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IPR on Marine Biogenetic Resources
 Bioprospecting to Biodiscovery & Question of
Ownership
Dr. Sabuj Kumar Chaudhuri
Assistant Professor
Department of LIS
University of Calcutta
Email-sabooj_c@yahoo.co.in
Lecture delivered in Refresher Course in
Environmental Sc. in UGC-ASC, University of
Calcutta18-03-2014
1. Property, Types, IP , IPR & its categorization
2. Landmark patents: Microorganism, Plant and animal
3. India’s International Obligations
4. Few Definitions, Criteria for Patent & PBR, Few Amendments
5. Limits of Marine Zonation
6. Deep Sea & Various Deep Seabed Ecosystems & MGR
7. Hydrothermal Vents & Species Diversity (Video)
8. Bioprospecting, Bioprospecting of MGR
9. Biodiscovery from MGR & Patents & Indian Initiatives
10. Legal Instruments
11. Question of Ownership & Few Facts
12. Current Status ,Few Bioprospectors & Huge Investments
13. Debate on ownership continues & Fill in the Blanks
14. Concluding Remarks
Lecture delivered in Refresher Course in
Environmental Sc. in UGC-ASC, University of
Calcutta18-03-2014
What is property?
What is Intellectual property (IP)?
What is Intellectual Property Rights(IPR)?
Lecture delivered in Refresher Course in
Environmental Sc. in UGC-ASC, University of
Calcutta18-03-2014
The term is extraordinarily difficult to answer.
Ordinary person defines property as ‘thing’ but attorney defines it as
‘right’.
It has two understandings :
Legal Understandings:
Property is the inclusion of rights of exclusive use and alienability
Economic Understandings:
Property includes all rights of individuals to valuable resources.
Lecture delivered in Refresher Course in
Environmental Sc. in UGC-ASC, University of
Calcutta18-03-2014
The tangible property includes physical objects such
as land, household goods, car etc.
The intangible property includes a list of products of
human intellect such as patents, copyright,
trademarks and industrial designs etc.
Lecture delivered in Refresher Course in
Environmental Sc. in UGC-ASC, University of
Calcutta18-03-2014
Intellectual property (IP) deals with the
creations of the human intellect and protects
the creations of the human mind, the human
intellect. This is why this kind of property is
called “intellectual property”. Intellectual
property is a cluster of legally recognized
rights associated with innovation and
creativity – the works of the mind, as against
physical products, land and other tangible
resources. Even though it is intangible,
intellectual property (IP) is often recognized
as personal property, to be sold and traded
like other forms of property.Lecture delivered in Refresher Course in
Environmental Sc. in UGC-ASC, University of
Calcutta18-03-2014
Intellectual property rights (IPR) are the
rights awarded by society to individuals or
organizations principally over Intellectual
Property i.e., creative works: inventions,
literary and artistic works, and symbols,
names, images, and designs used in
commerce. They give the creator the right
to prevent others from making
unauthorized use of their property for a
limited period.Lecture delivered in Refresher Course in
Environmental Sc. in UGC-ASC, University of
Calcutta18-03-2014
IPR
Industrial Property
Patent
Industrial Design
Trademark
Trade Secret
Geographical Indications (GI)
Utility Models
Artistic & Literary Property
Copyright
Sui generis System (“Latin Word means “of its own kind”)
Database
Integrated Circuit
Plant Breeders’ Right (PBR)Lecture delivered in Refresher Course in
Environmental Sc. in UGC-ASC, University of
Calcutta18-03-2014
3 Landmark Patents
Microorganisms
First product patent (US
Patent No.-141072 dated July
22, 1873) on living matter was
granted to L. Pasteur by the
USPTO for his invention of
anomalous yeast culture.
However some people believe
that US patent granted to Anand
Chakrobarty for his invention of
Oil eating bacteria in 1980 was
the first patent on
microorganisms.Lecture delivered in Refresher Course in
Environmental Sc. in UGC-ASC, University of
Calcutta18-03-2014
Plants
In 1930, the United States
began granting patents for
plants and in 1931, the first
plant patent was issued to
Henry Bosenberg for his
climbing, ever-blooming rose
by the USPTO (Patent No.-
PP00001 dated 18th August,
1931). Under patent law, the
inventor of a plant is the person
who first appreciates the
distinctive qualities of a plant
and reproduces it asexually.Lecture delivered in Refresher Course in
Environmental Sc. in UGC-ASC, University of
Calcutta18-03-2014
Animals
Researchers at Harvard Medical School in
the early 1980s produced a genetically
modified mouse (oncomouse) that was
highly susceptible to cancer, by introducing
an oncogene that can trigger the growth of
tumors. Harvard College sought patent
protection in the United States and several
other countries. The USPTO in 12th April,
1988 granted a patent no. 4,736,866 to
Harvard College claiming "a transgenic non-
human mammal whose germ cells and
somatic cells contain a recombinant
activated oncogene sequence introduced
into said mammal.
Lecture delivered in Refresher Course in
Environmental Sc. in UGC-ASC, University of
Calcutta18-03-2014
India’s International Obligations
 India is a member of WTO (World Trade
Organization) and many international agreements
and conventions. Thus India is bound to comply with
all these agreements and conventions through a series
of acts and ratifications to discharge of her
international obligations in the field of intellectual
property rights regarding the commercial uses of the
biological resources. The key set of acts for the IP
protection of biodiversity and biotechnology
inventions and ratifications to many international
agreements are:
Lecture delivered in Refresher Course in
Environmental Sc. in UGC-ASC, University of
Calcutta18-03-2014
Contd…
International Agreements/Convention India’s Compliance
India is WTO signatory & ratified TRIPS
agreement & Budapest Treaty
Indian Patent Act (IPA), 1970 and its
amendments in 1999, 2002 and 2005
India joined Conventions of Biological
Diversity (CBD)
Biodiversity Act, 2002
India followed UPOV (International
Union for the Protection of New
Varieties of Plants) of 1991
The Protection of Plant Varieties and
Farmer’s' Rights (PPV & FR) Act, 2001
India ratified International Treaty On
Plant Genetic Resources For Food And
Agriculture (PGRFA Treaty) on 10th June
2002
Seed Act, 2004
TRIPS agreement Geographical Indications of Goods
(Registration and Protection) Rules,
2002
India ratified both Paris Convention and
Patent Cooperation Treaty (PCT) in 1998
India changes its patenting procedures &
rules
Lecture delivered in Refresher Course in
Environmental Sc. in UGC-ASC, University of
Calcutta18-03-2014
Few Definitions
The Biodiversity Act, 2002 of India-- “Biological
Diversity” means the variability among living
organisms from all sources and the ecological
complexes of which they are part and includes diversity
within species or between species and of ecosystems.
