GENETIC ENGINEERING AND INTELLECTUAL PROPERTY: LEGAL AND ETHICAL IMPLICATIONS

ABSTRACT

This article explores the intricate intersection of genetic engineering, intellectual property, and ethics within the context of India’s regulatory framework. Examining legal considerations like patentability, infringements, and licensing, as well as ethical aspects such as ownership, accessibility, and consent, the discussion delves into the challenges and responsibilities associated with genetic engineering and gene editing techniques. Intellectual Property Rights, including patents, copyrights, and trademarks, play a crucial role in protecting innovations in biotechnological advancements. The article also scrutinizes biotechnological inventions, gene patenting, and the evolving landscape of genetic engineering and gene editing in organisms. Ethical implications, including concerns related to human genetic research, gene patenting, cloning, access to healthcare, and genetic modification, are thoroughly explored. The article emphasizes the need for ongoing dialogue, transparency, and a comprehensive ethical framework to navigate the evolving challenges associated with genetic engineering, intellectual property, and human well-being in India.

KEYWORDS

Biotechnological Inventions, Gene Patenting, Gene Editing, Human Genetic Engineering, Animal Genetic Engineering, Cloning, Animal welfare.

INTRODUCTION

The view of biology has transformed with the invention of genetic engineering and gene editing techniques, presenting unprecedented opportunities to alter the genetic makeup of organisms. Within the framework of India’s intellectual property regulations, it has played a major role in the legal and ethical considerations arising from these technologies.

Referring to the legal aspects such as dealing with issues relating to patentability, infringements, licensing, etc., whereas in the case of ethical concepts concerning matters such as ownership, accessibility, equitable sharing, consent, etc. By examining these complex matters, we can attain a thorough understanding of the challenges and obligations that are connected with genetic engineering and gene editing techniques in India.

MASTERING OF CERTAIN IMPORTANT CONCEPTS

Intellectual Property Rights

Intellectual Property Rights (IPR) are legal protections granted to the creations of the mind, such as inventions, literary and artistic works, designs, symbols, names, and images used in commerce. These rights give creators and inventors exclusive control over the use of their creations, encouraging innovation and creativity while providing a framework for fair competition. In the case of Bayer Corporation v. Union of India[1], Writ Petition No. 1323 of 2013, the Bombay High Court held this term as “Intellectual Property is the creative work of the human intellect. And, the right to intellectual property is an invisible/intangible right to a product of a man’s brain, such as a newly invented product, i.e. property of the mind. Intellectual property is at times described as Knowledgeable Goods”. Intellectual Property involves different matters such as copyrights, trademarks, patents, plant varieties, geographical indications, designs, and trade secrets.

Importance of Intellectual Property Regulations: Several Scientists all over the world invest years together in discovering and developing economically consequential transgenic plant varieties, Thus, protection of their rights is very much necessary which is achieved through intellectual property rights in the forms of patents, copyrights, trademarks, etc. These various types of IPRs empower scientists and organizations to safeguard and control the use of their products. Patents, lasting at least 20 years, grant exclusive rights to produce, sell, or import inventions, transitioning to public use after expiration. Trade secrets safeguard product information, SOPs, protocols, business ideas, and clientele. Copyrights protect software and database use. Geographical indications consider product quality, reputation, and origin information, preventing misinformation to the public. Similarly, Plant breeder’s rights restrict unauthorized use of genetically modified plant species for approximately 20 years.

Biotechnological Inventions

These involve products or processes with biological material containing genetic information. Genetic manipulation in farming and food production can enhance flexibility and yield. Biotech employs techniques like tissue and cell culture, hybridoma, and recombinant DNA technology. Tissue and cell culture create uniform cell lines for accurate testing. Hybridoma combines white blood cells and myeloma to produce antibodies, aiding immune system research. Recombinant DNA technology, or genetic engineering, manipulates matter at the subcellular level, altering DNA to influence protein production. In Silico, techniques use genetic and bioinformatics to attribute functions to gene sequences. These advancements, including gene identification, vaccine development, and genetically engineered organisms, lead to patent applications. However, legal objections arise, prompting a closer look at each issue.

Gene Patenting

Gene patenting involves obtaining exclusive rights to a specific gene sequence or its related functions through the patent system. This allows the patent holder to control the use, development, and commercialization of products or processes related to that gene. Gene patents have been a topic of debate due to concerns about limiting access to genetic information and hindering research and healthcare advancements. In India, Section 3(C) of the Patent Act, of 1970, disallows “discovery of any living thing or non-living substance occurring in nature” as a patentable subject matter. Further, Section 3(j) extends this restriction to plants and animals, except for micro-organisms. To keep pace with global biotechnology advancements, the Indian Patent Office introduced the Indian Biotechnology Guidelines in 2013 and the Manual of Patent Office Practice and Procedure in 2005 for same.

Genetic Engineering and Gene Editing

Genetic Engineering and Gene Editing both is the manipulation and modification of an organism’s genetic material (DNA) using biotechnological techniques. This process involves the insertion, deletion, or alteration of specific genes to achieve desired traits or characteristics in the organism. Genetic engineering can be applied to various organisms, including plants, animals, and microorganisms, to enhance new traits, create genetically modified organisms (GMOs), or conduct research for scientific and medical purposes.

Role of Genetic Engineering: In the 1980s, the advancement of plant genetic engineering led to a series of confirmations regarding the patentability of life forms, ensuring they met standard criteria like novelty, utility, and non-obviousness. In the case of Diamond v. Chakrabarty[2], 447 U.S. 303 (1980), the Supreme Court held that utility patents could be granted for inventions involving living organisms, specifically addressing a microorganism designed to break down crude oil for controlling spills. Subsequent decisions affirmed that plants, animals, and genetic sequences, including genes and promoters, could be protected by utility patents. Various means, such as utility patents, plant patents, Plant Variety Protection Certificates (PVPCs), and state trade secret laws, are now utilized by breeders to safeguard their research and breeding efforts. These measures grant control over the use, sale, import, and reproduction of patented plants, restricting others from using them for subsequent breeding or seed increase. Molecular and genomic tools in genetic engineering enhance intellectual property enforcement by establishing unique “fingerprints” for plants and seeds, akin to DNA profiling in criminal cases, allowing detection of unauthorized use of protected varieties or genetic material in breeding.

Genetic engineering of animals has surged recently, raising ethical concerns, particularly related to animal welfare, which is defined by the World Organization concerning Animal Health as the “state of the animal” in its living conditions, these issues demand attention from stakeholders, including veterinarians. To ensure a meaningful contribution to creating and using genetically engineered animals, all parties must be aware of the ethical considerations. Aligning scientific practices with societal values and recognizing the additional challenges posed by genetically engineered animals, governing bodies are developing policies that emphasize increased vigilance and monitoring of potential impacts on animal welfare. Veterinarians, particularly in research settings, play a vital role in carrying out such monitoring, especially when developing new strains of genetically engineered animals.

Currently, Genetic engineering technology has numerous applications involving wild, and farm animals and animal models used for scientific research. The majority of genetically engineered animals are still in the research phase, rather than actually in use for their intended applications, or commercially available.

ETHICAL AND LEGAL IMPLICATIONS

Human genetic research has paved the way for studying the “human genome,” “human embryo research,” and “stem cell” research. However, these fields raise significant ethical concerns. Human genomic research involves handling an individual’s genetic material, creating ethical complications. Ethics emphasizes the necessity of providing justifications for our actions and articulating our intentions. The merit of an action lies not solely in the intent to do good but in the articulation of the reasons behind the action and its purpose. Ethically, living beings are seen as divine creations, but not possessions subject to human patents. It is presumed that the responsibility for all life on Earth is attributed to God, emphasizing the inherent dignity and wholeness of each living being.

However, tampering with the natural order established by God through genetic engineering is often discouraged. India’s intellectual property laws lack explicit consideration of the ethical implications associated with genetic technologies. However, these ethical considerations can impact patentability, licensing, and broader societal implications in genetics.

In the realm of biotechnology, three crucial facets demand attention:

Incentives: Scrutiny should be directed towards how scientists are incentivized and promoted for their research endeavors.
Intentions: The ultimate outcomes of biotechnological research necessitate careful consideration and clarification.
Actions: Prospective applications of research must be elucidated, addressing concerns related to their societal impact.

