Abstract
The technological application that uses biological systems, living organisms, or their derivatives to make or modify products or processes for specific uses is referred to as “biotechnology.” Biotechnology has been increasingly prominent and contentious in agriculture in recent years. Recombinant DNA technology is frequently used in agricultural biotechnology, and the genetically modified (GM) or genetically engineered (GE) labels are applied to its product. According to a researcher, “genetic engineering of existing species is one option to boost the productivity and genetic variety of the existing food basis on which the human population depends. As a result, biotechnology has the potential to significantly improve the quality and abundance of the food supply. As Every invention, work of art, or development made with the use of the human brain inherently comes with ownership rights protected by applicable intellectual property laws. Human inventions in the biotechnological field likewise have the same claim to ownership. One’s inventions are protected by intellectual property rights. But the ownership rights and commercial exploitation of any technological breakthrough determine its success.
Literature Review
The major goal of the article is to emphasize and investigate how intellectual property rights interact and operate in the pharmaceutical and biotechnology industries. In order to safeguard the rights of the inventor and to develop and promote new abilities, ideas, and innovations that may be advantageous to the economy, such protection and licensing are now necessary. This industry is experiencing a rising tide of patent applications worldwide. The field of biotechnology is a young science that is still laying the groundwork for its foundation, but it holds out the prospect of revolutionizing the domains of medical, agriculture, pharmaceuticals, and industry, among other facets of the economy and contributing to GDP.
Biotechnology and IPR
Almost all branches of pharmaceutical science, genetics, molecular biology, biochemistry, immunology, stem cell research, embryology, cell biology, bioremediation, and biodegradation is now heavily reliant on biotechnology.
Biotechnology is the process of enhancing biodiversity’s genetic resources. According to the Congress of the United States, Office of Technology Assessment, 1990, biotechnology is broadly defined as any approach that uses living organisms or portions of organisms to create or change products, enhance plants or animals, or create microbes for particular purposes. Biotechnology has been employed by humans from the beginning of civilization. However, the recent development of novel biological techniques (such as recombinant DNA, cell fusion, and monoclonal antibody technology) has posed important ethical and philosophical issues and complicated the enforcement of intellectual property rights.
In addition to the pharmaceutical business, polymers & materials, agricultural industry, health care systems, and other industries are all benefited from biotechnology breakthroughs and research. The time and money required for research and development in this field is considerable, and there is a risk associated with the results. More emphasis is placed on patenting the inventions in this field in order to advance these outcomes and make it possible for the expanding research industry to support itself financially.
The Department of Biotechnology (DBT) created a Biotechnology Patent Facilitation Cell (BPFC) in July 1999 to aid patent seekers. In order to meet the demand for promoting biotech research, BPFC has been tasked with: –
- raising awareness among biologists and biotechnologists about patents, as well as the opportunities and challenges associated with them
- giving national biologists and biotechnologists access to patenting services so they can regularly apply for Indian and global patents.
- keeping an eye on IPR development and bringing key concerns to the attention of decision-makers, bio scientists, the biotech industry, etc.
Section 3(d) of the Patents Act of 1970 is one of the key provisions that is crucial to the patenting of inventions in the field of biotechnology (more specifically, in the pharmaceutical industry). According to the aforementioned sections, the following are not considered inventions under the Act: the simple discovery of a new form for a substance already known to be effective; unless it creates a new product or makes use of at least one new reactant, the straightforward discovery of a new property or application for a material already recognized to be useful. Therefore, the applicant may be required to prove that the applied invention has improved efficacy and different qualities from the existing product/substance when filing for a patent for a biotechnological innovation.
