Written by Kushagra Prasad, a student of law at Gujarat National Law University, Gandhinagar
INTRODUCTION
Biology has undergone a revolution thanks to the development of genetic engineering and gene editing techniques that provide unprecedented possibilities for modifying the genetic composition of living things. These technologies, especially in light of India’s intellectual property rules, develop important legal and ethical issues as they develop.
In light of India’s laws, this article examines the moral and legal ramifications of genetic engineering and gene editing technology. Legal factors to be taken into account include the definition of patentability, questions of infringement, licencing and technology transfer, research exemptions, and regulatory permissions.
The ownership and commercialization of living things, healthcare access, respect for human decency, safety, informed permission, privacy, and the fair sharing of benefits are ethical issues. By examining these complex issues, we can gain a comprehensive understanding of the multifaceted challenges and responsibilities associated with genetic engineering and gene editing technologies within India’s intellectual property landscape.
DEFINING GENETIC ENGINEERING AND GENE EDITING
Genetic engineering and gene editing are both scientific processes used to manipulate the genetic material of living organisms, but they differ in their methods and applications. Genetic engineering, also known as genetic modification, involves the deliberate alteration of an organism’s genetic material using biotechnology techniques. It typically involves the insertion or removal of specific genes to introduce new traits or modify existing ones. Genetic engineering can be performed on plants, animals, and microorganisms.
Gene editing, on the other hand, is a more precise and targeted approach to genetic modification. It involves making specific changes to the DNA sequence of a gene, either by adding, deleting or modifying nucleotides (the building block of DNA). The most widely used gene editing tool is called CRISPR-Cas9 which acts as molecular scissors to cut DNA at specific locations, allowing researchers to make precise modifications.
New and complicated ethical, legal, social, and policy challenges have been raised for both people and society as a result of genetic science’s quick advancements and uses. Fairness in the use of genetic information by insurers, employers, courts, schools, adoption agencies, and the military, among others, is one of the significant concerns that we must address.
Other concerns surround the ownership of genetic data, including who should have access to it, how it should be used, and how to protect the data’s privacy and confidentiality. Since the beginning of the human genome project, ELSI programmes that recognise and address these problems and their consequences have been a crucial component. The ELSI research aims to explore human DNA sequence completion, genetic technology integration, genomics and gene environment interaction, philosophical, theological, and ethical perspectives, and racial, ethnic, and socioeconomic factors affecting genetic information, services, and policy development.
ETHICAL IMPLICATIONS
From an ethical standpoint, it is believed that living beings are divine creations and cannot be treated as possessions by humans through the mechanism of patents. The responsibility of creating and owning all living beings on Earth rests solely with God. Each living being possesses inherent dignity and wholeness that must be safeguarded and assured.
Human beings should refrain from tampering with the natural order established by God by manipulating living beings. Genetic engineering and gene editing technologies have significant ethical implications, and these implications are not explicitly addressed in India’s intellectual property laws. However, the ethical considerations associated with these technologies can influence patentability, licensing, and the broader societal impact of intellectual property rights in the field of genetics. Some ethical implications to be considered includes: –
- Access to Healthcare: Patents and other intellectual property rights may make it difficult to get critical healthcare technology. When it comes to genetic engineering and gene editing, patents on vital genetic medicines or diagnostic equipment may prevent individuals who cannot afford the patented technologies from using them. Concerns about the ethical balance between private interests and the public good and equal access to healthcare are raised by this.
- Human Dignity and Autonomy: The basic qualities and properties of living things, including people, may be changed via genetic engineering and gene editing technology. When these technologies are used to alter human genetic material, such as germline editing, ethical issues arise that may have an influence on ideas of human dignity, autonomy, and the limits of allowable interventions.
- Equity and Justice: Genetic engineering and gene editing technologies have the potential to exacerbate existing social and economic inequalities. The concentration of intellectual property rights in the hands of a few entities may hinder the ability of other researchers, particularly in resource-constrained settings, to further develop or apply these technologies. Concerns arise when these technologies perpetuate or widen existing disparities.
Patenting living things is regarded as unethical since it privatises life and treats it like something that is owned. As with other private property, a patent can be bought, sold, or transferred. It is worth noting that while intellectual property laws can impact the development, commercialization, and accessibility of genetic engineering and gene editing technologies, they do not provide comprehensive solutions to the ethical implications associated with these technologies.
