Intellectual Property Rights to explore Biodiversity issues: Present inputs, current debates, and future prospects

1. Intellectual Property Rights to
explore Biodiversity issues: Present
inputs, current debates, and future
prospects
Dr. Sabuj Kumar Chaudhuri
Basanti Devi College, 147B, R. B.Avenue, Kolkata-700 029
Dr. Dipan Adhikari
Acharya B. N. Seal College, Cooch Behar,W.B.-736101
07/14/13 16:23 1

2. What is biodiversity?
The term ‘biodiversity’ is a simple contraction of ‘biological
diversity’
More precise definition of biodiversity and biological
resources are given in 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)] 07/14/13 16:23 2

3. 3 Levels of Biodiversity
 Thus biodiversity manifests at 3 levels for all living
organisms:
These three levels are, namely: (i) Species Level
(Species Diversity)- refers to number and kinds of
living organisms or diversity between species;
(ii) Genetic Level (Genetic Diversity) - refers to
genetic variation within a population of species or
diversity within species; and
(iii) Eco-System Level (Ecological Diversity)- refers
to the variety of habitats, biological communities and
ecological processes that occur in such habitats or
diversity of ecosystems.
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4. Values of Biodiversity
 Diversity is the most ecologically sustained form.
 Diversified crops maintain soil fertility.
 Diversity optimizes soil management in rain fed belts.
 Diversity means insurance against crop failure.
 Diversity optimizes labour availability.
 Diversity ensures food security.
 Diversity of range of foods ensures nutritional balance.
 Diversity provides a range of fodder to the cattle keeping
them healthy and productive.
 Diversity helps women control their farm economics and
seeds.
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5. Biodiversity in India
 India is one of the twelve mega biodiversity countries in
the world,. India is having two biodiversity hotspots,
namely the Western Ghats and the Eastern Himalayas,
which are included amongst the top eight most important
hotspots in the world.
 India has 850 species of bacteria, 14,500 species of
fungi, 6,500 species of algae, 2000 species of lichens,
2,850 species of bryophytes, 1100 species of
pteridophytes The endemism of Indian biodiversity is
high. About 33% of the country's recorded flora are
endemic to the country and are concentrated mainly in
the North-East, Western Ghats, North-West Himalaya and
the Andaman and Nicobar islands.
07/14/13 16:23 5

6. Contd…
 As many as 167 species of crops, 320 species of
wild crop relatives, and several species of
domesticated animals have originated here. The
genetic diversity within these species is astounding.
For example, there are 4,000 varieties of Rice,
hundreds of varieties of Mango, 27 breeds of Cattle
and 18 breeds of poultry. This amazing biodiversity
is not a freak of nature, but a result of careful
selection and even crossbreeding over centuries by
India’s farmers and pastoralists.
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7. Genetically Modified Foods

8. What are GM’s?
 are a result of technology that has altered the
DNA of living organisms (animals, plants or
bacteria)
Other terms that mean the same thing:
 Genetically engineered
 Transgenic
 Recombinant DNA (rDNA) technology

9. How does this differ from
Mendel and his peas?
GM vs. Selective breading
Selective breading
-slow
-imprecise
-modification of genes that naturally occur in the organism
GM
-very fast
-precise
-can introduce genes into an organism that would not occur
naturally!

10. Why do it?
 Rice- not high in essential nutrients
Modification:
 + daffodil genes and a bacterium = beta-carotene
content drastically increased
 + genes from a french bean = double the iron
content.
 Tomatoes- Introduce genes to increase shelf
life.

11. How is this done?: Transgenic
tomatoes

12. Other applications
 Potato - modified to produce a beetle killing toxin
 Yellow squash – modified to contain to viral genes
that resistant the most common viral diseases
 Develop foods that contain vaccines and antibodies
that offer valuable protection against diseases such
as cholera, hepatitis, and malaria
 Canola – modified to resist one type of herbicide or
pesticide

13. A Local Example:
GM Canola
Canadian-Australian Relations :
Bayer CropScience produces genetically modified canola inBayer CropScience produces genetically modified canola in
Australia for the Canadian market. It is produced to resistAustralia for the Canadian market. It is produced to resist
the herbicide “Liberty” and can yield up to 20% higher thanthe herbicide “Liberty” and can yield up to 20% higher than
conventional canola.conventional canola.

