The Indian patent regime, originating from as early as 1856, has morphed into one of the most competent mechanisms of the modern era. Having been subject to remodeling and amendments of sorts since its inception, the present Indian Patent Act stands fulfilling nearly all the requirements clamped down by the globalized patent regimes, as encapsulated in the TRIPS mandate, as also the Patent Co-operation Treaty, 1970. A patent refers to the protection accorded to any new and useful invention. The quintessence of the Patents Act lies in the norms laid down, to be satisfied in order for a patent to be granted for an invention. The invention should be novel, should involve some inventive step, and should possess some degree of industrial applicability. Filing of applications, framing provisional and complete specifications, redress of infringement grievances, grant of compulsory directions, secrecy directions and revocation of patents, among several other minor topics are found within the gamut of the Indian Patent Act.
In tandem with the changes in society, an operative change in technology has been witnessed. As newer avenues emerge, Science unfailingly throws challenge after challenge in the path of law, as each new mechanism knocks on the doors of the Intellectual Property system, seeking protection therein. Protecting some of these technologies are often grey areas in the Indian Patent system. One such avenue, which has kicked up much consternation, is the field of nanotechnology. The factor that makes nanotechnology unique is that it uses a process distinct from that of traditional forms of technology. Most top down manufacturing processes take the help of the top down process wherein larger blocks are broken down into smaller ones.
There are two main ways of applying nanotechnology so far: one is the top-down approach, whereby structures are made smaller and smaller until they reach a nanometre scale using larger elements. The other approach is the bottom-up approach, by which elements at the Nanoscale are chosen and assembled to form some sort of matter or mechanism. This way of manipulating matter at the atomic level obviously bears the potential of enormous developments. Why nanotechnology? The extent of the scientific demand and commercial worth of the branch of science pertaining to nanotechnology warrants an examination into the feasibility of the present patent regime in protecting the inventions arising in the aforementioned branch of knowledge. Between 1997 and 2002, the quantum of nanotechnology patents had increased by an astounding 600%. World over, patent offices are clamoring to develop methods to deal with nanotechnology. The subject encompasses a plethora of other disciplines within its gamut, such as chemistry, biology, physics, computer science, material science, engineering, medicine and even electronics. It becomes imperative that a completely new paradigm be explored, to cull out effective patent protection mechanisms. The grey areas, phrased in the form of questions include the following:
- Can these products be patented at all?
- Are these products and processes obvious, granted that molecular drugs and bulk metal catalysts are known elements?
- Can the Indian patent Office do the needful with regard to protecting nanotechnology?
The promises of nanotechnology are large. Given what is at stake and the high expectations put on the burgeoning industry, it is imperative for the current patent doctrines to effectively respond to new technology. Nanotechnology investors face uncertainty about the extent of their patent rights. Patents with broad claims, that lack reference to scale, on traditional products, might allow traditional patent holders to exact royalties from their nanoscale counterparts. Furthermore, bargaining between the traditional and nanoscale manufacturers might break down because of the diverging valuations that the parties place on their assets.
Nanotechnology- Learning the Ropes
Nanotechnology – the technology of the smallest objects – is slowly but surely progressing. The first products making use of nanotechnology are appearing on the market, amongst others: tennis racquets, ski wax, and sun burn crème. The European Patent Office has granted about 80,000 patents on inventions in the field of nanotechnology. Hitherto, European academic literature has had hardly any attention for the patenting of nanotechnology. This is remarkable in view of the fact that nanotechnology raises new and important questions of law, as well as questions relevant for the development of nanotechnology industry in Europe. Well-known examples of nanotechnology are nano-carbon tubes and bucky-balls for making extremely rigid constructions, quantum dots which can be applied as markers for labeling purposes, and dendrimers that may be used for drug delivery purposes. The EPO defines nanotechnology as follows:
"The term nanotechnology covers entities with a controlled geometrical size of at least one functional component below 100 nanometres in one or more dimensions susceptible to make 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 nanometres."
The general definition is that Nanotechnology refers to the science, building, visualizing and manipulating at the nanometer scale. Put simply, nanotechnology is the science and technology of building things from the bottom, upwards- one atom, or one molecule at a time. It stands to be the diametric opposite of traditional industrial technologies, which operate from the top, downwards. Raw materials in quintessential forms of traditional industries are broken down and machined into precisely crafted products, by removing the unwanted segments of the same. It was introduced by Richard P.Feynmann, a 1965 Nobel Laureate, in a lecture entitled “There’s plenty of room at the bottom”
However, this method differs greatly from natural processes in one way or the other. Every object on earth consists of molecules, cells and miniscule organelles. Based on the particular configurations, a construction of these molecular structures can create objects of astonishing size, like the coral reef, or a redwood tree, or even the human brain. This approach produces results which would normally seem impossible. It is often seen that these processes are taken for granted. A simple example for this is the human body. It begins as a single cell, but evolves into a mature human being consisting of 75 trillion complexly arranged cells. The molecular machinery responsible for this amazing, feat of production is capable of such results because it performs operations in parallel.
