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Nanotechnology, Human Rights, Patent law and the Global South: a brief overview

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Abstract

Starting from a Global South perspective, this chapter presents a brief overview of the potential of nanotechnology to serve either as vehicle for broader attainability of human rights or to undermine current efforts. Particular attention is drawn to the complex interconnected issues of ensuring even access to the benefits of technological development and the need to maintain adequate levels of economic incentive to innovation. The present chapter begins with a short characterization of nanotechnology followed by the description of the current key fields of scientific research, state of the art and expectations for the future. The second part explores the social and economic relevance of nanotechnology and its implication for the Global South. In the third part, social, ethical and legal aspects of nanotechnology are framed in terms of human rights issues. The fourth part devotes closer attention to an analysis of the current patent rules intended to safe keep accessibility while confronted with the new challenges brought by nanotechnology inventions. Throughout this chapter, it will be sustained that nanotechnology poses normative challenges implying the need to re-evaluate the functioning of exclusions, exceptions and limitations to patent rights as mechanisms for safekeeping accessibility.
Draft version, may contain typos. Final text published in:
Nordberg A, ‘Nanotechnology, Human Rights, Patent Law and the Global South: A Brief Overview’, in
Mario Viola de Azevedo Cunha, Norberto Nuno Gomes de Andrade, Lucas Lixinski, Lúcio Tomé Féteira
(eds), New Technologies and Human Rights: Challenges to regulation (Ashgate, 2013), 313-333.
1
CHAPTER 15
Nanotechnology, Human Rights, Patent Law and the Global South: A Brief Overview
Ana Nordberg
Associate Senior Lecturer, Lund University, Sweden
Introduction
Starting from a Global South perspective, this chapter presents a brief overview of the potential
of nanotechnology to serve either as vehicle for broader attainability of human rights or to
undermine current efforts. Particular attention is drawn to the complex interconnected issues of
ensuring even access to the benefits of technological development and the need to maintain
adequate levels of economic incentive to innovation. The present chapter begins with a short
characterization of nanotechnology followed by the description of the current key fields of
scientific research, state of the art and expectations for the future. The second part explores the
social and economic relevance of nanotechnology and its implication for the Global South. In the
third part, social, ethical and legal aspects of nanotechnology are framed in terms of human rights
issues. The fourth part devotes closer attention to an analysis of the current patent rules intended
to safe keep accessibility while confronted with the new challenges brought by nanotechnology
inventions. Throughout this chapter, it will be sustained that nanotechnology poses normative
challenges implying the need to re-evaluate the functioning of exclusions, exceptions and
limitations to patent rights as mechanisms for safekeeping accessibility.
Nanotechnology
Nanotechnology is an umbrella denomination that designates technologies involving the
manipulation of matter at the nanoscale (bellow 100 nanometers). A nanometer (nm) is equivalent
to 10-9m or 0.000000001m, in order to offer a sense of proportion it is usual to point out that one
nanometer is about 1/80000 of the diameter of the average human hair or the equivalent to 10
hydrogen atoms.
The study and manipulation of matter at the nanoscale enables building structures and new
materials at atomic, molecular and macromolecular scale. Such activities are not a question of
mere scaling down since at nanoscale the properties of materials reveal differences due to two
main reasons: firstly, quantum effects can dominate the behaviour of matter at the nanoscale,
particularly in the lower ranges and thus affecting the magnetic, optical, and electrical behaviour
of materials; and secondly, nanomaterials have a relatively larger surface area when compared to
the same mass of matter in larger forms. These characteristics open the possibility to new uses of
known materials, and the creation of novel functional materials. Nanotechnology is an
interdisciplinary technological field where the distinction between disciplines such as physics,
chemistry and biology becomes less clear. Such characteristics have consequences to the overall
legal regulation of these technological advances.
At the present moment the exact meaning of the terms Nanoscience and Nanotechnology
is still contentious among the scientific community. Such ambiguity, translates into the
inexistence of a widely accepted legal definition of nanotechnology. In the absence of uniformity,
the present work uses as main reference the definition formulated by the European Patent Office
(EPO):
The term nanotechnology covers entities with a controlled geometrical size of
at least one functional component below 100 nanometers in one or more
dimensions susceptible of making physical, chemical or biological effects
Draft version, may contain typos. Final text published in:
Nordberg A, ‘Nanotechnology, Human Rights, Patent Law and the Global South: A Brief Overview’, in
Mario Viola de Azevedo Cunha, Norberto Nuno Gomes de Andrade, Lucas Lixinski, Lúcio Tomé Féteira
(eds), New Technologies and Human Rights: Challenges to regulation (Ashgate, 2013), 313-333.
2
available which are intrinsic to that size. It covers equipment and methods for
controlled analysis, manipulation, processing, fabrication or measurement with
a precision below 100 nanometres.
1
This choice is justified not only by the topic of this chapter the interface between human rights
and patent law but also by the fact that the above definition was the basis for the current
formulation of subclass B82Y of the International Patent Classification (IPC),
2
thus embedding
it with an aura of international consensus.
Key Fields of Scientific Research, State of the Art and Expectations for the Future
Nanoscience is considered a horizontal or enabling scientific field, since its advances typically
can be applied to and developed in a wide range of scientific disciplines. Correspondently,
nanotechnology is considered a converging technology that combines expertise from different
scientific disciplines and applies in conjunction technologies originally developed in different
industrial and technological sectors. Technological advances afforded by nanotechnology will
typically have horizontal, cross-industry applications, and lead to overall progress in a wide range
of technological areas and in certain cases possibly even determine the emergence of new
industries.
Currently, the most promising fields of research concern medical and pharmaceutical
applications, information technologies, energy production and storage, novel materials, food,
water and environment, and security and law enforcement. To name a few examples: information
technologies and telecommunications already use nanotechnology to obtain faster, smaller and
more energy efficient devices; the use of nanotechnology in the medical sector is producing
remarkable results particularly in improved drug delivery systems, medical diagnostic and
therapeutic tools; finally, solar cells technology is expected to significantly benefit from
nanotechnology leading to the wide scale use of solar energy as a major power source.
Several nanotechnology based consumer products are currently available on the market
such as cosmetic products, textiles, metals, electronic devises and construction materials.
3
These
are mainly improvements of existing products (evolutionary nanotechnology). However, in the
future developments of major importance are expected, meaning new or radically improved
products, steaming from technological advances that from current time perspective will consist
of a leap forward in our technological development (revolutionary nanotechnology).
Social and Economic Relevance: Everyone Aboard the Nanotech-Train
With the EUA, EU and Japan currently occupying the leading carriages, followed by Korea, China
and Russia, not only is every nation claiming a place aboard the ‘nanotech-train’, every country
is making considerable effort to secure the best possible seat. These technologies are expected to
1
Definition of patent class Y01N (out of use since May 2011). EPO archive <http://forums.epo.org/espacenet-
archive/topic405.html > accessed 15 December 2011.
2
The IPC is a hierarchical classification system used to classify and search patent documents according to technical
fields. The IPC legal base is The Strasbourg Agreement, which entered into force in 1975. On June 2011, the Strasbourg
Union had 61 Member States. However, according to the WIPO, it is currently used in more than 100 countries, making
it the ‘the lingua franca’ of patent classification (<www.wipo.org> accessed 1 December 2011).
3
Currently there is lack of reliable data regarding the number of products on the market incorporating nanotechnology.
An on-line nanotechnology consumer products inventory counts 1317 nanotechnology consumer product or product
lines on the market by March 2011. The inventory is based on internet available information release by the
manufactures. Product lines using the same nanotechnology are only counted once and the inventory does not account
for industrial products or research tools. The authors acknowledge the possibility for a considerable margin of error;
see the Project on Emerging Nanotechnologies
<http://www.nanotechproject.org/inventories/consumer/analysis_draft/> accessed 1 December 2011. Another
inventory ‘provides an overview of how nanomaterials and nanostructuring applications are used today in industrial
and commercial applications across industries’ listing 196 industrial products or applications. The authors ‘note, that
this database is a work in progress’ <http://www.nanowerk.com/products/products.php> accessed 1 December 2011.
Draft version, may contain typos. Final text published in:
Nordberg A, ‘Nanotechnology, Human Rights, Patent Law and the Global South: A Brief Overview’, in
Mario Viola de Azevedo Cunha, Norberto Nuno Gomes de Andrade, Lucas Lixinski, Lúcio Tomé Féteira
(eds), New Technologies and Human Rights: Challenges to regulation (Ashgate, 2013), 313-333.
3
grant competitive advantage to the economies that first master them. Worldwide official
documents and political rhetoric indicate a widespread perception that the nanotechnology
industrial wave can bring changes to the world development and economic power status quo.
Nanotechnologies have been described in a European Commission staff working paper
4
as a
promising candidate to become the next and sixth Kondratieff wave.
5
The European Commission
officially expressed concerns over the possibility of industry across the EU losing competitiveness
should it fail to either lead, or follow closely, other economies in the development of
nanotechnology.
