Nanotechnology is a vast field which includes a range of technologies at the nano scale, being applied to pharmaceuticals, biotechnology, genomics, neuroscience, robotics and information technologies and more. In India it holds importance particularly in the nanobiotech & nanomedicine segments. The commencement of nanobiotechnology in India has unfurled a series of questions and challenges in terms of intellectual property protection. Therefore, it is of immense importance to explore whether the Indian Patent System presents suitable atmosphere for appropriate patent protection in India.

Like any new technology, nanobiotechnology also creates opportunities as well as challenges in adapting the patent regime to its particular context. This article strives to highlight problems and challenges faces by Nanobiotechnology invention owing to their multi-disciplinary character, crosssectoral applications, broad claims, as well as difficulties in fulfilling the patentability criteria of novelty, non-obviousness, and industrial application.

Challenges for Nanobiotechnology Invention under Indian Patents Act 1970

Nanotechnology is a novel and revolutionary branch of technology, where reduction in size has demonstrated magnificent results. Intersection with the field of biotechnology has given rise to nanobiotechnology. Involvement of living forms and the potential to meet human necessities have raised issues that are unique to nanobiotechnology. It has emerged as an interdisciplinary field of research and development that integrates engineering, physical sciences, and biology through the development of very small physical and biological devices using biomimetically inspired nanofabrication techniques1 .

Following challenges are faced under Indian Patent regime in Patenting of Nanobiotechnology Inventions:

  1. Discovery vs Invention: Under the Indian patent regime, virtues of matter and other fundamental scientific discoveries are not patentable. An initial challenge for the patent analysts is to decide how to obtain patent that is derived from the discovery of inherent properties of materials. Only developing a smaller dimension or size of a recognized structure would not be deemed to be patentable unless it has additional utility or novelty.
  2. Non-patentable under Section 3(b): Nano biotech invention has showed more environmental damage due to high permeation ability of the nanoparticles to absorb into the bodies of humans which results in nanotoxicity. Section 3(b) of Indian Patents Act, 1970, also forms a barrier to 'nano-biotechnologybased' patenting due to assumptions about nanotoxicity caused by the use of nanoparticles. As an instance, the case of Plant Genetic Systems/ Glutamine Synthetase Inhibitors involved an invention where genetic engineering was applied to plants to render them herbicide resistant. It was held that the unchecked use of technology to alter natural traits which caused injustice to other living organisms and adversely affected the environment was not patentable.2
    • To accomplish the requirement of section 3(b), nanobiotechnology invention has to be analysed in the light of environmental jurisprudence. Article 21 under the Indian Constitution is very broad and capable of imbibing various related rights including the right to live in a healthy and wholesome environment as has been laid in a series of cases.3 The "polluter pays" principle and the "precautionary" principles governing the environment have been judicially recognized in the form of precedent for future issues arising from conflicts between the environmental implications of technologies such as nanobiotechnology and the right to a healthy environment. The high permeation ability of nanoparticles in the bodies of humans and animals can result in environmental damage can likely be caused by nanobiotechnology visà-vis any other known technologies (nanotoxicology).4 Usage of ecomarks on nanobiotechnology products are recommended to certify the environmental safety. This would further help in dealing with the proposed barriers to nanobiotechnology products in light of Indian Patents Act 1970, section 3(b).
  3. Lack of Novelty

According to section 3(d) of the Act, if there is vagueness in the "particle size", it attracts the possibility of being included in non-patentable subject matter. In case of nanobiotechnology, the newness of technology is significantly derived from the reduction in size. The primary ambiguity is lack of a universal definition of nanobiotechnology. The word "nano" encompasses inventions of 100nm in size or smaller. Pharma industry is likely to be the most beneficiary segment from nano biotechnology aided research. Nano particle efficacy or accuracy of methods using nano particles for drug delivery is significantly ruled by particle size which may vary as different drugs are effective with different particle size. For this reason, fixing a size limit of 100 nm may rule out the patenting of such particles under the "nano" regime.5 There is lack of a standard for determination of the efficacy and quantification of enhancement of efficacy in the Indian patent regime.

Under this regime, nanotech invention would remain nonpatentable unless the particle size differed in its properties have showed enhanced efficacy. Patentability of drugs would revolve around the reduction in particle size to certify better efficacy, such contraventions with provision 3(d) is likely to occur. For example, Abbott Pvt. Ltd. sold an HIV drug Kaletra under brand name "Alluvia". To overcome the storage problems of the drug, Abbott claimed a heat-stable form of the same drug. A pre-opposition was filed by the organization, 'Initiative for Medicines, Access and Knowledge,' under section(d) of the Patents Act 1970.6

  • Utility requirement

Utility requirement is crucial for nanobiotechnologybased inventions. Nano biotechnology falls under the class of "unpredictable" arts like biotechnology. There is the possibility of huge variation in the laboratory results and authentic results when technology such as nanobiotechnology is put to use. In the laboratory stage, it is not possible to determine the possible impact of external factors on products born out of a technology. Inoperability of such products may render them non-patentable as they would fail to comply with the utility requirements.7

In addition, the problem-solving approach applied in both Europe and India would render them as not being inventions (thus rendering the problem insolvable). The case of EMI Group North America Inc v Cypress Semiconductor Corp8 provides a better insight into the requirement. The applicant claimed a patent for an invention that lacked utility.

