Biomedical Engineering Reference
In-Depth Information
a decentralized manufacturing system in which individuals use their own printer to create products
on-demand and on the spot. Because the products themselves may not enter a distribution chain, such
as from manufacturer, to distributor, to customer, 3D printed product sales may not be regulatable like
products that you would buy in stores. Instead, 3D bioprinters in hospitals or doctors' offices may be
used in two scenarios: (1) the doctor designs his/her own tissue or organ using specialized software,
and 3D prints the tissue/organ, or (2) the doctor downloads a digital blueprint for a certain organ or
tissue, and 3D prints the tissue/organ, with or without changes.
In the first scenario, the software used to create the tissue/organ design and the software used to
control the printer to create the tissue/organ are subject to copyright protection. Copyright infringe-
ment may be relatively easy to enforce in this scenario because the software would be distributed from
a known source.
In the second scenario, the 3D printer software and possibly the downloaded digital blueprint are
subject to copyright protection. As discussed earlier, the 3D printer software is less prone to copyright
infringement when obtained from a known source. However copyrights on digital blueprints may be
difficult to enforce when the files are distributed over the Internet, such as between medical profession-
als. If the digital blueprints are not copyrightable, copyright may not be an option for extracting profit
from digital tissue and organ blueprints.
Like the problems faced with MP3 file sharing in the 1990s and 2000s, digital blueprint file sharing
can include unregulated and unlicensed distribution of IP. The innovators who design successful 3D
printable tissue structures and organs stand to lose profits and recoupment of R&D expenses when their
digital blueprints are distributed freely and used without collecting any royalties. Like many demoral-
ized musical artists, unchecked file sharing of digital blueprints could disincentivize the innovators in
tissue engineering, especially if they are not copyrightable. But unlike MP3 file sharing issues, the end
users of the 3D bioprinting digital blueprints are sophisticated hospitals, laboratories, and doctors who
would stand to lose a lot from copyright infringement lawsuits. Therefore, the sophistication of the
medical and healthcare industries, coupled with ever-emerging protection mechanisms in digital files
(known as digital rights management, or DRM), may keep unauthorized copying at a manageable level
that does not significantly stifle innovation.
16.8.4
PATENT INFRINGEMENT
Patent infringement is probably the most important type of IP enforcement in the United States and
throughout the world. Proving patent infringement requires showing that an unlicensed, unauthorized
entity is making, using, or selling a product or service covered by the patent. The patent owner does
not need to prove that the alleged infringer knew about the patent, but proof of prior knowledge can
elevate the patent infringement claim to
willful
infringement, a more serious allegation with harsher
consequences. Willful infringers are true copycats who simply steal a patented idea and pass it off as
their own. Under U.S. patent law, even others who independently create the patented device (and are
therefore not willful infringers) are still liable for patent infringement, and independent discovery is not
a defense (
Cornell University Law School, 2014b
). Patent protection provides the ability for the patent
owner to exclude
anyone
from making, using, or selling a patented invention, as one of the incentives
for convincing inventors to disclose their inventions to the public when obtaining the patent.
Patent infringement in 3D bioprinting and nanotechnology may be extremely difficult to detect. Usu-
ally, patent owners watch open markets to identify infringing products and trace the infringing product
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