WIPO National Workshop on Intellectual Property for Diplomats Sana - PowerPoint PPT Presentation

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WIPO National Workshop on Intellectual Property for Diplomats Sana

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Title: WIPO National Workshop on Intellectual Property for Diplomats Sana


1
WIPO National Workshop onIntellectual Property
for DiplomatsSanaa, Republic of Yemen20-21
March 2007

  • The TRIPS Agreement
  • and Public Health
  • Roger Kampf
  • WTO Secretariat

2
  • I.
  • Overview
  • Relevant TRIPS Provisions
  • Transition Periods

3
TRIPS Provisions ofDirect Relevance to Public
Health
  • TRIPS Objectives and Principles
  • Patents (incl. compulsory licences)
  • Exhaustion
  • Protection of Undisclosed Information
  • Competition
  • Measures against Counterfeiting
  • Transition periods

4
 Patent Table 
  • Art.27.1 Patentable Subject-Matter
  • ? ? Exclusions Art.27.2 3
  • Art.29 Patent Application
  • ?
  • Art.28 Rights conferred ? Exceptions /
  • Limitations Art. 30 31
  • ?
  • Art.33 20 Years of Protection

5
Article 30 Exceptions
  • Exceptions may be provided if they
  • are limited
  • do not unreasonably conflict with normal
    exploitation of the patent and
  • do not unreasonably prejudice the legitimate
    interests of the patent owner, taking account of
    the legitimate interests of third parties
  • Examples in national legislation
  • Experimental use
  • Use to develop test data required to obtain
    marketing approval

6
Article 31 Compulsory Licences
  • Use of invention without authorization by right
    holder
  • government use
  • use by third parties
  • not limited to specific purposes
  • must meet certain conditions, including
  • prior efforts to obtain voluntary licence
  • exception public non-commercial use or national
    emergency
  • predominantly for supply of domestic market
  • exception adjudicated anti-competitive
    practices
  • adequate remuneration paid to patent owner
  • ? Doha Declaration / Para.6 System

7
Exhaustion of Rights
  • DS mechanism does not apply
  • Except for national / MFN treatment obligations
  • Effects in pharmaceutical sector
  • ? Doha Declaration freedom to establish regime
    which best fits domestic policy
    considerations

8
Article 39.3 Data Exclusivity
  • Members are obliged to protect test data against
  • unfair commercial use when
  • marketing approval for pharmaceuticals or
    agro-chemicals requires submission of undisclosed
    data
  • new chemical entities are utilized
  • origination of data involves considerable
    efforts
  • information is not publicly available
  • disclosure, unless
  • disclosure is necessary to protect the public
  • steps have been taken to protect the data against
    unfair commercial use

9
Transition Periods
  • 1996 2000 2005 2013 2016
  • ___?_______?_______?______?________?__
  • ? ? ? ?
    ?
  • Industrialised DCs and DCs LDCs
    1) LDCs
  • Countries Economies products
    pharma
  • in Transition 1) not (patents
  • previously test data)
  • patented EMRs
  • waived
  • National treatment and MFN treatment obligations
    apply as of 1996

10
  • II.
  • The Doha Declaration on the TRIPS Agreement and
    Public Health

11
The Declaration General Statements
  • Recognition of the gravity of the public health
    problems...,especially those resulting from
    HIV/AIDS, tuberculosis, malaria and other
    epidemics
  • Recognition that intellectual property protection
    is important for the development of new medicines
    and recognize concerns about its effects on
    prices
  • Agreement that the TRIPS Agreement does not and
    should not prevent Members from taking measures
    to protect public health.
  • Reaffirmation that TRIPS can and should be
    interpreted and implemented in a manner
    supportive of Members right to protect public
    health and, in particular, to promote access to
    medicines for all

12
Content of the Declaration
  • Guidance for disputes
  • Clarification compulsory licences
  • right to grant
  • freedom to determine the grounds
  • Clarification of emergency situations
  • right to determine what constitutes a national
    emergency of other circumstance of extreme
    urgency
  • Clarification of exhaustion
  • freedom to establish own regime
  • Transfer of technology
  • reaffirmation of Article 66.2 commitment

13
Instructions for Further Work / Implementation
  • Find expeditious solution to difficulties of
    Members with insufficient / no manufacturing
    capacities in pharmaceutical sector in making
    effective use of compulsory licensing
  • ? General Council Decision of August 2003
    (WT/L/540) Chairmans Statement (WT/GC/M/82,
    para.29)
  • ? General Council Decision of 6 December 2005
    (WT/L/641) - Protocol Amending the TRIPS
    Agreement Chairmans Statement (WT/GC/M/100)
  • Extend LDC transition period as regards
    protection and enforcement of patent rights /
    undisclosed information in the field of
    pharmaceuticals
  • ? TRIPS Council Decision extends LDC transition
    period until 1/1/2016 (IP/C/25)
  • ? General Council Decision waives obligations
    under Article 70.9 (WT/L/478)

14
  • III.
  • August 2003 Decision
  • Implementation of Paragraph 6
  • of the Doha Declaration on the
  • TRIPS Agreement and Public Health


