CHAPTER 3

STRATEGIES IN NANOTECHNOLOGY

A well-managed patent portfolio is the strongest weapon in a

company’s arsenal against IP litigation, no matter how small or large the corporation.
Patents allow market exclusivity, protecting entry into the market by potential
competitors that can lower the price and decrease profit margins. Patents can also remove
potential roadblocks set by third-party patent holders by giving the patentee leverage to
enter into cross-licensing agreements, and give sometimes needed leverage to encourage
other parties to enter into licensing or collaboration agreements1. Finally, patents will
reasonably allow a company to stay out of any patent litigation created by the PTO’s
issuance of overlapping patent claims. But in situations where a company is foreclosed
from obtaining patent protection on the manufactured product, then there are several
strategies to protect company from litigious situations and improve the bottom line2.
A. Due Diligence Analysis
The first step in any patent strategy when developing a new product is to
conduct a strategic analysis of the patent rights supporting or threatening the product,
typically through a due diligence investigation3. A due diligence investigation can be
straightforward, consisting of tracing ownership and title rights, and determining if any
potential restrictions apply. Analysis of the scope of any patent that can be applied to the
technology is also needed to assess the potential of the patent to protect, as well as block
competitors in the field4. Due diligence analysis in a complex technological field;
however, may not be as straightforward, and should involve experienced attorneys that

1
Bawa Raj et al, Bronzino JD (Ed.), Bionanotechnology patenting: Challenges and Opportunities, in The
Biomedical Engineering Handbook, CRC Press, Florida, 2006
2
ALBERT P. HALLUIN, Incorporation of Parts into the Whole: Avoiding Liability When Incorporating
Nanotechnology Improvements, Nanotechnology Law & Business, vol 3. no 1, February/march 2006
Available on http://www.wsgr.com/publications/PDFSearch/halluin0306.pdf
3
Id
4
Merrill S A , Levin R C & Myers M B (editors), A Patent system for the 21st century, National Academies
Press, Washington (DC), 2004
can provide more than a cursory analysis of the technology and applicable IP5. A
thorough due diligence analysis starts with identifying and locating key IP assets. A
company’s IP portfolio is the strongest weapon in protecting a company from litigation
disaster. Properly managing this portfolio is a key to keeping competitors at bay. This
includes evaluating your company’s IP assets—including patents, trademarks, copyrights,
trade secrets and other IP assets—in order to realistically determine the nature and scope
of the claimed rights in the IP. This evaluation encompasses not only determining if the IP
is owned or licensed, but also evaluating its breadth and strength6. In terms of patents,
evaluating the strength of a company’s IP includes not only determining that the claims
cover the commercial products made, but also surveying other relevant patents to see if
there are overlapping patents. A typical “freedom to operate” search usually involves
searching for patents in the relevant field using multiple search strategies across multiple
databases or searching facilities7. Different searching strategies should be designed to
search keywords, inventors and assignees within the PTO and international patent offices.
In order to design a comprehensive search strategy, the searcher should be familiar with
the jargon used both by patent lawyers and by practitioners who use the inventions to
identify obscure or obsolete search terms that could reveal pertinent references. Searches
can also be helpful in yielding information on possible inventor ship issues that may
assist in invalidating potentially relevant patents8.
B. Licensing Strategies
Technology agreements and other IP licenses should also be
reviewed to ensure that the company retains or possesses as many rights as possible to
sufficiently cover the commercial product incorporating the novel nanotechnology
material or article9. This is especially important when the company is collaborating with

5
Id
6
Id
7
Id
8
Id
9
Roco M C & Bainbridge W S, Societal Implications of Nanoscience and Nanotechnology, Kluwer
Academic Publishers, Boston, 2001
another institution (e.g., pursuant to joint development agreements), where a large portion
of nanotechnology research and advances are currently being made10.

The cross-licensing imperative

The backlog of patent applications at the USPTO presents additional
concerns for licensees and licensors. With the number of nanotechnology-related patent
application filings increasing every year, the USPTO is experiencing a significant reserve
of patent applications, which has slowed down its ability to examine and process patent
applications. A quick search of the USPTO patent applications database, using the term
‘nano’, resulted in nearly 32,000 hits of published patents11. Circumstances in which
parties may have similar or overlapping scopes should encourage those parties to grant
cross-licences to existing and future patent rights, so as to eliminate, or at least minimize,
the possibility of costly future legal battles12. One area currently experiencing increased
cross-licensing involves nanotubes. Cross-licensing allows the parties to license among
themselves patent rights with a promise not to sue one another. Each party may therefore
practice the other party's patent rights without infringing them. Such covenants not to sue
can decrease the costs associated with fighting infringement suits. Cross-licensing can
therefore offer a viable alternative to litigation for companies whose technologies have an
overlapping scope. Cross-licensing may also be a viable strategy for late-comers looking
to enter a technical area where there are existing players13. For instance, in the area of

10
Behfar Bastani et al., Technology Transfer in Nanotechnology: Licensing Intellectual Property from
Universities to Industry, 1 NANOTECHNOLOGY L. & BUS. 166 (2004) (in-depth discussion of licensing

nanotechnology).
11
Such a high number means that a nanotechnology-related patent application may not be examined for a
number of years after its filing and may not be issued for several more years thereafter. In addition, many
nanotechnology-related applications awaiting examination may contain a similar or overlapping scope. This
is frequently the case in technology areas which are inundated with new discoveries and constant advances.
Nanotechnology is particularly susceptible to this problem because nanotechnology spans a number of
disciplines, including chemistry, electronics, biology, and physics to name just a few
12
ALBERT P. HALLUIN, supra 1
13
For instance, in the area of nanotube technology, there are a few established players with basic patent
rights to nanotube technology. If a late comer enters the market, the late-comer may not be able to practise
nanotube technology, there are a few established players with basic patent rights to
nanotube technology. If a late comer enters the market, the late-comer may not be able to
practise those basic patent rights without infringing the rights of an existing player.

