TRIPS-TRADE RELATED ASPECTS OF IPR
The
World Trade Organization (WTO’s) Agreement on Trade-Related Aspects of
Intellectual Property Rights (TRIPS)
⇨ negotiated in the 1986-94
Uruguay Round
⇨ introduced intellectual
property rules into the multilateral trading system for the first time.
Why
TRIPS?
§ Ideas and knowledge are an
increasingly important part of trade
§ Many products that used to be traded
as
low-technology
goods or commodities now contain a higher proportion of invention and design in
their value
§ Creators can be given the right to
prevent others from using their inventions, designs or other creations
§ and to use that right to negotiate
payment in return for others using them
§ “intellectual property rights”
§ an attempt to narrow the gaps in the
way IP rights are protected around the world,
§ to bring them under common
international rules
§ minimum levels of protection
§ dispute settlement system for trade
disputes over intellectual property rights
The TRIPS agreement covers five broad issues:
§ basic principles
§ protection to intellectual property
§ enforcement of intellectual property
§ settlement of disputes on intellectual
property between members of the WTO
§ special transitional arrangements
during the period when the new system is being introduced
Basic
principles - Part I
⇨ national treatment
⇨ treating one’s own nationals and
foreigners equally
⇨ most-favoured-nation treatment
⇨ equal treatment for nationals of
all trading partners in the WTO
⇨ intellectual property protection
should contribute to technical innovation and transfer of technology
⇨ Both producers and users should
benefit, and economic and social welfare should be enhanced
Protection
of IP - Part II
⇨ The TRIPS agreement ensures that
adequate standards of protection exist in all member countries for:
⇨ Copyright
⇨ Trademarks
⇨ Geographical indications
⇨ Industrial designs
⇨ Patents
⇨ Layout-designs (topographies) of
integrated circuits
⇨ Undisclosed information,
including trade secrets
Enforcement
of IP - Part III
⇨ The agreement says governments
have to ensure that intellectual property rights:
⇨ can be enforced under their laws
⇨ penalties for infringement are
tough enough to deter further violations
⇨ procedures must be fair and
equitable
⇨ not unnecessarily complicated or
costly
⇨ should not entail unreasonable
time-limits or unwarranted delays
⇨ ability to ask a court to review
an administrative decision or to appeal a lower court’s ruling
⇨ The
agreement also prescribes:
⇨ how enforcement should be
handled, including rules for obtaining evidence, provisional measures,
injunctions, damages and other penalties
⇨ that courts should have the
right, under certain conditions, to order the disposal or destruction of
pirated or counterfeit goods
⇨ that willful trademark
counterfeiting or copyright piracy on a commercial scale should be criminal
offences
⇨ for assistance of customs
authorities to prevent imports of counterfeit and pirated goods
Transitional
Arrangements - Part VI
§ To ensure that their laws and
practices conform with the TRIPS agreement:
§ developed countries were given one
year, until 1996
§ developing countries and (under
certain conditions) transition economies were given five years, until 2000
§ least-developed countries have 11
years, until 2006, which has now been extended to 2016 for pharmaceutical
patents.
§ 10 years (until 2005) to developing
countries to provide for product patent protection
§ however, for pharmaceutical and
agricultural chemical products, during the transition period:
§ the country must accept the filing of
patent applications from the beginning of the transitional period, though the
patent need not be granted until the end of this period (‘mailbox’)
§ exclusive marketing right for the
product for five years, or until a product patent is granted, whichever is
shorter, during the transition period
Copyright
⇨ ensures that computer programs
will be protected as literary works
⇨ outlines how databases should be
protected
⇨ expands international copyright
rules to cover rental rights
⇨ Authors of computer programs and
producers of sound recordings must have the right to prohibit the commercial
rental of their works to the public
⇨ performers must also have the
right to prevent unauthorized recording, reproduction and broadcast of live
performances (bootlegging) for no less than 50 years.
⇨ Producers of sound recordings
must have the right to prevent the unauthorized reproduction of recordings for
a period of 50 years
Trademarks
The
agreement:
⇨ defines what types of signs must
be eligible for protection as trademarks
⇨ what minimum rights conferred on
their owners must be
⇨ says that service marks must be
protected in the same way as trademarks used for goods
⇨ marks that have become well-known
in a particular country enjoy additional protection
Geographical
indications
⇨ A place name is sometimes used to
identify a product. This “geographical indication” does not only say where the
product was made. More importantly, it identifies the product’s special
characteristics, which are the result of the product’s origins
⇨ Well-known examples include
“Champagne”, “Scotch”, “Tequila”, and “Darjeeling”
⇨ Using the place name when the
product was made elsewhere or when it does not have the usual characteristics
can mislead consumers, and it can lead to unfair competition. The TRIPS
Agreement says countries have to prevent this misuse of place names
⇨ Higher levels of protection for
wines and spirits i.e. even where there is no danger of the public being
misled.