“Biological Resources” means plants, animals and
microorganisms or parts thereof, their genetic material
and by- products with actual or potential use or value
does not include human genetic material [Chapter I
Clause 2(b) and 2(c)].
Lecture delivered in Refresher Course in
Environmental Sc. in UGC-ASC, University of
Calcutta18-03-2014
Criteria for obtaining Patent & PBR
 Criteria for obtaining patent
Novelty (new characteristics which are not “prior art”),
Non-obviousness (an inventive step not obvious to one skilled in the field),
and
Utility (as used in the US) or industrial applicability (as used in the UK) or
susceptible for industrial application (as used in the Europe) .
*Deposition of a microorganism at a recognized “international depositary
authority” (The Budapest Treaty ) if the patent is related to microorganisms.
 Criteria for obtaining PBR
New in the sense that they must not have been commercialized prior to certain
dates established by reference to the date of application for protection,
Distinct from the existing, commonly known varieties,
Uniform or sufficiently homogenous and
Stable (i.e. subsequent plantings of the variety must demonstrate the same
characteristics as the parent crop).
Lecture delivered in Refresher Course in
Environmental Sc. in UGC-ASC, University of
Calcutta18-03-2014
Few Amendments
 Process for curative, prophylactic, diagnostic, therapeutic or
other treatment of plants (to render them free from diseases and
pests).
 Process / method of preparing Genetically Modified Organisms
 The living entity of artificial origin such as micro-organism,
vaccines are considered patentable.
 The biological material such as recombinant DNA, Plasmids and
processes of manufacturing thereof are patentable provided they
are produced by substantive human intervention.
 The processes relating to micro-organisms or producing
chemical substances using such micro-organisms are patentable.
It may however be noted that it is not possible to get a plant
patent in India. New plant varieties can be protected through
registration under the ‘Protection of Plant Varieties and Farmers’
Rights Act’ of 2001. The most important thing to observe is that
patents are possible for many aspects of a plant and its
utilization except the plant itself.
Lecture delivered in Refresher Course in
Environmental Sc. in UGC-ASC, University of
Calcutta18-03-2014
Limits of Maritime Zonation
Lecture delivered in Refresher Course in
Environmental Sc. in UGC-ASC, University of
Calcutta18-03-2014
Deep Sea
1. 60% of our planet is covered by water over 1,600m deep, and nearly half the world's
marine waters are over 3,000m deep.
2. The deep sea starts where the sunlight starts to fade, around 200m below the surface
of the ocean.
3. A twilight zone extends down to 1,000m, after which almost no light penetrates. The
water is cold, reaching 1-2ºC, and contains very little oxygen.
4. And the weight of the water above creates enormous pressures, up to 1,000 times that
at the surface.
5. With no sunlight, almost plants cannot grow in the deep sea. And while animals and
bacteria have been found wherever people have looked, we know very little about
these dark, cold depths.
6. More people have travelled into space than have ventured into the deep.
Lecture delivered in Refresher Course in
Environmental Sc. in UGC-ASC, University of
Calcutta18-03-2014
The high seas are comprised of all parts of the sea that are
not included in the exclusive economic zone, in the
territorial sea or in the internal waters of a State.
COMPARATIVE SIZES OF THE VARIOUS MARITIME ZONES
Areas of the Earth covered by the Oceans approx. 335.0
million km2
High Seas 200.4 million km2
Territorial Seas 22.4 million km2
Contiguous Zones 6.6 million km2
Exclusive Economic Zones 101.9 million km2
Lecture delivered in Refresher Course in
Environmental Sc. in UGC-ASC, University of
Calcutta18-03-2014
There is no legal definition of deep seabed.
Following are the main deep seabed ecosystems:
Hydrothermal Vents
Cold seeps and other similar deep sea ecosystems
Seamounts
Almost no plants
Animals
-Zooplankton (Passive Swimmer)
-Nekton (Active Swimmer)
-Benthos (Bottom Dweller)
Bacteria
-Extremophiles (grow above 400 degree Celsius)
-Barophiles (grow above >40 MPa)
-Barotolerant (grow below <40 Mpa)
Lecture delivered in Refresher Course in
Environmental Sc. in UGC-ASC, University of
Calcutta18-03-2014
Hydrothermal Vents
Lecture delivered in Refresher Course in
Environmental Sc. in UGC-ASC, University of
Calcutta18-03-2014
http://www.youtube.com/watch?v=rTR6gG
DWcJk
Species Diversity in Deep sea
Lecture delivered in Refresher Course in
Environmental Sc. in UGC-ASC, University of
Calcutta18-03-2014
 http://www.youtube.com/watch?v=BtmXN_tH2iM
Bioprospecting can be defined as “the systematic search
for genes, compounds, designs, and organisms that might
have a potential economic use and might lead to a product
development”.
Bioprospecting is relevant to a wide range of sectors and
activities, including biotechnology, agriculture,
pharmaceutical and cosmetics industries, waste
management and bioremediation, biomonitoring, health,
pulp and paper processing, mining and fuel production
from biomass. There are, however, many steps between
identifying a potentially useful biological compound and
marketing a commercial product; it is typically a long,
expensive and uncertain process.
Lecture delivered in Refresher Course in
Environmental Sc. in UGC-ASC, University of
Calcutta18-03-2014
Orders of Magnitude of Drug Discovery
Lecture delivered in Refresher Course in
Environmental Sc. in UGC-ASC, University of
Calcutta18-03-2014
Bioprospecting of Marine Biogenetic Resources
Marine Bioprospecting has been increased manifold
over the years than terrestrial biopropecting. It is
because of
1. extraordinary high species diversity
2. Marine organisms produce unique chemicals for
their own use in a diverse array of functions
living in an extreme conditions including
defence, offence and signalling
Thus it holds promises for drug development and
higher probability of commercial success.
Potential applications for marine organisms include:
pharmaceuticals; enzymes; cosmaceuticals;
agrichemicals; bioremediators; nutraceuticals; and
fine chemicals.
