Open Access Research Article
DESIGNER BABIES THROUGH GENETIC ENGINEERING; LEGAL AND ETHICAL CHALLENGES UNDER PATENT LAWS.
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DESIGNER BABIES THROUGH GENETIC ENGINEERING; LEGAL AND ETHICAL
CHALLENGES UNDER PATENT LAWS.
AUTHORED
BY- UPASANA SAHANI
Research
Scholar, School of Law, Christ (Deemed to be University)
Abstract
The beginning of genetic engineering
has cleared and facilitate the concept of "designer babies," here the
parents of the babies have the option to modify or choose the specific traits
for their offspring by the new biotechnological methods. This new technic has
raised new significant legal and ethical challenges mainly concerning patent
laws and intellectual property rights associated with genetic modifications.
The ethical dilemma related to genetic modification starts with the problem of
ownership of genetic modification techniques and it is a complicated matter
which need a rigorous scrutiny. Patent laws currently lack comprehensive
frameworks to regulate the applications of genetic engineering in humans,
resulting in ethical thickets that may inhibit access to these medical
advancements, especially for underprivileged populations. So, it can be seen
that the commodification of human life is raising important moral questions
about the nature of parenthood, identity, and social equality. The research
also focuses on the moral issue where the gene modification can create a class
divide, benefitting the group of people those who can access and afford such
facility. These differences could intensify existing socio-economic
inequalities in a society where genetic traits become identical with social
value, thus prompting concerns of utilitarianism and eugenics. This paper
scrutinizes the connection of genetic engineering, patent law, and bioethics,
concentrating on whether genetic modifications in embryos can be patented and what
are the implications of such patents. By estimating the balance between incentivizing
innovation and safeguarding public interest, this research explains that a legislative
framework must be established to address the complexities surrounding genetic
enhancement, as well as the rights of genetically modified individuals and the
responsibilities of those involved in such enhancements. To mitigate abuses and
unintended consequences, related to legal, ethical, and scientific problems to
direct the complicated landscape of designer babies and genetic engineering.
Keywords: Designer babies, Genetic engineering, CRISPR, Patent law, Ethical
challenges etc.
INTRODUCTION
Genome editing technologies has great
potential for scientific research and society then the other invented
technologies, this provides rapid, effective, detailed, and effective tools to
alter or modify the content in the cells of any living organism. The use of the genome editing techniques, can
have a effect on the cells of the body or on the somatic cells can be modified,
treating or curing patients of chronic, lifelong illnesses. The speedy
progressions in genetic engineering have created the way for the creation of
designer babies, as editing the genome of human embryos to make changes in the
unborn child can also repair the germline of human beings, eliminating
hereditary diseases in new-born babies leading to various ethical and legal
concerns. Genetic engineering can now offer detailed information about an
unborn child's genes also known as designer baby refers to the creation of
babies who were genetically modified by the genetical engineering, or germline
editing. Germline editing is the unique technique that is used for altering the
DNA in the cell.[1] This
technique allows parents and healthcare providers to make decisions about the
child's traits and characteristics where there can be alteration or
modification in the embryo to create a specific quality in matter of
appearance, intelligence, obedience, gender or even disease immune and a lot
more. The germline modification in a designer baby can be created in a way that
those babies can be immune from the hereditary diseases like leukaemia,
haemophilia, HIV, and other such disorders, But this technology’s consequences
can beyond the individuals choice, as this can lead to discrimination, privacy
violations, and the commodification of human life[2]. This
process starts a concern with regard to ethical issue that is eugenics and the potential for creating a
genetically "superior" class of humans. And this process will affect
the human diversity and the inherent dignity of all individuals, irrespective
of their genetics. Additionally, the use of gene editing technique for
non-therapeutic purposes, like increasing physical or cognitive abilities,
raises concern about the equitable access to these technologies and the
potential for socioeconomic disparities.
