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The (Re)Newed Barrier To Access To Medication: Data Exclusivity, Srividhya Ragavan
The (Re)Newed Barrier To Access To Medication: Data Exclusivity, Srividhya Ragavan
Faculty Scholarship
This Article is set in the background of the consequences of the WTO’s prescriptions on patenting of life-saving medications which has largely contributed to the morphing of patents o n life-saving medication into a luxury. Remarkably, there has been a transformation of the role of patents in the context of pharmaceutical innovation into a strategic business tool leading to a larger interest in creation and sustenance of regulatory rights. The biggest global development in this area is an increased effort to strengthen exclusivity using regulatory protections for all chemicals, and even, biologics, involved in all stages of drug development. Consequently, …
The Drug Debate: Data Exclusivity Is The New Way To Delay Generics, Srividhya Ragavan
The Drug Debate: Data Exclusivity Is The New Way To Delay Generics, Srividhya Ragavan
Faculty Scholarship
The article discusses the protection regime for clinical trial data internationally and outlines the applicable protection regime. In doing so, this article outlines how the data exclusivity regime can operate in parallel with the patent regime to add a layer of protection for the data. Such protection operates at a regulatory level to delay the entry of generic medications. Internationally, the data exclusivity regime, which has become an important contemporary tool in trade negotiations with poorer nations, works to detrimentally affect access to medication