European Perspective on Nanotechnology Patents

European Perspective on Nanotechnology Patents An Overview of Nanotechnology Patents: A European Perspective The future world will to a large extent consist of a knowledge based society. Intellectual property (IP) will play an important role in generating wealth and employment in that society. A general rule is that the more developed a country is the more stricter and secure for IP and strict to uphold the IPR. IP assets have become between 50 and 70 percent of the gross domestic products of a developed country.[1] In that sense it can be said that IP has become one of the most important assets of knowledge based economies.[2] Creativity is essential to economic growth.[3] It is feared that the development of new technologies and thereby the progress of societies will be halted without the presence of intellectual property rights (IPR). IPRs encourage the development of new technologies. IPRs aim at creating a harmonious relationship among investors, inventors and consumers. Patent rights are one of the important branches of IPR. The ultimate goal of patent rights is to promote invention a nd encourage further development of that invention for the benefit of society. Before going into an in-depth discussion on nanotechnology patents, it will be wise to discuss patent rights. The main aim of patent rights is to protect technological inventions.[4] Patents can be seen as the outcome indicators of applied research and technological advancement.[5] A patent protects novel and non-obvious ideas and not mere the expressions of those ideas.[6] The patent system is meant to protect technology, actual machines, devices and new chemical, biotechnological/nanotechnological compositions rather than pure concepts.[7] The main of the system is to promote the continuation of intellectual community[8] and industrial and technological development. Generally a patent may be defined as the exclusive right granted by statute to a party who conceives or discovers a non obvious and novel invention, to use and develop that invention, to prevent others from manufacturing, selling or using the invention for a limited time, which depends on the inventions and jurisdictions. Patent terms are typically from 14 to 20 years.[9] The applicant of a patent must show that the invention is eligible subject matter, novel, having industrial application or utility, inventive step and non-obviousness i.e. that the invention is not obvious to a skilled person in the field with ordinary knowledge and lastly adequate disclosure. Its not enough that an invention is new for a company or in a definite country. The described invention must be new in the international context.[10] Patent is very important in the intellectual and scientific community because of it relate to their reputation and to enrich their resume. In the sense of commercial sector, it i s important because it creates barriers to entry into the market.[11] The emergence of a new and pioneer technology creates issues and possibilities in perfecting IP rights.[12] Like other present technologies, nanotechnology isnt merely a part of a distant future, but is also a significant technology today.[13] Its obvious that nanotechnology will be one of the essential technologies of the 21st century which have enough potentiality to create new markets and prosperity.[14] Nanotechnologies are treated not as a standalone topic, but as a potential and important approach to develop new materials and accomplishment new properties. Their potential for characterizing and building up nano-structure will meet future goals in nearly all sectors. Nanotechnologies have the merit of joining together chemists, physicists, biologists, medical doctors, sociologists, etc. It has been held that nanotechnology will be one of the largest sectors of economic growth of world in the foreseeable future.[15] Such technology will be used in a wide range of products from mi litary weapons to clothing.[16] Many multinational companies have already invested huge amounts in the field of nanotechnology. The nano-world is full of surprise and potential.[17] As its a nascent technology, it may pose problems and opportunities for IP regimes.[18] Nanotechnology patents are not treated differently than other patents but it is true that more complex technology creates more complex problem within the patent system. It may be the next legal challenge in the field of IPR. Although early predictions for nanotechnology commercialization are encouraging, however, there are formidable challenges that include legal, environmental, ethical and regulatory questions, as well as emerging thickets of overlapping patent claims. The rapid technological development of nanotechnology will challenge the traditional regulatory system in patent law.[19] Another problem will arise to classify the nanotechnology because advanced nano-products may suit into different categories simultaneously.[20] One thing is certain, however, nanotechnology is here to stay and will generate both evolutionary as well as revolutionary products in the future, thereby improving all sectors of our life.[21] The impact of nanotechnology on our way of life is widely belie ved to reach profound and hitherto unimagined levels in the coming decades.[22] Nanotechnology is just passing its early stage in the field of science and very little development has occurred in the legal arena on nanotech. In this thesis, I will focus on legal sides of nanotechnology patents. My overall point of discussion is legal rather than technical. The first part of the thesis will contain a general overview of nanotechnology from a scientific view point, different governmental and non-governmental organizations approach as well as the importance of nanotechnology from other general aspects. In the second part of the thesis, the relationship between nanotechnology and IPR will be discussed. The third part of the thesis addresses the possibility of patenting nanotechnology inventions. This part also contains a brief description on EU policy towards nanotechnology patents. Finally, the future legal challenges which may face legal experts in the IP field regarding the patenting of nanotechnology products are analyzed. 1. What is Nanotechnology: Technological and theoretical improvements have moved us to the place where our knowledge of atomic construction and behavior has significantly improved.[23] This advancement enables human to enter the age of nanotechnology.[24] Nanotechnology is mainly consists of ‘nano- materials- e.g. carbon nano-tubes, fullerenes, nano-particles, quantum dots, dendrimers, nano-crystalline diamonds, nano-wires, etc.[25] According to Eric Drexler, a nano-optimist, nanotechnology can change the world in the way that the steam engine did.[26] A proper definition is very important in a field of science and technology, not least for patents.[27] It is very important to define nanotechnology from a legal point of view. The world of nanotechnology is a world of individual atoms and molecules.[28] Its the science to study and use of the unique characteristics of materials at nano-scale.[29] A precise definition of ‘nanotechnology in law and science is yet to be decided. It encompasses many dif ferent concepts and fields simultaneously, which is a difficult task. Even scientists in the field maintain that it â€Å"depends on whom you ask.†[30] Many experts and different governmental institutions have tried to define the concept of nanotechnology. Generally ‘nanotechnology seems to refer to very small science.[31] ‘Technology derives from the Greek tekhne, which means ‘skill or ‘discipline and ‘logos which means ‘speech.[32] ‘Nano comes from the Latin word for ‘dwarf, but today the prefix is more known to denote one billionth (i.e. one billionth of a metre).[33] Therefore nanotechnology could mean the discipline of assembly at the nanometer scale or in other words, molecular assemblage and mass molecular production.