Patent protection and freedom to operate are essential for successfully commercializing nanotechnology innovations. The document provides a step-by-step process for navigating intellectual property issues from the lab to the market. It begins with defining functional requirements, prioritizing them, and using brainstorming to generate new ideas and inventions. Key intellectual property is then captured through patent applications. Further refinement and testing leads to additional intellectual property reviews and potential new inventions or licensing needs. Following this process helps establish value, allows for investment, and enables commercialization strategies while mitigating intellectual property risks.

1. THESIS
130 nature nanotechnology | VOL 2 | MARCH 2007 | www.nature.com/naturenanotechnology
From the lab to the market
Patents are a double-edged sword — they
are essential for the commercialization of
new technologies, but flaws in the system
also create challenges for universities
and smaller companies. On the upside,
patents protect ideas and intellectual
property (IP), drive innovation and
create new industries. On the downside,
however, they can favour the creation
of monopolies and also result in time-
consuming and costly litigation. As the
majority of nanotechnology innovation
occurs in universities, patents need to
bridge the gap between the specific focus
of the actual research and the potential
applications in the real world, balancing
the needs of research institutes — which
have limited funds to spend on filing
patents — and the monetary returns
of commercialization. Implementing a
strategy for patents will not eliminate all
the challenges posed by the IP system,
but it will reduce the risk (see flow
chart; Fig. 1).
Patents alone, however, are not
enough — it is also important to have
‘freedom to operate’, which means that
your new product or process does not
infringe on any other patents1
. Strategies
for obtaining freedom to operate
include purchasing or licensing existing
patents, cross-licensing (each company
giving the other access to the IP they
require), and ‘inventing around’ the
patents (which I will return to below).
However, it is important to realize that
the sheer number of patents that are
being filed and granted at different
patent offices around the world means
that you can never be 100% sure that
you have freedom to operate. One can
only be prudent, perform reasonable due
diligence, mitigate the risk and become
comfortable with the decisions necessary
to move forward.
So what can be patented? It is unlikely
that the actual physical phenomena
occurring at the nanoscale are patentable.
However, in the language of lawyers, the
tangible use or embodiment of a physical
phenomenon can be. In practice this
means that ‘composition of matter’ (that is,
the chemical structure of a material2
),
fabrication techniques and specific
applications can be patented. Within the
field of quantum dots and nanocrystals3
,
for instance, there are patents covering
all these areas, and companies that
actively acquire licenses can control
certain commercial applications that
rely on quantum dots and nanocrystals.
Indeed, their many potential medical
applications have resulted in tortuous
disputes about patents, and in smaller
companies being taken over by larger
rivals. This has been avoided in some
cases, however, with cross-licensing deals.
Another approach is to develop a different
solution to the problem. For example, as
an alternative to using quantum dots and
nanocrystals, the US company Keystone
Nano use nanoporous ceramics loaded
with fluorescent dyes for diagnostic
applications4
(Fig. 2).
The flow chart shows the process
I use to translate lab results into
commercial products. The first step is
to describe the functional requirements
of the specific application. The next
step is to prioritize these requirements.
This focuses attention on the areas
where development is needed and also,
crucially, identifies the key criteria
that need to be covered by the IP.
Once functional requirements and
their prioritization are understood, the
controlled chaos of the brainstorming
process can begin. The overall aim is to
generate new ideas and then funnel them
into the kernels of new inventions. When
seemingly insurmountable IP issues arise,
brainstorming can often identify ways to
overcome these barriers. The intellectual
creativity that occurs at the beginning of
the process is crucial to its success and
should focus on composition of matter
and application. Having a composition of
matter patent creates strong protection
as the rights to the relevant IP must be
acquired for the material to be used in
other applications, so this is the most
strategic approach. It is always advisable
to consult a patent lawyer before
submitting a patent application, but this
Patent protection and freedom to operate are essential for the commercialization of
nanotechnology. Michael Helmus offers a step-by-step guide on how to deal with
intellectual property.
Define functional requirements
Prioritize functional requirements
Brainstorming
Capture strategically important IP by filing invention records
and patent applications based on brainstorming and a review
of existing literature and patents. This will establish the initial
value of the technologies and products that will enable
investment and future commercial and business strategies.
Test proof-of-concept
Refine the design and fabrication processes
Review the IP with respect to freedom to operate.
This may lead to new inventions, as well as
demonstrating the need to license additional
technology to allow commercialization to proceed.
Model prototype components and test feasibility
Further refine the design and fabrication processes
This will initiate a new IP review addressing new inventions
related to fabrication processes, freedom to operate and
licensing of additional IP.
Review functional requirements
Perform FMEA (Failure Modes and Effects Analysis)
Finalize design
Model and test components and device
As the final design is completed a final IP review begins to
ensure that: all inventions have been captured; decisions
have been made on trade secrets versus patenting; and any
additional IP needed to enable commercialization has
been licensed.
Commercial Release
Figure 1 This flow chart highlights the major actions
and decisions related to patents and IP that are involved
in taking an invention from the lab to the market.This
approach is based on my experiences of brainstorming
sessions at the management consultants,Arthur D. Little,
in the mid-1980s.These sessions were similar in many
ways to the scenes in the movie Apollo 13 in which the
engineers brainstorm solutions to the loss of oxygen in
the command module.

2. THESIS
nature nanotechnology | VOL 2 | MARCH 2007 | www.nature.com/naturenanotechnology 131
is particularly true when trying to ‘invent
around’ existing IP.
The beginning of the inventive process
is peculiar and depends on the individuals
involved. One of my inventions, for
instance, is a medical implant with an
average surface charge density that was
inspired by miniaturized submarines
that travel through blood vessels and
traverse across cell membranes by
modifying the surface charge distribution
on the hull in Isaac Asmiov’s novel
Fantastic Voyage II. My invention uses
electrodes fabricated from micro- and
nanoelectromechanical systems attached
to medical devices, which, on coming into
contact with blood, modify the surface
charge of the device and hence control
its biological response (for example, to
make it thromboresistant). Full details are
available in US patent application number
20060089709. Although this technology
is not in production, it will become part
of a strategy to create commercialization
barriers for competitive technology.
Once an idea has been distilled,
performing the proof-of-concept may
reveal new compositions, manufacturing
processes and characterization methods
that can be patented (as well as
demonstrating that the invention actually
works as intended). When looking at
fabrication and characterization, key
decisions on whether to patent or keep the
methods as a trade secret need to be made.
In a company, trade secrets may be more
appropriate, whereas a patent might be
the best path to protection in an academic
environment. For those that are patented,
additional invention documentation
and patent applications should be filed
to take into account potential market
applications, processes for manufacture,
and composition of matter.
Risks can be reduced by evaluating
competitive IP at an early stage, at which
point a start-up company can be set up
or, alternatively, the technology can be
licensed to an existing company. Prior
to forming partnerships with other
companies it is important to investigate
freedom to operate — the more freedom,
the more valuable the technology. As
with all new technologies, following the
proper strategy for IP is essential for the
successful and timely commercialization
of new inventions in nanotechnology.
References
1. www.wipo.int/sme/en/documents/freedom_to_operate.html
2. www.baypatents.com/glossary/default.asp?ID_Glossary=88
3. www.pfc.org.in/ach/quant.htm
4. keystonenano.com/imagingtechnologies.asp
Michael N. Helmus is senior vice president for
Biopharma at Advance Nanotech
e-mail: michael.helmus@Advancenanotech.com
In Thesis next month:
Chris Toumey on privacy
and nanotechnology
Figure 2 Keystone Nano makes molecular dots for a variety of imaging applications in medicine.
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