Abstract

Evergreening under patents has emerged as a controversial strategy used by the pharmaceutical giants to extend monopoly rights beyond the standard patent term. The impact of Evergreening on the entry of generics poses a threat to public health and access to medicines as it can drastically increase the price of a drug. There are several instances where the companies have have used different mechanisms to extend their monopoly rights , one such instance is the case of insulin, where companies like Eli Lilly, Novo Nordisk and others have established their monopoly through the biosimilars of insulin and kept the prices high in the USA for more than 100 years. This practice has raised critical questions regarding access to affordable medicines and innovation in the pharmaceutical sector. Despite India’s stringent stance on patent evergreening through section 3(d) of the Patents Act, 1970, there are certain loopholes while balancing innovation and public health. This paper discusses all the facets of patent evergreening by analyzing the legal and regulatory responses to it. Further this paper highlights the implications of India’s stand for global access to medicines and suggests potential reforms to address the underlying challenges related to it.

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