[34] Nanotechnology is an umbrella term used to define the properties or products and process at the nano/micro scale that have resulted from the convergence of the physical, chemical and life science.[35] EPO[36] defines ‘nanotechnology as follows: The term nanotechnology covers entities with a controlled geometrical size of at least one functional component below 100 nano-metres in one or more dimensions susceptible of making physical, chemical or biological effects 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 nano-metres. The U.S. ‘National Nanotechnology Initiative (NNI) predicted in a report issued by the U.S. Department of Energys Office of Basic Energy Sciences, the near term benefits of the developments of this new technology. The White House Office of Management and Budget devised a broader, more functional definition for nanotechnology. It defines Nanotechnology as : research and technology development at the atomic, molecular or macromolecular levels in the length scale of approximately 1-100 nano-meter range, to provide a fundamental understanding of the phenomena and materials properties at the nano-scale and to model, create, characterize, manipulate and use structures, device and systems that have novel properties and functions because of their small or intermediate size.[37] Nobel laureate Richard Smalley defines nanotechnology as ‘the art and science of building stuff that does stuff on the nano-meter scale. Eric Drexler defines nanotechnology as â€Å"engineering in the molecular scale†.[38] Some legal expert characterizes it â€Å"as the skillful management of matter at the scale of one billionth of a meter or smaller†.[39] The US Nanotechnology Act[40] defines nanotechnology as the science and technology that will enable one to understand measure, manipulate, and manufacture at the atomic, molecular, and supra-molecular levels.[41] Although nanotechnology encompasses many different types of concepts, it can be said generally that nanotechnology is a science to manipulation of matter or things at the scale of nano-meter.[42] Nanotechnology covers several established domains and technologies, with the exact definition of what are nanotechnology still being debated.[43] 1.1 Why is nanotechnology important? Nanotechnology is important in many senses. Nanotechnology will certainly change the nature of almost every human made object in the next century and will reshape out interaction with the surrounding world.[44] It covers a multiple fields of science and will create a vital opportunity in the future world. In the view of transformational impact, its a simple fact that it gives us a set of tools that make us enable to transform the world at a far smaller scale than was ever available to us before.[45] Nanotechnology enables us to change the structure of many different fields by giving us opportunity to access a realm where many of the old rules associated with matter apply no more.[46] Nanotechnology attracts a considerable amount of attention because it gives us opportunity to access to radically different capabilities with wide range of materials, even though we have been using those materials for many years. Nanotechnology will give rise to a wealth of new materials and manufacturin g possibilities, which will cause a great impact on our future economy, environment and society. Nest I will address some fields where the application of nanotechnology will have an important impact: Economic Impact: Many economists predict that nanotechnology will be the next economic turning point in the global economy. It may be the issue of every economic sector as it encompasses a large and diverse field. In nearly every economic sector such as health and medicine, materials, computing and electronics, military weapons, environment, energy, transportation and virtually every other commercial sector nanotechnology will play a great role in coming decades considering its numerous fields of applications. Nanotechnology has attracted the worldwide companies vastly. As of 2004, 1500 companies worldwide have declared their plans on nanotechnology research and development and of these 80% were newly startup companies.[47] The U.S. National Science has presumed that the world market for nanotechnology will reach 1 trillion USD or more within 20 years.[48] According to Lux Research, within next ten years nanotechnology applications will affect nearly every type of manufactured goods.[49] The EU recog nized nanotechnology as an important element for the benefit of its citizens. In 2007 the European Commission allocated EUR 600 million for nanotechnology research and development.[50] The former president of the United States, George W. Bush signed the 21st Century Nanotechnology Research and Development Act[51] on December 3, 2004 authorizing approximately $3.7 billion in federal funding for the development and research of nanotechnology over the next four years.[52] According to Mike Honda, California House Representative and co-drafter of the original Nanotechnology Act, the worldwide market for nanotechnology products and services could reach $ 1 trillion by 2015.[53] Nanotechnology in food security, environmental and public health issues: Nanotechnology will have a great impact on food security and environmental issues. In September 2003, the United States Department of Agriculture published its roadmap and in that report the Department predicted that nanotechnology will change the appearance of food industry, changing the way food is produced, processed, packaged, transported and consumed.[54] Helmuth Kaiser Consultancy predicts that the market of nano-food will rise from 2.6 billion USD to 20.4 billion USD by 2010.[55] Nanotechnology is capable of changing the agriculture and food industry with e.g. new tools for the molecular treatment of disease, speedy disease detection, raising the ability of plants to absorb nutrients etc..[56] Intelligent sensors and small delivery systems will help the agricultural industry combat viruses and other crop disease producing agents.[57] There is strong possibility that in the near future nano-structured catalysts will be available which will enhance the competency of pesticides a nd herbicides, allowing lower doses to be used. In CEA (Controlled Environment Agriculture), nano-technological devices providing ‘scouting capabilities could enormously improve the growers ability to determine the suitable time of harvest for the crop.[58] Another important role for nanotechnology-enabled devices will be the increased use of automatic sensors linked into a GPS system for real-time monitoring. These nano-sensors could be fixed throughout the field where they can monitor soil conditions and crop growth.[59] Wireless sensors are already being used in specific parts of the US and Australia. Nanotechnology can help us to improve our understanding of the biology of different crops and thus potentially increase yields or nutritional values.[60] Nanotechnology has also potential to save our environment indirectly through the use of renewable energy supplies, and filters or catalysts to control environment pollution and clean-up existing pollutants.[61] Nanotechnology can also be used to clean ground water. The US Company Argonide uses 2nm diameter aluminum oxide nano-fibres (Nano-cream) as an element of water purifier. This nano-level filtration system helps to remove viruses, bacteria and protozoan cysts from water. Developing countries like India and South Africa are also running similar projects using the same technique.[62] Research at the Centre for Biological and Environmental Nanotechnology (CBEN) has shown that nano-scale iron oxide particles are tremendously effective at binding and removing arsenic from groundwater,[63] which will play a great role especially in the developing countries where environmental pollution is an important factor. The development of nano-technological based remediation techniques can resto re and clean-up environmental injury and pollution (e.g. oil in water or soil).