FARMER’S AND BREEDERS

RIGHTS(HONS.)

Faculty : Dr. Aarti Vyas Bhatt

Unit 1 : Biotechnology and Law
 Meaning and Concept of Biotechnology

 Evolution of Biotechnology

 Techniques involved in Biotechnology

 Applications of Biotechnology

Unit 3 : Biotechnologies and International Treatise

 UPOV(International Convention for the
Protection of new varieties of Plants, 1991)
 Difference between UPOV 1991 and Indian Law

 ITPGRFA(International Treaty on Plant Genetic

resources for Food and Agriculture)
 TRIPS Agreement(Trade Related Aspects of
Intellectual Property Rights)
PREFACE
 Biotechnology is a science that deals with living
organisms to produce materials or to provide some
services to humans.
 Biotechnology is a broad group of modern technologies
that use vital organs or parts of them to produce
products, such as medicines, food compounds,
environmentally friendly chemicals and biofuels.
 Biotechnology is the totality of techniques and
knowledge associated with the use of living things in
production processes arising from recent advances in
molecular biology.
 Biotechnology harnesses the knowledge of life sciences
and their applications for technological and industrial
purposes for constructive work in the service of
humankind.
 Biotechnology is multifaceted science that draws on
many other sciences such as applied biophysics,
chemistry, microbiology, biochemistry, genetics,
physiology, molecular biology, enzymology, analytical
chemistry, food science, chemical engineering,
industrial microbiology, and others.
 Biotechnology has become a broad base for various
development programs, and an indication of the extent
of scientific and cultural excellence and progress,
especially in the field of providing and developing
human food and pharmaceutical needs, as well as
environmental, economic, and other industries.
 UNIT 1 BIOTECHNOLOGY AND LAW
At a Glance

 In the beginning biotechnology was an artisanal skill rather

than a science and involved

 the production of beers, wines, cheeses and breads etc. where

the processes were well worked out and were reproducible.

 The role of microorganisms in all of these processes was not

recognized until the microscopic observations by Anton van
Leeuwenhook and the later experiments by Pasteur Industries
developed around non-sterile production of various organic
acids together with the rapid development of waste water and
solid waste treatment processes that were to lead to major
 In the 1940s there was rapid development of aseptic
fermentation processes (the bioreactor) which lead to the
production of antibiotics (penicillin), amino acids, enzymes,
steroids, polysaccharides and monoclonal antibodies creating
a new range of biotechnology industries.
 Applied genetics and recombinant DNA
DNA(Deoxyribonucleic acid) technology were to improve
important industrial microorganisms and to create new
aspects in plant and animal agriculture.
 Recombinant drug production is now a largely important
industrial aspect of biotechnology.
 Biotechnology is a complex, multifunctional but often
maligned activity.
 Biotechnology will undoubtedly present major opportunities
to human development in nutrition, medicine and industry
but it cannot be denied that some aspects are creating social-
ethical apprehensions.
 Notwithstanding, biotechnology will undoubtedly be the
major technology of the 21st Century and should be so
recognized by the lay public.
 INTRODUCTION
 Biotechnology is a field of science that deals with
techniques to manipulate the organism or its
components to produce products that are useful to
humans.
 The development of Biotechnology as a science is
supported by the advancement of DNA(Deoxyribonucleic
acid) technology.
 Success in making recombinant DNA provides an
opportunity for the development of sophisticated
techniques to analyze genes and gene expression.
 According to the structure of biological science,
Biotechnology discusses the structure, function, and
regulation at the molecular level of living things.
 The most primitive type of biotechnology is the cultivation of
plants and the training (in particular the domestication) of
animals.

 The domestication of animals stretches back over 10 000

years, when our ancestors also started maintaining plants as
a reliable source of food.

 The earliest examples of such domesticated plants are rice,

barley and wheat. Wild animals were also controlled to
produce milk or meat.

