Transcript 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.

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
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
TRIPS and the IP Universe
National laws
TRIPS
Regional
legislation
Paris
Berne
FTAs
(bilateral
or
Paris regional)
EU, OAPI,
ARIPO,
etc.
IPIC
Rome
IPIC
WIPO treaties, etc.
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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)
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
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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
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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”
Rights and obligations – patents (non
exhaustive examples)
Art.27.1: Patentable
subject matter
Art.29: Patent
application
Exclusions permitted:
Art.27.2 + 3
Requirements: novelty,
inventive step and
industrial applicability
+ disclosure
if granted
Art.28: Rights
conferred
Exceptions and
limitations: Art. 30 + 31
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”)
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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
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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)
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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]
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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
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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 2nd
extension
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Flexibility example - Exhaustion
Country A
Country B
Country C
national exhaustion
ARV Drug at 10 USD/dose
international
exhaustion
[Regime
irrelevant]
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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
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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
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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)
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
• How to accept the Protocol Amending TRIPS:
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
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Balance of interests –
the "virtuous triangle"
Right holder
Competitor
Consumer
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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 innovationR&D and access to medicines
• Short, Medium and Long-term visions
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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)
Consult our website
www.wto.org
Other questions to:
[email protected];
tel.: +41 22 739 57 05; # 3024
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