While the advantages of biotechnology are prominently advertised, the associated risks often lack comprehensive coverage. Ignorance regarding the social, legal, and ethical implications is untenable. In the U.S., ethical debates escalated when Stuart Newman applied for a patent on a non-human chimera, where human genes were manipulated into an animal. The patent office, for the first time, considered ethical principles in granting a patent, concluding that it would violate societal ethical standards. The court ruled that transgenic human beings cannot be patented under the 13th Amendment of the U.S. Constitution, which prohibits slavery. This established that patenting on moral grounds is restricted for human beings.

An illustrative case is the John Moore v. Regents of the University of California[3], 793 P.2d 4709 (Cal. 1990), where a patent was sought for the “cell line” derived from Moore during his treatment for hairy cell leukemia. The court, while rejecting Moore’s claim of property rights over his cell line, did acknowledge breaches of fiduciary duty and lack of informed consent, highlighting the nuanced ethical dimensions in biotechnological advancements.

The concerns surrounding gene patenting encompass various dimensions, namely:

Cloning: Cloning involves replicating biological material, such as DNA or cells, such alteration of genetic structures for utility raises ethical queries, asserting that humans should not be treated as commodities. Genetic material, viewed as a common heritage, should not be subject to monopolization. Due to ethical concerns, the U.S. judiciary and patent office asserted that cloning and patenting human beings violate the inherent dignity of human life and equate to slavery. Pioneer Hibred International restricted cloning based on ethical, moral, and public order considerations. While U.S. law allows patents on the process or methods of human cloning, it remains silent on the potential ethical issues arising from the process leading to human cloning. Cloning also poses risks, with cloned mammals often experiencing abnormalities.
Access to Healthcare: Patents on genetic medicines or diagnostic tools may hinder access to critical healthcare technology, raising concerns about the ethical balance between private interests and public welfare.
Biological Borders: Ethical impropriety is noted in the crossing of biological borders and the exchange of genetic material, for example, using genes from humans in animals, as seen in the “Dolly” sheep, is ethically wrong and raises concerns about crossing biological boundaries.
Genetic Modification: Genetically modified organisms risk being perceived as mere commodities, stripping them of intrinsic value. In simpler terms, genetically modified organisms face the risk of being perceived solely as commodities, emphasizing their economic value rather than recognizing their intrinsic worth. This perspective may overlook the potential benefits they offer, such as increased crop yield, resistance to pests, or improved nutritional content, reducing the focus to a narrow economic lens rather than appreciating their broader impact on agriculture and sustainability.
Exploitation in Reproductive Biology: The use of biotechnology in reproductive biology raises concerns about the exploitation of women, particularly in embryo research for purposes such as stem cell research.
Equity and Justice: Genetic technologies can worsen social and economic inequalities. The concentration of intellectual property rights may impede researchers, particularly in resource-constrained settings, from advancing or applying these technologies, raising concerns about perpetuating existing disparities.
Debates on Human Cloning: The creation of slaves is posited as a potential consequence of human cloning, adding a layer of ethical complexity.
Research Involving Humans: Human subjects in research institutions necessitate careful consideration and transparent communication of procedures before experimentation commences.
Concerns about owning the ideas and techniques used to create animals, and issues relating to animal welfare: Creating genetically engineered animals often involves surgeries on animals, like inducing superovulation in females and vasectomizing males. These procedures can be invasive, requiring sacrifices and causing distress. A large number of animals are used, and many embryos don’t survive genetic engineering procedures. This contradicts efforts to minimize animal use. Cryopreservation helps, but the rise in creating genetically engineered animals challenges the principle of reducing animal use.

There’s limited data on the welfare impact of genetic engineering. Unpredictable outcomes and inefficiencies arise, leading to variations in animal lines and unexpected side effects. Genetically engineered animals may exhibit diverse phenotypes, some causing welfare issues. Predicting these effects is challenging, requiring close monitoring. A proposed solution is a “genetically engineered animal passport” for individual animals, helping caretakers understand and address specific welfare needs. Advancements in genetic engineering may reduce unpredictability in gene insertion locations over time, potentially addressing welfare concerns. Environment Canada and Health Canada provide specific guidelines on this matter.

