Libro Yason Biotechnology

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The topic of this book, biotechnology, is about gene
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Biotechnology
Ronnee Yashon and Michael R. Cummings
MOMENTUM PRESS, LLC, NEW YORK
Biotechnology
Copyright © Momentum Press, LLC, 2019.
All rights reserved. No part of this publication may be reproduced,

stored in a retrieval system, or transmitted in any form or by any
means—electronic, mechanical, photocopy, recording, or any other
except for brief quotations, not to exceed 400 words, without the prior
permission of the publisher.
First published in 2019 by

Momentum Press, LLC
222 East 46th Street, New York, NY 10017
www.momentumpress.net
ISBN-13: 978-1-94664-631-6 (paperback)

ISBN-13: 978-1-94664-633-0 (e-book)
Momentum Press Human Genetics and Society C

ollection
Cover and interior design by Exeter Premedia Services Private Ltd.,

Chennai, India
First edition: 2019
10 9 8 7 6 5 4 3 2 1
Printed in the United States of America.
Abstract
Just as a little experiment, to open this fascinating and important topic.
First, go to your refrigerator or kitchen cabinet. Read the labels of a few
things in them.
You will see some are marked NON-GMO. If you think you under-
stand this labeling, you may be surprised how it ties in to politics, adver-
tising, science, medicine, farming, and the future.
New methods to edit DNA may bring about cures for genetic
conditions, better plant growth, diagnosis, and cure of cancer, as well as
learning about the human genome.
Keywords
amino acid; clotting factor; CRISPR; EPO; eugenics; GMO; h
emoglobin;
hybrid; mitochondria; mRNA; onco mouse; patents; protein; ribosome;
survival of the fittest; transcription; translation
Contents
Preface��ix
The Basics��xi
Chapter 1 Introduction��1
Chapter 2 How Is Biotechnology Used?��7
Chapter 3 A New Breakthrough: CRISPR��13
Chapter 4 Genetic Engineering in the Media��15
Chapter 5 GM Technology: What Are Pros and Cons?��17
Chapter 6 Patenting Genes��21
Chapter 7 Other Cases��25
Chapter 8 Ethical Issues: Who Will Decide?��27
Chapter 9 How Will This Influx of Genetic Information Affect
Our Future?��29
Chapter 10 The Papaya and the Biologist: The Man Behind
the Rainbow��31
Appendix: What Can We Learn from the Past?��35

Epilogue��39
References��43
About the Authors��41
Index��45
Preface
Not so long ago, science was only for scientists, and the general public
was not included. Our science education was ignored or poorly taught.
But today, science rears its ugly head in all our lives and looms over cer-
tain parts of our society; many things that no one, but science fiction
writers, could foresee.
I remember, not so long ago, a presidential election that used human
stem cells as an issue. Magazine articles were written, political speeches
discussed it, and religion had its opinion too. And, the president-elect
(George W. Bush) felt he had to do something about it.
But, in areas such as medicine (medical decisions), police work (DNA
identification, paternity testing), reproduction (sperm and egg freezing),
law (privacy, malpractice), and politics (abortion, global warming), this is
only the beginning.
This book is about one of the most controversial topics sitting center
stage: recombinant DNA aka genetic engineering. Keep science in mind,
as we discuss this issue.
Questions (in italics) are scattered throughout this chapter and the
following chapters. Watch for them, and think about how they may apply
to you and other ones.
The Basics
Here is a simple description of how the DNA works:
Cell
It all starts with the cell and its nucleus

Nucleus
An organelle that holds chromosomes
Chromosome
Are made up of the DNA
Genes
are lined along the DNA and code for
Amino Acids
The building blocks of proteins
Line up AA in the correct order.
And you get

Protein
Proteins are important chemicals in our body
CHAPTER 1
Introduction
First, biotechnology is a medical word. The first thing you do if you want
to discover the meaning of a medical word is separate it into its parts.
Luckily, our word has only three parts and you already know two of them:
Let us try: Bio---Techno---Ology
We all know the meaning of first syllable, Bio. It means life.
The last syllable, Ology means study of.
The middle part is a little harder; it has many meanings: Techno
generally means applying scientific knowledge for practical purposes

(medicine, farming, art, etc.).
When we define all the parts ----voila!, a meaning appears (well maybe
in your brain?).
Our word, biotechnology, means a study of how to apply technology
to living systems (see Figure 1.1).
The manipulation of small particles (such as DNA) has been available
for years. The fantastic microscopes and even more fantastic biologists
have opened our eyes to some amazing things.
So, here we go! First, go back to the page before Chapter 1 called—
The basics. This simply shows the mechanism of protein formation. We
will discuss this later as we go deeper into the DNA molecule.
What Does DNA do?
DNA has two main functions in living things:
1. Make perfect copies of itself. This is called replication and occurs in

mitotic division, when one cell is making two.
2. Assemble proteins for use in the human body (1,000s). This is called
translation.
The protein copies and DNA copies must be 100 percent perfect.
What if they are not perfect?
2 Biotechnology
Biotechnology
Genetic
engineering
New types of Production of

plants, animals human proteins
Genes are
inserted or Gene inserted
turned on in bacteria
or off
If inserted
Humalin* Human
they can
human insulin clotting factor
come from
Diabetes
Same type of
Another
animal or Hemophilia
plant species
Example: Example:
Turn off a Place the
gene to make a human insulin
plant immune gene in a
to a virus bacteria.
Figure 1.1 What is biotechnology?

