Thursday, June 18, 2009

NANOTECHNOLOGY AND IPR: IMPLICATION FOR GLOBAL SOUTH

CHAPTER I NANO TECHNOLOGY. Over the past few years a little word with big potential has been rapidly insinuing itself into the world’s consciousness. That word is “Nano”. Nanotechnology is a new approach to industrial production, based on the manipulation of things so small that they are invisible to the naked eye and even to most microscopes. While virtually all new technologies are difficult to define, nanotechnology has generated additional confusion because it defines more of a scale of measurement than a breakthrough in a particular field of science. Nanotechnology is a term used in describing technologies pertaining to the visualization and manipulation of materials at the nanometer scale. Nanotechnology encompasses many different concepts but it is more generally associated with the “manipulation of matter on an atom by- atom or molecule-by-molecule basis” to construct or build a certain atomic or molecular configuration[1]. Nanotechnology as a scientific field is only a few decades old. In 1959 Richard P. Feynman—the great American physicist and Nobel laureate—gave what may have been the premier talk on nanotechnology. Richard Feynman is commonly considered to be the father of nanotechnology due to his speech in 1959 entitled “There’s plenty of room at the bottom[2]”. But the term “nanotechnology” was first used in 1974 by Norio Taniguchi. The original definition of nanotechnology at that time was: “Nanotechnology mainly consists of the processing of separation, consolidation, and deformation of materials by one atom or one molecule.” According to this definition nanotechnology only describes the manipulation of materials on the molecular level and it refers to structures that are typically between 1 and 100 nm (1 nm = 10-9 m) in size. Nanotechnology applications and products make use of characteristics which occur in the transition area between the atomic and the mesoscopic scale. This means that nanoscale particles can have different physico-chemical properties with respect to micro scale or macro scale particles of the same material Basing on the International Standard Organization (ISO), nanotechnology may be defined as either or both of the following[3]: (1) Understanding and control of matter and processes at the nano scale, typically, but not exclusively, below 100 nanometers in one or more dimensions where the onset of size dependent phenomena usually enables novel applications, where one nanometre is one thousand millionth of a metre, (2) Utilizing the properties of nanoscale materials that differ from the properties of individual atoms, molecules, and bulk matter, to create improved materials, devices, and systems that exploit these new properties. The official definition of the US National Nanotechnology Initiative is that nanotechnology involves ‘research and technology development at the atomic, molecular, or macromolecular levels, in the length scale of approximately 1 to 100 nm range, to provide a fundamental understanding of phenomena and materials at the nanoscale and to create and use structures, devices, and systems that have novel properties and functions because of their small and/or intermediate size’. NANO TECHNOLOGY APPLICATIONS General Approaches There are generally two approaches for the production of nanomaterials. One approach is summarized under the so-called “top-down” technology and refers to the production of very small structures out of material building blocks by grinding, etching or other mechanical processing. The million fold produced, electronic microchips fall under this category. The desired conductor paths are predetermined through lithography. The distances and widths of the conductor paths currently are at less than 100 nm. On the other hand, nanomaterials can also be manufactured according to so-called “bottom-up” technology. In this case structures are built atom by atom or molecule by molecule. Often used forms of nanoparticles as an industrial raw material are oxide nanoparticles, non-oxide nanoparticles, quantum dots or metallic nanoparticles. Additionally, carbon nanotubes, fullerenes, nano wires and nano fibres are used. Other elements with particle at the nano scale are used as catalysts in industrial processes, because the high specific surface area of nanoparticles usually increases their catalytic activity. The “bottom-up” technologies are the manufacture of many raw materials by chemical synthesis, whereas the desired reaction product is available on the nano scale. The manufacture of carbon nanotubes however is based on “self assembly”, because the tubes continuously grow from the gas phase through an ordered assembly of carbon. There is a differentiation between chemical synthesis, “self assembly” and “positional assembly”. While in the case of “self-assembly” the single basic units (atoms, molecules) are autonomously positioned according to their natural properties, the exact position in the case of “positional assembly” is predetermined by external influences. The latter is very complex and not yet applicable on the industrial scale. By constantly refining the “top-down” approaches and an extension of “bottom-up” applications in greater structures the two approaches increasingly converge. Areas of Application Today, nanotechnologies already play a certain (minor) role in the shelves of supermarkets and, usually, nanomaterials are used to improve existing products in terms of quality or functionality. Many applications of nanotechnologies such as, for example, those in medicine, energy generation and storage or in the food sector are, on the other hand, often still in an early concept phase, and their presence on the market is still rather far away. Basing on a commonly accepted view nanotechnologies development is divided in four stages, with well distinct timelines[4]: ■ First Generation: Passive (steady function) nanostructures (as from 2000). The main applications are intermediary system components such as particles, wires, nanotubes and nanolayers whose properties allow for improvements to the performance of existing materials and products. One inventory lists over 500 consumer products on the market claiming to incorporate nanostructures, ranging from clothing and sporting goods to personal care and nutritional products. ■ Second Generation: Active (evolving function) nanostructures and nanodevices (as