Challenges for the patent system genetic resources, traditional knowledge, benefit sharing and equit

1
Challenges for the patent system -genetic
resources, traditional knowledge,benefit sharing
and equity

• KIPO Seminar
• June 14, 2005
• Presentation by Antony Taubman

2
Overview

• Linking equitable benefit-sharing from genetic
  resources and the patent system
• Issues and processes in WIPO fora
• Some working materials
• Cooperation with the Convention on Biological
  Diversity (CBD)
• Some substantive questions

3
Overview

• Linking equitable benefit-sharing from genetic
  resources and the patent system
• Issues and processes in WIPO fora
• Some working materials
• Cooperation with the Convention on Biological
  Diversity (CBD)
• Some substantive questions

4
Access equitable benefit-sharing what links
to the patent system?

• Access and benefit-sharing in line with
  objectives of CBD and FAO International Treaty
• e.g. CBD objectives (i) conservation of
  biological diversity (ii) sustainable use of its
  components (iii) fair and equitable sharing of
  the benefits arising out of the utilization of
  genetic resources
• Patent system - in particular treatment of
  inventions that arise out of the utilization of
  genetic resources (and associated TK)

5
Access equitable benefit-sharing what links
to the patent system?

• Two essential scenarios put forward
• Direct patenting of source material
• a patent (or application) directly claims as an
  invention genetic resources (or associated
  traditional knowledge) obtained from a separate
  source
• Patenting inventions derived from source material
• a patent (or application) claims an invention
  that is somehow derived from or somehow uses
  genetic resources or TK - this link expressed in
  several ways
• Has the GR/TK been legitimately accessed?
• Is the patent consistent with equitable
  benefit-sharing?

6
Access equitable benefit-sharing what links
to the patent system?

• Opens up some fundamental questions
• Legal what obligations arise (or should arise)
  from the circumstances of access and the nature
  of use of genetic resources (and associated TK)?
• How does (or should) this affect
• the entitlement to apply for and be granted a
  patent (should the applicant receive a patent?)
• the patentability of the invention as such (does
  the invention
• other interests and entitlements (e.g. equitable
  or ownership interests, expectation to benefit)
• other obligations (e.g. obligation to report on
  patenting activity, obligation to disclose)

7
Access equitable benefit-sharing what links
to the patent system?

• Disclosure requirements
• various existing mechanisms, national/regional
  legislative initiatives,and international
  proposals
• create or confirm a legal linkage betweenGR or
  TK used and the claimed invention
• beyond disclosure per se (provision of
  information), have variously been linked to
• patentability of invention as such
• entitlement to apply or be granted a patent
• capacity to enforce a patent

8
Access equitable benefit-sharing what links
to the patent system?

• Supplementing basic legal issues, some practical
  questions
• E.g. what kinds of practical arrangements would
• reduce the likelihood of illegitimate patents
  being granted that claim GR/TK directly, or
  non-inventive derivatives of GR/TK
• continuing work on various defensive protection
  and enhanced search and examination measures
• facilitate equitable sharing of benefits from
  legitimate patenting of derivative inventions
  (what kinds of agreements and partnerships
  promote monetary and non-monetary benefit sharing
  - Bonn Guidelines)
• information and capacity building work (database
  of benefit sharing agreements, practical guide to
  supplement general ABS capacity-building
  projects)
• UNEP-WIPO study on IP aspects of access and
  benefit-sharing

9
Overview

• Linking equitable benefit-sharing from genetic
  resources and the patent system
• Issues and processes in WIPO fora
• Some working materials
• Cooperation with the Convention on Biological
  Diversity (CBD)
• Some substantive questions

10
WIPO fora and GR/patent issues

• Intergovernmental Committee on IP and Genetic
  Resources, TK Folklore
• considers legal issues (technical study)
• oversees capacity-building initiatives
• Standing Committee on Patent Law
• proposed text for Article 2 of draft Substantive
  Patent Law Treaty
• reference to issue of disclosure at last meeting
• Working Group on PCT Reform
• Swiss proposal for amendment of PCT Regulations
  to allow for disclosure mechanisms

11
Overview

• Linking equitable benefit-sharing from genetic
  resources and the patent system
• Issues and processes in WIPO fora
• Some working materials
• Cooperation with the Convention on Biological
  Diversity (CBD)
• Some substantive questions

12
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• Analyses options under five aspects (Section VI)
  
