CUTS International Capacity Building Training Programme on Advance IPR, WTO-Related Issues and Patent Writing April 28-May 02, 2008, Jaipur TRIPS – CBD STATE OF PLAY Session 10 May 02, 2008 B. K. Zutshi

Outline of the presentation Importance of biodiversity in trade Developing country interest Discussions on CBD in international fora Disclosure Proposal –Mandate –Support and opposition –Approach of proponents Horizontal modalities text India’s domestic legislation Current state of play 2

Importance of Biodiversity for Trade Biodiversity is not just an environment issue but also a trade issue A wide range of sectors undertake research and develop commercial products from genetic resources. These include - pharmaceutical, biotechnology, seed, crop protection, horticulture, cosmetic and personal care, fragrance and flavor, botanicals, and food and beverage industries. Each sector is part of a unique market, undertakes research and development in distinct ways, and uses genetic resources and demands access to these resources very differently They also enter into partnerships with providers of genetic resources in distinct ways, have specific sets of stakeholders, negotiate prior informed consent in diverse ways, and have different approaches to benefit-sharing and intellectual property. 3

Interest of developing countries Developing countries are home to over 70% of earth’s biodiversity UNEP has identified 17 countries as megadiverse. These are: Australia, Brazil, China, Columbia, Congo, Ecuador, India, Indonesia, Kenya, Madagascar, Malaysia, Maxico, Papua New Guinea, Peru, Philippines, South Africa and Venezuela- mostly developing countries Seventeen countries rich in biological diversity and associated traditional knowledge have formed a group known as the Like Minded Megadiverse Countries (LMMC) in 2002– formed to coordinate approaches in CBD forum LMMC includes Brazil, China, Colombia, Costa Rica, Ecuador, India, Indonesia, Kenya, Mexico, Peru, South Africa and Venezuela 4

CBD discussion in other fora Due to its importance, CBD is being discussed in various fora CBD is being discussed in : –Food and Agriculture Organization of the United Nations –World Intellectual Property Organization –International Union for the Protection of New Varieties of Plants (UPOV), etc International Federation of Pharmaceutical Manufacturers and Associations (IFPMA) has also developed Guidelines for their members on “Access to Genetic Resources and Equitable Sharing of Benefits Arising out of their Utilization” (IFPMA, 2006). These guidelines support the objectives of the CBD Discussion in WTO in the TRIPS Framework – most important for effective implementation 5

Disclosure Proposal - Mandate Compilation of Outstanding Implementation Issues Raised By Members (JOB(01)/152/Rev.1, 27 Oct, 2001) –Tiret 88 under heading of TRIPS - “A clear understanding in the interim that patents inconsistent with Article 15 of the CBD shall not be granted.” CBD Art 15 – PIC and fair and equitable benefit sharing Para 12 of Doha Declaration - Ministers agreed that “negotiations on outstanding implementation issues shall be an integral part of the Work Programme, and that agreements reached at an early stage in these negotiations shall be treated in accordance with the provisions of paragraph 47.” Para 47 states that “the conduct, conclusion and entry into force of the outcome of the negotiations shall be treated as parts of a single undertaking.” It is clear therefore, that the implementation issues shall be a part of the Single Undertaking. 6

Mandate ….. Para 19 leaves no doubt that “the relationship between the TRIPS Agreement and the Convention on Biological Diversity, the protection of traditional knowledge and folklore” is a Para 12 implementation issue. Para 19 also adds that “In undertaking this work, the TRIPS Council shall be guided by the objectives and principles set out in Articles 7 and 8 of the TRIPS Agreement and shall take fully into account the development dimension.” Article 7 states that intellectual property rights should contribute to the promotion of …… social and economic welfare, and to a balance of rights and obligations. 7

Mandate.... At Hong Kong, Ministers identified 2 implementation issues (Para 39) viz. the relationship between the TRIPS Agreement and the Convention on Biological Diversity and extension of the protection of geographical indications provided for in Article 23 of the TRIPS. Noting this, the Ministers called on DG to “intensify his consultative process on all outstanding implementation issues under paragraph 12(b), if need be by appointing Chairpersons of concerned WTO bodies as his Friends and/or by holding dedicated consultations. “ Para 49 says that negotiations “shall be conducted with a view to ensuring benefits to all participants and to achieving an overall balance in the outcome of the negotiations.” 8

Disclosure proposal The Disclosure Proposal was submitted in May 2006 initially co-sponsored by Brazil, India, Pakistan, Peru, Thailand and Tanzania under TN/C/W/41 and WT/GC/W/564 Objectives: –Sets minimum standards for enhancing mutual supportiveness between TRIPS and CBD Address issues of bio piracy, misappropriation Avoidance of Erroneous patents Access and fair and equitable benefit sharing Promotes transparency in patents 9

Main elements of Disclosure Proposal Calls for an amendment of TRIPS Agreement by inserting a new article 29 bis The disclosure requirements envisaged in the Proposal are: –Disclosure of source and country of origin of the biological resource and / or associated traditional knowledge used in the invention; –Disclosure of evidence of prior informed consent (PIC) under the relevant national regime; –Disclosure of evidence of access and fair and equitable benefit sharing under the relevant national regime. Legal effects envisaged in case of failure to comply with the above obligations include revocation or stopping of processing of the patent application. 10

Support and Opposition Without exception, all Members agree with the objectives and that TRIPS Agreement and the CBD should be implemented in a mutually supportive manner. However, there is a wide divergence in the approaches to achieve this. Co-sponsorship – 77 countries – –Asia – India, China, Pakistan, Thailand –Americas – Brazil, Peru, Ecuador, Paraguay, Colombia, Cuba, Venezuela, Dominican Republic –Africa – Tanzania, South Africa –Groupings - Africa Group, LDC Group, ACP Group Middle ground countries – Norway, EC, Swiss – have similar proposals and are developed countries. Norway supports text based negotiations. Countries which oppose the proposal – US, Australia, NZ, Japan, Korea, Canada, Chile and Argentina etc 11

Opponents view and approach Agree with the ‘shared objectives’ and mutually supportive implementation of TRIPS and CBD – No amendment to the TRIPS Agreement is needed or warranted – Premature to engage in a text ‑ based discussion since no consensus yet, more fact based work – Amendment will open pandora’s box – demands for other amendments National access and benefit-sharing regimes could be more useful Suggest use of searchable organized databases, post grant opposition and re-examination for countering erroneous patents Suggest national contract-based systems which could be enforced outside the patent system - could be part of civil and criminal codes specifically designed to enforce access and benefit-sharing laws. Disclosure requirements will create legal uncertainty Japan has proposed organized databases for improving prior art search systems Argentina questions the mandate negotiations Suggest WIPO and CBD are more appropriate fora 12

Approach of proponents Considering the pockets of support and opposition, decided on parallelism between GIs and TRIPS-CBD in terms of processes and outcomes Also, this approach is based on the premise that GIs are a make or break for EC and Swiss Increasing base of co-sponsorship – crossed majority mark Proponents have made it clear at TNC/GC etc. that TRIPS-CBD is a critical implementation issue for developing countries. No outcome on the GIs is expected without a corresponding and comparable outcome on TRIPS-CBD. An outcome on this issue is an essential element of any ‘development package’ that emerges from the Doha Round. Called for Text-based negotiations on the basis of the submission (IP/C/W/474) must begin soon as an integral part of the single undertaking. Norway agrees Showed willingness to engage constructively and show flexibility 13

India’s domestic legislation India is fully compliant with the elements of the Disclosure Proposal Indian Patent (Amd) Act (2005) The Biological Diversity Act, 2002 and Biological Diversity Rules, 2004 National Biodiversity Authority 14

Current state of play in WTO Discussions on TRIPS-CBD in TRIPS Council – permanent agenda item Dedicated consultations held by DDG Rufus Yerxa DG has reported status at each TNC/GC Intensive consultations in the last three months of 2007.Were to be resume in April,2008. DG reported submission of modalities text. Also highlighted ‘substantial differences’ Proponents of GIs and CBD have highlighted the parallelism and called for Ministerial Guidance on both the issues of GIs and TRIPS-CBD. 15