Understanding Evergreening of Patents in the Pharmaceutical Industry

Abstract

Evergreening is a strategic practice widely adopted by pharmaceutical companies to prolong market exclusivity of patented drugs, often through incremental innovations and secondary patents. This review explores the legal, regulatory, and ethical dimensions of evergreening, detailing various strategies such as formulation changes, new therapeutic indications, polymorph patents, and novel delivery systems. While proponents argue that these practices support continued innovation and help recover high R&D investments, critics highlight how evergreening delays generic drug entry, maintains elevated drug prices, and restricts access to affordable medicines—especially in developing nations. Drawing from international case studies and legal frameworks from the U.S., EU, India, Canada, Brazil, and South Africa, the article evaluates global responses to curb excessive patent extensions. It also presents policy recommendations, including stricter patentability criteria, shorter exclusivity extensions, and alternative innovation incentives. Ultimately, the paper emphasizes the urgent need for balanced patent reform to align pharmaceutical innovation incentives with global public health priorities and ensure equitable access to essential medicines.