14. Benefits of Genetic
Engineering and Modifying
Higher yielding crops, more efficient use of land
2. Can save money and promote higher profits
3. Longer shelf life, less waste
Example// Tomatoes from genetically
modified seeds stay fresh
longer.
4. Enhanced taste and quality
5. Reduced maturation time

15. Benefits of Genetic
Engineering and Modifying
Increased and improved nutrients and stress tolerance
- A single gene genetically engineered into cauliflower can increase
production of beta-carotene 100 times.
- A gene can be implanted into a soybean upgrading the soy protein
to a quality equal to that of milk.
- Corn can be modified to contain its two limiting amino acids,
lysine or tryptophan
7. Improved resistance to disease or illness
- Foods can be enhanced with phytochemicals that help maintain
health and reduce the risks of chronic disease.
8. Improved crop resistance to disease, pests, weeds and herbicides
9. New products and growing techniques
- “Individuals allergic to milk may be able to buy milk that has been
treated with the lactase enzyme” (Whiney, 2002).
- Creating decaffeinated coffee beans are in a process of research

16. Benefits of Genetic
Engineering and Modifying
SocietySociety
Increased food securityIncreased food security
for growing populationsfor growing populations
and growth challengesand growth challenges
(Human Genome Project Information (2003),(Human Genome Project Information (2003),
http://www.ornl.gov/sci/techresources/Human_Genomehttp://www.ornl.gov/sci/techresources/Human_Genome
/elsi/gmfood.shtml)/elsi/gmfood.shtml)

17. Who Uses this technology
The Countries that Grow 99% of the
World's Transgenic Crops
69%
23%
7% 1%
USA
Argentina
Canada
China

18. Risks associated with Genetic
Modification
Safety
 Potential human health implications.
 Potential environmental impact.
 Out-crossing
 Inevitable out-crossing of transgenic plants with naturally
occurring ones.
 Creation of super-weeds
 Creation of biological weapons.
2. Access and Intellectual Property
 Domination of world food production by a few companies
and developing countries

19. Risks associated with Genetic Modification
– cont.
Ethics
 “Playing God”
 Tampering with nature by mixing genes among species.
4. Labeling
 Not mandatory in some countries (e.g., Canada and the United
States).
 Mixing GM crops with non-GM confounds labeling attempts.
5. Society
 New advances may be skewed to the interests of rich countries.
(Human Genome Project Information (2003), http://www.ornl.gov/sci/techresources/Human_Genome/elsi/gmfood.shtml)

20. Risks with GM continued
Biodiversity
 Addition of Bt gene into plants including corn, potatoes and
cotton to increase resistance to plants
 Bt gene obtained from Bacillus thuringiensis (a soil bacterium that
produces a natural insecticide)
 Problem: plants producing Bt toxin are releasing toxin in pollen
Draper, D. (2002). Our Environment: A Canadian Perspective 2nd Ed. Scarborough: Thompson Canada Lmt.

21. Risks with GM continued
 Pollen from a Bt plant was dusted on to milkweed:
- only 56% of young monarch butterfly larvae lived
- whereas pollen from organic plants dusted on the
milkweed produced a survival rate of 100%.
Approximately half of the monarch butterfly
population live in the “corn belt” of the USA
= this new gene could have serious repercussions for
this organism

22. Canadian Food Inspection
Agency
 Genetically modified foods are currently regulated
by the CFIA
 works collaboratively with Environment Canada,
Health Canada, and Fisheries and Oceans
 Goal: to ensure that products of biotechnology are
considered safe to human and animal health and the
environment.
 According to the CFIA, the assessment process for
GE foods is very rigorous

23. Canadian Food Inspection
Agency
 Assessment process
 Criticisms of process

24. Genetic Modifications:What
shall be the choice?
?or

25. What is Intellectual Property?
 Intellectual property (IP) deals with creations of
the human intellect. 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.

26. What is Intellectual property Rights
(IPR)?
 Intellectual property rights (IPR) are the rights awarded by
society to individuals or organizations principally over 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. IP is categorized as
Industrial Property (functional commercial innovations), and
Artistic and Literary Property (Cultural creations). Current
technological developments are blurring, to some extent, this
distinction, and some hybrid sui generis (Latin expression
meaning “of its own kind”) systems are emerging.

