The Legal Challenges Faced by the Pharmaceutical Industry Particularly in India: An Analysis of the Compulsory Licensing System and Section 3(D) of the Patents Amendment Act 2005

24 Pages Posted: 22 Oct 2012

See all articles by Kamini Shan

Kamini Shan

NORTHERN UNIVERSITY OF MALAYSIA

Date Written: September 30, 2012

Abstract

The impact of intellectual property rights in particular patent relating to public health has posed number of challenges faced by developing countries who are members of WTO. This paper will examine impact of TRIPS Agreement in relation to developing countries in general with specification made to India. However significant changes brought about by the TRIPS flexibilities in particular usage of compulsory licensing have to a certain extent benefited the developing countries. The TRIPS flexibilities by way of amendment have helped countries that do not have manufacturing capacities to import medicines. Importantly this paper will examine the impact of the TRIPS Agreement on Indian generic pharmaceutical industry and the legal challenges faced by Indian pharmaceutical industry after implementation of product patent regime effective from 1 January 2005. The Patent Amendment Act 2005 will be looked into especially on the controversy in respect of Section 3(d) of Patent Amendment Act 2005 on the requirement of patentability and comparisons with other jurisdictions on validity of second medical use. The section 84 of the Patent Act 1970 which provides the grounds to invoke TRIPS flexibilities in respect of compulsory licensing will be analysed as to whether Indian government has applied restrictive or broad approach in relation to compulsory licensing in the view of the recent case of NatcoPharma Limited and Bayer Corporation which has brought significant attention on the issue of compatibility with the TRIPS Agreement. India needs to achieve legal certainty by complying with the TRIPS Agreement before adopting those provisions into their patent law.

Keywords: TRIPS flexibilities, Compulsory Licensing, Article 27 requirement of patentability, novelty/new, involve an inventive step and capable of industrial application, Article 30 and Article 31 on other use without authorization of the right holder, Indian Patent Act 1970, Patent Amendment

Suggested Citation

Shanmugaiah, Kamini, The Legal Challenges Faced by the Pharmaceutical Industry Particularly in India: An Analysis of the Compulsory Licensing System and Section 3(D) of the Patents Amendment Act 2005 (September 30, 2012). Available at SSRN: https://ssrn.com/abstract=2165226 or http://dx.doi.org/10.2139/ssrn.2165226

Kamini Shanmugaiah (Contact Author)

NORTHERN UNIVERSITY OF MALAYSIA ( email )

Sintok
COLGIS, UUM
Kedah, KY KEDAH DARUL
Malaysia
006049284695 (Phone)

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