All the major pharmaceutical firms, including
Merck, Lilly, Pfizer, Hoffman-Laroche and Bristol-
Myers Squibb, have marine biology departments.
Lecture delivered in Refresher Course in
Environmental Sc. in UGC-ASC, University of
Calcutta18-03-2014
Biodiscovery from Marine Bioprospecting
Lecture delivered in Refresher Course in
Environmental Sc. in UGC-ASC, University of
Calcutta18-03-2014
Lecture delivered in Refresher Course in
Environmental Sc. in UGC-ASC, University of
Calcutta18-03-2014
Patents concerning discoveries of potential
relevance to the global community as to health
application (e.g. anti-cancer and leukaemia –
Patents US2006234920, JP10120563 and
JP2000229977)
Several patents concerning enzymes isolated
from species living in areas beyond national
jurisdiction such as Antarctica and the deep ocean
(Patents US5506137, US5342768, JP10084988 and
patent WO9833895)
Lecture delivered in Refresher Course in
Environmental Sc. in UGC-ASC, University of
Calcutta18-03-2014
Bioprospective Initiatives by India
Lecture delivered in Refresher Course in
Environmental Sc. in UGC-ASC, University of
Calcutta18-03-2014
International policies that address marine bioprospecting activities
include
1. The United Nations Convention on the Law of the Sea
(UNCLOS)
2. The Convention on Biological Diversity (CBD),
3. IPR Laws & Acts,
4. The International Treaty on Plant Genetic Resources for
Food and Agriculture
5. Other measures and instruments designed to regulate
access and benefit sharing (ABS) for genetic and other
natural resources.
Lecture delivered in Refresher Course in
Environmental Sc. in UGC-ASC, University of
Calcutta18-03-2014
UNCLOS provides that the high seas are open to all States; that
is, all States are free to use them with due regard for other States’
interests. High seas freedoms include navigation, fishing, marine
scientific research, laying of undersea cables and pipelines,
construction of artificial islands and other installations
permitted under international law. High seas freedoms are not a
license for unrestrained use they must be exercised under
conditions laid down by the Convention, including general
obligations to protect and preserve the marine environment
(Part XII) and to conserve and manage high seas living
resources (Part VII, Section 2).
Lecture delivered in Refresher Course in
Environmental Sc. in UGC-ASC, University of
Calcutta18-03-2014
The Convention on Biological Diversity and UNCLOS are
complementary instruments with respect to the conservation and
sustainable use of marine biodiversity [Article 22 (Section 2)]
Article 3 details the principle of sovereignty:
States have, in accordance with the charter of the United Nations and
the principles of international law, the sovereign right to exploit their
own resources pursuant to their own environmental policies, and the
responsibility to ensure that activities within their jurisdiction or
control do not cause damage to environment of other states or of areas
beyond the limits of national jurisdiction.
Article 4 says
(a) In the case of components of biological diversity, in areas within the
limits of its national jurisdiction
(b) In the case of processes and activities, regardless of where their
effects occur, carried out under its jurisdiction or control, within the
area of its national jurisdiction or beyond the limits of national
jurisdiction.
Lecture delivered in Refresher Course in
Environmental Sc. in UGC-ASC, University of
Calcutta18-03-2014
•Bonn Guidelines on Access and Benefit Sharing (ABS)
provide guidance for policy makers and persons using
and providing genetic resources. It is based on CBD.
•On the basis of the CBD’s jurisdictional scope, it follows
that the Guidelines are only applicable to marine genetic
resources found in areas under national jurisdiction.
However, the Guidelines provide a framework on the
basis of which a regime for access to deep seabed genetic
resources beyond the limits of national jurisdiction and
sharing of benefits can be organized.
Lecture delivered in Refresher Course in
Environmental Sc. in UGC-ASC, University of
Calcutta18-03-2014
On 3rd November 2001, the Food and Agriculture
Organization of the United Nations adopted the
International Treaty on Plant Genetic Resources for Food
and Agriculture. This is the principal international legal
instrument governing transfers of plant genetic resources
for food and agriculture (PGRFA). It is also known as ‘seed
Treaty.
This treaty is significant in radically altering the legal
status of plant genetic resources in international law. It
affirms states’ sovereign rights over PGRFA (Plant Genetic
Resources for Food and Agriculture) and condones the
introduction of IPR.Lecture delivered in Refresher Course in
Environmental Sc. in UGC-ASC, University of
Calcutta18-03-2014
The first international treaty, which makes it legal
– and compulsory – to patent life, is the World
Trade Organization's Trade Related Intellectual
Property Rights (TRIPS) Article 27.3(b). It requires
member states to provide patent protection for all
fields of technology. Articles 27.2 and 27.3 outline,
which inventions member states may exclude
from patent protection and under which
conditions.
Lecture delivered in Refresher Course in
Environmental Sc. in UGC-ASC, University of
Calcutta18-03-2014
WTO Members may exclude from patent protection:
Plants
Animals
Essentially biological processes for the
Production of plants or animals
Plant varieties
WTO members must provide protection for:
Micro-organisms (by patents)
Non-biological processes (by patents)
Microbiological processes (by patents)
Plant varieties (by an IP system that may be
Patents, a sui generis alternative, or a combination)
Lecture delivered in Refresher Course in
Environmental Sc. in UGC-ASC, University of
Calcutta18-03-2014
Patents have already been granted to inventions using deep seabed
organisms. Because commercial applications of deep seabed
organisms are likely to increase in the future, it is necessary to
consider how international instruments related to intellectual
property address genetic resources. Patenting life forms, including
genetic resources, has ethical aspects which cannot be overlooked.
Concerns have been expressed that patenting of a source material,
e.g. genetic resources or organisms, may lead to compromising a
growing proportion of biodiversity, discovered or yet-to-be found,
from unconditional use over time. It is essential to ensure that the
resources or organisms have been legitimately accessed and that
benefits arising out of the utilization of the source genetic resources
are shared between owners of the resources and users. This is
especially true for deep seabed genetic resources, the status of which
as open-access or common heritage of humankind is still disputed,
but the potential commercial applications of which are numerous.Lecture delivered in Refresher Course in
Environmental Sc. in UGC-ASC, University of
Calcutta18-03-2014
Fact 1: In recent years the rate of marine bioprospecting in deep sea has been
increased manifold .
