Module 1

1.1 -Application of Biotech

 Biotechnology uses living cells to develop or manipulate products for specific
purposes, such as genetically modified foods. Biotechnology is thus linked to genetic
engineering and emerged as a field in its own right at the beginning of the 20th century in
the food industry, which was later joined by other sectors such as medicine and the
environment.
 Today, the five branches into which modern biotechnology is divided human,
environmental, industrial, animal and plant — help us fight hunger and disease, produce
more safely, cleanly and efficiently, reduce our ecological footprint and save energy.
 From 2018 to 2022, the number of employees increased by 11%, while the economic
impact in the US is estimated at $2.9 trillion, according to BIO Media.
 Biotechnological innovations are already part of our daily lives and we find them in
pharmacies and supermarkets, among many other places. In addition, they were of key
importance during the fight against the COVID-19 pandemic as they helped decipher
the genome of the virus and in understanding how our body's defence mechanism works
against infectious agents.
 Biotechnology will therefore play a crucial role in the society of the future in
preventing and containing potential pathogens.
 Medicine- The development of insulin, the growth hormone, molecular identity and
diagnostics, gene therapies and vaccines such as hepatitis B are some of the milestones of
biotechnology and its alliance with genetic engineering.
 Industry- The revolution of the new smart materials hand-in-hand with biotechnology
has only just begun, with the main advantage that it can make easily degradable products.
Such products help the environment because they generate less waste at the time of
destruction, as is the case with biodegradable plastics.
 Food- In addition to the genetically modified foods mentioned above, thanks to
biotechnology products such as WEMA have been created, a type of crop resistant to
droughts and certain insects that may prove essential in fighting hunger in Africa.
Biofortification to eradicate malnutrition.
 Environment- Through bioremediation processes, very useful for ecological recovery,
the catabolic properties of microorganisms, fungi, plants and enzymes are used to restore
contaminated ecosystems.
 Modern applications of biotechnology work most often through genetic engineering,
which is also known as recombinant DNA technology. Genetic engineering works by
modifying or interacting with the genetic cell structures.
 However, with current movements, biotechnological practices such as organ transplants,
manipulating human embryos and using animals or creating microorganisms in research
may be particularly offensive to some groups of people.
Overview of types-

 Red Biotechnology- Biotechnology in medical processes, such as using organisms to

produce new drugs and stem cells to regenerate damaged human tissues and grow and
regrow entire organs.
 Green Biotechnology- Biotechnology in agricultural processes, such as producing pest-
resistant crops, disease-resistant animals and environmentally friendly agricultural
practices.
 Bioinformatics- is a cross between biological processes and informatics. It refers to the
methods healthcare workers use to gather, store and analyze biological data to treat
patients.
 Blue Biotechnology- in processes in marine and aquatic environments, such as
converting aquatic biomass into fuels and pharmaceuticals.
 White Biotechnology- It is related to Industrial Biotechnology and applied to various
industrial processes. It gives exceptional consideration to planning low asset cycles and
items, making them more energy-efficient
 Yellow Biotechnology- It’s an advanced agribusiness branch identified with food
creation where dynamic qualities in insects are used for application in agriculture and
medicine, the most popular application being the fermentation of alcohol and cheese.
 Dark Biotechnology in war such as bioweapons and warfare developed through
biotechnological processes.

1.2. DNA, RNA, rDNA, Genetic Engineering,

Gene Splicing, Cloning and Other
Developments- BT TERMS
DNA

 DNA (Deoxyribonucleic Acid): DNA is a molecule that carries the genetic instructions
used in the development and functioning of all known living organisms.
 Genes are made up of DNA encoded in chemical structure.
 DNA, while maintaining a similar structure in all living organisms, carries unique
sequences that vary among different species, individuals, and even within the same
individual
 By altering or inserting new sequences within an organism's DNA, it is possible to bring
about changes in its characteristics or traits.
 DNA contains genes that encode the instructions for the development, functioning, and
traits of an organism.
 Altering or introducing new sequences in the DNA can impact the expression of genes,
leading to changes in the organism's genotype.
 DNA- made up of Sugar, a Phosphate and one Nitrogen base.
 Nitrogen bases found only in pairs- A-T & G-C paired together.
 This structure is called the DOUBLE HELIX model.
  In 1953, James Watson & Francis Crick- Englishmen responsible for the discovery of
the double helix structure of DNA using X-ray photographs.