Source: This chart shows what can be done with biotechnology. Follow it down to “genetic engi-
neering” and notice how there are two main uses at this time. It will soon EXPLODE!
Steps of Replication
First: The helical DNA (see Figure 1.2) splits into two strands.
Second: Each half finds the matching triplset to its pairs, from the
fluid within the nucleus and makes a clone of itself.
Introduction 3
5’ 3’
5’
G C G C
T A T A
A T A T
A T
A
C G Sugar-phosphate G C
backbone
G C C G
G C C G
T A A
C G C G
A T A T
5’
Figure 1.2 (a) Flat DNA. (b) Helical DNA (double helix)
Steps of Protein Synthesis
DNA contains the code for all amino acids needed to create all human
proteins (proteins can have as many as 1,000 amino acids).
Protein synthesis: Follow along with Figure 1.3.
Figure 1.3 Protein synthesis in a cell
4 Biotechnology
• Nucleus showing the complete DNA. (#1)

• DNA splits and converts into messenger RNA (mRNA). (#2)
• Messenger RNA. (#3)
• Messenger RNA moves through cytoplasm and out of the
nucleus. (#4)
• Messenger RNA in cytoplasm. (#5)
• Messenger RNA moves to the ribosome that reads its the
code. (#6)
• Places the correct amino acid in the chain. (#7)
The mRNA moves to the ribosome that reads three bases (triplet) at a
time and presents the amino acids in order.
A mRNA is produced and takes the code, out of the nucleus into the
cytoplasm where a specific protein can be made.
This is called translation (translating a code hidden in the messenger
DNA).
Ribosomes read the code and place the correct amino acids in order.
An example of a few codes:
Amino Acid: Glycine (AA) GGA triplet code in normal DNA

Amino Acid: Lysine (AA) AAA code in normal DNA
What can go wrong?

Any mix up in the amino acid position can alter the protein being
produced. As little as one mistake on mRNA (in translation), no matter
how small, can cause a giant effect in the protein itself, and therefore in
the living thing.
Example: The DNA strand that codes for hemoglobin is a complex gene.
Statistics: Hemoglobin strand has 31 amino acids, which have to be
in perfect order.
One mistake (CTC normal code) becomes CAC (sickle cell anemia).
The normal form of the sickle cell gene creates the protein hemoglo-
bin (If mutated, this gene will lower the amount of hemoglobin, and less
oxygen will get to the cells some of you recognize this); it is the protein
that carries oxygen in the red blood cells.
Introduction 5
But what if we could cut the “wrong gene” and replace it with a
healthy one?
This is only one of the futures of biotechnology, some being done

now, and many more to come. Keep reading.
CHAPTER 2
How Is Biotechnology Used?

First, let us examine some definitions.
Genetic manipulation versus cross breeding:
For years, man has been engineering plants and animals to fill certain
needs. In the light of today’s amazing breakthroughs, it seems as if we
have been changing DNA.
And in some ways, we have…
Take for example, the seedless watermelon (Figure 2.1). We all love
watermelon, but we hate the seeds. But, what are the seeds really for?
The watermelon itself is a fruit (I know you know that already, but
bear with me), and the fruit is the reproductive part of any flowering
plant. It creates the embryo (the seed) and enough food for it to grow
(sugars) in the flesh for energy.
The seed, therefore, is the embryo and the red tissue is its food supply
until it develops leaves (and can create food by photosynthesis).
Once upon a time: Man discovered the watermelon and loved it.
But: Man hated the seeds (where do I spit them?)
And: Farmers want to sell more watermelons. $
So…
In the 1940s, O. J. Eigsti, a plant geneticist (see Chapter 10 for

another plant geneticist), thought about how to solve this problem, and
the seedless watermelon (Figure 2.1) was born, but it did not sell.
It started to catch on in the 1980s and has been around ever since.
Was this genetic engineering? Yes or no.
DNA and its components were still not known at this time.
A seedless watermelon is a sterile hybrid that is created by crossing male
pollen of a watermelon containing the normal number (22) of chromosomes
per cell (22), with a female watermelon flower with 44 chromosomes per
cell. When this seeded fruit matures, the small, white seed coats inside con-
tain 33 chromosomes, rendering it sterile and incapable of producing seeds.
8 Biotechnology
Figure 2.1 Seedless watermelon
I thought you might like to see a quote from the website www.wha-
taboutwatermelon.com.
“Seedless watermelons are NOT genetically modified. They are hybrid
watermelons that have been grown in the United States for more than
50 years and are safe and delicious in every way!”
More examples of human crossing plants and animals:
Apples: Hundreds of types of apples come from cross-breeding ones

already existing. For example: Fuji, Delicious, Envy, and 100s of
others.
Great race horses: Male race horses who win many races are retired
and mated with females. Also, sperm collection is done, so it can
be used for artificial inseminations. The sperm from a great horse
(Secretariat) could cost upward of a thousand dollars and be frozen
forever. Meaning, long after his death, he is still fathering colts.
Dogs: Many people show their dogs in dog shows, and they are
judged on different traits. These dogs are often called pure bred and
can be entered to win awards.
Farmers were just working with animals and plants to change their
genetic makeup using observation as their guide.
But, after using this method, for a long time (possibly hundreds of
years), DNA and laboratory methods began to sneak in.
Simply stated, we began to use this information when it became
available.
How Is Biotechnology Used? 9
What information was needed to start using biotechnology?
1. Find the gene that controlled the trait.

2. Cut the DNA at the correct spot releasing the gene itself.
3. Place a new segment of DNA in its place.
A gene can be manipulated by inserting or turning on and off certain

DNA segments that control the growth, yield, or health benefits of the
crop. It can also make them more beautiful (see Table 2.1).
Table 2.1 Plant manipulations

Is the
product
Original How is it Why was being
Trait DNA from done it done Proteins used
Resistance Immune cells Analyze Have Increase Yes
to viruses DNA of healthy yield
resistant plants
plants
Resistance A gene for Same Plants can Insecticide Yes
to pesticides resistance be sprayed, and weed
but not be control
harmed
Change Warm climate Turn on or Plants can Fruits will Only
temperature fruits can now off genes grow in a stay fresh experi-
tolerance in cold areas in different different longer mental
(strawberries ) environ- environment
ments
Speed up or Same Same Lengthen Tomatoes On sale

slow down the growing can travel once, but
growth season dropped
Increase A gene Add a Include Vitamins, Yes, golden
nutritional to make a gene for important amino rice
content certain production nutrients acids
of protein
Slower Any fruit Manipulate So, food does Adjust Yes
ripening temperature not become ripening
rotten to the
shipping
schedule
Fluorescence Jellyfish Jellyfish: Corn, Well-lit Yes, zebra
Gene aquarium corn fields, fish
placed in fish prettier
genome fish tanks
10 Biotechnology
Transferring a gene from a plant, animal, or human into a bacterium

causes the bacteria to make a human protein.
Animals have long been used in medical circles. If you want to know
about a disease or a condition, you should have a living thing to test
possible vaccines or side effects on an animal before moving to humans.
To do this, you need an animal that carries certain traits.
Table 2.2 Bacterial manipulations

