human tissue,

even when provided commercially, are not subject to the rules of this Restatement.”

RESTATEMENT (THIRD) OF TORTS: PRODUCT LIABILITY § 19(c) (AM. LAW INST. 1998).

230. RESTATEMENT (THIRD) OF TORTS: PRODUCT LIABILITY § 1 (AM. LAW INST. 1998).

231. U.C.C. § 2-315 (AM. LAW INST. & UNIF. LAW COMM’N 2015).

232. See, e.g., M.C. Skelton v. Druid City Hosp. Bd., 459 So. 2d 818, 823 (Ala. 1984).

AMMAR 6/6/2017 1:45 PM


Their unique status and the rendition of these sui generis services bear such a necessary and intimate relationship to public health and welfare that their obligation ought to be grounded and expressed in a duty to exercise reasonable competence and care toward their patients. In our judgment, the nature of the services, the utility of and the need for them, involving as they do, the health and even survival of many people, are so important to the general welfare as to outweigh in the policy scale any need for the imposition on dentists and doctors of the rules of strict liability in tort.233

Here, it is necessary to consider whether the principle of exempting health

providers from the rules of strict liability applies to 3D-printed organs. In

Whitehurst v. American Nat’l Red Cross, the plaintiff sought to recover damages

for the injuries that she sustained when she contracted homologous serum

hepatitis.234 She alleged that she contracted the disease from a transfusion of

impure whole blood that had been supplied by an agency of the American Red

Cross.235 The plaintiff argued that the furnishing of blood constituted a sale

within the Uniform Sales Act.236 The Court of Appeals, however, ruled that an

extra charge for blood is not indicative of a sale but is merely an “incidental

feature” of the services rendered.237 The majority of courts seem to agree that a

hospital administering blood transfusion to a patient is not a sale within the

meaning of the Uniform Sales Act and, therefore, “cannot be the basis of an

action for implied warranty.”238 There seems to be a consensus that hospitals and

doctors are medical services providers rather than being in the business of

“selling or even leasing, bailing or licensing equipment.”239 The incidental use

of a product, such as placing a prosthesis in a patient’s mouth, does not constitute

a “sale” of the device as required for a cause of action sounding in product

233. Brody v. Overlook Hosp., 317 A.2d 392, 396 (N.J. Super. Ct. App. Div. 1974); see

also Feldman v. Lederle Labs., 479 A.2d 374, 381 (N.J. 1984); Hoven v. Kelble, 256 N.W.2d

379, 392 (Wis. 1977); Cafazzo v. Cent. Med. Health Servs., Inc., 668 A.2d 521, 527 (Pa.

1995).

234. Whitehurst v. Am. Nat’l Red Cross, 402 P.2d 584, 584 (Ariz. Ct. App. 1965). A

similar conclusion was reached in Koenig v. Milwaukee Blood Center, Inc., 23 Wis. 2d 324,

329 (1964). Maintaining a steady stream of blood supply was the rationale behind the rulings

of those cases. See Murphy v. E.R. Squibb & Sons, Inc. 40 Cal. 3d 672, 680 (1985). For more

information about medical device product liability, see generally JAMES M. BECK & ANTHONY

VALE, DRUG AND MEDICAL DEVICE PRODUCT LIABILITY DESKBOOK 8.06(1)(a) (2016).

235. Id.

236. Id. at 585.

237. Id. at 586. A similar conclusion was reached in Koenig v. Milwaukee Blood Ctr.,

Inc., 127 N.W.2d 50, 53 (Wis. 1964).