6
Nanotechnology has been ranked a priority in economical and industrial
development policies both at national and supranational level. In recent years governments have
elaborated Nanotechnology action plans and policies. According to the literature, by 2005 62
countries had or were in the process of initiating and implementing national nanotechnology
initiatives (18 of them transitional and 19 developing);
7
16 countries had at least groups or
individual researchers working in nanotechnology (three transitional and 12 developing,
including one least developed country) and 14 additional others had shown official interest in
promoting research in this area (one transitional and 13 developing, including three least
developed countries).
8
Since nanotechnology entered the political agenda in the first years of the 21st century,
specific and direct public and private funding of research and development projects has grown
from marginal or non-existent to priority area of investment in research. A private consulting
survey reports that by 2010 the annual public investment on nanotechnology research and
development worldwide had reached 10 billion US dollars, and predicts a 20 percent increase of
investment until 2013. Between 2000 and 2011 governments worldwide have invested more than
67.5 billion US dollars in nanotechnology funding. If corporate research and various other forms
of private funding are taken into account, it is estimated that by 2015 nearly a quarter of a trillion
US dollars will have been invested in nanotechnology.
9
However, despite the enthusiasm and optimism created around the promises of a
revolutionary technological wave these are still yet to become reality. Simultaneously, the
scientific community has been recommending caution pointing out that the unrestrained
development of nanotechnology may pose high risks for human health, environment and earth
eco-systems, further adding that those risks are currently to a large extent unknown and
unpredictable. Currently, safety issues are a main concern and as far as the EU is concerned
regulatory authorities have stressed the importance of maintaining and applying a precautionary
4
Angela Hullmann, The economic development of nanotechnology An indicators based analysis (European
Commission, DG Research, Unit Nano S&T Convergent Science and Technologies 2006)
5
Kondratieff proposed a theory of long waves, or cycles, of economic boom and bust published in the 1920s, reputably
these cycles were first named Kondratieff waves by Joseph Schumpeter in Business Cycles (1939). Joseph Schumpeter
Business Cycles: A theoretical, historical and statistical analysis of the Capitalist process (first published 1939,
Porcupine Press 1989).
6
Communication from the Commission to the Council, The European Parliament and The Economic and Social
Committee, ‘Nanosciences and nanotechnologies: An action plan for Europe 2005–2009’, Brussels, 7.6.2005 (COM
(2005) 243 final).
7
Donald Maclurcan, ‘Nanotechnology and Developing Countries. Part 1: What Possibilities?’ (2005) 1, AZoNano:
Online Journal of Nanotechnology, <http://www.azonano.com/azompdf.asp?ArticleID=1428&heading=
Nanotechnology>; and ‘Part 2: What Realities?’ (2005) 2, AZoNano: Online Journal of Nanotechnology,
<http://www.azonano.com/azompdf.asp?Article ID=1429&heading=Nanotechnology>, accessed 15 December 2011.
8
Noela Invernizzi, Guillermo Foladori and Donald Maclurcan, ‘Nanotechnology’s Controversial Role for the South’
(2008) 13: 1 South, Science, Technology and Society 123, 124.
9
Tim Harper, ‘Global Funding of Nanotechnologies and its impact’ (2011) Cientifica <http://cientifica.com/wp-
content/uploads/downloads/2011/07/Global-Nanotechnology-Funding-Report-2011.pdf> accessed 15 December
2011. According to the author the report was based on official national documents and confirmed by the World
Economic Forum’s annual Global Competitiveness Report 2011. See Klaus Schwab (ed.), The Global Competitiveness
Report 20112012 (World Economic Forum 2011).
Draft version, may contain typos. Final text published in:
Nordberg A, ‘Nanotechnology, Human Rights, Patent Law and the Global South: A Brief Overview’, in
Mario Viola de Azevedo Cunha, Norberto Nuno Gomes de Andrade, Lucas Lixinski, Lúcio Tomé Féteira
(eds), New Technologies and Human Rights: Challenges to regulation (Ashgate, 2013), 313-333.
4
principle regarding nanotechnology safety issues
10
while promoting complementary research
concerning ethical, legal, social and governance aspects.
Developing World and Nanotechnology: The Global South Not Only is Joining the Train but
Claiming a Seat at the Leading Carriages
The characterization of nanotechnology as being the next industrial wave was not ignored by the
Global South. It is likely that developing countries
11
have interpreted such characterization in
official documents and public investment policies of the most developed nations as a signal to
follow suit, allocating resources to take advantage of what appears to be a unique opportunity to
recover in merely a few years from centuries of delay on the development race.
Commentators have mentioned that such hope may be misguided by the assumption that
technological innovation by itself can lead to social and economic development, and may not take
into account predicaments such as the dependency theory,
12
according to which ‘one country’s
industrial revolution is another country’s underdevelopment and these are two sides of the same
coin of world capitalist development’.
13
Schummer points out that under the predicament of such
theory even assuming that nanotechnology will be in fact the next industrial revolution wave it
would, as any the previous ones, necessarily reinforce the existing development gap rather than
diminish it.
14
Along this pessimistic view, it also has been observed that cutting edge technologies
are expensive and inappropriate for the existing realities of the developing world and for this
reason they are often viewed with scepticism by developing circles.
15
Others consider that
promoting investment in nanotechnology in countries such as Brazil and India brings forth the
danger to divert financial resources and political focus from the basic needs of the large poor
population in these countries.
16
Another voiced concern is the possibility that the high level of
investment needed to acquire new procedures and skill are likely to exacerbate the existing
divisions between rich and poor.
17
Sceptic views of development through emerging technologies present valid points: it may
be ill advised to place too high hopes on new technologies. To anchor policies on the expectation
that technological development by itself will be a quick fix to all human development issues is at
best a leap of faith. Also, mimicking industrial policies from the North may deter governments
from taking more appropriate, attainable and immediate options to manage each country specific
developing needs. However, such pessimism is susceptible to simple counter argumentation.
Assuming that such predictions are correct and dependency is inevitable, it can be equally validly
10
See: European Commission Staff Working Document, Summary of legislation in relation to health, safety and
environment aspects of nanomaterials, regulatory research needs and related measures, Brussels, 17.6.2008 (SEC
(2008) 2036).
11
Terms such as ‘developing world’ and ‘developing countries’ are contentious, for this reason in this chapter such
terms will be used for countries or regions with low or medium state of development according to the human
development index (HDI) put forward by the United Nations Development Programme. The HDI is a composite index
that combines per capita GDP with life expectancy and educational standards, and is currently the most consensual.
12
Joachim Schummer, ‘The Impact of Nanotechnologies on Developing Countries’ in Fritz Allhoff and others (eds),
Nanoethics: The Ethical and Social Implications of Nanotechnology (Hoboken 2007) 294 ff.
13
P. Hudson, The Industrial Revolution (Arnold 1992) 20, quoted by Schummer n 12, 295.
14
Schummer n 12, 295.
15
Mark Malloch Brown, ‘Foreword’ in United Nations Development Programme (ed.), Human Development Report:
Making new technologies work for human development (Oxford University Press 2001) iii.
16
Katie Mantel ‘Developing nations “must wise up to nanotechnology”’, Science and Development Network (Interview
with Andrew Scott and others, London, 4 September 2003) <http://www.scidev.net/en/news/developing-nations-must-
wise-up-to-nanotechnology.html> accessed 15 December 2011; and Andrew Scott, ‘Nanotechnology and Nanoscience’
(response from stakeholders n. 77, The Royal Society and Royal Academy of Engineering 2003)
<http://www.nanotec.org.uk/evidence/77a AndrewScott.htm> accessed 15 December 2011.
17
The Royal Society and Royal Academy of Engineering, Nanoscience and Nanotechnologies: Opportunities and
Uncertainties (London 2004) ch 6.
Draft version, may contain typos. Final text published in:
Nordberg A, ‘Nanotechnology, Human Rights, Patent Law and the Global South: A Brief Overview’, in
Mario Viola de Azevedo Cunha, Norberto Nuno Gomes de Andrade, Lucas Lixinski, Lúcio Tomé Féteira
(eds), New Technologies and Human Rights: Challenges to regulation (Ashgate, 2013), 313-333.
5
argued that if developing countries refrain from investing in science and technology the
development gap will deepen to an even greater extent. The industrial capability developing
countries have succeed in acquiring so far will become obsolete if such industries fail to
modernise and keep pace with technological development. Furthermore, changes in technology
and production will dictate changes in the needs for natural resources. There is a high probability
that nanotechnology technological advances will provide alternatives to the use of certain basic
commodities, and thus either make redundant or severely reduce the demand for natural resources
that are currently an important source of income for some countries in the Global South.
Like other emerging technologies, nanotechnology can be both relevant to address specific
challenges faced by developing countries and be part of sustainable development policies and
practice in developing countries, in particular for those who already have a relevant scientific and
industrial capability. Data collected by the World Economic Forum, seems to reinforce an
optimistic view of development through investment in emerging technologies, showing that while
competitiveness in advanced economies has stagnated over the past seven years, it has improved
in many emerging markets that invested in such technologies.