The legal outline which addresses
about the designer babies is also bounded with complexities as it has many
challenges. The patenting of the gene editing techniques and the genetic
technologies and the ensuing commercialization of these products and have
raised the concerns regarding the availability and affordability of these
treatments. In this the CRISPR has a major role in particular it represents a
revolutionary progression in genetic engineering. [3]As
it allows changes in the protein structure DNA for the purpose of gene editing,
and to modify specific needs which are required and have a effect on the disease
or other traits. Combined with IVF and PGD, which are traditionally used to
select embryos without genetic abnormalities, CRISPR has created the
possibilities for not only therapeutic interventions but also the enrichment of
human capabilities. And this rising interest in human germline modifications
changes to genes that can be passed to future generations and has been
associated with various challenges. These modifications have the capacity to
give solutions to inherited genetic disorders but also raise complex ethical
and societal issues[4].
However, these challenges are very much complex in nature it has a impact on
the law making and human rights and to resolve this a new approach that
balances the human right along with societal interest.
The designer babies and genetic
engineering are regulated emphasizing on the problems, evolving nature of this
issue. In this the ownership of genetic modifications raises questions about
intellectual property rights and the commercialization of human life [5]and
the need for comprehensive policies to govern the use of genetic technologies
and protect human rights, While the potential benefits of designer babies are
significant, the ethical and legal ramifications necessitate careful
consideration and regulation to ensure that advancements in genetic engineering
do not compromise fundamental human values. [6]These
variations emphasis more on the fact that while the science behind genetic
engineering is global, the legal and ethical boundaries are shaped by distinct cultural,
political, and societal values.
IMPLICATIONS
OF GENE EDITING TECHNOLOGIES AND ETHICAL ISSUES
Researchers must not be careless in
using gene editing and stem cell technologies though there is a general
understanding of the benefits it might hold in tackling genetic diseases and
eradicating them altogether. [7]Such
technologies can also help in the better understanding of the human body and
why and how certain people are more likely to susceptible to certain diseases.
But it must be kept in mind that there are far reaching implications of
carelessly using gene editing technologies. Chinese scientist Jiankui He of
Southern University of Science and Technology registered a clinical trial where
he had implanted genetically modified embryos using the CRISPR Cas9 technology.[8]
He had genetically edited the CCR5
gene relating to HIV/AIDS in the embryos. Two baby girls, namely Lulu and Nana,
were born from this clinical trial. He had not received approval to conduct the
trial and had taken a gigantic risk without any ethical considerations. Post
the investigation of his work, it came to light that the two embryos were
edited in different ways. While the process used was the same, the product was
different. [9]One of
the embryos was said to have lost five proteins due to the editing which could
have seriously affected her immunity. The consequences of this were drastic.[10]
There is also the possibility of mosaicism. This can lead to a myriad of
problems that can be inherited by future generations as well. A few mutated
cells in the body can lead to diseases and sometimes, a single cell might
develop a tumour and the consequences cannot be treated until the affected cell
or cells are destroyed.40 In addition to this, there can be off- target effects
of gene editing that can sometimes be missed even after thorough screening.
One of the most important ethical
concerns regarding designer babies is the potential for intensifying social
inequality. As genetic engineering technologies become available, they may only
be accessible to those with the financial means to afford them, thereby
creating[11] a
division in between those who can improve their future genetically and those
who cannot. This difference can be said to be a inequality and create a new
group of genetically "enhanced" individuals or persons who are
advanced, as they can enjoy certain benefit with respect to health,
intelligence, and physical abilities, ensuing in an increasingly stratified
society[12] this consist a different kind of
complexity, because the primary focuses of genetic engineering embryos cannot
provide harmony themselves. This raises ethical questions about parental rights
and the extent to which parents can make potentially life-altering decisions on
behalf of their future children. Critics argue that the inability of embryos to
consent creates a moral quandary that must be addressed before proceeding with
human genetic modifications[13]. Another
ethical issue associated with the option of unplanned consequences which are
the outcome of genetic modifications. The long-term effects of altering an
individual's genetic makeup are not fully understood, which raises concerns
about potential negative health impacts, both for the individual and future
generations.