⇨ Some exceptions are allowed, for
example if the name is already protected as a trademark or if it has become a
generic term.
⇨ further negotiations in the WTO
to establish a multilateral system of notification and registration of
geographical indications for wine
⇨ Also debated in the WTO is
whether to negotiate extending this higher level of protection beyond wines and
spirits
Industrial
designs
⇨ Protection of independently
created industrial designs that are new or original
⇨ Requirements for securing
protection for textile designs are simple and not expensive
⇨ Industrial designs must be
protected for at least 10 years.
⇨ Owners of protected designs must
be able to prevent the manufacture, sale or importation of articles bearing or
embodying a design which is a copy of the protected design
Patents
⇨ patent protection must be
available for inventions
⇨ for at least 20 years
⇨ for both products and processes
⇨ in almost all fields of
technology
⇨ patents can be refused if an
invention
⇨ is contrary to public order or
morality
⇨ involves diagnostic, therapeutic
and surgical methods, plants and animals (other than microorganisms), and
biological processes for the production of plants or animals (other than
microbiological processes)
⇨ is not fully disclosed or the
best mode for carrying out the invention is not indicated
⇨ Plant varieties must be
protectable by patents or by a “sui generis” system (such as the
breeder’s rights provided in the UPOV)
⇨ In order to prevent abuse of
exclusive rights or to meet national emergiencies, “compulsory license
⇨ allowing a competitor to produce
the product or use the process under license
⇨ under certain conditions aimed at
safeguarding the legitimate interests of the patent-holder
⇨ If a patent is issued for a
production process, then the rights must extend to the product directly
obtained from the process.
⇨ Under certain conditions alleged
infringers may be ordered by a court to prove that they have not used the
patented process.
⇨ Patents can be refused if an
invention
⇨ is contrary to public order or
morality
⇨ involves diagnostic, therapeutic
and surgical methods, plants and animals (other than microorganisms), and
biological processes for the production of plants or animals (other than
microbiological processes)
The
Doha Ministerial Conference in November 2001:
⇨ agreed that the TRIPS Agreement
does not and should not prevent members from taking measures to protect public
health
⇨ underscored countries’ ability to
use the flexibilities that are built into the TRIPS Agreement.
⇨ agreed to extend exemptions on
pharmaceutical patent protection for least-developed countries until 2016
⇨ agreed in 2003, to provide extra
flexibility, so that countries unable to produce pharmaceuticals domestically
can import patented drugs made under compulsory licensing
Undisclosed
information
⇨ Trade secrets and other types of
“undisclosed information” which have commercial value must be protected
⇨ against breach of confidence
⇨ and other acts contrary to honest
commercial practices
⇨ provided reasonable steps were
taken to keep the information secret
⇨ Test data submitted to
governments in order to obtain marketing approval for new pharmaceutical or
agricultural chemicals must also be protected against unfair commercial use
Curbing
anti-competitive practices
⇨ terms of a licensing contract
could restrict competition or impede technology transfer
⇨ governments have the right to
take action to prevent anti-competitive licensing that abuses intellectual
property rights
⇨ governments must be prepared to
consult each other on controlling anti-competitive licensing
Technology
transfer
⇨ Developing countries in
particular, see technology transfer as part of the bargain in which they have
agreed to protect intellectual property rights.
⇨ The TRIPS Agreement includes a
number of provisions on this.
⇨ For example, it requires
developed countries’ governments to provide incentives for their companies to
transfer technology to least-developed countries.
Objectives
(Art. 7)
⇨ Protection and enforcement of IP
rights should contribute to the promotion of
⇨ technological innovation
⇨ transfer and dissemination of
technology
⇨ to the mutual advantage of
⇨ producers and
⇨ users of technological knowledge
⇨ in a manner conducive to
⇨ social and
⇨ economic welfare, and
⇨ balance of rights and obligations
The
Patents Act
Embodies
TRIPS Agreement
q
Article 7 (OBJECTIVE): The Enforcement of Intellectual
Property
Rights should be
“……
in a manner conducive to social and economic
welfare, and to a
balance of rights and obligations”.
q
Article 8 (PRINCIPLES): WTO Members are Allowed to
“……
adopt measures necessary to protect public health and nutrition,
and to promote the public
interest”.