18
To a certain extent national authorities in the Global South appear to subscribe to this view.
A summary analysis of official documents and political discourse shows that the Global South is
investing in building nanotechnology research capability, not merely to keep pace with the North
but with tailor-made objectives adapted to specific needs and challenges, such as: First, seeking
more efficient and less expensive solutions to specific major socio-economic problems, including
economic dependence on the international market value of natural resources, sanitation, clean
water supply and combat of epidemic diseases; Second, modernize the existing industries,
increasing short term competiveness and preventing long term redundancy; and finally, find new
markets and market niches, not heavily patented and still relatively unexplored, that can serve as
future exporting goods and thus improve the commercial balance.
In the impossibility of a more detailed analysis, three countries in different continents with
diverse historical backgrounds and distinct internal political approaches are worth a brief mention
as interesting examples. China, Brazil and Russia are part of the six largest non-OECD economies
known collectively as BRIICS’s
19
and, despite profound historical differences, share some
common characteristics such as: abundance of natural resources, wide territorial base, large and
relatively young population and a respectable scientific community.
20
Generally, these countries
have seen the potential of nanotechnology and thus have channelled public funds to research in
this area, while making efforts in improving the ability to translate scientific successes into
commercial products.
In 2011 China became the country with the highest investment in nanotechnology research
in terms of Purchasing Power Parity (18 billion US dollars or approx. 14.4 billion euro),
surpassing even the USA. Although, in terms of actual investment adjusted for currency exchange
18
Schwab n 9.
19
Brazil, Russia, India, Indonesia, China and South Africa.
20
According to OECD data these countries show high old age support ratio (number of people of working age per
person of pension age) that ranges between double and six times the average of OCDE countries (currently 2.1). Despite
some of their infra-structural weaknesses and considerable internal inequities, these countries also have respectable
high education institutions in scientific fields and produce (home or abroad) a considerable number of relevant scientific
publications. Regarding the level of tertiary attainment the proportion of the population with a qualification at bachelor’s
degree level or above only Russia with a 54.2 percent rate of tertiary attainment in population aged 2564 is at the same
level as most OCDE countries. However, in absolute terms due to their large population all these countries possess a large
amount of scientists and qualified workers. See Organization for Economic Co-operation and Development Countries
statistic profiles (2011 OECD).
Draft version, may contain typos. Final text published in:
Nordberg A, ‘Nanotechnology, Human Rights, Patent Law and the Global South: A Brief Overview’, in
Mario Viola de Azevedo Cunha, Norberto Nuno Gomes de Andrade, Lucas Lixinski, Lúcio Tomé Féteira
(eds), New Technologies and Human Rights: Challenges to regulation (Ashgate, 2013), 313-333.
6
rates, in 2011 China has spent only 1.3 billion US dollars (approx. 800 million euro), while the
US has spent 2.18 billion US dollars (approx. 1.6 billion euro) during the same period.
21
Russia has also become one of the major public investors in nanoscience and
nanotechnology research with the establishment in 2007 of the Russian Corporation of
Nanotechnologies (RUSNANO) along with a scheduled governmental investment of 130 billion
roubles. The organization has an explicit focus on the commercialization of nanotechnology, and
essentially functions as a venture capital fund, investing in selected projects in exchange for equity
stakes (lower than 50 percent). The finance support is long term (over 10 years), and at the end
of such period equity stakes will be sold following the logic of retrieving investment costs and
not with the commercial approach of maximizing profit. From 2007 to 2009, RUSNANO had
approved 61 projects, committing to invest 92.4 billion roubles (approx. 2.4 billion euro), and in
the coming years RUSNANO predicts as outcome of the program that the volume of
nanotechnology production will reach 900 billion roubles (approx. 19.8 billion euro) per year by
2015, which signifies a significant increase from the 4-5 billion roubles (approx. 88 million euro)
registered in 2009.
22
Brazilian authorities have elected nanotechnology as a priority area in industrial
development. A federal program for development of nanoscience and nanotechnology was
created in 2003 with the general goal of creating and developing new products and processes in
nanotechnology, implementing them in order to increase the competiveness of the industry and
also building human capacity to benefit from the economic, technological and scientific
opportunities offered by nanotechnology.
23
According to official data, the Brazilian government
has directly invested 160 million reais (approx. 65 million euro) during 20002007 in
nanotechnology research. Adding to the investments from the private sector, it is estimated that
the total investment amounts to 320 million reais (approx. 130 million euro).
24
In 2005, Brazilian President Lula da Silva delivered a speech at the official opening of the
Brazilian National Program for the Development of Nanoscience and Nanotechnology, which in
a certain way summarizes the strategic vision of the Brazilian authorities concerning
nanotechnology. The Brazilian President expressed the view that investment in science,
technology and educations is the safest and best investment as it produces an almost immediate
return. Lula da Silva, also linked scientific and technological development to human progress,
irradiation of poverty and reduction of social inequities and declared that ‘science and technology
are instruments essential to economic development and constitute the basic priority of our
government’.
25
Investment in nanotechnology by the Global South started early to produce remarkable
results. In the period ranging between 1999 and 2004, China ranked 3rd, Russia 11th, India 13th
and Brazil 20th in the ranking of nanotechnology scientific publications indexed by the Science
Citation Index (SCI).
26
When the relative scientific quality of the publications is taken into
account as measured by a pre-defined number of citations threshold, these countries perform
21
Harper n 9, 4. The author uses the Short system of large-number names, in which the term billion refers to a thousand
millions (109).
22
ObservatoryNano Economic Report Public Funding of Nanotechnology (2010, Spinverse), ch 3.4
<http://www.observatorynano.eu/project/document/1838> Accessed 15 December 2011.
23
Ministério da Ciência e Tecnologia 2009 <http://www.mct.gov.br/index.php/ content/view/27137.html> accessed 3
December 2009.
24
Agência Brasileira de Desenvolvimento Industrial, Panorama nanotecnologia (2010 ABDI).
25
Luiz Inácio Lula da Silva, Discurso do presidente da República Luiz Inácio Lula da Silva, na cerimônia de
lançamento do Programa Nacional de Desenvolvimento da Nanociência e Nanotecnologia, Campinas, São Paulo, 19
de agosto de 2005 (translated from original) <http://www.mct.gov.br/index.php/content/view/14842.html> accessed 1
December 2011.
26
Angella Hullmann, ‘Who is winning the global nanorace?’ (2006) 1 Nature Nanotechnology, 81.
Draft version, may contain typos. Final text published in:
Nordberg A, ‘Nanotechnology, Human Rights, Patent Law and the Global South: A Brief Overview’, in
Mario Viola de Azevedo Cunha, Norberto Nuno Gomes de Andrade, Lucas Lixinski, Lúcio Tomé Féteira
(eds), New Technologies and Human Rights: Challenges to regulation (Ashgate, 2013), 313-333.
7
equally well, accounting for 12 percent of core papers and 22 percent of citing papers in
nanoscience and materials.
27
However, in terms of number of patents, indicators suggest that
patent activity has not accompanied scientific success given the strong concentration of patents
in the most developed countries.
28
In 2005 the European Union, Japan and the United States had
contributed to 84 percent of all nanotechnology patents, while the BRIICS accounted only for 2.6
percent.
29
Overall it can be observed that the investment in nanoscience and nanotechnology research
and development is not a prerogative of the most industrialized nations. Instead, these nations
face solid competition from emerging economies that see in cutting edge technologies an
opportunity to acquire a competitive advantage by claiming their stake in the field at an early
stage.
Every Rose has its Thorns: Nanotechnology and Human Rights
Nanotechnology promises to change the world and solve many of the most important global
challenges of our time. Emerging technologies of such magnitude, recipient of large amount of
public and private funding, are bound to generate heated regulatory debate. A debate that in itself
is crucial, not only for the future development of the technology but also for the fulfilment of the
predicted return of such investments: much is dependent on public and political understanding
and acceptance of technology. General mistrust can dictate consumer’s choices and future
political options, delaying for decades the availability of a technology in consumer products.
Most of the topics raised are neither novel, nor exclusive to nanotechnology, but rather
reflect timeless human interrogations and concerns in face of the uncertainty brought by
technological change. In general terms the issues under debate relate to concerns typical of human
rights, such as: unfair distribution of the economic benefits associated with technology; uneven
access to the benefits of technology; consumers, workers and environmental safety; negative
social and anthropological impact of the technology; privacy and informed consent. Each of these
topics, although intrinsically interconnected, can be analyzed using either a social, ethical or a
legal perspective. The latter is a commonly used classification that is believed to offer the benefit
of a clear analytic framework.
30
This chapter will attempt to conjugate this classification with a
human rights perspective by framing the issues that form part of the nanotechnology debate in
terms of potential either to strengthen or threaten human rights attainability.