[64] Most of the opposition to nanotechnology has been targeted on the long term risks connected with self-replicating nano-robots. Some environmental groups, e.g. the Action Group On Erosion, Technology and Concentration (ETC) predicts that nano-materials may cause harm to human health and environment. Moreover the group urges to ban the production of nano-materials.[65] Besides these, some experts feel worried about impact of nano-particles in the environment and predict that some nano-elements will also be harmful for the environment and suggest that there must be a risk assessment authority for nano-particles. Nanotechnology in the medical sector: Nanotechnology is a technology which has vast possibilities in the development of health and medical treatment.[66] Medical science has made big advances in understanding the structure and functions of living organisms down to the genetic level. Nanotechnology created the opportunity to apply that knowledge significantly more perfect to the diagnosis and treatment of illness and injuries than in the traditional way.[67] Nanotechnology applications in medicine are growing significant interest, which can be labeled as ‘nano-medicine. ‘Nano-medicine can be defined as the medical application of nanotechnology that will have potential to lead to useful research tools, advanced drug delivery systems and new ways to combat disease or repair injured tissues and cells.[68] The advancement of nano-medicine may result in more significant interventions in respect of illness.[69] Nano-medicine is capable of prevention, early and accurate diagnosis and treatment of different diseases.[ 70] The experts on physical science predict that in future nanotechnology will apply to surgery and to cure different complex diseases in human body. Nanotechnology in military weapons: The first wave of nanotechnology will primarily be used in the military for state security related purposes.[71] Many nanotechnology experts presume that in many states have already taken lots of initiatives in their military sectors and given top priority to research in making nanotechnology weapons and its potentiality at the time of war and other military uses. It should be remembered that the Internet, computer and other land marking inventions of the last century were also military projects and now these inventions have changed the world in every sector and are being used for the welfare of mankind. The ultimate question comes down to whether the good outweigh the bad with respect to the utilization of this technology in this domain.[72] Nanotechnology in Information Technology (IT): Nanotechnology has enough potential for creating faster computers with larger memories than the present transistors and other components permit.[73] Carbon nano-tubes will also be used in IT. These tubes could be either conducting or semiconducting and have the potential for memory and storage as well. By using nanotechnology, computer tools will be cheaper than today and will create a sustainable IT sector. Without doubt nanotechnology will vastly affect the IT sector in the future. 1.2 EU policy for nanotechnology: Presently nanotechnologies strengthen many useful and practical applications and have huge possibilities to improve the quality of life and protection of environment and accelerate Europes industrial competition.[74] The European Commission has taken several steps to take nanotechnology research benefits for the development of the EU[75]. The EU is proceeding toward a collective and correlated strategy for nanotechnology research and development.[76] The Commission has not yet adopted any broad and specific public policy for nanotechnology but has adopted a strategy plan for the allocation of significant resources for supporting nanotechnology research and development.[77] But this strategy has yet not been turned into any formal legislation and/or regulation.[78] On June 7, 2005 the European Commission passed an Action Plan for the implementation of a strategy for European nano-science and nanotechnology development.[79] This action plan is not obligatory by law and in apparently it is simply a declaration and a step towards regulating nanotechnology further. In this action plan, the importance of research and examining the future impact of nano-science and nanotechnology is emphasised. The Commission have divided the Action Plan into five steps: Promote RD in the Europe: In this phase, the Commission recognized that by collaborating with public and private sectors across Europe for the research and development of nanotechnology, an interdisciplinary initiative is necessary. In 2007-2008, the Commission invested EUR 2.5 billion under the Research Framework Programme and before that in 2003-2006 EUR 1.4 billion had been invested.[80] As nanotechnologies have multidisciplinary character, the Research and Development (RD) projects have taken in different industrial sectors such as health, food, energy, transport, environment, etc.[81] Frame a base of European â€Å"Poles of Excellence†: This phases main aim is to build up poles of excellence into present structures for establishing highly-presentable world class poles in the area of nanotechnology by providing necessary services to the research community.[82] State of art equipment and instrumentation is day by day a challenge for the development of nanotechnology and to establish whether RD is enabling to transform into capable of being wealth rendering product and process.[83] The Commission is giving support continuously by funding access to present facilities and creating new facilities, which have led to ‘durable integration in the form of new institutes and virtual infrastructure such as the European Theoretical Spectroscopy Facility (ETSF).[84] Investing in human resources: The purpose of this axis is to conforming European educational system to the specifies of nanotechnology in the higher level studies which also cover legal technical subjects such as patenting nanotechnology and encourage the young people in the EU to nanotech studies and research.[85] Actually the development of nanotechnology mainly depends upon the skilled manpower and interdisciplinary actions. The main aim of this phase is to transform the nanotech knowledge from academy to industry.[86] Patronizing the transformation of knowledge into Industrial Applications: In this phase the Commissions strategy and its Action Plan pointed to two issues connected to IP: Patents and Standardization.[87] In respect of patents, the Commissions Action Plan advocates to establish a patent monitoring system for nanotechnology and to harmonize the patent prosecution system especially ‘sufficiency of disclosure and ‘inventive step, (which are crucial in case of nanotechnology patents) among the leading patent offices in the world such as the European Patent Office (EPO), the US Patent and Trademarks Office (USPTO) and the Japan Patent Office.[88] Concerning standardization, the Commission encourages pre-normative research and development in combined actions with the activities of European Standard Bodies.[89] Integrate the Social Dimension: The purpose of this phase is to recall an EU strategy about ethical principles in respect of health, safety and environmental aspects in the development of nanotechnology and making a transparent approach by open dialogues with E.U. citizens and stakeholders.[90] The Commission has taken several actions to reflect the peoples expectations and take their views into account.[91] In February 2008, EC passed a recommendation of ‘Code of conduct for responsible nano-science and nano-technologies research which gives guidelines towards a responsible and open approach.[92] Every proposal considered for funding by the Commission must meet the requirements of ethical issues.