Data exclusivity: a tool to sustain market monopoly
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There has been a general downgrading of patent from its touted original has position of being the unique economic tool to promote innovation. The rhetoric of innovation which has long served as a platform to nestle “patents” have been challenged in all countries. For the pharmaceutical industry, the linking of patents—however unfairly—as the woe affecting pricing of life-saving medication in the developing world, the permeation of the pricing question as an election issue in the developed world, issues from secondary patents that potentially blocked further innovation, the low thresholds of biotechnology patents have all resulted in the industry assuming the avatar of defendants of patents globally. It has also resulted in the industry beginning its quest for new tools to help consolidate market exclusivity. This background has caused the pharmaceutical industry to scramble for tools to help sustain or maintain the longevity of their market monopoly. This paper will examine one such tool—data exclusivity—currently touted by the pharmaceutical industry. The focus of the paper will be on how data exclusivity can impact access to medication, specifically in developing countries. In doing so, the paper will discuss what data exclusivity is in Part II followed by an outline in Part III of the historic origins of data exclusivity. A description of Article 39 of the TRIPS agreement and its requirements are outlined in Part IV after which Part V addresses some of the controversial questions relevant to India. The Conclusion highlights the need to be cautious in adding a more TRIPS–plus form of exclusivity.