238. Id. at 52.

239. San Diego Hosp. Ass’n. v. Super. Ct., 35 Cal. Rptr. 2d 489, 493 (1994).

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liability.240 Furthermore, hospitals are considered to be “providers of

professional medical services rather than producers or marketers of products, nor

they are considered to be engaged in the “business of distributing” products.”241

Hospitals do not play an “integral and vital part in the overall production or

marketing” of products.242 In Silverhart v. Mount Zion Hospital, the Court of

Appeals ruled that a doctor “diagnosing and treating a patient normally is not

selling either a product or insurance.”243 One of the requisites, which the

Restatement prescribes for the imposition of strict liability, the court reasoned,

is that “the seller is engaged in the business of selling such product.”244 The court

then added that a hospital is not ordinarily engaged in the business of selling any

of the products or equipment it uses in providing its services. The relationship

between a hospital and its patients is based on the professional services that it

provides, rather than on any of the products it uses.245 Therefore, hospitals are

not subject to strict liability for “latently defective product[s] supplied . . . by

another for . . . use in rendering treatment.”246

With the above in mind, two important issues must be considered. First, it

seems that the transplantation of a 3D-printed organ by a hospital constitutes a

rendition of a medical “service.”247 Second, it is not clear whether the furnishing

of a 3D-printed organ for transplantation by a hospital constitutes a “sale” of

goods so as to give rise to an action for breach of warranty. If it does constitute

a sale of a good, this leads U.S. to the issue of whether hospitals or other service

providers should be strictly liable for claimed defects in 3D-printed organs that

are made exclusively under their control and used in medical procedures within

their premises, and, if they do, whether such hospitals or service providers should

qualify as the manufacturers or sellers of those 3D-printed organs.

Before investigating these issues, it is important to note that, in the case of

3D bio-printing, the medical service provider’s use of the 3D-printed organ (the

product) is not “incidental”; the service provider in question plays an integral

and vital part in the overall production/printing of the organ. While materials,

methods and processes used in the 3D printing of an organ can still be cleared by

the current system, patenting the end product, the organ itself, raises a whole set

240. See Goldfarb v. Teitelbaum, 540 N.Y.S.2d 263, 264 (N.Y. App. Div. 1989).

241. Pierson v. Sharp Mem’l Hosp., Inc., 264 Cal. Rptr. 673, 676 (Cal. Ct. App. 1989)

(citations omitted).

242. Hector v. Cedars-Sinai Med. Ctr., 225 Cal. Rptr. 595, 599 (Cal. App. 1986).

243. Silverhart v. Mount Zion Hosp., 98 Cal. Rptr. 187, 190 (Cal. Ct. App. 1971).

244. Id. at 191; see also RESTATEMENT (SECOND) OF TORTS § 402A (AM. LAW

INST. 1965).

245. Silverhart, 98 Cal. Rptr. at 190–91.

246. Snyder v. Mekhjian, 582 A.2d 307, 313 (N.J. Super. Ct. App. Div. 1990).

247. See Koenig v. Milwaukee Blood Ctr., Inc., 127 N.W.2d 50, 53 (Wis. 1964).

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of new issues. With this in mind, if the end product (the printed organ) is eligible

for patent protection ought to be patented, then it follows that healthcare

providers would be strictly liable for claimed defects in the 3D-printed organs

that are made exclusively under their control and used in medical procedures

within their premises. Under this scenario, healthcare providers should qualify

as manufacturers or sellers of 3D-printed organs. In the same vein, a 3D-printed

organ is likely to be characterized as a medical device. Paradoxically, in the bio-

printing field, it would seem that patenting the end product may not be, after all,

in the interests of the owner of the patent.

V. FUTURE IMPACT OF 3D TECHNOLOGY ON THE MEDICAL SECTOR

Based on the arguments in the two preceding parts, it is clear that 3D bio-

printing technology challenges patent law in a number of ways. The tension of

accommodating these challenges is likely to be felt in a distinct, though related,

field, namely the field of medical devices. It is here that 3D technology might

seriously contest the boundaries of patent law.

A. Size Matters: Medical Devices Under a 3D Lens

The tension between patent law and 3D technology is likely to be felt in the

medical devices sector. Yet, it is in this vital sector that the technology has

evidently gained ground, having been used already for the generation and

implantation of several types of medical devices. Successful examples include

multi-layered skin grafts, bone, vascular grafts, tracheal splints,248 cartilaginous

structures,249 hearing aids, dental, spinal implants and hip implants, and

advanced prosthetics.250 Using 3D printing, Widex has produced some of the

world’s smallest, most comfortable hearing aids such as CAMISHA (Computer-

Aided-Manufacturing-for-Individual-Shells-for-Hearing-Aids).251 The ear canal

is scanned and then a customized hearing aid shell is 3D printed.252 This

248. A degradable 3D printed splint is cleared through the FDA. Already, two

successful cases have been recorded. See, e.g., Additive Manufacturing of Medical Devices

Public Workshop 10/8/2014, FDA 65 (Oct. 8, 2014), https://www.fda.gov/downloads/

MedicalDevices/NewsEvents/WorkshopsConferences/UCM425399.pdf (statement of Dr.

Scott Hollister).

249. See generally Murphy & Atala, supra note 10, at 776.


251. See Tailor-Made Hearing Aid, EUROPEAN PATENT OFF., http://www.epo.org

/learning-events/european-inventor/finalists/2012/topholm.html (last updated July 7, 2014);

see also CAMISHA, WIDEX FOR PROFESSIONALS, https://www.widex.pro/en/evidence-

technology/technological-excellence/camisha (last visited Mar. 20, 2017).

252. See Tailor-Made Hearing Aid, supra note 251.

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customized “in-the-ear” hearing aid production technique is so successful that

some ten million custom-made hearing aids are already in use.253 The U.S.

FDA’s draft subjects this kind of 3D printed devices to a number of special rules

related to the quality of the image and algorithms used to manufacture the

device.254

A recent study suggests that the combined impact of 3D printing, intelligent

robotics and open-source electronics has laid the grounds for a manufacturing

environment that can be executed through managing software and data files.255

According to the same study, using these technologies (3D printing, intelligent

robotics and open-source electronics) is expected to “produce an average 23

percent unit cost benefit and will reduce [market] entry barriers by . . . [around]

90 percent.”256 In the case of hearing aids, 3D printing is currently the most cost-

effective way to produce some “significant components,” and it is expected that

“[b]y 2022, hearing aids made with open-source electronics and 3D printers will

be up to 65 percent cheaper than with traditional manufacturing approaches.”257

This success is due, in part, to the fact that there are few legal restrictions

governing the materials that can be used for producing devices that are worn on

the body rather than placed inside the body.258

In contrast to conventional manufacturing, 3D printing has the potential to

enable customization of medical products on a massive scale.259 Since the cost

of the set-up is minimal, it is possible to produce individual or many thousands

of highly customized items at minimal additional cost.260 Titanium replacement

hip joints and made-to-order polymer bones can now be tailored to fit a patient’s

specific needs.261 For example, in orthopedics, 3D printing technology is used to

make not only hips and knees but also other bone-like structures, such as

unusually-shaped skulls.262 In some head injury cases where bone removal is

necessary to make space for brain swelling, use of 3D printing to manufacture a


254. FDA draft guidance, supra note 227, at 9.

255. Brody & Pureswaran, supra note 96, at 1.

256. Id. at 9.

257. Id. at 10.

258. See Banks, supra note 7, at 23.

259. Carl Schubert et al., Innovations in 3D Printing: A 3D Overview From Optics to

Organs, 98 BRITISH J. OPTHAMOLOGY 159, 159 (2014).

260. Id. at 160.

261. Heidi Ledford, The Printed Organs Coming to a Body Near You: From Kidneys

to Hands, 3D Printers are Churning Out Made-to-Order Bones and Rudimentary

Organs, NATURE NEWS (April 15, 2015), http://www.nature.com/news/the-printed-organs-

coming-to-a-body-near-you-1.17320.

262. See Banks, supra note 7, at 24.

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perfectly fitting cranial plate could be lifesaving.263 In contrast to conventional

manufacturing, it is much easier, faster and cheaper to use 3D technology to

manufacture one-off customized implants.264 Many 3D-printed products are

made on demand. This improves the quality of the product substantially and,

thus, makes it biocompatible and flexible.265 Furthermore, whenever a researcher

wishes to produce an already published device, rather than mimicking the

original description of that device themselves, the original stereolithography

files, which are generated from CAD software during the device development,

could be shared, perhaps in academic repositories, which would save researcher

time and laboratory resources.266

Polymers, ceramics, metals and glass are all currently popular printing

materials.267 The ability to mix these materials or the possibility of using a new