Patent pool
Patent pools 14 may be an important tool to be used in acquiring multiple
licenses needed in one single package or agreement. Patent pools are agreements between
two or more patent holders that assign or license their patents to establish a
“clearinghouse” for related intellectual property. Although patent pools have been
associated with anti-trust issues,15 carefully constructed patent pools that avoid
anticompetitive implications can be an economical way for start-up companies to acquire
needed patent protection for their products16. Patent pools have the advantage of not only
decreasing costs for acquiring multiple technological licenses in complex technology
applications, it also provides a source of revenue and income to patent pool members as a
result of royalty streams generated from non-member licensees17. Subscribing into patent
pools may be an economical means to acquiring needed technology for protecting and
practicing your product in the commercial marketplace.

those basic patent rights without infringing the rights of an existing player.

14
A patent pool is a cooperative arrangement between multiple holders of patents that are necessary to
make a product. Under a patent pool, all of the needed patents can be licensed together at a single price.
15
Current viewpoints appear to view patent pools favorably in terms of competitive issues. See Andrea C.
Brunetti, Wading into Patent Pooling: The Clinton Justice Department is Becoming More Tolerant of High-
Tech Patent-Sharing Deals, INTELL. PROP. (Nov. 1997) (quoting Acting Assistant Attorney General Joel
Klein as stating “by promoting the dissemination of technology, cross-licensing and pooling arrangements
are often pro-competitive.”).
16
The Project on Emerging Nanotechnologies recently conducted a survey on the use of patent pools in
securing nanotechnology licenses and the results are expected shortly. See Project on Emerging
Nanotechnologies, Nanotechnology and Patent Pools: One-Stop License Shopping (forthcoming),
http://www.nantoechproject.org/index.php?id=12 (last visited Jan.17, 2006).
17
Michael A. Heller & Rebecca Eisenberg, Can Patents Deter Innovation: The Anticommons in
Biomedical Research, 280 SCIENCE 698, 699-701 (1998) (discussion on patent pools increasing
innovation).
Royalty stacking
Royalty stacking occurs where multiple patents overlap a technology, forcing a
company to take out a multitude of licenses from each patent holder. Depending upon the
number of patent holders demanding their share, royalty stacking can amount to
significant increases in the price of a product, ultimately increasing costs and decreasing
profitability of a product18. Although costs are usually passed on to the consumer, royalty
stacking in products where competition is already fierce, such as sunscreens and clothing,
may spell the demise for a product where cost is a deciding factor among consumers.
Companies have several options when dealing with royalty stacking19. For example,
licensing agreements can be structured to include a ceiling or cap, or maximum
percentage level of royalty payments for a product, regardless of the number of licenses
needed20. A typical anti-stacking provision will require royalty payments to be
correspondingly decreased, if other licenses are required for a given product. Payment of
up-front fees, rather than percent royalty payments, can also help to reduce effects caused
by royalty stacking. Finally, cross-licensing agreements or patent pools may prove
invaluable in avoiding increased costs and decreasing profits. Whatever the method
chosen, minimization of royalty stacking is essential to avoid making a product cost-
prohibitive to the consumer21.
C. Indemnification Clauses
Putting aside the exciting potential benefits of nanotechnology, the possible
and unknown side effects of the technology can further present difficulties for licensors
and licensees. Potentially foreseeable side effects include concerns about toxicity, the
environmental impact of nanomaterials, and health risks. Although there are no cases on
record, owners could conceivably face the possibility of liability for the side effects of
their technologies22.
18
ALBERT P. HALLUIN, supra 1
Available on http://www.wsgr.com/publications/PDFSearch/halluin0306.pdf
19
Roco M C & Bainbridge W S, Societal Implications of Nanoscience and Nanotechnology, Kluwer
Academic Publishers, Boston, 2001
20
Merrill S A , Levin R C & Myers M B (editors), A Patent system for the 21st century, National Academies
Press, Washington (DC), 2004
21
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22
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 From a licensee's perspective, a licensee may not want to risk potential
liability for unknown side effects. Even though licence agreements often contain rather
limited indemnity provisions which typically protect the licensee in the event of a third
party claim, licensees may demand a broader scope of indemnity to cover, for example,
unknown health and environmental-related claims23. This form of indemnity may require
the licensor to defend and hold harmless the licensee should a court finds liability. While
licensees would certainly benefit from this expanded indemnity provision, licensors who
are not engaged in the actual commercialization of the licensed technology may not want
to expand their indemnity obligations beyond strictly IPR-related areas that is licensors
may not be willing to indemnify licensees for any health or physical injuries caused by
the nanotechnology24. So to minimize risks and liabilities licensor may choose to
incorporate these standards into the licensing agreement as evidence of best industry
protocols. Accordingly, as long as the licensor abides by the standards, the licensor may
be able to protect itself against liability for unforeseen side effects25. Licensing IP
agreements does not need to be limited to the use or practice of the patented article.
Licensing agreements can also be tailored to protect the licensee from future litigation
exposure and/or costs through indemnification clauses. Indemnification, or “save
harmless,” clauses typically protect a licensee against infringement of third-party patents.
Indemnification clauses are not routine; because of the high costs of litigation and patent
awards, licensors are resistant to incorporating such clauses into licensing agreements26.
One should be prepared to negotiate for indemnification clauses, especially if due
diligence and freedom to operate results indicate uncertainty for patent litigation risks.
Agreements for increased royalties to the licensor may be needed in order to secure
insurance against future litigation liability.

