Biomedical Engineering Reference
In-Depth Information
printing tissue. Materials used to construct the 3D bioprinting hardware may be patentable, even if the
bio-ink is all natural and thus unpatentable.
Some types of 3D bioprinters do not print cells to create engineered tissue and organs. Instead,
the 3D bioprinter creates a biodegradable structure, called a “scaffold,” from biodegradable materials,
which is then covered with cultured living cells to grow into the tissue or organ structure. The living
cells may not be patentable if they are simply cultured natural cells, but man-made or artificially modi-
fied scaffold materials may be patentable. Furthermore, materials and processes that improve scaffold
materials to enhance biodegradability and increase adhesion to the living cells may be patentable pro-
cesses and compositions of matter.
16.6
INTELLECTUAL PROPERTY PROTECTION LIMITATIONS
FOR ENGINEERED TISSUE
The previous section addressed aspects of 3D bioprinting and nanotechnology that are protectable by pat-
ents, copyrights, and trade secrets. While there is broad range of IP protection available, modern laws and
court decisions have carved out some exceptions to IP protection for public policy reasons. For example, the
public would not benefit from granting monopolies over things that can be found in nature, or scientific prin-
cipals such as E= MC
2
. This section explores in more detail the limitations on aspects of tissue engineering
with 3D bioprinting and nanotechnology that are subject to IP protection, and the exceptions to protection.
Just as the bulk of IP protection for 3D bioprinting and nanotechnology technologies is patent
protection, the majority of exceptions to IP protection in these industries falls under exceptions to pat-
entability. Section 101 of the US patent laws broadly defines what can be patented, but the U.S. Patent
Office and the courts have carved out numerous exceptions and limitations (
United States Patent and
Trademark Office, 2014b
).
The most important exception to patentability is the human body. Courts have always prohibited
patents on the human body and human organisms as violations of the Constitution, because granting
property rights in the human body is akin to a form of slavery (
Torrance, 2013
). The recently enacted
America Invents Act codified the ban on human patents, stating “[n]otwithstanding any other provision
of law, no patent may issue on a claim directed to or encompassing a human organism (
Leahy-Smith
America Invents Act, 2011
).” This exception falls under the umbrella of a broader limitation on IP: that
one cannot hold IP rights on things found in nature. However, nonhuman organisms, animal tissues,
and even human genes have been patented for years, and are considered patentable subject matter so
long as they are man-made or man-modified into something that does not occur in nature.
4
Engineered tissue and organs created with 3D bioprinters and nanotechnology will probably remain
patentable to the extent that the tissue is considered “man-made.” Manufactured tissue, such as 3D
bioprinted tissue, is artificially created by assembling cells, and not by natural growth. Tissue grown
in Petri dishes may be deemed unpatentable because it grew by natural processes, albeit with the as-
sistance of man. But a machine undoubtedly constructs printed tissue with the use of artificial materials
4
According to
Chisum on Patents
(Chisum, Donald. Chisum on Patents, Vol. 9, Appendix 24, Updated 2014.), “To the extent
that the claimed subject matter is directed to a non-human 'nonnaturally occurring manufacture or composition of matter - a
product of human ingenuity'
(Diamond v. Chakrabarty)
, such claims will not be rejected under 35 U.S.C. § 101 as being
directed to nonstatutory subject matter.” See also Diamond v. Chakrabarty, 447 U.S. 303 (1980).
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