Fact 2:Significant Scientific & technological advance in marine zone exploration
Fact 3: Beyond the EEZ areas beyond national jurisdiction (ABNJ) the marine
zone is considered as “Common Heritage of mankind”
Fact 4: In search of new biogenetic resources and the rate of success is high as
deep sea marine biome mostly unexploredand under-investigated specially
micorbial realm
Fact 5: Rat race over patent for million/billion dollars
Fact 6: There are no clear international legal instruments in place specifically
addressing bioprospecting in these areas.
Fact 7: Very few States have the necessary technological and intellectual know-
how to carry out bioprospecting,
Fact 8: Very little is known about the conservation status of many
species used as sources of marine genetic resourcesLecture delivered in Refresher Course in
Environmental Sc. in UGC-ASC, University of
Calcutta18-03-2014
1. Today, about 18,000 natural products have been reported from
marine organisms belonging to about 4,800 named species. The
number of natural products from marine species is growing
at a rate of 4% per year
2. Advances in technologies for observing and sampling the deep
ocean,such as submersibles and remotely operated vehicles
(ROVs), have opened up previously unexplored areas to scientific
research.
3. Since 1999, the number of patents of genetic material from
marine species has increased at the rate of 12% per year.
Marine species are about twice as likely to yield at least one gene
in a patent than their terrestrial counterparts
4. The applications of genes of marine organisms cover a wide range
of activities, including pharmacology and human health,
agriculture, food, cosmetics and industrial applications. However,
it is in the area of pharmaceuticals that there has been most
public interest Lecture delivered in Refresher Course in
Environmental Sc. in UGC-ASC, University of
Calcutta18-03-2014
5. It has been estimated by the US National Cancer Institute
(NCI) that 1% of samples from marine animals tested in
the laboratory reveal anti-tumour potential (which
compares favourably with just 0.01% of samples of
terrestrial origin).
6. There is a particular interest in marine species that live in
extreme environments, such as hydrothermal vents and
seamounts (‘extremophiles’). The capacity of deep, cold and
hot vent ecosystems to produce novel chemistry and
genes has been under-investigated.
Lecture delivered in Refresher Course in
Environmental Sc. in UGC-ASC, University of
Calcutta18-03-2014
Sampling at sea costs a minimum of US$ 30,000 per day or US$ 1
million for a month. It typically takes 15 years overall, and an
investment of up to US$ 1 billion, to go from research to
commercial product. US$ 80000 per day for Hadal zone
exploration is required with ROVs. As a result the field is
dominated by relatively few nations. Patent claims associated
with marine genetic resources (MGR) originate from only 31
countries. 90% of these patents originate from 10 countries (USA,
Germany, Japan, France, UK, Denmark, Belgium, Netherlands,
Switzerland and Norway), with 70% originating from the US,
Germany and Japan).
Lecture delivered in Refresher Course in
Environmental Sc. in UGC-ASC, University of
Calcutta18-03-2014
Marine ABNJ is a zone of common heritage of mankind.
Any MGR belongs to these zone is a common property of
mankind
But the developed countries (China, UK, US, Brazil, Germany,
Japan, France, Russia) with sufficient scientific and technological
background for sea exploration can only access these MGRs and
commercially exploit through IPR systems
Virtual owner s of these MGRs are big MNCs of developed
countries
whether the benefits from exploiting these resources should be
shared by the entire international community or only by the
States or corporations with the capacity to exploit them
Lecture delivered in Refresher Course in
Environmental Sc. in UGC-ASC, University of
Calcutta18-03-2014
A. Extend CBD for marine ABNJ particularly for MGRs as
1. very little is known about the conservation status of many
species used as sources of marine genetic resources
2. many species occur in vulnerable and fragile ecosystems
3. the effect on ecosystems of removal of marine genetic
resources is poorly understood
B. UNCLOS must include international definition of
bioprospecting,
which is difficult to distinguish, in practice, from pure marine
scientific research – for which an internationally agreed
definition is also required;
Lecture delivered in Refresher Course in
Environmental Sc. in UGC-ASC, University of
Calcutta18-03-2014
C. Some countries including G 77 and China believe in ABS of
MGRs from marine ABNJ but some countries like US, Japan &
Korea- they say that a benefit-sharing mechanism for MGR
would hinder innovation and impede R&D by imposing
undue burden on an already expensive and risky enterprise.
D. Parallel system for MGRs like International Sea Bed
Authority (ISA) and Nagoya Protocol (monetary & non-
monetary) in the line of CBD for ABS of MGRs in ABNJ should
be developed.
E. The legitimacy of asserting intellectual property rights over
resources deemed of public interest collected from common
zone of mankind, and what constitutes a patentable
invention with regard to genetic resources particularly from
marine ABNJ must be resolved.
Lecture delivered in Refresher Course in
Environmental Sc. in UGC-ASC, University of
Calcutta18-03-2014
Determining the ownership of MGRs and its ABS in
ABNJ is very complex as well as debatable issue
that must be resolved internationally. Meeting of
UNCLOS scheduled in 2014 holds a promise in this
regard. Legal framework for the conservation and
sustainable use of MGRs and IPR issues should be
addressed and the same time we must look into the
progress of R & D issues because this is related with
the development of knowledge of mankind. These
issues must be resolved with orchestrated effort of
all stakeholders with a view to make marine ABNJ
true “Common Heritage of Mankind”.
Lecture delivered in Refresher Course in
Environmental Sc. in UGC-ASC, University of
Calcutta18-03-2014
1. Biodiversity Act, 2002
2. Bishop, J., Kapila, S., Hicks, F., Mitchell, P. and Vorhies, F. 2008.
Building Biodiversity Business. Shell International Limited and the
International Union for Conservation of Nature: London, UK, and
Gland, Switzerland. 164 pp.
3. Convention of Biological Diversity, 1992
4. Indian Patent Act, 1970 and its amendments
5. Marcel Jaspars, The Marine Biodiscovery Pipeline, PharmaSea
Consortium, 2013
6. Nagoya Protocol
7. PPV & FR Act, 2001
8. S. Arnaud--‐Haond,J.M. Arrieta & C.M. Duarte, Marine
biodiversity and gene patents.Science.331,1521-1522
9. TRIPS
10. United Nations Convention on the Law of the Sea
Lecture delivered in Refresher Course in
Environmental Sc. in UGC-ASC, University of
Calcutta18-03-2014
“Earth is abundant with plentiful
resources. Our practice of rationing
resources through monetary control
is no longer relevant and is counter-
productive to our survival.”
