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Article
Reconsidering the Rationale for the Duration of Data Exclusivity
University of the Pacific Law Review
  • Jonathan Kimball
  • Srividhya Ragavan, Texas A&M University School of Law
  • Sophia Vegas
Document Type
Article
Publication Date
5-2020
ISSN
1520-9245
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.

Num Pages
13
Publisher
University of the Pacific McGeorge School of Law
File Type
PDF
Citation Information
Jonathan Kimball, Srividhya Ragavan and Sophia Vegas. "Reconsidering the Rationale for the Duration of Data Exclusivity" University of the Pacific Law Review Vol. 51 Iss. 3 (2020) p. 525 - 537
Available at: http://works.bepress.com/srividhya_ragavan/311/