Investing in Ex Ante Regulation: Evidence from Pharmaceutical Patent Examination

49 Pages Posted: 28 Jul 2020 Last revised: 10 Nov 2022

See all articles by Michael Frakes

Michael Frakes

Duke University School of Law

Melissa F. Wasserman

The University of Texas at Austin - School of Law

Date Written: July 2020

Abstract

We explore how the Patent Office may improve the quality of issued patents on “secondary” drug features by giving examiners more time to review drug-patent applications. Our findings suggest that current time allocations are causing examiners to issue low quality secondary patents on the margin. To assess the merits of expanding ex ante scrutiny of drug-patent applications at the agency, we set forth estimates of the various gains and losses associated with giving examiners more time, including reduced downstream litigation costs and added personnel expenses, along with both the static gains and dynamic innovation losses associated with earlier generic entry.

Suggested Citation

Frakes, Michael and Wasserman, Melissa F., Investing in Ex Ante Regulation: Evidence from Pharmaceutical Patent Examination (July 2020). NBER Working Paper No. w27579, Duke Law School Public Law & Legal Theory Series No. 2022-01, Available at SSRN: https://ssrn.com/abstract=3661071

Michael Frakes (Contact Author)

Duke University School of Law ( email )

210 Science Drive
Box 90362
Durham, NC 27708
United States

Melissa F. Wasserman

The University of Texas at Austin - School of Law ( email )

727 East Dean Keeton St
Austin, TX 78705
United States

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