rDNA

 rDNA (Recombinant DNA): rDNA refers to DNA molecules that have been artificially
created by genetic engineering and combining genetic material from different sources.
 Using recombinant DNA technology, scientists can combine different DNA fragments to
create a new strand of DNA. This can involve inserting specific genes or modifying
existing genes within the DNA sequence.
 Transgenic organisms are organisms that have had foreign genes or DNA sequences
introduced into their genome through genetic engineering techniques allowing them to
express new traits and characteristics. GMOs, IVF, cloning, etc. are examples of such
creations.
 Herbert Boyer and Stanley Cohen are prominent scientists who played a crucial role in
the development of recombinant DNA technology. In 1973, they collaborated on an
experiment that successfully combined DNA from different sources, demonstrating the
ability to create recombinant DNA molecules.
 Gel electrophoresis is commonly used in molecular biology research and is an important
tool for analyzing DNA, including rDNA molecules. It involves placing DNA samples
into a gel matrix and applying an electric current. The DNA fragments migrate through
the gel at different rates, allowing for their separation and analysis.

RNA

 Ribonucleic acid (RNA) is an important molecule that consists of a long chain of

nucleotide units.
 Each nucleotide in RNA is composed of three components: a nitrogenous base, a sugar
molecule and a phosphate group.
 The four nitrogenous bases found in RNA are adenine (A), cytosine (C), guanine (G), and
uracil (U)
 RNA and DNA comparison: T replaced by G
o Strand
o Sugar
o N Base (Thymine is replaced by Uracil)
 The sugar component in RNA is ribose, which differs from the deoxyribose found in
DNA by having an additional oxygen atom.
 The arrangement of nucleotides in the RNA chain determines the sequence of bases,
which carries the genetic information encoded in the RNA molecule.

mRNA - Messenger RNA

 RNA plays a crucial role in the process of protein synthesis by carrying information from
DNA to the ribosomes.
 Unwinding of the DNA double helix starts synthesizing a complementary RNA strand
using one of the DNA strands as a template.
  Ribosomes are cellular structures composed of proteins and ribosomal RNA (rRNA).
They are responsible for protein synthesis in the cell.
 It translates the information they carried into Proteins with the help of RNA Polymerase.
 The process of protein synthesis involves the transcription of DNA into mRNA and the
translation of mRNA into a protein sequence.
 RNA polymerase plays a vital role in transcribing DNA, while ribosomes, composed of
proteins and rRNA, facilitate the translation of mRNA into proteins.

What is Genetic Engineering and GMOs?

 These are Modern Ag Bio tools based on rDNA. Genetic engineering involves the
manipulation and alteration of an organism's genetic material using techniques such as
recombinant DNA (rDNA) technology.
 GMOs are organisms whose genetic material has been modified through genetic
engineering techniques. This can involve the introduction of specific genes from the same
species or different species to confer desirable traits or characteristics. E.g- Bt toxic genes
(terminator technology)

What is Gene Splicing?

 Gene splicing, also known as genetic or DNA splicing, involves cutting a gene from one
organism and inserting it into the DNA of another organism.
 Gene splicing is a fundamental technique used in genetic engineering to transfer specific
genes or DNA segments from one organism to another. This technique allows scientists
to introduce desirable traits or characteristics from one organism into another, enabling
the recipient organism to express those traits.
 By splicing genes, it is possible to transfer specific characteristics or traits from one plant
or animal to another. This process can involve transferring genes responsible for traits
such as disease resistance, improved yield etc.
 Eg- Bacteria and Human Insulin
 Bt Cotton and Bollworm Resistance.

What is Gene Mapping?

 Gene mapping refers to the process of assigning specific DNA fragments or genes to
particular locations on chromosomes. By creating a genetic map, scientists can gain
insights into the organization and arrangement of genes within an organism's genome.
 A genetic map is a representation of the linear arrangement of genes on a chromosome.
Created by assigning DNA fragments to chromosomes.
 Alfred Sturtevant, an American geneticist, is credited with pioneering the concept of gene
mapping. In the early 20th century, Sturtevant conducted extensive experiments on fruit
flies and developed the concept of mapping genes based on their recombination
frequencies.
What is cloning?