Introduction
The ownership and utilization of intellectual property rights play a crucial role in determining the efficacy of technological innovations introduced in the market. These rights provide the necessary framework for sustaining technological progress and supporting the competitiveness of a country’s industry. Intellectual property rights (IPRs) enable the formulation of policies aimed at the diffusion and transfer of technology in a manner that can potentially provide optimal social advantages. It is widely acknowledged that the economic and social prosperity of a nation is maximized when diverse individuals within society possess a shared comprehension, distinct allocation of tasks and obligations, and a collective awareness of the shared values that underpin the societal fabric. The effective administration of intellectual property rights (IPRs) is therefore essential in ensuring appropriate motivations for ongoing technical advancements. Intellectual property rights (IPRs) play a crucial role in facilitating new business opportunities and enhancing the value of knowledge-based industries. India must promptly and effectively respond to the challenges presented by the ever-changing global technological landscape. The regulatory processes pertaining to intellectual property rights (IPRs) encounter inherent challenges within the context of new technologies, particularly in the field of biotechnology. The implementation of regulatory reform initiatives is necessary to effectively address and resolve the challenges within the emerging domains of intellectual property rights (IPR) system. This will enhance competitiveness in other important economic sectors, such as copyright, geographical indicators, right to information, patenting, and others. The process of patenting novel technology is regarded as the most effective means of safeguarding intellectual property (IP) within the current highly competitive landscape. However, a significant concern that warrants attention is the increasing prevalence of technology replication, a phenomenon that has been amplified by the advent of novel technologies. For instance, it has been observed that around 60% of patented innovations are replicated within an average timeframe of four years. Moreover, the average ratio of time taken for imitation compared to the time taken for creation is approximately 70%. Similarly, the average ratio of cost incurred for imitation compared to the cost incurred for innovation is approximately 60%. The proliferation of new technologies has prompted numerous business entities to employ alternative techniques for safeguarding their products and processes. One prevalent approach is the utilization of non-disclosure agreements, which serve as a means of protecting intellectual property (IP) in instances where the lifespan of new technologies is relatively brief. One prominent illustration of non-disclosure pertains to the situation involving Coca-Cola and Pepsi, wherein both companies have refrained from divulging their respective formulae to any external parties up to the present time. Simultaneously, the inventive sectors endeavours to continuously explore more effective strategies for safeguarding their intellectual property (IP).
Role of Market Demand in bagging the IPR Rights
Paradoxically, the contemporary scenario presents a circumstance wherein market demands compel the sector to prioritize immediate outcomes, while competitor nations allocate substantial resources towards scientific research and technological advancements, aiming to reap long-term advantages. There exists a significant need for the administration of cultural affairs, as it has the potential to foster comprehension of intellectual property concerns pertaining to research. In the current landscape of emerging technologies, numerous corporate entities have initiated their own research and development endeavours. The overall competitiveness of the industry is predominantly influenced by their capacity to harness the economic advantages of scientific and technological advancements, with a specific emphasis on knowledge-driven technologies as a whole, and biotechnology specifically. The emergence of novel technologies has not only yielded significant advantages for society, but has also engendered a range of concerns pertaining to the safeguarding of intellectual property. The subject of Intellectual Property Rights (IPR) pertaining to biotechnological discoveries has emerged as a contentious matter of discourse in recent times. These inventions encompass a wide range of concerns including science and technology regulations, ethics, and economics, among others. These challenges are intricately connected to the intricacies of international trade. The use of contemporary biotechnology has given rise to numerous intricate matters inside the intellectual property rights (IPR) framework as a whole, and specifically in the realm of patenting. Numerous situations are genuinely intricate. The advancements in biotechnology have implications in multiple domains such as science and technology policies, international trade policies, economics, and ethics. Consequently, the business practices in the field of biotechnology have become increasingly intricate. What is the rationale for acquiring knowledge and understanding of the scientific principles and ethical concerns associated with contemporary biotechnology? There exists a minimum of two rationales. One aspect pertains to the possible advantages that contemporary biotechnology presents to the human race. The significance of understanding biotechnology lies in the increasing prevalence of biotechnology-derived products in global markets. This trend extends to countries that may not actively engage in biotechnology for commercial purposes, yet are subject to substantial financial burdens as a result of stringent intellectual property rights (IPR) protection. In order to control biotechnological goods and successfully manage any potential bad impacts on the environment, human health, and social structures, it is imperative for a government to possess a comprehensive understanding of modern biotechnology. According to the European Commission (2002), modern biotechnology is seen as the subsequent advancement in the knowledge-based economy, following information technology. It is also recognized as one of the most promising frontier technologies.
Green Revolution vis a vis Biotechnology, Are they same in terms of IPR?