 The ancient production of cheese, yogurt and bread from

micro-organisms is also reported. Various alcoholic drinks
such as beer and wine were developed during this period,
when the process of fermentation was first discovered.
 DEFINITIONS
 Biotechnology is a science-driven industry sector that
makes use of living organisms and molecular biology to
produce healthcare-related products and therapeutics or
to run processes (such as DNA fingerprinting).
Biotechnology is best known for its increasingly
important role in the fields of medicine and
pharmaceuticals, and is also applied in other areas such
as genomics, food production, and the production
of biofuels (Source : Investopedia)

 : the manipulation (as through genetic engineering) of

living organisms or their components to produce useful
usually commercial products (such as pest resistant
crops, new bacterial strains, or novel
pharmaceuticals)also : any of various applications of
biological science used in such manipulation (Source :
Merriam- Webster)
 the use of biology to solve problems and make useful
products. The most prominent area of biotechnology is
the production of therapeutic proteins and other drugs
through genetic engineering.
Branches of biotechnology
The definition of biotechnology can be further divided into
different areas known as red, green blue and white.
1. Red biotechnology:
 This area includes medical procedures such as utilizing
organisms for the production of novel drugs or employing stem
cells to replace/regenerate injured tissues and possibly
regenerate whole organs. It could simply be called medical
biotechnology.
 Medical or Pharmaceutical biotechnology-related fields fall
under Red Biotechnology. It includes the production of drugs,
vaccines, antibiotics, medicines, and health-related items.
 It is related to the development of new drugs, treatment
techniques, biosimilars, hormones, stem cells, monoclonal
antibodies, siRNA, diagnostic techniques, gene therapy, stem
cells, genetic testing, etc.
 It is the second most popular field of Biotechnology in which
large-scale research institutes, hospitals, academic institutes,
and commercial industries work together for the development
of new techniques, drugs, artificial organs, medical diagnostic
kits, regenerative therapies, vaccines, etc.
2. Green biotechnology:
 Green biotechnology applies to agriculture and involves
such processes as the development of pest-resistant
grains and the accelerated evolution of disease-resistant
animals.
 Green Biotechnology includes techniques that are
directly related to the agriculture field. It by using plant
Biotechnology, tissue culture, bio-pesticides, and bio-
fertilizers applications reducing the dependency on
chemical or mechanical techniques. The development of
new crops by modifications in genes, micro-propagation,
and tissue culture falls under this category.
 It is a major branch of Biotechnology that is used on a
large scale in agriculture and the Agri-industrial field.
Green Biotechnology covers agriculture, environment,
bioenergy, etc. It provides solutions to the agriculture,
horticulture, and domestic animal breeding processes.
3. Blue biotechnology:
 Blue biotechnology, rarely mentioned, encompasses
processes in the marine and aquatic environments, such
as controlling the proliferation of noxious water-borne
organisms.
 Utilization of aquatic resources like fishes, aquatic plants,
shellfish, sponges, whale fishes, etc. for the production of
food, medicines, beverages, fabrics, plastics, and personal
care products that are used for human welfare by
applying Biotechnological techniques falls under the Blue
Biotechnology. Not only sea and ocean, fresh-water rivers
aquatic resource utilization comes under this category of
Biotechnology.
4. White biotechnology:
 White (also called gray) biotechnology involves industrial
processes such as the production of new chemicals or the
development of new fuels for vehicles.
 Application of Biotechnological techniques such as
biocatalysts in industrial processes, production of
biodegradable polymers, production of industrially useful
enzymes and microorganisms, and production of wine,
bread, or beer.
 It is the fastest-growing biotechnology field that uses
microorganisms in chemical production, plastics, textiles,
biofuels, cosmetics, paper, textile, tanning, and food
products.
5. Gold Biotechnology
 Gold Biotechnology which is now known as
Bioinformatics, deals with all types of computational
biology techniques that include computer science, chip
technology, Nanobiotechnology, etc. Bioinformatics is the
most advanced form of Biotechnology that is used in
analyzing biological data by computer applications.
 All biological data are available from the sequencing of
various genomes of different organisms used in various
areas like genomics, structural genomics, and proteomics
for developing new drugs or vaccines, phylogenetic
analysis, etc.
6. Grey Biotechnology
