Reconsidering the Rationale for the Duration of Data Exclusivity

13 Pages Posted: 5 Oct 2019 Last revised: 2 Jun 2020

See all articles by Jonathan Kimball

Jonathan Kimball

Association for Accessible Medicines

Srividhya Ragavan

Texas A&M University School of Law

Sofia Vegas

affiliation not provided to SSRN

Date Written: October 3, 2019

Abstract

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

Suggested Citation

Kimball, Jonathan and Ragavan, Srividhya and Vegas, Sofia, Reconsidering the Rationale for the Duration of Data Exclusivity (October 3, 2019). McGeorge Law Review, Forthcoming, Available at SSRN: https://ssrn.com/abstract=3463784 or http://dx.doi.org/10.2139/ssrn.3463784

Jonathan Kimball

Association for Accessible Medicines ( email )

United States

Srividhya Ragavan (Contact Author)

Texas A&M University School of Law ( email )

1515 Commerce Street
Fort Worth, TX 76102
United States

Sofia Vegas

affiliation not provided to SSRN

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