PHARMACEUTICAL PATENTS – INDIAN SCENARIO 

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Patentability of pharmaceutical inventions in India has been a topic of intense debate since 1970. In India, the patentability of pharmaceutical inventions is understood and interpreted in light of Section 2(1)(j), Section 2(1)(ja) and Section 3 [specifically, Sections 3(d), 3(e) and 3(i)] of the Patents Act, 1970 [hereinafter referred to as the Act]. Further, the ‘Guidelines for Examination of Patent Application in the field of Pharmaceuticals’, published by the Office of the Controller General of Patents, Designs and Trademarks assist the Examiners in examination of pharmaceutical inventions.

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BACKGROUND 

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In the 1970s, India quickly became a major supplier of cheap drugs to a number of developing and under developed countries. During the period 1970 - 1994, the Indian pharmaceutical industry became nearly self-sufficient and one of the largest exporters of generic medicines. A large number of developing countries depended on India for the supply of cheaper generic medicines. However, since Indian patent laws did not allow patenting of pharmaceutical products at the time, innovation was discouraged.

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The WTO agreement, of which India is a signatory, came into force from January 01, 1995. TRIPs (Trade Related Aspects of Intellectual Properties) agreement (Annexure 1C of the WTO agreement) under Article 27, required introduction of both product and process patenting in all fields of technology including drugs, foods, products of chemical reactions and micro-organisms. In order to become TRIPS compliant, India needed to revise its patent laws to provide product patent protection for pharmaceuticals. While traversing the history of the development of the legislation related to pharmaceuticals, Honourable Supreme Court of India referred to a letter written by the HIV/ AIDS Director of the WHO, dated December 17, 2004, to the then Minister of Health and Family Welfare, Government of India. A part of said letter is quoted herein below:

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“As India is the leader in the global supply of affordable antiretroviral drugs and other essential medicines, we hope that the Indian government will take the necessary steps to continue to account for the needs of the poorest nations that urgently need access to anti-retrovirals, without adopting unnecessary restrictions that are not required under the TRIPS Agreement and that would impede access to medicines”.

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Accordingly, the Indian Parliament amended section 3(d) of the Act in the year 2005 in order to strike a balance between the patent laws in India becoming TRIPS compliant vis-à-vis ensuring that such patentability does not have an adverse effect on public health and interest.

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The same is reflected in the fact that as per the data provided in the Annual Reports published by the Indian Patent Office [hereinafter referred to as the IPO], the grant rate of pharmaceutical inventions has increased by a phenomenal 60.17% in the duration of 2012 to 2017.

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