For the purposes of this chapter, human rights are to be understood in its broader sense,
including not only a normative perspective based on a formalistic classification of rights, but also
an ontological perspective. In this broad sense, the concept of human rights encompasses those
rights codified as such in international and national legal sources, plus any right that can
conceptually be constructed as an inalienable right based on core universal values intrinsically
connected with the human condition and inherent to all human beings. However, for sake of
clarity, such human rights lato sensu will be framed in terms of possible correspondence to the
27
Masatsura Igami and Ayaka Saka, ‘Capturing the evolving nature of science, the development of new scientific
indicators and the mapping of science’ (2007) OECD Science, Technology and Industry Working Paper 2007/1
<http://www.oecd.org/dataoecd/11/40/38134903.pdf> accessed 3 November 2011.
28
Susan Schneegans (ed.) The UNESCO Science Report, 2010: The Current Status of Science around the World
(UNESCO 2010).
29
Hélène Dernis, Dominique Guellec and Maria-Pluvia Zuniga-Lara, The OECD Compendium of Patent Statistics 2008
(OECD 2008) 1617.
30
The classification is used widely in EU documents, studies and reports. See for all: Angela Hullman, European
activities in the Field of ethical, legal and social aspects (ELSA) and governance of nanotechnology (European
Commission, DG Research Unit Nano and Converging Sciences and Technologies 2008).
Draft version, may contain typos. Final text published in:
Nordberg A, ‘Nanotechnology, Human Rights, Patent Law and the Global South: A Brief Overview’, in
Mario Viola de Azevedo Cunha, Norberto Nuno Gomes de Andrade, Lucas Lixinski, Lúcio Tomé Féteira
(eds), New Technologies and Human Rights: Challenges to regulation (Ashgate, 2013), 313-333.
8
UN human right system, since it is the result of the possible, even if imperfect, international
consensus on the matter.
31
Social Aspects of Nanotechnology: Preparing the Stage For the Nano (R)Evolution
Nanotechnology is generally profiled as either the next evolutionary step in industrialization or
even as a disruptive technology originating the next cycle in the industrial revolution: the nano
revolution. Either way, new technologies with wide cross-sector applications necessarily imply a
certain degree of social changes. Among the main social issues currently under debate particular
attention has been devoted to: (1) public acceptance; (2) workers, consumers and environmental
safety; and (3) access to nanotechnology. Translating these issues into human rights concerns,
these would mainly correspond to social and economic human rights, such as those codified under
the International Covenant on Economic, Social and Cultural Rights.
32
Public acceptance has been generally debated as an economic issue in terms of marketing
goods and services; however it also has a human rights dimension. Acceptance is connected with
information and knowledge over the safety of nanotechnology products and consequences of
long-term exposure to them; it is in this sense a right to information issue. Rights cannot be fully
enjoyed and exercised without access to knowledge and information. Thus, although in the
commercial context it may be contentious to speak of an absolute right to information, such right
necessarily underlines any construction of inalienable right based on the value of human dignity.
Public acceptance is crucial for the future development of any new technology, dictating not only
consumer behaviour and preferences, but also public and private investment decisions. Negative
public perception can have devastating consequences, delaying technological development for
decades. Several studies on risk communication and risk perception have found the existence of
a high level of scepticism and resistance to nanotechnologies in the EU.
33
In the EU the issue has
been linked with a low level of understanding of the technology by the general public,
34
thus
justifying the allocation of considerable financial resources to national and EU sponsored
programs in this area.
35
The issue of public acceptance is not merely a European concern. Often
countries that prioritize nanotechnology in their industrial policies have also included in their
national nanotechnology policies measures to disseminate knowledge through the general public,
such as popular science publications, public conferences and exhibitions, thematic web pages and
plans to introduce the topic in basic education programs.
Workers, consumers and environmental safety are currently central issues in the
nanotechnology debate and a major worldwide concern for regulatory authorities. In normative
terms, these concerns can generally be linked to the right to an adequate and progressively
improved standard of living, as well as to a right to health that cannot be attained without taking
into account environmental protection. The right to safe and healthy working conditions is
31
The UN human right system main legal instruments comprises the United Nations Universal Declaration on Human
Rights, adopted by the General Assembly on December 10, 1948, General Assembly Resolution 217A (III), U.N. Doc.
A/180 (UDHR); the International Covenant on Political Rights Adopted and opened for signature, ratification and
accession by General Assembly resolution 2200A (XXI) of 16 December 1966, entry into force 23 March 1976 (CPR);
and the International Covenant on Economic, Social and Cultural Rights, Adopted and opened for signature, ratification
and accession by General Assembly resolution 2200A (XXI) of 16 December 1966, entry into force 3 January 1976
(CESCR).
32
CESCR n 31.
33
Kate Seear, Alan Petersen and Diana Bowman, The Social and Economic Impacts of Nanotechnologies: A Literature
Review, Final Report Prepared for the Department of Innovation, Industry, Science and Research (Monash University
2009).
34
Communication from the Commission to the Council, The European Parliament and The Economic and Social
Committee, Nanosciences and nanotechnologies: An action plan for Europe 20052009, Brussels, 7.6.2005 (COM
(2005) 243 final).
35
Hullman 2008 n 30, 7.
Draft version, may contain typos. Final text published in:
Nordberg A, ‘Nanotechnology, Human Rights, Patent Law and the Global South: A Brief Overview’, in
Mario Viola de Azevedo Cunha, Norberto Nuno Gomes de Andrade, Lucas Lixinski, Lúcio Tomé Féteira
(eds), New Technologies and Human Rights: Challenges to regulation (Ashgate, 2013), 313-333.
9
protected under article 7 (b) CESCR, while consumer and environmental safety can be included
under the ‘right to a standard of living adequate for the health and well-being’ of individuals and
families.
36
The latter is developed in the CESCR as the right to adequate standard of living and
the continuous improvement of living conditions,
37
and the right to ‘the enjoyment of the highest
attainable standard of physical and mental health’
38
that includes both ‘the improvement of all
aspects of environmental and industrial hygiene’
39
and ‘the prevention, treatment and control of
epidemic, endemic, occupational and other diseases’.
40
The debate concerning nanotechnology safety gain public notoriety with the publication of
the Royal Society and Royal Academy of Engineering 2004 report, which raised the question
whether nanotechnology components or applications (such as, for example, nanoparticles and
carbon nanotubes) have a direct impact on the natural environment and on human health and
wellbeing.
41
The EU has stressed the importance of maintaining and applying a precautionary
principle while supporting further scientific studies and regulatory initiatives.
42
International
organizations have also been active in the field, and for the most part agree with the need for
caution and further research regarding safety issues. To mention a few examples, the OECD
established a Working Party on Manufactured Nanomaterials in September 2006; and the Food
and Agriculture Organization of the United Nations has convened, together with the World Health
Organization, a joint expert meeting to ‘develop global guidance on adequate and accurate
methodologies to assess potential food safety risks that may arise from nanoparticles’.
43
Technological development naturally leads to interrogations over the possibility of uneven
access to its benefits, and the need to ensure effective universal realization of the right ‘to enjoy
the benefits of scientific progress and its applications’.
44
Individual and collective access to the
benefits in terms of human development and the distribution of the economic advantages brought
by nanotechnology remain a concern often raised. A report prepared for the United Nations
Industrial Development Organisation (UNIDO) and published in 1997 is perhaps one of the
earliest publications to consider the potential implications of nanotechnologies in aggravating the
gap between developed and developing countries.
45
Since then, different macro-economic reports
concerning the effects of nanotechnology on international trade and world commerce have been
published emphasizing potential negative effects in less industrialized economies, such as
possibly facing high barriers to enter the nanotechnology market while simultaneously losing their
main source of income due to the redundancy of their currently valuable natural resources.
46
The possibility of nano-divides and nano-districts and their potential dangers has been
observed. Nano-districts refer to the possibility that these technologies will emerge in small
geographic areas, also referred to as ‘clusters’.
47
Nano-divides refer to the possibility that
36
Art. 25 UDHR n 31.
37
Art 11 (1) CESCR n 31.
38
Art 12 (1) CESCR n 31.
39
Art 12 (2) (b) CESCR n 31.
40
Art 12 (2) (c) CESCR n 31.
41
The Royal Society and Royal Academy of Engineering n 17.
42
COM(2005) 243 final n 33 and SEC(2008) 2036 n 11.
43
Food and Agriculture Organization of the United Nations and World Health Organization, FAO/WHO Expert meeting
on the application of nanotechnologies in the food and agriculture sectors: potential food safety implications, Meeting
report (FAO/WHO 2010).
44
Arts 27 (1) UNDHR and 15 CESCR n 31.
45
P. McKeown and others, Nanotechnology (Emerging Technology Series: New and Advance Materials, UNIDO
1997).
46
Action Group on Erosion, Technology and Concentration, Nanotech’s ‘Second Nature’ Patents: Implications for the Global
South (Special Report Communiqués No. 87 and 88, ETC group 2005).