Implements
Flexibilities
q
Criteria for Patentability - S.3 (d) & (e)
q
Use of Transitional Period - S.11A(7)
q
Pre-Grant Opposition - S.25
q
Compulsory Licence - S.84
q
Government Use Licence - S.92 & 92A
q
Exception For Early Working - S.107(a)
q
Parallel Imports – S.107A(b)
Focus on Quality of Patents & Public Health
IPRs
& Innovation
Source:
Swiss Federal Institute of Intellectual Property, October 2006
Beyond
a Point, IPRs are Counterproductive
IPRs
& Public Health
Key
Elements of India’s IPR Policy
q
Exclusive Rights should Not Prevent Pro-competitive
Environment. Both are Needed for Innovation
q
There is No “One-Size-Fits-All” Model for Striking the
Balance between IPR and Innovation
q
Stronger IPR = More Innovations? Not So Simple
q
Access to Medicine – Public Health
Need
for Flexibility in the IPR System
Protection
of IPRs in India
⇨ There is a well-established
statutory, administrative and judicial framework to safeguard intellectual
property rights in India
⇨ India is a signatory to various
International IP treaties and conventions and has taken steps to comply with
its obligations.
⇨ Recent amendments in the Patents
Act and Rules have set up a new product patent regime in chemicals, foods,
drugs and agrochemicals
⇨ The importance of IP protection
has been realized by legislators, courts, and the industry.
Significance
of Patents for Industry
⇨ Patent is an important tool for
creation, up-gradation and protection of technology
⇨ Helps industry to improve
existing technology to give cheaper and better products
⇨ A healthy patent system
induces capital investment in new lines of production and
encourages FDI, stimulating thereby technological development &
economic growth
AREAS
OF INTEREST FOR INDUSTRY
Ü
Improvement of the quality of the old product
Ü
Manufacturing of a new product
Ü
Increasing production
Ü
Create Corporate Identity
Ü
Enhancing Negotiating Skills and Access to Finance
Ü
Avoiding Unnecessary litigation
Challenges
before IP Administration
§ To meet the TRIPs obligation in
phased manner
§ Required legislative changes
To revamp the IP Administration-capacity building
§ Required modernization
§ Simplification of procedures
§ Improving performance and efficiency
§ To spread IP culture through awareness
programmes
Enforcement
issues
India’s
TRIPS Obligations –Three stage implementation
⇨ From 1.1.1995 :
⇨ Mail-Box
for pharmaceutical and agrochemicals products
⇨ EMR (Exclusive Marketing Rights)
⇨ From 1.1.2000
⇨ 20 years term,
⇨ Definition of invention
⇨ Reversal of burden of proof
⇨ Modification of compulsory
licence provision
⇨ Right of patentee (include
importation also)
⇨ From 1.1.2005
⇨ Product patents for food,
chemical and pharmaceutical
TRIPS
OBLIGATIONS MET IN PHASED MANNER
§ 1999-First Amendment - The Patents (Amendment)
Act, 1999 - made effective from 1.1. 1995.
´
‘mail-box’ for product patent applications and grant of exclusive marketing
rights (EMRs), from 1.. 1995
2002-Second amendment - The Patents (Amendment) Act, 2002 - made effective from
20.5. 2003
´
complied with obligations relating to rights of patentee, term of patent,
compulsory licensing, reversal of burden of proof
2005 - Third amendment - Patents (Amendment) 2005 - Effective from 1.1.2005
´
Introduction of product patent for foods, drugs and chemicals
3rd
Amendment – Main features
n
Legislative Obligations
§ Product patent protection for
invention in all fields of technology
§ Deletion of EMRs provisions and
inclusion of a provision for safeguarding existing EMRs
§ Para 6 Doha Declaration on TRIPs and
Public Health
Results
of Changes in the Patent System
Pharma industry – 10 billion dollar industry
Size of drug industry in India today
´
About 20,000 manufacturing units providing employment to approximately 33 Lakhs
people
n
Ranked 4th in terms of volume and 13th in terms of value world wide
n
R&D expenditure over Rs.1000 crores
Intellectual
Property and Herbal drugs
§ Building up IPR- covered
bio-industrial
enterprises
§ Herbal Drugs
§ Pharmaceuticals
§ Natural product development
sectors
§ Generating economic wealth and
improving quality of life and well- being of people
Bioprospecting
Chemical
Prospecting
§ Drugs and pharmaceuticals
§ Pesticides
§ Cosmetics
§ Food additives
§ Other industrially valuable
§ Chemical products
Gene
Prospecting
§ Genetic engineering
§ Crop development
§ Fermentation
§ Cell culture
Bionic
Prospecting
§ Designs
§ Sensor technologies
§ Architecture
§ Bioengineering
§ Biomodeling
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