Critics argue that until more
research is conducted to comprehend these risks, the use of gene-editing
technologies should be approached with caution.[14]
Ethical decision-making regarding designer babies also necessitates strict
regulation and oversight from governments and international organizations.
Different countries currently have varying levels of regulation regarding
genetic engineering, creating potential inconsistencies in ethical standards.
Striking a balance between fostering innovation and protecting human rights
remains a critical challenge as the technology develops, while ensuring that
the decision-making process remains informed and inclusive of diverse societal
perspectives[15]
The idea of designer babies brings
many important and debatable ethical dilemmas that the society must resolve as
it will be relatable due to technological advancements in genetic engineering
& it continue to evolve. Subjects like social inequality, informed consent,
eugenics, unintended consequences, and the enduring impacts on future
generations raise more complexity about the morality of editing human embryos. [16]The
ethical dilemmas of designer babies demonstrate the complexities that are
integral in advancing genetic engineering technology.? Thorough careful
consideration the future of genetic modifications can be shaped while
maintaining human dignity and ethical integrity.
THE
INTERSECTION OF GENETICS AND PATENT LAW
The quick advancing genetic engineering
technologies like CRISPR/Cas9 have much definition imposed on the whole nature
of the biomedical sciences, enabling capabilities that have not been identified
previously, even creating scopes such as the possibility of designer babies’
embryos with the genetic traits that are purposely defined. This is a new area
fraught with legal issues making the patent realm even more challenging against
the prongs of ownership, ethics, and commodification of human biology. Thus,
considering that the society is on the verge of a genetic revolution, it is
essential to look into the integrated legal framework concerning genetic
modifications as well as the ethical issues involved in such intense human life
intervention.
The designer babies and the
complexity related to it lies the patentability issue-the legal ownership and
commercial use of a biotechnical invention. Patent laws have customarily given
inventors exclusive rights over an invention that satisfies certain criteria;
it must be novel, non-obvious, and useful[17].
Yet, the ever-challenging life sciences place increasing strain on these
fundamental principles which witness the very question of whether genes
themselves-the basic building blocks of life-should be patentable. In a landmark judgement in the case of Association
for Molecular Pathology v. Myriad Genetics[18],
the Supreme Court held that patentability could not extend to human genes
occurring naturally and hence unmodified remains in the public domain. This
decision seems to resonate with the point made in patent law that human life
should not be commodified, a point that continues to trickle down and influence
the discussing relating to designer babies[19]. On
the other hand, notwithstanding these decisions, implicating patent law,
biotech firms and academia continue to act and maintain ownership and
commercialization rights on genetic engineering technologies. This ambiguity
fosters a landscape where the pursuit of profit may supersede ethical
considerations, leading to what some critics refer to as "biopiracy,"
the commodification of human genetic material for financial gain.[20]
In India patent regime, governed by
the Indian Patent Act, 1970, aligns with global standards of novelty, inventive
step, and industrial applicability and for the designer babies and gene editing
the patent acts is applied. The Act introduces additional exclusions under
Sections 3 and 4[21],
reflecting India's socio-economic and ethical priorities, as in Section 3(c) [22]Excludes
the patentability of "the mere discovery of a scientific principle or the
formulation of an abstract theory.", Section 3(j)[23]:
Prohibits patents on "plants and animals in whole or any part
thereof" and "essentially biological processes.", Section 3(b)[24]:
Disallows inventions if their primary use could harm public order, morality, or
human, animal, or environmental life. These provisions, particularly Sections
3(c) and 3(j)[25], pose
significant barriers to patenting gene-editing technologies in India which has
a direct relation with designer babies. Unlike the U.S. and Europe, where
patents can be granted on genetic materials and editing tools, India
prioritizes public interest and the prevention of biopiracy. While global
standards prioritize innovation and commercialization, India’s framework
reflects its developmental concerns, emphasizing accessibility, public
morality, and protection of biodiversity.[26]
The stricter exclusions in India ensure that gene-editing technologies remain
accessible but may discourage foreign investment and limit innovation within
the country. The divergence in patentability criteria underscores the need for
a balanced approach that harmonizes global standards with local ethical and
economic priorities, particularly in the case of transformative technologies
like gene editing.