 Cloning refers to the process of creating an identical copy of an organism, cell, or DNA
fragment.
 In the context of organisms, cloning can refer to reproductive cloning, where a
genetically identical organism is produced, or therapeutic cloning, where embryonic stem
cells are generated for medical purposes.
 The term "cloning" is derived from the Greek word "klon," which means "twig" or
"branch."
 Cloning typically involves a form of asexual reproduction, where offspring are produced
from a single parent without the involvement of gametes (reproductive cells) or
fertilization.
 In the laboratory, cloning can be achieved through techniques such as somatic cell
nuclear transfer (SCNT). This involves the removal of the nucleus from an egg cell and
replacing it with the nucleus from a non-reproductive cell of the organism to be cloned.
 Cloning can be used to reproduce desirable plants or animals with desired traits. In
medicine, cloning techniques can potentially be used to produce tissues or organs for
transplantation.
 The dolly case
 Animal cloning, such as the cloning of mammals, has proven to be a challenging and
inefficient process
 Low Success Rates: Animal cloning often has low success rates, meaning that a
relatively small number of cloned embryos actually develop into viable offspring.
 Telomere Shortening: Telomeres are protective structures at the ends of chromosomes
that shorten with each cell division. Cloned animals often have shortened telomeres
compared to their naturally conceived counterparts, which can lead to premature aging
and a shortened lifespan. (dolly case).

What is Stem cell technology? along with 1.3- stem cell therapy

 Stem Cell biological cells are found in multicellular organisms which can divide and
differentiate into special type of cell and can renew to produce more cells.
 Two types of stem cell in Mammals:
o Embryonic stem cells
o Adult stem cells
 Stem cells have the ability to differentiate into specialized cells, such as muscle cells,
nerve cells, or blood cells, allowing them to repair or replace damaged or diseased
tissues.
 Embryonic- Embryonic stem cells are derived from the inner cell mass of a developing
embryo during the early stages of embryonic development. They have the ability to
differentiate into any type of cell in the body. They have the potential to develop into
specialized cell types such as nerve cells, muscle cells, blood cells, and more.
 Adult (misnomer)- Adult stem cells, also known as somatic stem cells, can be found in
various tissues and organs throughout a person's life. They are responsible for
replenishing and repairing the tissue in which they are found.
 Research with adult stem cells is limited due to difficulty of growing in labs conditions.
  Stem cells are being used today in various ways and have provided life-saving treatments
for certain conditions.

- Bone marrow transplantation, involves the infusion of stem cells into a patient to replace
damaged or diseased cells in the bone marrow. This procedure is commonly used to treat
leukaemia, lymphoma, and other blood disorders.

- Peripheral blood stem cell transplantation (PBSCT) involves the collection of stem cells
from the bloodstream rather than the bone marrow.

- Umbilical cord blood, which is rich in stem cells, can be collected from the umbilical cord and
placenta after childbirth. These stem cells can be stored in cord blood banks for future use.

 Stem cells can proliferate in laboratory environments in a culture dish that contains a
nutrient broth known as culture medium (which is optimized for growing different types
of stem cells).

1.3 Stem Cell therapy

 Stem cell technology is not a new concept having been popular since last decade.
 Stem cell therapy is a revolutionary medical approach that utilizes the unique properties
of stem cells to treat and potentially cure a wide range of diseases and injuries.
 The process of stem cell therapy involves extracting stem cells from the patient or a
compatible donor, isolating and purifying them, and then administering them to the
patient.
 Stem cells are auto-generative cells which have the capability of indefinite division. They
can easily be maintained in laboratories as cell lines.
 Since they can divide and differentiate to form different cells of the body, they have vast
scope in medical realm with respect to repair and replacement of human tissues and a
probable cure for many conventional and non-conventional diseases.
 Embryonic- Embryonic stem cells are derived from the inner cell mass of a developing
embryo during the early stages of embryonic development. They have the ability to
differentiate into any type of cell in the body. They have the potential to develop into
specialized cell types such as nerve cells, muscle cells, blood cells, and more.
 Adult (misnomer)- Adult stem cells, also known as somatic stem cells, can be found in
various tissues and organs throughout a person's life. They are responsible for
replenishing and repairing the tissue in which they are found.
 The ethical and practical considerations surrounding the use of embryonic stem cells have
led to increased focus on adult stem cells, such as those derived from bone marrow,
adipose tissue, or umbilical cord blood.
 Stem cells have the ability to differentiate into specialized cells, such as muscle cells,
nerve cells, or blood cells, allowing them to repair or replace damaged or diseased
tissues.
 They hold great potential for treating conditions like heart disease, spinal cord injuries,
neurodegenerative disorders, and joint injuries.
  Stem cells are utilized in tissue engineering to create functional tissues or organs for
transplantation.
 Stem cell therapy has shown promising results in treating a range of conditions,
including:

- Blood Disorders: Stem cell transplantation, commonly known as bone marrow transplantation,
is used to treat various blood disorders, such as leukemia etc. It involves replacing damaged or
diseased blood cells with healthy stem cells that can regenerate the blood and immune system.

- Neurological Disorders: Stem cells hold potential for treating neurological conditions like
Parkinson's disease, Alzheimer's disease, and spinal cord injuries by replacing damaged neurons.

- Autoimmune Diseases: Stem cell therapy is being explored as a potential treatment for
autoimmune diseases like multiple sclerosis, systemic lupus erythematosus, and rheumatoid
arthritis.

 These include ethical concerns, ensuring the safety and efficacy of the therapy,
optimizing the delivery methods, and navigating regulatory frameworks.
 Nevertheless, As the field progresses, stem cell therapy holds the promise of transforming
the treatment landscape for various diseases and injuries, offering new hope to patients
and advancing the field of regenerative medicine.

PATENTABILITY OF STEM CELL RESEARCH

 The framework, patentability of this kind of research is highly varied among different
countries.
 For an invention to be patentable, it should suffice three basic requirements of i) novelty,
ii) non-inventiveness and iii) industrial applicability.
 Invention related to stem cell technology generally qualifies these requirements and
becomes a patentable subject matter. The Indian Patents Act (1970) says that an
application should also qualify criteria given under section 3, for it to be considered as an
invention.
 Stem cell technology falls under the purview of 3(b) of the Act, according to which 'an
invention, the primary or intended use or commercial exploitation of which could be
contrary public order or morality or which cause serious prejudice to human, animal or
plant life or health or to the environment, are not inventions'.
 Whether the stem cell technology should be considered non-ethical or against moral
values, vis-à-vis the various benefits it offers to those who do not have any other cure, is
a debatable topic, which keeps recurring between the researchers and the policy makers.
 As far as India and most of the other countries are concerned, they have voted for
technology only in case ethical ways are used to derive embryonic stem cells.
 These ethical ways, as reported by the researchers, like using human embryos, produced
by in-vitro fertilization, aborted fetuses, and asexually produced human embryos for
deriving such cells, are not against public order or morality in any way
1.4. Bioinformatics in healthcare
 Bioinformatics is an interdisciplinary field that combines biology, computer science, and
statistics to analyze and interpret biological data. It involves the application of
computational methods and tools to gather, store, organize, analyze, and visualize
biological information.

 Bioinformatics plays a significant role in healthcare by leveraging computational and

data analysis techniques to improve patient care, disease diagnosis, drug discovery, and
personalized medicine.

 The aim of the bioinformatics is to give path to big data generated by molecular biology
technology.

 Health informatics is combination of information and data of medical areas such as pre-
clinical, clinical, post clinical and health care administration management.

 Bioinformatics and analytics deals with analytic and interpretation, storage development
and optimization of huge biomedical data.

 Bioinformatics is employed in pharmacogenomics, which involves studying how an

individual's genetic makeup influences their response to drugs.

 By analysing genomic data, bioinformatics helps identify genetic variations that may
affect drug metabolism, efficacy, or adverse reactions.

 Drug Discovery and Development- Bioinformatics contributes to the drug discovery and
development process by analysing biological data, predicting drug-target interactions,
identifying potential drug candidates, and optimizing drug design.