from 2005). These products can change their state during operation. Typical applications are expected to be in device and system components such as sensors with a reacting actuator or drug delivery multi-component particles that change their structure as they reach their intended target. ■ Third Generation: Integrated nanosystems (systems of nanosystems) (after 2010). In this generation, it is anticipated that synthesis and assembly techniques will allow for: forms of multiscale chemical and bio-assembly; networking at the nanoscale; and, scaled, hierarchical structures. In nanomedicine this could mean the development of artificial organs and scaffolds for skin tissues. In nanoelectronic, this could lead to the development of devices based on states other than that of the electric charge. ■ Fourth Generation: Heterogeneous molecular nanosystems (after 2015). The system components and devices are reduced to molecules and supramolecular structures that have specific structures and play different roles within the nanosystems. For example, the molecules can be used as devices or engineered to assemble on multiple length scales. Natural biosystems work in this way, but researchers currently lack sufficient control at the nanoscale to duplicate them. Potential applications include nanoscale genetic therapies and supramolecular components for transistors. Presently, the nano-related products that exist relate to the first two stages, but those on the market are mainly based on passive nanostructures (nanomaterials). In the case of active nanostructures (nano-devices), they are still essentially at research level, though, sometimes, already at a very advanced phase of development, as in the case of medical products. Nanoproducts referring to the last two stages are expected on the market on a medium to long term timeframe and they are yet, partially undefined. They are linked to the improvement of the ability to manipulate matter at the nanoscale and to interact with biological systems, and open almost unlimited scenarios of applications. SOCIETAL AND ETHICAL IMPLICATIONS OF NANOTECHNOLOGES Societal and ethical implications of nanotechnology have become a hot topic of public debates in many countries because both revolutionary changes and strong public concerns are expected from its development[5] Impacts of nanomaterials on the environment and human health are uncertain. Nanoparticles can enter the blood stream through the lungs and possibly through the skin, and seem to enter the brain[6]. Few studies are available on the affects nanoparticles will have if inhaled by humans. Other human health concerns include largely unknown effects of using nanotechnology in pharmaceuticals. These nanoparticles will also enter the food chain affecting plants and animals. It is also not known if these particles are biodegradable. Recently in March 2006, the German and then the international press reported that people had become sick after using Magic-Nano products: aerosols designed to coat glass and ceramic with a protective, dirt-repellent film. Within days, about 100 consumers became ill with symptoms such as coughing, headaches, sleep disruption and vomiting. A small number were hospitalized with pulmonary oedema, but most recovered in a matter of days. The health scare renewed fears of nanotech products in Germany, the only country where the product was marketed, and the press had a field day reporting on the first "nano-recall" as authorities pulled the product from the shelves. However, after investigation, the German government and Kleinmann's supplier, Nanopool GmbH, concluded that the problem was not with the nano-components of the aerosol. So the first 'nano scare' did not actually involve any nanoparticles. But the incident did raise questions about the risks posed by these new products, and prompted calls for regulation.[7] “Thus it is clear that the current state of understanding of the risks to human health and the environment from nanomaterials is one of almost complete ignorance; there are reasons to think that there could be harmful impacts but the nature and extent of the hazards and risks are essentially unknown”.[8] Advances in nanoscience and nanotechnology are rapidly furthering the unification of domains— a profound convergence of our understanding of, and ability to manipulate at the most fundamental levels, the material constituents, and processes of inert substances and living things. Expressed succinctly, “From the point of view of nanotechnology, what used to be separate domains of biomedicine, information technology, chemistry, photonics, electronics, robotics, and materials science come together in a single engineering paradigm[9]”. “The convergence of nanotechnology with information technology linking complex networks of remote sensing devices could lead to covert surveillance that will be hard to detect. Tiny sensors and listening devices that cannot be detected by the eye are also seen possible[10]”. It does not take much imagination to see how nanotechnology could shrink video cameras and microphones while vastly expanding the ability to record and store information. In fact, this trend seems unavoidable in the long run. Possible future convergence of nanotechnologies with biotechnologies and other cognitive sciences could be used for radical human enhancements, thus raising ethical questions. Nanotechnology may also have military applications. It can be used to make smaller and more efficient weapons and bombs by taking chemical and biological weaponry to another level. Massachusetts Institute of Technology’s (MIT) Institute for Soldier Nanotechnologies has received US$50 million of research funding from the U.S. Army; and the U.S. Department of Defense is a key founder of nanoscience research and development for military purposes. Other countries have already followed suit[11]. Many are calling for a review of ethical considerations pertaining to nanotechnology. However it cannot be denied that many of the social and ethical issues are the same as those that affect a wide range of other high technologies. That is, while the technology is new, the issues it raises have been faced before by researchers and society[12]. The ethical challenges of nanotechnologies are very similar to the ethical challenges of biotechnology and biology and this knowledge base may be a good starting point and foundation for a discussion of ethical reflections on nanotechnology.