EDITING OF
HUMAN GENES
There is a lot of debate surrounding
the recent discovery of the CRISPR/CAS9, which works for the gene alteration.
These changes can be introduced to both a normal form of gene and mutant gene.
CRISPR/CAS9 is covered by several patentees in various fields following
multiple patents. The first human edited infants were created in China when Dr.
He cut away an HIV gene from human embryos, sparking a global moral outrage. Dr.
He facing criminal charges by the Chinese authorities. [27]
for the same so it can be clearly understood that editing of human genes is
only a scientific challenge to deal with but also a legal issue.
From an evolutionary point of view,
natural selection and other processes cannot significantly reduce the frequency
of disease associated gene expression in humans, especially within a brief
period of time. Genetic engineering plays a important part in this situation.
Scientists can boost a baby's resilience to a number of inherited disorders,
including breast cancer and cystic fibrosis, by changing the embryo's DNA etc.
The issue therefore starts from the fact that scientists try to improve the DNA
of infants by altering germline cells rather than somatic cells. Only that
person will see a change in gene expression when changes are done to their
somatic cells. But since germline cells are reproductive cells, any alterations
made to them will be inherited by subsequent generations. Thus, it is possible
to reduce the frequency of hereditary illness expression in subsequent
generations by genetically altering germline cells in embryos. Even while this
seems to have a lot of potential advantages, there are drawbacks that need to
be taken into account for the good of society.
The possible advantages of
genetically altering embryos are currently being balanced against the potential
drawbacks for society. In order to aid those who suffer from severe genetic
abnormalities, research on designer babies is being conducted "to avoid
their having heritable diseases coded by mutations in DNA". [28]However,
the growth in designer babies actually disproportionately affects people with
severe genetic diseases since their sickness often prevents them from achieving
socio-economic stability, making it impossible for them to afford the high cost
of genetic alteration.[29]
The expenses of genetic manipulation are currently very high, even though gene
editing will undoubtedly become less expensive as genetic technology advances.
Therefore, promoting genetic modification procedures will result in a limited
consumer base that includes only those who can afford gene editing. This will
make it more likely that those who don't need these resources will take
advantage of them, creating a social divide between those who can afford gene
editing and those who can't.
While those who more urgently need gene editing to prevent heritable diseases might not be able to afford it, consumers who can afford it might attempt to alter their child's genome to increase the likelihood that they will be tall or have particular colored eyes, both of which can be considered resource abuse.
Although there are many potential advantages to designer babies in terms of
preventing sickness, it is important to take into account the moral conundrum
that separates the exploitation of gene editing resources from their use for
ethical and sustainable purposes. [30]It's
also critical to assess the strategies being used by scientists to develop
designer offspring. The issue of whether gene editing should be restricted to a
person is brought up because altering germline cells in embryos can have an
impact on entire generations. Enhancing a baby's DNA can improve its health
potential, but the science of gene editing isn't independent of individuals who
can and will misuse it. Society must, therefore, decide whether or not to allow
the development of designer babies by weighing the potential benefits and
drawbacks.[31]
CONCLUSION
Designer babies are challenged with different
legal issues raised by genetic engineering technologies increasingly advancing,
and these will be worthy of careful examinations in many perspectives. For
patent law, it should continue developing in defining particular ownership and
ethical usefulness rules of genetic inventions within the balancing act of
innovation against the protection of human rights. Ethical matters should also
focus on the broader social context, informed consent for genetic alteration,
and the potential differences in status between enhanced and non-enhanced
individuals. Ethical legalistic & theological consensus needs to be reached
on the issues by which the society will come face to face with the reality of
designer babies.