Original Why Is the
DNA How is it was it product
Trait from done done Reason being used
Insulin Human Human insulin To make Early Yes, diabetes1
gene inserted pure insulin
in the genome human taken from
of a bacteria insulin animals
Human Human Human To make Early HGP Short stature
growth growth pure HGP from Not always
hormone hormone animals recommended2
Factor 8 Human Hemophilia To make No drug Clotting factor
blood factor 8 pure factor could stop for hemophilia3
8 bleeding
EPO Human Tissue To quicken Surgical
healing healing recovery4
1
Giant vats of the GMO bacteria are grown.
2
Doctors do not like to prescribe this unless the child is through puberty.
3
This immediately stops bleeding.
4
Patients can heal themselves, this speeds it up.
How Is Biotechnology Used? 11
Table 2.3 Animal manipulations

Is the
Original Why product
DNA How is it was it being
Trait from done done Reason used
Animal models Mice, fish Place Testing for The first Mice,
for human mutated vaccines testing before rabbits,
diseases DNA in a and cures human primates
mouse testing
Speed up growth Fish, cows, Fish in farms More fish Control Salmon
in animals and and wheat are mated on the of the Tilapia
plants with those market, environment Also,
that have the more milk for better fruits
development in cows yield
gene
Human organs Human HLR Human Many new Not enough Pig heart
(xenotransplant) sequence HLA gene is organs are people valves are
on DNA, transferred needed donate organs used now
chromosome to the pig
6 through
This controls surgery
rejection
Synthesizing Humans The gene is Similar Lack of Yes
hormones for placed in the to the hormones
human use animal (goats transgenic for specific
and cows), bacteria people
hormones are
released in
the milk
ONCO mouse Human Used to We want Make cancer Yes
cancer cells study human to cure or go away
First cancer and control
transgenic cancer cancer
mammal treatments
patent issued
CHAPTER 3
A New Breakthrough:
CRISPR
Have you heard of CRISPR?
Why? Why Not?
This controversial new genetic scissor (only a metaphor) can perfectly find a
DNA section and cut it out. It is the star of a new movie coming out SOON.
Some newspaper and magazine headlines this month read:
Editing Humanity The Economist

The gene machine Time cover
Babe New World New York Post
The Dawn of the Designer Baby The Daily Mail
DNA revolution National Geographic
The Old Versus the New

The science of genetic engineering started quite a few years ago when
researchers were discovering that they can precut the DNA at a specific
spot. We used this cutting mechanism to work mainly with restriction
enzymes (enzymes that cut the DNA for repair) in animals or plants.
If you look at Chapter 6, Chakrabarty’s oil eating bacteria was created by
the older process and was allowed a patent.
The new process explained in this chapter, clustered interspaced short
palindromic repeats (CRISPR), does primarily the same thing that restric-
tion enzymes do, but with more efficiency and never makes mistakes.
Oddly enough CRISPR is not new. Within a bacteria cell, it works
to protect against viruses coming back and affecting the cell over again.
When virus enters a cell, it leaves behind pieces of its DNA. That activates
the built-in mechanism called CRISPR-cas 9 to cut the viral segments out.
14 Biotechnology
Jennifer Doudna, (the scientist who reworked the CRISPR mole-

cule) and some others have changed the CRISPR molecule, so it can be
programmed to accurately cut on any section of the DNA.
Remove Bad Genes and Add Good Ones?

Enhancement of stronger bones, better immune system, essentially
designer humans. Any of these could be applied to the CRISPR tech-
nique and even more amazing are the far-reaching changes that could be
made to the human genome.
This may be available for clinical use within the next 10 years.
Dr. Doudna questions where do we go from here?
Watch this Ted Talk: https://youtu.be/1BXYSGepx7Q
CHAPTER 4
Genetic Engineering
in the Media
I am sure you have heard the phrase false news. One of the most aggressive
types is centered around nightly news.
But, many people wonder if what they hear is true.
Definitely, when we talk of science, drugs, over-the-counter medicines,
or alternative medicine, we wonder if we are hearing exaggerations or lies.
Let us take a look at some examples:
1. News, TV, radio, ads: 23 and me and genetic information; pater-

nity testing offered in drug store, drugs to fit a specific person, ads
for foods that say, “No GMO” (watch out for this, no one actually
knows how the companies test for this).
2. Exaggerations abound, often scientific discoverers exaggerate the
uses and importance of these discoveries.
3. What should we believe? I wish it was easy to answer that, consider-
ing the things we have been told over the years. Headlines like: Dis-
eases will be cured; cancer has new treatments; food additives are bad
for us such as sugar, dyes, and preservatives. Plastic is also a culprit.
4. Trusting science? Science is complicated and is done by scientists
who often do not know how to explain some of their own concepts.
We are bombarded with information!
The social media and online resources may help us, if we research
carefully.
Chapter 3 discusses CRISPR, a new idea in biotechnology. Many
people know about it, but do not understand it. I have heard it will change
everything.
16 Biotechnology
Not so long ago, no one thought we could freeze eggs, or 50-year-old

women could get pregnant or sperm would be available for sale. But, it
is happening!
We need to know about scientific breakthroughs in a clearly under-
standable way even without a good background in science. Then, we can
make our own decisions.
Video: https://youtu.be/jAhjPd4uNFY
Chapter 5
GM Technology: What Are