 Bioinformatics enables the analysis of various types of biological data, including

genomic data, to identify disease-specific biomarkers. These biomarkers can aid in early
disease detection, prognosis, and prediction of treatment response. Bioinformatics tools
also contribute to the development of diagnostic tests based on genetic or molecular
markers.

 Bioinformatics is utilized in tracking and analyzing disease outbreaks, studying the

spread of infectious diseases, and identifying patterns and risk factors associated with
disease occurrence.

 It aids in population-level data analysis, surveillance, and modelling to support public

health interventions and policy-making.
 The genomic technologies have the capacity to advance diagnosis, treatment of diseases
especially inherited diseases and intricate diseases such as cancer and accelerate the shift
in the direction of personalized and predictive medicine.

 The primary purpose of integrating biology and healthcare information is to give rooms
for exchanges in technology, data, and knowledge. This will in turn provide a database of
diseases, their causes, treatment etc.

 While bioinformatics has revolutionized healthcare, it also faces several challenges.

 The field requires continuous development of advanced algorithms, computational

infrastructure, and data management systems to handle the ever-growing volume and
complexity of biological data.

 It empowers healthcare professionals with the ability to analyse and interpret large-scale
biological data, leading to improved patient outcomes, optimized treatments, and targeted
interventions.

 As the field continues to evolve, bioinformatics will play a pivotal role in shaping the
future of data-driven healthcare.

 Advancements in machine learning, artificial intelligence, and data analytics will enhance
the accuracy and efficiency of data analysis.

 Bioinformatics tools enable efficient data retrieval, analysis, and visualization, allowing
researchers and healthcare professionals to extract meaningful insights from complex
datasets

 Integration of bioinformatics with electronic health records and wearable devices will
provide real-time personalized insights and improve patient monitoring.

 While bioinformatics has revolutionized healthcare, it also faces several challenges. The
field requires continuous development of advanced algorithms, computational
infrastructure, and data management systems to handle the ever-growing volume and
complexity of biological data.

 Bioinformatics has become an indispensable tool in healthcare, facilitating personalized

medicine, driving disease research, and revolutionizing drug discovery.

 It empowers healthcare professionals with the ability to analyze and interpret large-scale
biological data, leading to improved patient outcomes, optimized treatments, and targeted
interventions.
1.5.3. Biofortification
 Biofortification in crops refers to the process of increasing the nutritional value of food
crops through conventional breeding or genetic engineering techniques.
 The aim is to enhance the content of essential vitamins, minerals, and other beneficial
compounds in staple crops to address and prevent micronutrient deficiencies, particularly
in vulnerable populations.

1. Conventional Breeding: Traditional breeding methods are used to develop crop varieties
with improved nutritional profiles. This involves selecting and cross-breeding plants with
naturally higher levels of desired nutrients or traits. For example, breeding for higher iron
content in beans or zinc content in rice.
2. Genetic Engineering: Genetic engineering techniques are used to introduce or enhance
specific traits in crops. This involves the insertion of genes responsible for producing
specific nutrients or increasing their availability in the crop. For example, the
introduction of genes responsible for beta-carotene synthesis in rice to combat vitamin A
deficiency.

 The main goal of biofortification is to provide a sustainable and cost-effective solution to

