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 sets down 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 less developed 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, national interests, 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 Industrial Property (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

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 fight against 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, the exclusive use of his invention; and thereby added the fuel of interest to the fire of genius in the discovery and production of new and useful things." Abraham Lincoln, 1859 The 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 and trademarks, 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-1991 Protected & 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 Act Cost Plus norms for pricing, leading to no margins for R&D Administered Prices for some Sectors and Subsidies for others

Restrictions on Imports Aversion for taking business risks Mistrust of partners Unhealthy Competition & Price Wars Report Of The Mashelkar Committee on Art. 27 of TRIPS The Committee consisting of leading Scientists and Legal luminaries was given the mandate of determining 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 be TRIPS compliant. How To Handle The Concerns Of The Indian Industry And The Public Regarding The Indian Patent Act - 2005 Concerns Non-accessibility to Patented Drugs deal 2) Nonaffordability of patented drugs 3) Frivolous Patents Pre-Grant 4) Ever-Greening Patents 5) Disputes Problems 6) Impact Of Actions Invoking CL for refusing to . CLs And / Or Price Controls. Due Diligence & Opposition. Stringent Examination. Negotiations & DSB of WTO Entry Entry & Into R&D, Into More

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What Do We Need To Do Now? - Make maximum use of provisions under TRIPS to the Countrys benefit by appropriate interpretations. - Remove as many ambiguities as possible from the new legislation. - Rework the Rules to make them effective and implementeble.

- 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 changes through 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.