Abstract

Human gene patenting has become a contentious issue at the intersection of biotechnology, intellectual property rights (IPRs), and ethics. The rapid progress in genetic engineering and biotechnology prompts significant legal, ethical, and societal inquiries around the patenting of human genes. This dissertation does a thorough investigation of human gene patenting, exploring its ramifications for intellectual property rights, biodiversity, equity, and accessibility. The study intends to rigorously assess the current legal frameworks, ethical issues, and policy obstacles related to gene patenting, while offering recommendations for a fair and equitable approach to intellectual property rights in biotechnology.

The study initiates by examining the fundamental principles of intellectual property rights and their historical development within the realm of biotechnology. It underscores the ethical and environmental issues associated with the patenting of life forms, especially human genes, and analyzes the unequal effects of intellectual property rights on developing countries. The paper examines the legal and ethical challenges related to human gene patenting, evaluating the consequences of the Human Genome Project and the Universal Declaration on the Human Genome and Human Rights. Fundamental concerns including equity, accessibility, and the ethical limits of genetic manipulation are rigorously evaluated.

The legal and policy problems associated with human gene patenting. It assesses the ethical and legal structures regulating biotechnology patents, encompassing the discourse on the patentability of living organisms and the influence of international agreements like the Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPs). The research analyzes the Indian Patent Act on human gene patenting, juxtaposing it with international norms and pinpointing possibilities for enhancement.

The study highlights the significance of international collaboration and the function of entities such as the World Intellectual Property Organization (WIPO) in formulating worldwide standards for intellectual property rights in biotechnology. It emphasizes activities designed to foster transparency, equity, and ethical accountability in genetic research and patenting. The report concludes by pinpointing deficiencies in current frameworks and proposing ideas to fortify international agreements, improve collaboration, and guarantee that intellectual property rights in biotechnology align with the overarching objectives of innovation, equity, and sustainability.

These concerns, contributing to the discourse on the responsible governance of biotechnology and intellectual property rights. It promotes a balanced strategy that encourages scientific advancement while preserving ethical standards, biodiversity, and equal access to genetic resources, so fostering a just and sustainable future for global biotechnology innovation.

Introduction

The unyielding pursuit of progress and the improvement of human existence differentiates humans from other creatures. Historically, humanity has endeavoured to enhance living conditions by advancing the frontiers of science and technology. The quest for advancement has resulted in notable advancements, with Intellectual Property Rights (IPR) serving as a crucial instrument to safeguard and compensate creators. As scientific discoveries expand the boundaries of knowledge, the convergence of biotechnology and intellectual property has grown increasingly intricate and contentious.

A highly contentious aspect of biotechnology patenting is human gene patenting—the practice of conferring exclusive rights to genetic sequences and alterations. The extension of patent rights to genetic material, while necessary for stimulating research and innovation, presents significant ethical, legal, and social considerations. In contrast to conventional patents on mechanical inventions, gene patents assert ownership over life itself, converting naturally occurring biological entities into commercial assets.

The scope of Intellectual Property Rights has broadened to include plants, microbes, and human genetic material, in addition to inanimate objects. The crucial turning point in this transition occurred when the U.S. Supreme Court affirmed a patent on genetically modified microorganisms, thereby facilitating more extensive claims over genetic resources.[1] Significant examples, such as the patents awarded to Ananda Chakrabarty for genetically modified Pseudomonas bacteria[2] and Agracetus for altered soybean plants, have intensified discussions on the proprietorship of living organisms. The cloning of Dolly the sheep by Dr. Ian Wilmut at the Roslin Institute of Scotland and the ensuing claims of human cloning have heightened apprehensions about the commodification of genetic material.

The emergence of human gene patents has significant ramifications. Pharmaceutical businesses and biotechnology firms currently possess exclusive rights to particular genetic sequences, governing research and medical therapies derived from human DNA. This has resulted in monopolization, when access to life-saving medical interventions is constrained by exorbitant licensing fees and legal impediments. Moreover, patents encompassing complete genetic sequences and alterations enable corporations to dominate scientific research, agriculture, and essential components of healthcare, impacting millions globally.

The essential inquiry persists: Should human genes be subject to patenting? Proponents assert that gene patents stimulate research and investment, but critics emphasize issues of biopiracy, unequal healthcare access, and ethical breaches. The current legal disputes and international policy discussions highlight the necessity for a balanced framework that safeguards innovation while guaranteeing the accessibility of genetic resources for the benefit of humanity.

As biotechnology advances, our strategy for Intellectual Property Rights must also adapt. The goal is to promote innovation without compromising ethical standards, social fairness, and global parity in healthcare and research. This study examines the legal, ethical, and policy aspects of human gene patenting, assessing its effects on science, society, and the future of genetic research.

[1] US Patent no 4259444 dt March 31, 1981

[2] Patent no EP 301749