BIODIVERSITY AND PATENTING OF LIFE: PROBLEMS AND PROSPECTS

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BIODIVERSITY AND PATENTING OF LIFE PROBLEMS AND
PROSPECTS

• GURDIAL NIJAR
• CEBLAW,
• LAW FACULTY,
• UNIVERSITY OF MALAYA

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INTRODUCTION

• BIODIVERSITY AND PATENTS MEETING OF PATHWAYS

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BOOST TO BIOD

• PCR TECHNOLOGY
• EMERGING NEW IT
• BIOINFORMATICS
• FASTER IDENTIFICATION OF COMPOUNDS
• RAPID DEVELOPMENT FOR COMMERCIAL USE
• MODERN BIOTECH
• IPRS

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THE INTERFACE

• 1. SCOPE OF PATENTS LIFE FORMS
• 2. EXTENSION TO PRODUCTS OF NATURE
• 3. BREADTH BROAD
• 4. BASED ON TK
• 5. BENEFIT SHARING

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2 PERSPECTIVES

• 1. IPRS BASED ON TRADITIONAL PATENT LAW
• 2. EMERGING TECHNOLOGIES REQUIRE RESHAPING

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INTERNATIONAL CONTEXT

• 2 BIOD-RELATED TREATIES DEALING WITH
  ABS/BIODIVERSITY CBD IT-PGRFA
• 2 IPR RELATED TREATIES TRIPS UPOV

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PATENT LAWS - US

• PATENTS ON LIFE 1980 Chakrabartys Case
• BASED ON TREATING LIFE AS CHEMICAL SUBSTANCE
• HAND OF GOD v. HAND OF MAN
• PATENTABLE IF GIVEN A NEW FORM, QUALITY,
  PROPERTIES OR COMBINATION NOT PRESENT IN THE
  ORIGINAL IN NATURE

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CONTD - EUROPE

• DIRECTIVE ON THE LEGAL PROTECTION OF
  BIOTECHNOLOGICAL INVENTIONS
• NATURALLY OCCURRING - IF MATERIAL ISOLATED FROM
  NATURE OR PRODUCED BY MEANS OF TECHNICAL PROCESS
• PROCESS AS WELL
• IF SUBSTANCE CAN BE CHARACTERISED by structure
  by process etc IF NEW
• IF INDUSTRIAL APPLICATION OF GENE-SEQUENCEPLANT
  VARIETIES
• EXCLUSIONS ORDRE PUBLIC OR MORALITY

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CONTD. - JAPAN

• FOLLOWED THE US/EU LAW

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SCOPE

• PATANTABLE SUBJECT MATTER
• PRODUCTS OF NATURE
• BROAD PATENTS

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BASIS OR JUSTIFICATIONS

• LIVING MATTER -
• PRODUCT OF NATURE
• BROAD PATENTS

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CRITIQUE OF THE JUSTIFICATIONS

• LIFE FORMS JUST CHEMICALS? Cf CANADIAN SUPREME
  COURT ONCOMOUSE CASE
• PRODUCTS OF NATURE BLURRING THE DISTINCTION
• SCIENTIFIC BASIS FOR PATENTING GENES OR NUCLEIC
  ACID
• SUBJECT TO MUTATION
• FUNCTION UNCERTAIN, UNPREDICTABLE
• HUMAN GENES INTEGRAL OR DISTINCT FROM BODY?

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IMPLICATIONS FOR BIOD

• 1. IPRS AND THE HOLY GRAIL OF PLANT GENOMICS the
  golden rice case
• Closure to access key genetic material
• Food security
• Cumbersome 40 licences required

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contd

• 2. BLOCK ON BREEDING NEW PLANT VARIETIES?
• RELATIONSHIP BETWEEN PATENTS AND PVP HOLDERS

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• 3. BROAD PATENTS access to wide segment of
  plant germplasm
• 4. GENES WITH MULTIPLE FUNCTIONS
• 5. DISINCENTIVE FOR DOWNSTREAM INVENTIONS

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• 6. INDIRECT EFFECTS OF IPRS ON GENETIC EROSION
• 7. FOOD SECURITY AND LOCAL FARMING COMMUNITIES
• 8. ACCESS TO TECHNOLOGIES THAT MAKE USE OF
  GENETIC MATERIAL CBD

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• 8. EXTENSION OF TERRITORIAL PATENT RIGHTS
• 9. IPRS AND BENEFIT-SHARING USEFUL TOOL BUT
  extended patentable subject matter - difficulty
  of valuation

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TK AND PATENTS

• JUSTIFICATIONS AND CONCERNS
• 1. ISSUE OF NON-DEPLETETION BY USE BY OTHERS
• - WHO IS OWNER OF INVENTION?
• 2. THRUST OF THREAT TO KNOWLEDGE SYSTEM
  integrity of system market value and
  marginalisation

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SOLUTIONS?

• MAKING GENE AVAILABLE IN NATRUAL FORM
• OPPOSITION AND RE-EXAMINATION
• PRIOR VETTING BY EXAMINERS
• NEGOTIATING BENEFIT-SHARING IN A 2 PHASE PROCESS
  but problems. Contracts negotiated early also
  before any ABS arrangements in place electronic
  transfers of biomaterials
• A BALANCE? SEE THE H5N1 VIRUS DEBATE AT THE
  W.H.O.

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• 6. NO PATENTS FOR PRODUCTS OF NATURE/LIFE
• 7. STRICTER REQUIREMENTS FOR NEW
• 8. LIMITING TO PROCESS PATENTS WHERE NO
  STRUCTURAL CHANGE
• 9. UTILITY REQUIRMENTS FOR INVENTION.
• 10. NO PROTECTION OF PRODUCT BY ANY PRPOCESS
• 11. RESPECT FOR OTHERS EXCLUSIONS

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• 12. FOOD CROPS AND FOOD SECURITY
• 13. ACCESS TO TECHNOLOGIES ON PREFERENTIAL TERMS
• 14. RESEARCH EXEMPTIONS
• 15. ARTICLES 14 AND 15 TRIPS
• 16. NON-RECOGNITION OF IPRS THAT UNDERMINE CBD
  but resistance as in the TRIPS COUNCIL DEBATE

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FINDING THE BALANCE

• RIGHTS OF PROVIDERS AND THE RIGHTS OF USERS
• FOR COMMONS TO BE OPEN versus GREATER PROTECTION
  FOR IPRS
• THE CBD versus TRIPS

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YE OLDE WISDOM

• FOR ALL OUR RELATIONS NOT ONLY THE TWO-LEGGED,
  BUT
• THE WINGED ONES, THE CRAWLING ONES, THE
  FOUR-LEGGED, THE PLANTS, THE TREES AND THOSE THAT
  LIVE IN THE WATER AND THE AIR,
• WE MUST FIND THE BALANCE!!
• THANKSGIVING ADDRESS OF THE IROQUI
• (Mohawk, Seneca, Cayuga, Onodaga, Oneida,
  Tuscora Nations)

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END

• Thank you!