This presentation deals with the use of synthetic biology in current world to produce synthetic microorganisms and issues related to that. Three parent baby is also a part of synthetic biology where faulty mitochondria of one mother are replaced by healthy mitochondria of other women. It is a revolution towards the production of the designer baby. This designer baby will be a concern shortly as human are acting like God and may be started to produce the baby with other unknown defects or diseases which might be uncurable in the near future.

1. PRESENTATION ON
SYNTHETIC BIOLOGY AND
LEGAL ISSUES WITH THREE PARENT BABY
Prepared By
Vikram Jeet Singh
14IP60003
1Rajiv Gandhi School of Intellectual Property Law, IIT Kharagpur

2. Operational definition of Synthetic biology
• Synthetic biology is the engineering of biology the synthesis of complex,
biologically based (or inspired) systems which display functions that do not
exist in nature. European Commission Report of a NEST High- Level Expert
Group: “Synthetic Biology Applying Engineering to Biology” 2005.
• Synthetic biology is the engineering of biological components and systems that
do not exist in nature and the re-engineering of existing biological elements.
Synthetic Biology project EU FP6 2006.
• Synthetic biology aims to design and build new biological parts and systems or
to modify existing ones to carry out novel tasks by UK parliamentary office for
Science and Technology Post Note 2008.
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3. BACKGROUND
• The birth of synthetic biology is can be traced with genetic
engineering in early 1970’s.
• In 1972, Dr. Paul Berg created the first recombinant DNA
molecules by slicing DNA from a bacterial virus into that of a
monkey virus, SV40.
• After two years, first transgenic mammal is created and
introduced a foreign DNA into mouse embryos. In today world,
transgenic mouse is principal in biomedical research.
• In 1974, the Polish geneticist Waclaw Szybalski used the term
"synthetic biology”.
• SynBio is bringing together engineers and biologists to design and
build novel biomolecular components, networks and pathways,
and to use these constructs to rewire and reprogram organisms.
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4. First Minimal Bacterial Genome
• Mycoplasma laboratorium: SYNTHETIC GENOMES
• Patent Number: US 2007/0264688 by Venter et al.
• What is claimed is:
1. A method for constructing a synthetic genome
comprising:
• assembling nucleic acid cassettes that comprise
portions of the synthetic genome, Wherein at least
one of the nucleic acid cassettes is constructed from
nucleic acid components that have been chemically
synthesized, or from copies of chemically synthesized
nucleic acid components.
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5. Minimal Bacterial Genome
Cell with essential
and non essential
genes
Essential genes were put
together, a minimum genome
could be created artificially
By adding more genes,
the creation of an
organism of desired
properties
New Organism is created
J. Craig Venter Institute applied
for a broad patent of its
"minimal bacterial genome"
called Mycoplasma
laboratorium.
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6. Synthetic biology approaches and Uses
It has been characterized by two approaches:
• Top-down Approach
• Bottom-up approach
Use of Synthetic Biology
These re-engineered organisms will change our lives over the coming years:
 To create Super fermenting yeast and bacteria
 Bio-alcohols can be prepared
 Use of synthetic biology in Agriculture, food to save crops from disease and from bacteria.
 Used in the synthesis of Unnatural amino acids
 Hydrogen fuels for clean burning and producing water as a by-product.
 Phyto-synthetic algae can be produced
 leading to cheaper drugs,
 targeted therapies for attacking 'superbugs' and diseases, such as cancer.
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7. Issues Related To SynBio
• Ethical Issues: Playing with god.
• Legal Issues:
• Regulatory Issues:
 The shift to synthetic biology and other newer genetic engineering techniques will
leave many engineered plants without any premarket regulatory review.
 number and diversity of engineered microbes for commercial use will increase in
the near future, challenging EPA’s resources, expertise, and perhaps authority to
regulate them.
• Religious Issues: Italian Bishop, Cardinal Angelo Bagnasco gave his views in
synthetic biology that intelligence can never be without responsibility.
 Vatican View: The acceptability of the use of biological and biogenetic
techniques is only one part of the ethical problem: as with every human
behaviour.
 Pope St. John Paul II said that all research using stem cells from human
embryos is “morally unacceptable.
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8. • Intellectual Property issues: Patent law legal battles over
the patentability and monopolies of information technology and
business methods, genetic testing, medical information, and
stem cell research, and computer programs which includes
software for design of biological devices
• Other issues:
Biosecurity
infectious polio virus creation.
strain of influenza virus.
Artificial Life issues
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9. HISTORY OF THREE PARENT BABY
In the 1990s, embryologists tried to create a baby using
DNA from three people, when they injected mitochondrial
DNA from a donor into another woman’s egg, along with
sperm from her partner.
Two of the foetuses developed genetic disorders, and the
technique was halted by the US Food and Drug
Administration.
U.S. law prevents federal government funding research that
destroys human embryos or embryos created solely for
research. In February this year, however, a panel of experts
from the National Academy of Medicine told the Food and
Drug Administration that mitochondrial replacement
procedures were ethically permissible.
Rajiv Gandhi School of Intellectual Property
Law, IIT Kharagpur
9