[93] The Commission is also giving efforts to increase researchers awareness to the Code of Conduct on nanotechnology research. Actually the Commission seeks the nanotechnology research to reflect and comply with the basic ethical values described in the core European Agreements such as ‘the European Charter of Fundamental Rights. 2.0 Relationship between Nanotechnology and IP: IPRs play a significance role in the development of new technologies. IPRs are essential in the present technology-driven age.[94] For an international perspective, nanotechnology is presently one of the most effective new technologies, in terms of number of patent applications.[95] Moreover, competitors in the nascent nanotechnology industries employ trade secrets legislation to supplement their control over key technology and expertise. In spite of being less directly involved in the nanotechnology industry, copyright and trademark legislation are also affect competitors in nanotechnology markets as the companies use computer software for nanotechnology research and development. Moreover, companies are also active to give their products commercial identification and trademark is playing a great role in that respect. IP law yields the primary regulatory vehicle by which ownership, control and use of nanotechnology are managed. The basic purpose of IP law is to facilitate for creators or inventors and encourage continuation of further development and creation. Thus IP law plays an influential role in a new and highly divergent functioning field of research and development like nanotechnology.[96] IP law also plays an important role in the integration of nanotechnology development into commercial applications.[97] The next part investigates how nanotechnology is related to IPRs. Patent: Patent law give legal rights to inventors. For a patent right to be granted certain criteria should be fulfilled such as eligible subject matter, inventive step, novelty and usefulness or industrial application and lastly sufficient disclosure and description.[98] Patents are important to protect small, emerging technology business.[99] Most business enterprises need a quantity of patent portfolio as insurance towards their already risky investment.[100] These criteria are not technology specific and thus should also be fulfilled in case of nanotechnology inventions. As much of the research in nanotechnology has been conducted through multidisciplinary fields, it may challenge the present patent system. For an example, as its a newly adopted technology in the field of science the patent examiner may grant broad patent rights to the inventor which in the future may cause a great barrier in the development of nanotechnology and society may be deprived from the benefits of nanot echnology. Copyright: Copyright law protects original expressions of ideas of literary and artistic works but not for the ideas themselves.[101] The main key of copyright is the ‘originality of authorship.[102] The issues of copyright are mostly likely to arise in respect of nanotechnology regarding computer software programs which is likely to be used for nanotechnology research and development.[103] Trademarks: Trademark rights protect words, logos and any other type of commercial identifiers.[104] These marks help the public to identify the respective products or services of a company. It also helps customers from not being misled by deceptive use of marks. As many nanotechnology related companies will come into the market, trademarks will play an important role to identify the different company and their products which is most crucial for investment of a company. Trademarks also indicate the goodwill of the company. Trade Secrets: Trade secrets can be defined as ‘confidential information or knowledge which is not widely known and gives competitive advantages to its owner. Companies may be more interested to keep some information or know-how of their products as trade secrets because under patent law after the expiry of the protection period the product will come into public domain. For trade secrets there is no time limit and business advantages may come from by using trade secret protection wisely, or a combination of patents and trade secrets. The use of different forms of IP offers different options for developers of nanotechnology. While nanotechnology industry is highly patent oriented the possibility of vast legal battles over nanotechnology patents in the future is likely to be happen. It also should be kept in mind that aggressive assertion of IPRs can create obstacles in important research of nanotechnology.[105] Patent busting, generics, technical standards and open sources are a few of the leading examples of critical IP challenges to all technology, including nanotechnology.[106] The challenges of IPR management of nanotechnology are not only for the ownership of IP but also the possibility of huge economic value from nanotechnology. 3.0 Patentability of Nanotechnology-European Aspect: The recent advancement of industrial research and development in the nanotechnology field is a worldwide phenomenon. Since last few years national and international governmental authorities, research institutes and industrial companies have increasingly aware of nanotechnology as a driving force for innovation in different fields including chemistry, material science, biotechnology and electronics.[107] For nanotechnology, patents are the most used and by far most important form of IP.[108] Nanotechnology is incomparably among the most patentable technologies, in that it is exceptional in attributes and nascent.[109] The main attraction in nanotechnology patenting is not only its size but also its ‘unique cross-industry pattern. Nanotechnology is exceptional compared with other technologies because it does not originates in a single branch of science like biotechnology, information technology etc.[110] The main characteristic of nanotechnology is its size. Surprisingly this is nearly the first new field in almost a century in which basic ideas, i.e. ‘the basic building block was patented at the beginning.[111] Patent rights give the rights holder an opportunity to gain economic and other related profits for a certain period as a reward for the invention. In case of nanotech research and invention there is a need for huge long term investments thus patent rights play a substantial role to recoup the investment of a company. Without a clear and sound patent regulatory system, large companies will be reluctant to invest in the field of nanotechnology and the development of nanotechnology invention will be hampered. Its no doubt that the rapid growth of nanotechnology will result a multiple field of application and jurisdiction and obviously will create a legal challenge in future IP regimes. The most basic issue is that whether nanotech inventions are patentable or not? In this chapter the ‘patentability of nanotechnology will be discussed in the light of European legal instruments and the WTO TRIPS Agreement. All inventions are not patentable. A patentable subject matter might not be (a) an abstract idea; (b) laws of nature; and (c) physical phenomena.[112] As mentioned, to qualify the patentability of an invention certain conditions must be satisfied. i) patent eligible subject matter; ii) utility; iii) novelty; iv) non-obviousness; and v) sufficient disclosure. In addition to the already mentioned patentability criteria, the claims have to be clear, brief and must be supported by the description.[113] The application of the inventions requires disclosing the invention is such a way as a whole that a person skilled in the art is being capable to carry out the invention.[114] There are not separate patentability rules for nanotech inventions. Thus any patent connected with the nano-field must fulfill the general requirements of patentability.