Product Patent Regime in India
The major concern that the social and economic costs of introducing pharmaceutical patents India are likely to outweigh the benefits in the case of most developing countries suggests a cautious approach to intellectual property protection in the area of pharmaceuticals. On the other side, there is also evidence that the patent system has a detrimental impact on pharmaceutical prices, particularly if the product itself is protectable. The WTO’s Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS) introduced intellectual property rules into the multilateral trading system for the first time. The World Trade Organization (WTO) is the only most powerful legislative and judicial body which makes an economic relationship between trade and nations with its “free trade” agenda. The Agreement on Trade Related Aspects of Intellectual Property Rights (TRIPS) is a treaty administered by the World Trade Organization (WTO) which sets down minimum standards for forms of intellectual property (IP) regulation that was negotiated at the end of the Uruguay Round of the General Agreement on Tariffs and Trade (GATT) treaty in 1994. The new WTO regime effectively outlawed the generic production of new medicines It was made mandatory by the WTO for its developing nations to fully abide by their IP laws and enforcement practices with the agreement on TRIPS by no later than 1st January 2005. It lays down minimum standards for protection and enforcement of intellectual property rights in member countries which are required to promote effective and adequate protection of intellectual property rights with a view to reducing distortions and impediments to international trade. For the least-developed countries (LDCs) the transition period will remain in force for pharmaceutical patents and data protection at least until 2016 under Article 66. 1 of TRIPS under paragraph 7 of the Doha Declaration. Further, Article 27 of the TRIPS Agreement harmonizes the subject matter of patent in a broad manner which clearly states that the patents shall be available for any inventions, whether products or processes, in all fields of technology, provided that they are new, involve an inventive step and are capable of industrial application and patent rights enjoyable without discrimination as to the place of invention, the field of technology and whether products are imported or locally produced. Under article 28 (1) (a) of TRIPS, there are exclusive rights for product patents to prevent third parties not having the owner’s consent from the acts of: making, using, offering for sale, selling, or importing for these purposes that product. Overall, the TRIPS Agreement will have a substantial impact on intellectual property regimes in developing countries. Although, under the TRIPS Agreement member countries are bound to provide such protection, yet certain compensatory measures and schemes are taken in the hands to avoid the negative impact of monopolization of product patents especially in health and pharmaceutical sectors. Such measures as per the TRIPS are as follows: ? Transition periods
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