Presentation is loading. Please wait.

Presentation is loading. Please wait.

Patent-Related Flexibilities in Multilateral Treaties and their Importance for Developing Countries and LDCs – the TRIPS Agreement Thu-Lang TRAN WASESCHA.

Similar presentations


Presentation on theme: "Patent-Related Flexibilities in Multilateral Treaties and their Importance for Developing Countries and LDCs – the TRIPS Agreement Thu-Lang TRAN WASESCHA."— Presentation transcript:

1 Patent-Related Flexibilities in Multilateral Treaties and their Importance for Developing Countries and LDCs – the TRIPS Agreement Thu-Lang TRAN WASESCHA Senior Counsellor, Intellectual Property Division WTO Secretariat Tran Wasescha- May 2013 Second WIPO Inter-Regional Meeting on South-South Cooperation on Patents, Trademarks, Geographical Indications, Industrial Designs and Enforcement WIPO-Ministry of Foreign Affairs-ASRT Cairo, 6-8 May 2013

2 Outline The TRIPS (Trade-Related Aspects of Intellectual Property Rights) Agreement in the Intellectual Property (IP) universe TRIPS Patent flexibilities: a few examples TRIPS Balance of rights and obligations: a few examples Some final remarks

3 3 TRIPS and the IP Universe Paris IPIC Paris Berne IPIC Rome FTAs (bilateral or regional) TRIPS WIPO treaties, etc. National laws Regional legislation EU, OAPI, ARIPO, etc.

4 The WTO in a nutshell Presently 159 Members. Some 97 % of trade in goods and services (altogether) Multidisciplinary complex mechanism of negotiations, trade-offs across the board The multilateral character of WTO agreements (vs. Pluri-lateral) Single undertaking Dispute settlement system (DS)

5 5 General remarks (1) Patents in the Uruguay Round: area of IP where the discussion on pros and cons of IP protection has been most emotional and difficult. Delicate balance struck – within Section 5; and – within the TRIPS Agreement. – within the UR single package Flexibilities So-called constructive ambiguity Policy space

6 6 General remarks (2) Flexibility. What is flexibility? – Policy Space Defining policy orientation Implementation Space – Constitutional rules – Legislative systems – National interests but also a need for coherence and attraction of FDIs

7 TRIPS – balance of interests Paris, Berne Conventions. Balance of interests already carefully negotiated. Incorporation of WIPOs basic conventions TRIPS: Plus certain elements or re-affirmations or clarifications Balance of interests negotiation of flexibilities, e.g. exhaustion of rights, patentability, compulsory licensing Flexibilities and constructive ambiguity

8 Rights and obligations – patents (non exhaustive examples) Art.27.1: Patentable subject matter Art.29: Patent application if granted Art.28: Rights conferred Exclusions permitted: Art.27.2 + 3 Requirements: novelty, inventive step and industrial applicability + disclosure Exceptions and limitations: Art. 30 + 31

9 9 Minimum level of protection! Subject to transitional arrangements for certain Members Freedom to go beyond this level: national laws, regional legislation, bilateral and multilateral agreements "Shall" provisions But flexibility in "may" provisions + obligations tempered provisions (shall have the authority) TRIPS: general

10 10 Patents in general Area of IP where the discussion on pros and cons of IP protection has been most emotional and difficult. Delicate balance within Section 5, within the other TRIPS parts But have we really invented the wheel with TRIPS? The Paris Convention and its modernity – TRIPS preamble; Article 7: especially focused on patents; Modern dimension of this article – Article 8

11 11 Freedom to determine the appropriate method of implementing TRIPS (Art.1.1) Exhaustion of rights (Art. 6); usefulness for DS Article 8 (Doha on TRIPS-Public health) Exclusions from patentability (Art. 27) – The "may" provisions Exclusive rights = 20 years temporary monopoly?: NOT a blank check (see pharmaceuticals) Some TRIPS patent flexibilities (1)

12 12 Exceptions to rights Research exemption Regulatory exception (or so-called "Bolar exemption") Other limitations – Compulsory licenses (CLs) – Public non-commercial use – Government use – Dependent licenses – Confirmation by Doha Ministers of policy space (grounds for CLs) [but obligation to respect conditions for granting CLs] Some TRIPS patent flexibilities (2)

