ISSUES RELATED TO
NANOTECHNOLOGY
Legal Issues
• Patents
to have a solid grasp of certain applications the examiner may need an in depth knowledge of
engineering, biology and physics -- and the number of researchers in the world with such
capabilities are not easy to come by.
Michel Hoffmann, 2006
– biotechnology
– pharmaceuticals
Patent Applicability: It is generally accepted that the properties of
matter and other fundamental scientific discoveries are not patentable.
In order to secure a patent, the invention must be "any new and useful
process, machine, manufacture, or composition of matter, or any new
and useful improvement thereof.“
Terry K. Tullis, Current Intellectual Property Issues in
Nanotechnology, 2004 UCLA J.L. & Tech. Notes 12
http://www.lawtechjournal.com/notes/2004/12_040809_tullis.php
Legal Issues
• Regulation
– Nanotechnology is likely to produce a great deal of debate for
government regulation; the goal of this debate would be to achieve a
balance between comprehensive regulation, focused regulation, and, in
some instances, no regulation. Joel Rothstein Wolfson, Social and Ethical Issues in
Nanotechnology: Lessons from Biotechnology and Other High Technologies, 22 Biotechnology L. Rep. 376,
384 (2003).
– Any regulatory extreme may present a risk; on one end, very little
regulation may make investors reluctant to support development, on
the other hand, too much regulation may lead to undesirable, and
avoidable, consequences. Fiedler et al., 3 S. Cal. Interdisc. L.J. at 603.
– The vast range of devices and products that will likely be produced by
nanotechnology companies may require many agencies, such as the
Food and Drug Administration, the Environmental Protection Agency,
the National Institute of Health, or the Department of Health and
Human Services, to either have their own regulatory approach or to
develop a coordinated regulatory approach. Wolfson, 22 Biotechnology L. Rep. at
384.
Environmental Issues
• “Grey Goo”
At the grossest level, there is the fear that someone will
design self-replicating nanorobots, capable of making copies of themselves
from materials found in nature, and that those nanorobots will convert
everything in the world into copies of themselves, thus wiping out the entire
biosphere.
• Military Applications devices that can infiltrate electronics and
seize control at crucial moments, artificial “disease” agents that can rest
harmlessly in victims’ bodies until activated by an external signal, and so
on.
• Environmental Nanotechnology-based agents for crop destruction,
forest-cover removal, and area-denial applications are likely to pose familiar
environmental problems in a new fashion.
Glenn Harlan Reynolds 2001, Environmental Regulation of Nanotechnology:Some Preliminary Observations,
Environmental Law Institute®, Washington, DC., http://www.eli.org
Societal Issues
• Studying the societal impacts of a new technology
•
examines how a product will be used, what existing
technologies it might displace, what kind of jobs it might
create, and what might be the potential economic impact
of the technology.
New business opportunities in nanotechnology are
beginning rapidly while current industry leaders are
increasing their investments. Like many new research
areas, nanotechnology has the potential to change
industries, allowing smaller, more flexible businesses to
overtake larger, established businesses.
Societal Dynamics of Nanotechnology http://www.clarkson.edu/projects/nanobird
Health and Safety Issues
•
Health and Safety Issues
• The difficulty facing members of the scientific community when
studying these effects of nanomaterials on our health is that many
of these studies are being performed on animals instead of humans.
Though this is a frequent practice in pharmaceuticals and other
disciplines, there are difficulties in relating reactions observed in
animals with potential reactions in humans.
• Toxicity studies using mice and rats suggest that certain
nanomaterials could be more toxic than quartz, traditionaly thought
to induce serious damage in humans. However, these studies
directly injected nanoparticles into the tracheas of these rhodents,
rather than observing them inhaling the particles as a human might.
Societal Dynamics of Nanotechnology http://www.clarkson.edu/projects/nanobird
Conclusion
• Most issues on nanotechnology are still at
its infancy and inconclusive
• Patchy regulatory framework
• Rogue group may take advantage of this
loose work