European Perspective on Nanotechnology Patents
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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. In that sense it can be said that IP has become one of the most important assets of knowledge based economies. Creativity is essential to economic growth. 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. Patents can be seen as the outcome indicators of applied research and technological advancement. A patent protects novel and non-obvious ideas and not mere the expressions of those ideas. The patent system is meant to protect technology, actual machines, devices and new chemical, biotechnological/nanotechnological compositions rather than pure concepts. The main of the system is to promote the continuation of intellectual community 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. 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. It's 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. 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.
The emergence of a new and pioneer technology creates issues and possibilities in perfecting IP rights. Like other present technologies, nanotechnology isn't merely a part of a distant future, but is also a significant technology today. It's obvious that nanotechnology will be one of the essential technologies of the 21st century which have enough potentiality to create new markets and prosperity. 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. Such technology will be used in a wide range of products from military weapons to clothing. Many multinational companies have already invested huge amounts in the field of nanotechnology. The nano-world is full of surprise and potential. As it's a nascent technology, it may pose problems and opportunities for IP regimes.
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. Another problem will arise to classify the nanotechnology because advanced nano-products may suit into different categories simultaneously. 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. The impact of nanotechnology on our way of life is widely believed to reach profound and hitherto unimagined levels in the coming decades.
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. This advancement enables human to enter the age of nanotechnology. Nanotechnology is mainly consists of ‘nano- materials'- e.g. carbon nano-tubes, fullerenes, nano-particles, quantum dots, dendrimers, nano-crystalline diamonds, nano-wires, etc. According to Eric Drexler, a nano-optimist, nanotechnology can change the world in the way that the steam engine did. A proper definition is very important in a field of science and technology, not least for patents. 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. It's the science to study and use of the unique characteristics of materials at nano-scale. 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 scientists in the field maintain that it “depends on whom you ask.” Many experts and different governmental institutions have tried to define the concept of nanotechnology. Generally ‘nanotechnology' seems to refer to very small science. ‘Technology' derives from the Greek tekhne, which means ‘skill' or ‘discipline' and ‘logos' which means ‘speech'. ‘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). Therefore nanotechnology could mean the discipline of assembly at the nanometer scale or in other words, molecular assemblage and mass molecular production.
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. EPO 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 Energy's 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.
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 “engineering in the molecular scale”. Some legal expert characterizes it “as the skillful management of matter at the scale of one billionth of a meter or smaller”. The US Nanotechnology Act 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." 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. Nanotechnology covers several established domains and technologies, with the exact definition of what are nanotechnology still being debated.
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. It covers a multiple fields of science and will create a vital opportunity in the future world. In the view of transformational impact, it's 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. 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. 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 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:
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. The U.S. National Science has presumed that the world market for nanotechnology will reach 1 trillion USD or more within 20 years. According to Lux Research, within next ten years nanotechnology applications will affect nearly every type of manufactured goods. 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. The former president of the United States, George W. Bush signed the 21st Century Nanotechnology Research and Development Act on December 3, 2004 authorizing approximately $3.7 billion in federal funding for the development and research of nanotechnology over the next four years. 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."
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. Helmuth Kaiser Consultancy predicts that the market of nano-food will rise from 2.6 billion USD to 20.4 billion USD by 2010. 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.. Intelligent sensors and small delivery systems will help the agricultural industry combat viruses and other crop disease producing agents. 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 (Controlled Environment Agriculture), nano-technological devices providing ‘scouting' capabilities could enormously improve the grower's ability to determine the suitable time of harvest for the crop. 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. 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.
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. 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. 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, 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).
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. 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. 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. 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. The advancement of nano-medicine may result in more significant interventions in respect of illness. Nano-medicine is capable of prevention, early and accurate diagnosis and treatment of different diseases. 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. 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.
