Trips

Ms. Deepika
 WTO TRIPS Agreement

IPR Definitions of Terms:

* Patent – is the right given to inventors to have protected exclusive
use for specified period of time (“term”) for making, using, or selling
a new, useful, non-obvious invention. Patents are available for both
products & processes.
* Copyright – is the exclusive right to do certain things with an
original work, including the right to reproduce, publish, perform the
work in public, & to make adaptations of it. Copyright does not
protect ideas as such, but only the original expression of ideas.
* Trademark – consists of any sign, or combination of signs,
capable of distinguishing the goods or services of one person from
those of another, including personal names, designs, letters,
numerals, colours, figurative elements, shape of goods, or their
packaging. TMs include service marks, collective marks, & may
include certification marks.
 WTO TRIPS Agreement

WTO TRIPS Agreement

IPR Definitions of Terms (2)
* Trade Secrets – are information deriving its value from not being
known or available to the public, competitors, or other parties who
might otherwise gain benefit from its disclosure or use.
* Geographical Indications – (sometimes called appellations of
origin) are any indication that identifies a product as originating in
the territory of a Member, or a region or locality therein, for reason of
which a particular quality, reputation, or other characteristic of the
product is essentially attributable to geographical origin.
* Industrial Design – is the shape, configuration, pattern, or
ornamentation of a useful article but not a method or principle of
construction.
 WTO TRIPS Agreement
The UR TRIPS Agreement:
A. Background:
1) The Uruguay Round TRIPS Agreement is one of four new
agreements negotiated during the UR Round that deal with a substantive
area totally new & not previously governed by any part of the GATT’47 (the
others being Agriculture, Services, & Trade-Related Investment Measures
(TRIMS)). It incorporates by reference a number of other essentially
unenforceable international agreements or conventions on aspects of IPR.

2) The TRIPS Agreement is the most comprehensive international

agreement on intellectual property rights & the only one actually enforceable
(under GATT Arts. XXI & XXII & the WTO dispute settlement
understanding).

3) The TRIPS Agreement establishes enforceable minimum

standards for the protection & enforcement of IPR by WTO Members.

4) The TRIPS Agreement provides a transitional period for developing

Members until 01 January 2005 and for “least-developed” Members of 11
years from date of entry into effect of the WTO (until 01 January 2006) for
implementation of the TRIPS Agreement. (Extended since to 2016).
 WTO TRIPS Agreement

TRIPS Agreement: Main Provisions on Patents

Section 5, Part II contains the following standards:
1) Patents shall be granted for any inventions, whether products or
processes, provided they are new, involve an inventive step, & are capable
of industrial application.
2) Patents shall be granted in all fields of technology. No discrimination is
allowed with respect to the place of invention, or based on whether the
products are locally-produced or imported.
3) Members can exclude from patentability diagnostic, therapeutic, &
surgical methods of treatment for humans or animals, as well as plants &
animals & biological process for the production thereof.
4) Plant varieties shall be protected by patents, an effective sui generis
regime, or a combination of both.
5) Exclusive rights conferred in the case of product and process patents are
defined, subject in the case of imports, to the principle of exhaustion.
.
 WTO TRIPS Agreement

TRIPS Agreement: Main Provisions on Patents (2)

6) Inventions shall be disclosed in a manner which is sufficiently
clear & complete for a skilled person in the art to carry out the
invention. Indication of the best ode of carrying out the invention, as
well as information concerning corresponding patent applications &
grants, may be required.
7) Limited exceptions to the exclusive rights can be defined by
national laws (TRIPS Art. 30)
8) Conditions for granting other uses without authorisation of the
patent-holder (compulsory licenses) are set forth – Members can
determine the grounds to allow such uses.
9) Revocation/forfeiture of a patent is subject to judicial review.
10) The term of protection shall be at least 20 years from the date of
application.
 What is Intellectual Property?
• … books, CD’s, video games, paintings,
staplers, bags, fabrics, planes,
food/drinks, pharmaceuticals, plant
varieties, computer chips, cars, music,
broadcasts, sound recordings, etc…
• …an IP right provide the right holder
with an exclusive right to stop others
• ..IP right holder may provide licenses
• …IP rights are territorial in nature
 Forms of Intellectual property
Rights
• Patents
• Trade Marks
• Designs
• Copyrights
• Geographical Indications
• Industrial Designs
• Trade Secrets
• Utility Models
• Traditional Knowledge (?)
 Patent requirements

• New/novel
• Inventive step/non-obviousness
(not obvious to someone skilled in
the art)
• Industrial Applicability
• Patentable subject matter
 Patent requirements