• relationship between the claimed invention and
  the GR/TK or what would be a sufficient link
  between the two to trigger a disclosure
  requirement
• legal principle forming basis of requirement
• nature of the obligation placed on the applicant
• consequences of failure to comply with the
  requirement
• how the requirement would be implemented,
  verified or monitored
• Sets out specific methods for disclosure (Section
  VIII)

14

• Possible disclosure scenarios (191-199)
• TK as relevant prior art
• TK holder as inventor
• Disclosure of origin of genetic
  resources(enablement and best mode)
• Disclosure of the actual genetic resources
• Evidence of entitlement to apply
• Registration of equitable/ownership interests
• Disclosure of information in compliance with
  other legal obligations (e.g. access regimes)
• Specific GR/TK disclosure mechanisms
• various specific mechanisms, various legal bases
  for requirements

15
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UNEP-WIPO study on ABS and IP

• Pre-launch version submitted to Ministerial
  Conference, CBD COP VII
• Joint UNEP-WIPO launch imminent
• (inspection copies available today)
• Professor AK Gupta (Honey Bee Network)
• explores three case studies of the role of
  patents in access and benefit sharing
• independent analysis of the practical and legal
  issues that arise, limitations of current
  approaches

17
Overview

• Linking equitable benefit-sharing from genetic
  resources and the patent system
• Issues and processes in WIPO fora
• Some working materials
• Cooperation with the Convention on Biological
  Diversity (CBD)
• Some substantive questions

18
CBD invitation to WIPO

• Convention on Biological Diversity (CBD)
  Conference of Parties (COP) VI
• Decision VII/19 - interrelation of access to
  genetic resources and disclosure requirements in
  IP rights applications

19
Overview

• Linking equitable benefit-sharing from genetic
  resources and the patent system
• Issues and processes in WIPO fora
• Some working materials
• Cooperation with the Convention on Biological
  Diversity (CBD)
• Some substantive questions

20
Some substantive questions

• Legal and policy issues concerning
• eligibility of inventions per se for protection
• eligibility of applicants to gain patents
• ownership, inventorship and equitable interests
• capacity to exploit and benefit from patents
• interplay between obligations incurred in one
  jurisdiction arising from access to genetic
  resources, and the operation of the patent system
  in another jurisdiction
• Incentives to use patent system to promote ABS
• Sanctions for failure to comply with ABS
  regulations

21
The various avenues proposed

• CBD invitation
• model provisions
• practical options for triggers of disclosure
  requirements
• options for incentive measures for applicants
• implications for various WIPO-administered
  treaties
• IP-related issues from proposed international
  certificate
• PCT system Swiss proposal to enable disclosure
  requirements
• Standing Committee on Patent Law reference to
  genetic resources in draft, disclosure issue
  raised
• Intergovernmental Committee proposed guidelines
  and recommendations, policy and legal development
  

22
Overview of the issues

• Illegitimate patenting, and possible responses
• legal
• practical
• The call for positive protection of traditional
  knowledge
• an update on the WIPO process
• The challenges for the patent system
• TK as prior art
• TK practitioners as persons skilled in the art

23
Overview of the issues

• Illegitimate patenting, and possible responses
• legal
• practical
• The call for positive protection of traditional
  knowledge
• an update on the WIPO process
• The challenges for the patent system
• TK as prior art
• TK practitioners as persons skilled in the art

24
The usual suspects
but what is biopiracy? when has it occurred?
25
Is the problem

• the use of the patent system to facilitate - or
  validate - or encourage - the misappropriation of
  genetic resources and traditional knowledge?
• incidentally (or through indifference)
• or as a matter of policy (maintaining a
  technological edge/trade advantage)?
• the perception that it is so used?
• not a problem at all but merely evidence of the
  healthy transparency of the patent system?
• an artifact of trade-related negotiations?