Pros and Cons?
When I began to start this chapter, I was worried about how I would face
the opposition.
I didn’t want the book to come out showing only ONE SIDE.
Most articles I have read do state the pros and cons, but I didn’t really
know where to place myself.
SEE LINE BELOW:

CONS��PROS
X
As a genetics teacher you’d think I would be all the way on the PRO side,
but I surprised myself when I realized that no one knows the future.
Look and see where you would put yourself.
Questions to ask yourself:
Do I know enough about Genetically modified organisms?
Are they Harmful?
Are they Safe?
Are they Dangerous?
Are they Important to the future?
Another side of this, is money. Would anything be accomplished without

funding?
BIG business has developed some interesting GMOs to help their com-
panies and in addition they will make LOTS of money. Often people think if
a scientist gets paid to develop something, be it is somehow bad, but complex
science needs labs, equipment, and many other things.
Where should we begin?
18 Biotechnology
In Chapter 2, there are charts listing what is happening now. And in

Chapter 3, we saw what future work with CRISPR may allow us to do
possibly sooner or later. Some people might think these treatments and
genetic modifications rather than being good for mankind are changing
us and even hurting us.
Changes are already happening. Better choices in food stores, restau-
rants with “clean” menus. Also, clinical trials in medicine are using genetic
modification to target cancer cells.
Think about these possible scenarios that you might run across:
Scenario 1: Doctors can manipulate the embryo’s DNA while still in the
womb.
PROS CONS
Specific conditions can be cured Specific traits can be chosen
Fetus could be helped Fetus could be harmed
Removal of genes and replacement Expensive
Who will decide? Who will decide?
Scenario 2: Genes can be placed within the genome of an existing food

source (wheat,rice). That gene would create a protein to bring better
nutrition where needed.
PROS CONS
People starving can get proteins Poorer countries might have lack of
funding and doctors
Farmers can use these crops There might be allergic people
This can bring about healthy areas Farmers may not be able to sell
Scenario 3: Genes can be placed in white blood cells that target specific
cancer or bone marrow cells.
PROS CONS
Treatment for cancer Side effects from treatments
No need for surgery and chemo Expensive
Longer life Might not work (rejection)
More specific than chemo Someone had to donate a gene
GM Technology: What Are Pros and Cons? 19
Scenario 4: A person’s dog dies and she immediately calls a company to

make an exact clone.
PROS CONS
We love our dogs Would it have the same personality?
We can have our dogs back Cloning can bring about problems
Expensive (more people want it) If the clone dies, no money back
Scenario 5: Your grocery store cannot keep up with the need for fresh
salmon and begins to buy from fish farmers whose fish are much bigger
because of genetic manipulation.
PROS CONS
More fish for your money You may not know the difference
Sustainable for a long period of time They may be too big
Scenario 6: A woman needs a kidney transplant, she is offered a pig’s

kidney.
PROS CONS
The pig has human genes so no rejection Allergy to pork might cause serious
problems
Shorter wait list and less people die The organ may not fit
Someone doesn’t have to die to get an This may not work
organ
Open the way to use more animal organs The pig is sacrificed
Scenario 7: Strawberries are very popular in Alaska and Norway, two

scientists insert a gene from a cold water fish, so they can grow in the cold.
PROS CONS
Everyone could get fresh strawberries You may not know the difference
They can be harvested later They may be too big
Prices go down because they do not have Reactions to the fish gene
to ship them
There are many other pros and cons but these are just a few.
20 Biotechnology
Possibly you might want to know my opinion of these questions, well

OK, as long as you asked me…
Scenario 1: Yes, because we probably will. Responsible doctors and

scientists should be in charge.
Scenario 2: Yes, this can help whole populations and it is already being
used in China.
Scenario 3: Absolutely, we MUST get rid of cancer. There are trials
going on now and they look good.
Scenario 4: Clones of dogs have been created for a few years, and will
probably become a trend.
Scenario 5: Yes, with some reservations, money is important but this
could be a break for the wild salmon.
Scenario 6: Definitely yes, they have already used pigs to replace heart
valves and are working on more
Scenario 7: Yes, this would make things easier because of the travel
that goes into the cost.
ONE GIANT QUESTION is future safety. We can imagine changing

our child’s DNA for traits such as eye color, skin color, etc. Actually,
we might be able to pick any trait, if we locate the gene that makes the
protein it can be done.
CHAPTER 6
Patenting Genes
For many years, the U.S. Patent Office (USPO) issued patents following
a set of rules. Most of these rules discussed what could not be patented.
Here is a general list:
For a patent to be issued, the item must be:
Novel
Useful
And it cannot be:

Found in nature
Obvious
Over the years, this has been sufficient, and products, procedures,
methods, ideas, and inventions won patents.
But, the patent office was shocked when the idea of patenting genetic
material was presented. As you read through these cases, think about the
future and how they opened up the public awareness of working with
human genetic material.
Landmark Legal Cases
Diamond v. Chakrabarty
447 US 303 (1980)
In 1980, a patent was applied for, by Ananda Chakrabarty, who had

created a bacterium that could eat oil products. When placed in an area of
water with oil, the bacteria broke up the oil and consumed it. The method
used was the recombinant genetic method discussed earlier in Chapter 1.
The gene came from another bacteria and was transplanted into pseudo-
monas (a commonly found bacteria).
Chakrabarty had applied for a patent three times and was turned
down each time.
22 Biotechnology
The United States Patent Office (USPO) had a question: Is your

bacteria found in nature?
Chakrabarty’s answer was: No, it is changed by recombination tech-
niques (inserting a gene) and for that reason is not found in nature.
After his patent application was denied, he appealed, and his case
finally came to the Supreme Court of the United States (SCOTUS) (Dia-
mond v. Chakrabarty 1980), and he was issued a patent. In a 5–4 decision
the court determined that:
“A live human-made micro-organism is patentable subject matter
under Title 35 U.S.C. 101. Respondent’s micro-organism constitutes a man-
ufacture or composition of matter and therefore is allowed a patent number
#4,259,444.”
But this was just the beginning…
Two other landmark cases affecting patenting of human genes were
argued in Supreme Court since Chakrabarty.
These cases used different arguments.
Why is Chakrabarty important? This case was to move patents to a
new level and allow patents previously not allowed.
Amgen Inc. v. Chugai Pharmaceuticals