15
What is the problem ?
  • Members can issue compulsory licences for
    importation / domestic production
  • Concerns
  • availability of supply from generic producers in
    third countries
  • mandatory patent protection for pharma products
    as from 2005 in exporting countries with
    important generic industry
  • Problem Art. 31(f) requires production under
    compulsory licenses predominantly for the supply
    of the domestic market of the Member

16
Solution Paragraph 6 System (1)
  • August 2003 Decision is about addressing health
    problem in importing Member and legal problem in
    exporting Member
  • Decision consists of three waivers and calls for
    TRIPS amendment
  • General Council Chairmans statement
  • Decision in effect since 30 August 2003,
    terminates when amendment replaces it for each
    Member

17
Three Distinct Waivers
  • Of 31(f) to exporting Members subject to
    conditions on transparency and safeguards
  • scope and coverage diseases and products
  • importing Members
  • who is eligible
  • notification requirements
  • assessment of manufacturing capacities
  • notification requirements applying to exporting
    Members
  • safeguards against diversion
  • Of 31(h) to importing Members provided paid in
    exporting Member on same products
  • Of 31(f) to any LDC or developing country part of
    RTA where at least half LDCs

18
Difference BetweenTRIPS 1995 and Para.6 System
WTO Member with insufficient manufacturing
capacity for pharmaceuticals
  • Art. 31(h) may be waived to avoid double
    remuneration
  • special provisions for RTAs with 50 LDCs
  • other Art.31 conditions continue to apply

19
Other Elements
  • Facilitation of transfer of technology
  • Annual review substitutes review of waiver by the
    General Council
  • Preservation of existing flexibilities
  • including under Article 31(f)
  • non-violation complaints not available

20
Chairmans Statement
  • Represents key shared understandings of Members
  • Good faith use of the system
  • All reasonable measures to prevent diversion
  • Information on manufacturing capacities (how)
  • Expeditious review in TRIPS Council and good
    offices of DG or Chair of TRIPS Council
  • List of voluntary partial/full opt-out countries

21
  • IV.
  • December 2005 Decision
  • Protocol Amending
  • the TRIPS Agreement


22
GC Decision WT/L/641 of6 December 2005
  • Basis para.11 of August 2003 Decision which
    instructed TRIPS Council to initiate work on
    amendment by end 2003 with a view to its adoption
    within 6 months
  • Adopts Protocol amending the TRIPS Agreement and
    submits it to Members for acceptance
  • Protocol open for acceptance until 1/12/2007
  • Takes effect upon acceptance by two thirds of
    membership
  • ? Note that Paragraph 6 System as established
    under August 2003 Decision continues to apply
    until entry into force of amendment in a Member

23
TRIPS Amendment
  • Waivers of August 2003 Decision are transformed
    into permanent TRIPS amendment
  • ? technical exercise, no changes in substance
    to Paragraph 6 System
  • Inserts in TRIPS Agreement
  • new Article 31bis consisting of
  • 3 waiver provisions of August 2003 Decision
  • non-application of non-violation complaints
  • preservation of TRIPS flexibilities
  • Annex setting out terms for using Paragraph 6
    system
  • Appendix to Annex dealing with assessment of
    manufacturing capacities (former annex to August
    2003 Decision)

24
Statements by ChairmanRecognition by MC
  • Chairmans Statement
  • re-read prior to adoption of GC Decision
  • updates list of full opt-out countries
  • Chairmans Statement on non-violation complaints
    amendment without prejudice to overall question
    of applicability of NVCs to TRIPS
  • Hong Kong MC in December 2005 Ministers welcome
    work on TRIPS amendment to implement August 2003
    Decision

25
  • V.
  • Final Remarks


26
Implementing Legislation in Exporting Members
  • Based on information shared in the TRIPS Council
  • Norway, Canada, India, EC (in effect)
  • Korea
  • Switzerland (in process)
  • China also adopted implementing legislation in
    December 2005

27
Use of Paragraph 6 System
  • Possible reasons for absence of notifications so
    far
  • generic medicines available outside patent system
  • legislative changes in exporting countries recent
    or not yet done
  • meant to address situation where non-predominant
    limit proves restrictive
  • voluntary licences and reduction of prices
    offered by patent owners
  • Remember system not to be used if
  • local production
  • voluntary licences
  • no patents in exporting country
  • exporting country not a WTO Member

28
Concluding Remarks
  • TRIPS forms part of the solution next to other
    important factors infrastructure, national
    health systems, procurement regimes, import
    tariffs, etc.
  • Increased recognition of TRIPS flexibilities
  • ? but need for each country to take the
    necessary steps at national level to avail itself
    of such flexibilities
  • TRIPS beyond Doha new rules ? What role for DSU
    and FTAs ?

29
Some References
  • Doha Declaration on TRIPS and Public Health
    (WT/MIN(01)/DEC/2)
  • Decision on the implementation of paragraph 6 of
    the Doha Declaration on TRIPS and Public Health
    (WT/L/540 and Corr.1)
  • Decision on an amendment to the TRIPS Agreement
    (Protocol) (WT/L/641)
  • Decision on extension of transition period for
    LDCs with respect to pharmaceutical products
    (IP/C/25)
  • Decision on general extension of transition
    period for LDCs (IP/C/40)
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