47
Philip Shapira and Jan Youtie, ‘Emergence of Nanodistricts in the United States: Path Dependency or New
Opportunities?’ (2008) 22(3) Economic Development Quarterly 187.
Draft version, may contain typos. Final text published in:
Nordberg A, ‘Nanotechnology, Human Rights, Patent Law and the Global South: A Brief Overview’, in
Mario Viola de Azevedo Cunha, Norberto Nuno Gomes de Andrade, Lucas Lixinski, Lúcio Tomé Féteira
(eds), New Technologies and Human Rights: Challenges to regulation (Ashgate, 2013), 313-333.
10
nanotechnologies may come to have a negative social-economic impact, exacerbating existing
internal social inequalities in both developed and developing nations and aggravating the gap
between developed and developing nations.
48
One of the main concerns is affordability, since
concentration of intellectual property rights, know-how and industrial capacity, may lead to de
facto market monopolies and the temptation to practice high prices that generally cannot be
afforded by the Global South.
New horizontal technologies imply new production methods and techniques and require
the use of highly specialized work force. They may thus entail the danger of suddenly excluding
entire segments of the population from the labour market. It follows that those segments risk being
denied the right to ‘the opportunity to gain his living by work’,
49
with the aggravated risk that the
realization of such right through ‘technical and vocational guidance and training programmes’
50
may encounter barriers connected with the high complexity of the technology.
Ethical Aspects of Nanotechnology: The Age of the Homo Chimaera
The ethical debate concentrates on possible future revolutionary advances of nanotechnology that
advance the possibility to change the very anthropological definition of human being, bringing
forth the danger of new forms of social exclusion and eugenic trends in society. It comprises,
among others, important subjects that can be framed in terms of basic human rights, such as: the
protection of human dignity, freedom and equality;
51
non-discrimination;
52
right to privacy;
53
informed consent regarding medical acts;
54
freedom of thought, conscience and religion;
55
and
freedom of opinion and expression.
56
In the coming years, nanotechnology is expected to provide considerable advances in
prosthetics, organ replacement, reconstruction surgery and genetic therapy. These advances may
go beyond the concept of therapy understood as restoration of abilities and functions to the species
typical level, introducing widespread artificial human enhancement. It is an old dream of mankind
to acquire abilities typical of other species, such as flying, under water breathing, self-
regeneration, or enhanced hearing, sight and olfaction. The possibility to artificially improve or
enhance oneself will likely be appealing to many, and be regarded as harmless and conceptually
similar to the current cosmetic surgeries and treatments. However, it raises major ethical
questions, such as those concerning nano-exclusion and eugenic trends in society. In a world
where it is possible to correct any disability and enhance natural abilities, social and labour market
discrimination of those who do not wish or are not able to access enhancement is likely to occur.
57
Simultaneously, the ability of society to accept and integrate persons who fall short of the average
typical abilities of the species may experience a setback.
58
The mere possibility of ‘enhanced’
humans co-existing with ‘natural’ humans would likely create societal disruption and perhaps
48
Robert Sparrow ‘Negotiating the Nanodivides’ in Graeme Hodge, Diana Bowman and Karinne Ludlow (eds) New
Global Frontiers in Regulation: The Age of Nanotechnology (Edward Elgar, 2007) 87107.
49
Art 6 (1) CESCR n 31.
50
Art 6 (2) CESCR n 31.
51
Art 1 UDHR n 31.
52
Art 7 UDHR n 31.
53
Arts 12 UDHR and 17 CPR n 31.
54
Art 7 CPR n 31.
55
Arts 18 UDHR and 18 CPR n 31.
56
Art 19 UDHR and 19 CPR n 31.
57
Laura Cabrera, ‘Nanotechnology: Changing the Disability Paradigm’ (2009) 8(2) International Journal of Disability,
Community & Rehabilitation; and Fritz Allhoff, Patrick Lin, James Moor, and John Weckert ‘Ethics of Human
Enhancement: 25 questions & Answers’ (2010) 4.1 Studies in Ethics, Law, and Technology, 1
<http://works.bepress.com /palin/9> accessed 10 December 2011.
58
Geert Van Calster, ‘Regulating Nanotechnology in the European Union’ 3.3 (2006) Nanotechnology Law & Business,
356.
Draft version, may contain typos. Final text published in:
Nordberg A, ‘Nanotechnology, Human Rights, Patent Law and the Global South: A Brief Overview’, in
Mario Viola de Azevedo Cunha, Norberto Nuno Gomes de Andrade, Lucas Lixinski, Lúcio Tomé Féteira
(eds), New Technologies and Human Rights: Challenges to regulation (Ashgate, 2013), 313-333.
11
even call for the need to reformulate the concept of human being. Every human being has the
right to be considered a person before the law
59
and every person is entitled to enjoy human rights
protection.
60
Nanotechnology evolutionary manipulation of human DNA hypothetically may
enable a wide range of modifications to the human body. The availability of such technology
would raise complex philosophical and legal questions. Establishing a legal concept of person
and determining the beginning and end of a person life is a complex legal matter subject to
constant vivid debate in most jurisdictions. This subject has always remained very sensitive due
to its deep political and religious roots. Radical enhancement technology will add further
difficulties, which begin with determining if an enhanced human is still a homo sapiens sapiens
and by definition a legal person. To what extent is the concept of human being defined by
biological identity and/or by societal and environmental interaction? And, if a human being is to
be defined by societal and environmental interaction, would a being with, for example, infrared
vision and telepathic abilities necessarily experience and interact differently? Philosophical
interrogations concerning human enhancement have important legal ramifications concerning the
legal concept of person and its boundaries. Not only is it problematic to determine if an enhanced
human is still a human, other questions emerge, such as: Is it possible to measure and accurately
determine the boundaries of ‘humanity’ without infringing the principle of non-discrimination?
Will human rights apply unchanged to radically enhanced humans? Do equity and the principle
of justice and equality imply (or not) that different entities should be treated differently?
Another technological development that may soon be available and be the source of
concern is the possibility of implanting the human body, cloths or any other object with virtually
undetectable nano-tag mechanisms able to measure, store and relay large quantities of data. While
nano-tags can be used in unlimited beneficial contexts, they nevertheless raise important ethical
and legal issues such as respect for personal privacy, human dignity, informed consent, and
accountability for public or private abuses.
61
Many advocate strong and restrictive regulation as the answer to avoid the pitfalls of
scientific and technological development. However, the same technologies can be used in
different contexts. What is qualified has enhancement while applied to a healthy person, may be
merely therapeutic if used in a different individual; and what is intrusive for some, may enhance
the quality of life of others. Restrictions to scientific development and use of technology imply
interference with freedom of opinion and thought in its component of freedom of scientific
research,
62
as well as with the overall human right to enjoy the benefits of scientific progress.
63
Such restrictions need careful consideration, they can only be legitimized based on the protection
of human dignity, however the over expansion of this principle may be disruptive to the human
rights system.
64
Legal Aspects: Regulating the Infinitely Small and Largely Unknown
New technological waves imply changes in the social reality regulated by the law. This does not
mean that nanotechnology stands in a legal void. The existing legal and regulatory framework
remains applicable, however it is vital to consider the appropriateness of extending its application
59
Art 6 UDHR n 31.
60
Art 2 UDHR n 31.
61
The Royal Society and Royal Academy of Engineering n 17, 5354.
62
Arts 18 and 19 CPR n 31.
63
Art 15 CESCR n 31.
64
In the EU there are on-going efforts to harmonize national initiatives in this area, such as the Commission
Recommendation on a code of conduct for responsible nanosciences and nanotechnologies research, Brussels,
07/02/2008 (C (2008) 424 final). This is not a legally binding document but a mere recommendation providing
guidelines to Member States ‘as they formulate, adopt and implement their strategies for developing sustainable
nanosciences and nanotechnologies research’ (art 1). The final text benefited from extensive public debate but has
nevertheless been criticized for being too vague.
Draft version, may contain typos. Final text published in:
Nordberg A, ‘Nanotechnology, Human Rights, Patent Law and the Global South: A Brief Overview’, in
Mario Viola de Azevedo Cunha, Norberto Nuno Gomes de Andrade, Lucas Lixinski, Lúcio Tomé Féteira
(eds), New Technologies and Human Rights: Challenges to regulation (Ashgate, 2013), 313-333.
12
to nanotechnology research, nanotechnology products and nanotechnology induced social
phenomena. An out-dated and inadequate legal framework may lead to unbalanced and
conflicting decisions which pose a danger to the realization of the right to equality of treatment
by the law and justice system.
