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
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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
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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
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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
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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