PATENTING NANOTECHNOLOGY: EXPLORING THE ISSUES AND CHALLENGES

By-Nishi Rajput

WHAT IS NANOTECHNOLOGY?

Among emerging technologies, nanotechnology is one of the most prominent examples and it creates high expectations in a wide range of fields affecting daily life. Nanotechnology is a science that operates on an extremely small scale because it uses the so-called nanometric size, which ranges from 1 to 100 nanometers, or 1 to 100 billionths of a meter.

The world of nanotechnology first opened its eyes to the world in 1959, when Caltech physicist Richard Feynman sketched out a vision for the future of science. In a talk titled “There’s a LOT of Room at the Bottom,” Feynman theorized that atoms and molecules could be manipulated like building blocks.

WHY NANOTECHNOLOGY?

While the commercialization of nanotechnology products has so far been relatively modest, recent and current research activities predict extraordinary results for the benefit of mankind in the near future. For example, in the medical field, options such as diagnostic tools that penetrate (and possibly remain in) cells or micro therapeutic tools that directly treat diseased cells from the outside can be envisioned. 

Ultra-small electronic components allow much smaller and more powerful electronic devices to be developed. New materials can be made stronger, lighter and thinner than existing ones, which could be of great interest in aeronautics and spaceflight, construction or even clothing. In terms of environmental protection and energy-saving, microelements and materials can enable more efficient and powerful use of alternative energy sources, such as the development of solar panels. 

CONDITIONS OF PATENTING AND ITS EFFECTS ON NANOTECHNOLOGY

Although inventions in the field of nanotechnology have emerged, in general, to be eligible for patent protection, relevant conditions for patentability must be met, some of which may be subject to further consideration, including: 

  • Being shared with several other emerging technologies are overly broad granted claims that, at least in part due to lack of available technology, may allow patent holders to block the giant technology sectors. In this context, a risk of patent overlap can be recognized. 
  • Regarding the general conditions of patentability, the question may arise as to whether reproducing a known product or structure on the atomic scale meets the novelty or importance requirements. More important than that of the invention step. 
  • A related question to the previous question regarding whether patent rights granted on a product without the size specification of the invention could be considered infringing by nanotechnological inventions or is the basis for claiming royalties to the inventor of the invention.

In a developing country like India, which is a powerhouse of science and technology and the 4th military power in the world, patenting for multi-disciplinary and multi-purpose technology is getting more attention. 

The novelty criterion presents some contradictions with nanotechnology inventions, as the technology mainly focuses on reducing the size of existing inventions in a compatible and innovative way.

 A product or process that has no industrial application is not eligible for a patent in India. 

The purpose of this clause is to ignore an abstract idea or a pure creation. The intellect cannot be put to use for a patent. This provision seems necessary to achieve the real goal of the patent system. But for nanotechnology inventions, the terms seem a bit confusing. 

Nanotechnology is an “unpredictable” art, where there is the potential for huge disparities between lab results and real-world results.

The United States and China have combined several provisions to fill this void. According to the USPTO, the “utility” of a product or process can be trusted, specific and substantial. Unlike India, there is no requirement that there must be a real utility for the product; it can be a trusted utility or a specific one. Therefore, limiting the scope of “industrial applications” to only the real world, followed in India, will negatively affect the scope of nanotechnology inventions and patentability. 

PATENTABLE SUBJECT MATTER

In India, any invention seeking patent rights must not fall within the sixteen unpatented subjects listed in Chapter III of the Patent Act 1970. This is the first hurdle that an invention must overcome before it is finally granted a patent; other criteria such as novelty, invention step and industrial application are just behind. Some of the long lists deal with nanotechnology inventions. Important articles in the field of nanotechnology are section 3(d), 3(i), 3(p) and Section 4. Subjects of Sections 4 and 3(p) of the Patent Act also have implications for nanotechnology. 

PROCESSING METHODS: 

  • SECTION 3(I) 

Under the TRIPS Agreement, an invention must be patented in member countries if the invention meets the basic requirements of patentability (novelty, patent stage and industrial application). But the Member States “can exclude” diagnostic and therapeutic methods and surgery to treat man or animal from the field of patentability. 

First, product patents in the medical and therapeutic fields are mostly granted after considering the enormous cost of research and development requires the need for incentives. 

Second, a patented treatment has to go through all kinds of practical and theoretical experiments and tests. Only an invention that is effective and safe can be patented by the Patent Office.

Third, it is ironic that equipment, instruments and other products for medical, surgical, curative, prophylactic, therapeutic and other diagnostic treatments may be patented when the treatment itself is not. The role of nanotechnology has revolutionized the medical field with the advent of complex and sophisticated products, processes and methods. A nanotechnology-based product may be designed for a certain treatment only, and without it, the processing may not be possible. 

For example, laser treatment is the best way to treat eye diseases and disorders. Laser devices can be patented while treatments are not.

  • SECTION 3(D) 

Inventions in nanotechnology are multidisciplinary and multi-industrial in nature. That is, a unique invention, by its very nature, will have a wide range of applications often accompanied by broader patentability claims. Section 3(d) of the Patents Act 1970, as amended by the Patents (Amendment) Act 2005, “the mere discovery of any new property or new use for a known substance or the mere use of a known process, the machine or apparatus unless such known process results in a new product or employs at least one new reactant” is not considered to be an invention. 

As for the pharmacy, since it is about increasing the effectiveness of a drug and not always inventing a completely different drug, the question will always be to increase the efficiency rather than inventing a completely new drug.

However, it is interesting to note that the “standard of effectiveness” is not provided for by Article 3 (d) or any other law in force in India. Furthermore, it can be noted that the term effectiveness was not defined in the Patent Amendment Act 2005, although an effectiveness test was introduced under section 3 (d). As a result, the effect becomes too elusive in a field like a nanotechnology which is in its infancy, and this could seriously hamper development in the field. 

NANOTECHNOLOGY – A COMPLEX REGULATORY LANDSCAPE 

Any company seeking to develop and commercialize a nanotechnology-related product must therefore take a holistic view of the nanotechnology patent landscape to ensure that all patents held by third parties are identified. This, together with a well-planned licensing strategy – to ensure that all relevant patented technologies are licensed – can facilitate the process of establishing rights, freedom of action, and help avoid costly legal disputes. and unforeseen events.

When filing patent applications, nanotechnology patent holders must also keep in mind the complexity of the international patent landscape. The fact that different jurisdictions interpret the principles of patent law in different ways can affect the patentability of an invention. 

For example, the German Federal Supreme Court previously invalidated a nanotechnology patent issued by the EPO for a “selective invention” for lack of novelty

To date, the difficulties involved in monitoring infringement and applying patents have certainly granted researchers and inventors implicit and inevitable freedom of action. However, ignoring these patents will become riskier and more difficult as more and more nanotechnology products hit the market. The challenge for the future will be to promote sustainable innovation in nanotechnology by ensuring that an intellectual property regime allows innovators the freedom to act and develop new nanotechnology applications, without drastically reducing investment and patent disclosure incentives.

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