• New/novel
• Inventive step/non-obviousness
(not obvious to someone skilled in
the art)
• Industrial Applicability
• Patentable subject matter
 How to obtain a patent?
• Domestic patent/IP office: filing, obtain priority
date
• European patents: a bundle of patent rights at the
European patent office
• International level: WIPO
Application requirements:
• Description as how the invention works
• Claim covering the scope of the legal monopoly
claimed by the patentee
• Examination and publication
 Exclusions from patentability
• Discoveries are not patentable:
Einstein could not patent his celebrated law that E = mc^2;
nor could Newton have patented the law of gravity. Such
discoveries are “manifestations of . . . nature, free to all men
and reserved exclusively to none”
• Literary, dramatic, musical or artistic works
• Schemes, rules, games, computer programs as such
• Methods of medical treatment
• Contrary to public policy and morality: Those which by
publication or exploitation might result in offensive, immoral
or anti-social behavior. Current debate life patents/GM Food
• Plant and animal varieties (in EU not in US)
 Copyright
• Copyrights protects the rights of authors of literary and
artistic works
• Copyright is in essential a negative right which prevents
others from making copies of the work of an author
• No copyright in a pure idea/news/simple
works/information itself
• Expression/idea dichotomy
• If sufficient ‘selection, judgment and experience’ or
‘labour/skill and capital’ copyright can be granted, even in
a database (so not the content in the data base but the
compilation itself), in EU separate database right, not in
the US.
• Moral rights versus economic rights
 Rationale behind IPRs
Patents
To stimulate innovation/encourage investment the
inventor receives an exclusive right to his invention
in exchange for disclosure of the invention in such a
way that it allows replication, the inventor receives
a limited amount of time to recoup his investment

Trademarks
Protection of goodwill and reputation

Copyright
Protection of creativity
 Innovation: Methods and Factors
“Innovation is the development and implementation of an improved
(incremental) or new (landmark) product or process with success in a
business activity / society”
• Methods:
 Formal innovation
 Scientific method (evidence of efficacy and/or efficiency)
 Marketing strategies (new utility, design, process)
 Informal or Traditional
 Experience/belief
 intergenerational
 individual or collective
 Functional
• Factors:
 Culture, education, inventiveness/creativity, capital, enabling
environment, linkages, supplychain management, marketability,
etc.
 Why are IPRs important?
• IPRs allow control over technology, signs
and creations
• Original Purpose: to stimulate innovation
and creativity by compensating the
creator/innovator for their intellectual
efforts
• Lately: incentive to investment / change in
market players
--big multinationals
 The TRIPS Agreement

…sets minimum standards

…is part of a package deal – WTO Agreement
…is signed by 153 parties… is subjected to
dispute settlement body
...contains enforcement mechanisms
...is subjected to National Treatment and
Most-favoured-Nation Treatment (MFN)
Principles
 Contemporary Challenges in IPR negotiations...
• GIs
1. Creation of a multilateral register for wines and spirits
2. Extending the higher level of protection beyond wines and spirits
3. Linkage between GIs and the agriculture negotiations – clawback for terms in
common usage

• Disclosure of Origin Measure

1. Legal consequences: Voluntary or not, administrative or patent ability
requirement (revoke or criminal sanction)
2. Linked to CBD concepts ABS and PIC
3. Linked to WIPO or WTO

• Implementation of the WIPO Development Agenda

• Enforcement (WTO US versus China Panel Report)
• Ongoing norm setting activities / FTAs
• Technology Transfer
• Technical Assistance and Cooperation
 Why are IPRs controversial?

IPRs
• … create semi-monopolies also covering goods that
might be essential to society (e.g. pharmaceuticals and
environmentally sound technologies) /raises prices
(higher than production costs)
• …limit access to textbooks, educational material,
information
• …impacts on reverse engineering and imitation
• …exceptions are pushed to the limit/scope is widened:
– extension of subject matter - - patentability of life / software;
– extension of term of protection -- 70 years of copyright protection;
– creation of new rights -- non original databases;
– over relaxation of granting of patents -- lack of adequate description;
– inclusion of IP in trade, investment and stand alone agreements;
– primacy of private rights of public rights
 Development IPR Solutions
• WTO Doha (Development) Round
Doha Round Declaration 14 November 2001
Doha Declaration on TRIPS and Public Health

• WIPO Development Agenda (adopted September 2007)

2004 Initiative by group of developing countries lead by
Brazil and Argentina / development component in WIPO
as UN agency
– Use of flexibilities
– Transparency in technical assistance activities
– Development aspect in all norm-setting activities
 Doha Ministerial Declaration
14/11/2001
• “implementation and interpretation of the TRIPS in a
manner supportive of public health, by promoting both
access to existing medicines and research and development
into new medicines” (par 17)
• “the TRIPS Council shall be guided by the objectives and
principles set out in Articles 7 and 8 of the TRIPS
Agreement and shall take fully into account the
development dimension” (par. 19)

• Separate Declaration on the TRIPS Agreement and Public

Health
 Technical Assistance

• The Doha Declaration reconfirmed that

technical cooperation and capacity building
are core elements of the development
dimension of the multilateral trading system.
• 29/11/2005 TRIPS Council Declaration:
…requests LDCs to supply technical and
financial cooperation needs in order to
implement TRIPS
 Sierra Leone and Uganda - communications to the WTO
TRIPS Council, titled ‘Priority Needs for Technical and
Financial Cooperation’

