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“The patent scheme is designed to protect technology– devices, actual machines, and new chemical biotechnological/nano-technological compositions–rather than pure concepts”. “Once an invention is patented, the inventor alone obtains the benefits of his formation and has the right to exclude others from using his innovation and in return for this phase of exclusive use, the inventor fully discloses his invention to the public”. “Speedy technological development and commercialisation of the rising field of nanotechnology is challenging conventional international and domestic regulatory system, including intellectual property rights”.
What is Nanotechnology? Literally, nanotechnology is technology that provides us the capability to do things- measure, perceive, predict, and make- on the magnitude of atoms and molecules. Conventionally, the nanotechnological sphere is defined as being between 0.1 and 100 nanometres, a nanometres being one thousand of a micron (micrometer), which is, consecutively one thousand of a millimetre (or a billionth of a meter). “Nanotechnology has been indicated as the ‘new technological revolution’”. “This progressive technology is facilitating industry to manipulate matter at the atomic scale, in that way providing matchless possibilities across the fields of physics, chemistry, biology, computer science, information technology, biotechnology, agriculture, medicine, engineering and materials”. “Nanotechnology differs from customary chemical manufacturing as, the chemical reactions are not left to statistical arrangements of molecules in solutions, but instead the molecules are brought into proper location with suitable speeds and orientations to obtain required reactions. Nanotechnology also diverge from micro-manufacturing of silicon chips in that the top-down approach and frequent refinement of bulk materials (e.g., etching silicon) into micro or even nano-scale design suffers from intrinsic defects in the original bulk material. On the contrary, nanotechnology’s bottom-up approach will build essentially defect-free structure from the atoms up”. “The rapidity of investment in nanotechnology venture has been rising as products have begun to emerge in a large scope of industries representing it’s all prospective. To illustrate the multiplicity of products which utilise nanotechnology, here are a few examples:
• A fly rod from Orvis™ utilises a nanoceramic binder to enhance performance.
• Elan™ is developing nanocrystalline drug formulations that improve delivery of drugs that are hard to formulate.
• A tennis racquet from Babolat™ called the NanotubeTM uses carbon nanotubes (a material that is six times lighter than steel and 100 times more rigid).
• Trousers (pants) and other textiles are now utilising a stain-repellent nanoscale polymer engineering technology produced by Nano-Tex™”.
“The Action Group on Erosion, Technology and Concentration (Etc Group) note that prospective applications of nanotechnology will provide scientists the facility to modify matter and change every aspect of work and life”. “In spite of its developing nature, the commercial impact of nanotechnology is already being felt. While estimates fluctuate considerably, BCC research for example suggest that the global market value for nanotechnology-related products was approximately $US 10.5 billion in 2006”. Stunning development in the market has been predict over the next 5–10 years, with commentators suggesting that by 2015 the prospective size of this market will lie somewhere between $US1 trillion and $US2.4 trillion.The financial proposition of nanotechnology has guaranteed that research and development (R&D) has develop into a national precedence for the industrialised world. Today over 60 countries, including the United States (US), China, Japan, Germany, Taiwan, Israel and Australia, have implemented national nanotechnology initiatives with public sector’s financial support estimated at $US4.6 billion in 2004 alone . “Government expenditure has in the same way been matched by private sector investment, with companies such as Monsanto, IBM, NEC and DuPont all contesting to share in the profits of next generation scientific expansions”. “Notwithstanding with the concentration focused on the scientific and commercial potential of nanotechnology, until recently there has been inadequate debate on the broader legal, ethical and regulatory aspects of nanotechnology”. whereas many of the patent law and broader intellectual property rights (IPRs) issues raised by nanotechnology at present are not exclusive, the existing international intellectual property framework, as governed primarily by the World Trade Organisation’s (WTO), Trade-Related Intellectual Property Rights (TRIPS) Agreement, was realised at a time when nanotechnology was merely a futuristic ambition.
In this dissertation I would like to shed light upon the parameters of nanotechnology within the framework of the current IPRs system, as governed by the TRIPS Agreement. Following an assessment of the phenomenon of nanotechnology, I have tried to investigate whether nanotechnology falls within the patronage of Article 27 of the TRIPS Agreement. In doing so, the paper questions the applicability of Article 27 as a regulatory mechanism for nanotechnology, principally in light of the obvious blurring of the discovery/invention interface. The technicalities of this conversation are crucial for the scope of IPRs that may be afforded to commercialisation of nanotechnology products. In re-evaluating this issue, this report explores the development in nano-patents and discusses the implications of the “US PTO Class 977/Dig 1” with respect to the global harmonisation of nano-related classification. This paper will also argue that the lack of consistent definitions supporting the granting of IPRs gives rise to the prospective for overlapping and incompatible patents claims, and proposes that governments adopt a practical approach to protect the commercial interests of patent holders. In this thesis an attempt has been made to look at intellectual property challenges, legal and regulatory concerns and changing intellectual property scenarios with regard to nanotechnology.