65
An additional concern to the general realization of human rights is that without the
corresponding obligations human rights would be reduced to mere political declarations. In order
for human rights to become incrementally attainable, enforceable and enforced, the regulatory
framework needs to be updated so as to effectively reflect the protection of such rights. The
insufficiency of safety regulations and the lack of international harmonization raise concerns. On
the one hand, the possibility for national divergences can restrict de jure or de facto international
trade. On the other hand, the absence of, or the existence of, permissive regulations in some
countries could, in a world of global commerce and Internet trade, endanger consumer safety
worldwide. The lack of scientific consensus regarding potential dangers and long term exposure
effects undermines the efforts to evaluate and adapt safety regulations. As mentioned previously,
considerable attention is being devoted to the study of safety issues, although critical voices have
noted that not enough funding is being channelled to such projects.
The right to own private or collective property,
66
as well as the right to the protection of
and the right to benefit from ‘moral and material interests resulting from any scientific, literary
or artistic production of which he is the author’
67
are usually seen as the consecration of
intellectual property rights as human rights. In the case of nanotechnology, the protection of the
research results is of considerable strategic importance. The nature of the technology and the
considerable resources invested in research are leading all actors involved to actively seek
intellectual property rights protection and presumably to actively enforce their rights, all in all
giving rise to new challenges to the patent system. In order for inventors and investors to be able
to collect the fruits of their labour and investment, the patent system needs to be constantly
adapted to new technological developments. International harmonization and international
cooperation mechanisms between patent offices, international instruments of protection against
infringement of intellectual property rights, and technology transfer mechanisms are matters that
need continuous improvement efforts. On the other side, the trend for companies and research
institutions to engage in strong intellectual property rights strategies are often seen as potential
barriers to the fulfilment of other human rights, such as right to access and benefit from
technology in general and the right to health in particular.
Nanotechnology, Patent Rights and the Accessibility Debate
As succinctly described in the previous sections, nanotechnology may facilitate solutions to make
human rights de facto attainable for a large part of underprivileged populations either directly
through technical innovation, or indirectly through macro-economic effects but interrogations
over possible overall negative human rights repercussions persist. This section will further
examine the issue of the right to health and its intersection with patent rights, taking
nanotechnology inventions as the reference point.
Several different conceptual frameworks have been used to analyse the interface between
intellectual property right(s), and the right to health and access to healthcare and medicines. These
can be divided into (1) conflict, (2) coexistence and (3) ‘beyond conflict and coexistence’.
68
The
conflict of rights framework considers both rights individually, confronting the patent right with
65
Arts 7 UNDHR and 14 CCPR n 31.
66
Art 17 UDHR n 31.
67
Arts 27 (2) UNDHR and 15 (b) CESCR n 31.
68
Laurence Helfer and Graeme Austin, Human rights and intellectual property mapping the global interface (CUP
2011) 6481.
Draft version, may contain typos. Final text published in:
Nordberg A, ‘Nanotechnology, Human Rights, Patent Law and the Global South: A Brief Overview’, in
Mario Viola de Azevedo Cunha, Norberto Nuno Gomes de Andrade, Lucas Lixinski, Lúcio Tomé Féteira
(eds), New Technologies and Human Rights: Challenges to regulation (Ashgate, 2013), 313-333.
13
the right to health, including under the latter a right of access to patented inventions (e.g.
medicines). These rights are confronted in terms of relative hierarchical value, seeking to develop
rules to solve situations where a conflict of norms may exist. In a certain sense this is a legal
dogmatic approach, destined to find interpretative solutions to the application of existing
normative provisions to factual situations. The coexistence framework, on the other hand,
underlines that both fields of law have separate but coexistent objectives to provide for incentive
to innovation while improving accessibility. This framework allows for a broader analysis that
can serve as guidance for future legislative changes or treaty negotiations. Alternative
constructions, beyond conflict and coexistence, understand patent rights not as a property right
but instead constructed as a human right. To a certain extent, this is also a conflict framework
entailing a constitutionalization perspective, in the sense that it involves a confrontation between
different human rights by reference to their basis for legitimacy and relative precedence.
Without ignoring the existence of potential or actual normative conflicts, patent rights will
be analyzed in this chapter as part of the access paradigm, complementing other rights in
promoting accessibility.
The traditional understanding of the repercussion of patent rights in terms of accessibility
has justified the implementation in the patent system of mechanisms destined to introduce a
balance between incentive to innovation and access. Within the patent system exclusions and
exceptions to patentability and limitations to the exercise of patent rights assume the function of
gatekeepers of accessibility.
69
These restrictions have a long historic presence in patent legislation
and are currently internationally recognised under article 27 of the TRIPS agreement.
70
The traditional views of confrontation and coexistence described above, understand the
right to health as a static right and not as an incremental progressive right, largely ignoring the
importance of innovation and the devastating consequences to the attainability of the right to
health should the incentive for innovation be reduced or undermined. Health is often described
has a public good, by definition non-excludable, meaning that individual use cannot limit the
benefit to others.
71
However, the same can be said about technological knowledge. Inventions are
public goods privatized by means of a legal institute, the patent. In strict dogmatic terms, the right
to health is a public right, unlimited by nature and addressing primary public authorities, while
intellectual property rights have a private law nature and primarily concern the protection of
private economic interests.
72
Following this line of reasoning, there are few arguments to support
the inclusion of intellectual property rights in the UN catalogue of human rights,
73
unless a
distinction is made between fundamental and non-fundamental human rights.
74
Under this view,
the inclusion of the human rights discourse in the patent system debate is even counterproductive
by promoting an adversarial perspective or ‘zero-sum game’ between rights holders that hides the
existence of common interests
75
and prevents a global analysis of the accessibility problem.
69
For a general reflexion on patent law and accessibility see Jens Schovsbo, ‘Increasing Access to Patented Inventions
by post-grant measures’ (2009) 36 Science and Public Policy 609.
70
Agreement on Trade-Related Aspects of Intellectual Property Rights, contained in an Annex to the Marrakesh
Agreement Establishing the World Trade Organization, signed in Marrakesh, Morocco on 15 April 1994.
71
Johanna Gibson, Intellectual Property, Medicine and Health: Current Debates (Ashgate 2008) 80.
72
Willem Grosheide, ‘Intellectual property rights and human rights: related origin and development’ in Willem
Grosheide (ed.), Intellectual Property and Human Rights: A Paradox (Edward Elgar 2010) 3, 21.
73
Rochelle Dreyfuss ‘Patents and human rights where is the paradox?’ in Willem Grosheide (ed.), Intellectual Property
and Human Rights: A Paradox (Edward Elgar 2010) 72, 73.
74
Grosheide n 72, 20.
75
Dreyfuss n 73, 90.
Draft version, may contain typos. Final text published in:
Nordberg A, ‘Nanotechnology, Human Rights, Patent Law and the Global South: A Brief Overview’, in
Mario Viola de Azevedo Cunha, Norberto Nuno Gomes de Andrade, Lucas Lixinski, Lúcio Tomé Féteira
(eds), New Technologies and Human Rights: Challenges to regulation (Ashgate, 2013), 313-333.
14
However, an alternative view is possible. The right to health is a complex access right. It
includes a right to access all the direct and indirect determinants of health.
76
It includes access to
health facilities, goods and services; environmental factors, such as access to clean water, food
and basic sanitation; and access to information.
77
If the right to the highest possible attainable
standard of health is understood as an incremental right,
78
then the availability of adequate levels
of incentive to innovation necessarily becomes a central element of the right to health paradigm.
Without technical innovation and incentives to invest in such innovation, this right to health
cannot be fulfilled. Under this view the legislator’s choice does not lie between (1) to protect
investment of pharmaceutical companies by the grant of patents or (2) to guarantee effective
access to medicines to poor populations by reducing or eliminating such protection. Instead, the
real attainable public policy options are to determine what is more beneficial: (1) less expensive
medicines and medical instruments or (2) new medicines that are more efficient and less toxic, as
well as novel methods and instruments for treatment and diagnosis that are more precise, faster
and safer. The challenge is whether it is possible to pursue and attain both objectives
simultaneously and if so, how. Detractors of the patent system remark that patented inventions
marketed under monopolistic conditions are necessarily more expensive than equivalent goods
sold in a competitive market, thus concluding that the elimination or restriction of patent rights is
necessary to ensure access to health. Assuming the correctness of such statement, it should be
added that without the incentive provided by a marketing monopoly companies might refrain from
investing in research and development since there would be no guarantee of retrieving such
investment. Naturally, this argument requires innovation to be a function of the availability of
patents, something that typically these sectors contest. However, if we accept that in the absence
of patents the incentive to industrial innovation could be achieve by alternative means and that
companies would continue to invest in research for example in order to compete in the market
by introducing new products and improving product quality in such a case commercial logic
would dictate that there would be a strong incentive to keep research and industrial know-how
secret. Patent law provides incentive for knowledge dissemination since the grant of patents is
made conditional to the disclosure of technical information. Such has been a long-standing
justification of patent rights. Currently, sufficient disclosure is a mandatory obligation under
article 29 (1) of the TRIPS agreement, according to which, in order to be granted a patent, the
applicant has to describe the invention in a manner at least sufficiently clear as to allow others to
be able to understand its functioning and reproduce it. Allowing others to build upon the shared
knowledge is an important function of the patent system as a mechanism for promoting
innovation, and often an overlooked one in the accessibility debate. Without patents forcing the
disclosure of such vital knowledge, commercially valuable information would be kept secret and
scientists bound by contractual obligations would be prevented from publishing their results. It
has been argued that recent research demonstrates that patent law indirectly causes delay to
publication of scientific results.