Patient rights are defined negatively, a grant of exclusive rights to prevent third parties from using a patented product without approval. Licensing genes is crucial for promoting biotechnological innovation. Licensing agreements, by disseminating knowledge, benefit both parties. However, the cost of license fees is linked to royalty stacking issues. The Organization for Economic Co-operation and Development suggests including mechanisms to set reasonable overall royalty burdens for genetic inventions, aiming to decrease transaction costs in acquiring technology rights.

In the case of Novartis AG v Union of India[4], 13 S.C.R.148, the Supreme Court ordered to stop the practice of ever-greening patents, ensuring affordable treatments for India’s population. Section 3(d) specifically prevents patenting minor, ineffective medicine changes. This legal provision protects people’s rights, preventing pharmaceutical companies from charging exorbitant prices for medications, and prohibits marketing similar drugs by merely altering their molecular structure. The court focuses on maintaining accessibility and affordability of essential medications for the common individual.

CONCLUSION

In conclusion, I would like to say that dealing with genetic engineering, intellectual property, and ethics in India is like navigating a complicated path. Intellectual Property Rights, especially through patents, are crucial for safeguarding new ideas in genetic technology. Even though genetic engineering brings exciting progress, we can’t ignore the ethical concerns about human dignity, societal impact, and potential misuse. Balancing the encouragement of scientific research and ensuring public well-being requires careful examination of intentions, actions, and how it affects society. Recent legal changes, like key court cases, highlight the importance of considering ethics in genetic patents. As this field advances, ongoing conversations, openness, and a clear ethical framework are vital to handle the challenges and responsibilities linked to genetic engineering and how it impacts intellectual property and people’s well-being.

REFERENCES

BOOK – By VK Ahuja, Law Relating to Intellectual Property Rights, Page no – 03 Introduction, published by LexisNexis, 2007.
Author: Neeta, Editor: Aatima Bhatia, Article: Legal, social and ethical implications of gene patenting, Webpage: blog.ipleaders.in, Date: November 10, 2021, Link: https://blog.ipleaders.in/legal-social-and-ethical-implications-of-gene-patenting-2/
Author: Dr. Griffin, Canadian Veterinary Medical Association, Article: Genetic engineering of animals: Ethical issues, including welfare concerns, Webpage: National Library of Medicine, Date: May 2011, Link: https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3078015/
Author: Kushagra Prasad, Article: The Legal and Ethical Implications of Genetic Engineering and Gene Editing Technologies on India’s Intellectual Property Laws, Webpage: thelegallock.com, Date: October 15, 2023, Link: https://thelegallock.com/the-legal-and-ethical-implications-of-genetic-engineering-and-gene-editing-technologies-on-indias-intellectual-property-laws/
Author: Krupa Solanki & Dr Tushar Chauhan, Article: Values of IPRs- Intellectual Property rights in Genetic Engineering, Webpage: International Journal of Research and Analytical Reviews, Date: June 2019, Link: http://www.ijrar.org
Webmaster: Professor Edward P Richards, Article: Fiduciary Duty of Researchers – the Spleen Case – Moore v. Regents of University of California, Link: https://biotech.law.lsu.edu/cases/consent/moore_v_regents.htm
Author: Brain D. Wright, Article: Plant Genetic Engineering and Intellectual Property Protection, Webpage: ANR Publications 8186, Link: http://anrcatalog.ucdavis.edu
Author: Article: Hybrid too human to protect, Webpage: Nature Reviews Drug Discovery (Nat Rev Drug Discov), Date: April 2005, Link: https://www.nature.com/articles/nrd1710#:~:text=A%20New%20York%20scientist’s%207,to%20make%20the%20animal%20anyway
Bayer Corporation v. Union of India, Writ Petition No. 1323 of 2013
Diamond v. Chakrabarty, 447 U.S. 303 (1980)
John Moore v. Regents of the University of California, 793 P.2d 4709 (Cal. 1990)
Novartis AG v Union of India, 13 S.C.R.148

[1] Bayer Corporation v. Union of India, Writ Petition No. 1323 of 2013

[2] Diamond v. Chakrabarty, 447 U.S. 303 (1980)

[3] John Moore v. Regents of the University of California, 793 P.2d 4709 (Cal. 1990)

[4] Novartis AG v Union of India, 13 S.C.R.148

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