Compulsory Licensing Under Section 84 92 Of Indian Patent Act 1970 An Analysis And Consequences On Life Saving Medicines

Abstract

This thesis investigates compulsory licensing under Sections 84 92 of the Indian Patent Act, 1970, as a critical mechanism to address the affordability crisis for life-saving medicines while balancing innovation incentives in India s $50 billion generic pharmaceutical industry, which supplies 70% of medicines to low- and middle-income countries (LMICs). Employing a mixed-methods approach legal analysis, empirical data, case studies, and global comparisons it examines key problems hindering access to patented drugs like Trastuzumab (and#8377; 70,000/dose), Dolutegravir (and#8377; 15,000/month), Sofosbuvir (and#8377;60,000/course), and Nirmatrelvir (and#8377;50,000/course), which exclude 90% of patients, contributing to ~1 million annual deaths from cancer, HIV, and hepatitis C. newlineProblem 1: High Drug Prices and Limited Access Patented drugs exorbitant costs drive financial toxicity (1.6 million households) and poverty induction (50 million annually). newline newline