[115] 3.1 Procedures at the European Patent Office: In Europe, an applicant can file a patent application either in the national patent office or in the Europe European Perspective on Nanotechnology Patents European Perspective on Nanotechnology Patents An Overview of Nanotechnology Patents: A European Perspective The future world will to a large extent consist of a knowledge based society. Intellectual property (IP) will play an important role in generating wealth and employment in that society. A general rule is that the more developed a country is the more stricter and secure for IP and strict to uphold the IPR. IP assets have become between 50 and 70 percent of the gross domestic products of a developed country.[1] In that sense it can be said that IP has become one of the most important assets of knowledge based economies.[2] Creativity is essential to economic growth.[3] It is feared that the development of new technologies and thereby the progress of societies will be halted without the presence of intellectual property rights (IPR). IPRs encourage the development of new technologies. IPRs aim at creating a harmonious relationship among investors, inventors and consumers. Patent rights are one of the important branches of IPR. The ultimate goal of patent rights is to promote invention a nd encourage further development of that invention for the benefit of society. Before going into an in-depth discussion on nanotechnology patents, it will be wise to discuss patent rights. The main aim of patent rights is to protect technological inventions.[4] Patents can be seen as the outcome indicators of applied research and technological advancement.[5] A patent protects novel and non-obvious ideas and not mere the expressions of those ideas.[6] The patent system is meant to protect technology, actual machines, devices and new chemical, biotechnological/nanotechnological compositions rather than pure concepts.[7] The main of the system is to promote the continuation of intellectual community[8] and industrial and technological development. Generally a patent may be defined as the exclusive right granted by statute to a party who conceives or discovers a non obvious and novel invention, to use and develop that invention, to prevent others from manufacturing, selling or using the invention for a limited time, which depends on the inventions and jurisdictions. Patent terms are typically from 14 to 20 years.[9] The applicant of a patent must show that the invention is eligible subject matter, novel, having industrial application or utility, inventive step and non-obviousness i.e. that the invention is not obvious to a skilled person in the field with ordinary knowledge and lastly adequate disclosure. Its not enough that an invention is new for a company or in a definite country. The described invention must be new in the international context.[10] Patent is very important in the intellectual and scientific community because of it relate to their reputation and to enrich their resume. In the sense of commercial sector, it i s important because it creates barriers to entry into the market.[11] The emergence of a new and pioneer technology creates issues and possibilities in perfecting IP rights.[12] Like other present technologies, nanotechnology isnt merely a part of a distant future, but is also a significant technology today.[13] Its obvious that nanotechnology will be one of the essential technologies of the 21st century which have enough potentiality to create new markets and prosperity.[14] Nanotechnologies are treated not as a standalone topic, but as a potential and important approach to develop new materials and accomplishment new properties. Their potential for characterizing and building up nano-structure will meet future goals in nearly all sectors. Nanotechnologies have the merit of joining together chemists, physicists, biologists, medical doctors, sociologists, etc. It has been held that nanotechnology will be one of the largest sectors of economic growth of world in the foreseeable future.[15] Such technology will be used in a wide range of products from mi litary weapons to clothing.[16] Many multinational companies have already invested huge amounts in the field of nanotechnology. The nano-world is full of surprise and potential.[17] As its a nascent technology, it may pose problems and opportunities for IP regimes.[18] Nanotechnology patents are not treated differently than other patents but it is true that more complex technology creates more complex problem within the patent system. It may be the next legal challenge in the field of IPR. Although early predictions for nanotechnology commercialization are encouraging, however, there are formidable challenges that include legal, environmental, ethical and regulatory questions, as well as emerging thickets of overlapping patent claims. The rapid technological development of nanotechnology will challenge the traditional regulatory system in patent law.[19] Another problem will arise to classify the nanotechnology because advanced nano-products may suit into different categories simultaneously.[20] One thing is certain, however, nanotechnology is here to stay and will generate both evolutionary as well as revolutionary products in the future, thereby improving all sectors of our life.[21] The impact of nanotechnology on our way of life is widely belie ved to reach profound and hitherto unimagined levels in the coming decades.[22] Nanotechnology is just passing its early stage in the field of science and very little development has occurred in the legal arena on nanotech. In this thesis, I will focus on legal sides of nanotechnology patents. My overall point of discussion is legal rather than technical. The first part of the thesis will contain a general overview of nanotechnology from a scientific view point, different governmental and non-governmental organizations approach as well as the importance of nanotechnology from other general aspects. In the second part of the thesis, the relationship between nanotechnology and IPR will be discussed. The third part of the thesis addresses the possibility of patenting nanotechnology inventions. This part also contains a brief description on EU policy towards nanotechnology patents. Finally, the future legal challenges which may face legal experts in the IP field regarding the patenting of nanotechnology products are analyzed. 1. What is Nanotechnology: Technological and theoretical improvements have moved us to the place where our knowledge of atomic construction and behavior has significantly improved.[23] This advancement enables human to enter the age of nanotechnology.[24] Nanotechnology is mainly consists of ‘nano- materials- e.g. carbon nano-tubes, fullerenes, nano-particles, quantum dots, dendrimers, nano-crystalline diamonds, nano-wires, etc.[25] According to Eric Drexler, a nano-optimist, nanotechnology can change the world in the way that the steam engine did.[26] A proper definition is very important in a field of science and technology, not least for patents.[27] It is very important to define nanotechnology from a legal point of view. The world of nanotechnology is a world of individual atoms and molecules.[28] Its the science to study and use of the unique characteristics of materials at nano-scale.[29] A precise definition of ‘nanotechnology in law and science is yet to be decided. It encompasses many dif ferent concepts and fields simultaneously, which is a difficult task. Even scientists in the field maintain that it â€Å"depends on whom you ask.†[30] Many experts and different governmental institutions have tried to define the concept of nanotechnology. Generally ‘nanotechnology seems to refer to very small science.[31] ‘Technology derives from the Greek tekhne, which means ‘skill or ‘discipline and ‘logos which means ‘speech.[32] ‘Nano comes from the Latin word for ‘dwarf, but today the prefix is more known to denote one billionth (i.e. one billionth of a metre).[33] Therefore nanotechnology could mean the discipline of assembly at the nanometer scale or in other words, molecular assemblage and mass molecular production.