2. Patentability of nanotechnology
There is a complexity of discovering previous art in a technology that crosses a number of product regulations for nanotechnology patenting. For growing technologies like nanotechnology its patents are premature in the research process and perhaps not completely with the conventional understanding and meaning developed inventions. The endeavour of nanotechnology is focused on manipulating individual molecules or carbon nanotubes that can be used to make very light and extremely strong products. Therefore, nano-scale devices based on moving molecular system have the potential to modify technologies like, computing, communications, chemical manufacture, energy storage and drug delivery etc. But attaining these devices from the laboratory to the marketplace is far from guaranteed which means that the idea of patenting merely ideas is incorrect and so altering the role of patents law and barring innovation and science. The principles required for patenting of nanotechnological inventions are the same as in any other invention, namely:
2. Inventive Step and
3. Industrial Application.
1. NOVELTY: The invention must be new. The element of novelty in an invention is dependent upon the “state of prior art” i.e., the existing knowledge and similar invention already known in the particular field. An invention is considered to be novel if it has not been made available to the public by any means of oral/written description, or prior use before the date of filing for the patent. For example, Indian Council of Scientific and Industrial Research (ICSIR) challenged the grant of patent on “turmeric” by U.S Patent Office, on the plea that the patent could not be granted since there was no novelty in the invention. Also that what patented, was already published in Indian texts and use of turmeric preparations has been made in India since times immemorial. This illustration highlights the importance of the element of novelty for an invention to qualify for the grant of patent. The written description for an invention includes a description of the “background of the invention” a “summary of the invention,” and a “detailed description of the invention. “The background section should use simple and concise language. Although law holds that an applicant should use language directed to a person of skill in the art to which the invention pertains, nanotech applicants should draft the background section with an eye to the judge, jury, and investment banker, as well as the patent examiner”. The detailed description of the invention must be sufficiently full, clear, concise, and exact as to enable any person skilled in the art to which the invention pertains to make and use the invention. The detailed description also contains the best mode of carrying out the invention known to the inventor at the time of filing.The size of the nanoscale element should be sufficient to distinguish that element from that of the prior art. Novelty as a requirement for patentability is embodied in:
# Section 2, UK Patent Act, 1977
# Article 54, European Patent Convention
# Section 102, US Code Title 35 ¡V Patents
The novel properties characterising a material in Nanoparticle form are not noticeable on the same material at macro level though purposely looked for. It cannot be affirmed that the novel property demonstrated by the material at nanoscale was inherent in the same material known at macroscale.
2. Inventive Step:The claimed subject-matter involves an inventive step, such that it is not possible for a ‘person with ordinary prudence or skill’ in the art to derive it. “It must be based on earlier unachievable structure, size, compositions, organization, methods of measurement, and applications of the new properties along with methods of altering the property of materials”. The “skilled person”, in the context of nanotechnology would consist of a group of persons, each specialist of a different technical field. This requirement abides with the multi-disciplinary nature of nanotechnology, which brings together different areas of science. In nanotechnology, the outcomes of the experimentation are mostly unpredictable and based on the possibility of a suggested result. If there is accomplishment in achieving the suggested outcome through experimentation, the resulting invention (the nanoparticle) can be said to involve an inventive step.
3. Industrial Application: To achieve this criteria, the invention must be useful, must be industrially applicable and capable of being put into use. The technology must demonstrate a real-world advantage. The invention must also be practicable, not merely assumption or science fiction. Apart from these, the patent application in order to be acceptable must also adequately disclose the invention and set out the claims with precision. The centre of attention for the claims must be based on the nanotechnological aspects. The claims should define the objectives of the protection and shall be clear, concise and based on the description. Each and every technical term used in a claim should be properly explained in the disclosure. The patent application shall present adequate detail of the best method of performing the invention so that a skilled worker in the field is able to do so. Sufficiency is to be determined by the repeatability of the invention. The skilled person should be able to realise the invention essentially over the whole claimed ambit. The realisation of the invention, and therefore the achievement of the declared effects should not depend on chance. An arbitrary generalization of sizes or parameters would lead to the loss of repeatability of the invention. If the application comprises examples of one sole embodiment of the invention, no protection shall be given for equivalent embodiments, not sufficiently investigated. “In nanotechnology people started patenting the basic ideas at the outset, in contrast with computer hardware, software, the Internet, even biotechnology the basic building blocks of the field were unpatented.
It has to be taken into account that patent law does prohibit the patenting of ‘abstract ideas,’ preventing early-stage patenting of broad concepts”. “In order to meet the written description of the invention, the inventor must describe the invention, with all its claimed limitations’ which means that the claims must be supported by the written description in the specification, and the claims may have no more breadth than what is described in the specification”. “To that extent, the claims must be read in light of the specification, it is imperative that a patent drafter describe the invention with clarity in the specification”. “In nanotechnology efforts to patent basic concepts in advance of a developed market for end products are common and so ownership of nanotechnology patents is excessively fragmented, risking the development of a patent ‘thicket”, “a phenomenon peculiar particularly in patents in nanotechnology, basically refers to a situation where though a patent is granted to a nanotechnological invention, it becomes unworkable due to the operation of a previously granted patent for a similar invention.
The subsequent patent holders, in order to make their patent workable, have to first obtain licenses from the previous patent holders”. “It should be taken into account that it is not easy for courts to fit new technologies into old contexts because each new technology presents unique problems which means that nanotechnology promises to be even more problematic than common because of its interdisciplinary nature. In fact, nanotechnology can involve chemistry, biology, physics, computer science, pharmaceuticals, materials science, diverse fields of engineering, and other disciplines”. “Probably, nanotechnology’s interdisciplinary problems will be solved by applying its chemistry-based utility standard in most nanotechnology cases based on the idea that nanotechnology is the manipulation of atoms and molecules and taking into account that chemistry-based utility standard for new technology is used in biotechnology”. So, “given nanotechnology’s inventions uncertainty seems possible to handle it under the more demanding utility standard applied in chemistry and biotechnology cases than under the liberal standard for mechanical and electrical inventions”. Hence while filing a patent application relating to an invention in nanotechnology, requires careful consideration of the potential end uses so that they are adequately covered by the patent, an exercise which may draw upon expertise in several different fields. Unique legal issues will arise, that require an understanding of case law from diverse areas. Nanotechnology also poses some challenges to current conceptualizations of law. The previously recognized principles of novelty, unobviousness etc. need to be diluted in order to fit the need for a science like nanotechnology.
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