Monday, June 3, 2019
European Perspective on Nanotechnology Patents
European Perspective on Na n iodinchnology sp arsAn Over position of Nano technology Patents A European PerspectiveThe forthcoming orb leave behind to a large extent consist of a know leadge based society. Intellectual property (IP) bequeath play an authorized case in generating wealth and employment in that society. A general rule is that the to a outstandinger extent veritable a country is the to a gravider extent stricter and se bring back for IP and strict to keep on the IPR. IP assets charter be put in between 50 and 70 percent of the gross domestic products of a developed country.1 In that sense it stick outnister be said that IP has become single of the closely important assets of knowledge based economies.2 Creativity is essential to stinting exploitation.3 It is fe ard that the emergence of clean technologies and thereby the progression of societies forget be halted without the presence of intellectual property rights (IPR). IPRs encourage the developm ent of vernal technologies. IPRs aim at creating a harmonious relationship among investors, inventors and consumers. Patent rights atomic number 18 one of the important forkes of IPR. The ultimate goal of letters transpargonnt rights is to promote trick and encourage further development of that design for the benefit of society.Before going into an in-depth interchange on na nonechnology letters unmistakables, it get out be wise to discuss patent rights. The chief(prenominal) aim of patent rights is to value proficient inventions.4 Patents crowd out be seen as the la experimental conditionath indicators of applied seek and technological furtherance.5 A patent protects novel and non-obvious opinions and not mere the expressions of those ideas.6 The patent system is meant to protect technology, actual machines, subterfuges and parvenu chemical substance, biotechnological/nanotechnological compositions rather than thin concepts.7 The main of the system is to promot e the subsequence of intellectual comp all8 and industrial and technological development.Generally a patent whitethorn be defined as the undivided right earmarked by statute to a party who conceives or discovers a non obvious and novel invention, to lend oneself and develop that invention, to prevent others from manufacturing, selling or development the invention for a limited clipping, which depends on the inventions and jurisdictions. Patent impairment atomic number 18 typically from 14 to 20 years.9 The appli nominatet of a patent moldiness show that the invention is qualified subject matter, novel, having industrial drill or utility, inventive step and non-obviousness i.e. that the invention is not obvious to a skilled somebody in the compass with ordinary knowledge and live only adequate disclosure. Its not enough that an invention is new for a company or in a definite country. The expound invention must be new in the supranational context.10 Patent is actuall y important in the intellectual and scientific community beca economic consumption of it relate to their reputation and to enrich their resume. In the sense of commercial-grade empyrean, it is important beca phthisis it stools barriers to entry into the grocery.11The emergence of a new and pioneer technology creates issues and possibilities in completeding IP rights.12 Like other present technologies, nanotechnology isnt merely a part of a distant future, but is likewise a significant technology today.13 Its obvious that nanotechnology go a counseling be one of the essential technologies of the 21st light speed which occupy enough probableity 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 bodilys and accomplishment new properties. Their potential for characterizing and building up nano- organise go forth figure future goals in well all sectors. Nanotechnologies hav e 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 stinting growth of terra firma in the foreseeable future.15 Such technology will be used in a considerable range of products from military weapons to clo issue.16 Many transnational companies have already invested coarse amounts in the sphere of nanotechnology. The nano-world is full of surp organise and potential.17 As its a nascent technology, it whitethorn pose line of works and opportunities for IP regimes.18Nanotechnology patents are not treated divers(prenominal)ly than other patents but it is true that more complex technology creates more complex problem within the patent system. It may be the succeeding(a) reasoned challenge in the field of IPR. Although early signalions for nanotechnology commercialization are encouraging, however, there are unnerving challenges that include levelheaded, e nvironsal, ethical and regulatory interrogatorys, as well as emerging thickets of overlapping patent claims. The rapid technological development of nanotechnology will challenge the conventional regulatory system in patent natural right of nature.19 Another problem will arise to course of instructionify the nanotechnology because advanced nano-products may suit into assorted categories simultaneously.20 One thing is certain, however, nanotechnology is here to stay and will move over both evolutionary as well as revolutionary products in the future, thereby improving all sectors of our demeanor.21 The meet of nanotechnology on our way of life is widely believed to do profound and hitherto unimagined levels in the coming decades.22Nanotechnology is just passing its early stage in the field of science and very exact development has occurred in the sub judice arena on nanotech. In this thesis, I will focus on effective sides of nanotechnology patents. My overall point o f discussion is sub judice rather than technical. The first part of the thesis will contain a general overview of nanotechnology from a scientific view point, distinguishable 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 maneuveres the possibility of patenting nanotechnology inventions. This part in addition 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 NanotechnologyTechnological and theoretical amelioratements have moved us to the place where our knowledge of atomic construction and behavior has significantly improved.23 This advancement enables world to enter the age of nanotechnolo gy.