Nanotechnology in Information Technology (IT):
Nanotechnology has enough potential for creating faster computers with larger memories than the present transistors and other components permit. 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 Europe's industrial competition. The European Commission has taken several steps to take nanotechnology research benefits for the development of the EU. The EU is proceeding toward a collective and correlated strategy for nanotechnology research and development. 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. But this strategy has yet not been turned into any formal legislation and/or regulation. On June 7, 2005 the European Commission passed an Action Plan for the implementation of a strategy for European nano-science and nanotechnology development. 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 R&D 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. As nanotechnologies have multidisciplinary character, the Research and Development (R&D) projects have taken in different industrial sectors such as health, food, energy, transport, environment, etc.
Frame a base of European “Poles of Excellence”:
This phase's 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. State of art equipment and instrumentation is day by day a challenge for the development of nanotechnology and to establish whether R&D is enabling to transform into capable of being wealth rendering product and process. 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).
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. 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.
Patronizing the transformation of knowledge into Industrial Applications:
In this phase the Commission's strategy and its Action Plan pointed to two issues connected to IP: Patents and Standardization. In respect of patents, the Commission's 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. Concerning standardization, the Commission encourages pre-normative research and development in combined actions with the activities of European Standard Bodies.
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. The Commission has taken several actions to reflect the people's expectations and take their views into account. 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. Every proposal considered for funding by the Commission must meet the requirements of ethical issues. 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. For an international perspective, nanotechnology is presently one of the most effective new technologies, in terms of number of patent applications. 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. IP law also plays an important role in the integration of nanotechnology development into commercial applications. 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. Patents are important to protect small, emerging technology business. Most business enterprises need a quantity of patent portfolio as insurance towards their already risky investment. 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 it's 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. The main key of copyright is the ‘originality of authorship'. 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.
Trademarks: Trademark rights protect words, logos and any other type of commercial identifiers. 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. Patent busting, generics, technical standards and open sources are a few of the leading examples of critical IP challenges to all technology, including nanotechnology. 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. For nanotechnology, patents are the most used and by far most important form of IP. Nanotechnology is incomparably among the most patentable technologies, in that it is exceptional in attributes and nascent. 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.
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. 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. It's 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. As mentioned, to qualify the patentability of an invention certain conditions must be satisfied.
i) patent eligible subject matter;
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. 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. There are not separate patentability rules for nanotech inventions. Thus any patent connected with the nano-field must fulfill the general requirements of patentability.
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 European Patent Office (EPO) in Munich. Before going to the discussion of the nanotechnology aspects of the patentability, the practice of EPO rules and regulation will be briefly discussed.
To apply for a European patent an application must be consists of the followings:-
- A description of the patent claimed products.
- A set of claims which are the basis of description and the scope of protection are defined.
- To illustrate the features of invention, a set of drawings can be added as a useful supplement of the description.
- An abstract.
The patent examiner first performs a search. The search is conducted in both the EPO's in-house database EPODOC and commercial patent databases. In ‘high-tech' related fields like nanotechnology, the examiner also executes some extra searches in non-profits literature. For this work, EPO keeps a broad electronics library including on-line access to a very huge collection of scientific journals. After finishing the search, the examiner prepares a European search report which includes all the documents available to the office that are regarded relevant in examining novelty and inventiveness of the particular submission.
The search report is generally prepared on the patent claims, the description and any supplemented drawings. Then the examiner sends the search report to the applicant along with a copy of any cited documents. The report of the examiner also includes a primary opinion on the patentability of the claimed invention. The EPO generally publishes the applications along with the searching report after eighteen months following either the application filing date or the priority date. After publishing of the EPO report, the applicant has to claim their patent rights within six months from the date of publication by requesting a final examination.
If the applicant requests a final examination, the EPO examines whether the application and the invention satisfy the patentability requirements of the European Patent Convention (EPC). Generally, the patentability of the invention is examined in light of the documents referred to in the search report.
The examining division generally consists of three technically qualified patent examiner and they perform the substantive examination of European patent application. In most cases, the substantive examination is conducted by the same examiner who prepared the initial search report. The examiners are normally highly qualified in the relevant technical field. For examining of multi-disciplinary inventions like nanotechnology, experts in different technical field of technology are required. At the time of examination of a patent application, the examination also follows the corresponding rules of the Implementing Regulations of the EPC and the Guidelines for Examination of the EPO.
