Chapter --I: TRIPS; the Gateway of the Global Economy
“Everything that can be invented has (already) been invented”. -- Mr. Charles H. Duell, (Director of US Patent Office)
The events thereafter proved that inventions are waiting for those who are willing to “think out of the box”. Mankinds have moved in to the era of ideas, creativity, inventions and intellectual properties, intensively and aggressively in the 21st century and the dawn of the new millennium. Intellectual property (IP) has emerged as a key tool in value creation and innovative growth of communities and countries in the transition to the 21st century and the birth of the millennium. IP in knowledge industry such as pharmaceuticals has become more relevant in the post WTO-TRIPS era.
For many years, international trade was governed by GATT (General Agreement on Trade and Tariff). In mid-80’s, the Uruguay Round of GATT, proposed for the inclusion of Intellectual properties in the trade agenda. Long deliberations and complex negotiations later in 1994, WTO (World Trade Organization) was born effective 1st January 1995, where India was also a founder signatory. WTO brought in or activated many agreements, treaties and conventions as well as many new regulations. Important among all of them is, of course the TRIPS (Trade related aspects of Intellectual property rights) Agreement. TRIPS has emerged as the most widely impacting Agreement post WTO leading to harmonization of Intellectual properties among member states.
Chapter --II: Indian Patent Law and the Socio Economic Structure of India
India, the land of rich culture and heritage always gives priority to it’s traditional approach towards the advancement which unfortunately sometimes gives a huge set back to the India’s progress. The same happened in India’s progressive attitude to comply with the TRIPS agreement and for this reason India suffered a lot for almost a period of 10 long years. The major aspect of TRIPS is it’s flexibility (as per DOHA Conference) but such was not taken in a positive manner by India. Even the Ex-Prime Minister of India, Late Indira Gandhi once argued in favor of India’s traditionalistic approach to deny the grant of Patent Right to the life saving Drugs. It is the population of 1.2 billion, increasing poverty and the Tag of ‘DEVELOPING NATION’ always act like a barb wire to the boundary of achievement and progress.
Chapter --III: The Campaign to ensure Public Health Protection
The process of patent reform in India has been characterized by strong involvement of the national pharmaceutical industry and NGOs. The activism of civil society groups help explain why India was one of the countries that most strongly opposed the TRIPS Agreement and refused to implement product patents on pharmaceuticals until the deadline of January 1, 2005, despite intense external pressure. During the TRIPS Agreement negotiations and through the 1990s, Indian national pharmaceutical firms and NGOs worked together to pressure government and resist changes to the national patent system. The national pharmaceutical industry viewed the implementation of TRIPS obligations as being detrimental to their interest in generic manufacturing and favoring foreign firms, while NGOs were mainly concerned with the effects on access to generic medicines. The Indian Drug Manufacturers Association (IDMA) representing generic firms such as CIPLA, and Ranbaxy Laboratories Ltd., a large national pharmaceutical firm and generic producer that was part of IDMA in the 1990s, in lobbying the government to protect the generic market and support the domestic pharmaceutical industry, found common ground with NGOs such as the National Working Group on Patent Laws (NWGPL), an informal public interest expert group established in 1988.
Chapter --IV: TRIPS in Indian Patent Act; A Study of compliance and non-compliance
The TRIPS Agreement is one of the fifteen Agreements listed in Annex I of the Marrakesh Agreement establishing WTO. Though retaining the basic principle of mutuality and quid pro quo for patent grant, the TRIPS Agreement has widened the scope, duration, and strength of patent protection. India actually complied with some major provisions of the TRIPS agreement, i.e. Article 27.1, Article 33, Article 27.1, Article 27.1, and Article 31.
But provisions like Sec. 3(d) directly go into conflict with the TRIPS agreement. So still now, even after the amendment and the modification made to the Indian Patent Act lacunas prevail in this context.
Chapter --V: TRIPS Compliance by other nations, in comparison to Indian Patent Act; A Comparative Study
The TRIPS Agreement basically deals with countries which are developed, developing & less developed. Being the developed countries, USA, UK, Canada actually incorporated most of the TRIPS provisions but countries like India, Singapore, Bangladesh could not do the same because of it’s socio-economic conditions. Some countries have had much less amicable reactions to TRIPS. South Africa and Brazil stand out with regard to the health issue. Both countries have successfully attempted to chart out a new course, which goes much beyond what would have been deemed acceptable under TRIPS until recently. This is remarkable because both legal regimes were challenged and the challenge was abandoned in each case. But in reality, the patent law which was a model for other developing countries like Argentina, Mexico, Egypt, Brazil and Chile, has been replaced by the Indian Patent Act, 1999, which is modeled on the basis of the TRIPS (Trade-Related Aspects of Intellectual Property Rights) text. This amendment seeks to implement the obligations that India has taken in the field of patents by signing the TRIPS Agreement. The bill generally aims at making the 1970 Patents Act as TRIPS compliant as possible.