However, it is important for developing nations to keep in mind that modern biotechnology R&D is being undertaken within an institutional and economic environment that is very different from that in which Green Revolution technologies were developed. The latter were mostly the purview of government-funded research labs and charitable endowments. But commercializing contemporary biotechnology in agriculture is a cutthroat business where entrenched special interests from many sectors battle for success. Biotechnology is largely funded by multinational corporations in the seed, agricultural, chemical, pharmaceutical, and food-processing industries.
India & IPR’s rising significance in Biotechnology
The Department of Biotechnology within the Ministry of Science and Technology (the nodal ministry for all policy issues) has always placed a priority on the development of all aspects of IPR in biotechnology due to the technology’s potential and its connection to the requirements of society. For innovations and industrial growth, patenting or other relevant ways of protecting inventions have been given prominence. The Department has played a crucial role in coordinating the efforts of the country’s academic, industrial, and research entities to build a robust IPR system.
There are several problems with unprotectable intellectual property because India has been using conventional biotechnology for a long time. Strategic concerns involving moral and ethical issues mean that some inventions, such as those connected to national defence or the human and animal bodies, cannot or should not be protected. As a result of the varying degrees of distinction between discoveries and inventions, a universal regulation cannot be formed for the same and unprotected intellectual property would vary from nation to country.
The majority of nations do not allow patents on new scientific theories, legislation, or methods of conducting Biotechnology and IPR Regime. Many formerly unpatentable inventions, such as germs, animals, and plants, have been included in patenting in various countries over the past two decades or more. Over time, the boundaries of what is considered moral and ethical have shrunk as well. Although microorganisms are currently patented in many nations, plant varieties are patentable or protectable under sui generis systems, and animals are likewise patentable in some countries, there is no uniformity in this regard across the globe. Many biotech products use freely available genetic resources that can now be patented thanks to the Convention on Biodiversity (CBD). Many such items had previously circulated freely across nations. Neither the holding of such resources by governments is illegal, nor can laws be passed to retroactively bring them under the norms of sovereignty. The industrialized world has always been preoccupied with the question of whether or not to patent various kinds of life.
Issues with IPR in India
There are a number of intellectual property rights (IPR) issues that India and other developing countries must address. These include the stance that must be taken on the differences between biological discoveries and inventions, the definitions and scope of patentable micro-organisms, the scope of patentability or protection of other living materials like plants and animals, and the conditions of depositions connected to patentable inventions involving living entities such as viruses, bacteria, fungi and plasmids. The World Trade Organization has not taken a firm stance on many of these concerns, and its member countries are left to make their own educated guesses and predictions on the matter.
IPR in Pharmaceuticals
Recent controversy has surrounded the pharmaceutical business over claims that it prioritizes patents over human life. Seeing the industry’s involvement in drug discovery and development, and how intellectual property rights (IPR) on medicines underpin the drug research enterprise, is crucial at this time. Pharmaceuticals, immunologically developed medicines, and vaccines all play critical roles in modern medicine. Modern medicine has helped extend people’s lives. The pharmaceutical business is responsible for finding new treatments and bringing them to market. Companies want satisfactory returns on investment because of the huge cost and lengthy time commitment required to bring a new medicine to market. The pharmaceutical sector is founded on research, hence intellectual property is essential. Companies are guaranteed a return on investment and a rate of return on capital adequate to protect the interests of their shareholders under these rules. Companies cannot afford the massive and high-risk R&D expenditure required to deliver new medications, medicines, and other profile actives without the period of market exclusivity afforded by an effective patent protection regime. Most drugs would likely perish if the current system didn’t work so well.
Patents: Government’s Policy
The Ministry of Science and Technology has issued technology transfer and intellectual property rights guidelines to encourage scientists, research institutes, and universities to participate in department-funded initiatives. Key features of these guidelines:
a) Intellectual Property Ownership: Institutions should preserve R&D output IPR. They may retain IPRs. Technical, scientific, and academic institutions financed by Central/State Governments for research are institutions.
b) Technology Transfer: Institutions commercialize patents exclusively or non-exclusively.
c) Royalty to inventors: Owner institutions keep IPR profits. The institution can calculate inventors’ and affiliates’ earnings. These shares are limited to one-third of real earnings.