LEGAL IMPLICATIONS
The development of genetic testing has raised numerous concerns about autonomy, confidentiality, privacy, and equity that are exacerbated by the range of contexts in which such tests are undertaken, the sheer volume of tests that could be offered, the many uses that can be made of test results, and the variety of institutions that store genetic information.[1]
Gene patenting refers to “patenting a process of manipulating DNA and chemical substances related therewith, gene sequences and fragments of gene that are not present in their natural state in nature.”[2] According to section 3(C) of the Patent Act of 1970, an invention claiming “discovery of scientific principle” is not considered to be an invention, hence non-patentable[3].
Additionally, Section 3(j) of the same act specifies that “plants and animals in whole or any part thereof other than micro-organisms but including seeds, varieties and species and essentially biological processes for production or propagation of plants and animals.”[4]
However, there have been notable changes in India’s approach to patenting in recent years. Recognizing the global advancements in biotechnology and its impact on the Indian economy, the Indian Patent Office introduced the Indian Biotechnology Guidelines in 2013 and the Manual of Patent Office Practice and Procedure in 2005.
These guidelines and manuals were aimed at adapting to the evolving landscape of biotechnology and facilitating the patenting process in the field. The Manual requires a genetically modified gene sequence to be novel, inventive, and industrially applicable, with a novel expression method, protected antibodies, and a kit. It may be noted that once a gene patent is granted in India, the holder is entitled to reap the commercial benefits of the gene patent.[5]
The Supreme Court’s in the famous case of Novartis AG v Union of India[6] aimed to prevent patented items from ever-greening and provide affordable treatments for India’s 1 billion people. Section 3(d) aims to prevent patenting ineffective, small medicinal alterations, but may not significantly impact generic medication availability.
The court stated that it is forbidden to make patents ever greener. The court also protects the rights of regular people and forbids pharmaceutical companies from charging high costs for medications that are unaffordable to the common individual. Section 3(d) of the Patent Act prohibits companies from marketing similar drugs by just altering the molecular structure of the substance.
Imatinib Mesylate lacks an “innovative step,” which prevents patents from being perpetually greened. The owner of a patent, who has the sole right to capitalize on their invention, is the one who holds the exclusive license for a patented medicament.
India’s agricultural economy relies heavily on farming, but strong legal protection for genetic engineering in plants may disadvantage farmers and local communities. Gene patenting in other countries may benefit agro-biotech companies, leading to bio-piracy and cultural piracy.
Harmonizing IP laws globally may have different challenges and benefits. Harmonizing these laws would require extensive negotiations and compromises, as different countries have distinct legal systems and approaches to Intellectual Property rights. The patentability of gene-editing techniques and genetically modified organisms (GMOs) varies among countries.
Harmonizing these rules may pose challenges in determining patent eligibility criteria. On the other hand, harmonization promotes global collaboration, investment, and innovation in gene editing and genetic engineering technologies. It reduces legal complexities, enables streamlined research, establishes international ethical guidelines, and facilitates technology transfer. This ensures responsible research and prevents potential misuse of advanced technologies.
CONCLUSION
The legal and ethical implications of genetic engineering and gene editing technologies present a multifaceted challenge in India’s intellectual property landscape. The Novartis case and Section 3(d) of the Indian Patents Act, 1970[7] highlight the country’s efforts to uphold equitable healthcare access and preserve traditional knowledge.
Ethical considerations include responsible research, ethical conduct, and respect for human dignity. Addressing affordability and accessibility is crucial for democratizing the benefits of these technologies and promoting healthcare equity. To navigate these complexities successfully, India’s regulatory authorities must develop robust oversight mechanisms and international collaboration to capitalize on the transformative potential of these technologies.
[1] https://www.ncbi.nlm.nih.gov/books/NBK236044/
[2] Raghavendra, Archana. “Gene Patenting: An Indian Perspective – Patent – India.” Gene Patenting: An Indian Perspective – Patent – India, InvnTree Intellectual Property Services Pvt. Ltd., 29 June 2021, https://www.mondaq.com/india/patent/1085392/gene-patenting-an-india-perspective.
[3] Indian Patent Act, 1970, § 3(c) No. 39, Acts of Parliament, 1970(India).
[4] Indian Patent Act, 1970 § 3(j) No. 39, Acts of Parliament, 1970(India).
[5] https://www.mondaq.com/india/patent/1085392/gene-patenting-an-india-perspective
[6] Novartis AG v. Union of India, (2013) 6 SCC 1
[7] Indian Patent Act, 1970, § 3(d) No. 39, Acts of Parliament, 1970(India).
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