  • Multi-Patenting of Nanobiotechnology Invention

The Nanobiotechnology patent can be sought over the process of preparing the nanoparticles; the process of transfer of nano particles into the patient's body; the medical devices used etc.9 Here significant question is the distinct classification of methods as medicinal, surgical, curative, prophylactic, diagnostic and therapeutic and the subject matter that each of them cover. It is argued that exempting medical methods from the purview of patentability is on the one hand, in favour of public policy, whereas allowing patents in this field would draw unwarranted ethical, moral and practical problems and may also fail to fulfil the industrial applicability criteria.

The problem in the present perspective is whether methods using nanoparticles constitute diagnostic, surgical or therapeutic methods. Amendments to the Indian Patents Act 1970, sec 3(i) can be imported from the European jurisdiction which has proposed significant amendments to their provisions similar to the Indian Patents law, regarding medical methods. Many of the technologies being currently developed blur the line between non-patentable methods for treatment and diagnostics practiced on the human body on one side and patentable products (substances or compositions) and apparatus used in such activities on the other. Some of these important developments in diagnostics and treatment operate totally in vitro, others entirely in vivo, some have a combination of phases in vitro and in vivo, posing patentability questions concerning the patentability exception for Methods for treatment and diagnostic (Hosseini et al., 2011; Daneshyar et al., 2006)10.

Followings are some examples of Nanobiotechology inventions employed as drug delivery system in medical methods for treatment and diagnostic purposes:

  • Nanocarriers can be used in gene therapy.
  • Nanopore sequencing can be employed in the detection of single nucleotide polymorphism and the diagnosis of pathogens.
  • Nanoimplants can replace damaged sensory organs.
  • In the field of nanomedicine, sometimes a better efficacy is obtained with a molecule larger than 100 nm but less than 1000 nm (mathematically, 1 micron = 1000 nm). In such situations, it becomes challenging to classify them as nano pharmaceuticals. Nanoparticles, due to their small particle size and proportional increase in surface area, enhance the solubility in blood and bioavailability, thereby abating the need for adjuvant or co-solvents and reducing the dosage.
  • The presence of nanoparticles prevents biochemical reactions of the drug. Additionally, the exposure time to the drug is also prolonged. Innovation in nanomedicine mainly focuses on the delivery methods that make use of the above-described inherent properties of nanoparticles or nano carriers. This improves the administration of drugs.
  • It is speculated that established players in the pharmaceutical sector would make use of these nano-based novel drug delivery systems in conjunction with drugs whose patents have expired, thereby introducing new products. Such acts would restrict the entry of generic players in the market (Johnston et al., 2007; Ameden et al., 2005).


Nanoparticles due to their small size have proved to be more efficient, target specific, water soluble and stable tools in drug delivery compared with the conventional routes of drug administration. For decades pharmaceutical sciences have been using nanoparticles to reduce toxicity and side effects of drugs. This technology raises issues which are in disagreement with intellectual property rights protection and non-commercial laws (such as the environmental laws). In the absence of consonant patent law provisions, nanotechnology is facing challenges with respect to the criteria of novelty, inventive step, being capable of industrial application and eligibility of subject matter under section 3 of the Indian Patents Act 1970.

Nanobiotechnology inventions have generated technological revolution and emerged as a key technology for economic development in the twentyfirst century. The use of eco marks on nano biotechnology products are proposed to ensure environmental safety and consonance. This would further assist in dealing with the challenges discussed in the nanobiotechnology products Since patent law is technology-specific, providing guidelines to examiners for assessment of patent applications is a good practice and should be encouraged as it would aid in the issuing of better quality nanobiotechnology patents.


1 Daneshyar SA, Kohli K and Khar RK (2006) Biotechnology and intellectual property. Sci. Res. Essay. 1, 020-025




5 Hosseini et al., 2011; Daneshyar et al., 2006



8 "Intellectual Property Rights of Nanobiotechnology in Trade Related Aspects of Intellectual Property Rights Agreement (TRIPS)" Vol. 6, 56–64, 2012, Journal of Bionanoscience


10 Hosseini SJ, Esmaeeli S and Ansari B (2011) Challenges in commercialization of nano and biotechnologies in agricultural sector of Iran. Afr. J. Biotechnol. 10, 6516-6521.; Daneshyar SA, Kohli K and Khar RK (2006) Biotechnology and intellectual property. Sci. Res. Essay. 1, 020-025.

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