[34] Nanotechnology is an umbrella term used to define the properties or products and process at the nano/micro scale that have resulted from the convergence of the physical, chemical and life science.[35] EPO[36] defines ‘nanotechnology as follows: The term nanotechnology covers entities with a controlled geometrical size of at least one functional component below 100 nano-metres in one or more dimensions susceptible of making physical, chemical or biological effects 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 nano-metres. The U.S. ‘National Nanotechnology Initiative (NNI) predicted in a report issued by the U.S. Department of Energys Office of Basic Energy Sciences, the near term benefits of the developments of this new technology. The White House Office of Management and Budget devised a broader, more functional definition for nanotechnology. It defines Nanotechnology as : research and technology development at the atomic, molecular or macromolecular levels in the length scale of approximately 1-100 nano-meter range, to provide a fundamental understanding of the phenomena and materials properties at the nano-scale and to model, create, characterize, manipulate and use structures, device and systems that have novel properties and functions because of their small or intermediate size.[37] Nobel laureate Richard Smalley defines nanotechnology as ‘the art and science of building stuff that does stuff on the nano-meter scale. Eric Drexler defines nanotechnology as â€Å"engineering in the molecular scale†.[38] Some legal expert characterizes it â€Å"as the skillful management of matter at the scale of one billionth of a meter or smaller†.[39] The US Nanotechnology Act[40] defines nanotechnology as the science and technology that will enable one to understand measure, manipulate, and manufacture at the atomic, molecular, and supra-molecular levels.[41] Although nanotechnology encompasses many different types of concepts, it can be said generally that nanotechnology is a science to manipulation of matter or things at the scale of nano-meter.[42] Nanotechnology covers several established domains and technologies, with the exact definition of what are nanotechnology still being debated.[43] 1.1 Why is nanotechnology important? Nanotechnology is important in many senses. Nanotechnology will certainly change the nature of almost every human made object in the next century and will reshape out interaction with the surrounding world.[44] It covers a multiple fields of science and will create a vital opportunity in the future world. In the view of transformational impact, its a simple fact that it gives us a set of tools that make us enable to transform the world at a far smaller scale than was ever available to us before.[45] Nanotechnology enables us to change the structure of many different fields by giving us opportunity to access a realm where many of the old rules associated with matter apply no more.[46] Nanotechnology attracts a considerable amount of attention because it gives us opportunity to access to radically different capabilities with wide range of materials, even though we have been using those materials for many years. Nanotechnology will give rise to a wealth of new materials and manufacturin g possibilities, which will cause a great impact on our future economy, environment and society. Nest I will address some fields where the application of nanotechnology will have an important impact: Economic Impact: Many economists predict that nanotechnology will be the next economic turning point in the global economy. It may be the issue of every economic sector as it encompasses a large and diverse field. In nearly every economic sector such as health and medicine, materials, computing and electronics, military weapons, environment, energy, transportation and virtually every other commercial sector nanotechnology will play a great role in coming decades considering its numerous fields of applications. Nanotechnology has attracted the worldwide companies vastly. As of 2004, 1500 companies worldwide have declared their plans on nanotechnology research and development and of these 80% were newly startup companies.[47] The U.S. National Science has presumed that the world market for nanotechnology will reach 1 trillion USD or more within 20 years.[48] According to Lux Research, within next ten years nanotechnology applications will affect nearly every type of manufactured goods.[49] The EU recog nized nanotechnology as an important element for the benefit of its citizens. In 2007 the European Commission allocated EUR 600 million for nanotechnology research and development.[50] The former president of the United States, George W. Bush signed the 21st Century Nanotechnology Research and Development Act[51] on December 3, 2004 authorizing approximately $3.7 billion in federal funding for the development and research of nanotechnology over the next four years.[52] According to Mike Honda, California House Representative and co-drafter of the original Nanotechnology Act, the worldwide market for nanotechnology products and services could reach $ 1 trillion by 2015.[53] Nanotechnology in food security, environmental and public health issues: Nanotechnology will have a great impact on food security and environmental issues. In September 2003, the United States Department of Agriculture published its roadmap and in that report the Department predicted that nanotechnology will change the appearance of food industry, changing the way food is produced, processed, packaged, transported and consumed.[54] Helmuth Kaiser Consultancy predicts that the market of nano-food will rise from 2.6 billion USD to 20.4 billion USD by 2010.[55] Nanotechnology is capable of changing the agriculture and food industry with e.g. new tools for the molecular treatment of disease, speedy disease detection, raising the ability of plants to absorb nutrients etc..[56] Intelligent sensors and small delivery systems will help the agricultural industry combat viruses and other crop disease producing agents.[57] There is strong possibility that in the near future nano-structured catalysts will be available which will enhance the competency of pesticides a nd herbicides, allowing lower doses to be used. In CEA (Controlled Environment Agriculture), nano-technological devices providing ‘scouting capabilities could enormously improve the growers ability to determine the suitable time of harvest for the crop.[58] Another important role for nanotechnology-enabled devices will be the increased use of automatic sensors linked into a GPS system for real-time monitoring. These nano-sensors could be fixed throughout the field where they can monitor soil conditions and crop growth.[59] Wireless sensors are already being used in specific parts of the US and Australia. Nanotechnology can help us to improve our understanding of the biology of different crops and thus potentially increase yields or nutritional values.[60] Nanotechnology has also potential to save our environment indirectly through the use of renewable energy supplies, and filters or catalysts to control environment pollution and clean-up existing pollutants.[61] Nanotechnology can also be used to clean ground water. The US Company Argonide uses 2nm diameter aluminum oxide nano-fibres (Nano-cream) as an element of water purifier. This nano-level filtration system helps to remove viruses, bacteria and protozoan cysts from water. Developing countries like India and South Africa are also running similar projects using the same technique.[62] Research at the Centre for Biological and Environmental Nanotechnology (CBEN) has shown that nano-scale iron oxide particles are tremendously effective at binding and removing arsenic from groundwater,[63] which will play a great role especially in the developing countries where environmental pollution is an important factor. The development of nano-technological based remediation techniques can resto re and clean-up environmental injury and pollution (e.g. oil in water or soil).