Abstract
The rapid deployment of messenger RNA (mRNA) vaccine platforms during the COVID-19 pandemic highlighted profound structural inequities in global access to life-saving biopharmaceuticals. While the Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS) contains statutory flexibilities—such as compulsory licensing, parallel importation, and research exemptions—middle-income nations (MICs) faced substantial legal, regulatory, and technological hurdles in operationalizing these mechanisms. This article re-evaluates patent exclusivity for mRNA therapeutics within the post-pandemic international legal framework, focusing specifically on MICs that possess emerging biomanufacturing capacities but fall outside the automatic waiver provisions reserved for Least Developed Countries (LDCs). Through a comparative legal analysis of national patent statutes and WTO jurisprudence, alongside a structural mapping of key mRNA patent thickets—particularly lipid nanoparticle (LNP) delivery vectors—this study reveals how secondary patenting and regulatory data exclusivity undermine effective compulsory licensing. We argue that standard TRIPS flexibilities are insufficient for complex biologics absent compulsory technology transfer and trade secret access. To resolve these statutory deadlocks, the article proposes a modernized legal framework for MICs, incorporating streamlined compulsory licensing protocols, coordinated regional patent pools, and strategic updates to national patentability criteria to restrict broad platform claims.