[13] INTELLECTUAL PROPERTY RIGHTS IN NANOTECHNOLOGY Intellectual property rights are essential in today’s technology driven age. Building a strategic Intellectual Property portfolio is economically important from both an offensive and defensive stand point. The promotion of innovation leading to the creation of new technologies is the very philosophical basis of the Intellectual Property Right system. The standard justification for the intellectual property system is that it provides incentive for innovation, allowing the inventor to reap reward by protecting the work from imitators. Nanotechnology has been described as ‘the transformational technology of the 21st century. As with the emergence of any pioneering technology, nanotechnology creates issues and opportunities in perfecting intellectual property rights Types of IP Protection Patents The field of nanotechnology is currently one of the most active on an international basis, with respect to number of patent applications. By February 2004, the number of issued U.S. patents incorporating the term “nano” reached 1,348 patent titles and 82,740 patent descriptions[14]. Patents offer protection for functional concepts, methods, apparatus, or processes that are novel, useful and non obvious[15]. The Agreement in Trade-Related Aspects of Intellectual Property Rights (TRIPS Agreement) in 1994 defines patentable matter as any invention that involves an innovative step and has a potential industrial application[16]. The purpose of the patent is to advance innovation through disclosure and teaching of the details of the invention to the public, and in exchange, the inventor or owner is rewarded the legal rights of ownership. Copyrights Copyrights protect the original expression of an idea. By offering protection, copyright encourages the expression of original, artistic ideas into a tangible medium. Legal protection is effected instantly, when the original copyrightable subject matter is fixed into a tangible medium, e.g. on paper or in a digital storage form. Copyrights are much more inexpensive and expediently obtained than patents, and are valid for the author‘s lifetime plus 50 years. A longer period of validity (75/100 years) applies if the creation was work made for hire, which is generally the case in the nanotechnology industry. Trade Secrets Trade secrets protect any technical or business information that gives the business a competitive advantage. It need not be completely novel or exclusive, but it must have a derived or potential economic value from being unknown. Additionally, reasonable efforts must be made to keep the information secret, e.g. through diligent and the inexpensive use of Non-Disclosure Agreements (NDA). There is no formal filing procedure to register trade secrets to obtain protection. Trade secrets consist of information or knowledge that is not widely known and provides competitive advantage to its owner[17]’. Trade secret protection offers the advantage of avoiding the effort and expense of patent applications and has a potentially indefinite duration; subject, of course, to reverse engineering. With lengthy commercialization timelines for some nanotechnologies and the 20-year limit on the patent term, it may be advisable to opt for trade secret protection as long as the product is not easy to reverse engineer in the near future. However, trade secret protection requires continuous diligence, and once a trade secret is revealed, it has no further protective value. Maskworks In chip technology when the chip layout includes an original circuit design, the layout is protectable. Specifically, Maskworks protect against the unauthorized copying of the chip layout information. Federal registration is relatively quick and inexpensive, but filing must be done within two years of commercialization of the chip product. Trademarks Trademarks refer to the distinctive signature mark that can be used to protect the company, product, service, name or symbol. The trademark must not be descriptive or generic. Legal protection is not offered to the technology, rather to the company good will and quality associated with the use of the recognized name or symbol. Trademarks provide exclusive rights within a region or nation and as long as used commercially, they may be renewed indefinitely. Compared to patents, they are obtained within a moderate time period (usually under 2 years) and typically cost under $5K per registered mark. current issues and challenges encountered in nanotechnology intellectual property The large influx of investment in nanotechnology research should accelerate the availability of commercial nanotechnology applications. Therefore, it is critical to develop intellectual property strategies that allow for fluid transfer of government-funded science to the private sector for commercialization of nanotechnology[18]. As with the emergence of any pioneering technology, nanotechnology creates issues and opportunities in perfecting intellectual property rights. Today, nanotechnology intellectual property issues focus primarily on patents, with additional issues relating to trade secrets. Some of the current issues and challenges encountered in nanotechnology intellectual property are briefly described below[19]: a. Patent Applicability: It is generally accepted that the properties of matter and other fundamental scientific discoveries are not patentable. An initial challenge for patent strategists is to determine how to obtain patent coverage that is based on the discovery of inherent properties of materials. Simply submitting a smaller version of a known structure would not be considered patentable without additional utility or novelty. In order to secure a patent, the invention must be "any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof." The traditional bases for patentability—novelty, non-obviousness and utility—can be secured by focusing on previously unattainable size, structure, compositions, organization, methods of measurement and methods of changing the property of materials, as well as applications of the new properties[20]. It is generally accepted that the properties of matter and other fundamental scientific discoveries are not patentable. An initial challenge for patent strategists is to determine how to obtain patent coverage that is based on the discovery of inherent properties of materials. Simply submitting a smaller version of a known structure would not be considered patentable without additional utility or novelty. b. Patenting Abstract ideas – Nanotechnology is a new field and so most of its patents will be for basic inventions, not for fully developed final products, creating problems because patents on basic inventions are inclined to cover larger areas than final products but one is not allowed to patent purely abstract ideas with the exception of developing them in the future to more specific inventions. For emerging technologies like nanotechnology, its patents are early in the research process and perhaps not fully covered by the traditional understanding and meaning of developed inventions[21]. c. Overlapping ideas – Since nanotechnology is a broad discipline encompassing several others, the granting of such patents could be problematic. Broad patents granted to inventors can lock up or impede crucial improvements needed to take a new field from interesting lab results to commercial viability. d. Balancing Innovation and Restrictive Intellectual Property- The increasing rate of patent applications by universities and private research organizations highlights another potential challenge for the nanotechnology industry: striking a balance between maintaining freedom of operation for a large number of innovators, while rewarding innovations with patent rights[22]. A large number of patent owners exercising the right to exclude others from practicing various aspects of nanotechnology can seriously restrict future research and development. Before commercializing nanotechnology products, companies may have to obtain licenses from a large number of patent owners. In order to attain the proper balance between innovation and exclusion, patent strategists will need to consider ethical questions about the division and aggregation of legal rights and reassess the scope of licensing practices[23]. Granting exclusive patent rights can be restrictive to future research and could stifle the potential of more researchers getting involved. It is essential that a proper balance be maintained between granting exclusive patent rights to inventors on one hand and allowing access to others to continue research on the other. e. Procedures for technology transfer- Considering the potential of nanotechnology and its ability to converge with other technologies, it is essential that the granting of patents does not stifle the potential of this technology to be transferred between researchers, universities and even countries. It is essential that this immensely useful technology be transferred to poorer countries to enable them to utilize and benefit from some of the ground breaking research and products. With the increasing importance of securing nanotechnology patent rights in early stages of research, universities and laboratories need to refine mechanisms to ensure that researchers are aware of the diligence required to establish and transfer intellectual property rights. Organizations need to reassess intellectual property procedures governing invention disclosures, notebook keeping, publication approval, patent filing approval and confidentiality agreements, as well as implement reasonable precautions against the theft of trade secrets[24]. In the interest of avoiding ownership disputes and litigation over the huge market potential for nanotechnology products, special attention should be focused on securing intellectual property rights at each relevant step in the research process. f. Government IP Rights in Funded Research- Funding derived from the Nanotechnology Act will impact the nature of the patent rights derived from the funded research. Under the Bayh-Dole amendments to the Patent Act, universities and small business entities retain intellectual property ownership rights in federal government sponsored research[25]. The government retains a royalty-free license to any patented technology funded by the government. Transfer and acquisition of these rights require compliance with certain formalities, such as when a licensing deal is made with a corporation or when a company is spun out by a professor. The university also must consider the potential for premature disclosure in government reporting requirements associated with the funding of sponsored research. g. Business IP Rights in Funded Research- Global companies including IBM, Hewlett-Packard (“HP”), 3M, General Electric, Lockheed Martin, Chevron Texaco, Samsung, Mitsubishi and DaimlerChrysler are making significant investments in nanotechnology research efforts. IBM, HP and 3M are allocating approximately one-third of their respective research budgets to nanotechnology[26]. Venture capital investment is growing rapidly, with more than $1 billion in funding over the last three years and as much as $700 million in investments for 2004. A vast amount of funding from corporate and private sources has made its way into sponsorships of university research. For example, companies have made alliances with the California Nanosystems Institute at UCLA and UC Santa Barbara by investing millions of dollars in sponsorship of nanotechnology research. In exchange for funding, companies generally share intellectual property rights for specifically sponsored research projects. h. U.S. Patent and Trademark Office Challenges- In February 2004, the number of issued U.S. patents incorporating the term “nano” reached 1,348 patent titles and 82,740 patent descriptions[27]. At the same time, the term “nano” has been incorporated into an additional 911 published patent application titles and 28,779 published patent application descriptions. Considering the fact that the U.S. Patent and Trademark Office (“USPTO”) receives roughly 300,000 patent applications a year, nanotechnology now impacts almost 10% of applications under consideration[28]. It is unclear if the USPTO can handle the anticipated exponential increases in nanotechnology patent applications, especially in national and regional patent offices where examiners are generally assigned to examine a single class or related classes of technology. While the U.S. Patent Classification System organizes issued patents, published applications and prior art references based upon their common subject matter, there is no specific classification for nanotechnology-related inventions[29]. Today the USPTO designates ten classes as potentially containing prior art for nanoproducts. A potential problem