 Grey Biotechnology also known as Environmental
Biotechnology that related to environmental applications
and focuses on the solutions to environmental problems.
It includes bioremediation, waste management, sewage
treatments, etc. It works on maintaining the biodiversity
of flora and fauna in existing nature. It protects from
overexploitation of natural resources and reduces
pollution in the environment.
 It refers to the use of Biotechnological techniques for the
removal of contaminants from the environment such as
the use of microorganisms for waste management, plastic
decaying, soil treatment (bioremediation), oil spillage,
and radioactive contamination
7. Yellow Biotechnology
 Yellow Biotechnology refers to nutritional biotechnology
that is related to using Biotechnological techniques for
the development of nutrition-rich products. It includes
the research and development of food products like wine,
cheese, and beer by fermentation. Under this category
control of insects and changing their gene for agricultural
and medicinal purposes is also included.
 Under the yellow biotechnology improvement of food
products nourishing quality increases by fortified with
health-promoting additives. Golden Rice is one of good
example of it.
 It is achieved by using enzymatic and microbial genetic
modification processes to eliminate allergens and
unwanted components that cause its intolerance and
addition of nutrients adding genes for its fortification
with health-promoting components
8. Brown Biotechnology
 Brown biotechnology is a powerful toolbox for solving the
challenges of arid lands. Biotechnological techniques
such as versatile crops, bio-fertilization,
phytoremediation, desalination, and genetically modified
plants are used in arid regions.
 Management of deserts, arid lands, and dry and saline
soils for growing high-valued commercial crops in Africa-
like places fall under the Brown biotechnology. Using
Biotechnological techniques like GMO technology, high-
quality hybrid seeds, and disease-free, less water-
consuming crops growing in Sahara desert-type areas is
very beneficial for people who live in these regions
9. Violet Biotechnology
 Intellectual property rights, laws, ethical issues,
biosafety, biosecurity, philosophic issues, and legal issues
related to Biotechnology fields fall under Violet
Biotechnology. It started in 1980 when genetically
modified microorganisms (GMOs) first-time patent was
started.
 Violet or Purple Biotechnology includes protecting and
encouraging new biotechnology inventions by patenting
laws, providing detailed research and analysis on the
new publications on biotechnology research, ensuring the
IPRs of Biotechnology companies, scientists, and
research institutes, and solving any conflicts raised
related to these.
10. Dark Biotechnology
 Biotechnology has also dark sides that are used against
human welfare. All Biotechnology techniques that are
used against all living things and human welfare fall
under Dark Biotechnology. Use of Biotechnological
techniques in terrorism, biological weapons, biowarfare,
and the development of toxins that are harmful to all
types of living organisms like humans, animals, and
plants.
 Development of any Biohazardous things by applying
Biotechnological techniques and using microorganisms
falls under the Dark Biotechnology field. Microorganisms
like viruses, bacteria, or any other biological agents are
used as bio-weapons for any individual or mass public, or
for the nation.
Modern biotechnology
A major obstacle to scientific discoveries was the Second
World War. After the war, some essential discoveries were
explored.
These discoveries form the basis for modern biotechnology
and have brought this field to its current status. Some of
the prominent events of the modern age of biotechnology
are highlighted in table
Historical and current events that form the basis of
modern biotechnology.
Year Discoveries
1952 • George Otto Gey created a continuous cell
line taken from a human cervical
carcinoma. This cell line, known as HeLa, is still
used in therapeutic research.
1953 • Watson and Crick explored DNA as a genetic
material, and discovered its structure, called the
double-helix.
1954 • Joseph Murray carried out the first kidney
transplant between identical twins.
1957 • Scientists revealed that sickle-cell anemia occurs
due to an alteration in a single
amino acid in hemoglobin cells.
1958 • Arthur Kornberg created DNA in a test tube for
the first time. The first mechanical
protein sequencer, the Moore–Stein amino acid analyzer,
is developed.
1980: Patents allowed
 The US Supreme Court granted that genetically
modified living organisms could be patented.
According to a Supreme Court decision (1980) the
Exxon oil company was allowed to patent an oil-eating
micro-organism.
 Kary Mullis and other researchers at UC Berkeley,
California, established a tool for multiplying DNA
sequences in vitro using the polymerase chain reaction
(PCR)
1990: Patents and money