27. Contd.
 Patent, Industrial designs, trademarks, geographical
indications, trade secret come under Industrial
Property. Copyright and related rights are mainly
artistic and literary property. Plant Breeders’ Right
(PBR) comes under Sui Generis System. For our
present study patent and PBR – these 2 forms of
IPR are relevant. In some much complex forms trade
secret, copyright are also important for the
registration of gene sequence of flora, fauna,
microorganisms and for bioinformatics database
protection.

28. What is patent?
 A patent is an exclusive right awarded or granted by the
government of a country to an inventor to prevent others from
making, selling, distributing, importing or using their invention,
without license or authorization, for a fixed period of time
(TRIPS stipulates 20 years minimum from filing date). In return,
society requires that the patent applicant disclose the invention
in a manner that enables others to put it into practice. there are
3 requirements (although details differ from country to country)
that determine the patentability of an invention:
 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)or industrial application (as used in India) .
07/14/13 16:23 28

29. Contd…
 Apart from the usual criteria of
patentability, namely, novelty, non-
obviousness, and utility, patenting of
microorganisms has an additional
requirement, viz. deposition of micro-
organisms in an internationally
recognized depository authority (IDA)
for patent purposes.
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30. Utility Patents
 Utility patents protect the functional aspect
of a product. Utility Patents provide
protection for agricultural research products
such as herbicides, insecticides, fungicides,
transgenic plants, plant cells, plant genes,
plant DNA sequences, plant tissue cultures,
transgenic seeds, plant varieties, host vector
organisms and many other products of
agricultural research. Within Utility Patents
are Plant Patents that apply to single variety
of plants.
07/14/13 16:23 30

31. Plant Breeders Rights
(PBRs)
 Plant Breeders Rights (PBRs) are rights
granted to plant breeders to exclude others
from commercialising material of the plant
varieties they have developed. For a plant
variety to be eligible for protection through
PBRs, it must be clearly distinguished from
other protected varieties, uniform and stable
(DUS).
07/14/13 16:23 31

32. Transgenics
 Sequences from varied sources like bacteria,
viruses and eukaryotic systems can be
transferred to plants to develop transgenic
crop varieties. Thus Genetically Modified
Organisms (GMO) are the creations of
modern biotechnology in which the genetic
make up or genotype of an organism is so
engineered by man as to include or exclude
certain phenotypes (physical traits or
manifestations) for a desired effect.
07/14/13 16:23 32

33. Traditional Knowledge (TK)
 Traditional Knowledge (TK) or Indigenous Knowledge
(IK) refers to the local knowledge by indigenous people
that is unique to a given culture or society. It forms the
basis on which local decisions on fields such as
agriculture, natural resources management are made.
Such people depend on specific skills and knowledge
that have been influenced by internal creativity and
experimentation for their livelihoods over a long period
of time. While such knowledge is of value to the
owners, it is also of value to the world economy as it
forms part of the global knowledge. A major
distinguishing characteristic of indigenous knowledge is
that it is intergenerational.
07/14/13 16:23 33

34. Linkage among TK, IPR &
Biodiversity
 Whether it is plant, animals or microorganisms, it
will be useful when uses of the particular
biological resources are known. Indigenous
people are the source of virtually all our
knowledge about the uses of the plants and
animals, and even of the microorganisms in their
localities. This traditional knowledge about the
usage of biological resources has been
unethically accessed by many vested interest
groups and got protected through various IPR
forms leading to agrobiodiversity loss, genetic
erosion, loss of traditional varieties etc.
07/14/13 16:23 34

35. Legal Frameworks for Biodiversity
Management
Most important ones are:
 The Convention on Biological Diversity (CBD) in
1992,
 The Agreement on Trade-Related Aspects of
Intellectual Property Rights (TRIPS) in 1994,
 Union Internationale Pour La Protection Des
Obtentions Vegetales” (UPOV- International
Convention for the Protection of New Varieties of
Plants) (1961),
 The Budapest Treaty on the International
Recognition of the Deposit of the Micro-organisms
for the Purposes of Patent Procedures (1980)
07/14/13 16:23 35

36. India’s International Obligations on
IPR India is not yet a Member of the UPOV. However,
India is a founder member of the WTO (World
Trade Organization) , India has already
restructured various sections and articles of the
Indian Patents Act, 1970 to accommodate various
obligations of TRIPS. It has been amended three
times (1999, 2002, and 2005) in recent past so far.
These amendments have serious impact on
biodiversity of India. The future biotechnological
research and development will be guided and be
driven by this new Intellectual Property Rights
(IPR) regime.
07/14/13 16:23 36

37. Following are the patentable subjects in
India now after those 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
(GMOs)
 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.
 Gene sequences, DNA sequences without having disclosed their
functions are not patentable for lack of inventive step and industrial
application.
 The processes relating to micro-organisms or producing chemical
substances using such micro-organisms are patentable.
07/14/13 16:23 37

38. Contd…
 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 main focus of the act is on defining plant
breeder’s rights (PBRs). The legislation is
extended to all categories of plants, excluding
microorganisms (which are patentable).
07/14/13 16:23 38

39. Contd…
 The Biological Diversity Act, 2002 (BDA) of
India received the assent of the President on
the February 5, 2003.
 The BDA complies with the Convention of
Biological Diversity (CBD) 1993, to which
India is a party. It provides for ‘conservation
of biological diversity, sustainable use of its
components and fair and equitable sharing of
the benefits arising out of the use of
biological resources.
07/14/13 16:23 39

40. Current Debate and Key Issues
It can be organised into three fundamental
“issues”:
a) property and control of genetic resources,
b) impacts of IPRs on biodiversity and
c) benefit sharing from access to these
resources (and related TK).
Policy and legal questions are basically
associated to these issues.
07/14/13 16:23 40

41. Property and Control of Genetic
Resources
 Article 15 of the Convention makes genetic
resources subject to the ownership of a State (the
principle of national sovereignty) and “prior and
informed consent” of the State is a pre-requisite for
access to these genetic resources. This provision
has given rise to few pertinent issues, which need to
be examined in a long-term context. Genetic
resources are no more the “common heritage of
mankind” as was declared in Article 1 of the
International Understanding on Plant Genetic
Resources (IU) adopted under the auspices of the
FAO (Food & Agricultural Organization, UN) in 1983.
07/14/13 16:23 41

42. Contd…
 Article 27.3 (b) of TRIPS establishes that limited
exceptions are available for patentability in
relation to plants and animals, but that
protection must be made available for
microorganisms, non-biological and
microbiological processes. Furthermore,
member states shall also provide patent
protection or sui generis (specially generated/of
its own kind) protection for plant varieties (or
combination of both).
07/14/13 16:23 42

43. Impact of IPR on Biodiversity
The criteria for awarding PVP (Plant Variety Protection)
laws allows breeders to protect the varieties with very
similar characteristics, which means the system tends
to be driven by commercial considerations of product
differentiation and planned obsolescence, rather than
genuine improvements in agronomic traits. Similarly,
the requirements for uniformity (and stability) in UPOV
type systems exclude the local varieties developed by
farmers that are more heterogeneous genetically, and
less stable. But these characteristics are those that
make them more adaptable and suited to the agro-
ecological environments in which the majority of poor
farmers live.
07/14/13 16:23 43

44. Contd…
Another concern is the criteria for uniformity. While
proponents argue that PVP, by stimulating the
production of new varieties, actually increases
biodiversity but in reality requirement for uniformity, and
the certification of essentially similar varieties of crops,
will add to uniformity of crops and loss of biodiversity.
Moreover similar concerns have arisen in respect of
greater uniformity arising from the success of Green
Revolution Varieties, leading to greater susceptibility to
disease and loss of on field biodiversity.
07/14/13 16:23 44

45. Benefit Sharing
 Finally, the use and economic exploitation of
genetic resources (and related TK) has brought a
wide range of benefits to developing and
developed countries alike, including economic
benefits. The main challenge to be confronted in
implementing the ABS (Access & Benefit
Sharing) principles under the CBD is to
determine how the benefits (in terms of sharing
research results, capacity building, monetary
income, IPRs, etc.) are to be effectively shared
among users and providers of these materials.
07/14/13 16:23 45