printing material, however, could be a game changer. Take graphene (allotrope

of carbon) as an example: when mixed with polymers, it adds mechanical

strength and significantly improves the thermal and electrical conductivity

properties of the mix.268 This advancement means that it is possible, at least in

principle, to develop smart devices with built-in electronics.269

B. Collision Course: 3D Medical Device Patents and Biomedicine

The increasingly low cost of 3D technology has facilitated the production of

counterfeit products, particularly small, expensive and highly customized

products.270 If the promise of high-resolution imaging, which is required for

high-quality printing, materializes then the line between infringing and non-

infringing uses of patented inventions will likely be blurred. In such cases, it will

be necessary to take into account the volume and frequency of the infringing

activities of an individual. A one-off unauthorized printing of a patent-protected

part for the purpose of a sale does not usually make a significant impact on the

market.271 However, in the 3D context, the number of individuals who might

263. See id. at 24.

264. Id.

265. Additive Manufacturing of Medical Devices Public Workshop 10/8/2014, FDA 55

(Oct. 8, 2014), https://www.fda.gov/downloads/MedicalDevices/NewsEvents/Workshops

Conferences/UCM425399.pdf.

266. See Bethany C. Gross et. al., Evaluation of 3D Printing and Its Potential Impact

on Biotechnology and the Chemical Sciences, 86 ANALYTICAL CHEMISTRY 3240, 2350 (2014).

267. Id. at 3244.


269. See id.

270. See Jamil Ammar & Rachel Craufurd Smith, When a Trade Mark Use is Not a

Trade Mark Use? A 3D Perspective, 1 INT’L J. LAW & INTERDISC. LEGAL STUD. 4, 4 (2015).

271. See id. at 8-9.

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seek to manufacture 3D printable products for personal consumption or

otherwise could easily amount to an alarming level. This presents clear

difficulties for the enforcement of patent law since the distribution of a digital

representation of a product, for example, a CAD file, does not fit clearly under

the patent law definition of infringement under 35 U.S. Code § 271.272 Here, one

should consider what options are available to a patent owner/licensee when a

third party individual vendor sells a patent-protected 3D-printed product without

authorization, such as the above described CAMISHA product. Perhaps the

patent owner/licensee could sue the seller, the creator of the CAD file, or both.

To answer these issues, the two aforementioned examples addressed in this

paper, namely CAMISHA and the Atala 3D on-body printing example, will be

considered in turn.

1. 3D “Remaking” of Medical Devices

Unless exempted for non-commercial research purposes, the mere

unauthorized “making” of any patented medical device, say CAMISHA, by way

of 3D printing or otherwise, clearly constitutes a direct patent infringement.

Under Section 271(a) of U.S. patent law, direct infringement requires

unauthorized making, using, selling, offering for sale or importing the patented

invention.273 Encouraging or inducing of infringement- the printing of

CAMISHA with “knowledge that the induced acts constitute patent

infringement” may amount to indirect infringement.274 Provision of patented

and, thus, infringing material components to be incorporated into an infringing

product, in this case CAMISHA, does constitute contributory infringement under

Section 271(c).275 The unauthorized 3D printing of medical devices or any other

type of goods for that matter, therefore, does not raise novel legal issues under

patent law.

2. Stretching the Boundaries of Patentability

In some cases, 3D bio-printing technology seriously challenges patent law.

For example, the notion of patenting medical devices is not, in itself,

controversial. The application of patent law to specific types of 3D bio-printing

272. Id. at 10.

273. 35 U.S.C. § 271(a) (2012).

274. Id. § 271(b) (stating that “[w]hoever actively induces infringement of a patent shall

be liable as an infringer”); see also Global-Tech Appliances, Inc. v. SEB S.A., 131 S. Ct. 2060,

2068 (2011) (holding “that induced infringement under § 271(b) requires knowledge that the

induced acts constitute patent infringement”).

