IPR on MGR: Biodiscovery to Bioprospecting and Question of Ownership
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IPR on MGR: Biodiscovery to Bioprospecting and Question of Ownership

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Lecture Delivered in Refresher Course on Environmental Science in University Grants Commission-Academic Staff College, University of Calcutta

Lecture Delivered in Refresher Course on Environmental Science in University Grants Commission-Academic Staff College, University of Calcutta

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  • 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