This process, thus, serves as a kind of an “existence proof” for nanotechnology. Of course, putting these natural molecular machines to work is in effect, nothing new, as every living being does so constantly. But, where nanotechnology differs is, in the fact that it attempts to transcend the realm of the natural. Full fledged nanotechnology successfully exercises complete control over the physical structure of the matter, akin to what is done by a word processor over the form and content of textual matter.
Using nanotechnology, production would be carried out by large numbers of tiny devices, operating in parallel, in a fashion similar to molecular machinery already found in living organisms. These nanodevices wouldn’t have to be made out of protein or other substances extractable from the natural environment, but can be constructed out of whatever fashion is most suited to their task. Popularly known as ‘assemblers’, these miniscule devices would be capable of manipulating individual molecules rapidly and precisely. Instead of weaving cloth this method would seize individual atoms using selectively sticky manipulator arms, and then “plug” those atoms together until chemical bonding occurs. By repeating these steps according to a programmed set of instructions, a nanotechnologicial approach would be able to synthesize materials faster, and at a lower cost.
Besides such efficient and powerful manufacturing capabilities, there exist more sophisticated applications. For instance, specially designed nanodevices, the size of bacteria might be programmed to destroy arterial plaque, or fight cancer cells, or repair cellular damages caused by aging. Finishing with these tasks, the element shall be induced to self destruct, or remain in a surveillance mode, or cause, in some cases, to integrate with the body cells itself. In addition to treating diseases, the technology would be exceptionally useful in producing drastically enhanced mental, physical and sensory abilities. Substantial changes in human morphology would be possible and even copying thoughts and memories, and actually storing them, would soon be reality, thanks to nanotechnology.
Patenting Nanotechnology- Challenges posed to the Indian Patent Regime
Even though many patents on nanotechnological inventions have been granted, little has been written about how easy or how hard it is to obtain nanotechnology patents and which problems and peculiarities an applicant encounters. Therefore, the patentability of nanotechnology is here discussed in more detail. The analysis of nanotechnology patenting is a necessary input to the more fundamental questions concerning the patenting of nanotechnology. A patent is granted for any invention, based on any kind of a technology as given under A.27 of the TRIPS agreement, as long it satisfies the norms of novelty, inventive step and industrial application. Emerging technologies present newer challenges in the path of granting patents. The challenges posed are one too many to discuss in entirety, but a select few, in pertinence with the Indian patent regime are thus dealt with:
A. The nature of the technology itself
The TRIPS agreement mandates that patents shall be accorded to inventions based on any technology, whatsoever. However, it is unfortunate that India lags behind in this regard. The Indian patent regime is not accommodative towards the idea of granting patents to inventions in the field of biotechnology, and nanotechnology. The need of the hour is to patent these inventions, as the threat of infringement is imminent, particularly on account of the usefulness of the invention. Nanotechnology is not confined to a single field of endeavour but exploits the peculiar properties of matter at the nano-scale level, across a plethora of areas in modern engineering. It dabbles with fields such as semiconductor design, biotechnology, materials science, telecommunications, and textiles, even though the patent is held by a firm that works in only one of these industries.
Emerging technologies have always been at daggers drawn, with the issue of patentability. Huge amount of patents are being filed for already patented inventions, with the only difference being that they are mere improvements in that field. In the past when the software boom captured the commercial arena of technological use the patents were not allowed for software developments. Biotechnology was also not considered as patentable and many of the inventions therein were ineligible for patenting as they involved the human body, by virtue of the fact that they dealt with the human body. This trend had changed after the case of Diamond v Chakraborty. Here, a genetic engineer Ananda Mohan Chakraborty had developed a bacterium capable of breaking down crude oil which is proposed to treat in oil spills. Initially, the patent was rejected however subsequently the Supreme Court in a majority opinion held that a live human made micro organism is a patentable subject matter and is a manufacture therefore patentable under the Act and it was further observed in this case that any thing under the sun can be patentable.
The World Intellectual Property Rights Organization (WIPO) identifies certain complexities regarding nanotechnology. One problem, which is, to a certain extent, shared with a number of other emerging technologies is that the granted claims are overly broad, due at least in part to a lack of available prior art, which could allow patent holders to lock up huge areas of technology. In this context, there is also a perceived risk of overlapping patents.