23
Roco M C & Bainbridge W S, Societal Implications of Nanoscience and Nanotechnology, Kluwer
Academic Publishers, Boston, 2001
24
John C. Miller, Ruben Serrato, Jose Miguel Represas-Cardenas, Griffith Kundahl,
The Handbook of Nanotechnology: Business, Policy and Intellectual Property Law, John Wiley & Sons,
2005
25
Paul J. Sutton, Chinh H. Pham and Joanna Toke, Nanotechnology licence pitfalls,Journal of
Intellectual Property Law & Practice 2009

26
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D. Other Agreements
Other important agreements that should be tailored to ensure
benefit for the company in the use of the patented nanotechnology article include
collaboration and sponsored research and development agreements. A good portion of
research and development is concentrated in laboratories affiliated with universities.
Exclusively in-licensing key technology can enable the blocking of competitors from
entering into your market space, giving your company market exclusivity for the life of
the patent27. These agreements should not only accord the transfer of IP rights to the
technology, but also secure rights in later-developed inventions between the two entities.
Such collaborative agreements can not only give the company equal access to these
patents, but can often be a valuable vehicle in overcoming rejections by the PTO should
the company attempt to pursue the patented invention on its own 28. Other considerations
for collaborative and research agreements include ensuring the agreements have adequate
and enforceable confidentiality agreements, as well as other restrictive provisions. This is
especially important when employees of the collaborating company leave the research
arrangement to join a competitor company29. Restrictive provisions, such as non-compete
or confidentiality provisions will prevent the possible divulging of sensitive information
that could remove any competitive advantage built into the collaborative agreement 30.
Finally, because of the open and public nature of many research universities, it is also
important to ensure that university investigators do not have a potential or actual conflict
of interest with the company31. This includes either past or present ties to close
competitors, where proprietary information from the company could be divulged to the
detriment of the company. Such situations can be avoided through the careful review of
all agreements with the university investigators, including agreements where the
university is not a party to the agreement32.

27
ALBERT P. HALLUIN, supra 1
28
Id
29
Toby Shelley, Nanotechnology: new promises, new dangers, Zed Books, 2006
30
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31
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32
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E. Insurance Policies
Even after all precautions to avoid litigation are taken, a company
still has options to prepare and insulate the company should patent infringement litigation
be inevitable. For example, one cost-effective insurance policy is to ensure that damages
are minimized by conducting regular due diligence to identify patents that could pose
litigation problems for the company33. Companies however, should not stop there.
Although recognizing problem patents is important, ensuring that they are not a problem
is vital. Companies may protect themselves by obtaining non-infringement and/or
invalidity opinions on each problem patent identified.34 Non-infringement opinions serve
to distinguish a commercial product or method from patent claims by first defining the
claims according to case law, and then comparing the claims to the product or method,
both literally and under the doctrine of equivalents. An invalidity opinion letter, on the
other hand, seeks to neutralize a potential patent problem by determining that the claims
of the patent are invalid, either by searching for prior art, or by determining if the patents
fail to meet the statutory requirements for patentability35. Both opinion letters serve the
function of avoiding a willfulness finding by the accused infringer, where damages can
be tripled by a court. Companies may also obtain “patent infringement liability
insurance,” which insulates a company by covering the high costs of defending against a
patent infringement suit36. Most insurance policies will only cover the costs and damages
of a patent infringement claim if the infringement was not intentional. These policies will
also not cover treble damages associated with willfulness, making opinion letters even
more valuable in these situations.

33
Id
34
Suneel Arora, Preparing or Evaluating Freedom to Operate, Non-infringement, and Invalidity Opinions
for a Business Transaction, Part I, INTELL. PROP. TODAY32-36 (Aug. 2005),

http://www.iptoday.com/pdf_current /Arora_Part%201_Proof%204.pdf
35
Rickrt Charles E F &Austin Graeme W (editors), International Intellectual Property and the Common
Law World, Hart Publishing, Oxford, 2000
36
Memorandum by the Technology Group of Torys Insurance Co., Insurance for the High Technology

Industry, http://www.torys.com/publications/pdf/ARTech-11T.pdf (last visited Jan. 17, 2006).

PROPOSED AND EXISTING STRATEGIES AND ACTION PLANS

The existence of a Strategic Plan, focusing and coordinating the efforts, can
favour an approach aimed to the responsible development of nanotechnologies.

European Action Plan 2005-2009 (EC)

On 12 May 2004 the Commission adopted the
Communication towards a European Strategy for Nanotechnology in which a safe,
integrated and responsible strategy was proposed37. This aims to reinforce the Union’s
leading position in nanoscience and nanotechnology (N&N) research and development
(R&D) and innovation while addressing any environmental, health, safety and societal
concerns upfront. Based on this communication, the Commission has prepared an Action
Plan38, which defines a series of articulated and interconnected actions for the immediate
implementation of a safe, integrated and responsible strategy for N&N. The Action Plan
has been adopted by the European Commission in June 2005, and in September 2007, the
first implementation report to the Action Plan has been released, summarising the actions
taken and the progress made between 2005 and 200739. The Action Plan is structured into
eight main areas, each one with specific actions the European Commission and its
member states will take to promote R&D in N&N40.