with the lack of a unique classification for nanotechnology-specific prior art is that the examiner may have a difficult time locating the best available prior art to a nanotechnology patent application. Given the multidisciplinary nature of nanotechnology developments, specialized examiners may not be familiar with advances in other areas necessary for the complete examination of a new technology. The convergence of several fields with different terminologies for the same phenomena increases the chance that patents will be issued without proper narrowing of the scope of claims in view of prior work and publications, or in view of the practical difficulties in applying the technology. Although it has undertaken a nanotechnology customer partnership which attempts to address issues related to patent prosecution for interdisciplinary inventions in nanotechnology, the USPTO has no plans to create a nanotechnology classification or to form any new group to evaluate nanotechnology applications. The lack of cross-functional nanotechnology expertise at the USPTO and delays in establishing nanotechnology-specific guidelines may lead to the issuance of overly broad patents by examiners despite relevant prior publications, which is likely to lead to litigation. i. Foreign Patents- Patent protection is typically only effective within the issuing country. In light of the considerable worldwide efforts in nanotechnology research, early foreign patent protection will be essential. Securing international patents will increase the administrative effort and expense of nanotechnology patent protection. Many foreign patent offices follow the USPTO’s lead in dealing with novel subject matter. Although they may lag behind the USPTO in granting novel nanotechnology patents, certain foreign patent offices have taken steps beyond the USPTO in establishing unique classifications for inventions in nanotechnology. The World Intellectual Property Organization’s International Patent Classification system includes a specific nanotechnology classification (IPC Class B82B) and the Japanese Patent Office has likewise created an internal patent classification ("Micro-Structural Technology; Nanotechnology”)[30]. j. Trade Secret Challenges- Trade secret protection offers the advantage of avoiding the effort and expense of patent applications and has a potentially indefinite duration, subject, of course, to reverse engineering. With lengthy commercialization timelines for some nanotechnologies and the 20-year limit on the patent term, it may be advisable to opt for trade secret protection as long as the product is not easy to reverse engineer in the near future. However, trade secret protection requires continuous diligence, and once a trade secret is revealed, it has no further protective value. Pressure to publish in academic circles makes trade secrets difficult to maintain. It also is very difficult to obtain government funding and maintain trade secrets given the governmental funding reporting requirements. The increase in funding and companies pursuing nanotechnology applications further will increase employee mobility and necessitate stringent safeguards against the theft of trade secrets by departed employees. Finally, as a general matter, investors tend to avoid technologies that lack patent protection making trade secret protection a non-viable option for many innovative technology companies. k. Intellectual Property Litigation- Nanotechnology intellectual property litigation has already emerged around trade secret issues. Given the breadth of the field and opportunity for broad patent coverage, intellectual property litigation over patents is likely to emerge in the near future. Considering the expense of litigation, innovators lacking the resources to litigate patent validity may be forced to license these patents rather than contest them. Given the novelty of the technologies involved, the patentability of some nanotechnology inventions may ultimately be addressed by the courts rather than by the USPTO[31]. To date, litigation over nanotechnology scale patent infringement has been primarily focused on biotechnology products such as nanogold particle labels used in diagnostics, microfluidic devices and microarrays. Nanotechnology patents may be problematical to enforce because it is hard to discover infringement. Given the novelty of the technologies involved, the patentability of some nanotechnology inventions may ultimately be addressed by the courts rather than by the USPTO[32]. To date, litigation over nanotechnology scale patent infringement has been primarily focused on biotechnology products such as nanogold particle labels used in diagnostics, microfluidic devices and microarrays. Hence, in the long term, nanotechnology is likely to increase the relative importance of intellectual property for society. Nanotechnology is an emerging technology with exciting prospects for intellectual property, in both the near term and for many years to come. DOWNSIZING DEVELOPMENT: THE IMPACT OF NANOTECH IP IN THE GLOBAL SOUTH With calls for sustainable development nanotechnology (NT) is being depicted as the answer to development without wastage and without harming the environment. “Its exploitation and utilization is predicted to transform developing countries and help reduce poverty. Billions of people around the world still suffer from inadequate access to clean water, energy, information, shelter, health care, and other basic needs[33]”. One of nanotechnology’s most compelling promises is that of access to safe drinking water. Point-of-use water filtration could purify water for those who do not have clean and reliable water supplies. Nano filters can be used to remove bacteria, viruses and other contaminants. Natural arsenic in wells which is a problem in many countries can be solved using nanotechnology. Major sections of society in poor and developing countries do not have access to electricity. Having access to electricity has direct implications on pumping of water, saving firewood, powering of various appliances, lighting schools etc. Using nanotechnology cheap photovoltaic films can be produced. Integrated into roofing panels these could yield a safe and sustainable source of inexpensive energy. Nanotechnology can also be used to increase the efficiency of energy storage devices. “Packaging of integrated systems applying advanced nanotechnology for diagnostic testing, custom