79
Without contesting such conclusion, it should be noted that such
does not invalidate the beneficial role of patents in the dissemination of knowledge, since the
alternative generalized use of trade secrets would have in the current economic and
technological framework even more restricting results.
80
The more complex the technology is,
76
The right to the highest attainable standard of health contains the following interrelated and essential elements:
availability, accessibility, acceptability and quality. The ICESCR also implies among others the obligation for the states
to adopt appropriate measures towards the full realization of this right. See UN Committee on Economic, Social and
Cultural Rights (CESCR), General Comment No. 14: The Right to the Highest Attainable Standard of Health (Art. 12
of the Covenant), 11 August 2000,E/C.12/2000/4.
77
Gibson n 71, ch 3.
78
The principle of progressive realization, applicable to all rights protected under the ICESCR, implies that States must
take steps to achieve progressively full realization to the maximum of its available resources.
79
Gertrui Van Overwalle ‘Reconciling patent policies and university mission’, (2006) 13 Ethical Perspectives, 231.
80
Regarding the conditions that dictate the use of trade secrets see David Friedman, William Landes and Richard Posner
‘Some economics of trade secret law’ (1991) 5 Journal of Economic Perspectives, 61; and Wesley Cohen, Richard
Draft version, may contain typos. Final text published in:
Nordberg A, ‘Nanotechnology, Human Rights, Patent Law and the Global South: A Brief Overview’, in
Mario Viola de Azevedo Cunha, Norberto Nuno Gomes de Andrade, Lucas Lixinski, Lúcio Tomé Féteira
(eds), New Technologies and Human Rights: Challenges to regulation (Ashgate, 2013), 313-333.
15
the more relevant this function becomes. Reverse engineering always implies duplication of
efforts and resources. However, while in simple mechanical inventions it may be a relatively easy
and non-expensive task, the more complex and recent a technology is the more expensive and
time consuming such exercise becomes. Nanotechnology is often developed by long-term projects
employing interdisciplinary research teams and using expensive research instruments and tools,
making reverse engineering extremely costly and lengthy.
An incremental right to the highest possible attainable standard of health necessarily
implies innovation. It is thus an oversimplification to consider mechanisms destined to promote
innovation such as patents to be major obstacles to public health policies, or to address the
subject of balancing innovation and access as fundamentally separate realities.
Nanotechnology Patent Landscape Accessibility Implications
Nanotechnology inventions concern more than the mere scaling down of existing technologies,
thus while nanotechnology patents tend to experience some of the difficulties present in the
scientific field(s) of origin they face specific challenges.
Overall, nanotechnology patents display a number of distinct characteristics concerning
ownership, subject-matter of protection and scope of protection, namely: (1) a tendency to seek
patent protection at early stages; (2) broad and often overlapping patents are being issued over
technology building blocks and research tools;
81
(3) patent ownership is highly concentrated, and
remarkably nanotechnology major patent owners are not commercially orientated entities, but
rather universities and public funded research institutions;
82
(4) patent thickets have been
identified at least in carbon nanotubes, metal nanoparticles, ceramic nanoparticles dendrimers,
quantum dots, fullerenes and nanowires.
83
The literature generally argues that nanotechnology patent landscape is different from other
important technological developments.
84
The nature and potential of the technology in itself,
together with the considerable investment that this technology requires, is leading all actors
involved to actively seek intellectual property rights protection at very early stages of the research
process when a possible commercial application may be vague and distant. How actively and
aggressively are those rights being enforced is currently unknown and a matter for debate. There
is an observed general tendency to broad interpretation of the concept of invention that results in
blurring the distinction between invention and discovery. This is a consequence of the nature of
technological development that has rendered the traditional legal conceptual framework less
useful and the work of patent offices more difficult. The nature of the patent exam procedure
entails the general tendency for broad patents to be granted at the dawn of emerging technologies.
‘It is widely stated that changes in the nature of basic science have rendered more “basic science”
patentable than previously was the case.’
85
The issue is not new, nor specific to nanotechnology
patents, but it is likely that if such tendency persists it will have relatively more severe
consequences due to the specific nature and cross sector application of nanotechnology
inventions. Broad and overlapping patents, conjugated with a tendency for research institutions
Nelson and John Walsh, Protecting Their Intellectual Assets: Appropriability Conditions and Why U.S. Manufacturing
Firms Patent (or Not)’ (Working Paper No 7552, National Bureau of Economic Research, 2000).
81
Douglas Sylvester and Diana Bowman, ‘Navigating the Patent Landscapes for Nanotechnology: English gardens or
Tangled Grounds?’ (2001) 726:2 Biomedical Nanotechnology: Methods in Molecular Biology 359.
82
Mark Lemley, ‘Patenting nanotechnology’ (2006) 58 Stanford Law Review 601.
83
Lux Research, The Nanotech Intellectual Property Landscape (Lux Research 2005).
84
Lemley n 82.
85
Lionel Bently and others, Exclusions from Patentability and Exceptions and Limitations to Patentees’ Rights (WIPO
Standing Committee on the Law of Patents 2006), 31.
Draft version, may contain typos. Final text published in:
Nordberg A, ‘Nanotechnology, Human Rights, Patent Law and the Global South: A Brief Overview’, in
Mario Viola de Azevedo Cunha, Norberto Nuno Gomes de Andrade, Lucas Lixinski, Lúcio Tomé Féteira
(eds), New Technologies and Human Rights: Challenges to regulation (Ashgate, 2013), 313-333.
16
to seek patent protection for basic research at an early stage may hamper future research and the
public availability of the benefits nanotechnology.
86
Traditionally, universities were not particularly active in seeking patent protection for their
inventions, but surprisingly rank as the top patent owners in nanotechnology-related inventions.
87
Universities often work on first generation research, i.e. research that opens the field for later
commercially driven research. Thus, such patenting activity is bound to fall upon basic blocks of
the technology that in other technological waves were left in the public domain. This may create
obstacles to further research and technology innovation in developing countries since, as the
available data shows, such patents are owned in their majority by research institutions and large
corporations located in developed countries. However, it should be noticed that these adverse
consequences may be mitigated by new and more dynamic models of technology transfer,
collaborative research projects, and the Global South’s on-going investment efforts in
nanoscience and nanotechnology research.
Patent thickets can be described as an unintended formation of dense interconnected and
often overlapping intellectual property rights with different owners. Thickets are often a
consequence of the above-mentioned broad and overlapping patents and can cause prohibitive
costs for cross-license schemes (royalty stacking), and thus endanger the economic viability of
new products and serve as anti-competitive barriers.
The mentioned nanomaterials entail the potential to cross sector unlimited industrial and
commercial applications, including in the medical sector, thus patent thickets in this area lead to
accessibility concerns. Although such claims need to be observed with caution, the nature of this
technology points in such direction. On the other hand, observed excessive concentration of patent
ownership may give rise to different anti-commons issues, possibly originating not only barriers
to entry in the market, but also deterring third parties from conducting research in the field.
Broad and overlapping patents result in legal uncertainty. Concerns have been voiced that
the availability to the public of major developments in vital sectors such as medicine and
pharmaceuticals, energy and information and communications technology may be delayed due to
complex and lengthy multi-jurisdiction patent related litigation. Litigation activity has been
growing in the US and is expected to explode and spread to other major jurisdictions in the coming
years.
88
Despite the dark scenario drawn by comments and data collections, the fact that developing
countries are investing in building nanotechnology capabilities, leading to a respectable number
of publications in this subject, might point out to a brighter picture. Also, it is possible that the
existence of early, broad and overlapping patents might not become a major factor in delaying the
development of the technology since the lack of knowledge regarding toxicity and long-term
effects may become the major factor delaying the use of the technology. Currently, more research
is needed on this matter before definitive conclusions can be stated.
86
Gavin Clarkson and David DeKorte, ‘The Problem of Patent Thickets in Convergent Technologies’ (2006) 1093
Annals of the New York Academy of Sciences 180; and Joel D’Silva, ‘Pools, Thickets and open Source nanotechnology’
(2009) 31 European Intellectual Property Review 300.
87
In the US the Bayle-Dole Act allowed public funded research organizations to retain intellectual property rights over
their research, encouraging them to assume and establish a technology transfer function and thus changing the
university research paradigm from an open science model to a licensing model. In Europe a similar trend has been
observed. See Bayle-Dole Act (US 1980) University and Small Business Patent Procedures Act (December 12, 1980)
codified in U.S.C Title 35 part II, chapter 18 § 200-212. For an analysis of evolution of different models of research
and technology transfer see Laura MacDonald and others, Management of intellectual property in publicly-funded
research organisations: Towards European Guidelines (Expert Group Report, European Commission, 2004).