1. Research, development and innovation: Europe needs knowledge

Reinforce and promote N&N R&D in the European Union’s seventh framework
programme (FP), with specific support for European Technology Platforms
(nanoelectronics, nanomedicine) and collaborative R&D into the potential impact of

37
John C. Miller, Ruben Serrato, Jose Miguel Represas-Cardenas, Griffith Kundahl,
The Handbook of Nanotechnology: Business, Policy and Intellectual Property Law, John Wiley & Sons,
2005
38

Action Plan 2005-2009,EC, (07 June 2005) -

ftp://ftp.cordis.europa.eu/pub/nanotechnology/docs/nano_com_en.pdf
39

ftp://ftp.cordis.europa.eu/pub/nanotechnology/docs/com_2007_0505_f_en.pdf
40
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N&N. Therefore, public investment shall be increased and effective coordination among
the different stakeholders shall be established.
2. Infrastructure and European poles of excellence
Support interdisciplinary R&D infrastructure and “poles of excellence”, reinforce
cooperation between industry and academic R&D and advance transnational networking.
Some areas of N&N R&D would particularly benefit from such integration include
nanotoxicology and nanoecotoxicology, as well as nano-metrology.
3. Inter disciplinary human resources: Europe needs creativity41
Promote networking and disseminate best practices for education and training in N&N
and encourage the development of supporting activities. Training programmes should
also be targeted specifically at SMEs, who often lack the necessary ‘in house’ expertise or
resources. Interdisciplinary R&D in N&N goes beyond traditional concepts and a greater
awareness amongst these groups of entrepreneurship, ethical, health, safety,
environmental, and social issues is needed.
4. Industrial innovation: from knowledge to the market
Due to the enabling character of N&N, advances can be made in virtually all technology
sectors. Excellence in N&N R&D shall be translated into commercially viable, inherently
safe products and processes by fostering knowledge transfer, standards development and
best practice for commercialisation of N&N42. Patent monitoring and harmonisation will
be adapted. Standards provide a level playing field for markets and international trade
and are prerequisites for fair competition, comparative risk assessments and regulatory
measures.

5. Integrating the societal dimension: addressing expectations and concerns

Ethical issues and health, safety and environmental aspects shall be integrated into the
technological development of N&N and an effective dialogue with all stakeholders
established, informing about progress and expected benefits, and taking into account

41
Framing Nano, Mapping Study on Regulation and Governance of Nanotechnologies (January
2009),available at www.framingnano.eu.
42
Id
expectations and concerns (both real and perceived) so to steer developments on a path
that avoids negative societal impact43.
6. Public health, safety, environmental and consumer protection
Risk assessment related to human health, the environment, consumer and workers should
be integrated at all stages of the life cycle of the technology. Safe and cost-effective
measures to minimise exposure of workers, consumers and the environment to
manufactured nano-scale entities should be promoted, including the development of
terminology, guidelines, models and standards for risk assessment44. Inventories of use
and exposure will be fostered. Adaptations of EU regulations will be proposed paying
particular attention to toxicity thresholds, measurement and emission thresholds, labelling
requirements, risk assessment and exposure thresholds and production and import
thresholds.
7. International cooperation
International cooperation will intensify dialogue at international level with a view to
adopting a declaration or a ‘code of good conduct’ for the responsible development and
use of N&N. Industry shall be invited to adhere to these principles 45. Issues of common
nomenclature, metrology, approaches to risk assessment and the establishment of a
dedicated database to share toxicological and data, and also the support for N&N R&D in
less developed countries are promoted.
8. Implementing a coherent and visible strategy at European-level
Coherent and coordinated action is proposed to monitor and oversee the implementation
of the Action Plan in regard to conformity and coherence with Commission policies and
related initiatives, and to generate appropriate visibility and effective communication46. A
useful, beneficial, profitable and consensual exploitation and application of N&N in the
EU shall be promoted e.g. via dedicated ‘horizon scanning’ activities, pro-active and
responsive dialogue with the public and ad-hoc initiatives at international level.

43
Jeffrey Matsuura H, Nanotechnology Regulation And Policy Worldwide, Artech House Publishers, 2006
44
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45
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46
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 In February 2008, the EC produced a Recommendation on a Code
of Conduct for Responsible Nanosciences and Nanotechnologies Research that was
circulated to all Member States47. Consistent with the EU approach, this
Recommendation was developed in consultation with the public. The stated aim of this
Code of Conduct is to ―promote integrated, safe and responsible nanoscience and
nanotechnologies research in Europe for the benefit of society as a whole48. The Code is
underpinned by the principles of: meaning, sustainability, precaution, inclusiveness,
excellence, innovation, and accountability. The intention of this document is to guide the
actions of Member States in the formulation and implementation of both innovation and
regulatory research strategies in individual jurisdictions49. The Recommendation also
suggests that research funding schemes should be tied to the guiding principles therein,
and that Member States should encourage the voluntary adoption of the Code of Conduct
by all bodies with an interest in nanotechnology research. The Recommendation will be
reviewed every two years, and efforts will be made to monitor the extent to which
stakeholders adopt and apply the Code of Conduct50. Member States are also asked to
report annually to the Commission any measures taken pursuant to the Recommendation
and to communicate any results and best practices51.