formulation of medication, and targeted delivery of treatments, could help deliver medical care where doctors and hospitals are scarce. Nanoporous membranes may help with disease treatment in developing countries. They are a new way of slowly releasing a drug, important for people far away from a hospital[34]”. Continuing drastic reductions in the cost of information technologies, enabled by nanotechnology, would facilitate universal access to computing and communications. Thus nanotechnology may help make computers, cell phones and other related tools accessible to the poor. “Materials formulated with molecular precision could provide better shelter and tools. In agriculture and food processing, nanotechnology is predicted to make significant advances[35].” Its uses in food production could range from designing new and better food products to foods that do not rot. This could have implications on poor countries facing famines or droughts. Molecular manufacturing could enable clean production and new methods for environmental remediation, enabling global abundance to be both feasible and sustainable. Actual applications of nanotechnology will depend on a range of factors, including the evolution of related technologies such as biotechnology and information technology, economic systems, and institutions regulating intellectual property[36]. However like all technologies there is another side. Many scholars and thinkers have predicted that even with continuing progress in poverty reduction, many people will probably still be poor when molecular manufacturing technologies become available – as nanotechnology could still be expensive for much of the developing world. The effect and challenge of bridging the nanotechnology divide also needs to be considered. This divide may work contrary to claim that nanotechnology will help developing countries. Only a few developing countries are presently involved in nanotechnology research like India, China and South Africa. Most poor and developing countries lack the ability to research and exploit these new technologies. They lack qualified personnel as well as infrastructure. Over the past two decades the role of intellectual property in all areas of science and technology has exploded globally – primarily due to rules prescribed by the World Trade Organization’s Trade-Related Aspects of Intellectual Property (TRIPs) and by bilateral/regional trade agreements. The TRIPs agreement obligates all WTO member countries to adopt and enforce minimum standards of intellectual property. WTO has 150 members, and claims that it accounts for over 97% of all world trade[37]. In 1996 the WIPO and WTO established a collaborative relationship in order to implement the TRIPs Agreement. Among other IP rules, WTO members must allow patenting in all fields of technology. The initial grace periods and flexibility allowed by TRIPs for developing country members have nearly expired. By 2006, the so-called “least developed countries” are required to adopt the WTO/TRIPs standards. Over the past decade, civil society, social movements, the UN Human Rights Commission and some governments have warned of the inequities of IP for the global South. Recently, even at WIPO – the UN body whose mission is to promote and protect intellectual property – the uneven IP playing field and the negative impacts of TRIPs have become undeniable and untenable for many developing nations. In September 2004 the “Geneva Declaration on the Future of the World Intellectual Property Organization” warned that current IP regimes are having negative impacts in the developing world, resulting in lack of access to essential medicines, anticompetitive practices that hinder innovation and the misappropriation of social and public goods[38]. At WIPO’s General Assembly meeting, Brazil and Argentina, supported by 14 developing country co-sponsors, proposed that WIPO adopt a “development agenda,” stating that Intellectual property protection cannot be seen as an end in itself, nor can the harmonization of intellectual property laws leading to higher protection standards in all countries, irrespective of their levels of development. The role of intellectual property and its impact on development must be carefully assessed on a case-by-case basis. IP protection is a policy instrument the operation of which may, in actual practice, produce benefits as well as costs, which may vary in accordance with a country’s level of development. Action is therefore needed to ensure, in all countries, that the costs do not outweigh the benefits of IP protection. WIPO’s General Assembly adopted the decision to welcome a development agenda. But the US, UK and other industrialized nations are balking at the decision to give development concerns a higher profile within WIPO, acknowledging only that WIPO should give greater technical assistance to developing countries[39]. Reports will be prepared and the issue will be considered at WIPO’s General Assembly meeting in September 2005[40]. Meanwhile, developing nations are now facing a new technology wave – and the requirement to accommodate nanotechnology-related inventions – even while still grappling with unresolved controversies over biotechnology and information technologies. By next year, ready or not, most of the world’s developing nations will be obligated to evaluate and enforce nanotech patents. ETC Group is suggesting that nanotech, unencumbered by patents, will provide solutions for the South’s most pressing needs. On the contrary, ETC Group believes that a technological fix can never right social wrongs. However, much ink has been spilled of late on the benefits nanotech will bring to developing nations while ignoring the realities of technology transfer and intellectual property[41]. Multinational corporations, universities and nanotech start-ups (primarily in the OECD countries) have already secured numerous patents on essential nanotech tools, materials and processes. To the extent that these are “foundational” patents – that is, seminal breakthrough inventions upon which later innovations are built, researchers in the developing world could be shut-out. Nanotech patent thickets are already causing concern in the US and Europe. Researchers in the global South are likely to find that participation in the proprietary “nanotech revolution” is highly restricted by patent tollbooths, obliging them to pay royalties and licensing fees to