Biomedical Engineering Reference
In-Depth Information
mixed with living cells. The resulting printed tissue is considered to be “man-made” for the purpose of
IP protection. Ethical considerations related to IP rights on tissue and organs are discussed later.
An argument can be made that tissue grown over 3D printed scaffolding is “natural” and therefore
that the grown tissue cannot be protected, but at the very least variations of the process of creating that
tissue—printing the scaffolding, applying the cells, and growing the culture—is considered a patent-
able process.
5
Additionally, the legal restrictions on patenting human organisms do not categorically
exclude human tissue, organs, and other human organism components from being protected by patents
(
Kapmar, 2013
).
More questions about the patentability of engineered tissue arise when 3D printed tissue and organs
are indistinguishable from natural organs and tissues. Should man-made tissue and organs be patent-
able when they are identical in form and function to natural tissue and organs? Of course, any patents
on tissue and organs could only cover the man-made versions, but discerning between infringing prod-
ucts and naturally grown tissue could be extremely difficult when 3D printing and nanotechnology are
able to produce exact replicas of natural tissue and organs. One could argue that these products of 3D
printers are essentially the same as a naturally occurring organ or tissue, and should be regarded as
“naturally occurring” for the purpose of patentability. Others could argue that the tissue and organs,
although replicas of nature, are still “articles of manufacture” and should be patentable.
Science has yet to progress to the level where 3D bioprinted tissue is completely indistinguishable
from natural tissue, but at some point this IP dilemma will emerge. One possible solution for this po-
tential issue is marking or branding the fabricated tissue and organs to distinguish patented man-made
products from naturally grown tissue and organs, such as a DNA marker (
Hornick, 2014
). By purpose-
fully distinguishing man-made tissue from natural tissue, innovators may continue to protect the IP of
their inventions without challenging current patent laws.
16.7
ETHICAL CONSIDERATIONS OF ENGINEERED TISSUE INTELLECTUAL
PROPERTY
Despite the legality of IP protection for engineered tissue, moral implications of 3D bioprinting may lead
to spirited debate over the patentability of tissue, organs, and other medical products (
Gartner, 2013
).
Patents grant the right to exclude others from making, using, or selling the protected product or method.
Some view this exclusivity as a monopoly on the protected product or method, a monopoly that is unde-
sirable when public health and access to treatment may be adversely affected. While innovations in 3D
bioprinting and nanotechnology can improve the speed and quality of tissue and organ production, should
society grant the innovators the right to exclude others from creating human body parts? (
Gartner, 2014
).
The Food and Drug Administration (FDA), which evaluates and approves medical devices, drugs,
and treatments, may impose strict guidelines for approving 3D bioprinted tissue and organs, or ban
5
According to
Chisum on Patents
(§ 1.02 [7] (2009) Product of Nature-Biological Subject Matter, discussing
SC Computer
Prods. v. Foxconn Int'l
, 355 F.3d 1353, 1359 (Fed. Cir. 2004)), “An invention synthesized for the first time in a laboratory
is eligible for patent protection under Section 101. Processes for producing this synthetic product in the laboratory and/or
for using this synthetic product may also be eligible for patent protection under Section 101. However, a natural reproduc-
tion process, whether sexual, asexual, part of a chain reaction, or a process of decay, is ineligible for patent protection under
Section 101. An item reproduced by such a natural process, whether an inorganic structure or a life form, must ipso facto be
ineligible for patent protection under Section 101.”
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