Patents, data exclusivity, and the development of new drugs

F Gaessler, S Wagner - Review of Economics and Statistics, 2022 - direct.mit.edu
Review of Economics and Statistics, 2022direct.mit.edu
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 …
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.
MIT Press
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