Opposition and Appeal Procedures:
After the examination phase, the applicant may either be granted the European patent or the application may be refused. After grant of a European patent application any third party may oppose the granted patent. The opposition application is examined and handled by the EPO Opposition Divisions which consists of three to four members of which one of the members have been involved with the original application. The decisions of the EPO Opposition Division are open to appeal before the EPO's Board of Appeal.
3.2 Patentability of nanotechnology inventions in Europe
Nanotechnology covers a multi disciplinary field and to develop a nanotechnology product multi disciplinary teams are needed. At the first stage of nanotechnology patent, there is a presumption that nanotechnology related inventions face some unique problems. But after that closer scrutiny shows that nanotechnology related inventions are not face extra ordinary or unique challenges with patentability issues. In fact, same patent rules, regulations and procedure are followed with nanotechnology related inventions. As mentioned, it is immaterial whether the invention is related with nanotechnology or not, all patent applications must fulfill the criteria and rules of the EPC. The US approach is the same as the European. In the Re Kumar Case the CAFC (Court of Appeal for the Federal Circuit) stated that ‘the standard of review for nanotechnology will not be different than any other patent eligible subject matter.' The EPO has a similar position. The pre-requisites for patentability described in the EPC will be separately discussed:
Generally the requirements of novelty ensure that the invention have not been known or previously used by others. Novelty is examined against the prior art available as national and abroad patents, publications, public exhibition or use of invention. Article 54 of EPC describes novelty as follows:
“(1) an invention shall be considered to be new if it does not form part of the state of the art. (2) The state of the art shall be held to comprise everything made available to the public by means of a written or oral description, by use, or in any other way, before the date of filing of the European patent application. (3) additionally, the content of European patent applications as filed, the dates of filing of which are prior to the date referred to in paragraph 2 and which were published on or after that date, shall be considered as comprised in the state of the art.”
To fulfill the EPC novelty criterion, the size of nano-scale elements must be sufficient to distinguish from elements of the prior art. Prior art is the main obstacle to survive to obtain a patent on any technology, and nanotechnology is no exception. One of the problems in patenting nanotechnology products is that the most basic ideas in nanotechnology are either already patented or close to application. If an invention is defined by a standard only of its size, there is a possibility of creating problems in the patenting of nanotechnology inventions. For an example, if the standard of size for patenting nanotechnology inventions are “20-100nm”, many inventions at first sight would not be novel because the claimed range “20-100nm” is already included in the prior art, although the invention is unique and functionally different from prior art. For this reason, the so called ‘selection invention' method can be followed to establish novelty of nanotechnology inventions over prior art.
To satisfy novelty requirements of a sub-range selection invention from a broader numerical range of the prior art, the following criteria is to be followed:-
a) the claimed range must be narrow from the known range.
b) the selected sub-range also have to be sufficiently distant from the disclosed prior art and from the end points of the known range.
c) the selected sub-range should not be arbitrarily chosen part of the prior art and must be purposively selected along with having new technical teaching.
While nanotechnology is a nascent field of science, too few cases have been heard in the EPO. Some EPO Case Laws are the following:
Decision in the T 0006/02 (Photodegradable Cellulose Ester Tow) Case:
The increased photo degradability of cellulose ester by the inclusion of nano-particle size Titanium Dioxide was regarded as novel since a generic disclosure like plastics materials as laid down in the prior art does not generally take away the novelty of any specific example (cellulose esters) falling within that disclosure.
Decision in the T 0915/00 (Nanocrystalline Metals) Case:
The nano-crystal nickel material, taken by electrode position and having crystalline size of less than 11 nm, was novel over a distinguishingly identical material disclosed in the literature, constituted by macro crystalline Nickel obtained by electrode position.
Decision in the T 0509/92 (Dipeptide Crystals) Case:
The Board was of the opinion that there was no disclosure in any of the said prior art documents of aspartame type IIa crystals having the given X-ray attributes and moisture content. For these bases the novelty was acknowledged.