10. Recent Developments
• 3 - Parent Babies
• House of lords in U.K.
approved in Mar 2015.
1© http://www.dailymail.co.uk/ 27 Feb 2014 All
rights reserved
© Andrea Shugar (@ashugar2011) | Twitter, All rights
reserved

11. PROCEDURE FOR THREE PARENT BABY
• Take eggs from a mother with damaged
mitochondria.
• Take eggs from a donor with healthy mitochondria.
• Remove and save the nucleus from the mother's egg.
This contains the majority of her genetic material.
• Remove and discard the donor's nucleus.
• Place the mother's nucleus in the donor's egg with
the healthy mitochondria.
• The egg can then be fertilised by the father's sperm.
Rajiv Gandhi School of Intellectual Property
Law, IIT Kharagpur
11

12. FIRST THREE PATENT BABY IN MEXICO • Born in Mexico as there are no rules w.r.t. to
embryo replacement or to destroy the embryo.
• Procedure to produce the boy was approved by
an ethical committee, and the clinic is overseen
by a regulatory agency
• The first three parent baby boy was born on 6
April 2016
• HISTORY: A Jordanian couple was trying to start
a family for almost 20 years. Ten years after they
married, she became pregnant, but it ended in
the first of four miscarriages.
• In 2005, the wife gave birth to a baby girl. It was
then that they discovered the probable cause of
their fertility problems: a genetic mutation in
the mother’s mitochondria. Their daughter was
born with Leigh syndrome, which affects the
brain, muscles and nerves of developing infants.
Sadly, she died aged six. The couple’s second
child had the same disorder, and lived for 8
months.
• Using a controversial “three-parent baby”
technique, the boy was born on 6 April 2016. He
is showing no signs of disease.
MEXICO CLINIC PLANS 20 ‘THREE-PARENT’ BABIES IN 2017 12

13. TESTS CONDUCTED ON BOY FOR DISORDER
• Huang has confirmed that most of the boy’s mitochondria
come from the donor. The team tested cells from many
different parts of his body: hair follicles, saliva, cheek swabs,
blood, umbilical cord, urine and foreskin.
• In some tissues, no mutant mitochondria were detected at
all.
• Most had 3 to 4 per cent mutant mitochondria, while the
highest level was 9 per cent.
• That is far below the level that causes Leigh syndrome, and
the mother has seen no signs of the problems that her other
children had.
Rajiv Gandhi School of Intellectual Property
Law, IIT Kharagpur
13

14. SECOND THREE PARENT BABY
IN KIEV, UKRAINE
The girl baby was born on 5
January, 2017 in a fertility clinic
in Kiev, Ukraine.
A 34-year-old woman who had
suffered from infertility for more
than 15 years gave birth to a
healthy baby that’s genetically
her own
REGULATIONS ARE NOT THERE TO
PROHIBIT PROCEDURES
Rajiv Gandhi School of Intellectual Property
Law, IIT Kharagpur
14

15. WHY BRITAIN IS SO PERMISSIVE
About 2,500 women of child-bearing age in Britain are
thought to be at risk of passing on mitochondrial disorders
to their children.
About one in 6,500 babies is born with a severe form of the
disease, which affects vital organs such as the brain, heart
and muscles.
One of the reasons is the lack of education amongst the
general public, who have always tended to trust the ‘ruling
classes.
U.K. people are also proud of being ‘pragmatic,’ “though
this is actually only ‘lazy ethics,’ suggesting that what is
possible and useful is automatically ethical.
Proposed amendment to the 2008 Human Fertilisation and
Embryology Act
Newcastle University has already started offering women
£500 to become ‘second mothers’ to three-parent babies.
Rajiv Gandhi School of Intellectual Property
Law, IIT Kharagpur
15
Born in July 25, 1978 and Brown married in
2004 and now has two sons, both conceived
without IVF