275. See 35 U.S.C. § 271(c) (2012).

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devices, however, is likely to stir controversy. For a number of reasons,

establishing the scope of protection for particular 3D bio-printing devices, such

as the one identified by Atala, is problematic. To understand this issue, it is useful

to take a brief look at how a medical device is defined in the Federal Food, Drug,

and Cosmetic Act:

[A]n instrument, apparatus, implement, machine, contrivance, implant, in vitro reagent, or other similar or related article . . . intended for use in the diagnosis of disease or other conditions, or in the cure, mitigation, treatment, or prevention of disease, in man or other animals, or intended to affect the structure or any function of the body of man or other animals…276

As the definition clearly indicates, articles intended for use in the diagnosis,

cure, treatment, mitigation or prevention of disease, or those intended to affect

the structure or function of the body, are considered to be medical devices and

thus, in principle, are patentable subject matter. As such, the method of 3D

bioprinting on a patient’s body, as described by Atala,277 is patent eligible. The

fact that such a method is patentable could be problematic for a number of

reasons. A chief reason is that Section 278(c) of the U.S. patent law does not

protect practitioners who are performing a “medical activity” involving, inter

alia, the use of a “patented machine, manufacture, or composition of matter in

violation of such patent”, the practice of a patented use of a composition of matter

in violation of such patent, or the practice of a process in violation of a

biotechnology patent.278 Advances in 3D bio-printing and bio-ink technologies,

combined with powerful 3D mapping abilities, may open the door to the

automation of a number of procedures that are usually performed by surgeons,

thus blurring the line between patentable and unpatentable surgical procedures.

While the use of 3D technology may open the door, at least in principle, to the

patenting of what might otherwise be unpatentable subject matter, the prohibitive

costs associated with 3D “personalized medicine” and inaccessibility is likely to

stir a spirited debate regarding the application of general patent law principles to

certain 3D bio-printed devices. This could be very significant given the fact that,

contrary to the majority of the world, only Australia and the U.S. consider

medical procedures to be patent-eligible subject matter.279 The American

276. 21 U.S.C. § 321(h) (2006).

277. See Murphy & Atala, supra note 10, at 773.

278. 35 U.S.C § 287(c)(2)(A) (2012) (emphasis added).

279. See Adriana Lee Benedict, Is the USTR Trading Away Doctors’ Rights to Freely

Perform Medical Procedures?, HARV. L. BLOG: BILL HEALTH (Sept. 8, 2012),

http://blogs.harvard.edu/billofhealth/2012/09/08/is-the-ustr-trading-away-doctors-rights-to-

freely-perform-medical-procedures/.

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Medical Association contends that the “use of patents, trade secrets,

confidentiality agreements, or other means to limit the availability of medical

procedures places significant limitation on the dissemination of medical

knowledge.”280 Put another way, among others, 3D bio-printing and 3D mapping

technologies enable diagnostic and even surgical processes to be, at least

partially, performed in an automated manner. This makes the patenting of such

diagnostic and surgical processes in the U.S., in theory, noticeably easier. The

Supreme Court recently curbed the patenting of diagnostic methods by

invalidating the Prometheus patent of a diagnostic method that involved

administering drugs and observing chemical reactions in the body as a basis for

determining drug dosages.281 In light of Mayo, it remains to be seen whether

accessibility to 3D diagnostic and surgical methods will trump potential claims

in relation to 3D medical and surgical procedures.

3. Medical Device Distribution

One must consider whether the creator/distributor of a blueprint CAD file

(e.g., CAMISHA) would be held liable for infringement in cases where

individual consumers print their own products domestically (independently). The

sale of a CAD file is not, after all, a “sale” for the purpose of Section 271(a).282

Therefore, it is logical to consider whether it makes any difference, from a patent

infringement standpoint, if the creator/distributor of the CAD file made the

blueprint CAD file freely available via the Internet without inducing or

encouraging third parties to print the design file. In other words, can a CAD file

be considered to be a “component” of the patented product?283 In Microsoft Corp.

v. AT&T Corp,284 the Supreme Court made it clear that, until expressed in a

computer-readable format, any software that is detached from an activating

medium (such as a CAD file) remains “uncombinable,” and as such, it does not

fulfill Section §271(f)’s definition of “components.”285 Such lack of clarity in

relation to medical devices certainly poses many challenges to patent owners,

and the resolution of those challenges depends not only on how patent law deals

with this already fascinating field of CAD file distribution but, equally important,

also on advances in other fields such as 3D mapping.

