BIOTECHNOLOGY AND PATENT LAW

ALI KHAN

A1191113227

Semester 9 Section D B.A.LL.B (H)

Amity Law School

Amity University Noida, AUUP

 INDEX

BIOTECHNOLOGY

DEFINITION

THE LINK (The Technological Value of Biodiversity for

Biotechnology)

BENEFITS OF BIOTECH
PLANT BIOTECHNOLOGY
CONVENTION ON BIODIVERSITY
 AKNOWLEDGEMENT

The success and final outcome of this project required a lot of guidance and assistance from
many people and I'm extremely fortunate to have got this all along the completion of our project
work. Whatever I have done is only due to such guidance and assistance and I would not forget
to thank them.

I respect and thank Ms Mini Srivastava, faculty for , Amity Law School Noida, for giving us an
Biotechnology and Patent Law opportunity to do the project work and providing us all support
and guidance which made us complete the project on time.

.
BIOTECHNOLOGY

DEFINITION

• The term biotechnology is an abridgement of the term biological

technology. It implies both biochemical engineering and
biomedical engineering.
• It is defined as the application of scientific and engineering
principles to the production of biological organisms and to the
processing of materials by biological agents to provide goods and
services for the benefit of man.
• Biotechnology is defined as the use of biological processes for the
development of products such as food items, enzymes, drugs and
vaccines.
• In these cases biological processes are used to alter raw food
products to produce more stable foods.
• At present the term biotechnology is used to describe the process
of creating genetically engineered foods that contain genes
modified by modern technologies.
• CBD defines biotechnology as any technological application that
uses biological systems, living organisms or derivatives thereof, to
make or modify production processes for specific use.
• This does not however, include the traditional cross breeding of
plants to improve their yields, taste, or quantity and increase their
activity to withstand pests, diseases, and inhospitable
environments.
• Biotechnology however includes the new DNA techniques,
molecular biology, gene manipulation, and DNA typing and
cloning of plants and animals.

Strong link btw ability of a country to conduct state of the art applied
research and the strength of its economy. Industrial development based
on the applied life sciences including biotech is on the way to becoming
a key source of economic growth.
Biotechnologies are both old and new. Divides biotechnologies into 3
generations
First generation includes traditional technologies like beer brewing and
bread making.
The second begins with the microbiological applications developed by
Louis Pasteur culminating into mass production by fermentation of the
antibiotics. Tissue culture and modern plant and animal breeding.
Third generation biotechnologies include the various genetic engineering
techniques for transferring DNA from one life form to another to make
transgenic organisms expressing new and useful traits.

THE LINK (The Technological Value of Biodiversity for

Biotechnology)

 Biotechnology uses biological organism or their constituents to

transform inputs into commercial outputs.
 Biotechnology provides an opportunity to convert bio resources
into economic wealth.
• Biodiversity constitutes the raw material of the biotechnology
industry and the modern science of biotechnology is relevant to
various areas of agriculture including crops, animals, fisheries,
agro forestry and agro processing.
 • Undiscovered biogenetic resources in the richly endowed
developing word had massive economic potential
• Biotechnology is dramatically changing the structure and function
of biological systems.
• The last 20 years have seen the emergence of new technologies
that hold the prospect of new advances which will greatly benefit
medicine, and public health.
• Some biological products are genetically manipulated in order to
develop new commercial products, optimizing production and
ensuring the integrity of the product.
• The application of biotechnology can result in new ways of
producing existing products, the use of new inputs, and also in the
production of new products.
• In the former category falls gasoline, produced from ethanol,
which is in turn produced from sugar. In the latter category,
mention may be made of insulin, produced using recombinant
DNA technology.

BENEFITS OF BIOTECH

MEDICINES
• In the area of human health and welfare, biotechnology helps to
treat nutritional deficiencies in human growth hormones to produce
human insulin to treat diabetics, TPA to treat blood clots and heart
attacks, and vaccines for Hepatitis B and other diseases.
• Thus we need to see the potential economic, social and political
and ethical impact of this burgeoning field on society.
• Biotechnology has furthered our understanding of life. We now
assess the ability to manipulate genetic information and thus living
organisms.
 • The role of biotech in the area of HIV/AIDS research and cancer
research is well known.
• 5 genetically engineered pharmaceuticals – human insulin, human
growth hormone, alpha interferon, the hepatitis B vaccine, tissue of
plasminogen activator

PLANT BIOTECHNOLOGY

• Biotechnology is employed in the field of plant biotechnology and

thereby agricultural biotechnology.
• The food demands of a growing world population are estimated to
double by the year 2030 and plants directly or indirectly provide
almost all the food for man and animals.
• As pressure mounts to feed an expanding world population, there
is a need to grow more and more food, while causing less damage
and pollution to the environment.
• Plant biotechnology will have a major impact on agricultural
inputs as also on the agricultural products.
• The properties of crops can now be changed more efficiently in
defined ways to meet specific targets set by man to improve
production, products, industrial processes and the environment.
Already resistance to viruses where none previously existed has been
created in plants and animals

providing an opportunity to reduce the amounts of toxic insecticides

used in agriculture.

• The method of genetically modifying plants by inserting purified

genes is, however the subject matter of controversy. Whether foreign
genes and products derived from plants possessing them, may be
harmful to human beings, organisms in other food chains, or to the plant
species and their wild relatives to which such genes may pass.

• DNA techniques are being used to develop new plant varieties that
will be source of foods, such as fruits, vegetables and grains. These
techniques make it possible to introduce specific modifications in plants,
including modifications that introduce substances into plants that could
not otherwise be introduced by traditional methods.

• To ensue the safety of the resulting foods and to foster innovation

it becomes necessary to ensure, before foods from such plants are ready
to enter the market, that there is an agreed bass to evaluate the safety of
whole foods and animal feeds derived from new plant varieties.

• A good safety assessment approach should address imp food safety

tissues that pertain to the host plant, donor organisms and new
substances that have been introduced into the foods.

• There is a pressing need to assist developing countries in building

a regulatory infrastructure for scrutiny and review of recombinant
products, particulary transgenic plants.
• This leads us to the larger question of safety of genetically
engineered foods, labelling for public health and religious practices,
environmental safety, consumer safety etc.

• Food crops are being developed to resist pests and diseases, to

resist adverse weather conditions, to tolerate chemical herbicides and to
have improved characteristics for food processing.

• Many of the recent biotechnology developments such as genetic

mapping, diagonstics and propagation by tissue culture are already being
exploited for commercial gain.

• It is said that development and commercialization worldwide is

dominated by multinational seed companies and a likely consequence in
developed countries is that a major part of germplasm production in the
major crops, will be controlled by relatively few companies.

• The consequence for agriculture in developing countries will be

that this will limit advances in production of major crops, if access is not
granted to products of the multinational seed companies.

• Also, MNCs will acquire monopoly rights by patenting genes,

germsplasm, seeds and everything else resulting from the application of
biotechnology.

• Even in the field of biotech drugs, many of the new drugs are so
costly as to be inaccessible to the common man.
• It is reported that one year’s supply of Enbrel, a drug for arthritis
costs more than USD 14,000.

• Just as generic substitutes have established a foothold in markets in

the USA, thanks to the very low cost at which they offer generic
alternatives, generic drug makers plan to market generic versions of
biotech drugs.
 CONVENTION ON BIODIVERSITY
• The Convention on Biodiversity has 42 articles in all.
• Came into force in 1999 and now has 188 parties.

OBJECTIVES
The main objectives may be set out as:
• the conservation of biodiversity,
• the sustainable use of its components, and
• the fair and equitable sharing of the benefits arising out of the
utilization of the genetic resources, including appropriate access to
genetic resources and appropriate transfer of relevant technologies,
taking into account the right over those resources and to
technologies and appropriate funding.

GUIDING PRINCIPLES
• Convention assumes human use and benefit as the fundamental
purpose for conserving biodiversity, limited only by the
requirement of sustainability and the need to benefit future
generations.
• Preamble recognizes the intrinsic value of biological diversity.
• need for its conservation in natural habitats, - not just how to
prevent individual species from becoming extinct, provision of
nature reserves and other protected areas for conservation.
• that these genetic resources will be available through generations,
• that the nations have the sovereign rights over their genetic
resources,
• that conservation efforts need to be compensated,
• and that communities share the benefits that accrue from the use of
these resources.

INTERDEPENDENT CHARACTER
• The first of Article 1 reflects the policy laid down by UNEP,
stressing the interdependent character of conservation and rational
use of resources.
• Thus, reference to conservation of biodiversity must be read in
conjunction with the sustainable use of its components- a
qualification insisted on by developing countries during
negotiations.
• This is the heart of the convention, establishing the framework and
context for the subsequent articles.

SUSTAINABLE USE AND IT’S CONCEPT

• Article 2, use of the terms, does not define ‘conservation’, while
‘sustainable use’ is defined in general terms.
• It inter alia says that the use of the components of biological
diversity should not reach to the long-term decline of the biological
diversity, thereby maintaining its potential to meet the needs and
aspirations of the present as well as future generations.
• In this connection, it may be stated that the avoidance of long-term
decline will depend on how will the environmental impact
assessment and in situ and ex situ conservation operate and how
they operate in practice.

