Lessons from e-TRIPS
TRIPS Transparency Provisions
TRIPS Council
1
TRIPS Transparency Tools
Notifications
• Members’ IP laws
• Checklist on enforcement measures
• Contact points for cooperation
Reviews
• Members’ IP laws
• Geographical
indications (checklist)
• Biotech patenting and related questions
(checklist)
• Implementation of TRIPS
Reports
• Technical assistance programs
• Technology transfer for LDCs
Notified IP Laws
0 1000 2000 3000 4000 5000 6000
No. Cumulative
~5,400 documents relating to 4,000+ laws
from 138 Members
Notified IP Laws
Notified IP Laws
0 200 400 600 800 1000 1200
1995 1996 1997 1998 1999 2000 2001 2002 2003 2004 2005 2006 2007 2008 2009 2010 2011 2012 2013 2014 2015 2016 2017 2018 2019 2020
Developed Developing and emerging Least-developed
Notified IP Laws Hong Kong, China
0 10 20 30 40 50 60 70
First notification Amendment or revision Replacement or consolidation
Notified IP Laws Hong Kong, China
0 5 10 15 20 25 30 35
Enforcement Trademarks Patents (including plant variety protection) Copyright and related rights Industrial designs Layout designs of integrated circuits Geographical indications Other Undisclosed information Industrial property (general)
First notification Amendment or revision Replacement or consolidation
TRIPS Transparency Tools
Notifications
• Members’ IP laws
• Checklist on enforcement measures
• Contact points for cooperation
Reviews
• Members’ IP laws
• Geographical
indications (checklist)
• Biotech patenting and related questions
(checklist)
• Implementation of TRIPS
Reports
• Technical assistance programs
• Technology transfer for LDCs
112
37
27
Checklist responses
Thank you
Access Members’ IP laws,
checklist responses, and more:
http://e-trips.wto.org
Contact us with questions:
Geneva, 24 November 2020.
TRIPS Implementation as a Guide for Public Policy:
Intellectual Property Issues in Trade Policy Reviews
Josefita Pardo de León Legal Affairs Officer
Intellectual Property, Government Procurement and Competition Division
Trade Policy Review
Mechanism
“Early harvest” of the Uruguay Round:
• Provisionally established at the Montreal Mid-Term Review of the Round in December 1988.
• First TPRs: Australia, Morocco and the United States
1994 - Annex 3 of the Agreement Establishing the WTO
1
Trade Policy Review Mechanism
Objective of the TPRM:
• Facilitate smooth functioning of the multilateral trading system by enhancing transparency.
• Process of multilateral peer review of domestic trade policies covering goods, services and intellectual property.
2
Trade Policy Review
Mechanism
…since 1995:
• 157 Members have been reviewed
• +500 Trade Policy Reports by the Secretariat
• +6800 paragraphs on TRIPS-related issues
3
Trade Policy Review Mechanism
Review Periods:
• Four Members with the largest shares of world tradeare reviewed every three years: European Union, the United States, Japan and China;
• The next 16 Members are reviewed every five years;
• Others are reviewed every seven years;
• A longer review period may be envisaged for least-developed country Members.
4
Intellectual Property in TPRs
Evolution with the implementation of the TRIPS Agreement and their relation to national development policies on:
• Fostering research and innovation;
• Promoting exports;
• Attracting foreign direct investment;
• Participating in global value chains; and
• Overall improvement of competitiveness.
TRIPS in the TPR Q&R Process (2018-2019)
73
92
224
41
80
16
190
67
39
10
89
0 50 100 150 200 250
General IP Enforcement Copyrights Related Rights Trademarks Industrial design1 Patents R&D Trade secrets-Know-how Exhaustion GIs
Q&R Process
Questions on enacted laws or reforms to modernize the intellectual property regime, so that it can:
• Respond to technological evolution and new ways of doing business;
• Coherently implement obligations under the TRIPS Agreement, WIPO Instruments and Free Trade Agreements;
• Modernize institutions and procedures for the administration of intellectual property rights.
Q&R Process
Contemporary issues raised by Members:
• Copyrights and related rights in the digital environment;
• Registration of holograms, colour marks, sound marks and position marks;
• Geographical indications for non-agricultural products;
• Patent quality;
• Protection of trade Secrets;
• Protection of the collective knowledge of indigenous peoples related to biodiversity;
• TRIPS and Competition Policy;
• Enforcement, online and at the border; and
• Valuation and composition of assets related to intellectual property.