Jacque Fresco
Thank You
Lecture delivered in Refresher Course in
Environmental Sc. in UGC-ASC, University of
Calcutta18-03-2014

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IPR on MGR: Biodiscovery to Bioprospecting and Question of Ownership

  • 1. IPR on Marine Biogenetic Resources  Bioprospecting to Biodiscovery & Question of Ownership Dr. Sabuj Kumar Chaudhuri Assistant Professor Department of LIS University of Calcutta Email-sabooj_c@yahoo.co.in Lecture delivered in Refresher Course in Environmental Sc. in UGC-ASC, University of Calcutta18-03-2014
  • 2. 1. Property, Types, IP , IPR & its categorization 2. Landmark patents: Microorganism, Plant and animal 3. India’s International Obligations 4. Few Definitions, Criteria for Patent & PBR, Few Amendments 5. Limits of Marine Zonation 6. Deep Sea & Various Deep Seabed Ecosystems & MGR 7. Hydrothermal Vents & Species Diversity (Video) 8. Bioprospecting, Bioprospecting of MGR 9. Biodiscovery from MGR & Patents & Indian Initiatives 10. Legal Instruments 11. Question of Ownership & Few Facts 12. Current Status ,Few Bioprospectors & Huge Investments 13. Debate on ownership continues & Fill in the Blanks 14. Concluding Remarks Lecture delivered in Refresher Course in Environmental Sc. in UGC-ASC, University of Calcutta18-03-2014
  • 3. What is property? What is Intellectual property (IP)? What is Intellectual Property Rights(IPR)? Lecture delivered in Refresher Course in Environmental Sc. in UGC-ASC, University of Calcutta18-03-2014
  • 4. The term is extraordinarily difficult to answer. Ordinary person defines property as ‘thing’ but attorney defines it as ‘right’. It has two understandings : Legal Understandings: Property is the inclusion of rights of exclusive use and alienability Economic Understandings: Property includes all rights of individuals to valuable resources. Lecture delivered in Refresher Course in Environmental Sc. in UGC-ASC, University of Calcutta18-03-2014
  • 5. The tangible property includes physical objects such as land, household goods, car etc. The intangible property includes a list of products of human intellect such as patents, copyright, trademarks and industrial designs etc. Lecture delivered in Refresher Course in Environmental Sc. in UGC-ASC, University of Calcutta18-03-2014
  • 6. Intellectual property (IP) deals with the creations of the human intellect and protects the creations of the human mind, the human intellect. This is why this kind of property is called “intellectual property”. Intellectual property is a cluster of legally recognized rights associated with innovation and creativity – the works of the mind, as against physical products, land and other tangible resources. Even though it is intangible, intellectual property (IP) is often recognized as personal property, to be sold and traded like other forms of property.Lecture delivered in Refresher Course in Environmental Sc. in UGC-ASC, University of Calcutta18-03-2014
  • 7. Intellectual property rights (IPR) are the rights awarded by society to individuals or organizations principally over Intellectual Property i.e., creative works: inventions, literary and artistic works, and symbols, names, images, and designs used in commerce. They give the creator the right to prevent others from making unauthorized use of their property for a limited period.Lecture delivered in Refresher Course in Environmental Sc. in UGC-ASC, University of Calcutta18-03-2014
  • 8. IPR Industrial Property Patent Industrial Design Trademark Trade Secret Geographical Indications (GI) Utility Models Artistic & Literary Property Copyright Sui generis System (“Latin Word means “of its own kind”) Database Integrated Circuit Plant Breeders’ Right (PBR)Lecture delivered in Refresher Course in Environmental Sc. in UGC-ASC, University of Calcutta18-03-2014
  • 9. 3 Landmark Patents Microorganisms First product patent (US Patent No.-141072 dated July 22, 1873) on living matter was granted to L. Pasteur by the USPTO for his invention of anomalous yeast culture. However some people believe that US patent granted to Anand Chakrobarty for his invention of Oil eating bacteria in 1980 was the first patent on microorganisms.Lecture delivered in Refresher Course in Environmental Sc. in UGC-ASC, University of Calcutta18-03-2014
  • 10. Plants In 1930, the United States began granting patents for plants and in 1931, the first plant patent was issued to Henry Bosenberg for his climbing, ever-blooming rose by the USPTO (Patent No.- PP00001 dated 18th August, 1931). Under patent law, the inventor of a plant is the person who first appreciates the distinctive qualities of a plant and reproduces it asexually.Lecture delivered in Refresher Course in Environmental Sc. in UGC-ASC, University of Calcutta18-03-2014
  • 11. Animals Researchers at Harvard Medical School in the early 1980s produced a genetically modified mouse (oncomouse) that was highly susceptible to cancer, by introducing an oncogene that can trigger the growth of tumors. Harvard College sought patent protection in the United States and several other countries. The USPTO in 12th April, 1988 granted a patent no. 4,736,866 to Harvard College claiming "a transgenic non- human mammal whose germ cells and somatic cells contain a recombinant activated oncogene sequence introduced into said mammal. Lecture delivered in Refresher Course in Environmental Sc. in UGC-ASC, University of Calcutta18-03-2014
  • 12. India’s International Obligations  India is a member of WTO (World Trade Organization) and many international agreements and conventions. Thus India is bound to comply with all these agreements and conventions through a series of acts and ratifications to discharge of her international obligations in the field of intellectual property rights regarding the commercial uses of the biological resources. The key set of acts for the IP protection of biodiversity and biotechnology inventions and ratifications to many international agreements are: Lecture delivered in Refresher Course in Environmental Sc. in UGC-ASC, University of Calcutta18-03-2014
  • 13. Contd… International Agreements/Convention India’s Compliance India is WTO signatory & ratified TRIPS agreement & Budapest Treaty Indian Patent Act (IPA), 1970 and its amendments in 1999, 2002 and 2005 India joined Conventions of Biological Diversity (CBD) Biodiversity Act, 2002 India followed UPOV (International Union for the Protection of New Varieties of Plants) of 1991 The Protection of Plant Varieties and Farmer’s' Rights (PPV & FR) Act, 2001 India ratified International Treaty On Plant Genetic Resources For Food And Agriculture (PGRFA Treaty) on 10th June 2002 Seed Act, 2004 TRIPS agreement Geographical Indications of Goods (Registration and Protection) Rules, 2002 India ratified both Paris Convention and Patent Cooperation Treaty (PCT) in 1998 India changes its patenting procedures & rules Lecture delivered in Refresher Course in Environmental Sc. in UGC-ASC, University of Calcutta18-03-2014
  • 14. Few Definitions The Biodiversity Act, 2002 of India-- “Biological Diversity” means the variability among living organisms from all sources and the ecological complexes of which they are part and includes diversity within species or between species and of ecosystems. “Biological Resources” means plants, animals and microorganisms or parts thereof, their genetic material and by- products with actual or potential use or value does not include human genetic material [Chapter I Clause 2(b) and 2(c)]. Lecture delivered in Refresher Course in Environmental Sc. in UGC-ASC, University of Calcutta18-03-2014
  • 15. Criteria for obtaining Patent & PBR  Criteria for obtaining patent Novelty (new characteristics which are not “prior art”), Non-obviousness (an inventive step not obvious to one skilled in the field), and Utility (as used in the US) or industrial applicability (as used in the UK) or susceptible for industrial application (as used in the Europe) . *Deposition of a microorganism at a recognized “international depositary authority” (The Budapest Treaty ) if the patent is related to microorganisms.  Criteria for obtaining PBR New in the sense that they must not have been commercialized prior to certain dates established by reference to the date of application for protection, Distinct from the existing, commonly known varieties, Uniform or sufficiently homogenous and Stable (i.e. subsequent plantings of the variety must demonstrate the same characteristics as the parent crop). Lecture delivered in Refresher Course in Environmental Sc. in UGC-ASC, University of Calcutta18-03-2014
  • 16. Few Amendments  Process for curative, prophylactic, diagnostic, therapeutic or other treatment of plants (to render them free from diseases and pests).  Process / method of preparing Genetically Modified Organisms  The living entity of artificial origin such as micro-organism, vaccines are considered patentable.  The biological material such as recombinant DNA, Plasmids and processes of manufacturing thereof are patentable provided they are produced by substantive human intervention.  The processes relating to micro-organisms or producing chemical substances using such micro-organisms are patentable. It may however be noted that it is not possible to get a plant patent in India. New plant varieties can be protected through registration under the ‘Protection of Plant Varieties and Farmers’ Rights Act’ of 2001. The most important thing to observe is that patents are possible for many aspects of a plant and its utilization except the plant itself. Lecture delivered in Refresher Course in Environmental Sc. in UGC-ASC, University of Calcutta18-03-2014
  • 17. Limits of Maritime Zonation Lecture delivered in Refresher Course in Environmental Sc. in UGC-ASC, University of Calcutta18-03-2014
  • 18. Deep Sea 1. 60% of our planet is covered by water over 1,600m deep, and nearly half the world's marine waters are over 3,000m deep. 2. The deep sea starts where the sunlight starts to fade, around 200m below the surface of the ocean. 3. A twilight zone extends down to 1,000m, after which almost no light penetrates. The water is cold, reaching 1-2ºC, and contains very little oxygen. 4. And the weight of the water above creates enormous pressures, up to 1,000 times that at the surface. 5. With no sunlight, almost plants cannot grow in the deep sea. And while animals and bacteria have been found wherever people have looked, we know very little about these dark, cold depths. 6. More people have travelled into space than have ventured into the deep. Lecture delivered in Refresher Course in Environmental Sc. in UGC-ASC, University of Calcutta18-03-2014
  • 19. The high seas are comprised of all parts of the sea that are not included in the exclusive economic zone, in the territorial sea or in the internal waters of a State. COMPARATIVE SIZES OF THE VARIOUS MARITIME ZONES Areas of the Earth covered by the Oceans approx. 335.0 million km2 High Seas 200.4 million km2 Territorial Seas 22.4 million km2 Contiguous Zones 6.6 million km2 Exclusive Economic Zones 101.9 million km2 Lecture delivered in Refresher Course in Environmental Sc. in UGC-ASC, University of Calcutta18-03-2014
  • 20. There is no legal definition of deep seabed. Following are the main deep seabed ecosystems: Hydrothermal Vents Cold seeps and other similar deep sea ecosystems Seamounts Almost no plants Animals -Zooplankton (Passive Swimmer) -Nekton (Active Swimmer) -Benthos (Bottom Dweller) Bacteria -Extremophiles (grow above 400 degree Celsius) -Barophiles (grow above >40 MPa) -Barotolerant (grow below <40 Mpa) Lecture delivered in Refresher Course in Environmental Sc. in UGC-ASC, University of Calcutta18-03-2014
  • 21. Hydrothermal Vents Lecture delivered in Refresher Course in Environmental Sc. in UGC-ASC, University of Calcutta18-03-2014 http://www.youtube.com/watch?v=rTR6gG DWcJk
  • 22. Species Diversity in Deep sea Lecture delivered in Refresher Course in Environmental Sc. in UGC-ASC, University of Calcutta18-03-2014  http://www.youtube.com/watch?v=BtmXN_tH2iM
  • 23. Bioprospecting can be defined as “the systematic search for genes, compounds, designs, and organisms that might have a potential economic use and might lead to a product development”. Bioprospecting is relevant to a wide range of sectors and activities, including biotechnology, agriculture, pharmaceutical and cosmetics industries, waste management and bioremediation, biomonitoring, health, pulp and paper processing, mining and fuel production from biomass. There are, however, many steps between identifying a potentially useful biological compound and marketing a commercial product; it is typically a long, expensive and uncertain process. Lecture delivered in Refresher Course in Environmental Sc. in UGC-ASC, University of Calcutta18-03-2014
  • 24. Orders of Magnitude of Drug Discovery Lecture delivered in Refresher Course in Environmental Sc. in UGC-ASC, University of Calcutta18-03-2014
  • 25. Bioprospecting of Marine Biogenetic Resources Marine Bioprospecting has been increased manifold over the years than terrestrial biopropecting. It is because of 1. extraordinary high species diversity 2. Marine organisms produce unique chemicals for their own use in a diverse array of functions living in an extreme conditions including defence, offence and signalling Thus it holds promises for drug development and higher probability of commercial success. Potential applications for marine organisms include: pharmaceuticals; enzymes; cosmaceuticals; agrichemicals; bioremediators; nutraceuticals; and fine chemicals. All the major pharmaceutical firms, including Merck, Lilly, Pfizer, Hoffman-Laroche and Bristol- Myers Squibb, have marine biology departments. Lecture delivered in Refresher Course in Environmental Sc. in UGC-ASC, University of Calcutta18-03-2014
  • 26. Biodiscovery from Marine Bioprospecting Lecture delivered in Refresher Course in Environmental Sc. in UGC-ASC, University of Calcutta18-03-2014