26
Practical issues for the patent system concerning
traditional knowledge/GR

• recognition and of TK as prior art to pre-empt
  patents on TK/GR subject matter (defensive
  protection)
• definition of prior art (e.g. disclosed but not
  documented)
• broader scope of disclosed knowledge that
  pre-empts claims to novelty of the invention
• recognition of oral disclosure as prior art
• documentation of TK (translation, digitisation,
  dissemination)
• TK Digital Library
• making documented TK/GR practically available
  during patent examination
• TK within the International Patent Classification
• TK within the Patent Cooperation Treaty (PCT)
  minimum documentation required for International
  Search Authorities
• inventories of periodicals and databases
  containing TK

27
The dilemma of defensive publication is the
solution the problem?
Tribes query motives of knowledge databases
Nature, 31/10/2002 Attempts to set up databases
of traditional knowledge are coming under attack
from the very groups they are intended to
benefit. WIPO is keen to establish databases
in which indigenous groups would record their
cultural knowledge. Patent examiners would be
encouraged to check a countrys databases to see
if a new idea, such as a plant-based medicine, is
part of the traditional knowledge of that
nation. But delegates at the Worlds Indigenous
Peoples conference, held on 1619 October in
Kelowna, British Columbia, described how some
groups are concerned that the databases could be
used to exploit their cultural heritage.
28
The dilemma of defensive protection

• Protection against patent rights may require
  defensive publication
• But defensive publication requires a commitment
  to putting TK in the public domain
• how to make TK available to the patent examiner
  without putting it in the public domain?
• And, in practice, facilitating access to
  published TK may stimulate the use of the TK by
  third parties
• Pyrrhic publication

29
Clarifying the issues...

• Where there are claims of misappropriation of TK,
  or of genetic resources, is this due to
• Obtaining illegitimate patents?
• Or unauthorised use of the TK or genetic
  resources?
• A safeguard against obtaining patent rights
  (defensive publication) may precipitate the
  unauthorised use
• Existence of a patent may be more the symptom of
  a distinct, underlying problem
• a patent document brings to light unauthorized
  use or commercialisation, possible in breach of
  access laws or of contracts or licenses

30
The patent system genetic resources/TK

• Existing patent principles
• invention must be new and non-obvious, having
  regard to prior art
• title to patent comes from (all) inventors
• must disclose all that is necessary to carry out
  the invention as claimed
• in some jurisdictions
• requirement to disclose all known prior art
• fraud on the patent office / clean hands
• possible considerations of equitable interests

31
Practical issues for the patent system concerning
genetic resources...

• Concerns about patents granted on inventions
  based on genetic resources or traditional
  knowledge
• are the patents invalid?
• Not novel obvious
• Inventorship not properly reflected
• were the genetic resources illicitly accessed?
• A breach of contract or access agreement?
• A breach of national laws - trespass,
  unauthorised export of biological samples, breach
  of bioprospecting laws, breach of confidence
• are there ethical issues?

32
The patent system genetic resources

• The biopiracy scenario
• A patent is filed in one country Nomos
• The claimed invention is based on genetic
  resources or TK obtained in another country
  Phusis
• The genetic resources or TK were obtained without
  prior informed consent, or
• The patent has been filed without consent of the
  custodians of the TK/GR or in breach of
  restrictions under contract or regulations

33
What is the solution?

• two distinct national laws Nomos and Phusis
• and neighbouring jurisdictions?
• two distinct legal systems
• regulation of access to GR/TK
• grant of patent rights for inventive activity
• for an invention based on TK
• was the TK part of the inventive process?
• was the TK useful background for the inventive
  process? Is it part of the relevant prior art?
• or was it a useful lead (e.g. showing that a
  plant is worth screening in general for its
  pharmaceutical effects)? Is the invention still
  based on the TK?
• or the TK a necessary precondition - how is this
  defined?

34

• For an invention based on genetic resources
• what was the relationship between the patented
  invention and the genetic resource?
• is access to the genetic resources necessary to
  carry out the invention? Is identification of
  the actual source significant in itself (e.g. the
  resource is not generally available)?
• is access subject to agreement with the
  owners/custodians/access providers of genetic
  resources, or subject to national laws?
• What should be done to remedy breach of this
  agreement or of the laws
• Is the access provider eligible for share in the
  ownership of the patent?

35

• Solutions within the patent system
• Existing mechanisms
• Proposals for disclosure obligations
• source of traditional knowledge or GR
• prior informed consent regarding access
• documentation relating to access
• what is based on does this relate to
  inventorship or existing disclosure obligations
• what is the role of one national patent system in
  enforcing access regulations in another country
• Solutions through enforcement of national
  regulations and international principles on
  genetic resources and traditional knowledge
• Market solutions venture capital or development
  capital reduce commercial risk through an
  agreed statement of provenance

