Intellectual Property Rights to explore Biodiversity issues:

Present inputs, current debates, and future prospects

Dr. Sabuj Kumar ChaudhuriBasanti Devi College, 147B, R. B.Avenue, Kolkata-700 029

Dr. Dipan Adhikari Acharya B. N. Seal College, Cooch Behar,W.B.-736101

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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)] 04/08/23 03:41 2

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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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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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.

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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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Genetically Modified Foods

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

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!

Why do it?

Rice- not high in essential nutrientsModification: + 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.

How is this done?: Transgenic tomatoes

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

A Local Example:

GM CanolaCanadian-Australian Relations :

Bayer CropScience produces genetically modified Bayer CropScience produces genetically modified canola in Australia for the Canadian market. It is canola in Australia for the Canadian market. It is produced to resist the herbicide “Liberty” and can produced to resist the herbicide “Liberty” and can yield up to 20% higher than conventional canola.yield up to 20% higher than conventional canola.

Benefits of Genetic Engineering and ModifyingHigher yielding crops, more efficient use of

land 2. Can save money and promote higher

profits3. Longer shelf life, less waste Example// Tomatoes from genetically

modified seeds stay fresh longer.4. Enhanced taste and quality 5. Reduced maturation time

Benefits of Genetic Engineering and ModifyingIncreased 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 tryptophan7. 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

Benefits of Genetic Engineering and Modifying

SocietySociety Increased food Increased food security for growing security for growing populations and populations and growth challenges growth challenges

(Human Genome Project Information (2003), (Human Genome Project Information (2003), http://www.ornl.gov/sci/techresources/Human_Ghttp://www.ornl.gov/sci/techresources/Human_Genome/elsi/gmfood.shtml)enome/elsi/gmfood.shtml)

Who Uses this technology

The Countries that Grow 99% of the World's Transgenic Crops

69%

23%

7% 1%

USA

Argentina

Canada

China

Risks associated with Genetic ModificationSafety

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

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)

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.

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

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

Canadian Food Inspection Agency Assessment process

Criticisms of process

Genetic Modifications:What shall be the choice?

?or

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.

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.

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.

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) .

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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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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.

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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).

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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.

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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.

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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.

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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)

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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.

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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.

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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).

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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.

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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 andc) benefit sharing from access to these

resources (and related TK). Policy and legal questions are basically

associated to these issues.04/08/23 03:41 40

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.

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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).

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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.

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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.

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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.

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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.

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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.

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Literature cited 1. Canadian Food Inspection Agency. Novel Foods Retrieved April

1, 2002, from the World Wide Web: 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 the World Wide Web: 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 the World Wide Web: http://www.findarticles.com/cf_0m0999/7183_318/5417903/print.jhtml

6. Health Canada. Retrieved April 1, 2002, from the World Wide Web: http://www.hc-sc.gc.ca/food-aliment/mh-dm/ofb-bba/nfi-ani/e_novel_foods_and_ingredient.html

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 the World Wide Web: 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 the World Wide Web: 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 the World Wide Web: 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 the World Wide Web: 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.

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.shtml 17. Bayer CropScience (2004). http://www.

bayercropscience.com/bayer/cropscience/cscms.nsf/id/OurCustomers

Thank You