 The first gene-based treatment was performed on a

four-year-old girl suffering from an immunological
disorder known as adenosine deaminase deficiency
(ADA) deficiency.

 Gene therapy emerged, however ethical concerns

surrounding gene therapy were highly debated.

 Commencement of the Human Genome Project,

with the global objective to plot all of the genes in
the human body. The expected cost was $13 billion.
1997 : Dolly Sheep
 Researchers at the Roslin Institute in Scotland
announced that they had cloned a sheep called
Dolly from the cell of an adult ewe.
 Dolly was the first mammal cloned by a technique
called nuclear transfer technology.
 Nuclear transfer allows the introduction of
complete genetic material from one cell into
another enucleated unfertilized egg cell.
The development of biotechnology can be divided into broad
stages or categories, including:
• Ancient biotechnology (8000–4000 BC):
Early history as related to food and shelter; includes
domestication of animals.
•Classical biotechnology (2000 BC; 1800–1900 AD):
Built on ancient bio- technology; fermentation promotes food
production and medicine.
• 1900–1953: Genetics.
• 1953–1976: DNA research, science explodes.
•Modern biotechnology (1977):
Manipulates genetic information in organaisms; genetic
engineering; various technologies enable us to improve crop
yield and food quality in agriculture and to produce a
broader array of products in industries.
TECHNIQUES IN BIOTECHNOLOGY
The three important techniques of biotechnology
are:
(1)Recombinant DNA Technology
(Genetic Engineering)
(2) Plant Tissue Culture and
(3)Transgenic
(Genetically Modified Organisms).
 Technique # 1. Recombinant DNA Technology
(Genetic Engineering):
 Genetic engineering deals with synthesis of artificial
gene, repair of gene, combining of DNA from two
organism (recombinant DNA) and manipulating the
artificial gene together with the recombinant DNA for
the improvement of microbes, plants, animals & human
being.
 Genetic engineering or Recombinant-DNA
Technology involves cutting and pasting of desired
DNA fragments It is based on two important
discoveries in bacteria:
 (i) Presence of plasmids in bacteria which can undergo
replication along with and independent of chromosomal
DNA
 (ii) Restriction endonucleases which can break DNA at
specific sites. They are appropriately called molecular
scissors.
 The science of recombinant technology took birth when
Cohen and Boyer (1973) were able to introduce a piece of
gene containing foreign DNA into plasmid of Escherichia
coli.
 Berg (1979) was able to introduce a gene of SV-40 into a
bacterium with the help of lambda phage. Berg is often
considered “father of genetic engineering”
 Basic Tools of Genetic Engineering:
Three types of biological tools’ are used in synthesis
of recombinant DNA. These are as follows:
 1. Enzymes:

These include lysing enzymes (e.g., lysozyme), cleaving

enzymes (e.g., exo-nucleases, endonucleases, restriction
endonucleases), synthesizing enzymes (e.g., reverse
transcriptase’s) joining enzymes (e.g., ligases) and alkaline
phosphatases
 2. Vector or Vehicle DNA:

The DNA used as a carrier for transferring a fragment of

foreign DNA into a suitable host is called vehicle DNA or
cloning vector or gene carrier (e.g., plasmids,
bacteriophage DNA, cosmid – an artificial plasmid,
phagemid/phasmid, artificial chromosome vectors).
 3. Passenger DNA:
 It is the DNA which is transferred from one organism into
another by combining it with the vehicle DNA.
 Hazards of Genetic Engineering:
 Several hazards (dangers) are associated with
recombinant DNA technology.
The main dangers include:
(1) Spread of New Diseases:
 New dangerous forms of microorganisms can be
developed through recombinant DNA technique either
accidentally or deliberately. Escape of such
microorganisms from the research laboratory through
drainage, laboratory glassware, laboratory personnel
etc., may lead to the spread and origin of new diseases,
which may pose a serious problem. HIV (AIDS Virus) is
believed to be one such product.
(2) Effect on Evolution:
 Nature has provided several barriers for exchange of
DNA between prokaryotes and eukaryotes. Recombinant
DNA technology permits exchange of DNA between these
two classes of organisms and thus interferes with the
natural process of evolution.