(b) Inventive Step:
Obviousness or inventive step can be seen as the last hurdles to patentability and the reason behind the inventive step requirement is to ensure that an invention forms a perfect advance in technology to ensure an exclusive right. Article 56 of the EPC states about inventive step, it describes that
An invention shall be considered as involving an inventive step if, having regard to the state of the art, it is not obvious to a person skilled in the art. If the state of the art also includes documents within the meaning of Article 54, paragraph 3, these documents shall not be considered in deciding whether there has been an inventive step.
The applicant must prove that the invention is not obvious to a person having ordinary skills in the art. Inventive step is a highly complex matter in the field of patent and is usually the main issue in patent litigation. Thus inventive step or obviousness is too complex to describe in short terms. In the light of the novelty requirement, an invention may be obvious due to a combination of publication of the prior art. But taking into account of the prior art publications together, the total publications not only have to set forth each and elements of the invention, as with the novelty requirement above, but also have to show ‘teaching and motivation' that may be joined and show a logical expectation of attainment of successful position that the invention is obvious from the combination. In respect of nanotechnology, the outcome of the experimentation in most cases is not predictable and based on assumption of a suggested outcome. When examining the presence of an inventive step of nanotechnology inventions, the question is usually that whether merely miniaturization of a known device, which is also known as ‘top-down approach', is inventive or not.
A ‘top-down approach', however, may be taken into account as inventive, if the invention has technical value, more accurately, an invention may be considered as inventive “if it provides a technical advantage which is new and surprising. . . and this technical advantage can, convincingly, be related to one or more of the features included in the claim defining the invention.” If nevertheless, when taking into account the state of the art, the invention “would have been obvious for a skilled person to arrive at something falling within the terms of a claim, the unexpected result (would be considered) merely a bonus effect which would not confer inventiveness on the claimed subject matter.” The case of selection inventions, would also play a role at the of inventiveness assessment. In that case, “the subject matter of a selection invention differs from the closest prior art in that it represents selected sub-sets or sub-ranges.” If the selection is related to a definite technical effect and if the prior art holds no directions by which a skilled person can presume the selection, and then an inventive step is generally admitted. It has to be noted that when the technical effect is to be found within the selected range a similar effect may be found within a broader known range but with an unexpected degree. In that case, examiners have to take into account “whether the skilled person would have made the selection or would have chosen the overlapping range in the hope of solving the underlying technical problem or in the expectation of some improvement or advantage. If the answer is negative, then the claimed matter involves an inventive step.”
USPTO has suggested that ‘miniaturization down to the nano-scale, standing alone, would not claim as patentable invention.' Recently the U.S. CAFC held in a case that ‘when the only difference between the prior art and its claims was a recitation of relative dimensions of the claimed device, and a device having the claimed relative dimensions would not "exhibit qualitatively different phenomena" from the prior art, the claimed invention was not patentably distinct from the prior art'. The EPO also reasonably agree with the statement in the above mentioned decisions of the USPTO and took the same stand point of view.
A number of cases have been decided by EPO and its Board of Appeals with the question of whether miniaturization can be taken into account as an inventive step. The Siemens case related to field-effect transitions which consist of an insulating layer having thickness in the range of a 3 to 18 nm. When examining the contribution to the inventive step of this particular feature, the Board came to the conclusion that the claimed invention was merely a miniaturization to the thickness range of 3 to 18 nm for a dielectric film. Moreover the Appellant was not able to describe any special effects for the dielectric film having a thickness in the specified range. The Board regarded the claim as arbitrary and hence declared it as a non-inventive selection. There is also a similar decision regarding inventive step and miniaturization. In the Kabushi case, which related to a semiconductor device consisting of logic and memory components, the Board of Appeal stated that only miniaturization as such in not inventive. In spite of being not strictly about nanotechnology, in the Effymetrix Inc. case, the Board gave the same type of reasoning. The Board held that ‘top-down approach' and miniaturization is a general tendency in the field of biological research tools and inventive step can be characterized to smaller dimension just when a non-expected advantage or technical effects are found from the selected scopes.
