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21 April 2005 Felix Addor - Disclosure Requirement 1
Felix Addor
Head of the Swiss Delegation to the WTO/TRIPS-Council Deputy Director GeneralSwiss Federal Institute of Intellectual Property, Bern
WTO After 10 Years: Global Problems and Multilateral SolutionsGeneva, 21 April 2005
Addressing the Disclosure Requirement at the International Level – The Role of the TRIPS Agreement?
Felix Addor - Disclosure Requirement21 April 2005 2
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
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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
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Feature 1
= Requirement to disclose source of genetic resources and traditional knowledge in national and international patent applications
Amendment of WIPO / PCT and PLT
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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)
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Feature 3
A multitude of entities may be involved in access and benefit sharing Broad concept of „source“ of genetic resources and traditional knowledge
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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)
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Feature 5
Require declaration of source also in international patent applications
Include declaration of source in international publication of patent application
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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
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Feature 7
Notification system:
Establishment of an on-line list of government agencies competent to receive information on the declaration of source
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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)
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Draft Revision of Swiss Patent Law
Draft requirement to declare the source of 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
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Evidence of Prior Informed Consent and Benefit Sharing
A number of legal and practical problems
Swiss approach: declaration of the source notification system
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The Role of the TRIPS Agreement?
Relevant Provisions: Art. 27.1 Art. 29.1 Art. 62.1
Position of Switzerland: No amendment necessary
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PCT / PLT vs. TRIPS Agreement
Amendment of: PCT = regulations TRIPS = agreement
Necessary votes: PCT = 2/3 majority TRIPS = consensus
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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:[email protected]
