“When you control the atoms, you control just about everything”- Dr. Richard Smalley
Nanotechnology is the engineering of matter at the scale of atoms and molecules where size is measured in billionth of a meter (one nanometer= one-billionth of a meter). Nanotechnology is a very vast field which includes a range of technologies at the nano scale, such as, pharmaceuticals, biotechnology, genomics, neuroscience, robotics and information technologies, etc. In India it holds importance particularly in the nanobiotech & nanomedicine segment. The commencement of nanotechnology in India has hoisted a series of questions and challenges in terms of intellectual property protection. Therefore, it is of immense importance to explore crucially whether the Indian Patent System presents suitable atmosphere for patent protection in India.
Patenting criteria for Nanotechnology invention
Patenting of nanotechnology inventions is not the same as that of other technologies. To obtain a Patent in Nanotechnology following requirements must be fulfilled:
- The intended invention must be novel: Due to the multidisciplinary character of nanotechnology inventions determination of novelty of a particular application is very difficult. Here question also arises whether the reproduction of a known product or structure at an atomic scale would meet the requirements of novelty or more importantly, inventive step.
- It must be non-obvious: As Nanotechnology is fast evolving and covers rather a wide range of scientific areas, the types of applications for each invention are hypothetically unlimited. Due to the extent of impact and the interdisciplinary character of this area, nanotechnology inventions may be written across a broad range of applications. It is very difficult task to Identify the relevant prior art in an emerging technology. In this context, there is also a perceived risk of overlapping patents.
- It should have industrial application: Use of an invention may not always be known at the time of origin or there may be chances of decline of its use. Sometimes patentees in emerging technology companies claim unbelievable uses of their patents to obtain the broad protection. There is a risk that the patent may be denied due to deficiency of utility.
Challenges in Patenting of Nanotechnology Invention in india
Virtues of matter and other fundamental scientific discoveries are not patentable under Indian patent regime. 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.
Indian Patents Act, 1970
- section 3(b) renders nanobiotech inventions non-patentable on moral grounds:
Nanobiotech invention has showed more environmental damage due to high permeation ability of the nanoparticles to get absorbed into the bodies of humans which results in nanotoxicity. Section 3(b) of Indian Patents Act, 1970, forms a barrier to nanobiotechnology based 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.1
To accomplish the requirement of section 3(b), nanobiotechnology invention has to be analysed in the light of environmental jurisprudence. Article 21 of under Indian Constitution is very broad and imbibes various related rights including the right to live in a healthy and wholesome environment which has also been laid in series of cases.2 The “polluter pays” principle and the “precautionary” principle 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 than any other known technologies (nanotoxicology).3 To make use of ecomarks on nanobiotechnology products are recommended to certify the environmental safety. This would further help in dealing with the proposed barrierers to nanobiotechnology products in light of Indian Patents Act 1970, section 3(b).
- Section 3(d) renders nanotech inventions nonpatentable on the grounds of Novelty
According to section 3(d) of the Act, there is vagueness in the “particle size” 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 of nanobiotechnology 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.4 There is a lack of standard for determination of the efficacy and quantification of enhancement of efficacy in India.
Under Indian patent regime, nanotech invention would remain nonpatentable unless the particle size differed in its properties or 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. In an 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 section3(d) of the Patents Act 1970.5
- Utility requirement
Utility requirement is very crucial for nanobiotechnology-based inventions. Nano biotechnology falls under the class of “unpredictable” arts like biotechnology. There is a 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.6 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 Corp7 provides a better insight into the requirement. The applicant claimed a patent for an invention that lacked utility.
- Multi-Patenting of nanotechnology
The Nanobiotechnology patent may be over the process of preparing the nanoparticles, the process of transfer of nano particles into the patient’s body or the medical devices used.8 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 covered. 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 Indian Patents Act 1970, section 3(i) regarding medical methods.
Consequences of complexity of Nanotechnology Patent
In India the problem with nanotechnology is that it is an emerging technology and presents a picture of potentials that are yet to be explored. Nanotech patents may face the following difficulties in being granted:
- An improper rejection of a nanotechnology patent application due to an examiner’s erroneous conclusion that the subject matter is not novel; or
- Issuance of an “overly broad” nanotechnology patent that infringes on previously issued patents and/or gives far too much control over a particular swath of nanotechnology, allowing the patentees to unfairly exclude competition
- Issuance of nanotechnology patent in spite of existing prior art that was overlooked during the patent examination.9
- Unlike the nano classifications developed in US (United States) and EU (European Union) patent regime, the absence of a nanotechnology patent classification system in India makes patent landscaping discomfited which effects the future of nanotechnology patents in the field. Further, such challenges increase the burden on the examiner considering the patent applications: the lack of skilled, appropriately-qualified and trained examiners may result in the granting of poor quality patents.
At present Indian Patents Act, has no provision that even incidentally touches the field of nanotechnology. There have also been no guidelines or regulations framed with respect to regulating this technology though Trade-Related Aspects of Intellectual Property Rights (TRIPS) agreement which specifically provides that intellectual protection must be extended to all fields of science so that it encourages more research and innovations.
Nanoparticles due to their small size have proved to be more efficient, target specific, water soluble and stable tools in drug delivery as compared to 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 noncommercial laws (such as the environmental laws). In the absence of consonant patent law provisions, nanotechnology will encounter challenges with respect to the criteria of novelty, inventive step, being capable of industrial application and eligibility of subject matter under Section 3 of Indian Patents Act 1970.