(3) Biological Warfare:
 There is always a possibility that some unscrupulous
countries may use genetic engineering technology for
biological warfare. In such warfare, disease-carrying
microorganisms can be used against the enemy. This is
bound to lead to disaster. Thus genetic engineering has
several demerits also. Many of the results achieved
through genetic engineering can be achieved through
other less hazardous techniques.
 Technique # 2. Plant Tissue Culture:
 Man is dependent on plants for food, shelter and
clothing.
 It is this dependence of man on plants that has led him
to discover different ways to protect and preserve them
from being lost to natural and man-made calamities.
 While doing so, scientists hit upon a technique whereby
plants can not only be protected from being lost but are
able to develop into a complete plant from a single cell or
a small plant part.
 This technique, called tissue culture, subsequently
proved to be a boon for the mankind.
 Theoretically, any plant cell—except those lacking a
nucleus or enclosed by a rigid, secondary wall—is
potentially capable of regenerating the organism from
which it was taken. Such a cell is said to be totipotent.
 Collections of similar cells form tissues, and tissue
systems are organized into organs, and the specific
spatial arrangement of organs constitutes the organism
(i.e., full plant).
 Plants can be regenerated in vitro from organ explants
(root and shoot tips, buds, leaf primordia, developing,
tissue explants, cells and protoplasts.
 Various Types of Plant Tissue Culture:
 Plant tissue culture includes cell culture, protoplast
culture, organ culture, meristem culture etc. (see
following table). The organ culture includes any plant
organ which has separate identity such as anther
culture, ovule culture, embryo culture and bud culture.
Advantages of Tissue Culture
There are several advantages to using the tissue culture process.
 The new plantlets can be grown in a short amount of time.
 Only a small amount of initial plant tissue is required.
 The new plantlets and plants are more likely to be free of viruses and
diseases.
 The process is not dependant on the seasons and can be done
throughout the year.
 You need only a relatively small space to perform the process (ten
times the plants in one-tenth of the space).
 On a larger scale, the tissue culture process helps to supply the
consumer market with new subspecies and variety.
 People looking to cultivate challenging plants such as specific breeds
of orchid find more success with the tissue culture process than
traditional soil.
DISADVANTAGES OF TISSUE CULTURE
 Tissue Culture can require more labor and cost more
money.
 There is a chance that the propagated plants will be less
resilient to diseases due to the type of environment they
are grown in.
 It is imperative that, before being cultured, the material is
screened; failure to pick up any abnormalities could lead
to the new plants being infected.
 While the success rate is high if the correct procedures are
followed, success with the tissue culture is not a
guarantee. There is still a chance that the process triggers
a secondary metabolic chemical reaction, and the new
explants or cells' growth gets stunted, or even die off.
 Technique # 3. Transgenic (Genetically Modified
Organisms):
 Genetically engineered organisms are referred to as
transgenics or Genetically Modified Organisms (GMO). In
other words, a genotype developed by the process of
genetic engineering is called transgenic (pleural
transgenics). It may be a plant, an animal or microbes
such as fungi, bacteria and viruses. Thus transgenic
plants or Genetically Modified Plants (GM Plants) are
those plants which are developed by the techniques of
genetic engineering.
 Transgenes refer to foreign genes or modified genes of the
same species which are used for the development of
transgenic plants or genotypes. Transgenes maybe from
the same species (in modified form), related wild species,
unrelated species and microbes (bacteria, fungi and
viruses)
 Transgenic Breeding and its Advantages:
 Genetic improvement of crop plants, domestic animals
and useful microorganisms through biotechnology (tissue
culture and genetic engineering) in relation to their
economic use for mankind is referred to as transgenic
breeding.
 1. Rapid Method of Crop Improvement:

 Transgenic breeding is a rapid method of crop

improvement. By this technique, stable transgenic plants
can be developed in 3-4 years, whereas it takes 12-15
years to develop a new variety through conventional
methods of breeding such as pedigree, bulk and back
cross methods. The first generation of transgenic plants
obtained through regeneration is called T0 progeny.
 2. Overcome Crossing Barriers:
 Transgenic breeding permits gene transfer between
unrelated species and even between unrelated organisms.
It permits gene transfer even between plants and animals.
For example, a freezing resistant gene has been
transferred from fish to cultivated tomatoes. Similarly,
ovalbumin gene of chicken has been transferred in alfalfa
for improving protein quality. There are many other
examples of gene transfer between plants and animals
 3. Evolution of New Genotypes:

 Sometimes, transgenic breeding may lead to evolution of

altogether new plant species, because it permits gene
transfer between various plant species. Thus it will affect
the process of natural evolution.
 Limitations of Transgenic Plant Breeding:
 Transgenic breeding has some limitations. The
main limitations are:
(1) Unstable performance,
(2) Pleiotropic effect {i.e., multiple effects of a single gene) of
transgene,
(3) Position effect of transgene,
(4) Costly method of crop improvement,
(5) Low frequency of transgenic plants,
(6) Risk of evolution of problematic weed Species, etc
Applications of Biotechnology
 Biotechnology has application in four major industrial areas,
including health care (medical), crop production and agriculture,
non food (industrial) uses of crops and other products (e.g.
biodegradable plastics, vegetable oil, biofuels), and environmental
uses.
Applications of Biotechnology in Medicine
 Biotechnology techniques are used in medicine for diagnosis and
treating different diseases. It gives opportunities for the people to
protect themselves from dangerous diseases.
 The field of Biotechnology, genetic engineering has introduced
techniques like gene therapy, recombinant DNA technology and
polymerase chain reaction which use genes and DNA molecules to
diagnose diseases and insert new and healthy genes in the body
which replace the damaged cells.
 There are some applications of biotechnology which are playing
their part in the field of medicine and giving good results:
 • Biopharmaceuticals: The drugs are being developed with the
use of microorganisms without using any synthetic materials and
chemicals. Large molecules of proteins are usually the source of
biopharmaceutical drugs. They when targeted in the body attack
the hidden mechanisms of the diseases and destroy them without
any side effect(s). Now scientists are trying to develop such
biopharmaceutical drugs which can be treated against the diseases
like hepatitis, cancer and heart disease
• Gene therapy:
It is used in delicacy and diagnoses of diseases like cancer and
Parkinson’s. The apparatus of this technique is that the fit genes are
under attack in the body which either obliterate the injured cells or
replace them. In some cases, the fit genes make corrections in the
genetic information and that is how the genes start performance in the
favor of the body.
• Pharmaco-genomics:
Pharmaco-genomics is an additional genetically modified method which
is used to learn the genetic information of a personality. It analyzes the
body’s reply to sure drugs. It is the mixture of pharmaceuticals and
genomics. The aspires of this field is to expand such drugs which are
inserted in the person according to the genetic information there in the
individual.
• Genetic Testing:
It is a technique of heredity is used to conclude the genetic diseases in
parents, sex and carrier screening. The technique of genetic testing is to
use DNA probes which have the sequence alike to the mutated
sequences. This technique is also used to recognize the criminals and to
test the parenthood of the child.
 • It is completed that no field of science can be winning until it uses
the techniques of biotechnology. Scientists are operational in the
research area to expand new drugs and vaccines and are also
judgment cures for the diseases which were not easy to treat in the
past decade. Biotechnology is a field of miracle.
 Biotechnology has played major role in agriculture by altering
genes, studying and cloning various crops in order to provide
better quality products of foods ultimately improving our lives.
Some of its applications are:
• Vaccines:
Oral vaccines have been in the works for much existence as a likely
solution to the increase of disease in immature countries, where costs are
excessive to extensive vaccination. By planning and injecting antigenic
proteins into the Genetically Modified crops from transferable pathogens
that will activate an immune will be a great help in dealing with such
diseases.

An example of this is a patient-specific vaccine for treating cancer. An

anti-lymphoma vaccine has been made using tobacco plants carrying RNA
from cloned malignant B-cells. The resultant protein is then used to
vaccinate the patient and boost their immune system beside the cancer.
Tailor-made vaccines for cancer treatment have shown substantial promise
in preliminary studies.
• Antibiotics:
Plants are used to create antibiotics for both human and animal use. An
expressing antibiotic protein in stock feed, fed straight to animals, is less
expensive than traditional antibiotic production.
But, this practice raises many bioethics issues, because the result is
widespread, possibly needless use of antibiotics which may encourage
expansion of antibiotic-resistant bacterial strain.
• Flowers: There is extra to agricultural biotechnology than just
hostility disease or civilizing food quality. There is some simply
aesthetic application and an example of this is the use of gene
recognition and transfer techniques to improve the color, smell,
size and other features of flowers.
Similarly, biotech has been used to make improvement to other
common ornamental plants, in particular, shrubs and trees. Some
of these changes are similar to those made to crops, such as
enhancing cold confrontation of a breed of tropical plant, so it can
be grown in northern gardens.
• Biofuels: The agricultural industry plays a big role in the
biofuels industry, as long as the feedstock’s for fermentation and
cleansing of bio-oil, bio-diesel and bio-ethanol is concerned.
Genetic engineering and enzyme optimization technique are
being used to develop improved quality feed-stocks for more
efficient change and higher BTU outputs of the resulting fuel
products.
High-yielding, energy-dense crops can minimize relative costs
associated with harvesting and transportation (per unit of energy
derived), resulting in higher value fuel products.
• Plant and Animal Reproduction:
Enhancing plant and animal behavior by traditional
methods like cross-pollination, grafting, and cross-
breeding is time-consuming. Biotech advance let for
specific changes to be made rapidly, on a molecular level
through over-expression or removal of genes, or the
introduction of foreign genes.