Q&R Process
Intellectual Property as a component of national policies to support, for example:
• Micro, small and medium enterprises;
• Disadvantaged or remote regions;
• Environmentally friendly innovation; and
• Women entrepreneurs.
Looking at the Future
• Tracking the implementation of the TRIPS Agreement
• Mainstreaming IP into economic and trade policies
• Insights into policy choices and experience
• Real-life examples
• Develop “best practices”
Thank you!
Ms. Xiaoping Wu, Counsellor, Intellectual Property, Government Procurement and Competition Division, World Trade Organization
Geneva, Switzerland, 24 November 2020 11/22/2020
VIRTUAL SYMPOSIUM 25 YEARS OF THE TRIPS AGREEMENT
TRIPS and Technology Transfer - Lessons from the Implementation of Article 66.2 in the Past 25 Years
WTO-IPD-XWU 0
Article 66.2 of the TRIPS Agreement
"Developed country Members shall provide incentives to enterprises and institutions in their territories for the purpose of promoting and encouraging technology transfer to least-developed country Members in order to enable them to create a sound and viable technological
base."
11/22/2020 WTO-IPD-XWU 1
Overview of the Art 66.2 implementation over the past 25 years
• Before 1995, technology transfer was one of the LDCs’ three demands during the TRIPS negotiations.
• In 1997, Bangladesh raised the implementation issue in the TRIPS Council.
• In 2001, upon the request of the LDC Group, Members agreed to establish a reporting and review mechanism.
• In 2003, the Council adopted a decision on the Art 66.2 implementation.
• From 1998 to 2020, the Council received 337 reports from developed country Members.
• From 2004 to 2020, 291 reports were submitted under the 2003 Decision and 17 annual reviews have been conducted.
11/22/2020 WTO-IPD-XWU 2
Lessons can be learned from past experiences
The LDCs’ active engagement in the negotiations and the developed
countries’ positive responses to the LDCs’ concerns are essential for the inclusion and implementation of the Art 66.2 obligation.
11/22/2020 WTO-IPD-XWU 3
The unsolved issues
• Two substantive issues: the lack of common understanding the concept of technology transfer and the concept of incentive
• One procedural issue: the choice of format/template to present annual reports
11/22/2020 WTO-IPD-XWU 4
Some thoughts on
how to address these issues
• Are these any elements in these two concepts which are part of the shared understanding of Members?
• Are these any actual and concrete incentives and technology transfer projects presented in the Art 66.2 reports which, in the view of the LDCs, go in the direction?
• Would it be natural for the LDCs to identify areas of priority for technological development?
• Do the developed countries and the LDCs have a common interest in a well-designed reporting format?
11/22/2020 WTO-IPD-XWU 5
WTO Secretariat’s work on the Art 66.2 implementation
• 12 annual workshops have been organized since 2008.
• A forum for informal dialogue between the reporting members and the LDC members.
• Since 2019, the workshop has been organized back to back to the TRIPS Council’s meeting.
11/22/2020 WTO-IPD-XWU 6
The TRIPS Council’s discussion on the Art 66.2 implementation
• WTO is a member-driven organization.
• The discussion on both substantive and procedural issues will be guided by its Members.
11/22/2020 WTO-IPD-XWU 7
TRIPS Agreement Article 67:
Providing a Global Overview of Technical Assistance
TRIPS Capacity Building
TRIPS Capacity Building
Why does the TRIPS Agreement include a provision on technical assistance?
The big picture perspective…
TRIPS Capacity Building
Preamble to the Agreement Establishing the WTO
Recital II: Recognizing further that there is need for positive efforts designed to ensure that developing countries, and especially the least developed among them, secure a share in the growth in international trade commensurate with the needs of their economic
development;
TRIPS Capacity Building
Article 67
Technical Cooperation
In order to facilitate the implementation of this Agreement, developed
country Members shall provide, on request and on mutually agreed
terms and conditions, technical and financial cooperation in favour of
developing and least-developed country Members. Such cooperation
shall include assistance in the preparation of laws and regulations on the
protection and enforcement of intellectual property rights as well as on the
prevention of their abuse, and shall include support regarding the
establishment or reinforcement of domestic offices and agencies relevant to
these matters, including the training of personnel.
TRIPS Capacity Building
Contact points
An opportunity for interaction between technical assistance providers and technical
assistance beneficiaries
TRIPS Capacity Building
Reporting Mechanism
An opportunity to communicate technical assistance
programmes and projects
TRIPS Capacity Building
Reporting Mechanism
An opportunity to communicate technical assistance
programmes and projects A unique view of
IP capacity building
around the world
TRIPS Capacity Building
Technical cooperation reports: Global overview of facts and figures in 2020
Over 190 programmes
2020
Covering all regions
Programmes
benefiting over 148 WTO Members and
Observers
TRIPS Capacity Building
Technical cooperation reports: Global overview of facts and figures in 2020 A range of participants, including:
Policymakers
Parliamentarians IP examiners
Judiciary Police
Customs officials
Research community
TRIPS Capacity Building
Evolution of TRIPS technical assistance
As evidenced by the evolving needs of beneficiary Members, and the
corresponding assistance,
IP systems are dynamic systems…
Like living things, IP systems require attention so they can both help shape, and
adapt to, their rapidly changing environments.
TRIPS Capacity Building
Evolution of TRIPS technical assistance
Putting down roots
The early days of TRIPS TA focused
more on institution building and bringing IP laws into compliance with
international obligations.
TRIPS Capacity Building
Evolution of TRIPS technical assistance
Branching out to policy questions Increasingly, TRIPS TA focused on
cross-cutting IP-related policy issues.
TRIPS Capacity Building
Evolution of TRIPS technical assistance
Assisting with the evolution of IP
systems and enhancement of
institutions throughout the years.
TRIPS Capacity Building
WTO Secretariat IP-related technical assistance
Increasingly tailored, technical, holistic
– and always demand driven.
TRIPS Capacity Building
Thank you
WTO Intellectual Property, Government Procurement and Competition Division
[email protected]
25 Years of the TRIPS Agreement – Past, Present and Future
24 November 2020
Evolution of the TRIPS Agreement:
Doha, the Public Health Dimension &
Subsequent Cooperation
Roger Kampf, WTO Secretariat
I.
Setting the Scene:
TRIPS & Health –
Working in a Complex Environment
Pulling the relevant policy
dimensions together:
Intersections between health, IP and
trade
Source: WHO-WIPO-WTO Study on Access to Medical Technologies and Innovation,
2nd edition, 2020
Ensuring policy coherence
Multilateral Framework:
• WHO
• WIPO
• WTO
Bilateral&
Regional Trade
& Investment Agreements
Regional Framework:
• ARIPO
• OAPI
• EUIPO
• others
Domestically:
• IP policy &
strategy
• Legislation
• Courts Key actors:
• IGOs
• Regional Organizations
• Governments
• Private Sector
• Civil Society
4
Different Levels & Actors
Link Between Public Health, IPRs and Trade:
Key Questions Framing the Debate
• IPR as an important factor for development of new medicines, but: concerns expressed about effect on prices
• Importance of flexibilities recognized, but: need to preserve balance of rights and obligations
• TRIPS as part of wider national and international action to address health problems, but: cannot solve issues on its own
How best to reconcile the need for incentives to invest in R&D and access to medicines?
How best to achieve an optimal balance between IPRs and public health?
How best to ensure capacity to deal with innovation-access cycle in a holistic manner?
II.
Doha Declaration & Subsequent Instruments:
Affirming Capacity to Respond to Pressing Needs &
Making TRIPS Part of the Broader Picture
Why to Adopt the Doha Declaration?
• Context:
• HIV/AIDS crisis in Africa in late 1990s
• Coincides with TRIPS implementation by developing countries in 2000
• Purpose:
• Respond to concerns about impact of strengthened IPR protection on access to medicines
• Significance:
• Different views about the nature and scope of TRIPS flexibilities
• Interpretation of TRIPS flexibilities in a broad pro-public health manner
• Concerns about pressure from trading partners not to use existing flexibilities
Doha Declaration:
A Blueprint for Policy Coherence
8
Doha Declaration: A Milestone for the WTO
Main Achievements
Guidance in DS cases Basis for
multilateral cooperation
Clarification
Support for use of existing
flexibilities
Addition of new flexibilities
Special Compulsory
Licensing System
LDC Transition
Period in pharma
sector CLs:
• Right to grant
• And to determine grounds
Right to determine
what constitutes situation of
extreme urgency
Freedom to choose exhaustion
regime
Clarifying Policy Options:
The Example of Standard Compulsory Licences
• Implementation (WIPO document SCP/30/3, 2019):
• 156 jurisdictions provide for CL/government use licences
• Plus several regional instruments
• Use:
• Initially limited in most jurisdictions
• But: increased use in relation to pharmaceutical patents since 2010
• Trilateral Study analyzes 34 selected cases in which CL/government use licences have been considered or granted
• Other sources report 108 cases since 2001 with CL granted in 74 cases
Source: WHO-WIPO-WTO Study on Access to Medical Technologies and Innovation, 2nd edition, 2020
Creating Additional Flexibilities (1):
Trade-Related Compulsory Licences for Export
• Para.6 Doha Declaration
• Identified difficulties for Members with insufficient/no manufacturing capacities in the pharmaceutical sector to make effective use of CL
• Concern: availability of supply from generic producers in third countries
• Art. 31(f): production under CL "predominantly for the supply of the domestic market“
• Countries with important generic industry obliged to provide full patent protection for pharma products since 2005
• The solution: derogations from restrictive conditions in Art. 31(f) and (h) TRIPS
• A System that addresses…
…a health problem
In the importing Member
…a legal problem
In the exporting Member
Steps Towards Putting the System in Place
• 30 August 2003
• Adoption of waiver decision
• 6 December 2005
• Adoption of Protocol Amending TRIPS
• 23 January 2017
• Entry into force of permanent TRIPS Amendment
12
Members’ Voices (30 Jan. 2017):
• “Marks a significant step forward for the Members of the WTO” (LDC Group)
• “Truly a historic measure that has been
taken, the first ever amendment to the WTO Agreements” (Bangladesh)
• “Important because it demonstrates that the WTO is capable of responding in an
adequate way to essential needs beyond trade policy” (EU)
• “Provides legal certainty to our quest for affordable medicines” (African Group)
• “An important signal to everyone that this Organization is not only about trade
liberalization” and “the System is part of a broader picture which includes other
important aspects” (South Africa)
Creating Additional Flexibilities (2):
LDC Transition Periods and Waivers
1.1.2016 1.7.2021
Patents/undisclosed information for
pharmaceutical products (Doha&TRIPS Council) Article 70.9 Waiver
(General Council Decision)
2. Extension:
TRIPS Obligations / All Sectors
Extension (TRIPS Council Decision of 6.11.2015)
Extension
(General Council Decision) Art. 70.8 Waiver
(General Council Decision)
14.11.2001 1.1.2006 1.7.2013
1. Extension Initial Transition
Period
1.1.2033
WT/L/971IP/C/73
IP/C/64
III.
Cooperation:
Evolving from Silos to Inclusiveness
Intensifying Cooperation with External Partners
• More than 10 years of trilateral cooperation: WHO, WIPO, WTO
➢ Pulls expertise in different areas together
• Reach-out to other IGOs and key stakeholders
• For this to be effective: need to mirror close cooperation at
domestic level
16
WTO Secretariat:
Not Working in Silos Anymore!
Adoption of Doha
Declaration on TRIPS&Health
Adoption of WHO
GSPA- PHI
Since 2010:
Enhanced trilateral cooperation
From Working in “silos” To health contact group in 2013
Adoption of WIPO Development
Agenda
2001 2007 2008 2010
To COVID-19 Trade Monitoring Group
2020
Trilateral Study, 2nd
edition 2013
Trilateral Study,
1st edition Series of
Trilateral Symposia
Exemplifying Joint Secretariat Efforts
to Ensure Transparency and to Build Capacity
COVID-19 Related Work:
➢Regularly updated list of measures regarding trade-related aspects of IPRs, goods and
services
➢Information notes, e.g.:
• The TRIPS Agreement and COVID-19 (Oct. 2020)
• How WTO Members have used trade measures to expedite access to COVID-19 critical medical goods and services (July 2020)
➢Vaccines Checklist of Issues with Trade Impact and Infographic (November 2020)
➢Other resources:
• List of Members’ proposals
• List of Members’ notifications
• Enquiry points
https://www.wto.org/english/tratop_e/covid19_e/covid 19_e.htm
IV. Capacity Building:
Evolving Towards an Integrated
and More Tailored Approach
Annual Trade and Public Health Workshop
• Organized by WTO Secretariat since 2005
• Initial focus on IP
• Integrated approach since 2014
• Based on close collaboration
with WHO and WIPO Secretariats
• Organisation of similar activities
at regional and national level
News item and presentations
available at:
https://www.wto.org/
english/news_e/news 20_e/heal_21oct20_e.
htm
Full publication:
https://www.wto.org/trilat eralstudy2020
COVID-19 Extract:
https://www.wto.org/
english/res_e/booksp_
e/extract_who-wipo- wto_2020_e.pdf
WHO-WIPO-WTO Study (2nd edition, 2020)
Trilateral Symposia: Gathering Empirical Data
2019 Technical Symposium to address opportunities and challenges of cutting-edge health technologies
2018 Trilateral Symposium to examine how innovative technologies can promote health- related SDGs
2016 WHO, WIPO, WTO Symposium to examine how to foster appropriate use of antibiotics, access and innovation
2015 Symposium on Public Health, Intellectual Property, and TRIPS at 20: Innovation and Access to Medicines; Learning from the Past, Illuminating the Future
2014 Symposium on Innovation and Access to Medical Technologies: Challenges for Middle- Income Countries
2013 Technical Symposium on Medical Innovation — Changing Business Models
2011 Symposium on Access to Medicines: Patent Information and Freedom to Operate 2010 Symposium on Access to Medicines: Pricing and Procurement Policies
V.
Personal Thoughts:
Looking at the Way Forward
Taking Stock
• Experience from TRIPS implementation shows positive developments:
• Responding to pressing public health needs
• Placing TRIPS into broader context, developing from an IP-focused to an integrated approach
• Enhancing and exemplifying cooperation both in house and key stakeholders
• Demonstrating
• Possible positive sum impact of working within the existing framework
• Example: COVID-19 vaccines development within record time
• Need for non-static legislation, subject to constant review to adapt to specific circumstances
• Example: streamlining and facilitating domestic compulsory licensing provisions in the context of COVID-19 pandemic
• How to build on this experience?
Future Developments: What Is Needed?
• Empirical data and evidence to support informed decision-making
• More tailored capacity building responding to specific needs of Members
• Transparency, including easy access to patent information and patent landscape reports
• Further development of integrated approach:
• Government strategy for R&D and access, including financing and IP management
• Efficient and expeditious marketing approval mechanisms
• Transparent and efficient rules governing public procurement
• Legal and institutional framework for the effective application of competition law
• Alignment of industrial policy objectives with public health goals
• Consideration of broader trade issues, in particular as regards export/import opportunities
• Doha Declaration 2.0?
TRIPS as a benchmark for subsequent norm setting in international and bilateral treaties
Wolf Meier-Ewert Counsellor Intellectual Property, Government Procurement
and Competition Division
Virtual Symposium – 25 years of the TRIPS Agreement
TRIPS Agreement forms part of a coherent international IP system:
• “upstream” coherence by incorporating WIPO Conventions and treaties
• “downstream” coherence with subsequent international instruments
Coherence of the
international IP system
Three-step test
• originated in Art. 9.2 Berne Convention (reproduction right only)
• TRIPS Agreement Art. 13, Art. 17, Art. 26.2, Art. 30
• WCT Art. 10 and WPPT Art. 16
Relationship between Trademarks and Geographical Indications
• TRIPS Art. 22-24 and dispute settlement cases DS174/DS290
• Article 13.1 of the Geneva Act of the Lisbon Agreement recognizes the balance found in TRIPS as interpreted by WTO disputes
Coherence of the
international IP system
The MFN principle is established in:
• Article I of GATT – Trade in Goods
•
Exception for RTAs: Article XXIV• Article II of GATS – Trade in Services
•
Exception for RTAs: Article V• Article 4 of TRIPS – Intellectual Property
•
No general exception for RTAsWTO rules:
Most-favoured nation principle
4
IP content in RTAs
RTAs containing
general IP provisions
0 10 20 30 40 50 60 70 80
Commitment to IP protection TRIPS reaffirmation References to WIPO treaties Nat'l or MFN treatment Assistance, cooperation Enforcement procedures Border measures Exhaustion Non-violation complaints IP defined as investment
Percentage of RTAs that include IP provisions
Republic of Korea – United States of America (KORUS FTA)
ARTICLE 22.4: SCOPE OF APPLICATION
Except as otherwise provided in this Agreement or as the Parties otherwise agree, this Section shall apply … or wherever a Party considers that: …
(c) a benefit the Party could reasonably have expected to accrue to it under Chapter Two (National Treatment and Market Access for Goods), T… or Eighteen (Intellectual Property Rights)(1) is being nullified or impaired as a result of a measure that is not inconsistent with this Agreement, except that neither Party may invoke this subparagraph with respect to a benefit
under Chapter Twelve (Cross-Border Trade in Services) or Eighteen (Intellectual Property Rights) if the measure is subject to an exception under Article 23.1 (General Exceptions).
FN1 Neither Party will invoke subparagraph (c) with respect to a measure affecting benefits under Chapter Eighteen
(Intellectual Property Rights) during any period for which WTO Members have agreed not to initiate complaints of the type provided for under subparagraph 1(b) of Article XXIII of GATT 1994 under the TRIPS Agreement.
