INTELLECTUAL PROPERTY IN 3D PRINTING AND NANOTECHNOLOGY - 3D Bioprinting and Nanotechnology in Tissue Engineering and Regenerative Medicine - page 340

16.2 WHY IS INTELLECTUAL PROPERTY IMPORTANT?
IP laws foster advancements in science by providing mechanisms to (1) protect research and innova-
tion from copycats, thieves, and even accidental copying, and (2) provide recourse for IP owners.
Such protections and rights incentivize innovators and investors to spend time and money to develop
innovations and improvements in products and services that benefit society. Patent protection particu-
larly enables inventors and investors to capitalize on their investments in research and development
(R&D) by deterring or slowing down competitors, and forcing them to innovate in noninfringing ways
( Kapmar, 2013 ).
The ability to protect IP is especially important in the medical industry. Anything that is used on
or in the human body requires extensive testing to ensure biocompatibility, and to evaluate side effects
( U.S. Food and Drug Administration, 2009, 2012 ). Such testing substantially raises the costs of R&D
for new products such as drugs and implants. Innovators experimenting with new compounds, mate-
rial configurations, products, and methods bear the burden of research costs, with the hope that some
products will be successful, receive approval for sale, generate enough revenue to recoup research and
development costs for both successful and unsuccessful products, and make a profit.
R&D costs in medical technologies can be prohibitively expensive for many companies, caus-
ing some companies to copy others' successful products and sell them as their own. This creates
unhealthy competition that deprives the innovators and investors of profits and returns on their in-
vestments, which ultimately discourages further R&D for fear of copying. Indeed, high R&D costs
coupled with lost profits from copycatting can demoralize research initiatives and stifle innovation.
IP helps to prevent copycats from profiting from a free ride on others' R&D, and thus promotes
healthy competition.
Our modern IP system fosters innovation, but the system and its laws are not without controversy
and complications. New and emerging technologies that do not fit squarely into current IP laws cause
confusion and inconsistency in IP protection. For example, in recent decades, inventors, their attorneys,
the courts, and even Congress have struggled with the patentability of software, because the original
patent laws and even recent amendments do not explicitly address it. 2 Similarly, despite their potential
to advance science by leaps and bounds, 3D bioprinting technology, nanotechnology, and tissue engi-
neering technology raise more questions about what aspects of these new inventions and improvements
can be protected by IP, which cannot be protected, and which should not be protected for ethical and
public policy reasons.

16.3 TYPES OF INTELLECTUAL PROPERTY
IP laws are national systems. This chapter focuses on the US IP laws. US IP laws protect innovations
and creations through patents, trademarks, copyrights, and trade secrets. However, IP protection in the
United States does not extend throughout the world. Rather, with the exception of the European Union,
inventors must seek IP protection in each country where protection is desired, either through filing
separate applications or complying with national laws. Although IP laws vary by country, the types of
IP protection available throughout the world are fairly consistent.

2 Gottschalk v. Benson , 409 U.S. 63 (1972); Parker v. Flook , 437 U.S. 584 (1978); Diamond v. Diehr , 450 U.S. 175 (1981);
Bilksi v. Kappos , 561 U.S. __, 130 S. Ct. 3218 (2010).