36
Further development of the debate

• Four distinct legal bases
• administrative compliance (formality
  requirement/form or contents)
• eligibility of the invention - technical
  patentability
• eligibility of the applicant - entitlement to
  apply/be granted
• a stand-alone criterion for obtaining a patent or
  exercising a patent right
• The debate overlooks the fact that one can have
• a formality requirement with teeth or with
  sanctions
• a patentable invention for which the applicant is
  not entitled to be granted a patent
• Is the objective
• use of the patent system to monitor illegal
  activity in foreign jurisdictions (disclose
  origin/legal basis of access)
• sanctions for illegal activity (invalidate
  patent)
• benefit-sharing (exercise rights to/under the
  patent)

37
The technical-legal challenges

• Private international law the applicability and
  interpretation of, and compliance with, an access
  contract vis-à-vis a patent
• patent examiner/court in Canada called on to
  assess whether it conforms with a Guatemalan
  access contract
• to access the genetic resource at all
• to use the genetic resource in the manner
  described to invent the invention
• or to carry out the invention
• to apply for a patent in Canada with or without
  the access provider as a co-applicant (in the
  case of TK, as co-inventor or sole inventor)
• rough parallel - law of employees patents
  State interest in patents (US Bayh-Dole etc)

38
The technical-legal challenges

• International patent law
• PCT-PLT conformity
• TRIPS conformity
• Domestic patent law
• clean hands doctrine?
• Extension/mere application of disclosure
  principles?
• Entitlement to be granted/unencumbered chain of
  title from the inventor?

39
Overview of the issues

• Illegitimate patenting, and possible responses
• legal
• practical
• The call for positive protection of traditional
  knowledge
• an update on the WIPO process
• The challenges for the patent system
• TK as prior art
• TK practitioners as persons skilled in the art

40
traditional values and IP at odds?

• What does WIPO have to do with traditional
  knowledge? Disquiet on the part of proponents and
  opponents of the received IP system concerns
  raised about
• imposing an IP straitjacket on traditional
  cultures, overriding collective values of
  indigenous and other traditional communities
• IP concerns mainstream technology
  commercialises commodifies knowledge culture
  facilitates misappropriation of TK and cultural
  expressions
• IP rights are atomistic, private, individual - at
  odds with values of traditional communities
• IP is concerned with innovation, not tradition

41
Where did the IGC come from, where is it going?

• From 1998-99, WIPO visited some 60 locations for
  dialogue with around 3,000 representatives of TK
  holder communities
• idea was to base the new program on direct
  learning of the needs expectations of TK
  holders themselves
• these insights still central to WIPOs work
• follow-up case studies look more thoroughly into
  needs and expectations, practical and legal
  problems

42
Where did the IGC come from, where is it going?

• IGC established in 2001
• building on practical experience worldwide
• clarifies that this is an existing area of IP law
  and practice many laws and practical cases
  worldwide, within and beyond the conventional IP
  system
• but what is the international dimension?
• Inclusion a major concern
• participation of NGOs has accelerated (?100 new
  accreditations)
• specific initiatives for Indigenous local
  communities
• working documents draw extensively on these
  insights

43
Towards resolution back to basics

• The IP system criticized for misappropriating
  TK/TCEs, neglecting the interests of Indigenous
  local communities.
• But these very concerns often expressed in terms
  that echo core principles of the IP system
• promoting equity and balance,
• reconciling private and collective interests,
• recognizing distinctive origins and the
  legitimate source of innovation and creativity,
• suppressing free-riding and unjust enrichment,
• defending distinctive reputations from
  illegitimate exploitation,
• providing for rights of attribution and integrity
• Could this observation be the essence of an
  emerging consensus?

44
What kind of challenge to the IP system?

• Indigenous and local communities continue to
  innovate and create within their traditions
• but do not necessarily see innovation in
  isolation or in individual terms
• seek recognition for their past continuing
  contribution to humanitys cultural
  intellectual heritage
• seek appropriate respect for their customary laws
  and valuesas the basis for a partnership of
  trust

45
What kind of challenge to the IP system?

• IGC a process of reviewing the core principles of
  IP law, assessing how to apply those principles
  for equitable protection of TK and TCEs
• analysing validity, equity, effectiveness of IP
  system from the distinct vantage point of
  indigenous and local communities
• responding to critical concerns about the
  relevance and legitimacy of IP system, the IGC
  has seen deep reflection on the nature of IP, its
  objectives, its assumptions, its limitations and
  its boundaries
• recalling that intellectual property shades
  off into surrounding forms of civil liability
  (Cornish)
• laws on civil liability, unfair competition,
  unjust enrichment, biodiversity access,
  Indigenous affairs, cultural policy, etc.

