Competition Law Regulation of Pharmaceutical Patent Evergreening Strategies ——A Comparative Study of India and the EU for Uzbekistan’s Institutional Design

Abstract

Patent evergreening strategy means to extend the market monopoly period beyond the core patent term by filing secondary patents, it poses a major challenge to drug accessibility and market competition. This article adopts a combined methodology of comparative law and normative analysis to examine two main regulatory paths: India's ex ante model, which blocks evergreening strategies at the patent authorization stage by raising patentability standards; and the EU's ex post model, which corrects patent abuse through competition law enforcement. This article evaluates the respective advantages and limitations of the two models with the help of landmark cases such as the Gleevec case, the EU AstraZeneca case, the Servier case and the Teva/Copaxone case. On this basis, this article examines the current legal framework of Uzbekistan and identifies key institutional gaps: the lack of enhanced patentability standards for secondary pharmaceutical patents, the existence of broad intellectual property exemption clauses in competition law, and limited patent examination capacity. Accordingly, this article proposes a two-stage framework combining preventive screening at the patent grant stage with corrective intervention at the market conduct stage, and puts forward specific recommendations across four dimensions: substantive standards, examination capacity, opposition procedures, and competition law coordination. The research demonstrates that during WTO accession negotiations, Uzbekistan can establish an anti-evergreening institutional framework that both meets the requirements of the TRIPS Agreement and balances the incentivization of pharmaceutical innovation with public access to medicines.