Geneva, 24 Apr 2006
WORKING GROUP ON REFORM OF THE PATENT COOPERATION TREATY (PCT)
Geneva, May 8 to 12, 2006
DECLARATION OF THE SOURCE OF GENETIC RESOURCES AND TRADITIONAL KNOWLEDGE IN PATENT APPLICATIONS
Proposals submitted by Switzerland
1. Switzerland submitted its proposals regarding the declaration of the source of genetic resources and traditional knowledge in patent applications to the WIPO Working Group on Reform of the Patent Cooperation Treaty (PCT) in May 2003 .
2. In summary, Switzerland proposes to amend the Regulations under the PCT (PCT Regulations) to explicitly enable the national patent legislation to require the declaration of the source of genetic resources and traditional knowledge in patent applications, if the invention is directly based on such resources or knowledge (see the proposed new Rule 51bis.1(g)). Furthermore, Switzerland proposes to afford patent applicants the possibility of satisfying this requirement at the time of filing an international patent application or later during the international phase (see the proposed new Rule 4.17(vi)). Under present Rule 48.2(a)(x), such declaration of the source would be included in the international publication of the international application concerned. 3. In order to advance the discussions on its proposals, Switzerland presented two further submissions to the WIPO Working Group on PCT Reform in May 2004 and October 2004, respectively, containing more detailed explanations on its proposals . These submissions address the use of terms, the concept of the "source" of genetic resources and traditional knowledge, the scope of the obligation to declare this source in patent applications, the possible legal sanctions for failure to declare the source or for wrongful declaration of the source, and its optional vs. mandatory introduction at the national level.
4. For information purposes, Switzerland presented its proposals to the WIPO Intergovernmental Committee on Intellectual Property and Genetic Resources, Traditional Knowledge and Folklore (IGC) , to the WIPO Ad hoc Intergovernmental Meeting on Genetic Resources and Disclosure Requirements held June 3, 2005 , to the WTO TRIPS Council , and to the 3rd and 4th sessions of the Ad Hoc Open-Ended Working Group on Access and Benefit Sharing of the Convention on Biological Diversity (CBD) .
5. The thirty-fourth Session of the Assembly of the International Patent Cooperation Union (September 26 to October 5, 2005) "unanimously approved the proposals concerning the work program in connection with reform of the PCT to be undertaken between the September 2005 and September 2006 sessions of the Assembly" . This includes the proposals by Switzerland regarding the declaration of the source of genetic resources and traditional knowledge in patent applications. The present document is intended to serve as the basis for the discussions of the 8th session of the Working Group on Reform of the PCT, to be held May 8 to 12, 2006, on the proposals by Switzerland.
1. In the view of Switzerland, the proposed amendments to the PCT present one simple and practical solution to the issues arising in the context of access to genetic resources and traditional knowledge and the fair and equitable sharing of the benefits arising out of their utilization. These amendments could be introduced in a timely manner and would not require extensive changes to the provisions of relevant international agreements.
2. Disclosing the source can be seen as the "entering point" of the access and benefit sharing in the patent system. In this way, disclosing the source would help to build mutual trust in the North - South - relationship. Moreover, it would strengthen the mutual supportiveness between the access and benefit sharing system and the patent system.
3. The proposed declaration of the source of genetic resources and traditional knowledge in patent applications would allow States that are party to a contract on access and benefit sharing to verify whether the other contracting party is complying with its obligations arising under that contract. This transparency measure would not only assist in and simplify the enforcement of these obligations, but would also allow to verify whether prior informed consent (PIC) of the country providing the genetic resources has been obtained and whether provisions have been made for fair and equitable benefit sharing.
4. The proposals made by Switzerland would thus enable the Contracting Parties of relevant international agreements, including the CBD, the International Treaty of FAO, the PCT, the PLT and the TRIPS Agreement, to fulfill their respective obligations. This applies in particular to Articles 8(j), 15.4, 15.5, 15.7 and 16.5 of the CBD. Furthermore, the Swiss proposals would enable the Contracting Parties of the CBD to implement the provisions of the Bonn Guidelines, in particular their paragraph 16(d), as well as several of the decisions adopted by COP6 and COP7. And finally, the possibility to require the declaration of the source would also support the determination of prior art with regard to traditional knowledge, as it would simplify searching the databases on traditional knowledge that are increasingly being established at the local, regional and national level.
5. The Working Group is invited to consider the proposals contained in Annex I.
[Annexes follow] [...]
World Intellectual Property Organisation
World Intellectual Property Organisation