1. 1 Developments in International Discussions on Patent Law Harmonization including WIPO SCP Meeting Kay KONISHI Patents Committee, Japan Group APAA KR-JP Joint Meeting August 9, 2008, Jeju

2. 2 1.1. Harmo Landscape in WIPO Developing countries Developed countries (Tri-lateral, B+) North-South debates: -Disclosure of Genetic Resources and Traditional Knowledge -Public Health and access to essential drugs -Benefit share from developed countries -Measures against anti-competitive practice -Anti-patent North-North debates: Agreed to the extent of taking “ First package (i.e., definition of PA, Grace period, novelty, inventive-step) ”, but diversity remains in prior art but diversity remains in prior art issues to be resolved for SINGLE “ first package ” (WO/GA/31/10) “ first package ” (WO/GA/31/10) -Grace period -Secret prior art (prior art effect of prior-filed later-published application) prior-filed later-published application)

3. 3 2.1.Development after 2004 WIPO General Assembly 2004.9 WIPO GA First package stuck 2005.2 Casablanca Informal consultation 2005.3 Proposal from “ Group of Development ” (SCP/11/4) 2005.6 SCP #11 No consensus on future works 2005.9 WIPO GA 2006.3 Informal Open Forum Forum 2006.4 SCP Informal Session Session 2005.7 SCP #12 IGCs on WIPO Development Agenda Substantial AND procedural DEADLOCK

4. 4 2.2. Approaches are Different, while Having Minimum Common Interest -SCP should address “ First package only ” ( “ 4 issue list ” ) proposed by Tri-lateral Offices (SCP/11/3, WO/GA/31/10) “CONSTRUCTIVE APPROACH” (1)definition of prior art (1)definition of prior art (2)grace period (2)grace period (3)novelty (3)novelty (4)inventive step (4)inventive step -SCP should address all issues ( ” 9 issue list ” ) (SCP/11/4) “BALANCED/AS A WHOLE APPROACH” (1)development and policy space for flexibilities (1)development and policy space for flexibilities (2)exclusions from patentability (2)exclusions from patentability (3)exceptions to patent rights (3)exceptions to patent rights (4)anticompetitive practice (4)anticompetitive practice (5)disclosure of origin, prior informed consent and benefit- sharing (5)disclosure of origin, prior informed consent and benefit- sharing (6)effective mechanisms to challenge the validity of patents (6)effective mechanisms to challenge the validity of patents (7)sufficiency of disclosure (7)sufficiency of disclosure (8)transfer of technology (8)transfer of technology (9)alternative models to promote innovation (9)alternative models to promote innovation common interest: need for multilateral forum

5. 5 2.3.Development after 2007 WIPO General Assembly 2007.9 WIPO GA Recommendation: “ The WIPO Secretariat should establish a report on existing issues relating to the international patent system covering the different needs and interests of all member states ” (SCP/12/3). -Including empirical evidence -Containing no conclusions 2009 Conference on issues relating to the implications of patents on certain areas of patents on certain areas of public policy such as health, the environment, climate change or food security 2008.6 SCP #12 2009.FQ SCP #13 Get back to the grass and start the harmo discussion from scratch ! 2008.9 WIPO GA (New Director General: Francis Gurry)

6. 6 3.1. SCP #12 -Discussions based on the ice-breaking “Report on the International Patent System (SCP/12/3)” -Chaired by Mr.Maximiliano Santa Cruz (Chile) -“Many delegations recognized that document was covering a wide range of issues relating to the patent system and constituted a good basis for discussion”. -”The SCP identified a non-exhaustive list of issues (18 issues) for further elaboration and discussion in the future (ANNEX to SCP/12/4 Rev.)”. -”Following a proposal by the Chair, the SCP: (a)Decided that the list of issues would remain open for further discussion at the next session of the SCP; (b)Asked the WIPO Secretariat to establish, for the next session of the SCP, preliminary studied on four issues, which are not to be considered prioritized over the other issues.” -Some changes in leading developing countries (I.e., Brazil and India) observed…

7. 7 4.1. Economic Rationale for the Patent System (SCP/12/3) Economic Rationale for the Patent System (1)Incentives to invest in production of knowledge by prohibiting Free riding (e.g., copying or imitating) -Empirical evidence: “Stronger IPR has a positive and significant impact on R&D investment (Kanwar, S. and R. Evenson (2003), Oxford Economic Papers)” (2) Disclosure of knowledge in the public domain -Early disclosure of invention reduces duplication of R&D (3) Technology transfer (through licensing, FDI and joint ventures) -Empirical evidence: “Stronger patent laws in developing countries have a Positive impact on bilateral imports into both small and large developing Countries. (Maskus and Penubarti (1997), University of Michigan Press)

