The Interface Between Public Health, Trade & TRIPS: Current Work at the WTO and How it Relates to the Generic Industry
|
|
- Edward Hampton
- 5 years ago
- Views:
Transcription
1 15 th Annual IGPA Conference Kyoto, Japan, 5 December 2012 The Interface Between Public Health, Trade & TRIPS: Current Work at the WTO and How it Relates to the Generic Industry Roger Kampf, WTO Secretariat The views expressed are personal and cannot be attributed to the WTO, its Secretariat, or any of its Member governments. 1
2 I. Introduction: The Interface Between IPRs and Public Health
3 Where Do We Come From: the Interface between IPRs and Public Health Since last decade: Impact of IPRs on innovation of and access to medicines moved to centre of cross-cutting debate between separate policies TRIPS-related issues (as confirmed by Doha Declaration): IPR as an important factor for development of new medicines, but: concerns expressed about effect on prices How best to reconcile the need for incentives to invest in R&D and access to medicines? Importance of flexibilities recognized, but: need to preserve balance of rights and obligations How is optimal balance between IPRs and public health best achieved? TRIPS as part of wider national and international action to address health problems, but: cannot solve issues on its own How to ensure capacity to deal with innovation-access cycle in a holistic manner?
4 From Boundaries to Synergies: Bringing Together Distinct Policies Innovation & public research policies Human Rights International Trade & Domestic Economic Settings Public Health Framework IP Law, Management and Administration Quality, Safety, Efficacy Regulation Access to Medical Technologies
5 An Issue Addressed at Various Levels & By Different Actors Multilateral Framework: WHO WIPO WTO Regional Framework: ARIPO OAPI others Key actors: IGOs Regional Organizations Governments Private Sector Civil Society Free Trade Agreements Domestically: IP policy & strategy Legislation Courts
6 Provision on Patentability Patent term extension Compulsory licensing Exhaustion Test data exclusivity Patent linkage Enforcement Side letter or /reaffirmation of Doha Declaration Key Provisions Affecting Pharmaceutical Sector in Selected FTAs Notified to WTO FTA EFTA - Albania, Chile, Colombia, Egypt, Korea, Peru, Serbia, Singapore, Tunisia, Ukraine (10 in total) Mandatory (7) Optional (2) 5 to 8 years (7) Reasonable period (normally five years) (2) Adequate number of years or financial compensation (1) 4 2 EFTA - Jordan, Morocco EC Turkey, Stabilisation and Association Agreements with FYROM, Albania, Croatia, Montenegro EC Chile, Mexico, South Africa and Association Agreements with Algeria, Israel, Jordan, Morocco, Tunisia, Lebanon (Interim Agreement) EC Cariforum (pending as of 8/2012) Protection of patents on a level similar to that prevailing in the European Patent Convention Level of protection similar to common body of EU legislation and jurisprudence Protection in accordance with highest international standards EC Korea (provisional application) 5 years US - Australia, Bahrain, CAFTA/DR, 8 Mandatory (11) 3 2 Five years (8) Chile, Colombia, Jordan, Korea, Optional (1) Reasonable period Morocco, Oman, Panama, Peru, (normally 5 years) (3) Singapore (12 in total) 6
7 The Generic Industry: An Active User of the IP System As IP rightholder - for example: Trademarks for branded generic products Enforcement of trademarks and other IPRs As voluntary licensee Increased number of voluntary licensing programmes (new / pipeline products, broader range of countries) Different types of partnerships: Extended partnership, including acquisition of shares, right to distribute partner products, acquisition of manufacturing facility by generic partner (ex: GSK/Aspen) One licence agreement to manufacture a single product Reliance on generic companies as distributors (ex: Gilead) Medicines Patent Pool and WIPO Re:Search As compulsory licensee As user of litigation procedures As stakeholder in policy-making process Interest in balanced and well-functioning IP system
8 II. WTO s Mandate and Role in the Pharmaceutical Sector
9 General Overview Trade (rules) intersect with public health objectives in many ways: Positive link: trade - higher living standards improved public health conditions Defensive link: right to take trade-restricting measures to protect public health recognized in all WTO agreements The WTO s role is to: Offer a forum for discussion of the interface between trade rules and public health Settle disputes: Few cases challenged appropriateness of measure chosen to achieve public health objectives, not the right to protect public health Raise awareness and build capacity The WTO s mandate is NOT to interpret TRIPS provisions or to assess use of TRIPS flexibilities 9
10 WTO Is Not Just About TRIPS! (1): Tariffs Growing importance of international trade for supply of public health goods: +12%/year, from 92 bn. USD (1995) to 500 bn. USD (2010) Amounts to 4.2% of global merchandise trade Applied tariffs on health-related products: Affect both access and domestic production Pharmaceutical Sector Initiative (1994) selected WTO Members liberalize markets for >6500 products and ingredients (= estimated 79% of global trade) Sectoral initiative for open access to enhanced health care (2006) For detailed study see WTO Staff Working Paper: More Trade for Better Health? International Trade and Tariffs on Health Products (October 2012) 10
11 Imports of Health-Related Products: in bn. USD for 2010 Average Annual Growth A1 - Dosified medicines 202, % C2 - Medical equipment 97, % C1 - Hospital inputs 86, % B - General inputs 72, % A3 - Specific inputs 26, % A2 - Bulk medicines 9, % 11
12 Bound vs. Applied Tariffs on Health-Related Products 12
13 WTO Is Not Just About TRIPS! (2): Public Procurement Procurement policies and practices: Maximize competition in procurement process Helps to achieve best value for money The WTO s plurilateral GPA (42 Members): Ensures non-discrimination and transparency Magnitude of health-related procurement: US statistical report (2008): 40 bn. USD for hospitals, 50 bn. USD for health sector in general, 30 bn. USD for goods/services procured by Department of Health EU statistical report (2007): 11 bn. EUR for medical technologies covered by GPA Japan statistical report (2010): 1.8 bn. USD for contracts awarded by MoH Revised agreement signed in