[64] Most of the opposition to nanotechnology has been targeted on the long term risks connected with self-replicating nano-robots. Some environmental groups, e.g. the Action Group On Erosion, Technology and Concentration (ETC) predicts that nano-materials may cause harm to human health and environment. Moreover the group urges to ban the production of nano-materials.[65] Besides these, some experts feel worried about impact of nano-particles in the environment and predict that some nano-elements will also be harmful for the environment and suggest that there must be a risk assessment authority for nano-particles. Nanotechnology in the medical sector: Nanotechnology is a technology which has vast possibilities in the development of health and medical treatment.[66] Medical science has made big advances in understanding the structure and functions of living organisms down to the genetic level. Nanotechnology created the opportunity to apply that knowledge significantly more perfect to the diagnosis and treatment of illness and injuries than in the traditional way.[67] Nanotechnology applications in medicine are growing significant interest, which can be labeled as ‘nano-medicine. ‘Nano-medicine can be defined as the medical application of nanotechnology that will have potential to lead to useful research tools, advanced drug delivery systems and new ways to combat disease or repair injured tissues and cells.[68] The advancement of nano-medicine may result in more significant interventions in respect of illness.[69] Nano-medicine is capable of prevention, early and accurate diagnosis and treatment of different diseases.[ 70] The experts on physical science predict that in future nanotechnology will apply to surgery and to cure different complex diseases in human body. Nanotechnology in military weapons: The first wave of nanotechnology will primarily be used in the military for state security related purposes.[71] Many nanotechnology experts presume that in many states have already taken lots of initiatives in their military sectors and given top priority to research in making nanotechnology weapons and its potentiality at the time of war and other military uses. It should be remembered that the Internet, computer and other land marking inventions of the last century were also military projects and now these inventions have changed the world in every sector and are being used for the welfare of mankind. The ultimate question comes down to whether the good outweigh the bad with respect to the utilization of this technology in this domain.[72] Nanotechnology in Information Technology (IT): Nanotechnology has enough potential for creating faster computers with larger memories than the present transistors and other components permit.[73] Carbon nano-tubes will also be used in IT. These tubes could be either conducting or semiconducting and have the potential for memory and storage as well. By using nanotechnology, computer tools will be cheaper than today and will create a sustainable IT sector. Without doubt nanotechnology will vastly affect the IT sector in the future. 1.2 EU policy for nanotechnology: Presently nanotechnologies strengthen many useful and practical applications and have huge possibilities to improve the quality of life and protection of environment and accelerate Europes industrial competition.[74] The European Commission has taken several steps to take nanotechnology research benefits for the development of the EU[75]. The EU is proceeding toward a collective and correlated strategy for nanotechnology research and development.[76] The Commission has not yet adopted any broad and specific public policy for nanotechnology but has adopted a strategy plan for the allocation of significant resources for supporting nanotechnology research and development.[77] But this strategy has yet not been turned into any formal legislation and/or regulation.[78] On June 7, 2005 the European Commission passed an Action Plan for the implementation of a strategy for European nano-science and nanotechnology development.[79] This action plan is not obligatory by law and in apparently it is simply a declaration and a step towards regulating nanotechnology further. In this action plan, the importance of research and examining the future impact of nano-science and nanotechnology is emphasised. The Commission have divided the Action Plan into five steps: Promote RD in the Europe: In this phase, the Commission recognized that by collaborating with public and private sectors across Europe for the research and development of nanotechnology, an interdisciplinary initiative is necessary. In 2007-2008, the Commission invested EUR 2.5 billion under the Research Framework Programme and before that in 2003-2006 EUR 1.4 billion had been invested.[80] As nanotechnologies have multidisciplinary character, the Research and Development (RD) projects have taken in different industrial sectors such as health, food, energy, transport, environment, etc.[81] Frame a base of European â€Å"Poles of Excellence†: This phases main aim is to build up poles of excellence into present structures for establishing highly-presentable world class poles in the area of nanotechnology by providing necessary services to the research community.[82] State of art equipment and instrumentation is day by day a challenge for the development of nanotechnology and to establish whether RD is enabling to transform into capable of being wealth rendering product and process.[83] The Commission is giving support continuously by funding access to present facilities and creating new facilities, which have led to ‘durable integration in the form of new institutes and virtual infrastructure such as the European Theoretical Spectroscopy Facility (ETSF).[84] Investing in human resources: The purpose of this axis is to conforming European educational system to the specifies of nanotechnology in the higher level studies which also cover legal technical subjects such as patenting nanotechnology and encourage the young people in the EU to nanotech studies and research.[85] Actually the development of nanotechnology mainly depends upon the skilled manpower and interdisciplinary actions. The main aim of this phase is to transform the nanotech knowledge from academy to industry.[86] Patronizing the transformation of knowledge into Industrial Applications: In this phase the Commissions strategy and its Action Plan pointed to two issues connected to IP: Patents and Standardization.[87] In respect of patents, the Commissions Action Plan advocates to establish a patent monitoring system for nanotechnology and to harmonize the patent prosecution system especially ‘sufficiency of disclosure and ‘inventive step, (which are crucial in case of nanotechnology patents) among the leading patent offices in the world such as the European Patent Office (EPO), the US Patent and Trademarks Office (USPTO) and the Japan Patent Office.[88] Concerning standardization, the Commission encourages pre-normative research and development in combined actions with the activities of European Standard Bodies.[89] Integrate the Social Dimension: The purpose of this phase is to recall an EU strategy about ethical principles in respect of health, safety and environmental aspects in the development of nanotechnology and making a transparent approach by open dialogues with E.U. citizens and stakeholders.[90] The Commission has taken several actions to reflect the peoples expectations and take their views into account.[91] In February 2008, EC passed a recommendation of ‘Code of conduct for responsible nano-science and nano-technologies research which gives guidelines towards a responsible and open approach.[92] Every proposal considered for funding by the Commission must meet the requirements of ethical issues.