In short, the application of the inventive step criterion is varied from case to case and the Board does not acknowledge an inventive step when the shortening of dimensions is a part of the skilled person's routine procedure. Moreover an inventive step can exist if an additional or unexpected effect is achieved.
(C) Industrial Application:
Article 57 of the EPC provides that “An invention shall be considered as susceptible of industrial application if it can be made or used any kind of industry, including agriculture.” The EPC requires that to be patentable an invention must be industrially applicable. In a European Case the Board also stated that to be considered as susceptible of industrial application if it could made or used in any kind of industry. The industrial application must be particular and substantial, thus general industrial applications alone will not enough. It has to be qualified that the real-world will get benefit from the invention. The invention must be real, not only supposition or science fiction. In case of nanotechnology related inventions, there are no separate provisions and thus general EPC provisions have to be followed.
(D) Sufficiency of Disclosure:
The applicant for a patent or a patent practitioner should provide adequate description and claim so that person having ordinary skill in the art (PHOSITA) can understand and practice the invention. Actually claims determine the boundary of patent rights. Every patent application needs a sound written description, specific and comprehensive claims, history of background information, prior art and technology and instances of where the inventions will have specific industrial application. One of the reasons behind the sufficiency of disclosure requirement policy is the patent system quid pro quo (something for something). The purpose is that it prevents the inventors from a broader claiming of the invention which was not envisioned at time when the patent was described first. Article 83-85 of the EPC also requires a written description; specific, clear and concise claim and abstracts of the technical information of any inventions at the time of patent application and a PHOSITA can follow the invention and the invented process. In case of nanotechnology, to define PHOSITA is also difficult because nanotechnology is more cross disciplinary (nano-physics, nano-biotechnology, nano-chemistry, etc.) than any other technology. Moreover in the nano-scale the materials' behavior is unpredictable and not always constant. For this reason the description of nanotech inventions are sometimes too difficult. Sufficiency of disclosure of the invention is also needed to avoid patent thickets. In case of nanotechnology there is more possibility of patent thickets than any other technology as it covers a multiple fields of technology. Many commentators express that most of the issued nanotechnology patents are low quality because of its interdisciplinary nature and due to lack of patent examiners having broad multidisciplinary technical expertise. According to Lux Research Report, a large number of patents have been filed relating to nanotechnology with overlapping claims. In nanotechnology, the written description is an important policy lever because it narrows the scope of that kind of inventions to prevent overreaching claims.
For fulfill the requirement of disclosure or written description, in respect of chemical and biotechnological patents, genus of materials based requirement of some species and the descriptions are normally common in characteristics between species among the claimed genus are allowed except the species are closely related with each other. In these areas of technology the patentees are also allowed to do generic claims if the functional behavior of the claimed invention is connected with an unveiled correlation between that function and a known biological or chemical structure. Hence it can be suggested that in the field of nanotechnology patent can follow the similar approach for satisfying the written description requirement in patent applications.
4.0. Future challenges towards Nanotechnology patents:
Nanotechnology is passing its early stages compared to other fields of science. It is too early to predict how nanotech inventions will face patenting problems and how IPRs deals with nanotech inventions accurately. But it can be said that more of basic building blocks of nanotechnology will be patented than in any other branches of science and technology. Some experts believe that nanotechnology IP avoid ‘self destructed IP war'. Because huge numbers of cross-licensing agreements by starts-up and large numbers of IP for specific application licensed by group of large companies. Actually high cost of nanotech IP and too restricted licensing system are creating new legal challenges in the field of nanotechnology. The experts will face different types of legal problem for patenting nanotechnology inventions. Nanotechnology also challenges the present patent regulatory system and blurs the interface between discoveries and inventions. Some of the possible future legal challenges towards nanotechnology patents are given below:
Overlapping and classification:
Some experts fear that nanotechnology will create complicated broad patent thickets where it will be difficult to clarify the patent ownership. According to Lux Research ‘there may be multiple nano-thickets, covering different platform of technologies such as dendrimers, quantum dots and carbon nano-tubes.' Most companies are interested in fundamental building blocks inventions of nanotechnology. When any other company of the market wants to use the protected nanotechnology the production may take a lot of license negotiations because nanotechnology covers a multidisciplinary field of science with a wide area of application. Different companies may own different patents in nanotech and there is a huge possibility for patent infringement litigation. This may hamper the further development of nano-related inventions. According to NanoBusiness Alliance ‘several early nanotech patents are given such broad coverage; the industry is potentially in real danger of experiencing unnecessary legal slowdowns.' From the view of economists, the requirements of acquire rights from different players will also create ‘double marginalization' or ‘hold-up' problems.
Some of the experts think that by imposing a strict utility requirement like in chemistry and biotechnology may stop the overlapping of nanotechnology patents. On the other side, while a large portion of nanotechnology patent rights is owned by universities, to stop patenting basic building blocks by imposing exclusive licenses, may encourage downstream innovation of nanotechnology. Another possible way to stop overlapping litigations is to create patent pool agreements in the like software and biotechnology fields. The LuxReport suggested that nanotech firms could pool their patents and start licensing schemes. But many patent experts criticised the patent pool idea as being against the main spirit of IPR and a free market economy. Basically IPR encourage competition and innovation in the market but the patent pool system is anti-competitive manner and it encourages collusions and price fixing.
The massive economic possibilities connected with nanotechnology will not only result in a huge number of patents applications to the patent office but the courts will also face enormous challenges regarding nanotech patent infringement actions. Nanotechnology patents may be very difficult to enforce because it will be tough to detect infringement of nanotech products. If the court applies the doctrine of equivalent then for infringement action the plaintiff must prove that the accused product or process elements are identical or technically equivalent to the patented invention and hence enters within the scope of the claim. The court needs to interpret the language of the claims of the patent and other real evidence. This other real evidence also includes the specification and the prosecution history. But in nanotechnology the confined bordered written description is too difficult, thus in many cases the court finds difficulties to take on any infringement actions. For example, the accused infringer of macro scale carbon fibers can avoid the court action by claiming that a patent characterizing traditional materials would not meet the disclosure requirement for a nanotechnology invention. At the nano-scale level, the behavior of the materials is unpredictable; for this unique problem of nanotechnology, the law enforcing authority will face some problems to take infringement actions.
The ethical issues are mainly concerns about the question of fairness, equity, justice, non-discriminatory license practice and social relationships. It also includes the possible clash of interest arising from dealings among government, industry and universities and IP ownership. The advancement of nanotechnology is progressing on a daily basis and its outstanding inventions attract great public interest but critical voices are also rising at the same time. These voices assume that the products of nanotechnology will be harmful for public health and environment and that the risk assessment in nanotechnology research is insufficient. Some of the environmental experts express concern that the nano-manufacturing process will cause bad effects on the environment. Although no researchers yet are able to show the specific impact on the environment, it is true that human safety issues are one of the burning ethical issues towards nanotechnology development. Some nano-particles can easily enter into the human body but the human health implications have not found yet.
Another important issue is privacy issues related to nanotechnology. Nanotechnology leads are highly efficient and consist of smaller electronics and IT chips, by which one can easily monitor a person, retrieve one's personal or confidential data and information, medical records, etc. Without consent and a lawful authority, it's a threat for civil rights and privacy rights.
Quick technological progress and its business mode within the area of nanotechnology will challenge the traditional regulatory systems. This new technology raise more questions than answers. As nanotechnology is an extension of traditional technology within the area of engineering, biology, chemistry and physics, its unique character lies in the meaningful and accurate manipulation and handle of atoms and molecules for exploiting the unique properties of materials that emerge at the nano-scale. Nanotechnology may severely challenge the current regulatory competency to respond quickly and maintain the tough balance between risk and profit. Nanotechnology is closely involved with in a number of separate phases; each of its advancement is depending on of its own legal, regulatory, societal and political issues. The multidimensional uses and convergence of domains of nanotechnology such as in the food sector, medicine field, environmental field, military uses, IT, transformation and energy field etc. make it challengeable to regulate it and also require greater transparency between regulatory agency and government of a state. It should also be checked that each individual sector need nano regulation or ‘one size fit for all' i.e. one regulation which regulates all provable sectors of nanotechnology. There is also a question whether the regulation assesses each nano product basis or process basis. In this respect, EU took of the position of process basis assessment and regulation. Although there is no specific nanotechnology regulation in the EU and there is a great possibility of risk and dead lock in the trade relationship between state to state if there is separate regulation for nanotechnology in each national level. To regulate the nanotechnology and adopt a sound regulation system for nanotechnology priority must be given to human safety, environmental risk, privacy, intellectual property and lastly international law. In a low regulatory system, the advancement of nanotechnology is a great threat and also a danger in respect of global economy. Moreover the transitional NGOs (Non-Government Organization) can play an important role in future nano regulatory policy and debate relating with societal, democratic and jurisdictional legitimacy in the coming nano age.
In knowledge based society IPRs plays the role as the engine to develop the socio-economical condition of a country. Nanotechnology is a newly growing technology sector that consists of several different branches of science and having an enormous amount of potentiality to be used in products covering from biologics, automobiles, IT, polymers, healthcare and electronics to energy etc. The diversity of nanotechnology is one of the great strengths that there is a huge possibility of application in the many different areas, for example nano-biotechnology to nano-materials and also increases the possibility to produce more commercially benefitted products. It is sure that in the foreseeable future nanotechnology will be the largest sector of economic growth in the knowledge based society because of its application in the variety of field, from military projects to clothing sector. The European Commission also considers nanotechnology as one of the benefitted area of technology for its region and invested huge amount in the R&D of nanotechnology sector. The Commission also took different steps to develop and create new invention nano related inventions. To get the proper benefit of research in the any field of technology including nanotechnology, patent claim is one of the vital means to secure inventors' rights.
Although patenting nanotechnology is hugely benefitted for the society and economic perspective but many experts in this field expressed worry about its bad impact in the different area of society. Many environment specialists claim that the wastage of nano products will seriously harmful for human health and environment and they also claim that the risk assessment researches regarding nano-particles is also too poor. Moreover, some human rights NGO claim that some nano-particles can easily enter into human body and there is much possibility to violate ones privacy.
In case of patent, although as other field of technology same patent rules, regulation and procedures are followed in the nanotechnology related inventions but it's true that new technology creates new patentability problems. Nanotechnology covers a multiple field of technology. It is quite normal that no one can expert in multiple field of technology at the same time, thus at time of patentability examination, it is very difficult for the examiner to examine the different criteria and step of patentability so accurately. Especially to examine the novelty and inventive steps are crucial for examiner. Another problems will face patent office are the overlapping and classification problem. While start-up companies grant broad coverage patent claims, demand high price and adopt too restricted licensing policy which will create deadlock of patent litigations in the patent office and potential danger for innovation for a nascent technology like nanotechnology. Some patent experts say that strict utility requirement may stop the overlapping of nanotechnology patent claim like chemistry and biotechnology field. Some other experts suggested for patent pools to avoid patent infringement litigation but there is a much possibility of price monopoly which is contrary to open market system. Enforcement issue is also vital factor in case of nanotechnology. Week patent rights create more possibility of patent litigation which very much danger for new innovation because ventures will not invest in the area where there is possibility of confrontment of patent infringement liability and also danger for a country because it will cause to stop wealth creations. Finally it can be said that although there is many obstacles and challenges are facing for patenting nanotechnology related inventions but it is good news that many giant research companies are interested to invest in the field of nanotechnology and we can take lesson from previous other technologies, for example biotechnology and business method. The lesson learned from biotechnology and business method could also apply in the field of nanotechnology as well.
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