Chapter --VI: The Journey of a Decade; India’s attitude towards TRIPS Compliance from 1995-2005
The Patents Act, 1970 was amended for a second time in 1999, and again in 2002 and 2005. The Patent (Third Amendment) Act, 2005, extended product patents to products from all industry sectors, including pharmaceuticals. It also set the term of patent protection to 20 years to meet the TRIPS deadline for January 1, 2005. This closed the option of reverse engineering that largely contributed to the growth of the Indian pharmaceutical industry. It will not be possible to produce the patented product by adopting a different process. Some safeguard measures and flexibilities contained in the TRIPS Agreement were introduced in the patent system to protect public health, such as the Commissions on TRIPS that included leading senior former government officials and experts as members and held public consultations that recollected the views of experts, NGOs, industry associations and government officials. The reports produced by the People’s Commissions studied the debates in parliament on amendments to the Patents Act, 1970 and provided specific suggestions on changes to ensure the amended Act would prioritize the national interest and access to medicines.
Chapter --VII: The Reformation; Amendment of the Indian Patent Act -- The patent term is now 20 years, instead of a previous 7 for food and pharmaceuticals, and 14 for all else.
The law relating to computer software has been clarified. Although software per se is not patentable, software configured to achieve a particular technical result may be. Previous practice was to grant patents only to software coupled with hardware.
Methods of treating plants are now patentable, although processes for treating human beings and animals are not. Micro-organisms are now patentable, whereas previously all forms of life had been excluded.
Chapter -- VIII: The Revolution came with the Reformation
The amendments in the Patent Act will foster major changes in the Indian health sector. Indian companies will not be able to legally produce generic versions of drugs currently protected by patents. This in turn will have an important impact for companies mainly manufacturing generic drugs. From the consumer point of view, some of the main impacts will be the unavailability of cheap generic drugs before the 20-year period of protection elapses and the generally higher prices of drugs. The availability of product patents on drugs is generally meant to provide further incentives for private sector R&D in health. While this could theoretically be beneficial to both consumers and producers, it has been noted that the availability of patents does not necessarily lead to preferential investment in medicines needed by the poor. And after the amendment Foreign Investors started to pour their capital in Indian soil which started to give some positive effect to the National Income and the National profit in Stock Market.
Chapter -- IX: The Distance covered and to be covered
The present scenario is not altogether as disappointing as it was in the 1970s or 1990s; the scenario is better than it was before. The new amendment of the Indian Patent Act gave a crystal clear view of India’s progressive attitude and intention to enter in the arena of advancement. Since the amendment the Global Economic Competition welcomes India as a nation having huge prospect for investment. The Information era urges before India to wipe out the evils of social dilemma in regard to granting Patent right India must also take the convenient means to eradicate the lacunas in it’s Patent law (e.g., Sec. 3(d) of the Indian Patent Act) to coup up with the progress of other nations and achieve the tag of Developed Nation.
Suggestions & Conclusion
The Indian Patent System has geared up to provide a level playing ground for all stake holders. The recent amendments have brought the national IP Laws close to the TRIPS norms which were the real need to change the scenario prevailed in regard to Patent rights. The 40 years old system of limited term process patents for pharmaceutical products is getting abolished by virtue of the new Amendment. Multinational Companies are looking at the Indian market more seriously which will boost up Indian economy and progress.
The patent bill attempts to put India in compliance with its TRIPS obligations. In the process, it sets aside some of the most salient elements of the current legal regime which, together with other instruments such as the Drugs Price Control Order, have generally served well the interests of the country and its inhabitants. It is likely to bring about a legal regime that is less favorable from the point of view of access to drugs for the people of this country. Further, TRIPS cannot be implemented in isolation. India has a number of other international obligations, in particular in the field of human rights. As interpreted by UN human rights organs, the right to health requires that countries progressively take positive steps towards facilitating access. Dismantling the 1970 regime may constitute a violation of India's obligations under the covenant on economic, social and cultural rights.
# Intellectual Property Rights: Theory & Indian Practice by Garima Gupta & Avih Rastogi
# Changes to India’s patent law – One step closer to TRIPS compliance by Edward Heinkein
# B.L. Wadera, Law relating to Patents, Trademarks, Copyright, Designs & Geographical Indications (Universal Law Publising Co Ltd, New Delhi, 2nd edn., 1999).
# Correa, C., Trade Related Aspects of Intellectual Property Rights: A Commentary on the TRIPS Agreement 294 (Oxford University Press, Oxford, 2007).
# Daniel Gervais, TRIPS Agreement, The Drafting History and Analysis (Sweet & Maxwell, London, 3rd edn., 2008)
# Intellectual Property Law (3rd Edition) by Lionel Bentley & Brad Sherman
# The TRIPS Agreement
# The Indian Patent Act, 1970
# Patent Reform in India by Dr. Partha Pratim Mitra
# Will the lifeline of affordable medicines for poor countries be cut? Consequences of medicines patenting in India (Briefing document) by Médecins Sans Frontières (February 2005)
# Research Question and Hypothesis by Gerrit Muller, Embedded Systems Institute, Netherland
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