The last is possible using gene expression control

mechanism such as specific gene promoters and
transcription factors. Methods like marker-assisted
selection improve the efficiency of “directed” animal
breeding, without the controversy normally associated
with GMOs. Gene cloning methods must also address
species differences in the genetic code, the presence or
absence of introns and post-translational modifications
such as methylation
 • Pesticide Resistant Crops: Not to be mystified with pest-
resistance, these plants are broadminded of pesticides, allow
farmers to selectively kill nearby weeds with no harming their crop.
The most well-known example of this is the Roundup-Ready
technology, urbanized by Monsanto.
First introduced in 1998 as GM soybeans, Roundup-Ready plants
are unaffected by the herbicide glyph sate, which can be applied in
copious quantity to get rid of any other plants in the field. The profit
to this is savings in time and costs associated with conservative
tillage to reduce weeds, or multiple applications of different types of
herbicides to selectively eliminate exact species of weeds. The
probable drawbacks include all the controversial arguments against
GMOs.
 • Nutrient Supplementation: In an attempt to get better human
health, mainly in immature countries, scientists are creating
hereditarily distorted foods that hold nutrients known to help fight
disease or starvation. An example of this is Golden Rice, which
contain beta-carotene, the forerunner for Vitamin A manufacture in
our bodies. People who eat the rice create more Vitamin A, and
necessary nutrient lacking in the diets of the poor in Asian
countries.
Three genes, two from daffodils and one from a bacterium, proficient
of catalyzing four biochemical reactions, were cloned into rice to
make it “golden”. The name comes from the color of the transgenic
grain due to over expression of beta-carotene, which gives carrots
their orange color.
 • A biotic strain confrontation: A lesser quantity of
than 20% of the earth is arable land but some crops have
been hereditarily altered to make them more liberal of
conditions like salinity, cold and drought. The detection of
genes in plants in charge for sodium uptake has lead to
growth of knock-out plants able to grow in high salt
environments. Up- or down-regulation of record is usually
the method used to alter drought-tolerance in plants.
Corn and rapeseed plants, capable to thrive under lack
conditions, are in their fourth year of field trials in
California and Colorado, and it is predictable that they’ll
reach the marketplace in 4-5 years.
 Application of Biotechnology in Food Processing
 • Food processing is a process by which non-palatable and easily
perishable raw materials are converted to edible and potable foods
and beverages, which have a longer shelf life. The method, by which
the microbial organisms and their derivatives are used to increase
the edibility and the shelf life of foods, is known as fermentation.
Almost one-third of the diet in the whole world consists of fermented
food. Hence the process of fermentation must be carefully monitored
especially in rural areas as improper method of fermentation may
cause contamination of food thereby, affecting the health of the
people. Fermentation is also used in preparing microbial cultures,
food additives, preservatives, etc.
 • Biotechnology has a major application in the food sector. It helps in
improving the edibility, texture, and storage of the food; in
preventing the attack of the food, mainly dairy, by the virus like
bacteriophage; producing antimicrobial effect to destroy the
unwanted microorganisms in food that cause toxicity; to prevent the
formation of mycotoxins; and degradation of other toxins and anti-
nutritional elements present naturally in food.
 • Biotechnology also plays a very important role in protein
engineering. In this, favourable enzymes of the microorganisms,
which are responsible for the improved fermentation, are produced
commercially at a large scale by culturing the microorganisms in
tanks, etc.
 • Fermented foods have traditionally been known for their better
flavour, texture and nutritional value. Their high nutritional content
led an interest in development of more high yielding strains for
obtaining better quality products. Most fermented foods are produced
by solid state fermentation.
Some examples of fermented foods are cheese, idli , dosa, buttermilk
etc. Below are the production processes for some of these fermented
foods. The basic processes remain the same for these fermented food
production but the temperatures and detailed procedures differ from
place to place.
 Yoghurt:

Microorganism: Lactobacillus bulgaricus and Streptococcus

thermophilus (1:1 ratio).
 Buttermilk:

Microoganism: Streptococcus lactis and Streptococcus

cremoris, Lecuconostoc cremoris.
 Cheese:

Microorganism: Streptococcus lactis, Streptococcus cremoris,

Lactobacillus lactis for curd formation Penicillium roquefortii, P.
cammebertii for ripening.
 Application of Biotechnology in Environment
 The use of Biotechnology for solving environmental problems
and ecosystem is known as Environmental Biotechnology. It is
applied and is used to study the natural environment.
 According to the international Society for environmental
Biotechnology the environmental Biotechnology is defined as
“an environment that helps to develop, efficiently use and
regulate the biological systems and prevent the environment
from pollution or from contamination of land, air and water”.
 There are five major different types of Applications of
Environmental Biotechnology. They are as follows:

Bio-marker:
• This type of Application of environmental Biotechnology
gives response to a chemical that helps to measure the level of
damage caused or the exposure of the toxic or the pollution
effect caused. In other word, Biomarker can also be called as
the Biological markers the major use of this applications helps
to relate the connection between the oils and its sources.
  Bio-energy:
• The collective purport of Biogas, biomass, fuels, and
hydrogen are called the Bioenergy. The use of this application
of Environment Biotechnology is in the industrial, domestic
and space sectors. As per the recent need it is concluded that
the need of clean energy out of these fuels and alternative
ways of finding clean energy is the need of the hour. One of
the pioneer examples of green energy are the wastes collected
from the organic and biomass wastes; these wastes help use
to over the pollution issues caused in the environment. The
Biomass energy supply has become a prominent importance
in every country.
 Bioremediation:
• The process of cleaning up the hazardous substances into
non-toxic compounds is called the Bioremediation process.
This process is majorly used for any kind of technology clean
up that uses the natural microorganisms.
 Biotransformation:
• The changes that take place in the biology of the
environment which are changes of the complex compound to
simple non-toxic to toxic or the other way round is called the
biotransformation process. It is used in the Manufacturing
sector where toxic substances are converted to Bi-products.
Monsanto Technology LLC v. Nuziveedu & Ors AIR 2019 SC 559
 Monsanto Technology LLC (Monsanto) had a registered patent no.
214436 for Nucleotide Acid Sequence (NAS) containing the
gene Bacillus thuringiensis (Bt gene). On insertion into DNA of
cotton seeds, NAS killed bollworms from inside the seed and
therefore reduced the dependence of farmers on insecticides and
pesticides.
 The dispute between Monsanto and Nuziveedu Seeds Limited
(Nuziveedu) started in 2016, when Monsanto issued proceedings in
the Delhi High Court for patent infringement. In its reply, Nuziveedu
filed a counter-claim challenging the validity of the patent.
 The trial court held that the patent was prima facie valid. Against
the order, both the parties appealed to the division bench of the Delhi
HC.
 This Court revoked the patent on the ground that the said invention
was not patentable subject matter under Section 3(j) of the Patents
Act, 1970 (the Act), which excludes from patentability “plants and
animals in whole or any part thereof other than micro-organisms but
including seeds, varieties and species and essentially biological
processes for production or propagation of plants and animals”.
 It opined that the product of Monsanto was more suitably protected
under the Protection of Plant Variety and Farmers’ Rights Act, 2001
(PPV). Both parties appealed the decision to the Supreme Court.
 On 8th January 2019, the SC remanded the matter to the
division bench holding that the Delhi HC was wrong in
deciding the validity of the patent merely on the basis of
prima facie examination. It held that the question of
validity of a patent is a mixed question of fact and law
and therefore evidence and expert testimony were to be
considered.
Patentability of micro-organisms
 Monsanto’s claim was that NAS is a micro-organism and hence
patentable under the Act. It argued that patent protection was
not being claimed for the plant, but for NAS, which satisfied all
the conditions of patentability. It was indeed a product, novel
(not anticipated by use or publication), non-obvious to a person
skilled in the art and was in fact capable of industrial
application. Since NAS did not occur in nature, it was a result
of human intervention and not an essential biological process.
 Nuziveedu, on the other claimed that NAS on its own was not
capable of industrial application. It was only after insertion
into the seed that it produced the desired result. It argued that
once NAS was introduced, it became an integral part of the
seed and there existed no known technology which could then
isolate it from the seed.
 Moreover, since the gene also got transmitted in the progeny of
the plant, it constituted an essential biological process. It also
submitted that since NAS could not reproduce on its own, it
was merely a chemical composition and not a micro-organism.
Thus, it was outside the purview of patent protection because of
Section 3 (j).
 The Supreme Courts’ Missed Opportunity
 Article 27.3 of the TRIPS agreement imposes an obligation on
every country signatory to the agreement to protect plant
varieties either under patent law or through an effective sui
generis law or a combination of both.
 A country is free to choose any one of these alternatives,
depending upon which one it believes to be more favorable to
protection of farmers’ and breeder’s rights. It is therefore an
important public policy decision.
 While India has chosen the second alternative, other countries
like U.S.A have opted for the first. Since the matter involved
such an important question of law relating to public policy, the
SC thus missed an excellent opportunity by remanding the
same, more so because it was well aware of the judicial errors
committed by Delhi HC. Also, the peculiar circumstances of the
instant case warranted that the Supreme Court exercise its
extra-ordinary jurisdiction.
 The clock was ticking as Monsanto’s patent was due to expire
on the 3rd of November, 2019. The Supreme Court also turned a
deaf ear toward the fact that lower courts are often in flagrant
disregard of the principle that intellectual property disputes
must be decided expeditiously.
 Conclusion
 The matter is currently pending before the High Court of
Delhi. Monsanto’s patent has already expired, leaving
Monsanto’s claim for injunction defunct. The only remedy
available to it now is damages, that is, if the NAS is held to
be patentable subject matter. Though the decision of the
Delhi HC may not have any significance for the immediate
parties, it would definitely establish the law for future
applications involving NAS-like inventions.