46
Some key substantive issues

• misappropriation - what is it to misappropriate
  TK/TCEs, what is the cause of action and the
  nature of the damage?
• retroactivity - is the existing public domain
  legitimate inviolable?
• localisation - how to recognize and defer to a
  communitys customary law?
• collectivity - what legal status or legal
  personality for traditional communities?
• ownership - what is the nature of custodianship?
  Who benefits?
• subject matter - what makes knowledge and
  cultural expressions traditional ?

47
Some key process issues

• coordination - already an active area of national
  and regional legislation - what is the
  international layer?
• interface with IP law - what is the sui generis
  element?
• interface with other law - access regimes for
  genetic resources, cultural policy, etc. what
  is the (adapted, expanded or sui generis) IP
  element?
• depolarization - growing tacit consensus,
  underlying shared interests
• choice of forum /interagency comity - what home
  for genetic resources, what legal practical
  linkages substance vs. legal status

48
New IGC mandate for 2004-05

• continue work on questions included in previous
  mandate
• new work to focus on consideration of
  international dimension, without prejudice to
  work in other fora,
• no outcome is excluded, including possible
  development of an international instrument(s)
• the ICG urged to accelerate its work and to
  present a progress report
• International Bureau to continue to assist by
  providing necessary expertise and documentation.

49
folklore/traditional cultural expressions (TCEs)

• IGC decides in March 2004
• focus and accelerate substantive work on TCEs,
  including the preparation of drafts of
• an overview of policy objectives and core
  principles for protection of TCEs
  (WIPO/GRTKF/IC/7/3)
• a shared international perspective on protection,
  drawing on the experience of numerous countries
  and communities
• an outline of the policy options and legal
  mechanisms (WIPO/GRTKF/IC/7/4)
• a menu of options for national and regional
  action, based on choices already taken

50
Traditional knowledge (TK)

• IGC decides in March 2004
• focus and accelerate substantive work on TK,
  including the preparation of drafts of
• an overview of policy objectives and core
  principles for protection of TK
  (WIPO/GRTKF/IC/7/5)
• a shared international perspective on protection,
  drawing on the experience of numerous countries
  and communities
• an outline of the policy options and legal
  mechanisms (WIPO/GRTKF/IC/7/6)
• a menu of options for national and regional
  action, based on choices already taken

51
What objectives?

• Recognise value
• Promote respect
• Meet the actual needs of holders of traditional
  knowledge
• Empower holders of TK
• Support traditional knowledge systems
• Contribute to safeguarding traditional knowledge
• Repress unfair and inequitable uses
• Concord with relevant international agreements
  and processes

• Promote innovation and creativity
• Promote intellectual and technological exchange
• Promote equitable benefit sharing
• Promote community development and legitimate
  trading activities
• Preclude the grant of invalid IP rights
• Enhance transparency and mutual confidence
• Complement protection of traditional cultural
  expressions

52
What principles?

• Protection against misappropriation-
  suppression of misappropriation- general nature
  of misappropriation- acts of misappropriation-
  unfair competition
• Recognition of the customary context
• Legal form of protection
• General scope of subject matter
• Eligibility for protection
• Beneficiaries of protection
• Equitable compensation and recognition of
  knowledge holders
• Principle of prior informed consent
• Exceptions and limitations
• Duration of protection
• Application in time
• Administration and enforcement of protection
• International and Regional Protection

• Responsiveness to the needs and expectations of
  TK holders
• Recognition of rights
• Effectiveness and accessibility
• Flexibility comprehensiveness
• Equity and benefit-sharing
• Consistency with existing legal systems
• Respect for and cooperation with other
  international and regional instruments and
  processes
• Respect for customary use and transmission of TK
• Recognition of the specific characteristics of TK

53
policy objectives core principles drawing on
existing principles, regional and national
positions, previous IGC statements, IGC working
documents
options for recognizing TK/TCE protection in
foreign jurisdictionsscope for national
treatment, mutual recognition, etc. (document.
6/6)
An emerging framework
elements of TK protection sources may include
docs 5/8 6/4
elements of folklore/ TCE protection sources may
include documents 5/3 6/3
measures on IP genetic resources sources may
include documents 5/6 6/5 (general principles
on IP aspects of licensing access) and 5/10
(patent disclosure issues)
54
Genetic resources

• Draft guide on IP aspects of access and benefit
  sharing contracts - possible model provisions
• need to supplement and support CBD processes
  without preempting outcomes, eg on international
  regime on access and benefit-sharing
• Work on patent disclosure mechanisms for
  inventions based on TK and genetic resources
• study prepared at the request of the CBD
• further work to be reported to the CBD, so the
  CBD can provide additional information to the
  WIPO for its consideration in the spirit of
  mutual supportiveness

55
CBD invitation on genetic resources issues

• CBD COP invites WIPO to examine, and where
  appropriate address, taking into account the need
  to ensure that this work is supportive of and
  does not run counter to the objectives of the
  Convention, issues regarding the interrelation of
  access to GR and disclosure requirements in IP
  rights applications, including, inter alia
• (a) Options for model provisions on proposed
  disclosure requirements
• (b) Practical options for IP rights application
  procedures with regard to the triggers of
  disclosure requirements
• (c) Options for incentive measures for
  applicants
• (d) Identification of the implications for the
  functioning of disclosure requirements in various
  WIPO-administered treaties
• (e) Intellectual property-related issues raised
  by proposed international certificate of
  origin/source/legal provenance
• and regularly provide report to the CBD on its
  work, in particular on actions or steps proposed
  to address the above issues, in order for the CBD
  to provide additional information to the WIPO for
  its consideration in the spirit of mutual
  supportiveness.

56
Discussions on genetic resources issues

• Genetic resources and patenting issues have
  arisen in
• the Intergovernmental Committee
• the Working Group on PCT reform
• the Standing Committee on Patents
• Meeting at WIPO tomorrow (September 15) on
  genetic resources and intellectual property
• access and benefit-sharing generally, with views
  of CBD, FAO, UNEP, WTO
• five individual expert perspectives on patent
  disclosure and genetic resources
• UNEP-WIPO study on IP and benefit-sharing

57
Overview of the issues

• Illegitimate patenting, and possible responses
• legal
• practical
• The call for positive protection of traditional
  knowledge
• an update on the WIPO process
• The challenges for the patent system
• TK as prior art
• TK practitioners as persons skilled in the art

58
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59
Example of traditional knowledge patenting

• The problem concerns that TK may be the subject
  of third parties patent claims
• e.g. turmeric patent (US 5,401,504)Claim 1 A
  method of promoting healing of a wound in a
  patient, which consists essentially of
  administering a wound-healing agent consisting of
  an effective amount of turmeric powder to said
  patient.
• Turmeric powder (Raja Foods, Lincolnwood, Ill.)
  was applied topically in an amount of 0.5
  gm/cm.sup.2 of wound surface turmeric has long
  been used in India as a traditional medicine for
  the treatment of various sprains and inflammatory
  conditions (Rao T S et al., Indian J. Med. Res.,
  75574-578, 1982)
• The goal establish whether the claim is novel
  and not obvious
• ensure that any patent granted conforms to public
  policy interests ingrained in patentability
  criteria

60
Example of traditional knowledge patenting

• The problem concerns that TK may be the subject
  of third parties patent claims
• Legal aspect does the TK have the status of
  prior art (orally transmitted, made public in a
  foreign country) and is it relevant to assessment
  of non-obviousness (is the TK holder a person
  skilled in the art)?
• Practical aspect ensure information about the
  TK appears - literally - on the examiners screen

61
TK patenting issue and multilateral standards

• Substantive Patent Law Treaty (SPLT) on
  novelty/non-obviousness
• the prior art with respect to a claimed
  invention shall consist of all information which
  has been made available to the public anywhere in
  the world in any form- includes TK orally
  transmitted in a foreign country
• a person skilled in the art means a hypothetical
  person with general knowledge and ordinary skill
  in the relevant field of the art... (The general
  knowledge does not need to exist in writing, but
  may form part of the general body of know-how of
  the average skilled person)
• Patent Cooperation Treaty (PCT) reform process
  avoid unnecessary work duplication enhanced
  minimum documentation (TK publications)
• International Patent Classification revision to
  incorporate TK
• Intergovernmental Committee an array of measures
  for defensive protection of TK - greater
  practical recognition of TK as prior art
• Proposal for guidelines or recommendations to
  authorities responsible for patent search and
  examination to take greater account of TK
  systems.

