Biomedical Engineering Reference
In-Depth Information
them altogether when there is uncertainty regarding the consistency, quality, or safety of 3D bioprinted
tissue made in hospitals and doctors' offices. Perhaps IP can help reduce this uncertainty, by granting
patents to the innovators with particular tissue designs, manufacturing methods, and organ products.
The patent owners' right to exclude others would mean that the FDA could focus its efforts on ensuring
that the patented product or method is safe and yields consistent results, even when the tissue is printed
in individual medical facilities. Indeed, the freedom to print tissue and organs in individual offices
and hospitals using unregulated and untested product designs and methods may result in inconsistent
healthcare with the potential for harmful results and/or heavy regulation.
As discussed earlier, limited “monopolies” created by IP are necessary in the medical and biologi-
cal fields to allow inventors and investors to recoup upfront R&D expenses, and to help fund future
R&D, thus furthering the progress of science. This model has driven the pharmaceutical industry for
decades, granting drug makers a temporary monopoly on a particular drug before allowing generic
brands to start selling the same drug (
Schacht and Thomas, 2005
). The patent owner, in this case
a pharmaceutical company, bears the burden of accountability and ongoing testing by the FDA and
health organizations, and enjoys any resulting profits from sales of the patented drug. In some cases,
this allows the drug maker to set the price, and to control the drug supply, which could have the effect
of limiting accessibility to affordable treatment. But without this limited monopoly, drug quality could
be inconsistent and the healthcare industry could suffer from too many versions of the same drug, and
accountability could be spread over many pharmaceutical companies.
Granting an innovator the right to exclude others from making or using the invention allows the
public to hold the easily identified patent owner accountable if something goes wrong. The ability to
hold an identifiable entity accountable for harm and negligence is very important when public health is
at stake, as in the medical and healthcare industries. An IP owner is easier to identify as the responsible
party when something goes wrong, whereas, in contrast, everyone points fingers at one another when
companies are allowed to rip off ideas from one another and something goes wrong.
There are many arguments for and against granting IP rights for 3D printed tissue and organs. IP
generally fosters innovation and can serve societal interests by yielding consistent, quality products
with high accountability. Although one innovator may hold a limited monopoly over a certain tissue
structure or method, competitors are free to improve upon the patent or develop their own products that
may be eligible for IP protection. As tissue and organs created with 3D bioprinting and nanotechnol-
ogy become more mainstream and refined, these ethical debates will surely become more frequent and
prominent, and society will decide whether IP rights are suited for engineered tissue.
16.8
INTELLECTUAL PROPERTY INFRINGEMENT
IP laws are designed to prevent copycats and to advance the progress of science. However, IP laws are
not 100% efficient in deterring copycats from trying to make quick profits without any contribution to
society, and IP owners often need to enforce their rights and prosecute infringers.
Infringement involves the unauthorized use or sale of products and processes protected by IP. Dif-
ferent types of IP have different standards and requirements for proving infringement, but for any type
of IP the property owners have the responsibility of enforcing their rights. The U.S. Patent and Trade-
mark Office and the U.S. Copyright Office do not monitor and police infringing activity (
United States
Patent and Trademark Office, 2011; United States Copyright Office, 2012b
).
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