PATENT PROTECTION IN THE FIELD OF NANOBIOTECHNOLOGY
Nihaarika Prudhvi, Trainee – Intellectual Property Rights Practice
Since we live in a scientific era, it is important that we understand several aspects of rapidly developing field of nanobiotechnology, including patent protection.
Nanoscience is the study of marvels and manipulation of material at the nanoscale, in substance an extension of being lores into the nanoscale. Accoutrements reduced to the nanoscale can suddenly show veritably different parcels compared to what they show on a macroscale. With Nanotechnology, a large set of accoutrements with distinct parcels (optic, electrical or glamorous) can be fabricated. The lower a nanoparticle gets, the larger its relative face area becomes. Its electronic structure changes dramatically, too. Both goods lead to greatly bettered catalytic exertion but can also lead to aggressive chemical reactivity. Nanotechnology is the layout, characterization, production and alertness of systems, devices and structures by using controlling form and size at the nanoscale. Initially, to our knowledge dimensions of nano scale is approximately one to a hundred nanometers, where unique phenomena enable novel programs. The term extensively refers to such fields as biology, physics or chemistry, any scientific subject, or an aggregate thereof, that deals with the planned and managed production of nanostructures.
Bio nanomaterials create new possibilities for advancing scientific sciences and sicknesses remedy in relation to human fitness care. Innovations in the use of such nanomaterial’s and nano devices can result in full-size upgrades within the use of medicine/gadgets. Materials that have been scaled down to the nanoscale might suddenly display significantly different characteristics from those that are seen on a macroscale. A wide variety of materials with unique (optical, electrical, or magnetic) characteristics may be created using nanotechnology. A nanoparticle’s relative surface area increases as it grows smaller. Its electrical structure also undergoes significant alteration. Both outcomes result in significantly increased catalytic activity but can also trigger hostile chemical reactions.
Nanomaterial’s (materials that include nanoparticles) by themselves do not pose a concern. Only a few characteristics, most notably their heightened sensitivity and movement, might make them dangerous.
Three general categories can be used to categorize potential risks associated with nanotechnology:
(1) Risks to human health and the environment posed by nanoparticles and nanomaterials;
(2) Risks associated with molecular manufacturing (or advanced nanotechnology); and
(3) Societal risks, such as the potential for military applications of nanotechnology and the development of improved surveillance techniques using nano-sensors.
Nanobiotechnology, like any new technology, presents both possibilities and difficulties in tailoring the patent system to its unique circumstances. The goal of this paper is to draw attention to the difficulties that Nanobiotechnology inventions confront in meeting the patentability requirements of originality, non-obviousness, and industrial applicability due to their multidisciplinary nature, cross-sectoral applications, and extensive claims.
Challenges for Nanobiotechnology Invention under Indian Patents Act 1970
Nanotechnology is a unique and innovative sector of technology in which size reduction has produced spectacular achievements. Nanobiotechnology arose from the intersection of nanotechnology and biotechnology. The involvement of living entities, as well as the capacity to address human needs, has produced difficulties specific to nanobiotechnology. It has arisen as a multidisciplinary field of study and development that blends engineering, physical sciences, and biology by developing extremely tiny physical and biological devices utilizing biomimetic nanofabrication techniques.
Following challenges are faced under Indian Patent regime in Patenting of Nanobiotechnology Inventions:
- Discovery vs. Invention: Under the Indian patent system, discoveries relating to the properties of matter and other important areas of basic science are not subject to patent protection. Choosing how to secure a patent that result from the discovery of a material’s intrinsic qualities presents a first hurdle for patent analysts. The development of a known structure in a reduced size or dimension alone would not be considered patentable unless it included new functionality or novelty.
- Non-patentable under Section 3(b): Due to the great penetration potential of nanoparticles to penetrate into human systems and cause nanotoxicity, Nano biotech inventions have demonstrated significant environmental impact. Due to presumptions regarding nanotoxicity brought on by the use of nanoparticles, Section 3(b) of the Indian Patents Act, 1970 also creates a barrier to “nano-biotechnology based” patenting. For instance, in the invention known as Plant Genetic Systems/Glutamine Synthetase Inhibitors, plants were subjected to genetic engineering in order to make them herbicide resistant. It was decided that unregulated technological modification of natural characteristics that injured other living things and had a negative impact on the environment was not patentable. The development of nanobiotechnology must be evaluated in the context of environmental law in order to satisfy section 3(b) requirements. The right to live in a healthy and wholesome environment has been established in a number of cases, and Article 21 of the Indian Constitution can encompass several similar rights. As we all know “polluter pays” and “precautionary” are the basic principles existing in the environment which have been legally acknowledged as precedent for future disputes resulting from tensions between the environmental effects of technologies like nanobiotechnology and the right to a healthy environment. Compared to other known technologies, nanobiotechnology is more likely to cause environmental damage due to the high penetration potential of nanoparticles in the bodies of humans and animals (Nano toxicology).To verify the environmental safety of nanobiotechnology products, ecomarks are advised to be used. In view of Section 3(b) of the Indian Patents Act of 1970, this would help deal with the planned restrictions to nanobiotechnology goods even further.
- Lack of Novelty:
Lack of novelty, often known as expectation, is influenced by things like past publication, public use and understanding, commercialized goods, and a particular invention’s selection. Although the Patent Act does not define anticipation explicitly, Sections 29 to 34 specify what anticipation is not.
Repeating the previous art test might not be necessary, but expert judgement could be taken into account in order to more accurately identify anticipation utilizing the pertinent skill. It can also be distinguished by demonstrating the expected outcome of what is mentioned in the prior art, regardless of whether it results in a product or process that fits the claim’s definition.