14 Health Sector Coverage by Selected GPA Parties Party Coverage of health-related entities at the central government level Coverage of health-related entities at the subcentral government level Coverage of goods Coverage of health-related services Canada X European Union X Hong Kong, China N/A X Israel X X Japan X X Korea X X Norway X Singapore N/A X Switzerland X Chinese Taipei X United States 14
15 WTO Is Not Just About TRIPS! (3): SPS and TBT Agreements Avoid unnecessary barriers to international trade Human health or safety recognized as legitimate objective Use internationally-established health and safety standards Almost half of the issues raised in TBT Committee relate to human health and safety Directly affects the pharmaceutical sector: Health products, including herbal medicines (regulation and inspection) Medical devices 15
16 Examples from TBT Committee Brazil (2009) European Union (2009) Measure: GMP certificate required when applying for registration of certain health products at ANVISA Objective: Protection of human health and prevention of deceptive practices Concerns (selection): Acceptance of ISO certification as evidence of compliance? Availability of sufficient inspection resources at ANVISA? Measure: imported products, including APIs, required to be produced according to GMP equivalent to those of the EU, confirmed by written declaration of competent authority in exporting country Objective: Prevention of entry into supply chain of falsified medical products Concerns (selection): Unjustifiable burden for competent body in exporting country Acceptance of WHO API GMP certificate? 16
17 WTO Is Not Just About TRIPS! (4): Competition Law and Policy No multilateral framework at WTO, but: Art. 40, 31, 8 TRIPS (anti-competitive practices/ IPR abuse) Article 10bis Paris Convention (unfair competition) Relevant for: innovation and access generic companies (e.g. patent settlement agreements, agreements between generic companies, mergers) Objective: inform regulatory and other policy choices Corrective tool where needed to ensure competition from innovation to delivery Country experiences: South Africa: cases at Competition Authority EU: Commission pharmaceutical sector inquiry 17
18 WTO Is Not Just About TRIPS! (5): Conclusion Many of the other WTO disciplines directly affect the generic pharmaceutical industry, in particular: Bound and applied tariffs Government procurement TBT and SPS etc. Need for generic industry to take a holistic, multidimensional approach, and not to focus exclusively on TRIPS matters 18
19 III. IPRs and Public Health: TRIPS and later instruments
20 The Starting Point: Key TRIPS Provisions (1) Objectives and principles the shoulds under the TRIPS Agreement: Promotion of technological innovation Transfer and dissemination of technology Balanced approach, adapted to domestic policy objectives Patents a wide range of flexibilities: Definition of patentability criteria Disclosure requirement Exclusions Exceptions, including compulsory licences Exhaustion national vs. international: freedom to choose regime which best fits domestic policy objectives Illustrates need to think holistically within and beyond IP system 20
21 The Starting Point: Key TRIPS Provisions (2) Test data mandatory protection against unfair commercial use and disclosure: But: how to protect is not prescribed Application of pro-public health interpretation of TRIPS provisions under the Doha Declaration Enforcement important links to public health: Terminology: what is a counterfeit medicine Guided by objective to achieve a balance: preserve legitimate trade, important safeguards Transition periods for LDCs: 2013 in general: further extension requested by LDCs 2016 in pharmaceutical sector Need to address interface IPRs-public health not new, already recognized by TRIPS
22 The Turning Point: What the Doha Declaration Achieved Guidance: interplay IPRs and health Landmark in WTO and elsewhere Framework for multilateral cooperation Support of countries using TRIPS flexibilities The Doha Declaration 2001 Vision of TRIPS: supportive of balanced framework Clarifies TRIPS flexibilities: CL and exhaustion Extension of LDC transition period to 2016 Adoption of Paragraph 6 System
23 An Additional Flexibility: Para. 6 System Designed to address difficulties of Members with insufficient or no manufacturing capacities in the pharmaceutical sector in effectively using CL: Removes specific legal obstacles: waiver of certain TRIPS conditions otherwise applicable to CL Makes an additional flexibility available: Procedures are designed by national implementing legislation Only applies to narrowly defined circumstances Forms part of wider national/international action Requires further reflection on commercial incentives for generic manufacturers to engage in production First ever amendment proposed to a WTO agreement: Reflects importance that Members attach to intersection between IPRs and public health Has been endorsed by various other UN bodies: e.g.: Element 5.2 of WHO s GSPA-PHI 23
24 IV. Relevant Work in the WTO
25 Discussing and Informing Making available a forum for debate of IP issues: Assessment of LDC priority needs Technology Transfer (to LDCs) Enforcement trends (in-transit generic medicines, ACTA) New directions: Early discussion of draft agreements/legislation: Australia s Plain Packaging Bill for tobacco products Move towards a forum for policy debate - new agenda item on IP and innovation, introduced by Brazil and the US: Concept of innovation vs. invention Evidence for causal connection between IP & innovation Call for a balanced IP regime Recognition that IP policy must form part of wider national innovation strategy, is only one among many factors But not discussed in detail: Test data protection Counterfeit medicines Providing factual information and empirical data
26 Solving disputes (1) Regulatory review exception permitted as limited exception to patent rights (WT/DS114/R) Australia s Plain Packaging Bill (DS434/435/441) raises interesting questions, including for the generic industry: Link with public health debate in general: priority for public health or industrial policy objectives? Can pro-public health measures addressed in Art.8 TRIPS override substantive trademark provisions? Is there a positive right to use a trademark? Burden of proof: what does the defendant need to provide in order to show that use of trademark is not unjustifiably encumbered? Repercussions on open question of application of non-violation and situation complaints to TRIPS?