[93] The Commission is also giving efforts to increase researchers awareness to the Code of Conduct on nanotechnology research. Actually the Commission seeks the nanotechnology research to reflect and comply with the basic ethical values described in the core European Agreements such as ‘the European Charter of Fundamental Rights. 2.0 Relationship between Nanotechnology and IP: IPRs play a significance role in the development of new technologies. IPRs are essential in the present technology-driven age.[94] For an international perspective, nanotechnology is presently one of the most effective new technologies, in terms of number of patent applications.[95] Moreover, competitors in the nascent nanotechnology industries employ trade secrets legislation to supplement their control over key technology and expertise. In spite of being less directly involved in the nanotechnology industry, copyright and trademark legislation are also affect competitors in nanotechnology markets as the companies use computer software for nanotechnology research and development. Moreover, companies are also active to give their products commercial identification and trademark is playing a great role in that respect. IP law yields the primary regulatory vehicle by which ownership, control and use of nanotechnology are managed. The basic purpose of IP law is to facilitate for creators or inventors and encourage continuation of further development and creation. Thus IP law plays an influential role in a new and highly divergent functioning field of research and development like nanotechnology.[96] IP law also plays an important role in the integration of nanotechnology development into commercial applications.[97] The next part investigates how nanotechnology is related to IPRs. Patent: Patent law give legal rights to inventors. For a patent right to be granted certain criteria should be fulfilled such as eligible subject matter, inventive step, novelty and usefulness or industrial application and lastly sufficient disclosure and description.[98] Patents are important to protect small, emerging technology business.[99] Most business enterprises need a quantity of patent portfolio as insurance towards their already risky investment.[100] These criteria are not technology specific and thus should also be fulfilled in case of nanotechnology inventions. As much of the research in nanotechnology has been conducted through multidisciplinary fields, it may challenge the present patent system. For an example, as its a newly adopted technology in the field of science the patent examiner may grant broad patent rights to the inventor which in the future may cause a great barrier in the development of nanotechnology and society may be deprived from the benefits of nanot echnology. Copyright: Copyright law protects original expressions of ideas of literary and artistic works but not for the ideas themselves.[101] The main key of copyright is the ‘originality of authorship.[102] The issues of copyright are mostly likely to arise in respect of nanotechnology regarding computer software programs which is likely to be used for nanotechnology research and development.[103] Trademarks: Trademark rights protect words, logos and any other type of commercial identifiers.[104] These marks help the public to identify the respective products or services of a company. It also helps customers from not being misled by deceptive use of marks. As many nanotechnology related companies will come into the market, trademarks will play an important role to identify the different company and their products which is most crucial for investment of a company. Trademarks also indicate the goodwill of the company. Trade Secrets: Trade secrets can be defined as ‘confidential information or knowledge which is not widely known and gives competitive advantages to its owner. Companies may be more interested to keep some information or know-how of their products as trade secrets because under patent law after the expiry of the protection period the product will come into public domain. For trade secrets there is no time limit and business advantages may come from by using trade secret protection wisely, or a combination of patents and trade secrets. The use of different forms of IP offers different options for developers of nanotechnology. While nanotechnology industry is highly patent oriented the possibility of vast legal battles over nanotechnology patents in the future is likely to be happen. It also should be kept in mind that aggressive assertion of IPRs can create obstacles in important research of nanotechnology.[105] Patent busting, generics, technical standards and open sources are a few of the leading examples of critical IP challenges to all technology, including nanotechnology.[106] The challenges of IPR management of nanotechnology are not only for the ownership of IP but also the possibility of huge economic value from nanotechnology. 3.0 Patentability of Nanotechnology-European Aspect: The recent advancement of industrial research and development in the nanotechnology field is a worldwide phenomenon. Since last few years national and international governmental authorities, research institutes and industrial companies have increasingly aware of nanotechnology as a driving force for innovation in different fields including chemistry, material science, biotechnology and electronics.[107] For nanotechnology, patents are the most used and by far most important form of IP.[108] Nanotechnology is incomparably among the most patentable technologies, in that it is exceptional in attributes and nascent.[109] The main attraction in nanotechnology patenting is not only its size but also its ‘unique cross-industry pattern. Nanotechnology is exceptional compared with other technologies because it does not originates in a single branch of science like biotechnology, information technology etc.[110] The main characteristic of nanotechnology is its size. Surprisingly this is nearly the first new field in almost a century in which basic ideas, i.e. ‘the basic building block was patented at the beginning.[111] Patent rights give the rights holder an opportunity to gain economic and other related profits for a certain period as a reward for the invention. In case of nanotech research and invention there is a need for huge long term investments thus patent rights play a substantial role to recoup the investment of a company. Without a clear and sound patent regulatory system, large companies will be reluctant to invest in the field of nanotechnology and the development of nanotechnology invention will be hampered. Its no doubt that the rapid growth of nanotechnology will result a multiple field of application and jurisdiction and obviously will create a legal challenge in future IP regimes. The most basic issue is that whether nanotech inventions are patentable or not? In this chapter the ‘patentability of nanotechnology will be discussed in the light of European legal instruments and the WTO TRIPS Agreement. All inventions are not patentable. A patentable subject matter might not be (a) an abstract idea; (b) laws of nature; and (c) physical phenomena.[112] As mentioned, to qualify the patentability of an invention certain conditions must be satisfied. i) patent eligible subject matter; ii) utility; iii) novelty; iv) non-obviousness; and v) sufficient disclosure. In addition to the already mentioned patentability criteria, the claims have to be clear, brief and must be supported by the description.[113] The application of the inventions requires disclosing the invention is such a way as a whole that a person skilled in the art is being capable to carry out the invention.[114] There are not separate patentability rules for nanotech inventions. Thus any patent connected with the nano-field must fulfill the general requirements of patentability.[115] 3.1 Procedures at the European Patent Office: In Europe, an applicant can file a patent application either in the national patent office or in the Europe