62
Positive protection through patents -
implications for patent tests workload sharing

• State Intellectual Property Office (SIPO) of
  China received 20,864 patent applications in the
  field of traditional Chinese medicine (TCM) up to
  2002
• SIPO has a team of specialist patent examiners
  with expertise in the field of TCM.
• Countries with rich backgrounds in TK more likely
  to develop practical understanding in making
  judgements about whether claimed inventions are
  truly novel or inventive, having regard to the
  standards and conceptual framework of the TK
  holders and traditional communities themselves.
• Experience would illustrate how the conceptions
  of novelty, inventive step, and person skilled in
  the relevant art, may be adapted and applied most
  appropriately to innovations based on TK
• Ccould in time lead to the recognition of certain
  regional or national patent offices in countries
  which are the source of certain TK systems as
  having specific expertise in providing at least
  an initial judgement on the validity of patent
  claims directed to material using such TK
  systems.

63
The call for protection the deep forest case

• 1973 UNESCO recording Fateleka and Baegu Music
  from Malaita
• Baegu lullaby from Northern Malaita, "Rorogwela,"
  sung by Afunakwa
• Melody and vocal performance used in Pygmy
  Lullaby by Deep Forest
• Attributed to African cultures
• Huge commercial success
• Immediate legal issues musical work,
  performance, moral rights, economic rights
• Broader issues preservation vs. protection
  enforcement of legal rights recognition of
  traditional works, communal ownership, customary
  law
• Policy choices
• sui generis (stand alone) protection?
• adapted or extended use of existing intellectual
  property system?
• better, more equitable use of existing
  intellectual property system?

64
The call for protection the deep forest case

• 1973 UNESCO recording Fateleka and Baegu Music
  from Malaita
• Baegu lullaby from Northern Malaita, "Rorogwela,"
  sung by Afunakwa
• Sui generis protection under existing treaties
• WIPO Performers and Phonograms Treaty protects
  performances of expressions of folklore
• Moral rights
• Economic rights even if recordings are not for
  commercial gain
• Berne Convention protects certain unpublished
  works of unknown authorship
• including traditional musical works
• fifty years after the work has been lawfully made
  available to the public.

65
medicinal substances derived from plants156 PCT
applications published in 2002-3
IPC sub-classes A61K 35/78, 35/80, 35/82 and
35/84
66

• Asian Group The IGC should explore practical
  means of integrating into substantive patent
  examination procedures the teaching of TK systems
  in such a way that the person with ordinary
  skill in the art who is referenced in the
  determination of inventive step includes a person
  with ordinary skill in the relevant TK systems.
• Peru need to evaluate how it would be possible
  to organize and systematize much of this
  information on genetic resources and TK and the
  role that could be played by a national database
  in that regard. In summary, how is it possible
  to articulate this database and information with
  the search procedures and examinations of the
  main patent offices throughout the world in order
  to avoid patents being granted on the basis of
  partial and limited examinations of novelty and
  inventive step?
• Latin America and the Caribbean (GRULAC) the
  IGC could look into ways of devising a means of
  settling this problem at the international level
  in such a way as to include within the state of
  the art also that which has become known through
  use, traditional marketing, oral disclosure or
  any other means whereby a product or process has
  been made known to the public.

67
TK and multilateral negotiations on patents

• Before these diverse developments, risk that the
  patent system and the realm of TK may be seen as
  effectively distinct

Patent system
Traditional knowledge
68
TK and multilateral negotiations on patents

• Before these diverse developments, risk that the
  patent system and the realm of TK may be seen as
  effectively distinct
• Legal recognition of the scope of relevant prior
  art and persons skilled in the art broadens the
  horizon of the patent system to recognize TK

Patent system
69
TK and multilateral negotiations on patents

• Before these diverse developments, risk that the
  patent system and the realm of TK may be seen as
  effectively distinct
• Legal recognition of the scope of relevant prior
  art and persons skilled in the art broadens the
  horizon of the patent system to recognize TK
• Further practical legal steps extend the
  effective awareness actual recognition of TK
  during examination

Patent system
70
TK and multilateral negotiations on patents

• Before these diverse developments, risk that the
  patent system and the realm of TK may be seen as
  effectively distinct
• Legal recognition of the scope of relevant prior
  art and persons skilled in the art broadens the
  horizon of the patent system to recognize TK
• Further practical legal steps extend the
  effective awareness actual recognition of TK
  during examination

Patent system
Traditional knowledge
71
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