Abstract
<jats:title>Abstract</jats:title> <jats:p>Chapter 2 approaches the patent system normatively, challenging the presumption that a harmonized patent regime necessarily yields desirable outcomes across diverse socioeconomic contexts and local realities. Harmonized policies have been instituted with the presumption that they will result in a uniform, predictable outcome with manageable differences, leading to global development, trade, and innovation. Terming this as the presumption-risk, the chapter asserts that it has impacted countries that have emulated standardized international norms without fully engaging the impact of local sociopolitical conditions. Tracing patent theory from foundational concepts, the chapter highlights how, despite current outcomes, the justifications of patent law have been centered on public benefits. Thus, the historic role of patents is contrasted with contemporary operational inefficiencies integral to the innovation framework and as a barrier to global public health. The current system has relegated earlier notions of balanced norms to the sidelines and to the detriment of global health needs. The deviation from justifications for patent norms, combined with the realized losses stemming from public-health inequities, requires a distributional framework that views innovation and public-health needs in the context of local realities rather than in opposition to one another. Factors of local realities can influence and affect outcomes in a manner different from the theoretical predictions. The chapter calls for a reconciliation between the two imperatives—the objectives of the patent system and health-care access—to ensure productivity without sacrificing health equity, especially across different local realities.</jats:p>