88
Sean O'Neill and others, ‘Broad claiming in nanotechnology patents: Is litigation inevitable?’ (2007) 4
Nanotechnology L. & Bus. 29; Sylvester and Bowman n 80.
Draft version, may contain typos. Final text published in:
Nordberg A, ‘Nanotechnology, Human Rights, Patent Law and the Global South: A Brief Overview’, in
Mario Viola de Azevedo Cunha, Norberto Nuno Gomes de Andrade, Lucas Lixinski, Lúcio Tomé Féteira
(eds), New Technologies and Human Rights: Challenges to regulation (Ashgate, 2013), 313-333.
17
Exclusions, Exceptions and Limitations to Patent Rights as Mechanisms to Protect Accessibility
Patent rights are not absolute in nature. A patent is merely a right to exclude others from the
commercial exploitation of a certain subject-matter,
89
and is subject to several statutory
limitations. Firstly, time limitation a minimum duration of 20 years has been imposed by the
TRIPS agreement
90
and such limit is currently generally adopted as the patent term.
91
Secondly,
limitations regarding the object of the right can be found in practically all jurisdictions only
inventions must be patentable.
92
Thirdly, moral and ordre public considerations may impose that
certain inventions cannot receive patent protection,
93
including ‘diagnostic, therapeutic and
surgical methods for the treatment of humans or animals’
94
and ‘plants and animals other than
micro-organisms, and essentially biological processes for the production of plants or animals
other than non-biological and microbiological processes’.
95
Fourthly, limitations to the exercise
of the patent right for public interest reasons may lead, for example, to the granting of compulsory
licenses.
96
These public policy limitations, which were adopted in a considerable number of
jurisdictions, reflect the need to safe keep general societal needs or public goods in face of the
attribution (adjudication) and exercise of private rights. A study commissioned by the WIPO
found that, in 2010, 84 jurisdictions had limitations to patent rights based on morality and ordre
public, while the patentability of ‘therapeutic, surgical and diagnostic methods for treating
humans or animals was restricted in 79 countries.
In patent law, exclusions and exceptions are adaptation rules, providing room for including
ethical and social equity considerations in the system governing the grant of patents. In this sense,
such limitations assume a function of gatekeepers of accessibility allowing the introduction of
public policy considerations on the patent system, in order to mitigate possible adverse results in
terms of general access to and availability of industrial knowledge and innovation.
The limitation of patentability to inventions prevents the grant of the commercial
exploitation monopoly over scientific knowledge. Under such rule only technological innovation
is patentable, scientific discoveries or theories are excluded from or considered unsusceptible of
private ownership and thus left in the public domain. The second set of limitations provide for an
exception from the general patentability rule, determining that certain inventions that would
otherwise be patentable are unsusceptible of being the object of such right.
Nanotechnology, if proven to be a major leap forward in technological development, will
necessarily entail social changes and the emergence of the need to apply previously existing
normative structures and concepts to new realities and phenomena. Technological change
throughout history has brought forth moral and ethical dilemmas that require normative
translation at some stage. Nanotechnology inventions, due to their particular nature, pose new
challenges to the patent system since many of the technologies being currently developed blur the
line between patentable and non-patentable subject-matter. The distinction between what can be
considered an invention and thus patentable and, for example, a non-patentable discovery is
becoming less clear.
89
Art 28 TRIPS n 70.
90
Art 33 TRIPS n 70.
91
For active substances of medicines the reduction of commercial exploitation time induced by lengthy regulatory
approval processes in many jurisdictions is compensated by the availability of a patent extension/supplementary patent
certificate. However this does not extend the patent term.
92
Art 27 (1) TRIPS n 70.
93
Art 27 (2) TRIPS n 70.
94
Art 27 (3) (a) TRIPS n 70.
95
Art 27 (3) (b) TRIPS n 70.
96
Arts 30 and 31 TRIPS n 70.
Draft version, may contain typos. Final text published in:
Nordberg A, ‘Nanotechnology, Human Rights, Patent Law and the Global South: A Brief Overview’, in
Mario Viola de Azevedo Cunha, Norberto Nuno Gomes de Andrade, Lucas Lixinski, Lúcio Tomé Féteira
(eds), New Technologies and Human Rights: Challenges to regulation (Ashgate, 2013), 313-333.
18
Nanotechnology also challenges patentability exceptions by rendering the operative
concepts of legal norms less useful. In order to apply either exceptions to patentability of
inventions (Europe) or limitations to the exercise of the patent right (USA), different patent
jurisdictions rely on a distinction between methods for treatment and diagnostic methods
practiced on the human body, on one side, and products used in such activities, on the other side.
Regarding nanotechnology inventions, such distinction is increasingly difficult resulting in the
ability of the technology to circumvent such limitations.
Nanotechnology and the Exception from Patentability for Methods for Treatment and Diagnosis
The patentability exception of methods for treatment and diagnosis is allowed by the TRIPS
Agreement but not subject to harmonization. It has been adopted in several jurisdictions, and can
be described as holding a function of guardian of accessibility to medicine. In Europe it is stated
in article 53 (c) of the European Patent convention (EPC).
97
Although the formulation and ratio
legis of this norm has been a matter for doctrinal debate, it can be said that in its current
formulation and interpretation by the European Patent Office (EPO) boards of appeal, it has as
objective and function to guarantee the attainability of the right to health by safekeeping access
to methods for treatment and diagnosis. The norm is thus intended to simultaneously protect the
freedom of the medical practitioner to apply any known methods for treatment and diagnosis, and
to ensure the right of the patient to receive any methods for treatment and diagnosis available,
appropriate and efficient for his/her condition. It does so by keeping such methods under a regime
of exception from the general rule that determines that all inventions, new, inventive and
susceptible of industrial application can be object of a patent right. The EPC model inspired the
legislation of many jurisdictions
98
however it is a matter for discussion if the solution adopted in
article 53 (c) EPC is in fact the most appropriate. It can be questioned whether such function is
actually being fulfilled by the norm, as it can be discussed whether excluding economic incentive
to innovation in the field of methods for treatment and diagnosis does not in fact compromise the
realization of the right to the highest attainable standard of health, understood as an incremental
and progressive right.
Nanotechnology adds to this debate the fact that the nature of this technology further blurs
the line between what may or not fall under the exception, creating increased patentability options
and the possibility to avoid the prohibition almost completely.
99
Nanotechnology due to its nature
may be difficult to subsume to the operative concepts of article 53 (c) of the EPC, as interpreted
currently by the EPO. The distinction between methods, products or apparatus may turn out to be
artificial regarding most nanotechnology inventions, since often a nanotechnology invention can
be described both as an apparatus ‘nano-machine’ and as a chemical compound. Thus, allowing
the overall circumventing of the legal provision.
100
Conclusion
The right to the highest attainable standard of health, understood from a global and dynamic
perspective, necessarily includes the need to promote investment in scientific research and
97
‘European patents shall not be granted in respect of: […] (c) methods for treatment of the human or animal body by
surgery or therapy and diagnostic methods practised on the human or animal body; this provision shall not apply to
products, in particular substances or compositions, for use in any of these methods.’ Art. 53 (c), Convention on the
Grant of European Patents (European Patent Convention) of 5 October 1973 as revised by the Act revising the EPC of
29 November 2000.
98
The Patent Co-operation Treaty (1970) and the WIPO Model Law for Developing Countries on Inventions (Geneva,
1979) are also credited as important sources of influence.
99
Herbert Zech, ‘Nanotechnology New Challenges for Patent Law?’ (2009) 6 SCRIPTed 144
<http://www.law.ed.ac.uk/ahrc/SCRIPT-ed/vol6-1/zech.asp> accessed 14 December 2011.
100
Angela Follett and Teresa Lavoie, ‘Delivering macro-quality IP protection for nanosized therapeutics’ (2008) 5
Nanotechnology L. & Bus. 163.
Draft version, may contain typos. Final text published in:
Nordberg A, ‘Nanotechnology, Human Rights, Patent Law and the Global South: A Brief Overview’, in
Mario Viola de Azevedo Cunha, Norberto Nuno Gomes de Andrade, Lucas Lixinski, Lúcio Tomé Féteira
(eds), New Technologies and Human Rights: Challenges to regulation (Ashgate, 2013), 313-333.
19
industrial innovation in the medical and pharmaceutical sector. Without such innovation the
incremental development of generalized attainment of the right to health cannot be achieved. The
patent system has an important role to play in providing incentives to such investment.
Nanotechnology is recognized as a promising field of technological development, one that
can bring hope to solve many of the major health problems that humanity is currently facing, both
in developed and developing countries. However the nature of the technology poses normative
challenges that require careful consideration. Among the latter is the need to re-evaluate the
functioning of exclusions, exceptions and limitations to patent rights as mechanisms for
safekeeping accessibility.
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