Denmark Action Plan

47
European Commission, Commission Recommendation of 07/02/2008 on a code of conduct for
responsible nanosciences and nanotechnologies research, Available online from:
http://ec.europa.eu/nanotechnology/pdf/nanocode-rec_pe0894c_en.pdf;
48
Id
49
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50
Patrick M. Boucher, Nanotechnology: Legal Aspects, CRC Press, 2008
51
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 The Action Plan Technology Foresight on Danish Nanoscience and
Nanotechnology since 2004 52focuses on a series of recommendations: such as Prioritise
technology areas, create interplay between nanotechnological research and the
development of high technology in industry, establish nanotechnology centres for
strategic research and innovation, produce more university graduates and researchers,
spread nanotechnology widely to Danish enterprises, give attention to hazards and health,
environmental and ethical considerations.
According to the Action Plan, besides supporting the research and
development of nanotechnologies in Denmark, attention to hazards and health,
environmental and ethical considerations should be given, but except for this general
indication, no specific work programmes or projects on this matter could be found

Finland: FinNano 2005-2010

Finland’s first investments in nanotechnology date back to the
period of 1997–1999. Finland decided to increase public investment in nanoscience and
nanotechnology in 2004 by starting the National Nanoscience and Nanotechnology
Programme, FinNano. The total volume of the programme is approximately €70 million,
and the duration is five years (2005 – 2009). FinNano is carried out in close collaboration
with Academy of Finland's Nanoscience Research Programme53. The aim of the
programmes is to strengthen research, support national and international networking,
promote the effective use of infrastructures and encourage enterprises to see the potential
of nanotechnology in the focus areas of Innovative nanostructure materials, Nanosensors
and nanoactuators, New nanoelectronics solutions
The FinNano programme does neither mention environmental,
health or safety effects nor ethical, legal and social implications of nanotechnologies.
However, Tekes (the Finnish Funding Agency for Technology and Innovation) and
FinNano programme have identified the need to clarify and coordinate the field of

52
Technology Foresight on Danish Nanoscience and Nanotechnology, Norway, (2004) -
http://fi.dk/site/english/publications/2004/technology-foresight-danish-nanoscience-
andnanotechnology/technology-foresight-danish-nanoscience-nanotechnology.pdf

53
Framing Nano, supra 31
nanosafety research in Finland. Therefore, a survey54 has been dedicated to clarify the
relevant research, authoritative and business actors and their roles in the field of
nanosafety in Finland. The nanosafety study included a web-based survey that was
directed to nanotechnology researchers. According to the survey, nanosafety research is
oriented towards basic research and covers, for example, product life cycles only
partially. From the HSE point of view, especially the environmental effects have not been
included in the ongoing research activities. The existing risk management methods and
tools, legislation and the public risk management procedures were considered inadequate
for managing nanotechnology related risks. Furthermore, the report concluded that public
discussion on nanosafety has been scarce in Finland55.

Germany: Nano-Initiative - Actions plan 2010

After a strategic reorientation in 2002 the Federal Government
has published the extended Nano-Initiative Actions plan 201056, bundling research in
nanotechnology and its dissemination. The action plan is intended to provide a single
framework for action that goes beyond individual government departments, and which
brings together goals and plans for nanotechnology. The seven Federal Ministries for
Labour and Social Affairs (BMAS), Environment, Nature Conservation and Nuclear
Safety (BMU), Food, Agriculture and Consumer Protection (BMELV), Defense (BMVg),
Health (BMG) and Commerce and Technology (BMWi) together with the BMBF57 have
laid the foundations to58 speed up the transfer of nanotechnology research results into
innovations and to introduce further industrial sectors to nanotechnology59. To achieve
this, nanotechnology must be brought from the laboratories into the firms; remove
innovation obstacles and improve conditions through early coordination of different
54
Nanosafety in Finland – a summary report, Gaia consulting, (10 March 2008) -
http://www.tekes.fi/julkaisut/nanosafety.pdf
55
Framing Nano, supra 31
56
Nano-Initiative Aktionsplan 2010, BMBF - Germany, (November 2006) -
http://www.bmbf.de/pub/nano_initiative_aktionsplan_2010.pdf
57
Nanotechnologie in Deutschland – Strategische Neuausrichtung; BMBF 2002;
http://www.bmbf.de/pub/nanotechnologie_in_deutschland-strategische_neuausrichtung.pdf
58
. Framing Nano, supra 31
59
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fields of politics. To this end, the coordination of the departments is improved; young
talents as well as standardisation activities are supported; lead an intensive dialogue with
the public on the opportunities of nanotechnology including its risks. To this end, possible
effects on health and the environment will be analysed, a common strategy on
environmental risks of insoluble nanoparticles developed, and modern means of
information and participation of the public applied60.
To exploit market potentials and employment growth through
nanotechnologies, four leading innovation areas have been funded: NanoMobil for the
automobile industry, NanoLux for the optical industry, NanoFab for electronics and Nano
for Life for life sciences. Further lead innovation areas include production technology,
textile industry, construction industry, medicine, measurement technology, plant
engineering and construction, micro/nano integration, environment and energy61.