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 another(prenominal) different concepts and fields simultaneously, which is a difficult task. Even scientists in the field maintain that it depends on whom you ask.30 Many experts and different governmental institutions have tried to define the conc ept of nanotechnology. Generally nanotechnology seems to refer to very small science.31 applied science derives from the Hellenic tekhne, which means skill or crack and logos which means speech.32 Nano comes from the Latin word for dwarf, but today the prefix is more cognise to denote one billionth (i.e. one billionth of a metre).33 at that placefore nanotechnology could mean the discipline of assembly at the nanometer scale or in other words, molecular(a) assemblage and mass molecular proceeds.34Nanotechnology is an comprehensive 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 EPO36 defines nanotechnology as followsThe term nanotechnology covers entities with a authorityled 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. interior(a) 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 agency of Management and Budget devised a broader, more functional definition for nanotechnology. It defines Nanotechnology as search 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 lowstanding 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.37Nobel laureate Richard Smalley defines nanot echnology as the art and science of building stuff that does stuff on the nano-meter scale. Eric Drexler defines nanotechnology as plan in the molecular scale.38 round legal expert characterizes it as the skillful management of matter at the scale of one billionth of a meter or smaller.39 The US Nanotechnology Act40 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 primarily 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 be debated.43 1.1 why is nanotechnology important?Nanotechnology is important in many senses. Nanotechnology will certainly change the nature of al around every human made o bject in the neighboring century and will reshape out inter proceeding with the surrounding world.44 It covers a multiple fields of science and will create a vital probability in the future world. In the view of transformational clash, its a simple fact that it gives us a set of tools that puzzle us enable to transform the world at a far smaller scale than was ever available to us in front.45 Nanotechnology enables us to change the structure of many different fields by giving us opportunity to gateway a realm where many of the old rules associated with matter dupe no more.46 Nanotechnology attracts a considerable amount of wariness 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 manufacturing possibilities, which will cause a great impact on our future economy, purlieu and society. Nest I w ill address some fields where the application of nanotechnology will have an important impactEconomic ImpactMany 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(prenominal) as health and medicine, materials, computing and electronics, military weapons, environment, energy, transportation and close every other commercial sector nanotechnology will play a great reference in coming decades considering its numerous fields of applications. Nanotechnology has attracted the worldwide companies immensely. As of 2004, 1500 companies worldwide have declared their plans on nanotechnology look into 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 authorize 1 trillion USD or more within 20 years.48 According to Lu x inquiry, within next ten years nanotechnology applications will affect nearly every type of manufactured goods.49 The EU recognized nanotechnology as an important factor for the benefit of its citizens. In 2007 the European Commission allocated EUR 600 million for nanotechnology research and development.50 The creator president of the United States, George W. Bush subscribe the 21st Century Nanotechnology Research and Development Act51 on December 3, 2004 authorizing approximately $3.7 billion in federal bread and butter 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 aliment security, environmental and mankind health issuesNanotechnology will have a great impact on nutrition security and environmental issues. In phratry 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 attention, 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 subject of changing the agriculture and food industry with e.g. new tools for the molecular treatment of unsoundness, speedy disease detection, raising the ability of plants to absorb nutrients etc..56 Intelligent sensors and small delivery systems will help the agricultural industry scrap 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 energy of pesticides and herbicides, allowing lower doses to be used. In CEA (Controlled milieu Agriculture), nano-tech nological 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 remindering. These nano-sensors could be fixed throughout the field where they can monitor soil conditions and crop growth.59 Wireless sensors are already cosmos used in detail parts of the US and Australia. Nanotechnology can help us to improve our understanding of the biology of different crops and therefore potentially increase yields or nutritional look ons.60Nanotechnology has in addition potential to save our environment indirectly through the use of renewable energy supplies, and filters or catalysts to control environment contamination and clean-up existing pollutants.61 Nanotechnology can alike be used to clean ground water. The US association Argonide uses 2nm diameter alu minum 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 caterpillar tread 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 restore and clean-up environmental injury and pollution (e.g. oil in water or soil).64Most of the opposition to nanotechnology has been targeted on the long term risks connected with self-replicating nano-robots. whatsoever environmental groups, e.g. the movement Group On Erosion, Technology and Concentr ation (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 in a bad way(p) 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 sectorNanotechnology is a technology which has vast possibilities in the development of health and medical treatment.66 medical examination 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. Nan o-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 exposed 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 weaponsThe first wave of nanotechnology will primarily be used in the military for give in security link up purposes.71 Many nanotechnology experts presume that in many states have already taken lots of initiatives in their military sectors and given top precession 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, information processing system and other land marking inventions of the withstand 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 careing or semiconducting and have the potential for retentivity 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 nanotechnologyPresently nanotechn ologies 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 EU75. The EU is proceeding toward a collective and correlated strategy for nanotechnology research and development.76 The Commission has not yet select 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 regulation 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 exertion plan is not obligatory by law and in apparently it is simply a declaration an d 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 stepsPromote RD in the EuropeIn this form, the Commission recognized that by collaborating with public and private sectors across Europe for the research and development of nanotechnology, an interdisciplinary initiative is obligatory. 