46. Options Ahead
 Benefit-sharing mechanism must be properly devised,
which should reward the conservers of genetic resources
 Formation of Group (like trade block) of megabiodiverse
countries.
 More emphasis should be given on traditional farming and
procedures and extensive R & D must be done for the
same
 Complete Biodiversity documentation of India and area
wise biodiversity registers along with its associated
traditional knowledge should be done as soon as possible
to stop biopiracy in the name of bioprospecting by various
multinational companies.
07/14/13 16:23 46

47. Contd…
 Biodiversity Information System (BIS) in the Perspective
of IPR should be created.
 Recognising the available strengths for animal genetic
resources and generation of competitive technology in
farm animals, poultry and fish in the country, and also
realising that appropriate IP protection laws in this area
are lacking, steps should be initiated on the analogy of
Protection of Plant Varieties and Farmers’ Rights Act,
2001 so that in future animal and fish breeds/strains and
also farmers’ rights on these genetic resources are
protected by law.
 Awareness generation is important for confidence
building.
07/14/13 16:23 47

48. 07/14/13 16:23 48
Literature cited
 1. Canadian Food Inspection Agency. Novel Foods Retrieved April 1, 2002, from
theWorldWideWeb:
http://www.inspection.gc.ca/english/plaveg/pbo/pbobbve.shtml
 2. Canadian Food Inspection Agency.(2000) Plant Health and production
division, plant biosafety office on Regulatory directive 2000-07: Guidelines for
the environmental release of plants with novel traits within confined field trails
in Canada. Retrieved April 4, 2002, from theWorldWideWeb:
http://www.inspection.gc.ca/english/plaveg/pbo/dir/dir0007e.shtml
 3. Draper, D. (1998). Our Environment: A Canadian Perspective 1st Ed.
Scarborough:Thompson Canada Lmt.
 4. Draper, D. (2002). Our Environment: A Canadian Perspective 2nd Ed.
Scarborough:Thompson Canada Lmt.
 5. Jones, L. (1999, February 27). Genetically modified foods. British Medical
Journal. [Journal,Online]. Retrieved April 1, 2002, from theWorldWideWeb:
http://www.findarticles.com/cf_0m0999/7183_318/5417903/print.jhtml
 6. Health Canada. Retrieved April 1, 2002, from theWorldWideWeb:
http://www.hc-sc.gc.ca/food-aliment/mh-dm/ofb-bba/nfi-
ani/e_novel_foods_and_ingredient.html

49. Contd.
 7. Health Canada. A Bureau of Food Policy Integration (Food Directorate)
Response to: Food Safety of GM Crops in Canada: toxicity and allergenicity:
Retrieved April 5, 2002 from theWorldWideWeb: http://www.hc-
sc.gc.ca/food-aliment/mh-dm/ofb-bba/nfi-
ani/e_health_canada_response_gmo.html
 8. McCalla, D.R. (2000). Why we should proceed cautiously with plant
biotechnology? Retrieved April 4, 2002, from theWorldWideWeb:
http://www.canadians.org/ge-alert/
 9. Mitchell, B.C. (1997). Resource and Environmental Management 2nd Ed.
Harlow: Pearson Education Lmt.
 10. Reason Online. Retrieved April 1, 2002, from theWorldWideWeb:
http://reason.com/bi/bi-gmf.shtm
 12. Steiner, M. (2000, May 9) Petition to the Auditor General: By the Sierra
Legal Defense Fund. Retrieved April 6, 2002, from theWorldWideWeb:
http://www.sierralegal.org/m%5Farchive/2000/pr00%5F05%5F09b.htm
 13. Sizer, F.,Whitney, E. (1997). Nutrition Concepts and Controversies 7th
Edition.Waltsworth publishing Company: Belmont Ca.
 14.Whitney, E.N., Rolfes, S.R. (2002). Understanding Nutrition. 9th
Ed.
Wadsworth Group: Belmont Ca.

50. Literature cited
 15. http://allergies.about.com/library/blificbio.htm
 16. Human Genome project(2004).:
http://www.ornl.gov/sci/techresources/Human_Genome/elsi/gmfood.sh
tml
 17. Bayer CropScience (2004).
http://www.bayercropscience.com/bayer/cropscience/cscms.nsf/id/OurC
ustomers

51. Thank You