Dutch Nano Action Plan

In 2006 the Dutch government has launched a ‘Cabinet’s View
Nanotechnologies: From small to great’. This document describes both opportunities and
risks of nanotechnologies and resulted in a Dutch Action Plan Nanotechnology62
concentrating on ethics, risk research, and innovation and development. For elaboration
and implementation of the action points, an interdepartmental working group has been
formed.
The Dutch Action Plan focuses on various types of actions. In
relation to risks the most significant actions are63: First, proposal of a new strategic
research agenda in summer 2008 from the research community. The research budget
should include annual investment of at least 15% for risk research during at least 5 years.
Second, a Knowledge and Information point Risk of Nanotechnology (KIR nano). RIVM
is, as described in the Cabinet’s View, already hosting such a point since 2007. They have

60
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61
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62
Dutch Nano Action Plan, Dutch Ministry of Economic Affairs, The Netherlands, (July 2008) –
http://www.ez.nl/Actueel/Kamerbrieven/Kamerbrieven_2008/Juli_2008/Actieplan_Nanote
chnologie - http://appz.ez.nl/publicaties/pdfs/08OI36.pdf
63
Framing Nano, supra 31
published a first assessment in autumn 2008: Nanotechnology in perspective. Third,
Participation in OECD sponsorship programmes Fourth, A dialogue with relevant parties,
initiated by the Dutch Department of Housing, Spatial Planning and the Environment.
Finally, a broad societal committee will be formed advising the government on ethical
aspects, societal dialogue and communication64.
In terms of the current legal position on the technology, the Dutch
government has concluded that at present no new legislation is needed to govern
nanotechnology65.

Norway: National Strategy for Nanoscience and Nanotechnology

The Research Council of Norway has since 2002 has a research
program called “Nanotechnology and new materials, nanoscience and integration”
(NANOMAT)66. In the period 2007-2016 NANOMAT will focus on: Firs, Thematic areas
(order of priority): Energy and the environment, ICT including Microsystems, health and
biotechnology, ocean and food. Second, expertise areas: Bio-nanoscience and
bionanotechnology; Ethical, legal and social aspects; Fundamental physical and chemical
processes at the nanometre level; Interface and surface science and catalysis;
Components, systems and complex processes that exploit nanoST; New, functional and
nano-structured materials. Finally, Infrastructure and coordination of tool platforms with
advanced scientific equipment67
The work programme belonging to NANOMAT is based on the foresight
study “Advanced Materials Norway 2020”, “The National Strategy for Nanoscience and
Nanotechnology (nanoST, adopted 2006)” and “Nanotechnologies and New Materials:
health, environment, ethics and society –national research and expertise requirements68”.
The Spanish National Plan for R&D and Innovation 2008-2011

64
Id
65
Id
66
Nanotechnology and New Materials (NANOMAT), Research Council of Norway,(September2007)
http://www.forskningsradet.no/servlet/Satellite?cid=1088796688084&pagename=nanomat%
2FPage%2FHovedSideEng
67
Framing Nano, supra 31
68
Id
 In September 2007 the Ministers Council approved The
Spanish National Plan for Scientific Research, Development and Technological
Innovation 2008-2011 (R&D&I)69 with a very significant increase of the budget. The Plan
has underlined five strategic objectives, with nanoscience / nanotechnology being one of
them. Although topics related to nanotechnologies’ potential impact on human health and
the environment are among their lines (e.g. nano-ecotoxicity), the focus of the
programme clearly lies in fostering research, industrial development and
commercialisation of nanotechnologies rather than supporting research on EHS and
ethical, legal and societal issues70.

Swiss Action Plan on Manufactured Nanomaterials

In spring 2006, the Federal Office for the Environment (FOEN) and the
Swiss Federal Office of Public Health (SFOPH) started a project to develop an Action
Plan called "Risk Assessment and Risk Management for Manufactured Nanomaterials
2006-2009" in order to show what endeavors are required in Switzerland to fill the
knowledge gaps71. It is based on a comparable EU Action Plan from June 2005. The plan
lays out guidance for responsible long term development of nanotechnology and sets out
a differentiated public dialogue on its risks and benefits.
This includes providing a summary of the uses of nanoparticles in
Switzerland and developing exposure scenarios; conducting a dialogue with the relevant
stakeholders (scientists, trade associations, offices, insurers, politicians, investors, general
public); devising scientific principles for danger and risk assessment; drawing up
harmonized definitions, measurement methods and validated test guidelines for the
danger and risk assessment in cooperation with the OECD, EU, ISO; motivating the
research and business communities to develop and apply self regulation measures;

69
The Spanish National Plan for Scientific Reserach, Development and Technological
Innovation,Comision Interministerial de Ciencia y Tecnologia, -
http://www.plannacionalidi.es/documentos/Plan_ingles_web.pdf
70
Framing Nano, supra 31
71
Synthetische Nanomaterialien, Bundesamt für Umwelt (BAFU), Bundesamt für Gesundheit
(BAG), Switzerland, (2007) -
http://www.bafu.admin.ch/publikationen/index.html?action=show_publ&lang=de&id_them
a=30&series=UW&nr_publ=0721
adapting existing legislation if this is needed to guarantee the safety; introducing
immediate measures to protect employees in industry and research72.
In addition, the action plan submits a concept whereby despite existing
scientific gaps, the risks of synthetic nano-materials can be recognized and controlled in
the context of the existing legislation. Besides the Action Plan, in November 2007 the
Parliament made the decision to launch a national research program (NFP) with an aim to
extend knowledge in the area of risks and benefits of nanotechnologies. These projects
will complement the actions taken resulting from the Action Plan73

Nanotechnology Action Plan for Russia - 2015

Russia has announced a “Nanotechnology Action Plan for Russia– 2015”
at the OECD Tour de Table Meeting in Paris (November 2007) which would contain a
special subprogram covering nanosafety and potential impacts of nanomaterials on health
and environment74.

