Bioprospecting and biopiracy hdt unit 4

Prepared By:
MOHAMMAD KHALID
(Assistant Professor)
Krishna Pharmacy College, Bijnor (UP)
1

Introduction
Concept of Bioprospecting
Why is it needed
Process of Bioprospecting
Who does bioprospecting
Added potential environmental impacts of Bioprospecting
Key issues & challenges
Lack of legal clarity
Greater sector involvement:
A comprehensive bioprospecting policy
23 April 2020 Krishna Pharmacy College, Bijnor

Introduction:
 Bioprospecting is the process of discovery
and commercialization of new products based on
biological resources.
 • Bioprospecting, also known as biodiversity
prospecting, is the exploration of biological
material for commercially valuable genetic and
biochemical properties.

Introduction continue……..
 In simple terms this means the investigation
of living things to see how they can be
commercially useful to humans.
 These resources or compounds can be
important for and useful in many fields,
including pharmaceuticals, agriculture,
bioremediation, and nanotechnology,
among others.
3 April 2020 Krishna Pharmacy College, Bijnor 4

Introduction continue……..
 Between 1981-2010, one third of all small
molecule new chemical entities approved by
the U.S. Food and Drug Administration (FDA)
were either natural products or compounds
derived from natural products.
 Despite indigenous knowledge being intuitively
helpful, bioprospecting has only recently begun
to incorporate such knowledge in focusing
screening efforts for bioactive compounds

Concept of Bioprospecting
Extreme environments, provide habitats for
“extremophiles”, organisms with unique
characteristics developed for survival.
The biological processes and materials
which enable these extremophiles to survive
in extreme temperatures, pressures, salinity
etc, and other unique conditions are sources
of great potential for scientific advancement
and commercial application.

7
3 April 2020
Krishna Pharmacy College, Bijnor
• These Enzymes derived from extremophiles
have been used in detergents, food processing,
cleaning, dyeing, medical diagnosis, skin
protection products, and forensics.
• Bioprospecting of marine environments is
conducted almost exclusively in regions at
extreme depths specifically around submarine
trenches, cold seeps, seamounts and
hydrothermal vents.
Concept of Bioprospecting…….

Examples

Why is it needed?
The underlying aim of bio prospecting is to find
new resources and products from nature that can
be used by humans.
Improving human health, through both medicine
and better nutrition are key focal areas.
It plays a dominant role in discovering leads for
drug development, since existing/known
compounds for developing drugs for human use
are limited.

Why is it needed……..
A study showed that between 1983 and
2003, almost two thirds of anti-cancer
agents being investigated as drug candidates
were derived from natural products..
Other related sectors, such as crop plant
biotechnology, screen natural resources for
useful traits, such as disease resistance.

Where?
Although bioprospecting can happen wherever there is
biodiversity, it tends to be focused where biodiversity is at its
richest, as this raises the chances of finding something useful.
Statistically, the chance of a successful “hit” is one in 10,000
for synthetic compounds and one in 30,000 or 40,000 for
natural products.
Extreme environments and unique ecological niches are also
good sources for diversity, such as Antarctica. Yet, only a tiny
fraction of the world’s biodiversity has actually been explored
and the richest areas of biodiversity tend to be in developing
countries.

Process of Bioprospecting
As a process, it generally consists of four phases:
Phase 1: on-site collection of samples;
Phase 2: isolation, charactisation and culture of
specific compounds;
Phase 3: screening for potential uses, such as
pharmaceutical or other uses; and,
Phase 4: product development and
commercialisation, including patenting, trials,
sales and marketing.

Who does bioprospecting?
Pharmaceutical, agribusiness (biotechnology,
seed, crop protection and horticulture), cosmetic
and personal care, fragrance, botanicals, and the
food and beverage industries.
The pharmaceutical and agri-business sectors
are more involved.

Added potential environmental impacts of
Bioprospecting
In situ experiments in and around the Deep
Seabed can introduce light and noise or change
water temperature, which, in-turn, can affect
procreation and the survival of organisms in
these areas.
Bioprospecting activities can also produce
pollution in the form of debris or discharge
from vessels and equipment.

Added potential environmental impacts of
Bioprospecting………..
Additionally, inadvertant movement of
organisms through disrupting currents or
discarding of scientific samples can lead to
biological contamination.
Finally, there is the usual possibility of
over-exploitation in harvesting organisms in
these regions and the flow on environmental
impacts.

Key issues & challenges
Conservation versus exploitation:
Conservation is not always the top priority
of nations, and some seek to make a quick
profit from their natural resources rather
than preserving them. As a result, the
biodiversity they wish to exploit is
disappearing.

Lack of legal clarity
There is a need for clearer, more specific rules
on how origins of samples and IK are
recorded and their benefits shared, both
nationally and abroad.
The commercial benefit should be accrue to
those who discovered the active ingredient or
the biotech company able to identify/ improve
on this key ingredient

Greater sector involvement:
Many sectors actively involved in
bioprospecting remain ignorant of the
regulations, and are committing biopiracy.
Education and participation in relevant
international and national discussions is
needed to ensure regulation across all sectors.

A comprehensive bioprospecting policy
Legislation and regulation: Appropriate
legislation and regulations are the basis for
implementation of the policy, and are needed in
order to make it enforceable. Probably the most
crucial issue to be addressed is regulation of
access to biological resources, and to the
associated knowledge.

A comprehensive bioprospecting
policy……..
Legislation and regulations should…..
(i) ensure that clear conditions and procedures govern
access to genetic resources,
(ii) make access subject to written agreement based on
prior informed consent and
(iii) require fair and equitable sharing of the benefits.
Enforcement is needed to ensure that the handling of
genetic resources, both by nationals and foreigners, is
consistent with the national policies and laws.

• Benefit Sharing Mechanisms:
A mechanism for benefit sharing should be developed.
Benefits should be distributed fairly and equitably among
all parties concerned, including local communities,
indigenous groups, universities, etc.
• Capacity Building:
Building technological capacity, including the capacity to
innovate, is important in order to increase the possibilities
to add value to genetic resources, thus generating greater
social and economic benefits.
Similarly, education and training are needed to encourage
the protection of biodiversity. Institutional development
should also be included in capacity building efforts.

Financing:
Obviously, sources of funding will have to be identified for
the development and implementation of the policy. Often, the
process of formulating a policy is as important as its contents,
since it can generate commitment and thereby facilitate
implementation.
Assessment or situation analysis: A sound assessment of
relevant aspects, notably the opportunities, needs, resources
and capacities of a country to make sustainable use of its
biological and genetic resources should be the basis for
developing an appropriate policy and for devising sound
strategies on bio prospecting and access. National capacity
should also be assessed in order to make optimal use of
existing opportunities.

Monitoring and evaluation:
Procedures for monitoring and evaluation
should be put in place, so that progress - or
the lack thereof- can be assessed.
Moreover, this will allow for adjustment of
policy goals and strategies as and when
needed.

Contents
Definition of biopiracy
History
TYPES OF BIOPIRACY
How does it happens?
Famous Cases
Why is There a Need to Stop Biopiracy ?
Actions Taken Against Biopiracy
Conclusion

Definition of biopiracy
The term biopiracy was coined by Pat Mooney, {co-founder of
RAFI (Rural Advancement Foundation International)}, to describe a practice
in which indigenous knowledge of nature, originating
with indigenous peoples, is used by others for profit,
without authorization or compensation to the indigenous
people themselves.
From the root words “bio” and “piracy”, biopiracy literally
means “the patenting of life.”
When biodiversity or related knowledge is collected
without permission from the owners of these resources and
then patented, it is known as biopiracy.

Definition…
It can be defined as (unauthorized or
uncompensated) appropriation and commercial
exploitation of genetic resources in Developing
Countries and/or traditional knowledge of
indigenous communities by corporations, mostly
from Developed Countries, which seek then
“monopoly control”, usually patents, over these
resources or inventions derived from these
resources.

• Biopiracy is the illegal appropriation of life
microorganisms, plants and animals (including
humans) and the traditional cultural knowledge
that accompanies it.
• It is illegal because, in violation of international
conventions and corresponding domestic laws, it
does not recognize, respect or adequately
compensate the rightful owners of the life forms
appropriated or the traditional knowledge
related to their propagation, use and commercial
benefit.

3500 years ago, Egyptian rulers began
bringing plants home after military
expeditions.
In the last century, the British Empire
instituted regular plant collections. During
the Voyage of the Beagle, Charles Darwin
simply took what interested him and
brought it home.

The Royal Botanical Gardens took rubber trees from
Brazil, and planted them in Southeast Asia. They
took cinchona seeds from Bolivia, in violation of
national law, and planted them in India.
More recently, during the mid-twentieth century,
Richard Schultes was able to befriend local shamans,
who allowed him to collect thousands of voucher
specimens of medicinal plants, hundreds of which
had never previously been identified taxonomically.

Traditional Knowledge Biopiracy:
 Genetic resources can be defined as “any living
material containing functional units of heredity”.
Genetic Resource Biopiracy:
 Traditional knowledge refer to indigenous communities,
comprising “knowledge, innovations and practices of
indigenous and local communities embodying traditional
lifestyle”.
 Traditional knowledge is based on experience and is usually
passed on through generations.