27 Solving Disputes (2): In-Transit Generic Medicines What happened? Principal measure at issue: EU Regulation concerning customs enforcement of IPRs goes beyond TRIPS requirements, as applicable to goods in transit and patent infringing goods Discussed in TRIPS Council, followed by DS consultations (India, DS408 & Brazil, DS409) Alleged violations include GATT (Art.V), TRIPS (Art.1.1, 7, 8, 31, 41, 42, 51) and Doha Declaration Mostly about cases of alleged patent (and not trademark) infringement in transit country State of play: mutually agreed arrangement in summer 2011 ECJ judgment in December 2011 Commission Guidelines of February 2012 What is the right approach? 27
28 Reviewing the Operation of Para.6 System TRIPS Council looks into narrow and broader aspects (see annual reviews ) Narrow aspects focus on operation of System as such, in particular whether it is delivering effective and expeditious results Broader aspects discussed include: Funding Partnerships Pricing (including transparency mechanisms) procurement practices Competition policies Taxes, tariffs and mark-ups Quality, safety and efficacy Discussion contributes to better understanding of interplay between IPRs and public health 28
29 Intensifying Cooperation Essentially among WHO, WIPO, WTO, but also involving other IGOs Traditional fields of cooperation, in particular through capacity building activities: Example: jointly designed workshops dedicated to the interplay between IPRs and public health Series of joint technical symposia on: Pricing and procurement policies (July 2010) Patent information and Freedom to operate (February 2011) WHO/WIPO/WTO study on Promoting Access and Medical Innovation: Intersections Between Public Health, IP and Trade
30 Trilateral Study (1): Purpose Aims at assisting decision-makers by providing information on: legal and policy options (IPRs: particular focus on options/practices regarding patents) interplay between trade, IP and health rules empirical data Illustrates the need to adopt a holistic approach: from research and discovery to delivery: need to take innovation and access equally into account encompassing health, trade and IP dimensions Forms an integral part of technical co-operation offered by WHO/WIPO/WTO in response to growing and diversified demands strengthening policy coherence
31 Trilateral Study (2): Content Introduction (Chapter I) Need for international co-operation and policy coherence Overview of international key stakeholders Policy Context (Chapter II) Analyses key intersections between innovation & access Provides data on global burden of disease Discusses various dimensions: public health, trade and IP Sets out the economics of innovation and access Innovation Dimension (Chapter III) Describes historical pattern and current landscape of medical R&D Looks at the role of IPRs in innovation cycle Access Dimension (Chapter IV) Sets out WHO access framework for essential medicines Analyses access determinants: Health systems IP system Other trade-related aspects
32 V. Conclusions
33 Trends in the Pharmaceutical Sector Rethinking the business model: How will stronger links between R&D companies and generic manufacturers impact on IP regime? New molecular entities: How will generic industry be affected by significant decline since late 1990s? Patent cliffs: A changing perspective for generic companies? Biologics: Will more complex technologies and higher development costs slow down entry of generics / limit price reductions? Counterfeit medicines: What can the generic industry contribute to minimize the risk, in particular in view of strong reliance on API imports? Domestic IP legislation takes different directions: Is diversity better for business than uniformity of rules? How to handle diversity from the user s perspective? FTAs and non-discrimination principles: What are the implications of existing and future agreements for generic companies?
34 Where Do We Stand? According to progress indicators GSPA-PHI: Coordination of IGO work TRIPS flexibilities in national law IPR application & management capacities Access Policies Techtransfer initiatives/strategies Monitoring & reporting
35 Why WTO Matters to the Generic Industry Clarify TRIPS flexibilities through capacity building activities (example: what is required under Article 39.3 to protect clinical test data) Ensure that legitimate trade can take place (as stipulated in Article 41) Raise and settle sensitive issues (example in transit generic medicines clarify that generics are not counterfeit products warn against dilution of narrow meaning of counterfeiting under TRIPS Agreement) Provide information sources and empirical data to facilitate well-founded decisions and to promote holistic approach (example: trilateral study; notification of legislation, TPR reports) Ensure coherence, co-operation and dialogue at all levels
36 What the Generic Industry Can Do Make constructive contribution to ongoing debate on functioning of the Paragraph 6 System: What is needed to make production under mechanism commercially viable for generic manufacturer? Support the WTO s efforts to promote a balanced IPR regime and a holistic approach, involving all relevant dimensions Actively participate in capacity building activities to share the generic industry s perspective Offer a well-structured interlocutor that can represent the generic industry s common interests at international level
IPRs and Public Health: Lessons Learned Current Challenges The Way Forward
Local Pharmaceutical Production in Africa International Conference Cape Town, 4-6 April 2011 IPRs and Public Health: Lessons Learned Current Challenges The Way Forward Roger Kampf WTO Secretariat 1 Acknowledging
More informationThe TRIPS Agreement and Patentability Criteria
WHO-WIPO-WTO Technical Workshop on Patentability Criteria Geneva, 27 October 2015 The TRIPS Agreement and Patentability Criteria Roger Kampf WTO Secretariat 1 Trilateral Cooperation: To Build Capacity,
More informationRTAs and the WTO in Todays Trading Environment IATRC Theme Day San Diego 9 December 2012
RTAs and the WTO in Todays Trading Environment IATRC Theme Day San Diego 9 December 2012 Rohini Acharya Regional Trade Agreements Section Trade Policies Review Division World Trade Organization RTAs and
More informationDr. Biswajit Dhar Professor, Jawaharlal Nehru University, India and Member DA9 Advisory Board
Dr. Biswajit Dhar Professor, Jawaharlal Nehru University, India and Member DA9 Advisory Board Intellectual Property Rights in Preferential Trade Agreements Many Preferential Trade Agreements (PTAs) adopted
More informationWTO NEGOTIATIONS ON TRIPS AND PUBLIC HEALTH: AN OVERVIEW. Jayashree Watal WTO Secretariat
WTO NEGOTIATIONS ON TRIPS AND PUBLIC HEALTH: AN OVERVIEW Jayashree Watal WTO Secretariat Outline Background to discussions in the TRIPS Council, including WHO-WTO Workshop on Differential Pricing and Financing
More information19 Progressive Development of Protection Framework for Pharmaceutical Invention under the TRIPS Agreement Focusing on Patent Rights
19 Progressive Development of Protection Framework for Pharmaceutical Invention under the TRIPS Agreement Focusing on Patent Rights Research FellowAkiko Kato This study examines the international protection
More informationDraft Plan of Action Chair's Text Status 3 May 2008
Draft Plan of Action Chair's Text Status 3 May 2008 Explanation by the Chair of the Drafting Group on the Plan of Action of the 'Stakeholder' Column in the attached table Discussed Text - White background
More informationTRAINING SEMINAR PHARMACEUTICALS AND INTELLECTUAL PROPERTY ACCESS TO MEDICINE: Exploitation of pharmaceutical patents: compulsory licences SESSION 4
TRAINING SEMINAR PHARMACEUTICALS AND INTELLECTUAL PROPERTY 1 12 14 March 2012 Pretoria, South Africa SESSION 4 ACCESS TO MEDICINE: COMMERCIALISATION, DISTRIBUTION, COMPETITION ----------------- Exploitation
More informationThe 45 Adopted Recommendations under the WIPO Development Agenda
The 45 Adopted Recommendations under the WIPO Development Agenda * Recommendations with an asterisk were identified by the 2007 General Assembly for immediate implementation Cluster A: Technical Assistance
More informationB) Issues to be Prioritised within the Proposed Global Strategy and Plan of Action:
INTERGOVERNMENTAL WORKING GROUP ON PUBLIC HEALTH, INNOVATION AND INTELLECTUAL PROPERTY EGA Submission to Section 1 Draft Global Strategy and Plan of Action The European Generic Medicines Association is
More informationWIPO Development Agenda
WIPO Development Agenda 2 The WIPO Development Agenda aims to ensure that development considerations form an integral part of WIPO s work. As such, it is a cross-cutting issue which touches upon all sectors
More informationMultilateral negotiations on IP - Traditional Knowledge and Genetic resources
Multilateral negotiations on IP - Traditional Knowledge and Genetic resources Alejandro Neyra Lima, March 2010 Intellectual property multilateral negotiations WIPO treaties/processes WTO: TRIPS Agreement
More informationFlexibilities in the Patent System
Flexibilities in the Patent System Dr. N.S. Gopalakrishnan Professor, HRD Chair on IPR School of Legal Studies, Cochin University of Science & Technology, Cochin, Kerala 1 Introduction The Context Flexibilities
More informationMarket Access and Environmental Requirements
Market Access and Environmental Requirements THE EFFECT OF ENVIRONMENTAL MEASURES ON MARKET ACCESS Marrakesh Declaration - Item 6 - (First Part) 9 The effect of environmental measures on market access,
More informationStanding Committee on the Law of Patents
E SCP/24/4 ORIGINAL: ENGLISH DATE: JUNE 29, 2016 Standing Committee on the Law of Patents Twenty-Fourth Session Geneva, June 27 to 30, 2016 PROPOSAL BY THE AFRICAN GROUP FOR A WIPO WORK PROGRAM ON PATENTS
More informationEstablishing a Development Agenda for the World Intellectual Property Organization
1 Establishing a Development Agenda for the World Intellectual Property Organization to be submitted by Brazil and Argentina to the 40 th Series of Meetings of the Assemblies of the Member States of WIPO
More informationStanding Committee on the Law of Patents Twenty-Sixth Session
Standing Committee on the Law of Patents Twenty-Sixth Session Marco M. ALEMAN Director, Patent Law Division, WIPO Geneva, July 3 to 6, 2017 SCP/26/5 CONSTRAINTS FACED BY DEVELOPING COUNTRIES AND LEAST
More informationGlobalizing IPR Protection: How Important Might RTAs Be?
Globalizing IPR Protection: How Important Might RTAs Be? Keith Maskus, University of Colorado Boulder (keith.maskus@colorado.edu) NAS Innovation Policy Forum National and International IP Policies and
More information372 index. predominantly for supply of domestic market 113, 132 3, 184 5, 186; remedying anticompetitive
INDEX acceding countries 23 Access to Medicines, Patent Information and Freedom to Operate (WHO/ WIPO/WTO) 195 Access to Medicines: Pricing and Procurement Practices (WHO/WIPO/WTO) 195 Agreement on Trade-Related
More informationCarnegie Endowment for International Peace
Carnegie Endowment for International Peace How the U.S. and India could Collaborate to Strengthen Their Bilateral Relationship in the Pharmaceutical Sector Second Panel: Exploring the Gilead-India Licensing
More informationTrade facilitation in the context of the SPS Agreement
Trade facilitation in the context of the SPS Agreement WCO Regional Workshop on Strategic Initiatives for Trade Facilitation - Mercator Programme Christiane Wolff Agriculture and Commodities Division World
More informationAccess to Medicines, Patent Information and Freedom to Operate
TECHNICAL SYMPOSIUM DATE: JANUARY 20, 2011 Access to Medicines, Patent Information and Freedom to Operate World Health Organization (WHO) Geneva, February 18, 2011 (preceded by a Workshop on Patent Searches
More informationPATENT PROTECTION FOR PHARMACEUTICAL PRODUCTS IN CANADA CHRONOLOGY OF SIGNIFICANT EVENTS
PRB 99-46E PATENT PROTECTION FOR PHARMACEUTICAL PRODUCTS IN CANADA CHRONOLOGY OF SIGNIFICANT EVENTS Margaret Smith Law and Government Division 30 March 2000 Revised 31 May 2000 PARLIAMENTARY RESEARCH BRANCH
More informationTRIPS, FTAs and BITs: Impact on Domestic IP- and Innovation Strategies in Developing Countries
Innovation, Creativity and IP Policy: An Indo-European Dialogue TRIPS, FTAs and BITs: Impact on Domestic IP- and Innovation Strategies in Developing Countries Henning Grosse Ruse NUJS & MPI Collaborative
More informationStatement by the BIAC Committee on Technology and Industry on THE IMPACT OF INTELLECTUAL PROPERTY PROTECTION ON INNOVATION AND TECHNOLOGY DEVELOPMENT
Business and Industry Advisory Committee to the OECD OECD Comité Consultatif Economique et Industriel Auprès de l l OCDE Statement by the BIAC Committee on Technology and Industry on THE IMPACT OF INTELLECTUAL
More informationTBT Provisions in RTAs: Do they go beyond the TBT Agreement?
TBT Provisions in RTAs: Do they go beyond the TBT Agreement? Xinyi Li Trade Policies Review Division, WTO Secretariat 12 th ARTNeT Capacity Building Workshop December 2016 1 Motives and Objectives TBT
More informationTopic 2: Patent-related Flexibilities in Multilateral Treaties and Their Importance for Developing Countries and LDCs
Topic 2: Patent-related Flexibilities in Multilateral Treaties and Their Importance for Developing Countries and LDCs McLean Sibanda Chief Executive Officer - The Innovation Hub Second WIPO Inter-Regional
More informationGENEVA WIPO GENERAL ASSEMBLY. Thirty-First (15 th Extraordinary) Session Geneva, September 27 to October 5, 2004
WIPO WO/GA/31/11 ORIGINAL: English DATE: August 27, 2004 WORLD INTELLECTUAL PROPERT Y O RGANI ZATION GENEVA E WIPO GENERAL ASSEMBLY Thirty-First (15 th Extraordinary) Session Geneva, September 27 to October
More informationIPEG Convenor Report to CTI
2014/SOM2/CTI/032 Agenda Item: 11.1 IPEG Convenor Report to CTI Purpose: Information Submitted by: IPEG Chair Second Committee on Trade and Investment Meeting Qingdao, China 10-11 May 2014 OAA ISSUE AREA:
More informationSubregional Seminar on the Legal Protection of Biotechnology and Genetic Resources Banska Bystrica, May 2 and 3, Access and Benefit Sharing
Subregional Seminar on the Legal Protection of Biotechnology and Genetic Resources Banska Bystrica, May 2 and 3, 2007 Access and Benefit Sharing Hans Georg Bartels 1 Overview The Context The Patent system
More informationTRIPs & PATENTS. In 1899, Mr. Charles H. Duell, Director of US Patent office said Everything that can be invented, has (already) been invented.
TRIPs & PATENTS Dr.Gopakumar G. Nair In 1899, Mr. Charles H. Duell, Director of US Patent office said Everything that can be invented, has (already) been invented. The events thereafter proved that inventions
More informationWIPO-WTO Colloquium for Teachers of Intellectual Property
E WORLD TRADE ORGANIZATION COLLOQUIUM WIPO-WTO/COL/18/INF1.PROV ORIGINAL: ENGLISH DATE: JANUARY 2018 WIPO-WTO Colloquium for Teachers of Intellectual Property organized by the World Intellectual Property
More informationImplementing Global Strategy and Plan of Action on Public Health, Innovation and Intellectual Property in the Eastern Mediterranean Region
Implementing Global Strategy and Plan of Action on Public Health, Innovation and Intellectual Property in the Eastern Mediterranean Region 1 Table of Contents LIST OF ACRONYMS AND ABBREVIATIONS -----------------------------------------------------------------------------------
More informationthe Companies and Intellectual Property Commission of South Africa (CIPC)
organized by the Companies and Intellectual Property Commission of South Africa (CIPC) the World Intellectual Property Organization (WIPO) the International Criminal Police Organization (INTERPOL) the
More informationIntellectual Property
Intellectual Property Johnson & Johnson believes that the protection of intellectual property (IP) is essential to rewarding innovation and promoting medical advances. We are committed: to raising awareness
More informationWHO workshop on IP and Vaccines. Geneva 19 th -20 th April Introduction to the IP issues Christopher Garrison Consultant to WHO
WHO workshop on IP and Vaccines Geneva 19 th -20 th April 2004 Introduction to the IP issues Christopher Garrison Consultant to WHO Vaccine access, R&D and technology transfer issues are intimately linked
More informationGlobal strategy and plan of action on public health, innovation and intellectual property
SIXTY-FIRST WORLD HEALTH ASSEMBLY WHA61.21 Agenda item 11.6 24 May 2008 Global strategy and plan of action on public health, innovation and intellectual property The Sixty-first World Health Assembly,
More informationTERMS OF REFERENCE. Preparation of a Policymakers Handbook on E-Commerce and Digital Trade for LDCs, small states and Sub-Saharan Africa
TERMS OF REFERENCE Reference: Post Title: NBCWG0923 Preparation of a Policymakers Handbook on E-Commerce and Digital Trade for LDCs, small states and Sub-Saharan Africa Project Location: home-based with
More informationSettlement of Pharma Disputes and Competition Law in Korea
Settlement of Pharma Disputes and Competition Law in Korea October 22, 2012 Monica Hyon-Kyong Leeu AIPPI PHARMA WORKSHOP I Topics Patent Disputes in Korean Pharma Industry Korean Competition Law and KFTC
More informationA/AC.105/C.1/2014/CRP.13
3 February 2014 English only Committee on the Peaceful Uses of Outer Space Scientific and Technical Subcommittee Fifty-first session Vienna, 10-21 February 2014 Long-term sustainability of outer space
More informationINDIA Market Projections and Developments
The Seventh Annual IGPA Conference INDIA Market Projections and Developments by D G Shah Secretary General Indian Pharmaceutical Alliance Prague: June 2004 1 Potential & Problems Indian Pharmaceutical
More informationWIPO Development Agenda
WIPO Development Agenda William New William New Intellectual Property Watch Geneva wnew@ip-watch.ch WIPO Development Agenda* Background to Agreement 2007 Development Agenda Availability of Information
More informationWIPO Sub-Regional Workshop on Patent Policy and its Legislative Implementation
WIPO Sub-Regional Workshop on Patent Policy and its Legislative Implementation Topic 2: The Patent system Policy objectives of the patent system Ways and means to reach them Marco M. ALEMAN Deputy Director,
More informationElements of a global strategy and plan of action
INTERGOVERNMENTAL WORKING GROUP A/PHI/IGWG/1/5 ON PUBLIC HEALTH, INNOVATION AND 8 December 2006 INTELLECTUAL PROPERTY Agenda item 2.3 Elements of a global strategy and plan of action Progress to date in
More informationCommittee on Development and Intellectual Property (CDIP)
E CDIP/6/4 REV. ORIGINAL: ENGLISH DATE: NOVEMBER 26, 2010 Committee on Development and Intellectual Property (CDIP) Sixth Session Geneva, November 22 to 26, 2010 PROJECT ON INTELLECTUAL PROPERTY AND TECHNOLOGY
More informationDraft global strategy on public health, innovation and intellectual property
IGWG: Outcome document at 14.00 hours, Saturday 3 May 2008 Draft global strategy on public health, innovation and intellectual property The context 1. In resolution WHA59.24 the Health Assembly recognized
More informationProtecting Intellectual Property under TRIPS, FTAs and BITs: Conflicting Regimes or Mutual Coherence?
Protecting Intellectual Property under TRIPS, FTAs and BITs: Conflicting Regimes or Mutual Coherence? Henning Große Ruse International Investment Treaty Law and Arbitration Conference Sydney, 19-20 February
More information2.5.2 NON-DISCRIMINATION (ARTICLE 27.1)
2.5.2 NON-DISCRIMINATION (ARTICLE 27.1) Article 27.1: Patentable Subject Matter... patents shall be available and patent rights enjoyable without discrimination as to the place of invention, the field
More information5 th Annual Pharma IPR Conference 2016
5 th Annual Pharma IPR Conference 2016 9 11 March 2016, Mumbai DAY 1 : 9 th March 2016 Country: US 09:40 American Invents Act Updates on Americas Invents Act and current scenario of US Patent laws Implications
More information1. Recognizing that some of the barriers that impede the diffusion of green technologies include:
DATE: OCTOBER 21, 2011 WIPO GREEN THE SUSTAINABLE TECHNOLOGY MARKETPLACE CONCEPT DOCUMENT EXECUTIVE SUMMARY 1. Recognizing that some of the barriers that impede the diffusion of green technologies include:
More informationVirtual Mentor American Medical Association Journal of Ethics December 2006, Volume 8, Number 12:
Virtual Mentor American Medical Association Journal of Ethics December 2006, Volume 8, Number 12: 834-838. Health law Intellectual property and access to medicine for the poor by Tara Leevy, LLB, LLM India
More informationSubmission to the Productivity Commission inquiry into Intellectual Property Arrangements
Submission to the Productivity Commission inquiry into Intellectual Property Arrangements DECEMBER 2015 Business Council of Australia December 2015 1 Contents About this submission 2 Key recommendations
More informationStanding Committee on the Law of Patents
E SCP/15/INF/2 ORIGINAL: ENGLISH DATE: JULY 20, 2010 Standing Committee on the Law of Patents Fifteenth Session Geneva, October 11 to 15, 2010 STATUS OF WORK RELATING TO THE NON-EXHAUSTIVE LIST OF ISSUES
More informationWORLD TRADE ORGANIZATION
WORLD TRADE ORGANIZATION IP/C/W/368/Rev.1/Corr.1 1 9 March 2006 (06-1045) Council for Trade-Related Aspects of Intellectual Property Rights THE RELATIONSHIP BETWEEN THE TRIPS AGREEMENT AND THE CONVENTION
More informationThe Trans-Pacific Partnership (TPP) as an Opportunity for Integration A WTO Perspective
The Trans-Pacific Partnership (TPP) as an Opportunity for Integration A WTO Perspective Comments by Robert B. Koopman Chief Economist, World Trade Organization Presented May 16, 2016 The Rise of the South
More informationCounterfeit, Falsified and Substandard Medicines
Meeting Summary Counterfeit, Falsified and Substandard Medicines Charles Clift Senior Research Consultant, Centre on Global Health Security December 2010 The views expressed in this document are the sole
More informationObservations from Pharma
Observations from Pharma Indian Patent Enforcement in the Chemical Arts Gurmeet Kaur Sidhu, Senior Patent Litigation Counsel London, 26/9/11 a Novartis company The Indian Pharmaceutical sector: Overview
More informationCER-ASEAN Integration Partnership Forum. CER-ASEAN participation in global frameworks for international recognition and harmonisation of measurement
CER-ASEAN Integration Partnership Forum CER-ASEAN participation in global frameworks for international recognition and harmonisation of measurement Dr Angela Samuel Director, International Relations Mr
More informationIP Strategies to Enhance Competitiveness: India s Experience
IP Strategies to Enhance Competitiveness: India s Experience N. N. Prasad Wednesday July 15, 2009 Innovation in Brazil, India and South Africa: A New Drive for Economic Growth and Development Strategy
More informationDigital Trade Policy: TPP as Minimum Standard or More?
No. 145: Day 1, 6 December 2016, 13:50-14:10 Guadalajara, Mexico Digital Trade Policy: TPP as Minimum Standard or More? Kenta Mochizuki Attorney at Law (New York) Yahoo Japan Corporation 1 Outline I. Introduction:
More informationAn overview of India's approach to key IP issues at home and abroad. Dr. Bona Muzaka King s College London
An overview of India's approach to key IP issues at home and abroad Dr. Bona Muzaka King s College London valbona.muzaka@kcl.ac.uk Why Intellectual Property? Why India? UNITAID (patent pools since 2008,
More informationQuality assurance in the supply chain for pharmaceuticals from the WHO perspective
1 Quality assurance in the supply chain for pharmaceuticals from the WHO perspective Dr Sabine Kopp Quality Assurance and Safety: Medicines Medicines Policy and Standards World Health Organization Presentation
More informationSpotlight: Buenos Aires Ministerial Conference 32
Our year Our year The WTO held its 11 th Ministerial Conference in Buenos Aires in 2017, the first time such a meeting has been held in South America. The Conference ended with the adoption of a number
More informationPROTECTION OF INTELLECTUAL PROPERTY
Chapter 12 PROTECTION OF INTELLECTUAL PROPERTY OVERVIEW OF RULES In today s economic environment, intangible assets are becoming increasingly important. These assets, which are the result of human intellectual
More informationEnhancing and focusing EU international cooperation in research and innovation: A strategic approach. Policy Research and Innovation
Enhancing and focusing EU international cooperation in research and innovation: A strategic approach A Rapidly Changing Context From a triad to a multipolar world STI increasingly internationally interconnected
More informationMedical Technology Association of NZ. Proposed European Union/New Zealand Free Trade Agreement. Submission to Ministry of Foreign Affairs & Trade
Medical Technology Association of NZ Proposed European Union/New Zealand Free Trade Agreement Submission to Ministry of Foreign Affairs & Trade February 2016 1 Introduction The Medical Technology Association
More informationHORIZON 2020 INTERNATIONAL COOPERATION
HORIZON 2020 INTERNATIONAL COOPERATION SWISSCORE RESEARCH & INNOVATION SEMINAR 2015 THE BIP, PLACE ROYALE 10-11 1000- BRUSSELS 2 DEC. 2015 Philippe Vialatte European Commission DG Research & International
More informationWIPO: Working on the balance
WIPO: Working on the balance Use and Abuse of IP and Related Rights : Getting the Right Balance Second Session October 17, 2010 Matthew Bryan, Director, Patent Cooperation Treaty Legal Division Trolls
More informationPractical measures to encourage the diffusion of green technologies: Licensing Fast tracking of green patents The GreenXchange Platform
Practical measures to encourage the diffusion of green technologies: Licensing Fast tracking of green patents The GreenXchange Platform Ahmed Abdel Latif Senior Programme Manager Innovation, Technology
More informationTRIPS and Access to Medicines. The Story so far
TRIPS and Access to Medicines The Story so far TRIPS and Access to Medicines : A brief history 1981: HIV first clinically observed 1982-83: Named AIDS 1984: Discovery that it is caused by a virus 1986:
More informationUSTR NEWS UNITED STATES TRADE REPRESENTATIVE. Washington, D.C UNITED STATES MEXICO TRADE FACT SHEET
USTR NEWS UNITED STATES TRADE REPRESENTATIVE www.ustr.gov Washington, D.C. 20508 202-395-3230 FOR IMMEDIATE RELEASE August 27, 2018 Contact: USTR Public & Media Affairs media@ustr.eop.gov UNITED STATES
More informationHistory of the WIPO Development Agenda
South Unity, South Progress. History of the WIPO Development Agenda Nirmalya Syam Development, Innovation and Intellectual Property Programme South Centre 4 October 2017 1 Process Leading to DA 2004 proposal
More informationAccess to Technology in the Post-2015 Development Agenda. Alessandra Casazza Policy Advisor UNDP Asia-Pacific Regional Center
Access to Technology in the Post-2015 Development Agenda Alessandra Casazza Policy Advisor UNDP Asia-Pacific Regional Center TECHNOLOGY IS ESSENTIAL FOR ACHIEVING SUSTAINABLE DEVELOPMENT MDG 8 ICT & Access
More informationUniversity IP and Technology Management. University IP and Technology Management
University IP and Technology Management Yumiko Hamano WIPO University Initiative Program Innovation Division WIPO WIPO Overview IP and Innovation University IP and Technology Management Institutional IP
More informationAn Essential Health and Biomedical R&D Treaty
An Essential Health and Biomedical R&D Treaty Submission by Health Action International Global, Initiative for Health & Equity in Society, Knowledge Ecology International, Médecins Sans Frontières, Third
More informationFunctionality of the Nagoya ABS Protocol with a view to AnGR and a side-look to Anti- Conterfeiting Trade Agreement (ACTA)
Functionality of the Nagoya ABS Protocol with a view to AnGR and a side-look to Anti- Conterfeiting Trade Agreement (ACTA) Morten Walløe Tvedt Senior research fellow International Technical Expert Workshop
More informationSEMINAR: INTELLECTUAL PROPERTY ARRANGEMENTS: IMPLICATIONS FOR DEVELOPING COUNTRY PRODUCTIVE CAPABILITIES IN THE SUPPLY OF ESSENTIAL MEDICINES.
SEMINAR: INTELLECTUAL PROPERTY ARRANGEMENTS: IMPLICATIONS FOR DEVELOPING COUNTRY PRODUCTIVE CAPABILITIES IN THE SUPPLY OF ESSENTIAL MEDICINES Report The two-day seminar was opened by Mr. Khalil Hamdani,
More informationAfrican Civil Society Meeting
African Civil Society Meeting Intergovernmental Working Group on Intellectual Property, Innovation and Health Topic: Considering Domestic Manufacturing Issues Nairobi Kenya 28-29 August 2007 DR W.O. WANYANGA
More informationGenetic Resources and Intellectual Property: Recent developments under the Convention on Biological Diversity
Genetic Resources and Intellectual Property: Recent developments under the Convention on Biological Diversity 15 September, 2004 Secretariat of the Convention on Biological Diversity Dan B. Ogolla OUTLINE
More informationLucinda Longcroft, Head, New York Office, World Intellectual Property Organization (WIPO)
General Assembly Structured Dialogues Stock-taking of the international debates on development, transfer and dissemination of clean and environmentally sound technologies UN HQ, New York April 29, 2014
More informationAccess and Benefit Sharing (Agenda item III.3)
POSITION PAPER Access and Benefit Sharing (Agenda item III.3) Tenth Meeting of the Conference of the Parties to the Convention on Biological Diversity (CBD COP10), 18-29 October, 2010, Nagoya, Japan Summary
More informationONLINE INTELLECTUAL PROPERTY COURSES BY FEDERATION OF INDIAN CHAMBERS OF COMMERCE AND INDUSTRY (FICCI) About FICCI Established in 1927, FICCI is the largest and oldest apex business organisation in India.
More informationNanomaterials: Applications, Implications and Safety Management in the SAICM Context Rob Visser
Nanomaterials: Applications, Implications and Safety Management in the SAICM Context Rob Visser The Regulatory Challenge of Nanotechnology 20 January 2012 Bern, Switzerland 1 SAICM context: ICCM 2 considered
More informationThe TRIPS Tightrope public health, innovation, incentives and access
International Federation of Pharmaceutical Manufacturers & Associations The TRIPS Tightrope public health, innovation, incentives and access Helsinki, 6 September 2013 1 IFPMA 2013 Definitions (I) Doha
More informationNZFSA Policy on Food Safety Equivalence:
NZFSA Policy on Food Safety Equivalence: A Background Paper June 2010 ISBN 978-0-478-33725-9 (Online) IMPORTANT DISCLAIMER Every effort has been made to ensure the information in this report is accurate.
More informationTechnical Assistance. Programme of Activities
Technical Assistance Programme of Activities 2011-2012 July 2011 The present programme of technical assistance activities reflects the decisions taken at the fifth meeting of the Conference of the Parties
More informationThe Green Economy: Trade and Sustainable Development Implications. From Rio to Rio:Technology Transfer, Innovation and Intellectual Property
Ad Hoc Expert Meeting on The Green Economy: Trade and Sustainable Development Implications Geneva, Switzerland. 8-10 Nov 2011 From Rio to Rio:Technology Transfer, and Intellectual Property By Mr. Ahmed
More informationOperational Objectives Outcomes Indicators
UNEP/CBD/BS/COP-MOP/5/17 Page 106 ELEMENTS OF STRATEGIC PLAN FOR THE CARTAGENA PROTOCOL ON BIOSAFETY VISION Biological diversity is adequately protected from any adverse effects of living modified organisms
More informationInterim Report on the Heiligendamm Process at the G8 Summit in Hokkaido Toyako 7 to 9 July 2008
Interim Report on the Heiligendamm Process at the G8 Summit in Hokkaido Toyako 7 to 9 July 2008 Prepared by the Steering Committee of the Heiligendamm Process consisting of the personal representatives
More informationHistorical Background, General Provisions and Basic Principles of the TRIPS Agreement and Transitional Arrangements*
J:mrnal ofinoollectual Property Rights Vol 3 March 1998 pp 68-73 Historical Background, General Provisions and Basic Principles of the TRIPS Agreement and Transitional Arrangements* Mart Leesti Former
More informationNote by the secretariat * Summary
UNITED NATIONS Distr. GENERAL 20 May 2008 Original: ENGLISH SUBSIDIARY BODY FOR IMPLEMENTATION Twenty-eighth session Bonn, 4 13 June 2008 Item 6 of the provisional agenda Development and transfer of technologies
More informationIntellectual Property and Public Health - International Framework and Recent Developments in WIPO: SCP and CDIP
Intellectual Property and Public Health - International Framework and Recent Developments in WIPO: SCP and CDIP WTO-ESCAP-IIUM REGIONAL WORKSHOP ON IP AND PUBLIC HEALTH AND ENVIRONMENT PLOICY FOR THE ASIAN
More informationWORLD TRADE ORGANIZATION
WORLD TRADE ORGANIZATION Activity Sheet TITLE OF THE EVENT / Advanced Course on Intellectual Property for Government Officials VENUE AND DATES Geneva, Switzerland, 10-21 March 2014 Course description This
More informationThe stakes within diverse global policy deliberations concerning treatment of Intellectual Property related to standard-setting
The stakes within diverse global policy deliberations concerning treatment of Intellectual Property related to standard-setting ANSI CMF/ICSCA Meeting Agenda 3.4 Miami, Florida: April 10, 2008 Presented
More informationCOMMISSION RECOMMENDATION. of on access to and preservation of scientific information. {SWD(2012) 221 final} {SWD(2012) 222 final}
EUROPEAN COMMISSION Brussels, 17.7.2012 C(2012) 4890 final COMMISSION RECOMMENDATION of 17.7.2012 on access to and preservation of scientific information {SWD(2012) 221 final} {SWD(2012) 222 final} EN
More informationIssues at the Intersection of IP and Competition Policy
Issues at the Intersection of IP and Competition Policy WIPO Symposium 11 May 2010 Jeremy West OECD Competition Division jeremy.west@oecd.org The Big Picture IP and competition policy are mostly complementary,
More informationBIPF Munich. South Africa Enforcement of Pharmaceutical Patents and the New Draft IP Policy
BIPF 2014 - Munich South Africa Enforcement of Pharmaceutical Patents and the New Draft IP Policy Russell Bagnall Danie Dohmen 1 OVERVIEW Enforcement of Pharmaceutical Patents The Role Players Compulsory
More informationDRAFT. "The potential opportunities and challenges for SMEs in the context of the European Trade Policy:
DRAFT "The potential opportunities and challenges for SMEs in the context of the European Trade Policy: Brussels - June 24th, 2014 European Economic and Social Committee V. President Giuseppe Oliviero
More informationIGDRP Mission, Scope, How it works
IGDRP Mission, Scope, How it works IGDRP-EDQM Workshop Strasbourg, France 13 May 2016 Dr. Craig Simon Associate Director, Bureau of Pharmaceutical Sciences Therapeutic Products Directorate Health Canada
More informationFlexibilities in the Patent System
Flexibilities in the Patent System Joseph Straus, Munich WIPO Colloquium on Selected Patents Issues Geneva, February 16, 2007 J. Straus 2007 1 Topics to Consider Facts First Pre-TRIPS-Regime TRIPS & Mandatory
More information