How%20to%20operationalize%20the%20disclosure%20requirement%20at%20the%20national%20level%20in%20a%20manner%20supportive%20to%20the%20TRIPS%20Agreement%20and%20the%20CBD?

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How to operationalize the disclosure requirement
at the national level in a manner supportive to
the TRIPS Agreement and the CBD?

• Dr. N.S. Gopalakrishnan,
• Centre for IPR Studies, School of Legal Studies,
• Cochin University of Science Technology,
• Cochin, Kerala, India

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Over view

• Disclosure in IP Laws
• Details to be disclosed on source and origin
• Disclosure of evidence of PIC ABS
• Implications for non-disclosure or wrong
  disclosure
• Indian Experience

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Disclosure in the IP Laws

• Patent and Plant Varieties Protection laws
• Obligation to disclose
• Details of the country of source and origin
• Evidence of PIC and ABS
• Nature of the obligation mandatory
• Implications for non-disclosure and wrong
  disclosure

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Obligation to Disclose

• Obligation to disclose in the patent application
• Use of genetic material and tk in the invention
  directly or indirectly
• Directly
• Part of the claims in the invention
• Indirectly
• Used during the process of developing the claimed
  invention
• Used as a necessary prerequisite for the
  development of the invention
• Used to facilitate the development of the
  invention and
• Used as necessary background material for the
  development of the invention.

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Disclosure of Source

• Source of genetic materials
• Complete details of the place or person from whom
  the material was obtained by the applicant
• Individual, collection centers like gene bank or
  botanical garden, research institutions, open
  market etc.
• Details of the disclosure
• Name of the person or institution etc, details of
  the nature of the genetic material, knowledge
  about the genetic material and the source of the
  information

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Disclosure of Origin

• Country of origin of the genetic material in its
  original state - without any modification
• Name of the country
• Name of the place with in the country
• Details of the nature of the genetic material
• Details of the knowledge about the genetic
  material
• Details of the source of the information

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Evidence of PIC ABS

• Document issued by the authority recognized by
  the national law of country of origin
• Declaration in the application
• Attach the certificate issued by the competent
  authority showing PIC and ABS
• National/regional authority
• Agency recognized by local or indigenous
  community
• Declare in the application that no legal
  mechanism in the country of origin
• No arrangement with in the local or indigenous
  community

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Nature of obligation

• What is the nature of obligation?
• With reference to source
• Full responsibility to give correct information
• With reference to country of origin
• Information collected after making reasonable
  effort
• With reference to PIC and ABS
• Full responsibility to produce original documents
  issued by the competent authority

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Implications

• Consequences of non-disclosure or wrong
  disclosure in the patent application
• Before grant of patent
• With hold the examination of patent
• Provide sufficient time for disclosure
• If not disclosed application deemed to have
  withdrawn the application
• After grant of patent
• Revocation
• Transfer of rights
• Modification of claims

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Biodiversity Law

• Special Legislation on PIC and ABS
• Obligation to take PIC and ABS
• Identification of the persons/authorities
  authorized to issue certificate of PIC and ABS
• Form of the certificate showing details
• Time bound procedure for the issue of
  certificates

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Indian Experience

• Patent (Amendment) Act 2002
• TK is not an invention
• an invention which in effect, is traditional
  knowledge or which is an aggregation or
  duplication of known properties of traditionally
  known component or components are not
  inventions for grant of patents (Section 3 (p)).

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Indian Experience

• Obligation to disclose
• Disclose the source and geographical origin of
  the biological material in the complete
  specification, when used in an invention (Section
  10(4)(D)
• Prior art Anticipation oral knowledge
• That the invention so far as claimed in any claim
  of the complete specification is anticipated
  having regard to the knowledge, oral or
  otherwise, available within any local or
  indigenous community in India or elsewhere

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Indian Experience

• Grounds of opposition and revocation
• that the complete specification does not disclose
  or wrongly mentions the source or geographical
  origin of biological material used for the
  invention
• Anticipated by oral or documentary knowledge
  (Sections 25(1)(j) (k) and 64(1)(p) (q))

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Indian Experience

• The Protection of Plant Varieties and Farmers'
  Rights Act 2001
• Disclosure in the application full details of the
  prior art of TK including location (section 18(e)
• Evidence of prior informed consent (section 18(h)
  
• Take prior informed consent in case of use of
  essentially derived varieties - Section 43

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Indian Experience

• The Biological Diversity Act, 2002
• Prior informed consent for use of TK associated
  with genetic resources from the National
  Biodiversity Authority by the foreigners
• Prior informed consent from the NBA before grant
  of patent protection for the invention based on
  genetic resources of India
• Sharing of benefits with the community

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Challenges

• Create new institutional arrangements in patent
  offices of the countries rich with genetic
  resources for prior art search and examination
• Creation of traditional knowledge documentation
• Pool of experts in traditional knowledge
  including TK holders to assist examination of the
  patent application
• Patent offices of foreign countries to seek
  assistance from these institutions for prior art
  search and examination in case of patent
  applications based on genetic resources and
  associated TK of that country.
• Recognize these institutions as international
  searching and examination authorities for PCT
  applications

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