927 F2nd 1200
Both Amgen, Inc. and Chugai Pharmaceuticals held patents involving

the production and marketing of a naturally occurring hormone called
erythropoietin, or EPO. Amgen, a company based in California, had a
patent for the DNA sequence (or gene) that produced EPO.
As we know from reading Chakrabarty, substances cannot be p
atented
if they exist in nature. Therefore, EPO itself could not be patented
(because it was not changed), but each company patented a procedure
used.
Genetics Institute (GI), a subgroup of Chugai Pharmaceuticals, a
Japan-based company, owned a patent for purification of the chemical
itself (patent number 4,677,195) entitled “Method for the purification
of Erythropoietin and Erythropoietin composition.” Chugai was issued
its patent on June 30, 1987. Four months later, on October 27, 1987,
Amgen was awarded the patent number 4,703,008 entitled “DNA
sequences e ncoding Erythropoietin.”
Patenting Genes 23
EPO, a hormone made in the kidneys, stimulates the production of

red blood cells. It has been used to help anemics (people who have a low
number of red blood cells) make red blood cells and replace blood cells
lost during chemotherapy. Some forms of anemia are fatal, and this drug
had the potential to save lives.
Amgen was using, recombinant DNA techniques to make EPO
(Chapter 1). Using these techniques, the gene is placed within the
DNA of a bacteria and the bacteria then makes EPO (just as it was in
Chakrabarty). Large numbers of bacteria can create large amounts of
human EPO, which can be marketed to doctors for treatment of anemia.
What happened when Amgen was awarded its patent?
This allowed a great deal of creativity on the part of patent attor-
neys and the courts that heard the early cases. In Diamond v. Chakrabarty
(477 US 303), the Federal Court decided that, once a gene was isolated
and cloned (duplicated), it was no longer a naturally occurring substance,
therefore leaving the door open for many more patents.
The court held that the conception of the EPO gene by Chugai was
defective because it contained no description of the actual gene. Patenting,
they claimed, could not be done unless you actually have isolated the
gene. Both companies tried to patent the process.
The court said: If a gene is patented, it will then be used to create a
specific protein, as with EPO, the patent must contain a clear description
of the gene and protein. The court said that it is impossible to have that
description unless you first have the gene. Therefore, Amgen, who had
isolated and cloned the gene, owned not only the gene itself, but the pro-
cess by which the gene makes the protein.
Why is this case important? It opened the way for many patents in
genetic research.
Association for Molecular Pathology v. Myriad Genetics, Inc.

569 US 576 (2013)
This case involved the well-known BRCA1 and BRCA2 genes, which can
involve mutations that increase the likelihood (risk factors) of breast cancer.
The ruling is significant for a variety of companies (including Myriad) that
hold important DNA patents. Other inventions derived from human DNA
might be affected. Justice Scalia filed an opinion concurring the judgment.
24 Biotechnology
Does §101 of the Patent Act allow patents on human genes?

The Association for Molecular Pathology (AMP) along with several
other medical associations, doctors, and patients sued the USPO and
Myriad Genetics to challenge several patents related to human genetics.
The patents cover the BRCA1 and BRCA2 genes that contain certain
mutations that indicate a high risk of developing breast cancer.
Myriad’s arguments:
1. Once a gene is isolated, and therefore distinguishable from other