16. ARGUMENTS FOR AND AGAINST
FOR
• It would be immoral not to take
advantage of a technique that could
prevent devastating and potentially lethal
diseases.
• fertility regulator, the Human Fertilisation
and Embryology Authority (HFEA) to
judge each application on its merits and
decide whether or not it should be
approved. Licences permitting
mitochondrial donation will only be
granted if the Authority is satisfied that
women or their babies will not be put in
harms way.
• Mitochondrial DNA only accounts for 0.1
per cent of a person's total DNA, and
affects metabolism but not individual
characteristics such as facial features and
eye colour, which are determined by
nuclear DNA.
AGAINST
• Procedures have so far only been tested
in the laboratory and on animals. No
clinical trial has taken place to show
conclusively that the treatments are safe
in humans.
• mDNA affects personal traits as well as
metabolism in unforeseen ways.
• Epigenetic effects are seen as another
hazard. These are environmental
influences that can affect the way genes
work, either switching them on or off to
produce permanent changes.
• It crosses an ethical boundary. It could
leads to the creation of "designer
babies" whose genes are tweaked to
provide desirable characteristics.
Rajiv Gandhi School of Intellectual Property
Law, IIT Kharagpur
16

17. ISSUES IN THREE PARENTS BABY
Inherited mitochondrial diseases include devastating
conditions that result in:
 poor growth,
 muscle weakness,
loss of co-ordination,
seizures, vision and hearing problems,
learning disabilities and organ failure.
As safety issues around mitochondrial donation are still being explored.
• ‘Third-Parent’ Concerns
• MIGHT BE STERILE IN NATURE
• CHANGES ON DEMAND: Revolutionary new gene-editing
method called CRISPR could make possible to safely alter the
main genome in human embryos
Rajiv Gandhi School of Intellectual Property
Law, IIT Kharagpur
17

18. CONCLUSION
• No legal definition of SynBio.
• Regulatory processes are not defined.
• Commercialization.
• Ethical Issues
• Bio-safety concerns
Bio-Terrorism
Bio-war
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19. References
• OPERATIONAL DEFINITION
– European Commission Report of a NEST High- Level Expert Group: “Synthetic Biology Applying Engineering to
Biology” 2005
– http://ec.europa.eu/health/scientific_committees/consultations/public_consultations/scenihr_consultation_21_
en.htm
– Presidential Commission for the Study of Bioethical Issues, NEW DIRECTIONS The Ethics of Synthetic Biology and
Emerging Technologies, December 2010.
• BACKGROUND
– Presidential Commission for the Study of Bioethical Issues, NEW DIRECTIONS The Ethics of Synthetic Biology and
Emerging Technologies, December 2010.
– Patent Number: US 2007/0264688, patft.uspto.gov/
– https://docs.google.com/viewer?url=patentimages.storage.googleapis.com/pdfs/US20070264688.pdf
– Nature Reviews Genetics 11, 367-379 (May 2010), Ahmad S. Khalil & James J. Collins, Synthetic biology:
applications come of age
– http://www.jcvi.org/cms/research/projects/synthetic-biology-and-the-us-biotechnology-regulatory-
system/overview/#sthash.fouXBCrE.dpuf
• Use of Synthetic Biology
– New Directions The Ethics of Synthetic Biology Emerging Technologies, Presidential Commission for the Study of
Bioethical Issues, December 2010
• ISSUES RELATD TO THE SYNTHETIC BIOLOGY
– Parens et al 2009
– Bugl et al 2007
– http://www.vatican.va/roman_curia/pontifical_councils/justpeace/documents/rc_pc_justpeace_doc_20060526_
compendio-dott-soc_en.html
– http://www.jcvi.org/cms/research/projects/synthetic-biology-and-the-us-biotechnology-regulatory-
system/overview/
– Synthetic Biology: Navigating the Challenges Ahead by Arjun Bhutkar, The Journal of Biolaw & Business vol.8,
no.2, 2005
– Public will fear biological accidents, not just attacks , Markus Schmidt in Nature, 2006, vol. 441, no. 7097
•
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20. THANKS
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