Biomedical Engineering Reference
In-Depth Information
the FDA draft guidances, the EC recognized the importance of proper character-
ization of NMs to gather information that can be sued as the basis for the safety
evaluation and the material safety data sheet (MSDS).
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It is recommended that
NMs be subject to biological systems for safety evaluation because they may be
coated with proteins and other biomolecules that can considerably change their
properties such as the size distribution due to agglomeration or aggregation of
the particles.
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In addition the toxicity of NMs in solution or suspension may
be caused by the soluble species released from the nanomaterial. The need for
reference NMs is indicated to allow the assessment of fate, behavior as well as
effects that could be related to the properties and characteristics.
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From the
characterization to safety evaluation, the challenges are the absence of well-
defined parameters to measure and standardize test protocols for the identifica-
tion of reference material for production.
8.6 THE NM
s
INTELLECTUAL PROPERTY PERSPECTIVE
When a new technology emerges that is completely different from what is famil-
iar and known to most, the patent offices are faced with problems. They receive
patent applications covering the new field but there are not enough people with
the experience and knowledge to examine them. These result in delays, dissatis-
fied patent authors, and a lot of overlaps that lead to controversies which either
leads to litigations or are accepted by the market.
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The patent landscape in nanotechnology is very broad because NMs and
the corresponding related processes can be applied to almost any manufactured
product across potentially all industry sectors. Thus, control and ownership of
nanotechnology is vital for all governments and civil entities. Intellectual prop-
erty (IP) will control the nanotechnology market and the price of the NMs and
the nano-enabled products. IP will dictate innovations that affect multiple sec-
tors from electronics, energy, sports, mining, defense, aviation, health, medi-
cine, pharmaceuticals, and agriculture.
The current state of intellectual property related to nanotechnology is in
chaos. Because it was and still is an emerging technology that is different from
existing technologies, broad patents on NMs, tools, and processes have been
granted too early. The flooding of new patent applications has led to rejections
of valid claims and the issuance of broad-overlapping claims. The chaos and
other challenges in nanotechnology patents may be attributed to several factors.
(1)
Due to the lack of in-depth and complete knowledge of nanotechnology,
patent examiners may not have the tools necessary to understand the com-
plexities of the field.
(2)
Because nanotechnology is in its infancy, there is a lack of available prior
art, which could allow patent claims to be overly broad allowing stakehold-
ers to lock up huge areas of the technology. At the same time, this can lead
to overlapping patents.