There can be establishment of a
responsible framework accommodating scope for genetic engineering within the areas
of pain-protection life and dignity of every person unless there is
constructive deliberation among legal experts, ethicists, scientists, and the
public. It is under patents where designer babies, conceived in the womb of
gene engineering, stir up tremendous rights and responsibilities. Emerging
technologies such as CRISPR-Cas9 facilitating accurate germline gene editing
make the question of embryo manipulation even more complicated. This introduction
deals with the issues of crossover between gene engineering, ethics, and law on
the issue of designer babies requiring responsible governance in the rapidly
evolving field. Though it foresees significant benefits from designer babies
for individuals and societies, most especially the elimination of genetic
diseases, the ethical and legal complexities need very careful consideration
and a strong regulatory framework within which to venture into this territory.
[1] Contributor, Designer Babies:
An Analysis of Legal And Ethical Considerations?», (May 2, 2024), https://www.lawaudience.com/designer-babies-an-analysis-of-legal-and-ethical-considerations/
(last visited Mar 15, 2025).
[2] Ibid.
[3] Contributor, Designer Babies:
An Analysis of Legal And Ethical Considerations?», (May 2, 2024), https://www.lawaudience.com/designer-babies-an-analysis-of-legal-and-ethical-considerations/
(last visited Mar 14, 2025).
[4] Christopher Gyngell & Tom
Douglas, The Ethics of Germline Gene Editing, Journal of Applied
Philosophy, https://www.academia.edu/29210545/The_Ethics_of_Germline_Gene_Editing
(last visited Mar 15, 2025).
[5] Ibid.
[6] Bartha Maria Knoppers &
Erika Kleiderman, “CRISPR Babies”: What Does This Mean for Science and
Canada?, 191 CMAJ E91 (2019), https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6342697/
(last visited Mar 15, 2025).
[7] Ibid.
[8] Chinese-University-v.-Controller,
https://spicyip.com/wp-content/uploads/2023/10/Chinese-University-v.-Controller.pdf
(last visited March 10, 2025).
[9] Supra Note 04.
[10] Supra Note 08.
[11] Designer Babies: An Ethical
Dilemma, Hadron, IMSA (Nov. 27, 2023),
sites.imsa.edu/hadron/2023/11/27/designer-babies-an-ethical-dilemma. (last
visited March 10, 2025).
[12] Ibid.
[13] Designer Babies: The Ethics
of Human Genetic Engineering, Mirage News (Apr. 24, 2023), https://www.miragenews.com/designer-babies-ethics-of-human-genetic-992678
(last visited March 10, 2025).
[14] Ibid.
[15] Ibid.
[16] Supra Note 09.
[17] Supra Note 01.
[18] Molecular Pathology v. Myriad Genetics, Inc., 569
U.S. 576 (2013)
[19] Assoc. for Molecular Pathology
v. Myriad Genetics, Inc., 569 U.S. 576 (2013), Justia Law, https://supreme.justia.com/cases/federal/us/569/576/
(last visited March 10, 2025).
[20] Supra Note 01.
[21] The Indian Patent Act, 1970,
Sections 3 and Section 4.
[22] The Indian Patent Act, 1970,
Sections 3(c).
[23] The Indian Patent Act, 1970,
Section 3(j).
[24] The Indian Patent Act, 1970,
Sections 3(b).
[25] The Indian Patent Act, 1970,
Sections 3(c) and Section 3(j).
[26] Supra Note 11.
[27] Supra Note 01.
[28] Supra Note 07
[29] Supra Note 05.
[30] Designer Babies: An Ethical
Dilemma – Hadron, (Nov. 27, 2023), https://sites.imsa.edu/hadron/2023/11/27/designer-babies-an-ethical-dilemma/
(last visited Mar 15, 2025).
[31] Supra note 08.
Article Information
DESIGNER BABIES THROUGH GENETIC ENGINEERING; LEGAL AND ETHICAL CHALLENGES UNDER PATENT LAWS.
Authors: UPASANA SAHANI
- Journal IJLRA
- ISSN 2582-6433
- Published 2025/03/17
- Issue 7
About Journal
International Journal for Legal Research and Analysis
- Abbreviation IJLRA
- ISSN 2582-6433
- Access Open Access
- License CC 4.0
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