280. CODE OF MEDICAL ETHICS § 7.2.3 (AM. MED. ASS’N 2016).

281. See Mayo Collaberative Servs. v. Prometheus Labs., 132 S. Ct. 1289, 1305 (2012).

282. Brean, supra note 24, at 790–92.

283. Under section 271(c), a component constitutes “a material part of the

invention.” Id. at 784 (quoting 35 U.S.C. § 271(c) (2006)).

284. Microsoft Corp. v. AT&T Corp., 550 U.S. 427, 449 (2007).

285. Id.; see generally Brean, supra note 24, at 798.

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VI. CONCLUSION

Like other intellectual property legislation, patent law is technology neutral.

Patent law does not differentiate between 3D technology and any other

technology when applying its general principles.286 However, the patentability

of a functional 3D-printed organ is the most pressing issue that courts and

specialists must address. The Supreme Court’s case law makes it clear that a bio-

invention must have markedly different characteristics to those that are found in

nature in order to be patentable. The 3D printing process of an organ does not, in

itself, result in that organ having markedly different characteristics for the

purposes of patent protection. The 3D-printed organ must have some

demonstrable improvement to the naturally occurring organ. For example, an

improvement in biological performance of the printed organ is likely to make it

markedly different from what is found in nature. With the USPTO’s guideline in

mind, the terms “similarity” and “difference” are not to be construed in a

trademark kind of way. A 3D-printed organ that is similar, or even an identical,

to what is in nature may still be patent eligible, so long as it has markedly

different characteristic.

In the EU, the patenting of 3D-printed tissue/organs is permissible providing

that the 3D bio-printed invention is produced by means of a technical process

and providing that nature is incapable of manufacturing the same organ by itself

outside the human body.

Current advances in 3D technology are likely to acutely challenge patent law

in the U.S. and Europe in a number of ways. Some sophisticated medical

procedures that have been, until very recently, performed by healthcare providers

are now performed, either partially or completely, by 3D printing machines;

Atala’s method of printing on a patient’s body is a notable example. Patenting

such a method of treatment, particularly under Article 53(c) of the EPC, is likely

to raise controversy. In the U.S., however, given that a medical procedure is

patentable subject matter, Atala’s method of treatment is likely to be patent

eligible.

3D bio-printing requires a complicated set of technical and biomedical skills

as well as access to a wide range of biological and synthetic materials which, in

principle, can be approved for use in humans via traditional drug and device

approval pathways. The patenting of a 3D-printed organ (the final product itself

rather than the processes or materials used), however, opens the door to a number

of legal challenges. For example, it is possible that when a hospital provides a

3D-printed organ for transplantation, a “sale” of goods takes place which, in turn,

286. But see Dan L. Burk & Mark A. Lemley, Is Patent Law Technology-Specific? 17

BERKELEY TECH. L. J. 1155, 1156 (2002) (noting a few exceptions).

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might give rise to an action for breach of warranty. If so, it follows that the

hospital should be held strictly liable for claimed defects in the 3D-printed organ

that is made exclusively under its control and used in medical procedures within

its premises for two reasons. First, the hospital’s use of the 3D-printed organ

(“the product”) is not “incidental.” Second, the hospital plays an “integral” part

in the overall manufacturing processes (printing) of the organ.

Finally, the field of medical devices is where 3D technology, advanced 3D

mapping and the open source movement will have a significant impact. The

expiration of a significant number of critical 3D patents,287 combined with a

predicted drop in the cost of this technology, not only will improve the quality

and variety of printed materials,288 but more importantly for our discussion, will

also make the unauthorized making, selling or offering to sell a range of medical

devices noticeably easier.

287. See Brody & Pureswaran, supra note 96, at 5 (noting that “[f]ifty-one critical [3D-

related] patents . . . will expire in the next ten years”).

288. Id.

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