UK -Ministerial Group on Nanotechnologies

In 2007, in response to a recommendation made by the Council for
Science and Technology in their review of government progress on policy commitments,
a Ministerial Group on Nanotechnologies was established. Since its creation, the
Ministerial Group has engaged with stakeholders and coordinated progress by
Government Departments on policy, regulation, and research. In February 2008, this
Ministerial group issued a Statement by the UK Government about Nanotechnologies.
This document outlined a vision for nanotechnologies, as follows75: The vision of the UK
Government for nanotechnologies is for the UK to derive maximum economic,
environmental and societal benefit from the development and commercialisation of

72
Framing Nano, supra 31
73
Swiss Action Plan "Synthetic Nanomaterials", FOPH, Switzerland, (April 2008),
http://www.bafu.admin.ch/publikationen/index.html?action=show_publ&lang=en&id_them
a=30&series=DIV&nr_publ=4002
74
Framing Nano, supra 31
75
Jennifer Pelley and Marc Saner, International Approaches to the Regulatory Governance of
Nanotechnology, Regulation Papers, April 2009 ,available on
www.regulatorygovernance.ca
nanotechnologies, and to be in the forefront of international activity to ensure there is
appropriate control of potential risks to health, safety and the environment.
In January 2009, this Ministerial group reiterated their
commitment to the responsible development of nanotechnology in the UK and outlined
seven deliverables76. These seven specific commitments, which are as follows, will be
carried out by the Departments represented on the group. First, respond to the
recommendations outlined in the November 2008 report by the Royal Commission on
Environmental Pollution. Second, develop a better understanding of UK industry sectors
(their objectives and needs) that are likely to make use of nanotechnologies and
nanomaterials. Third, Work with industry to develop a workable reporting scheme for
nanomaterials. Fourth, involve the spectrum of interested parties (academia, industry,
NGOs, and the general public) in the development of a strategy. Fifth, Improve the
targeting and prioritization of UK research devoted to understanding and managing the
health risks associated with nanotechnologies. Sixth, Ensure that appropriate action is
taken whenever there is evidence that products containing nanoparticles may pose a risk
to workers, consumers or the environment. Finally, Work with industry to develop a
workable way of providing information about products that are being developed and
brought to market77.

The UK government has also established two groups, with the responsibility for
coordinating policy and research activities, respectively, across Government departments,
agencies, and research councils. These groups are the Nanotechnology Issues Dialogue
Group and the Nanotechnology Research Coordination Group. These two bodies report
directly to the Ministerial Group on Nanotechnologies78

USA- National Nanotechnology Initiative (NNI)

76
http://nds.coi.gov.uk/environment/fullDetail.asp?ReleaseID=391430&NewsAreaID=2&NavigatedFromD
epartment=False
77
Jennifer Pelley and Marc Saner, supra 60
78
Id
 The National Nanotechnology Initiative is a strategic program established
in Fiscal Year (FY) 2001 to coordinate Federal nanotechnology R&D. The NNI provides
a vision of the long-term opportunities and benefits of nanotechnology. By serving as a
central locus for communication, cooperation, and collaboration for all Federal agencies
that wish to participate, the NNI brings together the expertise needed to guide and
support the advancement of this broad and complex field79. Including the NNI budget
requests for FY 2009 of $1.5 billion, the total NNI investment since its inception in 2001
is nearly $10 billion. Given the dynamic nature of the field, the NNI Strategic Plan is
periodically reexamined. The 21st Century Nanotechnology Research and Development
Act80 of 2003 calls for the NNI Strategic Plan to be updated every third year; the most
recent plan of December 2007 updates and replaces the December 2004 plan. The 2007
NNI Strategic Plan81 describes the vision, goals, and priorities of the NNI.
Goal 1: Advance a world-class nanotechnology research and development program
Goal 2: Foster the transfer of new technologies into products for commercial and public
benefit
Goal 3: Develop and sustain educational resources, a skilled workforce, and the
supporting infrastructure and tools to advance nanotechnology
Goal 4: Support responsible development of nanotechnology
Besides the more R&D oriented objectives, goal 4 aims to maximize
the benefits of nanotechnology and at the same time to develop an understanding of
potential risks and to develop means to manage them. The NNI pursues a program of
research, education and communication focused on environmental, health, safety and
broader societal dimensions of nanotechnology development. As in the earlier strategic
plan, this NNI Strategic Plan identifies major subject areas, or program component areas
(PCAs), in which investments are needed to, ensure success of the initiative. The two

79
http://www.nano.gov/NNI_Strategic_Plan_2007.pdf

80
The full text of this Act can be found online at:
http://frwebgate.access.gpo.gov/cgi-bin/getdoc.cgi?dbname=108_cong_public_laws&docid=f:publ153.108
81
The National Nanotechnology Initiative strategic plan: December 2007, US National
Nanotechnology Initiative, (December 2007)-
http://www.nano.gov/NNI_Strategic_Plan_2007.pdf
PCAs related to societal effects are titled “Environment, Health and Safety” and
“Education and Societal Dimensions82”. In the latter, education-related activities such as
development of materials for schools, undergraduate programs, technical training, and
public communication, including outreach and engagement are provided. Research
directed at identifying and quantifying the broad implications of nanotechnology for
society, including social, economic, workforce, educational, ethical, and legal
implications. In the April 2008 assessment of the NNI by the President’s Council of
Advisors to Science and Technology83, the panel concluded that at present,
nanotechnology does not raise ethical concerns that are unique to the field. Rather,
concerns over implications for privacy and for equality of access to benefits are similar to
concerns over technological advances in general.
In February 2009, the US House of Representatives passed the
National Nanotechnology Initiative Amendments Act of 2009. This bill will reauthorize
the National Nanotechnology Initiative, and additionally contains important measures
that will result in increased funding for and emphasis on the potential environmental,
health, and safety risks of nanotechnology.

Australia: National Nanotechnology Strategy (NNS)

The National Nanotechnology Strategy (NNS) aims to establish the
environment that allows Australia to capture benefits of nanotechnology while addressing
the issues impacting on successful and responsible development of nanotechnology84. It
complements other Australian Government initiatives (for example, CSIRO Niche
Manufacturing Flagship) and existing research, innovation and industry policies that
promote the development of enabling technologies and facilitate greater coordination of
policies affecting nanotechnology. The NNS includes specific initiatives to: address the
health safety and environmental (HSE) impacts of nanotechnology on regulations and
standards; establish a nano particle metrology capability at the National Measurement

82
Framing Nano, supra 31
83
The National Nanotechnology Initiative : Second assessment and recomendations of the
National Nanotechnology Advisory Panel (PCAST), (April 2008) -
http://www.nano.gov/PCAST_NNAP_NNI_Assessment_2008.pdf
84
National Nanotechnology Strategy,NNS Australia, (21 February 2008) -
http://www.innovation.gov.au/Section/Innovation/Documents/NNSFeb08.pdf
Institute; facilitate a whole of government approach to nanotechnology through
establishing the Australian Office of Nanotechnology.
A key activity in the Strategy includes analysis of the impact of
nanotechnology on regulatory frameworks. An independent report completed in
September 2007 entitled “A Review of the Possible Impacts of Nanotechnology on
Australia’s Regulatory Framework” is currently being considered by government
agencies. The program is aimed to raise awareness and develop knowledge of the
opportunities and potential of nanotechnology, and to encourage an informed debate
based on balanced and factual information, therefore it intends85: increase awareness and
understanding among the general public about nanotechnology and its potentials; enable
an informed public debate through improved awareness and understanding of social and
ethical issues regarding the use of nanotechnology; understand the publics' knowledge,
concerns and aspirations for nanotechnology, provide the Australian public with timely
updates on the Government's response to emerging nanotechnology issues; create public
awareness and understanding of Australian regulatory bodies and practices concerning
nanotechnology and related health and safety issues86.
The Public Awareness and Engagement Program will arrange public
forums, promotional materials, conference events and mobile exhibitions with targeted
publicity in metropolitan, regional and rural media to support these initiatives. The
current NNS will cease in June 200987.

China
In China, although being one of the foremost countries in terms of
publications regarding nanotechnologies, no specific action plan exists with the aim to
frame the development of nanotechnologies in terms of ethical, legal and societal aspects,
and public investment into nanosafety research is very low88. In 2004 a meeting on EHS

85
Framing Nano, supra 31

86
Patrick M. Boucher, Nanotechnology: Legal Aspects, CRC Press, 2008
87
Id
88
Zhao, Feng ; Yuliang Zhao ; Chen Wan, Activities related to health, environmental, and
societal aspects of nanotechnology in China,Journal of Cleaner Production, (01 May 2008),
issues was organised by the Chinese Governments, with the participation of the Ministry
of Science and Technology (MOST), the National Natural Science Foundation of China
(NSFC), the Ministry of Education (MOE) and CAS (Chinese Academy of Sciences), and
certain framing activities in the field of health and safety have been dedicated to a
research institution for “Bio-Environmental Health Sciences of Nanoscale Materials” at
the CAS89. In 2006, the National Center for Nanoscience and Technology (NCNST)
decided to establish a nanosafety lab focusing on the economic, environmental and
societal aspects of nanotechnologies90. Although its mission clearly lies in the research of
the properties and health and safety effects of nanomaterials, the drafting of standards and
regulatory frameworks for research and industrial activities is also one point of activity.

Japan
Nanotechnology research is promoted in Japan through the Science
and Technology Basic Plan, which is currently active in the third version starting in April
2006 for five years. New in this revision, the topic of “public confidence and
engagement”, this, among others, emphasizes responsible actions in terms of ethical,
legal and societal issues, reinforcements of accountability and public relations of science
and technology activities91. The strategy also includes R&D on the social acceptance of
nanotechnology. Besides various programmes to promote research on health impacts of
nanomaterials, in 2004, a first multi-stakeholder dialogue on the health, environmental
and societal aspects of nanotechnology called “Nanotechnology and Society” has been
organised in Japan92. This led to subsequent governmental projects in 2005 and 2006
which resulted in policy recommendations for public research institutes, the private sector
and the government. Besides these activities, a series of international meetings and
workshops on the topic of health, environmental and societal issues of nanotechnology

89
http://www.edf.org/article.cfm?ContentID=5135
90
Framing Nano, supra 31
91
Id
92
Framing Nano, supra 31
were held in Japan and abroad93. Chemicals regulatory area on health and environmental
safety aspects of manufactured nanomaterials.

93
Takemura, Masahiro, Japan's engagement in health, environmental and societal aspects of
nanotechnology,Journal of Cleaner Production, (01 May 2008)