How does it happens?
 An inventor, claims their ‘intellectual property rights’ over a particular
product, usually by taking patent that protects their product by allowing the
inventor to prevent other people from making, using or selling the product
without permission.
 The inventor applies for a patent from the governments of the territories
over which he wants to assert his rights to prevent others from using his
invention, to apply for an international patent that will apply in as many
countries as the inventor chooses. This is all perfectly legal.
 The problem arises when the product is based on plants whose unique
properties are the result of years of breeding by farmers whose investment
and work is unacknowledged and unrewarded – stolen, in effect.
 In these cases the patent holders have failed to both obtain the farmer’s
permission – or Prior Informed Consent (PIC) – and agree adequate
compensation.

Famous Cases
Neem Tree (India)
Basmati Rice (India)
Turmeric (India)
Kava (Fiji and vanuatu)
Quinoa (Andes)
Banaba and other medicinal plants (Philippines)
Bitter gourd (Thailand)
Ilang-Ilang (Philippines)
Rosy Periwinkle (Madagascar)

Examples:
Neem:
 Botanical name is Azadirachta indica.
 Neem act as anti bacterial, anti parasitic, anti fungal, anti
protozoal and anti viral thus helps in protection from all the
microorganisms, which are always ready to invade in our body
causing serious ailments.
 The neem tree is indigenous to the Indian subcontinent and parts
of South and Southeast Asia.
 In 1994 the multinational corporation W.R. Grace and the US
Department of Agriculture was granted a patent by the EPO
“covering a (special) method for controlling fungi on plants by
the aid of a hydrophobic extracted neem oil” that is diluted with a
certain percentage of water.

A member of the European Parliament of the Green Party joined by
the Research Foundation for Science, Technology, and Natural
Resource Policy from India and the International Federation of Organic
Agriculture Movement (IFOAM) based in Germany filed an opposition
to this patent.
The opponents claimed “that the fungicidal effect of hydrophobic
extracts of neem seeds was known and used for centuries on a broad
scale in India” both in traditional medicine to fight human skin fungi
and in agriculture to protect crops. The opponents also claimed that
the invention lacked the two major patentability requirements “novelty”
and “inventive step.
The EPO withdrew the patent grant in 2000, finding it lacked novelty.

Basmati rice:
 India is the second largest producer of rice after China.
 In 1993, Basmati rice attracted the highest premium because it
is very-long grained rice, with an aroma of its own which
enhances the flavors it’s mixed with.
 Basmati rice means the "queen of fragrance or the perfumed
one." This type of rice has been grown in the foothills of the
Himalayas for thousands of years.
 In late 1997, an American company RiceTec Inc, was granted a
patent by the US patent office to call the aromatic rice grown
outside India 'Basmati'. RiceTec Inc, had been trying to enter
the international Basmati market with brands like 'Kasmati' and
'Texmati' described as Basmati-type rice with minimal success.

The Council of Scientific and Industrial Research in India
[CSIR] challenged the rice patent.
After reexamination, the USPTO disallowed all the
physical characteristic claims.
The Indian government, a strong advocate of
geographical indications for food products, claimed victory
when the USPTO limited the number of claims granted to
RiceTec.
 RiceTec still has a patent and can still call its rice
Basmati.

Turmeric:
 Botanical name is Curcuma longa.
 In Ayurvedic medicine, turmeric has been used to aid digestion
and liver function, relieve arthritis pain, and regulate menstruation.
Turmeric has also been applied directly to the skin for eczema and
wound healing. Today, turmeric is used for conditions such as
heartburn, stomach ulcers, and gallstones. It is also used to reduce
inflammation, as well as to prevent and treat cancer.
 In 1995 the USPTO granted two Indian nationals at the University
of Mississippi for a “method of promoting healing of a wound in a
patient” by “administering a wound healing agent consisting of an
effective amount of turmeric powder”. The patent applicants
recognized the traditional use of turmeric in India but claimed that
they had been the first who administered.

This patent was challenged by the Indian Council for
Scientific and Industrial Research (“CSIR”) in 1996 on the
ground of prior art.
In the re-examination process the CSIR claimed “that
turmeric has been used for thousands of years for healing
wounds and rashes and therefore its medicinal use was not
novel”.
The USPTO upheld these objections and revoked the patent
in its entirety in April 1998. It based its decision on the
grounds of lacking novelty and obviousness of the invention.

Why is There a Need to Stop Biopiracy ?
Because of the patenting of biological
materials, the locals of the affected countries
would have less, if not none at all, access to
those new developments which is possibly their
original idea or discovery in the first place.
Those who are granted the patents would have
exclusive rights to their “inventions” and can
therefore raise the prices if they choose to.

