21 April 2005Felix Addor - Disclosure Requirement1 Felix Addor Head of the Swiss Delegation to the WTO/TRIPS-Council Deputy Director General Swiss Federal Institute of Intellectual Property, Bern 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 - Disclosure Requirement21 April Overview n Swiss proposals re. disclosure of source:  Policy objectives  Main features n Evidence of prior informed consent (PIC) and benefit sharing n Role of WIPO / PCT & PLT Agreements n Role of WTO / TRIPS Agreement

Felix Addor - Disclosure Requirement21 April Policy Objectives of the Swiss Proposals “The Four T’s”: 1. Transparency in access and benefit sharing 2. Traceability for providers of genetic resources and traditional knowledge 3. Technical prior art regarding traditional knowledge 4. Mutual Trust among the various stakeholders

Felix Addor - Disclosure Requirement21 April 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 Requirement21 April Feature 2 Terminology: n “Genetic resources” n “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 Requirement21 April 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 Requirement21 April Feature 4 The scope of the obligation to declare the source: n Invention makes immediate use of the genetic resources (= depend on the specific properties of this resource) n Invention is directly based on traditional knowledge (= inventor must consciously derive invention from this knowledge)

Felix Addor - Disclosure Requirement21 April Feature 5 n Require declaration of source also in international patent applications n Include declaration of source in international publication of patent application

Felix Addor - Disclosure Requirement21 April Feature 6 Sanctions: n Current sanctions of PCT (Rule 51bis.3(a) PCT Regulations) and PLT (Article 10 PLT) n National (criminal) sanctions such as n fines n publication of ruling

Felix Addor - Disclosure Requirement21 April 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 Requirement21 April Feature 8 Optional introduction at national level (“enabling clause”)  4 advantages: n Faster progress n Possibility to gain experience without prejudice to further international efforts n Switzerland (and many other European countries) plans to introduce the requirement n No additional obligations for developing countries (esp. LDCs)

Felix Addor - Disclosure Requirement21 April Draft Revision of Swiss Patent Law n Draft requirement to declare the source of genetic resources and traditional knowledge in the patent application (Art. 49a) n Draft Sanctions for wrongful declaration (Art. 81a): n fines up to CHF 100’000 n publication of ruling

Felix Addor - Disclosure Requirement21 April Evidence of Prior Informed Consent and Benefit Sharing n A number of legal and practical problems n  Swiss approach: n declaration of the source n notification system

Felix Addor - Disclosure Requirement21 April The Role of the TRIPS Agreement? n Relevant Provisions: n Art n Art n Art n  Position of Switzerland: No amendment necessary

Felix Addor - Disclosure Requirement21 April PCT / PLT vs. TRIPS Agreement n Amendment of: n PCT = regulations n TRIPS = agreement n Necessary votes: n PCT = 2/3 majority n TRIPS = consensus

21 April 2005Felix Addor - Disclosure Requirement16 Further information n Swiss proposals re Disclosure: n Revision of Swiss patent law: n For more information: