INTELLECTUAL PROPERTY IN 3D PRINTING AND NANOTECHNOLOGY - 3D Bioprinting and Nanotechnology in Tissue Engineering and Regenerative Medicine - page 344

protected by IP, including improvements on technologies that are already protected, and innovative new
technologies that do not fit squarely within current IP laws. To better understand what new aspects of
3D bioprinting and nanotechnology can be protected, this chapter also addresses the aspects of tissue
engineering and bioengineering currently protectable under US IP laws.
Historically, implanted devices, surgical treatments and procedures, and pharmaceutical drugs have
been protected by utility patents, design patents, trademarks, copyrights, and trade secrets. Implanted
devices fall squarely within the “machine” category of utility patent laws, and possibly design patents
for the ornamental, nonfunctional design of the implanted devices. Surgical treatments and procedures,
although not protectable in some countries, fall within the “process” category of US utility patent
laws. Pharmaceutical drugs have been protected by patents for “compositions of matter,” where the
patents are granted for the man-made chemical structures of the drugs. Other medical inventions are
also afforded IP protection although they do not fall squarely within the original IP law definitions. For
example, although subject to much controversy, nonhuman organisms, tissue, and even human genes
have been patented, subject to limitations discussed later.
IP laws may apply to nearly all aspects of 3D bioprinting and nanotechnology, including the hard-
ware used to print an item or handle nanoparticles, software involved in the design of tissue structures
and the operation of the hardware to create the tissue, and specialized materials used to form or process
the created tissue. 3D bioprinters combine cutting-edge machinery, electronic circuitry, software, ma-
terials, and processes in each creation of tissue, and the resulting tissue and organs may be protectable
as well.
The most prominent forms of IP involved in 3D bioprinting and nanotechnology are patent and
trade secret protection, discussed in detail later. Copyrights also protect the software executed by 3D
bioprinting and nanotechnology machinery.
Section 101 of the US patent laws broadly defines a patentable invention as a “new and useful pro-
cess, machine, manufacture, or composition of matter, or any new and useful improvement thereof.” 3
For a long time after the US patent system was established by The Patent Act of 1790, patents were
mostly granted for new and improved machines, and methods for creating or physically transforming
objects. The advent of computers brought waves of patent applications for computers and for computer
software. Now, software such as medical diagnostic programs, device control programs, and computer-
aided design (CAD) programs, are patentable for the functions that processors perform while executing
the software, and even for the physical memory or media on which the software is stored. 3D bioprint-
ing and nanotechnology combine many known technologies with groundbreaking and unknown tech-
nologies, and open new frontiers in IP. The main categories of patentable aspects of these technologies
are hardware, software, processes, and materials.
16.5.1 HARDWARE
The machines involved in creating engineered tissue with 3D bioprinting and nanotechnology fit
squarely within the “machine” category of patentable subject matter. Of course, 3D printers are ma-
chines whose functionality can be protected by utility patents. Many patents can cover different parts
or part combinations of a single piece of hardware. Within a single 3D bioprinter, there may be numer-
ous systems working to move print heads, process raw materials such as the cells and binding agents,
3 35 U.S.C. § 101 (added in 1952).