By Aishwarya Dhakarey
There is an unanswered question that demands discussion and a foray into the field of nanotechnology: whether the Indian IPR regime is adequately equipped to handle nanotechnology, in terms of both law and infrastructure to execute and implement the laws themselves.
Another question is whether the regime strikes a fine balance between public interest and the intellectual rights of inventors, and whether the operation of the Indian IPR regime is in consonance with global trends in nanotechnology. This commentary attempts to delve into research on nanotechnology to find amicable solutions and answers to these questions, as well as commercialization strategies for this nascent yet budding industry.
At this stage, it is imperative to understand what nanotechnology is and how it is different from other kinds of technologies.
Nanotechnology can be defined as the nano-scale manufacture of materials and machines made to atomic specifications. It is a field at the junction of chemistry, physics, biology, computer science and engineering.
The European Patent Office defines nanotechnology as covering entities with a controlled geometrical size of at least one functional component below 100 nanometres in one or more dimensions and equipment and methods for controlled analysis, manipulation, processing, fabrication or measurement with precision below 100 nanometres.
Thus, nanotechnology essentially refers to the application of science at the nano scale, from 1 to 100 nanometres. Besides, there can be other competing definitions as well.
Problems of Commercialization
There are multiple barriers to the commercialization of nanotechnology, including lack of infrastructure, lack of scientific expertise, unfavourable tax policies, inability of small industries to afford infrastructure, lack of Research & Development funding and intellectual property issues.
These barriers can broadly be classified as capital deficit, high manufacturing and processing costs, shortage of qualified manpower, regulatory unpredictability, health and safety concerns and consumer perception. They have to be overcome by formulating all-embracing principles and policies.
The multi-disciplinary and multi-dimensional nature of nanotechnology creates a hurdle in the correct examination and grant of patents. This is further complicated by the cumbersome and time-consuming process of challenging a patent.
Commercialization Strategies for Nanotechnology
Commercialization entails a sequence of steps to achieve market entry of new technologies, processes and products. There are two basic strategies for nanotechnology: product innovation or process innovation.
Product innovation concerns tangible products, while process innovation concerns employable technology in nano development. Process patenting of nanotechnology can spur more market growth and demand than product patenting.
Research and development spending and commercialization costs represent significant barriers to entry for firms entering the nanotechnology market. Investors must consider short- and long-term costs associated with nanotechnology compared to expected value.
Government funding is usual in India, although other sources such as corporate funding and venture capital also exist. With government funding, less emphasis is generally placed on commercial viability and rates of return than with commercial funding.
Types of IPR which subsist
The accelerating advances in nanotechnology pose another challenge in identifying the kind of intellectual property involved. Mostly, this concerns patenting of products and technology. Copyright may subsist in academic research, and eventually copyright law may supplant patent law in relation to some nanotechnology products.
Premature disclosure without authorization of literature could defeat the rights of an innovator or researcher associated with trade secrets. Technology transfer and collaboration can still be protected contractually by way of non-disclosure clauses or non-compete terms.
In the long run, there will also be a necessity of obtaining foreign patents for broad patent coverage. There is a possibility of employing nanotechnology in software and designs, and IPR litigation in this field may therefore see a steep rise.
The Indian Regime
Developing countries like India have become quite active in recent times, with patenting activity growing exponentially between 2001-2007. Nanotechnology in India is a government-led initiative, meaning most research is publicly funded, while industry participation is of more recent origin.
Most challenges and concerns of the sector could be addressed through subordinate legislation, amendments to existing instruments or interventions at the level of implementation.
One fundamental aspect of obtaining a valid and enforceable patent is that claims must be novel and unobvious over the prior art. An overview of nano-patenting activity in India indicates that India is still nascent in terms of nanotechnology investment and patent applications.
An application for a nano patent is filed under the Indian Patent Act, 1970. The patentability criteria enumerated in Section 3 apply to nano patents, including novelty, non-obviousness, inventive step and industrial application.
The National IPR Policy, 2016 highlights awareness, education, creation and commercialization in areas of national importance including nanotechnology and lays down that guidance and encouragement must be provided to researchers and innovators.
The Global Regime
The Trade-Related Aspects of Intellectual Property Rights (TRIPS) Agreement obligates WTO member countries to adopt and enforce minimum standards of intellectual property and requires WTO members to allow patents in all fields of technology.
At this early stage of nanotechnology, lack of case law and jurisprudence provides little assistance on the scope of nano patents and other IPR issues. The article discusses T 0915/00 (Nano Crystalline Metals), where nano-crystal nickel material with crystalline size of less than 11 nm was held novel over substantially identical material comprising macro-crystalline nickel.
The decision in T 0952/01 (Method of coating a Substrate) held that prior art did not suggest the use of particles in the claimed size range of 20 to 70 nm because it recommended a preferred size range of 100 to 500 nm and thus taught away from sizes below 100 nm.
For a country like India just beginning to engage in nanotechnology, patent thickets and high licensing costs payable to multiple patent holders could act as a severe roadblock in developing indigenous capacity.
There are challenges in the ability of examiners, courts, costs and infrastructure. Policy interventions are required to enable patent attorneys to understand the precision of nanotechnology and draft claims appropriately.
The utility of an invention may not be ascertainable at the time of application because of the scope for evolution of the technology. Emerging technology companies may want broad patent protection, but claiming incredible uses may work against obtaining patent protection.
Conclusion
After reviewing the relevant literature, the article concludes that the Indian patent regime is not well equipped to provide protective coverage to nanotechnology inventions because of the difficulty of fulfilling patentability criteria. It therefore calls for separately and distinctly framed laws and regulations on nano patents, and recommends creation of a prior-art database similar to a traditional knowledge database.
It also suggests separate classification of patents, speedy administrative measures for IP infringement, attention to broad claims and evergreening of nanotechnology patents, and emphasizes the underlying principle that patented knowledge must be freely accessible to all and public interest must be served.