B. Lack of technical knowledge
Few individuals are equipped with sufficient knowledge with regards to nanotechnology. Knowledge driven economies like Europe and the USA have also expressed their inabilities with regard to the subject. India isn’t far behind, where this issue is concerned. This lack of knowledge and understanding would hamper the advancement of the field. Either patents may simply Not be issued altogether due to the lack of knowledge, or, the construction of claims and their scope would be put through indiscriminate questioning because the examiners fail to grasp the nuances of the invention altogether.
Another consequence of the lack of knowledge is that the patents granted would be far too wide, or too loosely defined, making it difficult to enforce the granted patent. The Indian patent offices are not equipped with the individual and organizational structure, to deal with nanotechnology. While information on different technology, branches are made available to the patent offices, there is next to nothing on nanotechnology. Conquering ignorance in the field of nanotechnology is a major challenge to the Indian patent regime. Further, the gamble of not knowing the utility of an invention is a major challenge to the Indian Patent Regime.
C. Novelty and Identifying Prior Art
The broad scope of nanotechnology arises on account of the fact that manipulation of materials or particles at the atomic level applies to a wide array of fields. This multi-dimensional feature causes the identification of previously distinguishable technological fields. Identifying prior art itself, is a tedious task, posing another challenge to the Indian Patent Regime. This is especially so in the case of nanotechnology. The absence of a proper prior art database is the major drawback in the Indian patent regime. Since the crux of nanotechnology vests mainly on the size factor, a number of size related questions arise: how do nanoscale inventions relate to prior art that does not specifically relate to a nano size? Could such prior art anticipate a nanoscale invention? Could prior art that refers to micro or larger scale take away the novelty of a nano scale invention? Is size alone enough to confer novelty upon an invention? What happens if size ranges mentioned in a prior art document and a nano scale patent application overlap? An invention is only anticipated if it has been described completely and inclusive of all its elements in the prior art. If the prior art refers only to the micro or larger scale the nano scale equivalent is generally not anticipated.
Novelty is evaluated against the available prior art. The multidisciplinary nature of nanotechnology results in the bridging of different fields of application, which makes it difficult to cull out the element of novelty altogether. Since novelty depends on the extent of prior art, it is necessary for a strong database of prior art. The Indian patent database ought to be made stronger. Akin to the Traditional Knowledge Database (TKD), there ought to be one with fully updated information, pertaining to nanotechnology, in India. If the prior art does not refer to size, could it be true that a nano scale invention can be anticipated? Is the novelty of the nano scale invention destroyed simply because it is covered by the terms of a prior art document? This is not necessarily the case. In the first place, the prior art is destructive of novelty if it contains an enabling disclosure.
Even if a nano scale invention is covered by the terms of a prior art document, it may still be novel if the person skilled in the art cannot practice the invention without knowledge of the claimed invention or engaging in inventive activity. If it is not clear to the person skilled in the art how to manufacture a nano scale variant of the prior art invention, this could well be enough to preserve the novelty of the nano scale invention. While the patentability of nanotechnology invention can be questioned in certain cases, the existing patent law framework gives enough inroads to confer novelty upon most nano scale inventions. This mainly derives from applying well-known patent principles to nano scale inventions.
D. Inventive Step
An invention must involve an inventive step, making it non-obvious to a person skilled in the art. Even if a nanoscale invention is novel over the prior art, the inventive step requirement must be met. The first question one would ask is as to whether in nanotechnology inventions, downsizing in itself is not an obvious step for the person skilled in the art to take. From the decision of the Technical Board of Appeal, USA in case T 0070/99 (about micro scale analytical devices), it can however be derived that mere downscaling does not give rise to an inventive step. On what grounds, then, could one deem the existence of an ‘Inventive step’ in a Nanotechnology invention? An inventive step may reside in the fact that other processes have to be used to arrive at the nano scale products than is the case with bigger products. The other processes must of course not be obvious to the person skilled in the art, confronted with the problem of producing at nano scale.
If there is an unexpected function at the Nanoscale, it could be construed as an inventive step. The crux is that the unexpected function must solve a problem stated in the patent. Such unexpected results have been known to occur in nanotechnology. Carbon nanotubes can, for instance, depending on their construction, carry a much bigger current per surface unit as opposed to traditional metal conductors. The unexpected function must not be a mere side or bonus effect. If there are good reasons for a person skilled in the art to go down the road of the invention, then the occurrence of the ‘unexpected’ bonus effect does not contribute towards inventiveness.
