Abstract
The impact of intellectual property rights in particular patent relating to public health has posed numerous challenges faced by developing countries who are members of World Trade Organisation (WTO). This paper examines the impact of TRIPS Agreement (Trade Related Intellectual Property Rights) in relation to developing countries in general with specification made to India. Significant changes brought about by the TRIPS flexibilities in particular usage of compulsory licensing and Bolar provision have to a certain extent benefited the developing countries in the field of public health during national emergency. The TRIPS flexibilities by way of amendment have helped countries that (do not possess manufacturing capacities) to import medicines. Some developing countries even utilised TRIPS flexibilities in an aggressive manner to enforce their right to have access to medicines from other countries for the benefit of their citizens. Further, TRIPs flexibilities have helped developing countries to manufacture generic products to make it affordable to the people. This paper specifically examines the impact of the TRIPS Agreement on Indian generic pharmaceutical industry and the legal challenges faced by Indian pharmaceutical industry after the implementation of product patent regime effective from 1 January 2005. The Patent Amendment Act 2005(India) will be looked into especially on the controversy in respect of Section 3(d) of the Patent Amendment Act 2005(India) on the requirement of patentability. The new Section 92A of the Patent Amendment Act 2005(India) on the grounds to invoke compulsory licensing will be analysed to see whether Indian government has applied restrictive or broad approach, as compulsory licensing is certainly an important legal
Highlights
Modern science and technology medicine have made available many new drugs to cure and manage various ailments
In relation to this study, the author will be looking into mainly the legal analysis in the context of TRIPS (Trade-Related Intellectual Property Rights) and the adoption and implementation of TRIPS Agreement into the national patent law of developing countries
In the author’s view, strong will of the country to promote healthy competition between generic and big pharmaceutical companies to ensure accessibility and affordability to serve the public interest can be shown in the implementation of TRIPS flexibilities such as compulsory licensing and Bolar provision effectively
Summary
Modern science and technology medicine have made available many new drugs to cure and manage various ailments. The actual essence of the TRIPS Agreement will be analysed, as to whether TRIPS is a legal weapon to protect the right of the patentee exclusively balancing between patent holder rights and public health objectives in relation to accessibility and affordability of medicines in the developing countries. In the author’s view, strong will of the country to promote healthy competition between generic and big pharmaceutical companies to ensure accessibility and affordability to serve the public interest can be shown in the implementation of TRIPS flexibilities such as compulsory licensing and Bolar provision effectively. In relation to the TRIPS Agreement one of the significant flexibilities can be seen in the Doha Declaration on paragraph 5(b) which states ‘each member has the right to grant compulsory licenses and the freedom to determine the grounds upon which such licenses are granted. So grounds on compulsory licensing should not be used restrictively. As we can observe, compulsory license is often issued only when patented invention is not available to the public at a reasonable price and on the grounds of working the patented invention for the domestic generic pharmaceutical industry
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