According to Section 3(d) of the Act, ambiguity in “particle size” invites the potential of inclusion in non-patentable subject matter. In the case of nanobiotechnology, the novelty is derived mostly from the reduction in size. The main uncertainty stems from the lack of a common definition of nanobiotechnology. The term “nano” refers to inventions that are 100nm or less in size. The pharmaceutical business is anticipated to benefit the most from nano biotechnology-assisted research. The efficacy or accuracy of systems utilizing nano particles for drug administration is heavily influenced by particle size, which varies since various medications are efficacious at different particle sizes. As a result, establishing a size restriction of 100 nm may exclude the patenting of such particles under the “nano” regime.
In the Indian patent regime, there is a lack of a standard for determining efficacy and quantifying efficacy enhancement.
Under this paradigm, nanotechnology inventions would be unpatentable unless the particle size changed in its attributes and demonstrated increased effectiveness. Patentability of pharmaceuticals would rely around particle size reduction to certify higher effectiveness, and such contraventions with clause 3(d) are possible.
Abbott Pvt. Ltd. commercialized an HIV medicine Kaletra under the name “Alluvia”. To address the medicine’s storage issues, Abbott claimed a heat-stable version of the same substance. The ‘Initiative for Medicines, Access, and Knowledge’ filed a pre-opposition under section (d) of the Patents Act 1970.
The demand for utility is critical for nanobiotechnology-based innovations. Nanobiotechnology, like biotechnology, belongs within the category of “unpredictable” arts. When technology such as nanobiotechnology is used, there is the risk of significant variance between laboratory results and actual outcomes. It is not feasible to assess the potential influence of external circumstances on items created from a technology in the laboratory. The inability of such items to function may render them non-patentable since they fail to meet the utility criteria.
Furthermore, the problem-solving technique used in both Europe and India would exclude them as innovations (thus rendering the problem insolvable).
The case of EMI Group North America Inc. v Cypress Semiconductor Corp8 clarifies the necessity. The applicant sought a patent for an inapplicable innovation.
Patenting Nanobiotechnology Inventions Multiple Times
The technique of creating nanoparticles; the procedure of transferring nano particles into the patient’s body; the medical equipment employed, and so on can all be covered by a nano biotechnology patent. The important point here is the distinction between medicinal, surgical, curative, prophylactic, diagnostic, and therapeutic approaches, as well as the subject matter that each of them covers. It is stated that exempting medical procedures from patentability is in favour of public policy, whereas permitting patents in this sector would create unnecessary ethical, moral, and practical issues, as well as failing to meet the industrial application standards.
The following are some examples of Nanobiotechnology innovations that have been used as medication delivery systems in medical treatments for treatment and diagnosis:
Nano carriers have the potential to be employed in gene therapy.
Nano pore sequencing can be used to detect single nucleotide polymorphisms and to diagnose infections.
Nano implants have the potential to replace damaged sensory organs.
In the field of nanomedicine, molecules larger than 100 nm and smaller than 1000 nm (mathematically 1 micron = 1000 nm) may provide better results. This situation makes it difficult to classify them as Nano pharmaceuticals. Due to their small particle size and proportionally increased surface area, nanoparticles improve blood solubility and bioavailability, reduce the need for adjuvants or co-solvents, and reduce dosage. The presence of nanoparticles prevents biochemical reactions of the drug. In addition, the exposure time to the drug is also increased. Nanomedicine innovations are primarily focused on delivery methods that exploit the unique properties of the nanoparticles or Nano carriers described above. This improves drug delivery. Established players in the pharmaceutical sector are speculated to be using these nano-based new drug delivery systems in combination with drugs whose patents have expired, thereby introducing new products. Such legislation would restrict market access for generic drug suppliers.
Nanobiotechnology Patents: A Multijurisdictional Approach
This Article intends to analyse patenting trends in various fields and compare patentability criteria and disclosure standards for nanobiotechnology inventions in countries such as the United States, the European Union, and India in the field of diagnostics and therapies. Method: Nanobiotechnology patents were discovered by a Relecura search utilizing IPC/CPC and keywords (a web-based patent and portfolio analysis platform). The growth of filings/grants was examined by area. To identify problems in the prosecution of nanobiotechnology applications, a comparative examination of patentability criteria was performed. As a result, the United States, China, and Europe are the top patent filing countries in nanobiotechnology. The primary area of patenting, according to topic maps, is pharmaceutical preparations. Since 2000, there has been a rise in patenting in the BRIC countries. The evaluation of novelty, inventive step, and particular disclosure standards in several jurisdictions connected to nanobiotechnology inventions reveals patent prosecution issues. Hence it is concluded that 79% of all nanobiotechnology patents are for pharmaceutical preparation, with a considerable proportion for diagnostic and surgical uses. The increased trend in patenting demonstrates the possibility for diagnostic inventions. The establishment of objective and subjective criteria for patentability suggests that patent office practice and prosecution in this field should be more refined.
Due to their small size, nanoparticles have proven to be more efficient, target-specific, water-soluble and more stable tools in drug delivery compared to traditional drug delivery routes. For decades, pharmacy has used nanoparticles to reduce the toxicity and side effects of drugs. This technology raises issues that conflict with intellectual property protection and non-commercial law (such as environmental law). In the absence of consistent patent law provisions, nanotechnology faces challenges as to the criteria for novelty, inventive step, industrial applicability and suitability of subject matter under Section 3 of the Indian Patents Act, 1970. To ensure environmental safety and compliance, it is proposed to use eco-labels for nanobiotechnology products. This will further help address the challenges discussed in Nano biotech products. As patent law is technology specific, providing guidance to examiners on how to evaluate patent applications is good practice and should be encouraged as it helps issue high quality nanobiotechnology patents.
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