improve the nutritional status of populations that rely heavily on staple crops.
 By enhancing the nutrient content in these crops, biofortification aims to tackle hidden
hunger and reduce the prevalence of micronutrient deficiencies.
 Biofortified crops aim to reach populations in resource-limited settings who have limited
access to diverse diets or nutritional supplements. Biofortification focuses on staple crops
that are widely consumed, making the improved nutrients more accessible and affordable
to communities.
 Sustainability: Biofortified crops provide a long-term and sustainable solution to address
nutritional deficiencies. Once biofortified varieties are released and adopted by farmers,
the increased nutrient content becomes a permanent feature of the crop.
 Biofortification can be integrated into existing agricultural practices without significant
changes to farming techniques or infrastructure. This allows farmers to continue
cultivating biofortified varieties alongside their traditional crops.
 Biofortification reduces dependency on external interventions such as nutrient
supplementation or fortification of processed foods. By enhancing the nutritional content
of crops, it provides a direct source of essential nutrients to populations, especially in
rural areas
 Biofortification efforts typically focus on addressing specific nutrient deficiencies
prevalent in particular regions or populations.
 For instance, vitamin A deficiency is a significant public health concern in many
developing countries, leading to various health problems. Biofortification can involve
developing crops with higher levels of provitamin A, which can be converted into
vitamin A in the body.
 Plant breeding techniques are employed to develop crop varieties with higher levels of
specific nutrients. This can be achieved through traditional breeding methods, selecting
and crossbreeding plants with naturally higher nutrient content.
  Preservation of Food Culture: Biofortification focuses on enhancing the nutritional
quality of staple food crops, thereby maintaining dietary habits and cultural practices
while addressing nutrient deficiencies.
 Biofortification can be implemented in different ways, including breeding for nutrient-
dense crop varieties, promoting agronomic practices that enhance nutrient uptake, or
fortifying processed food products with biofortified ingredients.
 Biofortification can be implemented in different ways, including breeding for nutrient-
dense crop varieties, promoting agronomic practices that enhance nutrient uptake, or
fortifying processed food products with biofortified ingredients.
 Biofortification has shown promising results in improving the nutritional status of
communities. However, challenges remain in terms of regulatory frameworks, consumer
acceptance, and ensuring the stability and effectiveness of biofortified crops under
different agricultural and environmental conditions.

1.6 Overview of developments in

Biotechnology - Patenting
Evolution in biotechnology- with cases

1) Intro to Playing god - Frankenstein and biotechnology

 The concept of "playing god" in biotechnology refers to the ethical and moral
implications of humans manipulating and altering the natural world, particularly in the
field of genetic engineering and biotechnology.
 Critics argue that certain biotechnological practices, such as genetic modification of
organisms, cloning, or creating synthetic life forms, are examples of humans taking on a
role traditionally attributed to a higher power or nature.
 They express concerns about the ethical implications of playing with the fundamental
building blocks of life and the potential unintended consequences that may arise from
altering the natural order.
 Manipulating genetic material or creating synthetic organisms may have unforeseen
ecological or health consequences
 Tampers with ecological system- beliefs exist that every creature born into the earth has a
certain way of adapting into the ecosystem which may not be possible for a genetically
modified creature amongst natural organisms.
 Concerns also arise regarding the equitable distribution of the benefits and risks
associated with biotechnological advancements. Critics argue that playing god may
exacerbate existing inequalities, with potential benefits primarily benefiting those with
resources and power, while the most vulnerable populations bear the risks.
Frankenstein scenario

 Mary Shelley's "Frankenstein" is a novel published in 1818, which tells the story of
Victor Frankenstein, a scientist who creates a creature through scientific experimentation
and then faces dire consequences as a result of his actions.
 The novel explores themes of scientific ambition, ethical responsibility, and the potential
dangers of playing god-like roles in creating and manipulating life.
 In the context of biotechnology, the term "Frankenstein case" could be used to refer to a
hypothetical legal case involving controversial scientific practices or technologies.
 It might involve debates about the ethical boundaries of scientific experimentation, the
potential risks and consequences of manipulating life forms, or the rights and
responsibilities associated with creating and using genetically modified organisms
(GMOs).

Now

 Today, with modern biotechnology and genetic engineering, scientists are truly in a
position to redesign living creatures by altering the biological blueprint that guides their
growth.
 The issues at the heart of “Frankenstein” feel modern where Biotechnology and
bioengineering are real things now.
 Since 1992, genetically modified foods have been derided as “Frankenfoods,” even
though the vast majority of scientists regard them as safe and beneficial.
 With Frankenstein, Shelley wrote the first novel to forefront science as a means to create
life, and as such, she wrote the first major work in the science fiction genre. The 'monster'
in the case is said to have rejected its creation and creator after its labors had been
accomplished, providing through a human emotion of repulsiveness towards itself as a
'monster'.
 The effect of creating human like creatures through science has always had its drawbacks
explained through the concept of playing god in science that could possibly lead to an
end of the naturally introduced human race.
 Synthetic biologists today however - are vocal about the potential dangers of the
technologies they develop and are actively working to ensure their safety.
 Frankenstein is not only the first creation story to use scientific experimentation as its
method, but it also presents a framework for narratively examining the morality and
ethics of the experiment and experimenter.
 Safeguards, protocols and institution approvals by committees educated in the horrible
and numerous examples of unethical experiments done in the name of science are used to
prevent something like Victor Frankenstein from undertaking his garret experiments.
 'Frankenstein' is not only the first creation story to use scientific experimentation as its
method, but it also presents a framework for narratively examining the morality and
ethics of the experiment and experimenter.
The Dolly experiment

 Dolly was part of a series of experiments at The Roslin Institute that were trying to
develop a better method for producing genetically modified livestock.
 Scientists at Roslin also wanted to learn more about how cells change during
development and whether a specialised cell, such as a skin or brain cell, could be used to
make a whole new animal.
 Dolly was cloned from a cell taken from the mammary gland of a six-year-old Finn
Dorset sheep and an egg cell taken from a Scottish Blackface sheep.
 Dolly was important because she was the first mammal to be cloned from an adult cell.
 Her birth proved that specialised cells could be used to create an exact copy of the animal
they came from.
 When Dolly was one year old, analysis of her DNA showed that her telomeres were
shorter than would be expected for a normal sheep of the same age.
 As Dolly's DNA came from that of an adult sheep's, the birth and growth development
was stunted, which meant that her she was further in age than that her actual age .

Re roslin case - Dolly

 An attempt to patent Dolly, and lay commercial claim to animals produced by cloning
lasted for a long time until 2014 when the United States Court of Appeals for the Federal
Circuit ruled that Dolly the cloned sheep, and any other genetic clones, are patent
ineligible in the United States because the “claimed clones are exact genetic copies of
patent ineligible subject matter.
 In many jurisdictions, including the United States, patent law excludes naturally
occurring phenomena, laws of nature, and abstract ideas from being eligible for patent
protection.
 This exclusion is based on the idea that these are fundamental aspects of knowledge that
should be freely accessible to all. Patent protection is generally granted to inventions that
are novel, non-obvious, and have utility.
 The case involving Roslin and the Federal Circuit underscores the difficulty of obtaining
patent protection for a clone that is genetically identical to the original organism.
 The court's decision indicates that the clones created by Roslin were not considered
distinct from the donor animals since they were intended to be identical copies. As a
result, the court may have deemed the clones to be a natural phenomenon rather than a
patentable invention.

Diamond v. Chakaroborthy

 After genetically engineering a bacterium capable of breaking down crude oil, Ananda
Chakrabarty sought to patent his creation providing patents for people who invent or
discover "any" new and useful "manufacture" or "composition of matter."
 Patentee stated he had produced a new bacterium with markedly different characteristics
from any found in nature and one having the potential for significant utility.
 However, the Patent Office Board of Appeals affirmed, stating that living things are not
patentable under Section 101. Appeal follows after.
  Impact- Non-naturally occurring non-human multi cellular living organisms, including
animals to be Patentable subject matter within the scope of 35 USC 101.
 This Judgment caused an impact on the whole biotech patenting and even life could be
possible for patenting under certain circumstances where they serve a purpose such as
breaking down crude oil and are non occurring in nature.

Myriad Gene - Myriad Genetics v. Association for Molecular Pathology

 Myriad Genetics, a biotechnology company, discovered and isolated two human genes
called BRCA1 and BRCA2, which are associated with an increased risk of breast and
ovarian cancer.
 Myriad filed multiple patents claiming patentability for methods for identifying mutations
in these genes, and methods for screening potential cancer therapeutics.
 The Association for Molecular Pathology (AMP), along with several other plaintiffs,
filed a lawsuit against Myriad Genetics in 2009.
 The plaintiffs argued that genes are products of nature and should not be patentable
subject matter.
 Argued that it limited the development of alternative testing methods and access to
affordable genetic testing

 District court: declared that isolated DNA sequences were not eligible for patent
protection as they were products of nature
 Court of Federal circuit- Partially reversed the decision of district court.
 Supreme court: Invalidated Myriad's claims to isolated genes. The Court held that
merely isolating genes that are found in nature does not make them patentable.
 Impact: Isolation of human genes by human intervention, was under consideration and
allowed for affordable genetic testing options and facilitated advancements in
personalized healthcare.