Reconsidering the Rationale for the Duration of Data Exclusivity
McGeorge Law Review, Forthcoming
Texas A&M University School of Law Legal Studies Research Paper No. 19-56
13 Pages Posted: 5 Oct 2019 Last revised: 2 Jun 2020
Date Written: October 3, 2019
The paper’s focus is the singular one question of whether the 12-years of exclusivity that was needed in 2008 remains justified in 2019 given that technological advancement reduces the cost and the time for drug discovery? Basically, new and emerging technologies are deployed every day to enhance efficiencies and reduce the time it takes to bring a drug to the market. The paper asserts that as new technologies are adopted and advances in scientific understanding are leveraged, it results in shorter drug development timelines. This factum, the paper asserts should have a bearing to reduce the period of exclusivity granted to small molecule drugs and biologics. The paper discusses how both cost and efficiencies are improved from the use of technology, thus making the case for reducing the time period for protection of data exclusivity.
Keywords: Data Exclusivity, Pharmaceutical Exclusivity, Clinical Trials, AI, Access to Medication
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