Patents, Data Exclusivity, and the Development of New Drugs

A-Tier
Journal: Review of Economics and Statistics
Year: 2022
Volume: 104
Issue: 3
Pages: 571-586

Score contribution per author:

2.011 = (α=2.01 / 2 authors) × 2.0x A-tier

α: calibrated so average coauthorship-adjusted count equals average raw count

Abstract

Pharmaceutical firms enjoy market exclusivity for new drugs from concurrent patent protection and exclusivity of the clinical trials data submitted for market approval. Patent invalidation during drug development renders data exclusivity the sole source of protection and shifts the period of market exclusivity. In instrumental variables regressions, we quantify the effect of a one-year reduction in expected market exclusivity on the likelihood of drug commercialization. The effect is largely driven by patent invalidations early in the drug development process and by the responses of large originators. We provide estimates of the responsiveness of R&D investments to market exclusivity expectations.

Technical Details

RePEc Handle
repec:tpr:restat:v:104:y:2022:i:3:p:571-586
Journal Field
General
Author Count
2
Added to Database
2026-01-25