Balancing Intellectual Property Rights And Public Health: An Examination Of Section 3(D) Of The Indian Patents Act

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Sharmathi S, Christ University, Bangalore

ABSTRACT

The practice of patent evergreening, where drug innovators prolong monopolies by making incremental changes to established medicines, is a persistent threat to balancing intellectual property rights with public health needs. Section 3(d) of the Indian Patents Act, 1970, enacted as part of India's implementation of the TRIPS Agreement, is a unique legislative approach to this problem. By mandating demonstrable improvement in curative effect for the grant of patents for new forms of old drugs, Section 3(d) acts as a substantive gatekeeper against trivial patents as well as a protector of access to medicines. The article critically examines the making, construction, and implications of Section 3(d) as part of India's overall patent regime. Analyzing path-breaking judicial pronouncements such as Novartis AG v. Union of India (2013), the paper identifies how Indian law has built a robust pro-public health narrative that resists multinational pharma tactics of incremental innovation. The study also contrasts India's policy with United States and European Union patent standards, where broader definitions of novelty and utility generally permit secondary patents. While Section 3(d) has been welcomed as a model for developing countries that desire to balance innovation with access, it has also faced criticism for potentially discouraging incremental research and for vagueness in outlining "enhanced efficacy." The article explores that Section 3(d) is a bold but contentious attempt at reconciliation between innovation and social justice. It highlights the importance of greater direction to discriminate between true therapeutic development and minor changes and situates the provision in the global context of access to drugs. Lastly, the analysis reaffirms Section 3(d)'s role as a pioneering legal response to evergreening, acknowledging the continued competition between intellectual property protection and the needs of public health.

Keywords: Ever greening, patents, efficacy, AYUSH, sec 3(d), Novaratis AG v UOI.

254. BALANCING INTELLECTUAL PROPERTY RIGHTS AND PUBLIC HEALTH- AN EXAMINATION OF SECTION 3

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