Overview of needs in terms of …

 Administrative reform
 Short and long term goals
 IP policy and regulatory framework
 Administrative reform
 Development of IP curriculum and general public training
 Positive IPR agenda
 Promotion of traditional knowledge (museums, national gallery etc,
formalization of music industry etc…)
 Train police and judiciary
 Improve cooperation between players (government departments,
private sector, farmer organisations, music industry, police,
customs…)
 Value edition in food and drinks>GI protection (market branding and
marketing efforts)
 Provide management services to SMEs
 Use public domain knowledge, avoid reinventing the wheel
 Find niche / comparative advantage, “specialization is the need for
civilization”
 Declaration on the TRIPS Agreement and
Public Health 14/11/2001
• “we recognize the gravity of the public health problems
afflicting many developing and least-developed countries,
especially those resulting from HIV/AIDS, tuberculosis,
malaria and other epidemics” (par 1)

• “ we recognize that IP protection is important for the

development of new medicines. We also recognize its effects
on prices” (par 3)

• “we agree that the TRIPS does not and should not prevent
members from taking measures to protect public health,
TRIPS should be interpreted and implemented in a manner
supportive of public health and promote access to
medicines” (par 4)
• “Each member has the right to grant compulsory licences
and the freedom to determine the grounds upon which
such licences are granted” (par 5b)

• “each member has the right to determine what constitutes

a national emergency or other circumstance of extreme
urgency (par 5c)

• “leave each member free to establish its own regime for

exhaustion without challenge, subject to the MFN and
national treatment” (par 5d)
 Compulsory license:
Right to use the patent without
permission of the patent holder subject to
certain conditions

(Art. 31 TRIPS)
 Compulsory Licensing
Article 31 TRIPS

(a) authorization of such use shall be considered

on its individual merits;
(b) such use may only be permitted if, prior to
such use, the proposed user has made efforts to
obtain authorization from the right holder on
reasonable commercial terms and conditions
and that such efforts have not been successful
within a reasonable period of time. This
requirement may be waived by a Member in the
case of a national emergency or other
circumstances of extreme urgency or in cases of
public non-commercial use.
 Article 31 TRIPS
(c) the scope and duration of such use
shall be limited to the purpose for
which it was authorized
(d) such use shall be non-exclusive;
(e) such use shall be non-assignable
(f) any such use shall be authorized
predominantly for the supply of the
domestic market of the Member
authorizing such use;
Paragraph 6 TRIPS Declaration of TRIPS and
Public Health addressed the difficulties WTO
Members with limited pharmaceutical
production capacity have in making effective use
of the compulsory licensing:

“We recognize that WTO Members with insufficient or no

manufacturing capacities in the pharmaceutical sector
could face difficulties in making effective use of
compulsory licensing under the TRIPS Agreement. We
instruct the Council for TRIPS to find an expeditious
solution to this problem and to report to the General
Council before the end of 2002”
Contentious points:
--countries eligible to export the
generic medicine

--the limited scope of the diseases

being allowed for CL

--anti-diversion measures to
prevent parallel import of medicines to
other countries rather than the intended
beneficiary
• Waiver Decision: 30/8/2003
• Article 31bis TRIPS Agreement : 6/12/2005
(first TRIPS amendment)

allowing countries with inadequate

production facilities to import medicines
produced under compulsory license in third
countries
...
under certain cumbersome conditions
• Compulsory licenses are controversial
but…

• 1000 United States

• 600 Europe
• 300 Japan
• 1-5 Developing countries
 Transition Periods
• Developed countries had 1 year (1/1/1996)
• Developing countries had 4 additional years
(1/1/2000) to apply the TRIPS provisions following
date of entry into force (1/1/1995)
plus 5 additional years to comply with the TRIPS
Agreement provisions on pharmaceutical patents
(1/1/2005)
• In view of special needs of LDCs, they had till 1
January 2006 to apply TRIPS with possible
extension to allow them to “create a viable
technological base”
• The Decision of the Council for TRIPS of 29
November 2005 called ‘Extension of the Transition
Period Under Article 66.1 For Least-Developed
Country Members’ provides under paragraph 1
that:
• “LDCs shall not be required to apply the
provisions of the Agreement, other than Articles 3,
4 and 5, until 1 July 2013, or until such a date on
which they cease to be a least-developed country
Member, whichever date is earlier.”

• Par 7 Declaration on TRIPS and Public Health

extends till 1/1/2016 for pharmaceutical protection
 Need to…
• rebalance innovation incentives and the public interest
• realize that IPRs will not solve all problems (neither will TK prot)
• balance public and private rights at the international level
• promote coherence among different international agreements and FTAs
• expand civil society participation/consultations in national, regional and
international rules setting processes on IPRs
• focus on implementation of WIPO Development Agenda, link with WTO
negotiations
• implement flexibilities, let IPRs work for you!
• build on Disclosure of Origin Momentum
• avoid adopting new IPRs before implementing existing ones
• carry out cost-benefit analysis of GI extension and register