genes, it could be patented. By patenting the genes, Myriad had
exclusive control over diagnostic testing and further scientific
research on the BRCA genes. Petitioners argued that patenting those
genes violated §101 of the Patent Act because they were products
of nature.
2. Patent Law (§101) limits patents to “any new and useful process,
machine, manufacture, or composition of matter, or any new and
useful improvement thereof.”
Court Decisions
The district court granted summary judgment in favor of petitioners
(AMP) holding that isolating a gene does not alter its naturally occurring
fundamental qualities.
The U.S. Court of Appeals for the Federal Circuit reversed, holding
that isolated genes are chemically distinct from their natural state in the
human body.
In March 2012, Petitioners (AMP) took the case to the U.S. Supreme
Court that vacated the Federal Circuit Court judgment, and sent it back
for further consideration in light of more recent cases. The Federal Circuit
again upheld the patentability of the BRCA genes.
Note: AMP was representing a number of patients who could not afford
the astronomical price of the test and needed it because of their high risk.
Who lost? Myriad.
Who won? Patients that could now afford the testing.
Why was this case so important? It would have far-reaching effects on
the science community at large and availability of drugs.
CHAPTER 7
Other Cases
Case 1 Ethical problems Legal problems
In 1999, an 18-year-old, • Doctors did not tell Jesse • Jesse’s parents did
Jesse Gelsinger, died about other deaths. not sue.
during a gene therapy • Jesse was only 18. • This case would
trial designed to treat • Everyone associated with probably be a wrongful
his metabolic condition this messed up. death suit.
(ornithine transcarboxylase • The doctors did things • Even if Jesse’s parents
deficiency). At the time, that were not only did not sue, the
the genes were transferred unethical, but illegal. government who
into human cells via a • Because Jesse was not told funded the experiment
virus. His condition was everything, and he was wanted to cover up
not that serious, but he very excited about doing what happened.
wanted to “help the babies.” it, no one stopped him.
His parents were not sure
because of the dangers, but
he was 18 and went ahead.
His immune system
over-produced antibodies
that attacked his organs.
Within 48 hours,
he was dead.
Mostly, this case is an
example of a gene therapy
that worked for some.
Many said, we should stop
trials immediately!
Case 2
It looked like just an • This type of transplant had • Was the experiment
ordinary farm. They had been done before. The first legal?
mostly pigs, and they was baby Fay, who was born • Babies cannot consent
seemed to be taken care with a heart defect and for any treatment, and
of very well. What was would have only lived a therefore the parents
not obvious was that these few hours. had to decide this.
were not ordinary pigs. • The parents gave • There were a lot of
They had been genetically permission to put problems with people
engineered. a baboon heart who are angry, and
(experimentally) in her. many people argued
• Was this ethical?
(Continued)
26 Biotechnology
A human gene on the p • The arguments against that the law should have
arm of chromosome six doing it were very stepped in and stopped it.
had been spliced into strong. The parents were These studies usually
their genome. These ostracized, and the public are called clinical trials
experiments were done did not understand why studies. Often have
so that the organs of the they did it. They felt they many people in them
pigs (livers, hearts, and were helping science. to test things like drugs,
kidneys) would have vaccines, and other
histocompatibility with medicines.
humans. The company
that owed the farm realized
a number of years ago that
a shortage of human organs
for transplant would make
xenotransplantation a
necessity and profitable.
This has become closer and
closer to reality.
Case 3
For many years, the • Viruses actually insert • Will these technologies
medical community their genes into a cell and be more expensive?
thought that cancer was the cell begins to make
caused by a virus and today copies of the virus.
viruses are helping to cure • About 25 years ago,
it. Viruses are created to scientists who study
bring the lifesaving genes viruses had ideas about
and treatments directly to using it to cure diseases.
the cancer cell. And, as we saw in other
You probably also know chapters, if the correct
about chemotherapy, genes can be placed, we
chemicals given to patients can cure diseases.
that will kill the cancer
cell, but they also kill
healthy cells. This method
made people sick and
sometimes die.
CHAPTER 8
Ethical Issues:
Who Will Decide?
From the beginning of this book, we have discussed some of the work
being done in genetic engineering and a little about the future and what
this might mean for all of us. Now, let us take time to talk about the
ethical issues that might come up when we discuss genetic engineering.
In Chapter 3, we went through what might be done with the CRISPR
technology and asked should we or shouldn’t we continue on?
Should we allow more genetic modifications in plants?
Should we allow human gene therapy to eradicate serious illnesses?
Should we allow human gene therapy to strengthen the immune
system?
Should we allow animal gene therapy for organ transplant?
But when it comes to a decision: Who will allow or disallow these
therapies?
Let us look at a list.
Should patients Very new experimental treatment needs permission of the

decide? person participating or their next of kin
Should doctors As of the laws today, doctors can give patients information and
decide? recommendations. But are careful not to suggest any action.
Should a hospital Hospitals are businesses and worry about mistakes and law suits
decide?
Should laws be made Would states be able to control misuse?
to control this? Should the federal government make these laws?
Should politics play Often scientific breakthroughs are discussed as part of a
a part? candidate’s opinions and many of them could be tied to
pharmacology companies and money
Who pays? $$ for research is extremely important.
Also, who owns drugs and tests after they are developed?
28 Biotechnology
Government? Should we have more and more money allotted to more

development?
Should they indicate who can use this technology? Is that
personal?
Patients? Patients must have give permission for using this technology.
But in truth, that cannot be all.
Insurance companies? When assisted reproduction first started, it was only for the rich
and many doctors convinced their patients to use it. Forcing
insurance companies to cover it.
Medical doctors? Unclear. No doubt we will have a number of doctors who
specialize in these techniques.
Manipulating genes at the following levels may also be a problem:
In a growing fetus in the womb.

In egg and sperm before fertilization.
In an embryo? At its earliest stages.
In newborns? Soon after birth.
In people with genetic diseases?
This group of questions gives us even more to think about:

Any gene could be changed in the egg or sperm and this change would
be passed on to future generations.
This is not the same as picking a person to have children with……
hmmmm.
Why? genetic changes at any stage after conception will not affect
future generations.
CHAPTER 9
How Will This Influx of

Genetic Information Affect
Our Future?
With the discovery of CRISPR (see Chapter 3), we have been forced to
look ahead to the future asking questions like:
• In identifying more and more genes, what will this mean for
humans?
• Is gene therapy safe?
• Will we misuse gene therapy?
• Will we change the human genome?
Many of you are probably science fiction fans. What you may not
know is that science fiction writers actually foresaw what we now take for
granted.
Examples: Brave New World (Aldous Huxley, 1932) contained test-
tube babies, genetical engineering of human babies, and cloning.
Star Trek movies: Communicators, cell phones.
The White Plague: Arthur C Clarke (1982) wrote about an angry man,
wanting to get revenge for the death of his family, used biotechnology to
create a virus to all women sterile.
But, you can go back even further to Leonardo da Vinci (1452–1519)
as his idea of helicopters and human body functions and anatomy that
are still used today.
In a recent edition of National Geographic Magazine, some of the
newest uses of national and international genetic engineering were listed.
Here are some of them:
30 Biotechnology
• At Inova women’s hospital in Fall’s Church, Virginia, all

newborns will have seven genes studied. They involve drug
metabolism, and in the future, a physician will use these to
tailor medications specifically for their patients.
• Human blood is being filtered through pig lungs to study the
pig tissue. These studies will make it possible to rid pig organs
of dangerous viruses, making them ready for transplant.
Other possible future developments from genetic modification are:
1. Crops with bigger yield and no pesticides.