8. 8 4.2. Use of the Patent System (SCP/12/3) Non-resident filing:37.8%(2005)

9. 9 4.2. Use of the Patent System (SCP/12/3)

10. 10 4.2. Use of the Patent System (SCP/12/3)

11. 11 4.2. Use of the Patent System (SCP/12/3)

12. 12 4.2. Use of the Patent System (SCP/12/3) -Each country has different needs (1)Australia, Canada, Japan, Korea, U.S., Singapore: high non-resident filing both as a country of origin and as a target office (2)Brazil, China, Chile, Thailand, South Africa: high target countries, but low origin countries (3)Low target-high origin (4)Low target-low origin

13. 13 5.1.Initial “ List of Issues ” LIST OF 18 ISSUES (in the order of their appearance in SCP/12/3) -Economic impact of the patent system -Transfer of technology -Competition policy and anti-competitive practices -Dissemination of patent information (including the registration of licenses) -Standards and patents -Alternative models for innovation -Harmonization of basic notions of substantive patentability requirements (e.g., Prior art, novelty, inventive-step, industrial applicability, disclosure) -Disclosure of inventions -Database on search and examination reports -Opposition system -Exceptions from patentable subject matter -Limitations to the rights -Research exemption -Compulsory licenses -Client-attorney privilege -Patents and health (including exhaustion, the Doha Declaration and other WTO Instruments, patent landscaping) -Relationship between the patent system and the CBD (Genetic resources/ Traditional knowledge/ Disclosure of origin) -Relation of patents with other public policy issues “Neutral” issues picked up

14. 14 5.2.Picked-up Four Issues (1) Dissemination of patent information (inter alia the issue of a database on search and examination reports); reports); -Limited coverage of accessible patent data and status information; -Linguistic diversity of the prior art; -Role of the public and private sectors. (2) Exceptions from patentable subject matter and limitations to the rights, inter alia research exemption and compulsory licenses;<Concerns> -The scope of the term “invention”, as well as how it is defined in the national legislation, are not uniform, and the differences in the national laws reflect the political choice of the country; -TRIPS mandates minimum standard so that the member countries have little flexibility to apply their own public policy (e.g., essential drugs for HIV/AIDS).

15. 15 5.2.Picked-up Four Issues (3) Patents and Standards; -Patent owners in the field of technical standard may have an interest in the adoption, In the standard, of their own patented technology in order to benefit, at a later stage, From royalties beyond RAND/Royalty free royalties. -How to strike a balance between the interest of patent holders in exploiting their patents, The producers who want to license and produce the goods covered by the standard At a reasonable price, ant eh public which seeks the widest possible choice among Interoperable product. (4) Client-Attorney Privilege; <Concerns> -When a client seeks the opinion of a patent attorney, not all countries provide privilege To the advice the patent attorney gave to his client or keep the communication between the patent attorney and the client confidential from the court, the national rules vary significantly from one country to another; -Since more and more applications seek patent protection abroad, the lack of uniform Standardized rules on privilege and on the recognition of a privilege in different countries Cause serious concerns.

16. 16 6.1. Revisiting SPLT … B+ Follow-up -2007.9 B+ Plenary Meeting in Geneva -2008.9 B+ Plenary Meeting in Geneva -2008.6 “ POLICY INTENTS OF ITEMS TO BE INCLUDED IN A REDUCED PACKAGE FOR AN INTERNATIONAL PATENT LAW HARMONISATION TREATY ”

17. 17 6.2. Thumbs-up items 1.First-to-file 2.Elimination of the Hilmer Doctrine 3. Grace Period -12 month with on formal declaration -12 month with on formal declaration -GP covers published patent applications -GP covers published patent applications only if publication is erroneous only if publication is erroneous 4. 3 rd party ’ s right (optional or partially optional) 5. Definition of Prior Art (incl. secret prior art), Novelty, and Inventive-step 6. Inclusion of PCT applications in the secret prior art as of the PCT filing or priority date filing or priority date 7. The abstract does not form part of the ‘ whole contents ’ 8. Inventive step methodology is not included in the SPLT Articles

18. 18 Kay KONISHI MIYOSHI & MIYOSHI konishi@miyoshipat.co.jp