• By having the license to do whatever they please,
patent owners can also hinder the local production.
This can have a large impact on the livelihood of
those concerned; the ones who are normally free to
use as much of the crops or produce as they need
are banned from manufacturing such goods.
Therefore, if those goods are a source of income for
them, they would lose much of the profits that they
usually get.
• Patent owners can prohibit farmers from breeding
such plant and animal varieties as well. In doing so,
they have also taken away privileges that the
indigenous people have rightfully earned
themselves.

• As the patent owners benefit from the
information and materials that they do
not actually “own”, the indigenous
people who have long been developing
and cultivating these resources get
nothing.
• They do not have a choice unless
knowledge of the materials has been
proven traditional and the patent has
been canceled

Actions Taken Against Biopiracy
 Bio prospecting Contracts
• To minimize the detrimental effects of biopiracy
and to “legalize” such transactions, there is the
so-called “bio prospection contract.” With this
contract, economic income or royalties would be
provided to the local communities concerned
while the patent owners generate earnings.
However, the fairness of these contracts has been
a subject of debate.

 Patent Law:
• In the United States, patent law is used to protect
“isolated and purified compounds” that were newly
discovered and invented. A patent is the exclusive
rights given to a person so that others will be
prohibited in making, using, or selling the invention.
• One common misunderstanding is that
pharmaceutical companies patent the plants they
collect. While obtaining a patent on naturally
occurring organisms is not possible, patents may be
taken out on specific chemicals isolated or developed
from plants.

 Convention on Biological Diversity
• In 1993 Convention on Biological Diversity
(CBD) establishes sovereign national rights
over biological resources and commits
member countries to conserve them, develop
them for sustainability, and share the benefits
resulting from the use. Sustainable use of
biological resources means finding new drugs,
crops, and industrial products, while
conserving the resources for future studies.
Sovereign rights would be tempered by
providing access to genetic resources, in
exchange for a share of the benefits, including
access to biotechnology.

Conclusion
Biopiracy if not stopped, will continue to erode the
biological/genetic resources of the developing countries as well
as denying them fair and equitable benefits derived from their
losses.
There is need to strengthen the policy, institutional and legal
frameworks in the developing countries particularly those in
Southern Africa which to date have no national legislation on
ABS.
ABS legal regime should be flexible and tailored made to a
particular country’s needs.
Use of the Capacity Building Training Module on Policy and
Law for Biological/Genetic Resources

 Beattie AJ, Hay M, Magnusson B, de Nys R, Smeathers J, Vincent JF (May
2011). "Ecology and bioprospecting". Austral Ecology. 36 (3): 341–
356. doi:10.1111/j.1442-9993.2010.02170.x. PMC 3380369. PMID 22737038.
 ^ Saslis-Lagoudakis CH, Savolainen V, Williamson EM, Forest F, Wagstaff SJ, Baral SR,
Watson MF, Pendry CA, Hawkins JA (September 2012). "Phylogenies reveal predictive
power of traditional medicine in bioprospecting". Proceedings of the National Academy of
Sciences of the United States of America. 109 (39): 15835–
40. Bibcode:2012PNAS..10915835S. doi:10.1073/pnas.1202242109. PMC 3465383. PMI
D 22984175.
 Bastuck.C. ‘Biopiracy’ and Patents – Developing Countries’ fears are exaggerated.,
Master Thesis for LLM by coursework and dissertation in International Law, Remshalden,
08 April 2006
 Bioprospecting/Biopiracy and Indigenous Peoples’, ETC Group, November 30,
 KOHLS.M., BLACKBEARD OR ALBERT SCHWEITZER: RECONCILING
BIOPIRACY, 2007, Chicago-Kent Journal of Intellectual Property.
 Shubha Ghosh, Traditional Knowledge, Patent and New Mercantilism, 85 J. Pat. &
Trademark Off. Soc’y.

 http://www.medindia.net/alternativemedicine/turmeric.asp#ixzz1Lyz3j3Zl
 http://www.nytimes.com/2001/08/25/business/india-us-fight-on-basmati-rice-is-
mostly-settled.html?src=pm
 http://www.organeem.com/neem_tree.html
 http://www.primalseeds.org/biopiracy.htm
 http://www.rediff.com/money/2008/dec/24the-controversy-over-basmati-...
 http://www.turmeric.co.in/turmeric_ayurvedic_use.html.
 www.merriamwebster.com/dictionary/ecoterrorism.
 www.unl.edu/eskridge/ecoterrorism.html.

Bioprospecting and biopiracy hdt unit 4

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