gain access. Most of the nanotech products are being patented in developed countries. This will prevent other developing countries from exploiting these technologies and create the same patent conflicts witnessed with the digital and biotech revolutions. Corporate interests will almost certainly control the lions share and will dominate ownership and access, putting poor countries at a severe disadvantage[42]. In terms of public awareness and regulation, developing countries have shown themselves to be inadequately equipped to cope with these advanced technologies. Many developing countries tend to lack appropriate environmental, health and other safety regulations. They also lack monitoring and enforcement capabilities. A recent RAND report titled ‘The Global Technology Revolution 2020[43]’ highlights the fact that in 2020, areas of particular importance for technology trends will include biotechnology, nanotechnology, materials technology, and information technology. Despite the projections and benefits of NT’s to developing countries and the poor, caution is required. This new field about which a lot more is yet to be known may just become the poor man’s nightmare Six “Pro-South Science” Policy Proposals: ETC Group offers the following recommendations related to nanotech IP. 1. Poor applause: In the G8 meets to discuss its dubious “Pro-Poor Science” strategy, leaders of rich nations shouldn’t ignore the restrictions implicit in intellectual property that make it difficult or impossible for the South to develop its own independent technology solutions and to have access to the useful technologies of others. A truly “Pro-South” science policy would establish a global ten-year sunset clause on all monopoly patents. 2. Patent pause: WIPO should initiate a global suspension of patent approvals related to any applications that meet the USPTO’s Class 977 standard (the criteria for nanotechnology patents) until further social review, including wide public debate, is undertaken on the impacts of nanotech IP. 3. Technology flaws: In close cooperation with social movements, including trade unions, the Food and Agriculture Organization (FAO) and the United Nations Conference on Trade and Development (UNCTAD) should cooperate with WIPO in producing a study on the impact of nanotech-related intellectual property on monopoly practices, technology transfer and trade. The UNCTAD Commission on Science and Technology for Development, also in conjunction with social movements, should examine the implications for technology transfer and the needs and interests of developing countries. 4. TRIPs clause: South governments and countries-in-transition should suspend any Class 977 equivalent patent grants or applications pending a full evaluation of their impacts. In particular, governments should determine whether or not such patents compromise access to the basic elements of nature or contravene national legislation or international agreements, such as WTO TRIPs, concerning intellectual property over living material. 5. Ordre public laws: National governments and relevant international organizations such as WIPO and UNCTAD should examine the social and ordre public significance of Class 977 equivalent patents that could compromise access to the fundamental components of nature. 6. Diversity laws: With input from indigenous peoples and peasant farmers’ organizations, the Convention on Biological Diversity (CBD), the Commission on Sustainable Development (CSD) and FAO should consider the impact of intellectual property on fundamental elements of nature with respect to biodiversity and national sovereignty over genetic resources (especially in such fields as synthetic biology or Nanobiotechnology). In a wider context, either the CBD or the CSD should adopt a permanent agenda item to monitor developments in nano-scale technologies. [1] Frederick Fiedler & Glenn Reynolds (1994), ‘Legal Problems of Nanotechnology: An Overview’, 3 S. Cal. Interdict. L.J. pp. 593- 595. [2] Feynman, R. (1960), There’s plenty of room at the bottom. Presented in 1959 and first published in the February 1960 issue of California Institute of Technology’s Engineering and Science, which owns the copyright. www.its.caltech.edu/~feynman/plenty.htm [3] Business Plan ISO/TC229 Nanotechnologies. ISO, (April 2007) http://www.iso.org/iso/standards_development/technical_committees/list_of_iso_technical_committees/iso_technical_committee.htm?commid=381983 [4] White Paper on Nanotechnology Risk Governance, International Risk Governance council (IRGC), (2007) http://www.irgc.org/IMG/pdf/IRGC_white_paper_2_PDF_final_version-2.pdf [5] Rosalyn W. Berne and Joachim Schummer (2005), ‘Teaching Societal and Ethical Implications of Nanotechnology to Engineering Students through Science Fiction’, Bulletin of Science Technology Society; 25; p. 459. [6] The UK's Health and Safety Executive has published a review of nanoparticle exposure in the UK. Prepared by the Institute of Occupational Medicine, "Nanoparticles: An occupational hygiene review" concludes that all four main groups of nanoparticle production processes may result in exposure by inhalation, dermal or ingestion routes. Available at: UK reviews Nanoparticle exposure October 2004. http://nanotechweb.org/articles/society/3/10/1/1 Accessed on 19 April 2006. [7] Roland Clift, ‘Risk management and regulation in an emerging technology’, in Geoffrey Hunt & Michael Mehta (2006), Nanotechnology: Risk, Ethics and Law, Earthscan, UK pp. 144-146. [8] Roland Clift, ‘Risk management and regulation in an emerging technology’, in Geoffrey Hunt & Michael Mehta (2006), Nanotechnology: Risk, Ethics and Law, Earthscan, UK pp. 144-146. [9] Nordmann, A. (2004), Converging technologies—Shaping the future of European societies. Available at http://www.ntnu.no/2020/pdf/final_report_en.pdf [10] Wei Zhou (2003), ‘Ethics of Nanobiotechnology’, 19 Santa Clara Computer & High Tech. L. J. pp. 481- 483; [11] Langley, C., with Parkinson, S., & Webber, P. (Eds.). (2005), ‘Soldiers in the laboratory: Military involvement in science and technology – and some alternatives’. Available at: www.sgr.org.uk/ArmsControl/Soldiers_in_Lab_Report.pdf [12] Joel Rothstein Wolfson (2003), ‘Social and Ethical Issues in Nanotechnology: Lessons from Biotechnology and Other High Technologies’, 22 Biotechnology L. Rep. p. 376, [13] Mette Ebbesen, Svend Andersen and Flemming Besenbacher (2006), ‘Ethics in Nanotechnology: Starting From Scratch?, Bulletin of Science Technology Society; 26; pp. 451- 462. [14] Terry K. Tullis, ‘Current intellectual property issues in nanotechnology’, 2004 UCLA J.L & Tech. Notes 12. Available at: <> accessed on 20 March 2007. [15] 35 U.S. Code, Sect. 101, 102, 103 [16] .Results of the Uruguay Round, 6-19, 365-403 (1994); McCabe, K. W. 1998. The January 1999 Review of Article 27 of the TRIPS Agreement: Diverging Views of Developed and Developing Countries toward the Patentability of Biotechnology. J. Intell. Prop. L., 6(1), 41-67 [17] Jeffrey Matsuura (2006), Nanotechnology regulation and policy worldwide, Artech House, pp.37-57. [18] . Vicki Norton, What nanotechnology means for IP, Managing Intellectual Property, June 1, 2003, [19] Terry K. Tullis, Current Intellectual Property Issues in Nanotechnology, 2004 UCLA J.L & Tech. Notes 12, available at http://www.lawtechjournal.com/notes/2004/12_040809_tullis.php [20] Vicki Norton, What nanotechnology means for IP, Managing Intellectual Property, June 1, 2003, [21] Georgios Zekos, ‘Patenting abstract ideas in nanotechnology’, The Journal of World Intellectual Property (2006), Vol. 9, no.1, p. 126. [22] Michael A. Heller and Rebecca S. Eisenberg, Can Patents Deter Innovation? The Anticommons in Biomedical Research, in Perspectives on Property Law, 3rd ed.,159, 160 (Ellickson, Rose & Ackerman Ed., 1998). [23] Wei Zhou, SYMPOSIUM REVIEW: Ethics of Nanobiotechnology at the Frontline, 19 Santa Clara Computer & High Tech. L.J. 481, (May 2003). [24] Vicki Norton, What nanotechnology means for IP, Managing Intellectual Property, June 1, 2003, [25] The Bayh-Dole Act, codified at 35 U.S.C. §200-212 [26] John Miller, Note, Beyond Biotechnology: FDA Regulation of Nanomedicine, 4 Colum. Sci. & Tech. L. Rev. 5 (2002/2003). [27] United States Patent and Trademark Office, at http://www.uspto.gov/patft/index.html [28] United States Patent and Trademark Office: 2003 Patent Performance, at http://www.uspto.gov/web/offices/com/annual/2003/040201_patentperform.html In FY 2003, the Patent Organization received 333,452 Utility, Plant, and Reissue patent applications. Additionally, preliminary data indicates that 243,007 pending applications were published within 18 months after filing and 173,072 patents were granted [29] Lance D. Reich, Protecting Tiny Gizmos: The Patent and Trademark Office is preparing for nanotech applications, The National Law Journal, at http://www.law.com/jsp/newswire_article.jsp?id=1075219818243 (Jan. 29, 2004). The classification of an incoming patent application initially determines which technical group and art unit will examine the application, and also determines the technical area(s) of search to locate potential prior art to the patent application. Generally, the existence of prior art that either discloses or makes obvious the invention claimed in the new patent application will block issuance of a patent. [30] Lance D. Reich, Protecting Tiny Gizmos: The Patent and Trademark Office is preparing for nanotech applications, The National Law Journal, at http://www.law.com/jsp/newswire_article.jsp?id=1075219818243 (Jan. 29, 2004). The classification of an incoming patent application initially determines which technical group and art unit will examine the application, and also determines the technical area(s) of search to locate potential prior art to the patent application. Generally, the existence of prior art that either discloses or makes obvious the invention claimed in the new patent application will block issuance of a patent. [31] See Lance D. Reich, Protecting Tiny Gizmos: The Patent and Trademark Office is preparing for nanotech applications, The National Law Journal, at http://www.law.com/jsp/newswire_article.jsp?id=1075219818243 (Jan. 29, 2004). The classification of an incoming patent application initially determines which technical group and art unit will examine the application, and also determines the technical area(s) of search to locate potential prior art to the patent application. Generally, the existence of prior art that either discloses or makes obvious the invention claimed in the new patent application will block issuance of a patent. [32] See Lance D. Reich, Protecting Tiny Gizmos: The Patent and Trademark Office is preparing for nanotech applications, The National Law Journal, at http://www.law.com/jsp/newswire_article.jsp?id=1075219818243 (Jan. 29, 2004). The classification of an incoming patent application initially determines which technical group and art unit will examine the application, and also determines the technical area(s) of search to locate potential prior art to the patent application. Generally, the existence of prior art that either discloses or makes obvious the invention claimed in the new patent application will block issuance of a patent. [33] Fiona Moore (2004), ‘Implications of Nanotechnology’, Health law Review, Vol. 10 (3), p. 10. See also, Barrett Hazeltine & Christopher Bull (1999), Appropriate Technology, Academic Press - London, p. 263- 265. [34] , Glenn Hanlan Reynolds (2003), ‘Nanotechnology and Regulatory Policy: Three Futures’ Harvard Journal of Law and Technology, Vol. 17(1), pp. 188 – 205. [35] Charles Vordran (2004), ‘The Many faces of Nanotechnology’, 16 No. 7 J. Proprietary Rts. pp. 6- 8. [36] The Royal Society and the Royal Academy of Engineering. (2004), ‘Nanoscience and Nanotechnologies: Opportunities and Uncertainties’, pp.20- 22. Available at: www.nanotec.org.uk/finalreport.htm [37] From “The WTO in brief,” available on the Internet at http://www.wto.org/english/thewto_e/whatis_e/inbrief_e/inbr00_e.htm [38] The Declaration, translated into six languages, can be found on the Consumer Project on Technology website at http://www.cptech.org/ip/wipo/genevadeclaration.html. [39] William New, “Nations Clash On Future Of WIPO Development Agenda,” Intellectual Property Watch, April 11, 2005. Available on the Internet: http://www.ip-watch.org [40] WIPO’s decision is available on the Internet: http://www.cptech.org/ip/wipo/wipo10042004.html [41] Salamanca-Buentello F. et al., “Nanotechnology in the developing world,” PloS Med 2 (5): e97, May 2005. [42] Barry Newberger (2003), ‘Intellectual Property and Nanotechnology’, 11 Tex. Intell. Prop. L.J. pp. 649 – 652 [43] RAND technical report (2006), ‘The Global Technology Revolution 2020’. Available at http://www.rand.org/pubs/technical_reports/TR303/

No comments:

Post a Comment