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ISSUES RELATED TO NANOTECHNOLOGY Legal Issues Patents

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legal issues
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 issues3
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
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 Applicationsdevices 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
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
  • http://www.clarkson.edu/projects/nanobird/2.2.php
health and safety issues7
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
Conclusion
  • Most issues on nanotechnology are still at its infancy and inconclusive
  • Patchy regulatory framework
  • Rogue group may take advantage of this loose work