  • 27. Lecture delivered in Refresher Course in Environmental Sc. in UGC-ASC, University of Calcutta18-03-2014
  • 28. Patents concerning discoveries of potential relevance to the global community as to health application (e.g. anti-cancer and leukaemia – Patents US2006234920, JP10120563 and JP2000229977) Several patents concerning enzymes isolated from species living in areas beyond national jurisdiction such as Antarctica and the deep ocean (Patents US5506137, US5342768, JP10084988 and patent WO9833895) Lecture delivered in Refresher Course in Environmental Sc. in UGC-ASC, University of Calcutta18-03-2014
  • 29. Bioprospective Initiatives by India Lecture delivered in Refresher Course in Environmental Sc. in UGC-ASC, University of Calcutta18-03-2014
  • 30. International policies that address marine bioprospecting activities include 1. The United Nations Convention on the Law of the Sea (UNCLOS) 2. The Convention on Biological Diversity (CBD), 3. IPR Laws & Acts, 4. The International Treaty on Plant Genetic Resources for Food and Agriculture 5. Other measures and instruments designed to regulate access and benefit sharing (ABS) for genetic and other natural resources. Lecture delivered in Refresher Course in Environmental Sc. in UGC-ASC, University of Calcutta18-03-2014
  • 31. UNCLOS provides that the high seas are open to all States; that is, all States are free to use them with due regard for other States’ interests. High seas freedoms include navigation, fishing, marine scientific research, laying of undersea cables and pipelines, construction of artificial islands and other installations permitted under international law. High seas freedoms are not a license for unrestrained use they must be exercised under conditions laid down by the Convention, including general obligations to protect and preserve the marine environment (Part XII) and to conserve and manage high seas living resources (Part VII, Section 2). Lecture delivered in Refresher Course in Environmental Sc. in UGC-ASC, University of Calcutta18-03-2014
  • 32. The Convention on Biological Diversity and UNCLOS are complementary instruments with respect to the conservation and sustainable use of marine biodiversity [Article 22 (Section 2)] Article 3 details the principle of sovereignty: States have, in accordance with the charter of the United Nations and the principles of international law, the sovereign right to exploit their own resources pursuant to their own environmental policies, and the responsibility to ensure that activities within their jurisdiction or control do not cause damage to environment of other states or of areas beyond the limits of national jurisdiction. Article 4 says (a) In the case of components of biological diversity, in areas within the limits of its national jurisdiction (b) In the case of processes and activities, regardless of where their effects occur, carried out under its jurisdiction or control, within the area of its national jurisdiction or beyond the limits of national jurisdiction. Lecture delivered in Refresher Course in Environmental Sc. in UGC-ASC, University of Calcutta18-03-2014
  • 33. •Bonn Guidelines on Access and Benefit Sharing (ABS) provide guidance for policy makers and persons using and providing genetic resources. It is based on CBD. •On the basis of the CBD’s jurisdictional scope, it follows that the Guidelines are only applicable to marine genetic resources found in areas under national jurisdiction. However, the Guidelines provide a framework on the basis of which a regime for access to deep seabed genetic resources beyond the limits of national jurisdiction and sharing of benefits can be organized. Lecture delivered in Refresher Course in Environmental Sc. in UGC-ASC, University of Calcutta18-03-2014
  • 34. On 3rd November 2001, the Food and Agriculture Organization of the United Nations adopted the International Treaty on Plant Genetic Resources for Food and Agriculture. This is the principal international legal instrument governing transfers of plant genetic resources for food and agriculture (PGRFA). It is also known as ‘seed Treaty. This treaty is significant in radically altering the legal status of plant genetic resources in international law. It affirms states’ sovereign rights over PGRFA (Plant Genetic Resources for Food and Agriculture) and condones the introduction of IPR.Lecture delivered in Refresher Course in Environmental Sc. in UGC-ASC, University of Calcutta18-03-2014
  • 35. The first international treaty, which makes it legal – and compulsory – to patent life, is the World Trade Organization's Trade Related Intellectual Property Rights (TRIPS) Article 27.3(b). It requires member states to provide patent protection for all fields of technology. Articles 27.2 and 27.3 outline, which inventions member states may exclude from patent protection and under which conditions. Lecture delivered in Refresher Course in Environmental Sc. in UGC-ASC, University of Calcutta18-03-2014
  • 36. WTO Members may exclude from patent protection: Plants Animals Essentially biological processes for the Production of plants or animals Plant varieties WTO members must provide protection for: Micro-organisms (by patents) Non-biological processes (by patents) Microbiological processes (by patents) Plant varieties (by an IP system that may be Patents, a sui generis alternative, or a combination) Lecture delivered in Refresher Course in Environmental Sc. in UGC-ASC, University of Calcutta18-03-2014
  • 37. Patents have already been granted to inventions using deep seabed organisms. Because commercial applications of deep seabed organisms are likely to increase in the future, it is necessary to consider how international instruments related to intellectual property address genetic resources. Patenting life forms, including genetic resources, has ethical aspects which cannot be overlooked. Concerns have been expressed that patenting of a source material, e.g. genetic resources or organisms, may lead to compromising a growing proportion of biodiversity, discovered or yet-to-be found, from unconditional use over time. It is essential to ensure that the resources or organisms have been legitimately accessed and that benefits arising out of the utilization of the source genetic resources are shared between owners of the resources and users. This is especially true for deep seabed genetic resources, the status of which as open-access or common heritage of humankind is still disputed, but the potential commercial applications of which are numerous.Lecture delivered in Refresher Course in Environmental Sc. in UGC-ASC, University of Calcutta18-03-2014