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.81Frame a base of European Poles of ExcellenceThis phases main aim is to build up poles of excellence into present structures for establishing super-presentable worl d 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 speculative Spectroscopy Facility (ETSF).84Investing in human resourcesThe 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 custod y and interdisciplinary actions. The main aim of this phase is to transform the nanotech knowledge from academy to industry.86Patronizing the transformation of knowledge into Industrial ApplicationsIn 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 adequateness of disclosure and inventive step, (which are crucial in case of nanotechnology patents) among the steer patent offices in the world such as the European Patent Office (EPO), the US Patent and Trade label 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.89Integrate the Social balanceThe purpose of this phase is to reca ll 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 diffuse 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 be with the basic ethical values described in the core European Agreements such as the European Charter of Fundamental Rights.2.0 Relationship between Nanotechnol ogy and IPIPRs 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 just about effective new technologies, in terms of number of patent applications.95 Moreover, competitors in the nascent nanotechnology industries employ alternate secrets legislation to supplement their control over mention 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 program 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 decent 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 hence should also be fulfilled in case of nanotechnology inven tions. 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 nanotechnology.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.103Trademarks 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 i ndustry 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 AspectThe 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 induction 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.110The 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 investme nts 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 stipulate the patentability of an invention certain conditions must be satisfied.i) patent eligible subject matterii) utilityiii) noveltyiv) non-obvious ness andv) 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.1153.1 Procedures at the European Patent OfficeIn Europe, an applicant can file a patent application either in the national patent office or in the EuropeEuropean Perspective on Nanotechnology PatentsEuropean Perspective on Nanotechnology PatentsAn Overview of Nanotechnology Patents A European PerspectiveThe 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 th at 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 and 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 community8 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 e ligible 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 is important because it creates barriers to entry into the market.11The 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 military 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.18Nanotechnology patents are not treated differently than other patents but it is true that more complex technolog y 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 believed to reach profound and hitherto unimagined levels in the coming decades.22Nanotechnology 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 NanotechnologyTechnological and theoretical improvements have moved u s 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 different concepts and fields simultaneously, which is a difficult task. Even scienti sts in the field maintain that it 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.34Nanotechnology 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 EPO36 defines nanotechnology as followsThe term nanotechnology covers entities with a controlled geometrical size of at least one functional component below 100 nano-m etres 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 prope rties and functions because of their small or intermediate size.37Nobel 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 engineering in the molecular scale.38 Some legal expert characterizes it as the skillful management of matter at the scale of one billionth of a meter or smaller.39 The US Nanotechnology Act40 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?Nanotech nology 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 manufacturing possibiliti es, 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 impactEconomic ImpactMany 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 wi ll 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 recognized 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 Act51 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 issuesNanotechnology 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 and herbicides, allowing lower doses to be used. In CEA (Controll ed 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.60Nanotechnology 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 diamet er 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 restore and clean-up environmental injury and pollution (e.g. oil in water or soil).64Most 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) pred icts 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 sectorNanotechnology 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 medic al 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 weaponsThe 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, compu ter 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 nanotechnologyPresently nanotechnologies strengthen many useful and practical applications and have huge possibi lities 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 EU75. 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 impor tance of research and examining the future impact of nano-science and nanotechnology is emphasised. The Commission have divided the Action Plan into five stepsPromote RD in the EuropeIn 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.81Frame a base of European Poles of ExcellenceThis 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 r esearch 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).84Investing in human resourcesThe 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 nanot ech knowledge from academy to industry.86Patronizing the transformation of knowledge into Industrial ApplicationsIn 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.89Integrate the Social DimensionThe purpose of this phase is to recall an EU strategy about ethical principles in respect of health, safety and environmen tal 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 IPIPRs play a significance role in the development of new technologies. IPRs ar e 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. Th us 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 cha llenge 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 nanotechnology.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.103Trademarks 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 futur e 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 AspectThe 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 m ost 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.110The 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 matterii) utilityiii) noveltyiv) non-obviousness andv) 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.1153.1 Procedures at the European Patent OfficeIn Europe, an applicant can file a patent application either in the national patent office or in the Europe
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