ISSUES RELATED TO ISSUES RELATED TO NANOTECHNOLOGYNANOTECHNOLOGY

Legal IssuesLegal Issues

• PatentsPatentsto have a solid grasp of certain applications the examiner may need an in depth knowledge of 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 engineering, biology and physics -- and the number of researchers in the world with such capabilities are not easy to come by.capabilities are not easy to come by. Michel Hoffmann, 2006Michel Hoffmann, 2006

– biotechnologybiotechnology– pharmaceuticalspharmaceuticals

Patent ApplicabilityPatent Applicability: It is generally accepted that the properties of matter : It is generally accepted that the properties of matter and other fundamental scientific discoveries are not patentable. In order and other fundamental scientific discoveries are not patentable. In order to secure a patent, the invention must be "any new and useful process, to secure a patent, the invention must be "any new and useful process, machine, manufacture, or composition of matter, or any new and useful machine, manufacture, or composition of matter, or any new and useful improvement thereof.“ improvement thereof.“

Terry K. Tullis, Current Intellectual Property Issues in Terry K. Tullis, Current Intellectual Property Issues in Nanotechnology, 2004 UCLA J.L. & Tech. Notes 12 Nanotechnology, 2004 UCLA J.L. & Tech. Notes 12

http://www.lawtechjournal.com/notes/2004/12_040809_tullis.phphttp://www.lawtechjournal.com/notes/2004/12_040809_tullis.php

Legal IssuesLegal Issues

• RegulationRegulation– Nanotechnology is likely to produce a great deal of debate for Nanotechnology is likely to produce a great deal of debate for

government regulation; the goal of this debate would be to achieve a government regulation; the goal of this debate would be to achieve a balance between comprehensive regulation, focused regulation, and, balance between comprehensive regulation, focused regulation, and, in some instances, no regulation. in some instances, no regulation. Joel Rothstein Wolfson, Joel Rothstein Wolfson, Social and Ethical Issues in Social and Ethical Issues in Nanotechnology: Lessons from Biotechnology and Other High TechnologiesNanotechnology: Lessons from Biotechnology and Other High Technologies, 22 Biotechnology L. Rep. , 22 Biotechnology L. Rep. 376, 384 (2003).376, 384 (2003).

– Any regulatory extreme may present a risk; on one end, very little Any regulatory extreme may present a risk; on one end, very little regulation may make investors reluctant to support development, on regulation may make investors reluctant to support development, on the other hand, too much regulation may lead to undesirable, and the other hand, too much regulation may lead to undesirable, and avoidable, consequences. avoidable, consequences. Fiedler et al., 3 S. Cal. Interdisc. L.J. at 603.Fiedler et al., 3 S. Cal. Interdisc. L.J. at 603.

– The vast range of devices and products that will likely be produced by The vast range of devices and products that will likely be produced by nanotechnology companies may require many agencies, such as the nanotechnology companies may require many agencies, such as the Food and Drug Administration, the Environmental Protection Agency, Food and Drug Administration, the Environmental Protection Agency, the National Institute of Health, or the Department of Health and the National Institute of Health, or the Department of Health and Human Services, to either have their own regulatory approach or to Human Services, to either have their own regulatory approach or to develop a coordinated regulatory approach. develop a coordinated regulatory approach. Wolfson, 22 Biotechnology L. Rep. at Wolfson, 22 Biotechnology L. Rep. at 384. 384.

Environmental IssuesEnvironmental Issues

• ““Grey Goo”Grey Goo” At the grossest level, there is the fear that someone At the grossest level, there is the fear that someone will design self-replicating nanorobots, capable of making copies of will design self-replicating nanorobots, capable of making copies of themselves from materials found in nature, and that those nanorobots themselves from materials found in nature, and that those nanorobots will convert everything in the world into copies of themselves, thus will convert everything in the world into copies of themselves, thus wiping out the entire biosphere.wiping out the entire biosphere.

• Military ApplicationsMilitary Applications devices that can infiltrate electronics devices that can infiltrate electronics and seize control at crucial moments, artificial “disease” agents that and seize control at crucial moments, artificial “disease” agents that can rest harmlessly in victims’ bodies until activated by an external can rest harmlessly in victims’ bodies until activated by an external signal, and so on. signal, and so on.

• Environmental Environmental Nanotechnology-based agents for crop Nanotechnology-based agents for crop destruction, forest-cover removal, and area-denial applications are destruction, forest-cover removal, and area-denial applications are likely to pose familiar environmental problems in a new fashion.likely to pose familiar environmental problems in a new fashion.

Glenn Harlan Reynolds 2001, Environmental Regulation of Nanotechnology:Some Preliminary Observations, Glenn Harlan Reynolds 2001, Environmental Regulation of Nanotechnology:Some Preliminary Observations, Environmental Law Institute®, Washington, DC., http://www.eli.orgEnvironmental Law Institute®, Washington, DC., http://www.eli.org

Societal IssuesSocietal Issues

• Studying the societal impacts of a new technology Studying the societal impacts of a new technology examines how a product will be used, what existing examines how a product will be used, what existing technologies it might displace, what kind of jobs it technologies it might displace, what kind of jobs it might create, and what might be the potential might create, and what might be the potential economic impact of the technology. economic impact of the technology.

• New business opportunities in nanotechnology are New business opportunities in nanotechnology are beginning rapidly while current industry leaders are beginning rapidly while current industry leaders are increasing their investments. Like many new research increasing their investments. Like many new research areas, nanotechnology has the potential to change areas, nanotechnology has the potential to change industries, allowing smaller, more flexible businesses industries, allowing smaller, more flexible businesses to overtake larger, established businesses. to overtake larger, established businesses.

Societal Dynamics of Nanotechnology http://www.clarkson.edu/projects/nanobirdSocietal Dynamics of Nanotechnology http://www.clarkson.edu/projects/nanobird

Health and Safety IssuesHealth and Safety Issues

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• http://www.clarkson.edu/projects/nanobird/2.2.phphttp://www.clarkson.edu/projects/nanobird/2.2.php

Health and Safety IssuesHealth and Safety Issues

• The difficulty facing members of the scientific community The difficulty facing members of the scientific community when studying these effects of nanomaterials on our health is when studying these effects of nanomaterials on our health is that many of these studies are being performed on animals that many of these studies are being performed on animals instead of humans. Though this is a frequent practice in instead of humans. Though this is a frequent practice in pharmaceuticals and other disciplines, there are difficulties in pharmaceuticals and other disciplines, there are difficulties in relating reactions observed in animals with potential relating reactions observed in animals with potential reactions in humans.reactions in humans.

• Toxicity studies using mice and rats suggest that certain Toxicity studies using mice and rats suggest that certain nanomaterials could be more toxic than quartz, traditionaly nanomaterials could be more toxic than quartz, traditionaly thought to induce serious damage in humans. However, thought to induce serious damage in humans. However, these studies directly injected nanoparticles into the tracheas these studies directly injected nanoparticles into the tracheas of these rhodents, rather than observing them inhaling the of these rhodents, rather than observing them inhaling the particles as a human might.particles as a human might.

Societal Dynamics of Nanotechnology http://www.clarkson.edu/projects/nanobirdSocietal Dynamics of Nanotechnology http://www.clarkson.edu/projects/nanobird

ConclusionConclusion

• Most issues on nanotechnology are Most issues on nanotechnology are still at its infancy and inconclusivestill at its infancy and inconclusive

• Patchy regulatory frameworkPatchy regulatory framework

• Rogue group may take advantage of Rogue group may take advantage of this loose workthis loose work