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投资于事前监管:来自药品专利审查的证据

Investing in Ex Ante Regulation: Evidence from Pharmaceutical Patent Examination
American Economic Journal: Economic Policy · 2023 · Michael Frakes、Melissa F. Wasserman

中文摘要

我们探讨专利局能否通过给予审查员更多时间审查药品专利申请,提高针对药品“次要”特征所授予专利的质量。我们的研究结果表明,当前的时间分配正导致审查员在边际上授予低质量的次要专利。为评估在该机构扩大对药品专利申请事前审查的利弊,我们估算了给予审查员更多时间所带来的各种收益与损失,包括下游诉讼成本的降低和人员开支的增加,以及仿制药更早进入市场所带来的静态收益和动态创新损失。

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.
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