13 13 Plant variety protection Enforcement of patent rights – Takes account of specific national systems – No need to devote additional resources – May provisions; shall have the authority provisions – Transition periods for LDCs Some TRIPS flexibilities (3)

14 14 Transitional periods Developed countries DCs & economies in transition DCs: Additional for DCs (pharma) LDCs (general (Art. 66.1) LDCs (pharma & test data) 1 year (1995-1996) 5 years (2000) Another 5 years (2005) 11 years 2006 11 years 2006 7.5 years (1 July 2013) Doha TRIPS-Public health: 1 January 2016 (pharma & test data) Currrent negotiations for a 2 nd extension

15 15 Flexibility example - Exhaustion Country B [Regime irrelevant] ARV Drug at 5 USD/dose Country C international exhaustion ARV Drug at 10 USD/dose Country A national exhaustion ARV drug at 30 USD/dose

16 16 Article 7 – Confirmation of Doha ministerial declaration (public health) – Interpretation for dispute settlement cases Exceptions to rights Research exmption Regulatory exception (or so-called "Bolar exemption") Other limitations – Compulsory licenses (CLs) – Public non-commercial use – Government use – Dependent licensing – Confirmation by Doha Ministers of policy space (grounds for compulsory licenses) but obligation to respect conditions for granting CLs Balance of rights and obligations (1)

17 17 Rightholders – competitor – Safeguards for both – R&D is important for technology progress – Accessibility to products; the special case of pharmaceuticals – Consumers role Balance of rights and obligations (2)

18 Doha Declaration TRIPS-Public health and Paragraph 6 System Doha declaration on TRIPS-Public health Confirmation of flexibilities and public policy space Importance of R&D but also accessibility and affordability Paragraph 6 system: – Waivers (WT/L/540 and Corr.1 ) – Procotol (amendment) (WT/L/641)

19 19 TRIPS-Public Health - Some References Doha Declaration on TRIPS and Public Health (WT/MIN(01)/DEC/2) Decision on the implementation of paragraph 6 of the Doha Declaration on TRIPS and Public Health (WT/L/540 and Corr.1) Decision on an amendment to the TRIPS Agreement (Protocol) (WT/L/641) Annual Review of the Functioning of the System Members laws implementing the Para.6 System: http://www.wto.org/english/tratop_e/trips_e/par6laws_e.htm http://www.wto.org/english/tratop_e/trips_e/par6laws_e.htm How to accept the Protocol Amending TRIPS: http://www.wto.org/english/tratop_e/trips_e/accept_e.htm http://www.wto.org/english/tratop_e/trips_e/accept_e.htm Decision on extension of transition period for LDCs with respect to pharmaceutical products (IP/C/25) Decision on general extension of transition period for LDCs (IP/C/40) - 30 June 2013, being discussed /negotiated

20 20 Right holder Competitor Consumer Balance of interests – the "virtuous triangle"

21 21 TRIPS: first most comprehensive treaty on IP Balance struck (but balances are fragile) Pendulum effect Great flexibility, perhaps not always well understood Doha Declaration: useful to give some comfort to certain Members Test for future: how the patent system is used. Important to keep the balance between innovation- R&D and access to medicines Short, Medium and Long-term visions Remarks

22 Patent flexibilities Common sense use of IP, of rights and obligations, of flexibilities (e.g. patentable inventions), otherwisePendulum effects, which is not in the benefit of any party. Sound and reasonable use of IP Foreign direct investment (even if it is one pre-requisite only among others). Other factors to tackle? DCs and LDCs: group of countries of hopes and possibilities (natural resources inventive activities patentable inventions)

23 23 Consult our website www.wto.org Other questions to: thu-lang.tranwasescha@wto.orgthu-lang.tranwasescha@wto.org; tel.: +41 22 739 57 05; # 3024


Download ppt "Patent-Related Flexibilities in Multilateral Treaties and their Importance for Developing Countries and LDCs – the TRIPS Agreement Thu-Lang TRAN WASESCHA."

Similar presentations


Ads by Google