In a written agreement, institutions and industrial concerns can share IPR created through joint research. The university or industry may license the technology to a third party for commercialization. Exclusively licensed third parties must manufacture innovations in India. Joint owners can profit from IPR commercialization. The institution may distribute up to one third of actual earnings to inventors and others, to create a patent enabling fund, the owner institutions must give the Biotechnology and IPR Regime 25% of IPR income. The owner will utilize the fund to upgrade inventions, file new patents, preserve IPR, and develop IPR expertise.
Conclusion: Way forward
Policymakers in developing nations have a range of choices for protecting national policies from international advances in the IPR system. Perhaps one of the weakest areas that needs additional strengthening is the institutional capacities of developing nations to coordinate policies across government, policymakers, and the participatory process for IPR.
When compared to the active and influential participants from the developed world, developing countries are seen to have a wide range of representation and involvement in the World Trade Organization and the World Intellectual Property Organization’s (WTO and WIPO, respectively) forums. Before it’s too late, these countries’ policymakers need to be on high alert and improve their capacity for learning.
However, most developing countries’ limited resources and personnel make it difficult for them to effectively apply new laws, and standard operating procedures, however the following steps should be considered by them: –
- they should consult their countries close by, such as India.
- It is crucial for developing nations to make certain that their legal protections for intellectual property are heavily & to the fullest degree practicable, protecting intellectual property rights and supporting the existing civil justice system and administrative action.
- They should seek to recoup 100% of the money spent on repairs and upgrades to all national intellectual property system in terms of fees for registering intellectual property rights on a nationwide level.
- Developing the world’s nations ought to maximize their use of any opportunities that come there as a result of savings and streamlined administration from the regional mechanisms of international cooperation, including bilateral deals on intellectual property rights, especially with a fellow developing nation neighbourhood.
- Countries in similar stages of development & coordinated actions to promote communication at the highest levels on emerging regional and international programs for the management and instruction of intellectual property rights and IPR data management and statistical collection.
1 United Nations, Framework Convention on Biological Diversity, 5 June 1992, art. 2, 31 I.L.M. 818, 823 (199
2 “Intellectual Property Rights for Biotechnology.” Ciesin.org, Groombridge, 2019, www.ciesin.org/docs/008-265/008-265i.html.
3 Griffiths, A.J.F., J.H. Miller, .T. Suzuki, R.C. Lewontin, and W.M. Gelbart. 1996. An Introduction to Genetic Analysis. New York: W.H. Freeman and Company. Helen Pearson. 2003. “Human Genome Organization Calls for Open-access Sequence Repositories”. Nature, October 6.
4 Sharma, Manju and K.K. Tripathi. 2000a. “21st Century Belong to Biotechnology”. (India’s Biotechnology Sector offers Excellent Scope for Indo-US Collaborations, Joint Ventures through Harnessing Research Fruits, Developmental Efforts). Business Times, Washington D.C. XVIII (2): P 41-44
5 Sharma Manju and K.K. Tripathi. 2000b. “Excellent Opportunities in India’s knowledge based Biotech Industry”. US-India cooperation in scientific research aiding entrepreneurs in excellerating pace of revolution in fast-growing biotech industry. Business Times, Washington D.C., XVIII
6 Tripathi, K.K. 2001a. “Biotechnology: Government of India Initiatives”. Indian Investment Center News Letter. (Ministry of Finance), February 25, pp. 4-9
7 Tripathi, K.K. 1999. “Bioinformatics: The Foundation of Present and Future Biotechnology”. Current Science 79(5): 2000: p. 572-575
8 Tripathi K.K. 2003. “Regulatory requirements for recombinant product application processing”. Express Pharma Pulse, 13th & 20th November
9 National Cancer Institute. 2002. “Cancer Facts”. National Cancer Institute Online; available from http://cis.nci.nih.gov; Internet; accessed 06 October
10 Tripathi, K.K. 2001a. “Biotechnology: Government of India Initiatives”. Indian Investment Center News Letter. (Ministry of Finance), February 25, pp. 4-9.
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Submitted By: – Akash Tiwari(20BAL154) and Madhur Gahlot(20BAL193)
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