E. Industrial Application
For an invention to be patentable, it must be capable of use in any kind of industry. Since nanotechnology is still in its infancy and many applications have not progressed beyond the laboratory stage, one couldn’t possibly fathom the extent of plausible industrial application. The nature of nanotechnology inventions often points the way to their industrial applicability: nanotubes for making light and strong constructions, nano drug delivery systems, or nanotechnology used to create high electric conductivity are self-evidently industrially applicable. In India, the problem that nanotechnology presents is that it is a technology that is completely unknown and presents a picture of potentials that are yet to be explored. The Indo-US joint forum on science and technology has identified this area of intense cooperation.
F. Enablement Issues
The patents act requires an inventor to disclose the best way of manufacturing his invention, to enable a person skilled in the art to do the same, post expiry of the patent. A major problem posed by nanotechnology to the present patent regime, is that the scope of the invention and the field of knowledge itself is far too wide. Expressing and explaining the contents of the invention in full detail is next to impossible. The quintessence of the criterion of ‘sufficiency of disclosure’ is thus encapsulated:
1. That the invention is disclosed in a way that allows it to be practiced, and
2. That the (teaching of the) invention must be reproducible.
The first requirement implies that the person skilled in the art on the basis of the disclosure can rework the invention without an undue burden. Reproducibility indicates that the result of the invention can be reached over and again and not just on the basis of chance or only with a smaller or larger degree of predictability. If the examining or opposition division has no way of knowing or inferring the practicability of a nanotechnology invention, let alone its practicability across an entire range, it may very well require the patent applicant or patentee to beef up its disclosure and provide more detailed instructions for the reworking of the invention. Additionally, the fact that the invention produces the claimed results in a repeatable way may pose problems for nanotech inventors. In nanotechnology, analytical methods, tools and metrologies are often not available to the person skilled in the art. Without these the reproducibility of an invention may be difficult to ascertain. An inventor would thus be obliged to disclose these in the patent in order to make his claims verifiable.
Suggestions- The measures to allow the patent regime to rise to the challenges
Till date, India has been very laid back in terms of research and development in the field of nanotechnology even though research and development and the possible commercial benefits of Nanotechnology are clear to all. The possible reasons for the same could be that at the moment the true characteristics and use of the technology has not been properly understood. The other reason is that even though the Indo-US civil nuclear deal is one of the most important steps for the energy requirements of India, but the government has been so busy in formulating policies and rules on this technology that little attention is being paid to other technologies. The patent if properly granted facilitates more and more innovations in the field to which the invention belongs however the growth retards once the patents are wrongly granted or rejected.
At present the Indian Patent Act has no provision that even incidentally touches the field of nanotechnology. There have been no guidelines or regulations framed with respect to regulating this technology even though the TRIPS agreement specifically provides that intellectual protection must be extended to all fields of science so that it encourages more research and innovations. The need of the hour is to firstly formulate a plan for increasing the research and development in the field of nanotechnology, secondly to provide for funding and special incentives for research in this field. One of the methods or possible solution to the present problem of patenting Nanotechnology can be addressed by bringing amendments in the Indian Patent Act that may not be exhaustively directed to nanotechnology however they must have some mechanism to recognize the field of nanotechnology and formulate a comprehensive regulatory plan that deals with Nanotechnology providing for research, possible hazards and a framework for regulating the same.
Sweeping changes ought to be brought, in the Indian Patent Regime, to rise to the occasion, and take on newer technologies with ease. A few of these suggestive measures may be put to use for the same:
- Patent applications are to be examined by a team of examiners, as opposed to a single examiner, as multiple inspections would prove better in understanding the claims
- Creation of a database of prior art, akin to the Traditional Knowledge Database.
- One single organized and centralized command centre must be established, for the sake of nanotechnology patenting. This would ensure uniformity in patent claim interpretation.
- Training to personnel on a periodical basis would help meet the challenge of lack of information on the subject.
- Creating expanded prior art databases would be prudent mechanisms to help ascertain the elements of novelty and inventive step.
- The patent offices must be open to accepting wider claims as the case shall prove, in order to accommodate technologies in their nascent stages.
Nanotechnology will be an important part of our lives, providing us with the ability to do things on an atomic and molecular scale. To succeed as a business, companies that develop new discoveries and uses for nanotechnology will need patent protection. With a carefully developed patent strategy, the Indian Patent Regime can successfully rise to the challenge thrown in by Nanotechnology. Though the grey areas are numerous to count, the same should not act as a bar to the grant of patents to the inventions arising out of nanotechnology. Laws are enacted for society, by society, and works in society. It would be unfortunate to allow our legal systems to remain redundant, while science and technology take giant leaps. Science depends on law, to protect its new creations. A development in law, is thus, not too much to ask in the light of an advancement in Science.
KIRTHI JAYAKUMAR is a 5th year student pursuing B.A. LL.B (Hons) from The School of Excellence, Chennai.