2. Curing genetic diseases in humans and animals.
3. Removing HIV from human cells.
4. More cures of genetic diseases (as we discover more genetic ties).
5. Editing human genes in embryos (just to affect the gene within the
child).
6. Possible lengthening of or slowing down of deterioration of telo-
meres (ends of chromosomes), which seem to control aging.
7. Correct genetic errors that cause diseases.
8. Eliminate microbes that cause diseases.
9. Create hybrids of extinct animals and a living animal (DNA of a
mammoth mixed with elephant).
10. Eradicate mosquitoes. What would happen we did this?
In a lab in Guangzhou China:

Created dogs with double the muscular mass (myostatin).
And, cloned many breeds.
Worked with human embryos (legal in China).
Started clinical trials on humans.
Newest information: Japan has put together guidelines for using CRISPR
in human embryos but not for reproduction.
CHAPTER 10
The Papaya and the

Biologist: The Man Behind
the Rainbow
Back in the 1940s, Hawaiian papaya growers began to see the ringspot
virus (PRSV) (see Figure 10.1), a plant virus that reduced papaya produc-
tion by 50–90 percent from 1993 to 2006 and just kept spreading. Small
farms faced the loss of their livelihoods.
A plant pathologist, Dr. Dennis Gonsalves, was working at Cornell
University in plant genetics and heard the story. He was born in Hawaii,
and he remembered a papaya tree on his street and the taste of the papayas
he could pick every morning, they were sweet and beautiful. No question
he was going to help. He was sure his work in biotechnology could help.
He and his team had already identified and copied the gene of a similar
virus’ coat and thought they would try to work with PRSV.
In the lab, they copied PRSV coat gene in 1999 and decided to test a
few years later in a field trial.
This field trial showed that, in two different groups of plants, one
with the gene from the genetically changed coat and the other without it,
showed the following results:
The unchanged papaya: 99 percent were infected with PRSV.
The papaya (has no circles): No PRSV!!!!!
After developing a virus-resistant variety called the Rainbow (Figure
10.2), the seeds were given to struggling farmers—for free. And, it worked
very well. These transgenic papayas are now used in Brazil, Jamaica,
Venezuela, and Thailand.
There are quite a few things to like about this story, and it seems
easy to admire the researcher, the success of independent local farmers,
32 Biotechnology
Figure 10.1 Papaya with PRSV (ringspot is a good name)
Figure 10.2 Healthy Rainbow papaya
and the beauty and taste of the fruit. But there is one detail that could
change everything about how you see it: The Rainbow papaya is genetically
modified.
The Papaya and the Biologist 33
In his paper, Dr. Gonsalves said “I say GMO, you think Big Agriculture,
lobbyists, corporate interests and money, but none of these played a major
role in the GM Rainbow papaya. And for me, that led to an important
realization. Genetic engineering technology is not the same thing as Big
Agriculture policy. It’s a tool. And like all tools, it can be used for good or
bad ends.”1
Would you buy a GM papaya?
1
Gonsalves, D. AgBioForum vol. 7 no. 1 and 2.
APPENDIX A
What Can We Learn

from the Past?
Long before scientists knew about DNA and control of genes, man used
animal and plant breeding to get the trait they wanted: more milk pro-
duction, prettier flowers, and so on.
Biotechnology can get better results and faster. Although some have
mixed feelings about the technology, one thing no one is sure of is who
will control this.
The question about who will decide how this technology proceeds is
extremely important.
This may be the time to think about this problem and its solution.
Do you think so?
Maybe we should look to the past to help us:
Has man done this before?
Yes!
Here in the United States, in the 1920s–1930s, a social movement
called Eugenics, and the American Eugenics Society, was founded and
spread throughout the country.
These organizations wanted to create a better society by controlling
certain families reproductive rate.
This kind of manipulation is called Eugenics. Because it was the
1900s, scientists did not know much about genes, but they did know,
through observation, that traits run in families.
Question: How can we get certain people to have children and others
have none?
The top group of people (desirable) were called fitter families, and they
were searched out. Birth records and special exhibits at state fairs were
36 APPENDIX A
used. When found, they were given a family tree, an award, and a trophy.
In addition, they were encouraged to have more children.
Those who had any trait on the list of undesired traits were discour-
aged from having children. Actually they were sterilized by law! (without
their consent)
See Table A.1.
In order to do this, a list of traits that they consider good must be
made. Women who have these traits are encouraged to have large families.
Maybe you realize that, if you have list of good traits, you must also
have a list of undesirable traits. See the following lists:
Table A.1
Positive traits Negative (undesirable traits)
Good skin Alcoholic
Good jobs Criminalistics
Usually white Feeble minded
Generations showing these traits Syphilitic
Vagrant
APPENDIX A 37
Eugenics Record Office, “The Study of Human Heredity”
You might be thinking who made up these lists? The Eugenics

Committee of the United States was headed by Francis Galton, Charles
Darwin’s (survival of the fittest) cousin.
Keep this in mind as we go on…
Almost all states had mandatory sterilization laws; see the following
figure:
38 APPENDIX A
Figure A.1 Map of US sterilization laws this map was prepared in

1935, when much of the science of genetics was not known. Notice
how many states had laws, those with stripes. Notice the stripes on
the states that had enforced sterilization.
Epilogue
This book tries to show the pluses and minuses of genetic engineering and
how they apply to medicine, food, and human heredity.
But this is science!
In science, we analyze by testing and observing. Both of these take time.
And, things may come up that we do not foresee!
Should we stop or continue advancing?
This is a great question (with no answer).
In addition, who will control this technology in the future?
In Chapter 5, we list some possible choices, see what you think!
References
Cummings, M.R. 2017. Human Genetics.
Douda, Jennifer. TED talk, on CRISPR YouTube. https://youtube/1BXYS
Gepx7Q
Freedman, D.H. Winter 2017–18. “Are Engineered Foods Evil?” Scientific
American Special Edition, p. 76.
Harrison, J. “Gadgette’s Top Scientific Innovation of 2015-CRISPR.”
www.gandgette.com
Held, E. 2016. “How GMO Technology Saved the Papaya.” Foodinsight.org
“How GM Papaya Saved Hawaii’s Papaya Industry” Posted at SAIFood.com
Pringle, P. 2010. Food, Inc.: Mendel to Monsanto: Promises and Perils of the Biotech
Harvest. Simon & Schuster.
Sparknotes.com. “Protein synthesis”
Yashon, R. 2014. Landmark Legal Cases in Science.
Yashon, R., and M. Cummings. 2012. Human Genetics and Society. Cengage
Learning.
About the Authors
Ronnee Yashon is a nationally known expert in teaching genetics, ethics,
and law on all levels. She has a background in teaching in the high school,
undergraduate, graduate, and law school levels.
Her case study methodology for introducing bioethics and law in the
curriculum uses simple, personalized, and current scenarios that involve
the students in decision making. Ronnee has presented this case study
method all over the country, and she has six case study books.
Michael R. Cummings is the author or coauthor of several leading c ollege

