1. WIPO-Ministry of Foreign Affairs-ASRT
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
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

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. TRIPS and the IP Universe
National laws
TRIPS
FTAs (bilateral or regional)
Berne
Paris
Paris
Regional legislation
EU, OAPI, ARIPO, etc.
IPIC
Rome
IPIC
WIPO treaties, 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. 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. 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 WIPO’s 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
Requirements: novelty, inventive step and industrial applicability + disclosure
Exceptions and limitations: Art

9. TRIPS: general 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”)

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. Some TRIPS patent flexibilities (1)
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)

12. Some TRIPS patent flexibilities (2)
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]

13. Some TRIPS flexibilities (3)
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

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
( )
5 years
(2000)
Another 5 years
(2005)
11 years
2006
7.5 years
(1 July 2013)
Doha TRIPS-Public health:
1 January 2016
(pharma & test data)
Currrent negotiations for a 2nd extension

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

16. Balance of rights and obligations (1)
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

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

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. 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:
How to accept the Protocol Amending TRIPS:
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) June 2013, being discussed /negotiated

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

21. Remarks 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

22. Remarks Patent flexibilities
“Common sense” use of IP, of rights and obligations, of flexibilities (e.g. patentable inventions), otherwise “Pendulum 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. Consult our website www.wto.org
Other questions to:
tel.: ; # 3024