  • 38. Fact 1: In recent years the rate of marine bioprospecting in deep sea has been increased manifold . Fact 2:Significant Scientific & technological advance in marine zone exploration Fact 3: Beyond the EEZ areas beyond national jurisdiction (ABNJ) the marine zone is considered as “Common Heritage of mankind” Fact 4: In search of new biogenetic resources and the rate of success is high as deep sea marine biome mostly unexploredand under-investigated specially micorbial realm Fact 5: Rat race over patent for million/billion dollars Fact 6: There are no clear international legal instruments in place specifically addressing bioprospecting in these areas. Fact 7: Very few States have the necessary technological and intellectual know- how to carry out bioprospecting, Fact 8: Very little is known about the conservation status of many species used as sources of marine genetic resourcesLecture delivered in Refresher Course in Environmental Sc. in UGC-ASC, University of Calcutta18-03-2014
  • 39. 1. Today, about 18,000 natural products have been reported from marine organisms belonging to about 4,800 named species. The number of natural products from marine species is growing at a rate of 4% per year 2. Advances in technologies for observing and sampling the deep ocean,such as submersibles and remotely operated vehicles (ROVs), have opened up previously unexplored areas to scientific research. 3. Since 1999, the number of patents of genetic material from marine species has increased at the rate of 12% per year. Marine species are about twice as likely to yield at least one gene in a patent than their terrestrial counterparts 4. The applications of genes of marine organisms cover a wide range of activities, including pharmacology and human health, agriculture, food, cosmetics and industrial applications. However, it is in the area of pharmaceuticals that there has been most public interest Lecture delivered in Refresher Course in Environmental Sc. in UGC-ASC, University of Calcutta18-03-2014
  • 40. 5. It has been estimated by the US National Cancer Institute (NCI) that 1% of samples from marine animals tested in the laboratory reveal anti-tumour potential (which compares favourably with just 0.01% of samples of terrestrial origin). 6. There is a particular interest in marine species that live in extreme environments, such as hydrothermal vents and seamounts (‘extremophiles’). The capacity of deep, cold and hot vent ecosystems to produce novel chemistry and genes has been under-investigated. Lecture delivered in Refresher Course in Environmental Sc. in UGC-ASC, University of Calcutta18-03-2014
  • 41. Sampling at sea costs a minimum of US$ 30,000 per day or US$ 1 million for a month. It typically takes 15 years overall, and an investment of up to US$ 1 billion, to go from research to commercial product. US$ 80000 per day for Hadal zone exploration is required with ROVs. As a result the field is dominated by relatively few nations. Patent claims associated with marine genetic resources (MGR) originate from only 31 countries. 90% of these patents originate from 10 countries (USA, Germany, Japan, France, UK, Denmark, Belgium, Netherlands, Switzerland and Norway), with 70% originating from the US, Germany and Japan). Lecture delivered in Refresher Course in Environmental Sc. in UGC-ASC, University of Calcutta18-03-2014
  • 42. Marine ABNJ is a zone of common heritage of mankind. Any MGR belongs to these zone is a common property of mankind But the developed countries (China, UK, US, Brazil, Germany, Japan, France, Russia) with sufficient scientific and technological background for sea exploration can only access these MGRs and commercially exploit through IPR systems Virtual owner s of these MGRs are big MNCs of developed countries whether the benefits from exploiting these resources should be shared by the entire international community or only by the States or corporations with the capacity to exploit them Lecture delivered in Refresher Course in Environmental Sc. in UGC-ASC, University of Calcutta18-03-2014
  • 43. A. Extend CBD for marine ABNJ particularly for MGRs as 1. very little is known about the conservation status of many species used as sources of marine genetic resources 2. many species occur in vulnerable and fragile ecosystems 3. the effect on ecosystems of removal of marine genetic resources is poorly understood B. UNCLOS must include international definition of bioprospecting, which is difficult to distinguish, in practice, from pure marine scientific research – for which an internationally agreed definition is also required; Lecture delivered in Refresher Course in Environmental Sc. in UGC-ASC, University of Calcutta18-03-2014
  • 44. C. Some countries including G 77 and China believe in ABS of MGRs from marine ABNJ but some countries like US, Japan & Korea- they say that a benefit-sharing mechanism for MGR would hinder innovation and impede R&D by imposing undue burden on an already expensive and risky enterprise. D. Parallel system for MGRs like International Sea Bed Authority (ISA) and Nagoya Protocol (monetary & non- monetary) in the line of CBD for ABS of MGRs in ABNJ should be developed. E. The legitimacy of asserting intellectual property rights over resources deemed of public interest collected from common zone of mankind, and what constitutes a patentable invention with regard to genetic resources particularly from marine ABNJ must be resolved. Lecture delivered in Refresher Course in Environmental Sc. in UGC-ASC, University of Calcutta18-03-2014
  • 45. Determining the ownership of MGRs and its ABS in ABNJ is very complex as well as debatable issue that must be resolved internationally. Meeting of UNCLOS scheduled in 2014 holds a promise in this regard. Legal framework for the conservation and sustainable use of MGRs and IPR issues should be addressed and the same time we must look into the progress of R & D issues because this is related with the development of knowledge of mankind. These issues must be resolved with orchestrated effort of all stakeholders with a view to make marine ABNJ true “Common Heritage of Mankind”. Lecture delivered in Refresher Course in Environmental Sc. in UGC-ASC, University of Calcutta18-03-2014
  • 46. 1. Biodiversity Act, 2002 2. Bishop, J., Kapila, S., Hicks, F., Mitchell, P. and Vorhies, F. 2008. Building Biodiversity Business. Shell International Limited and the International Union for Conservation of Nature: London, UK, and Gland, Switzerland. 164 pp. 3. Convention of Biological Diversity, 1992 4. Indian Patent Act, 1970 and its amendments 5. Marcel Jaspars, The Marine Biodiscovery Pipeline, PharmaSea Consortium, 2013 6. Nagoya Protocol 7. PPV & FR Act, 2001 8. S. Arnaud--‐Haond,J.M. Arrieta & C.M. Duarte, Marine biodiversity and gene patents.Science.331,1521-1522 9. TRIPS 10. United Nations Convention on the Law of the Sea Lecture delivered in Refresher Course in Environmental Sc. in UGC-ASC, University of Calcutta18-03-2014
  • 47. “Earth is abundant with plentiful resources. Our practice of rationing resources through monetary control is no longer relevant and is counter- productive to our survival.” Jacque Fresco Thank You Lecture delivered in Refresher Course in Environmental Sc. in UGC-ASC, University of Calcutta18-03-2014