TRIPS Agreement
• The TRIPS Agreement, which came into effect on 1 January 1995, is to date the most
comprehensive multilateral agreement on intellectual property.
• The areas of intellectual property that it covers are: copyright and related rights (i.e. the
rights of performers, producers of sound recordings and broadcasting organizations);
trademarks including service marks; geographical indications including appellations of
origin; industrial designs; patents including the protection of new varieties of plants;
the layout-designs of integrated circuits; and undisclosed information including trade
secrets and test data.
The three main features of the Agreement are:
1. STANDARDS :
In respect of each of the main areas of intellectual property covered by the TRIPS
Agreement, the Agreement sets out the minimum standards of protection to be
provided by each Member. Each of the main elements of protection is defined,
namely the subject-matter to be protected, the rights to be conferred and permissible
exceptions to those rights, and the minimum duration of protection. The Agreement
sets these standards by requiring, first, that the substantive obligations of the main
conventions of the WIPO, the Paris Convention for the Protection of Industrial
Property (Paris Convention) and the Berne Convention for the Protection of Literary
and Artistic Works (Berne Convention) in their most recent versions, must be
complied with.
With the exception of the provisions of the Berne Convention on moral rights, all the
main substantive provisions of these conventions are incorporated by reference and thus
become obligations under the TRIPS Agreement between TRIPS Member countries.
The relevant provisions are to be found in Articles 2.1 and 9.1 of the TRIPS Agreement,
which relate, respectively, to the Paris Convention and to the Berne Convention.
Secondly, the TRIPS Agreement adds a substantial number of additional obligations on
matters where the pre-existing conventions are silent or were seen as being inadequate.
The TRIPS Agreement is thus sometimes referred to as a Berne and Paris-plus
agreement.
2. ENFORCEMENT
The second main set of provisions deals with domestic procedures and remedies for
the enforcement of intellectual property rights. The Agreement lays down certain
general principles applicable to all IPR enforcement procedures. In addition, it
contains provisions on civil and administrative procedures and remedies,
provisional measures, special requirements related to border measures and criminal
procedures, which specify, in a certain amount of detail, the procedures and
remedies that must be available so that right holders can effectively enforce their
rights.
3. DISPUTE SETTLEMENT
• The Agreement makes disputes between WTO Members about the respect of the
TRIPS obligations subject to the WTO's dispute settlement procedures.
• In addition the Agreement provides for certain basic principles, such as national
and most-favoured-nation treatment, and some general rules to ensure that
procedural difficulties in acquiring or maintaining IPRs do not nullify the
substantive benefits that should flow from the Agreement.
• The obligations under the Agreement will apply equally to all Member countries,
but developing countries will have a longer period to phase them in. Special
transition arrangements operate in the situation where a developing country does
not presently provide product patent protection in the area of pharmaceuticals.
• The TRIPS Agreement is a minimum standards agreement, which allows
Members to provide more extensive protection of intellectual property if they so
wish. Members are left free to determine the appropriate method of
implementing the provisions of the Agreement within their own legal system and
practice
TRIPS Waiver or Compulsory License
India and South Africa have piloted the proposal to waive key provisions of the TRIPS
agreement on Covid-19 vaccines, drugs, therapeutics, and related technologies. This
proposal has been now backed by the U.S also.
The TRIPS waiver proposal would give immunity to member countries from a legal
challenge at the WTO if their domestic Intellectual Property Regulation (IPR) laws
suspend or do not enforce IP protection.
The core idea behind this TRIPS proposal is that the IPR should not become barriers
in scaling up production of medical products essential to combat Covid-19. However,
the TRIPS waiver is unlikely to solve India’s Covid-19 vaccine shortage.
Instead of trying to obtain an IP waiver, the Indian government must enable vaccine
manufacturers to expand production (through compulsory licensing) & reduce
inefficiencies in procurement & distribution.
TRIPS Agreement & Indian Law
The TRIPS agreement was negotiated in 1995 at the WTO, it requires all its signatory
countries to enact domestic law.
It guarantees minimum standards of IP protection.
Such legal consistency enables innovators to monetise their intellectual property in
multiple countries.
In 2001, the WTO signed the Doha Declaration, which clarified that in a public health
emergency, governments could compel companies to license their patents to manufacturers,
even if they did not think the offered price was acceptable.
This provision, commonly referred to as “compulsory licensing”, was already built
into the TRIPS Agreement and the Doha declaration only clarified its usage.
Under Section 92 of the 1970 Indian Patents Act, the central government has the
power to allow compulsory licenses to be issued at any time in case of a national
emergency or circumstances of extreme urgency.
Why is the TRIPS waiver unlikely to solve India’s Covid-19 vaccine shortage?
Complex Intellectual Property Mechanism: The process of vaccine development
and manufacturing has several steps, and involves a complex intellectual property
mechanism.
Different types of IP rights apply to different steps and there is no one kind of IP
that could unlock the secret to manufacturing a vaccine.
The expertise to manufacture it may be protected as a trade secret, and the data
from clinical trials to test vaccine safety and efficacy may be protected by
copyright.
Complex Manufacturing Mechanism: Manufacturing vaccines will need to design
the process for manufacturing the vaccines, source necessary raw materials, build
The manufacturing process itself has different steps, some of which may be
subcontracted to other parties.
Thus, a patent waiver alone does not empower manufacturers to start vaccine
production immediately.
Way Forward: Need for Invoking Compulsory Licensing
Plugging Shortage of Vaccine: The richest countries have cornered about 80
percent of vaccine supplies so far.
While India needs to supplement its output to ensure that a population of over 900
million which is above 18 years of age gets about 1.8 billion doses at the earliest.
Thus, compulsory licensing can be used to augment the supply of drugs and other
therapeutics.
Nudging Voluntary Licensing: An assertive posture on compulsory licences would
also have the advantage of forcing several pharmaceutical companies to offer
licences voluntarily.
.
Leading By Example: Licensing Covaxin widely would enable India to live up to its
reputation of being the ‘pharmacy of the world’ and also put pressure on developed
countries to transfer their vaccine technology to developing countries.
Thus, the government should not only transfer Covaxin’s technology to domestic
pharmaceutical companies, to boost national supplies, but also offer it to foreign
corporations.
By unlocking its vaccine technical know-how to the world, India would demonstrate its
resolve to walk the talk on the TRIPS waiver.
.
Favorable Regulatory Environment: A commitment to supply vaccines to
India requires trust in the country’s regulatory and institutional environment,
which the government must strive to instil through dependable commitments.
Such confidence, combined with the expedited process for vaccine approval,
can help India quickly overcome its supply shortage