textbooks, including Human Heredity Principles and Issues, Concepts of
Genetics, and Essentials of Genetics. He also authored an introductory
biology text for non-majors titled Biology: Science and Life.
For several years, he wrote and published a newsletter about advances
in human genetics for instructors and students. He was a faculty member
at the University of Illinois at Chicago for over 25 years. While there, he
was recognized as an outstanding faculty member and mentored many
junior faculty in undergraduate teaching.
Index
American Eugenics Society, 35 fitter families, 35–36
Amgen Inc. v. Chugai Pharmaceuticals, flat DNA, 3
22–23
animal manipulations, 10 genes, patenting, 21–24
Association for Molecular Pathology v. genetic engineering
Myriad Genetics, Inc., 23–24 ethical issues in, 27–28
in media, 15–16
bacterial manipulations, 10 genetic manipulation versus cross
biotechnology breeding, 7–8
CRISPR in, 13–14 genetic modification (GM)
definition of, 2 future developments, 30
genetic manipulation versus cross in papaya, 31–33
breeding, 7–8 technology, 17–20
overview, 1–5 Genetics Institute (GI), 22
uses of, 7–11 Gonsalves, Dennis, 31
See also genetic engineering; genetic
modification (GM)
Brave New World (Aldous Huxley), 29 helical DNA, 2–3
BRCA1 genes, 23–24 human blood, 30
BRCA2 genes, 23–24
mRNA, 4
cancer, 18 Myriad Genetics, 24
Chugai Pharmaceuticals, 22
CRISPR. See clustered interspaced National Geographic Magazine, 29
short palindromic repeats
Clarke, Arthur C, 29 papaya with PRSV, 31–32
clustered interspaced short patenting genes, 21–24
palindromic repeats plant manipulations, 9
(CRISPR), 13–14, 29–30 protein synthesis, 3–5
Cornell University, 31
cross breeding
genetic manipulation versus, 7–8 rainbow papaya, 31–32
in plants and animals, 8 replication, 1, 2–3
ribosomes, 4
ringspot virus (PRSV), 31
da Vinci, Leonardo, 29
Diamond v. Chakrabarty, 22
DNA, functions, 1 social media, genetic engineering in,
Doudna, Jennifer, 14 15–16
“The Study of Human Heredity,”
Eigsti, O. J., 7 37
Eugenics, 35
Eugenics Record Office, 37 translation, 1, 4
46 Index
U.S. Patent Office (USPO), 21, 22 decisions, 24

U.S. Supreme Court Diamond v. Chakrabarty, 21–22
Amgen Inc. v. Chugai other cases, 25–26
Pharmaceuticals, 22–23 US sterilization laws, 38
Association for Molecular Pathology
v. Myriad Genetics, Inc., 23–24 The White Plague (Clarke), 29
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Appendix: What Can We Learn from the Past?����������������������������������������35

It all starts with the cell and its nucleus

An organelle that holds chromosomes

Line up AA in the correct order.

And you get

Proteins are important chemicals in our body

1. Make perfect copies of itself. This is called replication and occurs in

New types of Production of

Figure 1.1 What is biotechnology?

Steps of Protein Synthesis

Figure 1.3 Protein synthesis in a cell

• Nucleus showing the complete DNA. (#1)

Amino Acid: Glycine (AA) GGA triplet code in normal DNA

What can go wrong?

This is only one of the futures of biotechnology, some being done

How Is Biotechnology Used?

In the 1940s, O. J. Eigsti, a plant geneticist (see Chapter 10 for

Figure 2.1 Seedless watermelon

Apples: Hundreds of types of apples come from cross-breeding ones

What information was needed to start using biotechnology?

1. Find the gene that controlled the trait.

A gene can be manipulated by inserting or turning on and off certain

Table 2.1 Plant manipulations

Speed up or Same Same Lengthen Tomatoes On sale

Transferring a gene from a plant, animal, or human into a bacterium

Table 2.2 Bacterial manipulations

Table 2.3 Animal manipulations

Editing Humanity The Economist

The Old Versus the New

Jennifer Doudna, (the scientist who reworked the CRISPR mole-

Remove Bad Genes and Add Good Ones?

1. News, TV, radio, ads: 23 and me and genetic information; pater-

Not so long ago, no one thought we could freeze eggs, or 50-year-old

GM Technology: What Are

SEE LINE BELOW:

Another side of this, is money. Would anything be accomplished without

In Chapter 2, there are charts listing what is happening now. And in

Scenario 2: Genes can be placed within the genome of an existing food

Scenario 4: A person’s dog dies and she immediately calls a company to

Scenario 6: A woman needs a kidney transplant, she is offered a pig’s

Scenario 7: Strawberries are very popular in Alaska and Norway, two

Possibly you might want to know my opinion of these questions, well

Scenario 1: Yes, because we probably will. Responsible doctors and

ONE GIANT QUESTION is future safety. We can imagine changing

And it cannot be:

In 1980, a patent was applied for, by Ananda Chakrabarty, who had

The United States Patent Office (USPO) had a question: Is your

Amgen Inc. v. Chugai Pharmaceuticals

Both Amgen, Inc. and Chugai Pharmaceuticals held patents involving

EPO, a hormone made in the kidneys, stimulates the production of

Association for Molecular Pathology v. Myriad Genetics, Inc.

Does §101 of the Patent Act allow patents on human genes?

1. Once a gene is isolated, and therefore distinguishable from other

Appendix: What Can We Learn from the Past?��35

Michael R. Cummings is the author or coauthor of several leading c ollege

Momentum Press offers library-friendly terms: