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WTO After 10 Years: Global Problems and Multilateral Solutions Geneva, 21 April 2005. Addressing the Disclosure Requirement at the International Level – The Role of the TRIPS Agreement?. Felix Addor Head of the Swiss Delegation to the WTO/TRIPS-Council Deputy Director General
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WTO After 10 Years: Global Problems and Multilateral Solutions Geneva, 21 April 2005 Addressing the Disclosure Requirement at the International Level – The Role of the TRIPS Agreement? Felix Addor Head of the Swiss Delegation to the WTO/TRIPS-Council Deputy Director General Swiss Federal Institute of Intellectual Property, Bern Felix Addor - Disclosure Requirement
Overview • Swiss proposals re. disclosure of source: Policy objectives Main features • Evidence of prior informed consent (PIC) and benefit sharing • Role of WIPO / PCT & PLT Agreements • Role of WTO / TRIPS Agreement Felix Addor - Disclosure Requirement
Policy Objectives of the Swiss Proposals “The Four T’s”: • Transparency in access and benefit sharing • Traceability for providers of genetic resources and traditional knowledge • Technical prior art regarding traditional knowledge • Mutual Trust among the various stakeholders Felix Addor - Disclosure Requirement
Feature 1 = Requirement to disclose source of genetic resources and traditional knowledge in national and international patent applications Amendment of WIPO / PCT and PLT Felix Addor - Disclosure Requirement
Feature 2 Terminology: • “Genetic resources” • “Traditional knowledge associated with genetic resources” in consistency with international agreements on access and benefit sharing (CBD, Bonn Guidelines and FAO International Treaty) Felix Addor - Disclosure Requirement
Feature 3 A multitude of entities may be involved in access and benefit sharing Broad concept of „source“ of genetic resources and traditional knowledge Felix Addor - Disclosure Requirement
Feature 4 The scope of the obligation to declare the source: • Invention makes immediate use of the genetic resources (= depend on the specific properties of this resource) • Invention is directly based on traditional knowledge (= inventor must consciously derive invention from this knowledge) Felix Addor - Disclosure Requirement
Feature 5 • Require declaration of source also in international patent applications • Include declaration of source in international publication of patent application Felix Addor - Disclosure Requirement
Feature 6 Sanctions: • Current sanctions of PCT (Rule 51bis.3(a) PCT Regulations) and PLT (Article 10 PLT) • National (criminal) sanctions such as • fines • publication of ruling Felix Addor - Disclosure Requirement
Feature 7 Notification system: Establishment of an on-line list of government agencies competent to receive information on the declaration of source Felix Addor - Disclosure Requirement
Feature 8 Optional introduction at national level (“enabling clause”) 4 advantages: • Faster progress • Possibility to gain experience without prejudice to further international efforts • Switzerland (and many other European countries)plans to introduce the requirement • No additional obligations for developing countries (esp. LDCs) Felix Addor - Disclosure Requirement
Draft Revision of Swiss Patent Law • Draft requirement to declare the sourceof genetic resources and traditional knowledge in the patent application(Art. 49a) • Draft Sanctions for wrongful declaration(Art. 81a): • fines up to CHF 100’000 • publication of ruling Felix Addor - Disclosure Requirement
Evidence of Prior Informed Consent and Benefit Sharing • A number of legal and practical problems • Swiss approach: • declaration of the source • notification system Felix Addor - Disclosure Requirement
The Role of the TRIPS Agreement? • Relevant Provisions: • Art. 27.1 • Art. 29.1 • Art. 62.1 • Position of Switzerland: No amendment necessary Felix Addor - Disclosure Requirement
PCT / PLT vs. TRIPS Agreement • Amendment of: • PCT = regulations • TRIPS = agreement • Necessary votes: • PCT = 2/3 majority • TRIPS = consensus Felix Addor - Disclosure Requirement
Further information • Swiss proposals re Disclosure: www.ige.ch/E/jurinfo/j105.shtm#6 • Revision of Swiss patent law: www.ige.ch/E/jurinfo/j100.shtm • For more information: felix.addor@ipi.ch Felix Addor - Disclosure Requirement