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Trips- Pharmaceutical sector

Trips- The Agreement on Trade Related Aspects of Intellectual Property Rights (TRIPS)

is an international agreement administered by the World Trade Organization (WTO) that setsdown minimum standards for many forms of intellectual property (IP) regulation as applied to

nationals of other WTO Members.

TRIPS contains requirements that nations' laws must meet for copyright rights, including the

rights of performers, producers of sound recordings and broadcasting organizations;

geographical indications, including appellations of origin; industrial designs; integrated circuit

layout-designs; patents; monopolies for the developers of new plant varieties; trademarks; trade

dress; and undisclosed or confidential information.

The Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS Agreement) is

one of the more controversial international intellectual property agreements that have entered

into force. Its negotiations were highly contentious, and the perspectives of developed and lessdeveloped countries on the role of intellectual property protection and enforcement remain far

apart.

In recent years, less developed countries

including both developing and least developed countrieshave expressed their deep

dissatisfaction with the way the Agreement has been interpreted and implemented. They are also

frustrated by the ongoing demands by developed countries for protections that are in excess of

what they promised during the TRIPS negotiationsoften through new bilateral and regional

trade and investment agreements. As they claim, the Agreement as interpreted by their developed

trading partners and the additional TRIPS-plus demands ignore their local needs, nationalinterests, technological capabilities, institutional capacities, and public health conditions.1 These

concerns and frustrations eventually led to the establishment of a set of development agendas at

the WTO, the World Intellectual Property Organization (WIPO), and other international for .

The TRIPS negotiations

The negotiations of the TRIPS Agreement began with the Ministerial Conference of the General

Agreement on Tariffs and Trade (GATT) in Punta del Este, Uruguay. Held in September 1986, the

conference came at a critical point in time when the negotiations between developed and less

developed countries over the revision of the Paris Convention for the Protection of IndustrialProperty (Paris Convention) was deadlocked at WIPO.3 During that ministerial conference, the GATT

contracting parties set out their negotiating objectives for the new Uruguay Round, which included

the establishment of a new multilateral intellectual property agreement.

The WTO panels clarification


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Since the TRIPS Agreement entered into force on January 1, 1995, WTO member states have

explored the use of Articles 7 and 8 to support their positions. The divergence of these positions

was well reflected in CanadaPatent Protection of Pharmaceutical Products.12 In this dispute, the

European Communities challenged the regulatory review and stockpiling exceptions in Canadian

patent law for violation of the TRIPS Agreement. Calling attention to Articles 7 and 8 of the TRIPS

Agreement, Canada contended that these provisions call for a liberal interpretation of the three

conditions stated in Article 30 of the Agreement, so that governments would have the necessary

flexibility to adjust patent rights to maintain the desired balance with other important national

policies.

THE TRIPS AGREEMENT AND PHARMACEUTICALS

The international innovative pharmaceutical industry's perspective (IFPMA)-

The importance of intellectual property rights for pharmaceutical R&D

New medicines and access to these new medicines, which will be vital in the fightagainst communicable and non-communicable diseases, are dependent on strong

patent and other intellectual property protection.

"The patent system . secured to the inventor, for a limited time, theexclusive use of his invention; and thereby added thefuel of interest to the fire

of genius in the discovery and production of new and useful things."

Abraham Lincoln, 1859The patent system represents a compromise between competing short-term and longterm

economic and social interests. Along with a well-functioning regulatory structure

and marketing system, it allows the private pharmaceutical industry to operate and

contribute to a socially driven public health sector by providing it with cost-effective

new technologies.

The WTOs Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS)attempts to strike a balance between the long term social objective of providing incentives for

future inventions and creation, and the short term objective of allowing people to use existing

inventions and creations.The agreement covers a wide range of subjects, from copyright andtrademarks, to integrated circuit designs and trade secrets. Patents for pharmaceuticals and other

products are only part of the agreement.

IMPACT OF TRIPS ON INDIAN INDUSTRY

Indian Mindset : Pre-1991Protected & Sellers Markets

Dependency on Government For Licences & Favours.Unviable Economies of Scale in Production

Unrealistic Restrictions To Growth, eg., Under the Licensing

System and MRTP ActCost Plus norms for pricing, leading to no margins for R&D

Administered Prices for some Sectors and Subsidies for others


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Restrictions on Imports

Aversion for taking business risks

Mistrust of partnersUnhealthy Competition & Price Wars

Report Of The Mashelkar Committee on Art. 27 of TRIPSThe Committee consisting of leading Scientists and Legal luminaries was given the mandate ofdetermining whether Amendments to Art. 27 in Indian Patents Act 2005 are TRIPS compliant or

not.

The two contentious issues were:- The provision in IPA 2005 that only new NCEs or NMEs would be patentable, not their

derivatives such as new salts, new esters, polymorphs, new crystalline forms etc.

- Patenting of Microorgnisms

The Committee submitted its report on Dec. 28th

2005 that the Amendments would not beTRIPS compliant.

How To Handle The Concerns Of The Indian Industry And The Public Regarding TheIndian Patent Act - 2005

Concerns Actions

1) Non-accessibility Invoking CL

to Patented Drugs for refusing to

deal .

2) Nonaffordability CLs And / Or

of patented drugs Price Controls.

3) Frivolous Patents Due Diligence &

Pre-Grant Opposition.

4) Ever-Greening Of Stringent

Patents Examination.

5) Disputes & Jurisdictional Negotiations &

Problems DSB of WTO

6) Impact On Indian Industry Entry Into R&D,

Major Entry Into

Generics & More

Collaborations

What Do We Need To Do Now?- Make maximum use of provisions under TRIPS to the Countrys benefit by appropriateinterpretations.

- Remove as many ambiguities as possible from the new legislation.

- Rework the Rules to make them effective and implementeble.


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- Create adequate awareness among Scientists, Industry, Trade and the Judicial System about

IPRs.

- Build up adequate infrastructure and professionalise the Patent Offices.- Have strict and impartial examination and patent grant systems.

- Continue to negotiate with the TRIPS Council to endorse the amendments made to IPA 1970

and further improve on them.- Review the impact of the new Act on the Industry, Drug Prices, the Consumers and Society.Take appropriate action under DPCO, Anti-Competition Law , Compulsory Licenses etc when

needed.

- Enlist the support of other like-minded Member Countries to make further beneficial changesthrough the TRIPS Council & IMC of WTO .

All In all, We are in for a major change in the way the patent system will be utilised in India.To succeed you need a change in mindset, new approaches & motivation . To Get Something, You Need To Combine Both Method And Motivation.

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