Concept:
• It implies a duty to preserve biodiversity to the extent that the
resource has to be maintained in order to ensure that there is no
long-term decline.
• The needs and aspirations of future generations to be considered
and the principle of intergenerational equity to be taken into
account.
• Given that the resource is biological diversity, it implies that it
must be managed on a biological basis as opposed to a political
one.
• Due to the interdependence of the biological system, management
of living resources cannot simply focus on the particular species
being used, it must also consider the impact on other species and
the ecosystem as a whole.
• It also implies duty to undertake research to develop a better
understanding of the biological systems, a duty to monitor both the
use and ecosystem, so as to ensure that the use remains sustainable.
• Article 3 lays down the ‘principles’. It states that countries have
the sovereign right own environmental policies.
• However, sovereignty is not unlimited or absolute.
• It is subject to the requirements of conservation and sustainable use
set out in the other articles of the convention. (Articles 6 – 9) and
to the customary obligation not to cause damage to the
environment of other countries or to areas beyond their national
jurisdiction.

IN SITU-EX SITU CONSERVATION

• In Situ conservation means the conservation of ecosystems and
natural habitats and the maintenance and recovery of viable
populations of species in their natural surroundings and, in the case
of domesticated or cultivated species, in the surroundings where
they have developed their distinctive properties.
• Ex situ conservation means the conservation of components of
biological diversity outside their natural habitats.
• Article 8 call for in situ Conservation while Article 9 deals with ex
situ conservation.

IN SITU
• Article 8 calls for measures to establish a system of protected
areas, and develop guidelines for their management;
• Establish means to regulate, manage or control risks associated
with the use and release of biotechnology which are likely to have
adverse environmental effects, also taking into account risks to
human health.
• Subject to national legislation, efforts be made to preserve and
maintain knowledge and practices of indigenous and local
communities.
• The application of such knowledge and innovations must also be
promoted and
• Equitable sharing of benefits arising from the utilization of such
knowledge, innovations and practices must be encouraged.
• Article 8 embodies the principal obligations for the conservation of
biological diversity.
• These include:
(a) protected areas;
(b) regulation and management of biological resources both inside
and protected areas;
(c) protection of ecosystems, natural habitats, and viable
population of species;
(d) environmentally sound and sustainable development in area
adjacent to protected areas;
(e) rehabilitation of degraded areas and recovery of species;
 (f) control of use and release of modified living organisms where
they are likely to have adverse
environmental impacts;
(g) protection of threatened species and populations; and
(h) regulation or management of processes and activities which
threaten biodiversity.
• Protected areas are often vulnerable to threats and accidents
emanating from outside, such as resource explorations and
chemical contamination.
• Extinction rates increase with human density in the surrounding
areas because of increased hunting pressures.
• Article 8, therefore, requires the management of biological
resources both within and outside of them, so as to insure that the
development in areas adjacent to protected areas does not
undermine the capacity of those protected areas to conserve
biodiversity.
• Article 8(c) requires that the parties regulate or manage use of
‘biological resources’.
• Article 8 (d) calls upon parties to regulate activities which have
significant impacts upon the conservation and sustainable use of
biodiversity. For instance, Article 8(d) which calls for promotion
of the protection of the ecosystems, can only be achieved if it is
carried out on a biological basis as opposed to a political one.
• Control of products of biotechnology is called for in Article 8(g)
and for the establishment of regulation and control release of
Living Modified Organisms (LMOs) into the environment which
could affect adversely the conservation and sustainable use of
biodiversity, taking into the risks to human health.
• Article 8(k) deals with protection of threatened species and the
overall ecosystem approach or philosophy adopted by the
convention.
• Although, the convention does not use the term ‘preservation’, It is
nonetheless implicit in the meaning of ‘conservation’ as used
(Article 8[ j ]). It calls for the preservation of the knowledge of
indigenous and local communities.

EX_SITU CONSERVATION

• Ex situ measures may include seed banks, sperm and ova banks,
culture collections (e.g., of plant tissues, artificial propagation of
plants and captive breeding of animals.
• Key issues here include the short and long-term validity of both
captive and wild populations, the relationship between the two;
including the use and efficacy of reintroductions of species into
areas in which they have become extinct, and to bolster declining
natural populations.
 Bibliography

https://www.springer.com/
https://libraryguides.law.pace.edu/

Biotechnology and Intellectual Property Rights

Legal and Social Implications

Authors: Singh, Kshitij Kumar