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The issues concerning Intellectual Property Rights are always sensitive, serious and to a large extent controversial and contentious due to conflict of national interest of each member country in the WTO. When the issue of IPR was first brought in through Uruguay Round and Dunkel Proposal (1986-1993) in the form of Trade Related Aspects of Intellectual Property Rights (TRIPs), the developing countries had expressed their concern about its nonrelevance to the international trade which largely deals with movement of goods and services. However, despite résistance from the developing countries the eveloped countries who were under the pressure from big pharmaceutical Companies, the TRIPs agreement was introduced as a matter of commercial diplomacy. The developing countries had to amend their respective patent laws in order to grant product patent to pharmaceutical industries from 01.01.2005. It may be noted that the WTO primarily deals with three issues namely (i) Movement of Goods, (ii) Movement of Services, and (iii) Trade Related aspects of Intellectual Property Rights (TRIPs).
The Indian Government has amended its Patent Act, 1970 by deleting section 5 to enable product patent along with process patent for food, medicines and drugs and thereby bringing the Indian Patent law in full compliance with the TRIPS requirement. In order to prevent frivolous inventions from being patented as ever greening and for safeguarding the national interests especially in the area of public health, Section 3(d) was introduced which inter- alia lays down certain restrictions and criteria such as enhancement of the known efficacy for medicines and pharmaceutical substances. In one of such case, the Controller General of India refused to grant patent to Novartis of Switzerland for their cancer drug Glivek on the ground of novelty and the Honourable Supreme Court of India also upheld the decision of the Controller General of India for such refusal of the patent. In another different instance the Controller General of Patent issued a compulsory license to NatcoPharma of India for a cancer drug “Nexavar” which was patented by Bayer Corporation of Germany. Natco is a reputed Indian drug manufacturing company and was denied a license by Bayer corporation and as a result the Controller General of India granted compulsory license to Natco to manufacture Nexavar in pursuance of section 84(1) (a), (b) and (c) of the Indian Patent Act. Today Natco is supplying the drug to cancer patients at a cost of below ` 10,000 per month as against the exorbitant cost of approximately ` 3,00,000 per month charged by Bayer corporation and this has brought substantial relief to Indian cancer patients.
The above two provisions in the Indian Patent Act regarding novelty under section 3(d) and for compulsory licensing under section 84 has bought undesired controversies by the big Pharma companies in the developed countries. The USA has published the Special 301Report for the year 2014 on 30th April, 2014 which classifies India as a “Priority Watch List Country” mainly on the ground of provision of section 3(d) and for issue of compulsory licenses under section 84 of the Indian Patent Act. The Special 301 process is a unilateral measure taken by USA under The Trade Act 1974, to create pressure on countries like India to provide IPR protection beyond TRIPS agreement. It is an extra territorial law of the USA and is not tenable under the overall WTO regime. It is also a matter of fact that no WTO member countries have so far brought any dispute for any alleged violation of the TRIPS agreement by India. In such a situation the extra territorial pressure from USA is undesired and has been objected by the Government of India.
Meanwhile, the Government of India is in the process of drafting its National Intellectual Property Rights policy and a draft has been submitted by the task force on the 24th December 2014.A joint working group is also appointed by the Government of India and United States to look into the working of the Intellectual Property laws of the country.
It is a matter of utmost surprise that in a recently held meeting of the TRIPS Council in the first week of June 2015 at Geneva, United States and Switzerland has tried to invoke the provisions of ‘Non Violation Complains’ stipulated under article XXIII (1b) and (1c) of GATT 1994 read with Article 64.2 of TRIPS agreement. The said proposal has been strongly opposed by India, Brazil and other 17 countries on the ground that the said Non Violation Complain is neither relevant nor legitimate in case of TRIPS agreement for which a moratorium is in force. The said Non Violation Complain is applicable only in a limited manner to movement of goods and services alone and does not apply to issues relating to Intellectual Property Rights under the TRIPS agreement. The illicit desired proposals of United States and Switzerland with ulterior motives just before the ensuing 10th Ministerial Conference in Nairobi on 15-18December 2015, needs special attention of the Government and for the persons invited in drafting the National IPR Policy.It may be noted that the Indian Patent Act is in due compliance of Article 27 for grant of Patents and Article 27 for grant of Compulsory License as contained in the TRIPs Agreement of the WTO.
The author is the Founder Director, ITAG Business Solutions Ltd. and Global IP Convention (GIPC)
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